SYSTEM AND METHODS OF CELLULITE TREATMENT

Abstract

Systems and methods for treating cellulite include an applied device or a method that involves breaking, stretching, reorienting, or tearing the septa to eliminate or reduce the appearance of cellulite. In one procedure, an expandable member is placed between the tissue layers to stretch or tear the septa that connect the tissue layers between which the fat deposits are contained.

Description

SYSTEM AND METHODS OF CELLULITE TREATMENT Field of Invention This disclosure relates generally to systems and methods for treating cellulite. This application claims the benefit and priority of U.S. Patent Applications Nos. 62 / 702,314 filed July 23, 2018; 62 / 736,016 filed September 25, 2018; and 62 / 798,515 filed January 30, 2019, the contents of which are incorporated herein by reference. Background of the Invention There is a continuing need for an effective and atraumatic procedure to treat cellulite, also known as gynoid lipodystrophy, nodular liposclerosis, edematous fibrosclerotic panniculopathy, panniculosis, edematous adiposis, deforming demopaniculosis, or state protrusus cutis. Furthermore, there is a need for proactive treatment modalities that prevent future or recurring cellulite and that are easy and effective to use. It has been reported that over 85% of women have cellulite, suggesting that cellulite is a physiological rather than a pathological condition. The presence of fat in the reticular dermis alone is not believed to cause cellulite. Cellulite can be described as the herniation of subcutaneous fat within the fibrous connective tissue, which manifests as dimpling in the skin. This fat load can cause stress on the connective tissue located between the fat lobules. This type of dimpling is more common in women than in men due to the orientation of the subcutaneous fibrous structures that define the chambers containing fat cells. In fact, it is this structure that is believed to cause the appearance of cellulite more than being overweight. Cellulite frequently appears in the pelvic region, including the buttocks, lower extremities, and abdomen. The subdermal fat layers beneath the epidermis are contained between the dermal layers and connected by septa, which act as connective tissue between the dermal layers. In men, the septa are arranged more randomly and densely in a more crisscrossed configuration, while in women, they are generally arranged more parallel to each other. Furthermore, men have a thicker dermis and more angled septa relative to the skin's surface, while women have a relatively thinner dermis that thins with age and septa that are perpendicular to the skin's surface. Additionally, women with cellulite have shown thickening of the septa in the affected areas, and the tension of the septa accentuates the cellulite. In women, fat storage in adipose tissue serves a biological purpose, as it is maximized to ensure adequate caloric availability for pregnancy and lactation. Increased fluid retention or proliferation of adipose tissue in these subdermal fat layers can also result in the appearance of cellulite, where the septa maintain a greater distance between the dermal layers, creating dimples, while the cavities between the septa become more prominent.Over time, the septa can stretch, then eventually contract and harden, thus holding the tissue layers at fixed distances, but the cavities between these septa can expand, increasing the appearance of cellulite. Several procedures have been adopted to treat or address cellulite. Early treatments involved attempts to increase circulation and fat oxidation in areas affected by cellulite. In these cases, substances such as hyaluronic acid and aminophylline were injected into the target areas to reduce cellulite. Other procedures involved electroporation of the target areas followed by mesotherapy or the application of dermatological creams or other cellulite supplements. These procedures could be complemented with massage, or massage was used alone to promote greater fat reabsorption or drainage of fluids and toxins in the treated areas. Ultrasound has also been proposed to alter subcutaneous tissues and fat and has been used in combination with liposuction.Low acoustic pressure combined with microbubble infiltration has also been used to reduce the appearance of cellulite, as has the use of other energy sources such as lasers and radiofrequency. Such procedures have been characterized by limited or unpredictable results. More recently, septum cutting with blades or needles in the subdermal region has been employed. However, this procedure has been found to be laborious and highly traumatic to the tissue, resulting in bleeding, bruising, hard tissue nodules, prolonged and painful recoveries, and inconsistent results. A procedure attempted in a less traumatic cellulite treatment is The procedure described in Altshuler et al. (US2011 / 0046523A1) aims to stretch rather than cut the septa. To minimize the stretching force required to eliminate the appearance of cellulite, the procedure involves heating the septa and the fascia tissue adjacent to the adipose tissue to a sufficient temperature for a sufficient time to achieve lasting septal lengthening. By increasing the temperature of the connective tissue being treated with a stretching force, the amount of force required to improve the length (i.e., lengthen) of the connective tissue is reduced. Altshuler et al. state that in this way, negative side effects in the treated area, such as tearing, bruising, and pain, can be reduced and / or avoided.It is also stated that a similar improvement in the appearance of cellulite can be achieved by exposing at least one of the fasciae and / or septa to a relatively cold temperature and a stretching force for a sufficient time to achieve lasting elongation of the septa and / or fascia. It is believed that both the elongation and the fracturing of the septa and / or fascia improve the appearance of cellulite. To perform the treatments described by Altshuler et al., it is necessary to take and maintain measurements and control of the temperature of the septa and fascia, as well as control the stretching force. Therefore, there is a need for atraumatic, effective, and efficient procedures to treat, minimize, or eliminate cellulite using simple systems. These procedures should be associated with predictable results and be relatively easy to use. This exhibition addresses these and other needs. Summary of the Invention Briefly and in general terms, this presentation addresses atraumatic cellulite treatment systems and methods that minimize tissue trauma and reduce or eliminate bleeding and bruising. The system includes a device that facilitates, and methods involving, the reorientation, tearing, and / or stretching of the septum(s) at the site of the cellulite. In one aspect, the treatment procedure involves a focal balloon contouring system. In one modality, a stabilizer is provided for cellulite treatment and is configured with a plurality of suction ports arranged to -4 Stabilize the tissue and include a proximal lower portion that defines the tissue-engaging structure arranged to facilitate the creation of a tissue insertion site. In a procedure, the application of downward pressure facilitates the creation of a tissue insertion site. In another configuration, a cellulite treatment stabilizer also includes, or alternatively includes, a plurality of channels to receive the cellulite treatment instrumentation. In one aspect, the channels are arranged to facilitate access to multiple tissue depths. In an additional modality, a stabilizer for cellulite treatment is configured to be arranged generally or approximately parallel, along a common plane or in a similar direction with a balloon on an axis configured to advance between tissue layers, the stabilizer including a structure configured to extend longitudinally along the outside of the skin and a lower proximal portion configured to create a tissue insertion site. In yet another modality, an elongated stabilizer is provided for the treatment of cellulite and is configured to be arranged parallel, along a common plane or similarly directed with a balloon on an axis configured to be placed between the tissue layers, with a lower surface of the stabilizer configured with a friction structure to engage and stabilize the tissue. In another modality, a cellulite treatment balloon is mounted on a rigid axis and is sized and shaped to advance between tissue layers. It is used in conjunction with a stabilizer positioned parallel to or similarly directed, which stabilizes the tissue during the balloon's advancement. In one procedure, the stabilizer is configured to be removed once the balloon is placed at a treatment site, prior to treatment. In one particular aspect, the fibrous septa connecting the superior and inferior fascial plateaus within the skin can be crossed with a dilator using one or more of a variety of tools, such as a needle, guide wire, expandable limbs, or balloon devices, to stretch, tear, or reorient the septum or septa. By doing so, the targeted subcutaneous connective tissue associated with the surface defect can be directly modified with minimal impact on surrounding blood vessels, the lymphatic system, and fat distribution, allowing for a more even distribution and enabling the skin to assume a more natural appearance. -5. A gentler, atraumatic approach. In one method, anesthetic is injected transcutaneously or subcutaneously into the treatment site, stabilizing and / or retraction force is applied to the target skin to create a stabilized surface, an introducer tube and / or wire is inserted subcutaneously through the treatment site, stabilizing and / or retraction force is released, and an expandable limb is placed subcutaneously into the treatment site and repeatedly expanded as needed. Remote imaging or ultrasonic or fluoroscopic energy may be used to observe the procedure. A change in size or an alternative configuration of the dilating or expandable limb and further expansion may be used to complete treatment of a particular area. Afterward, the treatment device is repositioned to treat additional areas.The treatment device can be configured to treat multiple areas simultaneously or sequentially without repositioning, or a localized treatment procedure can be adopted. Langer's lines can be used as a reference for direct treatment. Furthermore, several treatment pathways and expansion areas are directed through one or more entry points, and in certain applications, an orientable introducer is used to access the treatment areas. Additionally, anti-inflammatory medications, collagenase, deoxycholic acid, salicylic acid, glycolic acid, hyaluronic acid, or cellulite treatment medications can be applied separately at the intervention site or directly via an expandable dilator or other procedural instrument. In one particular modality, the system includes one or more generally elongated suction stabilizers configured, sized, and shaped to cooperatively provide and create a stable insertion site and controlled depth. It includes an access needle, an introducer tube and / or a guide wire, and an expandable member attached to an elongated member associated with each of the stabilizers or with a single stabilizer. The suction stabilizer includes multiple ports configured to apply suction to a patient's skin to create a stabilizing surface and includes one or more guide channels through which the instrumentation is configured for subcutaneous insertion at the treatment site. In another procedure, the guide channel can be adjusted and locked at various locations to establish the insertion location or depth in the skin. Furthermore, the stabilizer may MA / t / ZUZ I / U4 I004 -6. Employ other mechanical procedures to adhere to the tissue, such as adhesive or tightening or rolling structures. In various aspects of atraumatic treatment, the dilator is a balloon available in various sizes, numbers, and shapes; a balloon on a needle that defines a single assembly; a balloon with rigid members on its surface to enhance localized force; an expandable cage; a mechanically expandable dilator; dual balloons configured to expand tissue on opposite sides of the septum; a resorbable stent; resorbable filling material; the patient's own fat harvested from another location; permanent fillers or retractors; or, in a more traumatic modality, a structure that includes a rotating blade or frame. In other aspects of slightly more traumatic modalities, the expandable member may be replaced by, or further include, a cutting balloon or harmonic scalpel, a selective cauterization structure, or an energy-delivery structure for dissecting tissue and / or controlling bleeding. The cellulite treatment system also involves, in certain procedures, a bright light configured or emitted through a tip of the treatment device or placed along or at strategic locations along the device to illuminate intradermal structures at the intervention site. This allows for direct observation of the treatment device via transillumination through the skin, and the operator can easily access and perform the subcutaneous placement and application. In an additional modality, means are provided for anchoring a distal end or tip of the intervention device to provide a rail during device exchange and other movements along and within the intervention site for therapy delivery. Accordingly, one or more coils, magnets, hooks, or other structures are configured to stabilize the instrumentation. In addition, objective measuring devices are included in the treatment system to evaluate therapy results. In one procedure, laser light energy, such as bright light or laser light, is emitted and received by the measuring device, and the surfaces of the treated areas are scanned. The measuring device creates a complete three-dimensional map of all the cellulite in relation to normal skin. By comparing the improvement in the volume of the lumps with idealized normal surfaces, the operator can calculate the - 7 benefits of total and local volume therapy and track improvement over time. Furthermore, the dilating procedure for creating subcutaneous space has applications in treating other conditions or diseases. For example, the dilators described are used for body sculpting, wrinkle reduction, acne scar treatment, and / or skin lifting and repositioning. Foam fillers or separators of varying lengths and other structures, such as subcutaneous sutures that are either absorbable or permanent, are used to achieve these objectives. These and other features of the exposure will become evident to those skilled in the art upon reading the details of the systems and methods described in more detail below. Brief Description of the Figures of the Invention Figures 1A to 1H are various views, depicting a stabilizer configured to facilitate the creation of an entry site in the skin. Figures 11 to 1K are enlarged views depicting the structure of the cavities formed in a stabilizer. Figures 1L to 1P are various views, representing details of an alternative modality of a stabilizer. Figure 1Q is a partial cross-sectional view, showing a stabilizer with a detachable suction matrix. Figure IR is a partial cross-sectional side view, showing a reinforcement to facilitate treatment location. Figure 1S is a partial cross-sectional side view, showing a dilator cover. Figures 2A and 2B are perspective views depicting cellulite on a subject's skin and a plan for treating cellulite. Figure 2C is a perspective view depicting the treatment along the length and breadth of Langer's lines. Figures 3A to 3L are cross-sectional views depicting various aspects of a cellulite treatment procedure. Figures 4A to 4C are longitudinal views depicting the connective tissue before and after treatment. Figure 4D is a perspective view, depicting the rupture and the -8 stretching of the septa. Figure 4E is a side view, showing the filling spaces created by expansion. Figures 4F to 4J are remote images depicting the expansion of a dilator at an intervention site. Figures 4K to 4M are side views, depicting the treatment of a plurality of dimples with a single dilator. Figures 5A to 50 are side and cross-sectional views, depicting procedures for anchoring the proximal and distal portions of the interventional instrumentation. Figures 6A to 6U are side, cross-sectional, and perspective views depicting various procedures for expandable dilators. Figures 7A to 7J are perspective views, representing another modality of a cellulite treatment system. Figures 8A to 8K are perspective views representing components of a localized treatment system. Figures 8L to 80 are cross-sectional views depicting a treatment involving a loop. Figures 9A and 9B are cross-sectional views depicting an atherectomy device and its use. Figure 10A is a schematic representation showing the functionality of a pump-assisted installation. Figure 10B is a partial cross-sectional view, showing a fast pump-assisted installation. Figure 10C is an enlarged perspective view, showing the internal structure of the rapid pump-assisted installation of Figure 10A. Figure 10D is a side view, depicting the fast pump-assisted installation of Figure 10A. Figures 11A to 11D are partial cross-sectional views, representing another treatment procedure. Detailed Description of the Invention Before describing the present systems and methods, it should be understood that this description is not limited to the particular modalities described, as these may, of course, vary. It should also be understood that the terminology -9 used herein is intended to describe particular modalities only, and is not intended to be limiting, since the scope of this exposition will be limited only by the attached claims. When a range of values ​​is provided, it is understood that every intermediate value, down to the tenth of a unit of the lower limit, unless the context clearly indicates otherwise, between the upper and lower limits of that range is also specifically described. Every smaller range between any stated or intermediate value within a stated range and any other stated or intermediate value within that stated range is included within the description. The upper and lower limits of these smaller ranges may be independently included or excluded from the range, and every range where neither or both limits are included within the smaller ranges is included in the description, subject to any limits specifically excluded within the stated range. When the stated range includes one or both limits, ranges that exclude one or both of the included limits are also included in the description. Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by a person skilled in the art to which this description pertains. Although any method and material similar to or equivalent to those described herein may be used in the practice or testing of this exposition, the preferred methods and materials are described herein. It should be noted that, as used herein and in the appended claims, the singular forms a, one, and the include plural referents unless the context clearly indicates otherwise. Thus, for example, the reference to the system includes the reference to one or more systems and equivalents thereof known to those skilled in the art, and so forth. With reference to Figures 1A to 1E, several views of a procedure for a stabilizing assembly 100 for a focal balloon contouring system are shown. In addition to the stabilizing assembly, as described below, the focal balloon contouring system includes one or more suction tubes, a trocar needle, a guide wire, an introducer, an inflation device, and a balloon catheter or dilator. The stabilizing assembly includes first stabilizing bodies 102 and second stabilizing bodies 104 that define elongated structures 106 extending from a loop portion 108. The stabilizing bodies 102, - 10 104 are arranged in parallel and joined at two points by screws 110. In addition, spacers 112 are provided to maintain the parallel positioning of the stabilizing bodies 102, 104. Formed at a terminal end 114 of each elongated portion 106 is an opening 116 in communication with an elongated chamber 118 that extends within the elongated portion 106. As best seen in Figure ID, the chamber 118 includes a plurality of downward-directed lateral openings 120 that expand to define generally conical or cup-shaped cavities 122 directed towards the lower surface 124 of the elongated portion 106. The lower surface has a dimension that varies from approximately 5 cm to 24 cm, preferably 10 cm.A suction force is applied through the terminal opening 116 and the cavities 122 to provide a stabilizing and / or retraction force that can be applied to one side of the treatment, creating a stable platform for inserting an interventional device into the tissue. In one procedure, the suction force is provided by a suction or vacuum pump. In an alternative procedure, suction and vacuum are provided by a syringe or, alternatively, by a cam-based structure involving pulling a lever, such as in a cam-based suction cup. In use, the 130 stabilizer adheres to the skin to create a stable intervention plane at a fixed distance below the skin level for inserting interventional devices into the tissue. The skin-adhering stabilizer supports the skin and creates a counterforce as the skin is punctured and treatment tools are advanced subcutaneously to the desired location. In certain modalities, the stabilizing and / or retraction force can be used to lift or position tissue to create a stable insertion site without pulling the tissue into a cavity or hollow. In alternative procedures, the system may include a single stabilizing body or a guide structure between the two stabilizing bodies for instrument insertion.Additionally, a patch or film can first be applied to flatten the skin before using the stabilizer, the patch or film providing a surface against which more uniform and consistent suction can be applied. In one or more modalities, the stabilizing assembly is used to guide the initial device or guide wire to the site and then withdraw it, allowing the impact of the therapy to be observed directly in real time at the skin level without distortion from suction, and utilizes a pathway along the - 11. A single device or a sequence of devices can be used to treat one or more injury areas. Furthermore, the stabilizing assembly does not create large suction areas where blood can accumulate, leading to large hematomas or tissue damage. It also facilitates access to multiple areas of skin over a wide range of areas through a reduced number of entry points, perhaps even a single entry.In addition, several other structures can be used to adhere to the tissue to create a stable insertion site, such as adhesive or double-sided adhesive strips attached to the tissue that hook onto the lower portion of the stabilizer, or clamping or rolling structures configured to hold the tissue. In one particular procedure, as shown in Figure 1F, a stabilizer may include rollers 127 configured to grip and retain the structure for the purpose of stabilizing a surgical site. Furthermore, adhesive 129 (Figure IG) is applied to the lower surface 124 of the elongated portion 106, and when placed in contact with the tissue, the adhesive 129 bonds to the tissue, thus providing the force required to hold the tissue. Such procedures can be used in addition to, or instead of, the use of suction force.In yet another procedure (see Figure 1H), the stabilizer 100 is simply placed against the fabric and pressure is applied instead of using suction as a stabilizing component. To aid in the coupling between the stabilizer 100 and the fabric, the underside of the stabilizer 100 can be knurled or have a rough texture. Alternatively, a sticky mat material can be configured along at least a portion or all of the underside of the stabilizer. Furthermore, the structure associated with providing suction can be omitted from the stabilizer, thus simplifying its design. The loop portion 108 includes an upper portion 126 and a lower portion 128. The upper loop portion 126 (not shown in Figure 1H) is sized and configured for hand gripping during device manipulation. The lower loop portion 128 includes a series of channels 130 that are parallel and vertically separated. These channels 130 are sized and shaped to slide into and receive interventional treatment instrumentation. An optimal interventional treatment site has been observed to be in the range of 6 to 10 mm below the skin surface. Therefore, the channels 130 are arranged to introduce the instrumentation. - 12 instrumentation between tissue layers within that range. In an alternative procedure (Figure 11), instead of having multiple parallel channels 130, the lower loop portion 128 is equipped with a single channel or a plurality of channels that can be changed and locked in the desired positions. Likewise, the number of channels can be reduced or include only one channel, and / or the channel or channels can be enlarged to accommodate a dilator assembly. Therefore, the stabilizer can remain in place while a dilator and / or balloon catheter is advanced to and from a surgical site. Furthermore, the channels can include threads, and the external portions of the various devices intended to advance through the channels can include the corresponding threaded structure to provide more controlled advancement and withdrawal of the components through the channels.Therefore, it should also be recognized that the structure of the stabilization device itself, such as the lower portion 128 of loop 108, can be used to create an indentation in the skin and a pathway to create an insertion site by inserting tools through the channels 130 formed in loop 108. Furthermore, in one or more configurations, as best seen in the enlarged views of Figures 1J and 1K, the suction regions of the stabilizer 100 include a plurality of cavities 122, each comprising a rim 131 and a central orifice 120 configured within a relatively deep cup 135 defined within the cavity 122. This structure is arranged and configured to facilitate the application of a suction force to the target tissue, such as the skin surface. In use, the rim 131 of the cavities 122 is placed against the target tissue, and suction force is applied. The cavities 122 provide a conduit or pathway through which the suction force is delivered to the target tissue, thereby providing tissue stabilization. Returning to Figures 1L to 1P, yet another modality of a stabilizer 100 is shown. As with the stabilizers presented above, this modality is designed to stabilize the skin during the introduction of cellulite intervention devices between tissue layers. As before, to achieve this, the stabilizer is connected to a controllable suction device (not shown) found in a standard office or procedure room. Once the connection is made, a vacuum is supplied to the cavities configured along the elongated portion 106. Once the vacuum is achieved, - 13 Intervention devices are introduced through guide channels 130 placed in the lower handle portion 128. In the present procedure, the stabilizer 100 includes an arm 137 that is configured to rotate between open, partially open, and closed positions relative to the lower handle portion 128. When closed, a needle is inserted into the guide channel slots in each arm for the cylindrical channel 130. In certain procedures, the needle is omitted, and the tip of the dilator is made sharp enough to pierce the skin and, with sufficient guidance, is delivered to a target site. The arm 137 can be rotated within the lower handle 128 so that the user can press the upper lever 136 against the stabilizer to release the cylindrical channel 130 from around the needle and allow the needle to be withdrawn while leaving the needle in place. The arm 137 can be slid out of the stabilizer 100 for disassembly.As best seen in Figures 10 and 1P, the magnet 139 is positioned on one or both of the arm 137 and the lower handle portion 128, with the magnet 139 configured to maintain a loose coupling between the arm 137 and the lower handle 128. Furthermore, disassembly of the arm 137 from the lower portion 128 facilitates cleaning and sterilization of these parts. In one procedure, the magnets are formed from samarium-cobalt and held in place and encapsulated with a medical-grade epoxy. Additionally, the arm 137 and the remaining stabilizer parts are created from stainless steel (grade 316). The stabilizer 100 is designed to be steam sterilized in an autoclave according to standard autoclave procedures before each use. As mentioned, the subdermal fat layers beneath the epidermis are contained between the dermal layers, connected by septa that act as connective tissue between them. Women with cellulite have shown thickening of these septa in the affected areas, and tightening of the septa accentuates the cellulite. In women, fat storage in adipose tissue serves a biological purpose, maximizing it to ensure adequate caloric availability for pregnancy and lactation. These septa can eventually contract and harden to retain tissue layers at fixed distances, leaving pockets between the expanded septa that contribute to the appearance of cellulite. It is these septa that must be stretched, reoriented, or torn to minimize or eliminate the appearance of cellulite. As shown in Figure 1Q, the stabilizer 100 may include a - 14 Removable suction matrix 141. In this way, the stabilizer's suction component can be removed when suction is not required and reattached when suction is needed. Various procedures can be used for the removable connections, such as press-fit or snap-fit. Instead of a suction matrix being removed or incorporated into separate instrumentation, a frame 147 may be provided to give a visual cue as to the location of a dilator or balloon 149 of a treatment device (see Figure IR). That is, the frame may include markings, or its length may be used to indicate the location or range of locations where a balloon 149 resides when it is placed in the lower loop 128 and advanced between tissue layers and out of the user's direct view. The frame 147 may be removed and replaced as desired by the operator to aid in the treatment process. As shown in Figure 1S, a cover 151 (e.g., PTFE material) can be configured around a dilator assembly both for protection during shipping and to hold the balloon 153 tightly around the support shaft 155 for insertion to the desired depth in the skin. Once the device is inserted, the cover is no longer required, and the cover 151 is configured to release the balloon 153 and stop at an insertion site. In one aspect, the cover may include a structure that facilitates its coupling with the corresponding structure of a stabilizer. After completing a treatment, the balloon 153 is withdrawn into the cover 151 to prepare it for reinsertion at a new location. Returning to Figure 2A, a person is shown with cellulite 200 around their thighs and buttocks. In a treatment procedure, the characteristic dimples of cellulite 200 to be treated are identified or circled with markings 204, preferably while the patient is standing. An instrument insertion site 210 is then selected, and pathways 212 for treating the cellulite in the most effective and atraumatic manner are selected and determined. Preferably, an instrument insertion site is selected that is located in a crease or fold, such as where the buttocks meet the thigh or in the crease between the two buttocks in a location that is not visible when the buttocks are in contact. - 15 natural treatments to improve aesthetics after the procedure's healing period. These treatment pathways are selected by the operator, preferably using a straight edge that bends or contours to the patient, or they can be generated automatically using a computerized controller programmed to more efficiently target and measure cellulite residing in a predefined treatment site. The computerized controller can be associated with a scanner that identifies dimples and specific areas for treatment, such as when employing laser technology.In this regard, the computerized controller includes a specific program for cellulite treatment and is used in conjunction with an electronic and mechanical device. It comprises a computer-readable, non-transient storage medium and an embedded computer program mechanism for both identifying treatment areas and graphically representing primary and alternative treatment procedures. Once a treatment regimen is developed, the system is used to minimize or eliminate cellulite in a target area. Furthermore, the measuring device creates a complete three-dimensional map of all cellulite in relation to normal skin. By comparing the volume improvement of the dimples or lumps with idealized normal surfaces, the operator calculates the total and local volume benefits of the therapy and tracks the improvement over time. In one specific procedure, as shown in Figure 2C, the cellulite treatment follows or references the Langer lines 214 present in the tissue. The Langer lines 214 correspond to natural orientations of tissue fibers in humans and are generally recognized as parallel to the orientation of muscle fibers. The Langer lines 214 can be used as a reference for treating cellulite. In particular, cellulite appears to be related to and distributed along the locations of the Langer lines. In one procedure, multiple treatment targets are addressed along the Langer lines from a single entry point 216, with the Langer lines 214 providing a map along which the treatment is achieved.Therefore, treatment can be directed along Langer lines 214, as shown on the thigh for illustrative purposes, to treat the target septa. Alternatively, treatment can be directed transversely to Langer lines 214, as shown on the buttock for illustrative purposes, to treat the target septa. - 16 can also be directed at various positions around the connective tissues or septa. That is, the septa can be stretched, torn, or altered from various sides or angles. Therefore, the septa can be treated from above, below, or from the side to achieve the best results. For example, in a particular situation, treatment may be more effective from above a particular connective tissue to take advantage of gravity, where the treatment forces placed on the connective tissue coincide with the direction of gravity or the direction in which gravity most frequently acts on a standing body, since cellulite is often more visible in a standing person. With reference now to Figures 3A to 3K, several aspects of a modality of the present invention for treating cellulite expressed as dimples 210 on the skin surface are shown, involving a focal balloon contouring system (Figure 3A). While following a treatment regimen and aligning the channels 130 of a lower loop portion 128 of one or more stabilizing bodies 102, 104 with an identified insertion site 210, suction is applied within the treatment system 100, such as by employing any of the conventional suction means, such as through a tube 302. As suction force, or alternatively other adhesion force or pressure, is applied to the skin 304 of a subject undergoing a cellulite treatment procedure, the skin 304 is applied in coupling with the lower side or lower portion 124 of the stabilizer 102, 104 and against the cup-shaped cavities 122 (Figure 3B).When held in this configuration, a stable platform or base is provided for creating subcutaneous access through insertion site 210 (Figure 3C). The particular channel 130 selected for inserting interventional instruments is chosen based on the subject's anatomy with regard to the septa 350 (only one is shown for simplicity) that connect the tissue layers 360, 362, defining the chambers that retain fatty or other tissues. While anesthesia and / or sedation take effect, ultrasound can be used to assess the subcutaneous trajectory and depth of the various connective tissue bands responsible for surface irregularity. Ultrasound assessment can assist in selecting the particular channel for the desired depth. Ultrasound assessment can also help in strategically positioning the dilator. ML / I / U4 I004 - 17 connection point between the connective tissue and the dermis or fascia. After determining the subcutaneous depth to which the septum is to be accessed for stretching, tearing, reorienting (e.g., crisscrossing), or breaking 350, a catheter or hypotube 370 containing a trocar-tipped obturator or needle 380 or another tool such as a dilator with a sharp tip is inserted through the desired channel 130 formed in the lower loop portion 128 of the stabilizer 102, 104 (Figure 3C). When a dilator with a sharp tip is used to create access to the target tissue, the guidewire can also be omitted, thus allowing the dilator to create the desired pathway both into the tissue and between the target tissue layers. Furthermore, the dilator itself can also be omitted, and the treatment can therefore be performed using a balloon catheter having a sharp tip and a proximally tapered shape designed to create a pathway within the tissue.As indicated, the depth to which these tools are inserted is expected to be between approximately 6 and approximately 10 mm below the skin surface 304, but it is anticipated that shallower and deeper depths may also be optimal for a particular subject. In any case, the selected depth is chosen to stretch, break, tear, or reorient the subject's septa 350. Furthermore, in one modality, it should be appreciated that the catheter or hypotube 370 is formed from a substantially rigid material such that a consistent plane below the skin surface is accessed. The lower loop portion 128 of the stabilizer 102 presses against the thigh or buttocks to create a depression behind the tool, resulting in a vertical portion of skin in the notch between the lower loop portion 128 and the lower surface 124 of the elongated portion 106. Alternatively, the lower loop portion 128 can be positioned along the side of the thigh or buttock that naturally forms a substantially vertical wall relative to another thigh or buttock surface. The vertical portion created by the depression or the naturally formed portion allows for the selection of the desired channel 130 corresponding to the desired treatment depth. Once the hypotube 370 and needle 380 are advanced to a desired location and between the skin and fascia, the needle 380 (Figure 3D) is withdrawn from the intervention site. A guide wire is then placed through the hypotube (Figure 3E), and the hypotube is removed from the site, followed by the stabilizer (Figure 3F). As can be seen in Figure 3F, removal of the stabilizer results in MA / I / U4 I004 - 18. This results in the reappearance of dimple 201, while the guide wire 400 remains between the tissue layers. The guide wire can assume a trajectory that mimics dimple 201 subcutaneously (not shown). A guide wire 400 inserted through the introducer assembly 390 is positioned so that it extends beyond a distal end of the introducer assembly and through the target septum. As will be described later, a distal end of the guide wire 400 may include a structure that facilitates anchoring the guide wire 400 in place. The guide wire 400 thus provides a pathway along a desired and predetermined depth within the tissue and between the skin and fascia. With the guide wire in place, an introducer assembly 390 is introduced over the guide wire (Figure 3G).It is observed that stabilization, retraction, or compression forces are no longer required since the desired tissue plane has been accessed, and the guide wire facilitates subsequent instruments remaining along the pre-marked treatment path. The 390 introducer assembly can be used in the present treatment pathway as well as in subsequent treatment pathways performed from the same insertion site 210. Preferably, the introducer has an outside diameter of 18 French, more preferably 16 French or less, such that the insertion site does not require a stitch or sutures for closure and can be closed with an adhesive or adhesive bandage. The 390 introducer includes a lumen that is sized and shaped to accept interventional instrumentation and, in certain modalities, includes a structure that seals the access site to prevent body fluids from flowing outside the subject's body. In addition, as indicated above, several procedures are contemplated for creating stabilizing and / or retraction forces and / or insertion sites in the tissue, including the use of friction or adhesion to the tissue and holding said tissue against lateral movement, applying squeezing or rolling forces and / or lifting tissue, or applying a downward force on the tissue, such as with an inclined surface or a wedge, to create space for instrument insertion without using suction, friction, or adhesion. With the guide wire 400 in place, in one modality, the fixed dilator within the introducer assembly is withdrawn, and then an expandable dilator 410 attached to an elongated member 412 is advanced through the lumen of the introducer 390 and along the guide wire 400 and into the septum or septa to stretch, tear, or reorient them (Figure 3H). In another modality, the assembly is withdrawn MA / E / ZuZu / U4 I004 - 19 introducer 390 and then an expandable member attached to an elongated member is advanced along the guide wire 400. Palpation, direct visualization (e.g., transillumination or endoscopic) or non-invasive visualization (e.g., ultrasound or fluoroscopic) or other means are used to determine the position of the expandable dilator 410, such as markings along the length of the instruments or simply knowing the length of the dilator 410 and its path within the tissue, or providing the interventional instrumentation with radiopaque markers, placing the expandable dilator 410 at a site below where cellulitis (e.g., a dimple 201) is observed in the subject's skin. Once positioned, the dilator expands to stretch, break, reorient, or tear the septum 350 connecting the tissue layers (Figure 31).The expansion of the dilator results in selective rupture or tearing (Figure 3J) or stretching (Figure 3K) of the target septum, and the elimination or minimization of dimpling and cellulite expression on the skin. To facilitate this treatment and allow the use of a smaller dilator, the skin is actively pushed closer to the dilator as it expands. The use of a smaller dilator aids in deployment and re-coating, as the smaller structures are more easily deployed and withdrawn. Re-coating is also facilitated after deployment, where the dilator is partially retained within the introducer, which is left in place rather than being completely removed from the treatment site.

[0073] In one embodiment, the dilator is a non-adaptable balloon with a diameter of 14 millimeters and a length of 40 millimeters. An advantage of the present invention is that sufficient force (e.g., inflating the balloon to between approximately 1 atmosphere and approximately 4 atmospheres) is applied focally to a septum or septa quickly and easily to tear, redirect, or stretch the septum or septa with minimal or no trauma to other tissues. Preferably, the dilator has a diameter between approximately 10 millimeters and approximately 30 millimeters, more preferably between approximately 12 millimeters and approximately 20 millimeters. Preferably, the dilator has a length between approximately 14 millimeters and approximately 60 millimeters, more preferably between approximately 20 millimeters and approximately 50 millimeters.In another form, the dilator is a semi-adaptable balloon that is relatively better at re-folding and re-covering. A dilator may also include a reduced taper. -20 so that the assembly has a better working length-to-tapering ratio and therefore less material overall to bend. In yet another embodiment, the dilator is a non-adaptable balloon covered by an elastic sleeve that helps the non-adaptable balloon return to a low-profile shape upon deflation. After sufficiently treating said septum 350, the dilator 410 is deflated and retracted along the guide wire 400 to treat other septa residing beneath depressions formed in the skin according to the predetermined treatment pathway. The procedure is repeated along additional pathways according to the treatment regimen. The insertion site 210 is reused repeatedly for subsequent treatments. Various treatment procedures include over-wire, quick-exchange, fixed-wire, and stylet procedures.In another procedure, the 410 dilator remains inflated, and the user gradually pulls or drags the inflated dilator backward along a portion or the entire length of the treatment pathway. This allows a dilator to be deployed in the most distal position and dragged proximally to deform the tissue and break or realign septa, thus requiring fewer deployments to treat a target area. In a related procedure, as shown in Figure 3L, the treatment device includes two or more 410 dilators arranged in a line or parallel (not shown) that expand independently to break or stretch the septa. In this way, a larger area can be treated without having to reposition the 410 dilator. Returning to Figures 4A to 4J, the effect of dilation on the septa 350 connecting the tissue layers can be seen. As shown in Figure 4A, before treatment, sections of the septa 350 form an uninterrupted wall of connective tissue between the tissue layers 450. After treatment (Figure 4B), the septa 350 are stretched and / or torn, thus releasing the connection between the tissue layers associated with these septa 350. In this respect, dilation achieves the selective tearing, stretching, rupture, or reorientation of the septa that had previously maintained a fixed distance between the tissue layers, resulting in the elimination and / or substantial reduction of depressions on the skin surface.In particular, as shown in Figure 4C, the reorientation or cross-linking of small fiber networks 350 results from dilation in such a way that some of the fibers will stick together or have friction between them. MA / / U4 I004 - 21 of them so that they do not return to their previous configuration or pre-dilation where they had a more generally perpendicular orientation with respect to the skin surface. Dilation according to the present exposition works to selectively break down septa that have become rigid and / or have shrunk in size or due to other physiological factors to accommodate the separation of tissue layers in some cases of fat accumulation between layers. In addition, the procedures described for dilation selectively target, break down, reorient, stretch, and / or tear septa that have thickened or are characterized by high tension in order to treat, minimize, or eliminate the appearance of cellulite.The location, expansion, and performance of the expandable limb along the treatment pathways can be identified by: palpation; transillumination incorporated in the tool or guide wire or at the end of an illuminated obturator; ultrasound imaging; or visualization through the skin; fluoroscopically; or magnetically. As also shown in Figures 4B and 4C, a subcutaneous space is created between the tissue layers and can be used for the introduction of retractors, medications, or resorbable materials. As shown in Figure 4D, when expanded, the dilator 410 ruptures and stretches the less dense septa 350, helping to maintain tissue elevation and creating a fragment of a subcutaneous passage. Additionally, a foam piece configured to fill this space, such as a foam piece, is delivered in a compressed configuration within a sheath in an over-wire procedure to the intervention site. A similar procedure can be employed to deliver other filling material, such as fat 351 (see Figure 4E). In this latter respect, a fat collector or mixer may be part of the present system.The fat collector or mixer is configured to extract fat from nearby tissue and redistribute that material in the vacuum created by expansion. Returning to Figures 4F to 4J, several images are shown illustrating the expansion of a 410 expandable dilator at a surgical site. As the 410 expandable dilator expands, it encounters varying resistance from the septa along its length. Consequently, the 410 dilator is configured to exhibit sufficient expansion force to achieve selective septal treatment. With reference to Figure 4F, the 410 expandable dilator may encounter greater septal resistance at two - 22 locations creating girdles 452 along its length. With the application of further controlled expansion of the expandable dilator (Figure 4G), the girdles are reabsorbed. As shown in Figures 4H to 4J, deep girdles can also initially be created in the expandable dilator 410, and these can be reabsorbed by multiple increases in the expansion forces provided by the expandable dilator. Figure 41 shows partially reabsorbed girdles 452, and Figure 4J shows a fully expanded expandable dilator 410. Such girdle creation and reabsorption can be observed using conventional remote imaging techniques (ultrasound, fluoroscopy, or magnetic resonance imaging), physically through palpation, or by transillumination incorporated in the tool, guide wire, or end of an illuminated obturator.Once it is determined that the expandable dilator has fully expanded, the operator can assess whether the targeted cellulite has been treated as desired. If further expansion is required, a larger, different-sized, or differently shaped expandable dilator is used at the treatment site. Furthermore, as shown in Figures 4K to 4M, it should be appreciated that one or more septa 350 can be penetrated with a dilator 410. Once positioned as desired, the dilator expands to stretch and / or break the septa 350. In this way, a plurality of dimples formed on the skin surface can be treated with a single dilator 410. As indicated, after completing treatment of one target area, the procedure is repeated to treat other target areas. Therefore, using the same introducer assembly 390, the combination of stabilizer 102, 104, hypotube 370, and needle 380 can be used to access tissue layers beneath other existing sites or depressions in the skin, and an expandable dilator 410 can be advanced over the guide wire 400 to such sites. It should be recognized that the system may further include a structure that allows the assembly to be oriented to subcutaneous treatment sites. In such a configuration, the hypotube 370 and needle 380 would be configured to define the longitudinally flexible material, and the instrumentation would be directed to the desired position within the tissue. Furthermore, in certain applications, the hypotube 370 has a stiffness that varies along its length.In another modality, a steerable or deviatable catheter or tube is used after the needle has been removed. -23As noted, anchoring portions of cellulite interventional instrumentation can enhance the effectiveness of a procedure. Furthermore, the guidewire tip may incorporate flat ribbon constructions, tapered internal shafts, or tips configured to be atraumatic or blunt structures when positioned or deployed, as the tip is not required for navigating tortuous pathways. Several procedures can be used to stabilize or anchor a proximal portion of a guidewire 400. For example, as shown in Figures 5A and 5B, a proximal guidewire anchor assembly 502 includes a base 504, a lower side 506 that includes adhesive for bonding to the skin of a subject undergoing a cellulite procedure. An upper side of the assembly includes a pair of spring-loaded or lockable, sliding protrusions 508 that are positioned to engage freely with a proximal end of the guidewire 400. In other procedures, the guidewire 400 includes structures configured on or attachable to a distal portion thereof. As shown in Figure 5C, the terminal end 600 of a guidewire 400 is located within, or may be curved and advanced outward from, the skin of a subject undergoing the interventional procedure, or it may be a straight limb emerging from a natural or formed curve in the subject's body, and the terminal end 600 is held in place with a clamp 602 or similar tool. When curved, the guidewire 400 can advance and retract from and within a sheath 603. The terminal end 600 of the guidewire 400 can also be straight and advanced through raised and / or curved skin as shown in Figure 5D. Once this straight terminal end 600 emerges from the tissue, a clamp may be used to hold the device in place. In another procedure (Figure 5E), the terminal end 600 of a guide wire 400 is fitted with a pair of curved portions 610 that act to anchor the guide wire 400 against both proximal and distal movement. The curved portions 610 can be ejected and retracted by sliding a sleeve 612 over the guide wire 400. In a similar procedure (Figures 5F and G), the distal portion of the guide wire 400 can be provided with a V-hook 620 and an atraumatic terminal end that is ejectable and retractable through a lateral hole 622 formed in a sleeve 624 that can be advanced over the guide wire 400. In still other procedures for distal anchoring of the guide wire 400, the terminal end 600 is fitted with an expandable balloon 624 (Figure 5H) or cage 626 - 24 (Figure 51) which acts to couple the surrounding tissue and anchor the guide wire 400 in place. Expansion, stabilization, and retraction of this structure can be achieved by relative movement of the guide wire and the terminal structure, or a sheath can be provided to deploy and capture the expanding structure. In addition, the terminal end 600 of the guide wire 400 can be magnetized and held in place using a magnet 630 held outside the skin to achieve anchorage (See Figures 5J to 5K). Here, the north / south poles of the magnet can be placed against the skin, or the magnet can incorporate a button (Figure 5K) that magnetizes the magnet so that the north or south pole is placed against the skin and the opposite pole is oriented away from the skin.In addition, several other configurations can be used for the terminal end 600 of the guide wire 400 for anchoring, such as a semicircle 640 or an L-shaped bar 642 configured at the terminal end 600 (Figures 5L and 5M). Again, a sleeve can be provided for folding and unfolding such a terminal structure. In still other procedures for stabilizing the distal end of a guidewire, the guidewire 400 can be slid into a sheath 612 and terminate with a longitudinally extending coil 650 (Figure 5N). In another configuration, the terminal portion of the guidewire 400 ends with a pair of laterally extending curved portions 660, configured proximally from a wavy longitudinal structure that terminates with a curved portion 662 (Figure 50). Each of these procedures also provides resistance against both proximal and distal movement of the guidewire once it is ejected from the sheath 612. Advancing the sheath 612 folds the lateral or longitudinal structure so that the sheath 612 and guidewire 400 can be withdrawn or repositioned within a surgical site. Several expandable dilator procedures and modalities are also part of the 100 system, and the system may incorporate a kit that includes various sizes of system components, including different expandable dilators. In one modality, the expandable dilator may be an expandable balloon, a stent, an expandable cage, or another structure, or it may incorporate an expandable dilator that includes a plurality of telescopic members that define sequentially stacked and advanced dilators with progressively larger diameters that perform the dilation function. Furthermore, in one or more modalities, the dilator is guided by a guide wire and includes jaws. -25 configured to mechanically open and dissect and / or separate and dilate tissue. To treat a large area, a series of two or more expandable dilators are deployed in parallel simultaneously. In addition, in slightly more traumatic and ancillary modalities, the dilator may be replaced by, or additionally include or cooperate with, a cutting balloon, a retractable deployable cutter, a harmonic scalpel, a selective cauterization structure, or an energy transmission structure to dissect tissue and / or control bleeding. Furthermore, in a separate modality employing traumatic aspects of the intervention, an atherectomy-style cutter configured to extract tissue through an opening on the side of the instrument, possibly also by suctioning tissue, may be used in certain ancillary procedures. In addition, certain modalities include a compression tool that reproducibly applies lateral forces to the skin to accentuate the dimple or expression of cellulite, allowing for a before-and-after effect to be observed without the patient having to stand or remove the intervention tools. The compression tool is a clamp with elongated legs on opposite sides or includes four prongs that pull radially inward once deployed on the skin surface and activated over the targeted cellulite area. The elongated member attached to a balloon dilator serves as a mechanism to expand and / or contract the expandable dilator by supplying or removing air or another fluid (such as saline solution) through the elongated member. It should also be understood that various configurations, materials, lengths, and sizes of balloon(s) can be expandable dilators, and such balloons may include rigid members on their surface to enhance localized force. Furthermore, the balloon catheter can be relatively short and rigid, thus eliminating the need for a guidewire during the treatment procedure. Expandable dilators can be made of semi-adaptable or non-adaptable materials and can assume a generally cylindrical structure or a variety of other shapes. In one instance, the expandable dilator is made of nylon.As such, balloon dilators can assume an unexpanded, folded, or coiled configuration and then expand to their desired dilated configuration. Furthermore, expandable dilators can be symmetrical or asymmetrical around the elongated member in axial or rotational directions. MA / / U4 I004 -26 in each modality. Furthermore, the balloon can elute / absorb medication or be coated with medication or other materials for cellulite treatment, such as anti-inflammatories, collagenase, deoxycholic acid, salicylic acid, glycolic acid, hyaluronic acid, or cellulite treatment medications. Additionally, other instruments can be used to inject these materials, hydrogel, or other biodegradable solutions into the treatment pathway or site. In this way, cellulite can be treated completely physically and chemically or medically, and depending on the anatomy being treated, a particular dilator or series of dilators can be selected for use. Furthermore, a gel is formulated to achieve the desired stretching or rupture of the tissue and remain in place long enough to generate the desired plastic deformation or rupture, dissolving shortly thereafter. Such a gel can be applied with a syringe. With reference now specifically to Figures 6A to 6L, several procedures for expanding dilators are presented. It is recognized that there is a ratio of balloon size, depth of application to the skin, and adjacency to the central target region of the dimpled area that results in the optimal mechanical advantage for producing the best effect. The clinician or operator will select the balloon size, depth of administration, and target location. In some circumstances, they may use additional sizes, select an alternative depth, or a different target location. In one or more procedures, a depth of 10 mm and / or 10 mm adjacent to the lesion in the direction of the major subcutaneous attachments, and employing a balloon size of at least 12–16 mm in diameter, produces the desired therapies.As shown in Figure 6A, the expandable dilator 410 has a relatively large midsection 702 and proximal 704 and distal 706 portions that taper gradually in a generally symmetrical manner to the elongated member 412 that supports the expandable dilator 410. The expandable dilator 410 may also gradually increase in size 618 distally, and then taper to the elongated member 412. Here, the expandable dilators are generally rotationally symmetric about the elongated member. In other procedures, the expandable dilator 410 is rotationally asymmetric about the elongated member 412. For example, the expandable dilator 410 in an expanded configuration assumes a generally flattened or laterally extended appearance 620 such that the expandable dilator MA / / U4 I004 - 27 410 extends laterally a greater distance than in the vertical direction (Figure 6C). In this way, the dilator is configured to treat a relatively larger area between tissue layers as lateral subcision is enhanced. It should be recognized that this is only one example of such a dilator, as various other shapes and sizes of dilators that generally extend laterally define other modalities in this discussion. With reference to Figure 6D, the expandable dilator 410 includes an enlarged midsection 624 and a relatively large taper 626 extending distally from the midsection 624. Such an arrangement lends itself well to gradually separating the tissue layers as the dilator advances through the subcutaneous route. In other embodiments (Figures 6E and F), the expandable dilator 410 is equipped with one or more illuminating structures 630, such as LEDs. The illuminating structures are thus placed on one or more portions, or the entirety, of the structure defining the expandable dilator 410, or on a portion or the entirety of the elongated member 412 that supports the expandable dilator 410. In an alternative embodiment (Figure 6G), the light source 630 can also be associated with a sliding member 631 within a transparent lumen inside the dilator 400, allowing the light source to be positioned along the length of the dilator 410 while the balloon is stationary. These lights 630 are useful for employing transillumination in an interventional procedure. The location of the expandable dilator 410 is directly visualized by an operator as it is moved subcutaneously between tissue layers.The lights are also useful for communicating whether a dilator has expanded fully or partially. This information is helpful to an operator regarding the degree to which complete or partial dilation within the tissue can indicate the progress of a treatment. In an additional embodiment (Figure 6H), a sheath 634 is provided around the elongated member 410 and can be placed around the expander 410 to control the degree to which the expander 410 expands. Smaller and / or larger regions can thus be treated with the expander 410 as desired or dictated by a particular application. The sheath 634 also serves as a means of folding the expander for removal and repositioning between the tissue layers. In a related procedure, as shown in Figure 61, the ML / I / U4 I004 The expandable dilator 410 is defined by a plurality of expandable portions 638 enclosed in an outer membrane 640. In this embodiment, the elongated member 412 includes a structure that allows each expandable portion 638 to expand and retract independently. For example, in a modality that includes three expandable portions, the elongated member is equipped with three separate lumens and / or ports, each in communication with an expandable portion. The membrane 640 provides an outer surface with a smooth transition between the sections of the dilator 410. Furthermore, in one or more embodiments, a wire-over-wire procedure can be employed to deliver a dilator to and into a surgical site. Additionally, as shown in Figure 6J, a quick-exchange procedure is used in certain embodiments for dilator delivery. In this procedure, instead of advancing a full length of an expandable dilator 410 and its elongated member 412 over the guide wire 400, the dilator 410 is provided with an additional lumen 642 through which the dilator is advanced. In this manner, one or more dilator assemblies can be guided, withdrawn, and replaced from the guide wire in a faster manner or sequence. In this regard, the entire content of EU Patents Nos. 6,921,411 and 6,273,879 is incorporated herein by reference. As shown in Figure 6K, a 410 dilator may include jaws 647 that assume open, partially open, and closed configurations. In use, the device is advanced to the intervention site in a closed configuration and then opened to stretch or break down septa to treat cellulite. The 410 dilator is guided over a guide wire, and the jaws are opened and mechanically dissected and / or separated, dilating the tissue. The 410 dilator is advanced, retracted, or repositioned as desired to treat various locations. In another procedure (Figure 6L), the dilator 410 includes a plurality of telescopic tubes 651 that are sequentially stacked and advanced dilators having progressively larger diameters. As the overall diameter of the assembly increases to a desired target, the dilation function is achieved. As shown in Figures 6M and 6N, the dilator can be a plurality of wires 655 projecting radially outward from a tube 657 by forced displacement in a repeatable manner. Such a structure provides the desired mechanical control through direct actuation and lateral bending of the wires 655 in both directions, distal and lateral. MA / / U4 I004 -29proximal, and is associated with minimal re-coating problems. The wires can be round or flat in cross-section, and various numbers of wires can define the expandable structure. In addition, the wire matrix can be coated with an elastomeric material to distribute the load and allow the mechanism to retract without other material obstructing the matrix. The dilator can also be (see Figures 60 and 6P) a balloon 659 attached distally to a sliding structure 661 that is driven distally to pull the flat balloon when not actively inflating. In one particular procedure, a spring 663 is provided in a central member of the balloon 659, the spring 663 being configured to compress and shorten the longitudinal span of the balloon 659. The spring 663 can be positioned within a longitudinal span of the balloon or simply proximal to it. In this arrangement, a non-adaptable or mostly non-adaptable balloon can be made to expand beyond its established shape, an objective being to provide a force balance such that the balloon can be placed in its target-formed shape at a particular pressure, and then, with additional pressure, transform into an even more extended shape.This facilitates the supply of balloons of various diameters and an overrun diameter where the user determines that additional expansion is needed. Here, the central / transverse member of balloon 659 is one of the restraint points that allows a non-adaptable balloon to achieve its designed shape under pressure. When the center of balloon 659 includes a spring 663 with sufficient stiffness, the balloon 659 can initially achieve a designed shape at a target pressure. If further expansion is desired, the pressure on the balloon is increased, and instead of the pressure stretching the balloon material to increase its size, the elastic portion of the central member compresses it, actually shortening the overall length of the balloon. This allows the additional pressure to reshape the now-shortened balloon to a larger diameter. As the pressure is reduced, the spring 663 is released.This arrangement also facilitates a wider range of retrievable balloon sizes, beyond what fitting alone provides. Furthermore, other procedures for providing this functionality involve including a proximal balloon mounting point configured to move and be restrained by a spring, or a springless modality where a central member is positioned at two lengths, with the user controlling which one is used. MA / t / ZUZ I / U4 I004 In yet another procedure (Figure 6Q), the dilator 665 may include an element 667 configured along a central axis 669. The element 667 may be formed from a nichrome wire to resistively heat the fluid used to expand the dilator or balloon 665. Thermistors or thermocouples may be placed along the axis 669 to facilitate temperature control. The element 667 may alternatively function as a thermocouple, thus forming a cooling circuit. Lower energies would be associated with heating or cooling the small volume of fluid contained within a dilator. Alternative procedures to heated or cooled dilators may rely on heated or cooled fluids (e.g., saline solution) used to expand the dilator. Cooling or heating the balloon may aid in the delivery of therapy in several ways.In the case of heating, applying a lower level of heat softens the collagen and increases its flexibility. When combined with balloon inflation, this facilitates the restructuring of the bands that cause cellulite and reduces the forces required for the balloon to exert this effect. Applying higher heat to the collagen and combining balloon inflation with heat allows for the treatment of any existing skin laxity, effectively tightening the tissue. Cold or cooling also works to limit the flexibility of any septa or bands, so that less of the force applied by the balloon is lost to stretching and acts more directly on breaking them down. In another modality, the cooling temperature can be controlled to stimulate cryolipolysis.Although krasa loss is not necessarily required when treating cellulite, it can aid in the overall healing process and allow for faster remodeling of the area after the procedure. With reference to Figures 6R and 6S, a treatment device is shown that includes a double-balloon structure 670 arranged to alter, stretch, or break septa. In this procedure, the balloons 670 are attached to an elongated member 671, such as a tube, and the elongated member 671 is both transferable and rotationally supported in a housing 672. Therefore, the balloons 670 can be positioned as desired with respect to the septa, such as rotationally oriented before deployment and / or expansion, and then preferably expanded in a direction most likely to achieve the desired height, stretch, or rupture of the septa. The device can MA / / U4 I004 -31 to be deployed on a wire frame. In addition, as shown in Figure 6S, a curved or deflectable member 674 can be provided as a support for the balloons 670 (balloons not shown in Figure 6S). Alternatively, a single balloon can be used. In this way, greater control over the proper orientation and placement of the balloons 670 is possible, and the balloon or balloons can be configured or positioned near and around the target partitions. In one aspect, the balloon structure surrounds the target partitions. In addition, in certain procedures, a toroidally shaped balloon is presented around the partitions. In another additional or alternative aspect, the treatment ensures tensioning of the partitions without movement at a location of lower tension away from the treatment balloon. In other alternative or additional aspects (see Figure 6T), instead of a member 677 supporting and crossing the balloon 670 being concentric and centered, it would be offset level to one side or the other. This can then be repeated in a mirror image to define the structure of the balloon 670 on the opposite side of member 677. In several additional or alternative aspects, a balloon can be larger or have a different shape in one direction than in the other, either dimensionally, through inflation, or by using different materials. This can be advantageous if there is a need to reduce the overall volume of the balloon for extensive deployment or expansion. In one particular embodiment, a single assembly of the lumen version includes a larger balloon with one or more welded areas that would restrict expansion along one axis (see Figure 6U). Turning now to Figures 7A and 7B, the various components of the present description can be combined into a cellulite treatment set 702 for ease of use. This device is placed inside the introducer or other port described above (Figure 7B) to access the subcutaneous site. For example, as shown in Figure 7A, the treatment set 702 includes a handle 704 sized and shaped to fit comfortably in an operator's hand. A lever 706 is rotatably attached to the handle 704 and configured to control the expansion and contraction of an expandable dilator 410. In particular, when the dilator is a balloon, the device may have an integrated fluid contained in the handle that expands the balloon when the lever is retracted and deflates the balloon when the lever is advanced. Additionally, the device may have a pressure gauge to display the pressure inside the balloon.Alternatively, the device can be connected via tubing to an external fluid source. Here, the expandable dilator 410 is installed on a needle 708 and is presented as follows. MA / / U4 I004 -32 a single piece. A sliding control lever 710 is also provided on the handle 704 and is configured to control the extension and retraction of a cover 712 that can be placed over the dilator 410. Manipulation of the cover 712 thus allows the expandable dilator 410 to be released and retrieved, as well as controlling the expansion of the dilator 410. A structure is also provided for administering anesthetics or medications to or within a surgical site. In one embodiment, a tube 718 is attached to the loop 704 and placed in fluid communication with a distal port of the needle 708. The fluid to be delivered through the needle 708 is connected by a plunger 720 or other means to a proximal end of the tube 718 and conveniently arranged so that an operator may deliver the fluid as required or desired. In addition, an alternative introducer port 730 may be provided to maintain access to the surgical site (Figure 7B). Such a port 730 includes a through-channel 732 sized and shaped to receive surgical instrumentation. A distal end of the port 730 is fitted with an expandable member 736, such as a balloon, configured to secure the port 730 at the insertion site.In addition, a 740 tubing assembly is provided to allow fluids such as medications to be infused through the insertion site. A stopcock for this controlled infusion is also provided. With reference now to Figures 7C to 7J, in one particular procedure, the intervention tool 750 is incorporated into a balloon attached to a shaft. In one or more embodiments, an integrated tool is provided that additionally or alternatively includes a rigid, double-lumen shaft with one lumen for a trocar-tipped obturator 752 and the other lumen an inflation lumen for the expandable member 410. The integrated tool 750 is preferably 18 French in outside diameter, more preferably 16 French or less, such that the insertion site 210 does not require a stitch or stitches for closure and can be closed with an adhesive or adhesive bandage. The expandable member 410 can be of different sizes between approximately 10 mm and approximately 30 mm in diameter and approximately 20 mm to approximately 100 mm in length.At the distal end of the shaft, there is a long, tapered 760 tip with a shallow taper angle that allows the tool to be pushed through the tissue more easily. Behind the tapered tip, initially in a folded profile that is equal to or less than the diameter of the proximal end of the tapered tip, there is a... The expandable member 410 is installed on the double-lumen shaft. An integrated cover 766 initially lies over the expandable member 410 and forms a continuous taper at the proximal end of the tapered tip 760. The suction, compression, or adhesive stabilizer 102, 104 is used while the tool is inserted into the distal treatment location along the previously depicted treatment pathway (see Figures 3B, 7C, and 7D). Once the expandable member 410 has been inserted into the desired location, the adhesive or suction stabilizer is removed (Figure 7E), and the trocar-tipped obturator is withdrawn as shown in Figure 7F, or it can simply be pulled back into the long tapered tip for safety. If removed, a guide wire 400 can optionally be placed through its lumen and extended out of the distal end of the shaft (Figure 7G).In an alternative modality, the intervention tool has a third lumen such that the trocar-tipped obturator is pulled back into the long, tapered tip, and the guide wire is placed through the third lumen and extends out of the distal end of the shaft. The guide wire can be used to reposition a larger expandable limb tool if the initial size selected did not produce the desired result. To treat septa, the integrated cover 766 is slid proximally to expose the expandable member 410 (Figure 7H). The expandable member 410 is either inflated / deflated or expanded / compressed (Figures 71 and 7J). The cover 766 is then pulled back over the deflated expandable member 410, and the entire tool is pulled back to the next most distal treatment location along the previously depicted treatment pathway. The procedure is then repeated: the cover is slid proximally, the expandable member is inflated / deflated, and the cover is pulled back over the deflated expandable member. The entire tool is then carried to the next treatment location, and these steps are repeated until the previously depicted treatment pathway is completed.Next, the tool is pulled back into the skin opening, and the procedure is repeated along the next previously depicted treatment pathway. As noted above, the location and performance of the expandable limb along the treatment pathways can be identified by: palpation; transillumination incorporated in the tool, guide wire, or obturator end. -34Illuminated; ultrasound imaging or viewing through the skin; fluoroscopically; or magnetically. In an alternative approach, localized treatment of the septa is possible using an 800 cellulite treatment system configured to target one intervention site at a time. Such procedures may employ one or more of the described stabilizers or introducer structures, or the treatment systems may lack one or more of these structures. Therefore, the cutting structures may be inserted perpendicular to the skin to perform the treatment or may be advanced beneath the skin in a direction generally parallel to the skin surface or at angles to it. Furthermore, the described guide wire structures may be configured alternatively or additionally to define cutting structures.In one particular aspect, the cutting action is rotary, such that the cutter rotates at controlled speeds configured to cut the septa in a manner dictated by the observed structure of the septa at the intervention site. The cutter is also configured to perform the cutting action by engaging or dragging it against the target septa. Again, the degree to which the dragging occurs is dictated by the septa and their inherent structure. In one procedure, an 800 system includes an elongated handle 802 provided for operator gripping (see Figures 8A to 8C). 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 target area of ​​cellulite, or directly into a dimpled cellulite site.Furthermore, it is through the 804 needle assembly that instrumentation of the intervention site is advanced to access and treat the septa located beneath a dimpled skin appearance. For example, any of the dilators described above can be used to treat the septa. In a slightly more traumatic approach, the dilator can be replaced with, or combined with, a harmonic scalpel, a selective cauterization device, or an energy delivery device to dissect tissue and / or control bleeding. In this procedure, once the correct depth is reached, a cutting instrument is swept 360 degrees to cut the surrounding septa. Alternatively, an endoscope can be used in an assembly that includes a cutter to cut the septa. MA / / U4 I004 -35 septa in a targeted manner. That is, the septa seen by the endoscope are intended to be cut by the cutter. Here, direct visual confirmation of a treatment is provided. In one embodiment, the 804 needle can be configured with a stop 810 that can be positioned along the length of the 804 needle as desired or dictated by a particular procedure or anatomy. The stop 810 is positioned so that when the 804 needle is inserted into the tissue, its terminal end is placed at a desired depth, such as between tissue layers connected by septa. A lateral opening 822 is also provided at the terminal end of the 804 needle. It is through this lateral opening 822 that interventional devices such as dilators, scalpels, cauterization structures, or energy delivery devices are advanced between tissue layers. These devices are then used to selectively treat the septa located beneath the skin in order to eliminate or reduce the appearance of cellulite.Once it is determined that the treatment has been successful, the Localized Cellulite Treatment System 800 is removed and used in another area exhibiting cellulite. Turning now to Figures 8D to 8J, other aspects of the tools used for the localized treatment of cellulite in alternative procedures are shown. With reference to Figure 8D, a localized treatment device can be equipped with a wire that includes articulated mechanisms 830, the manipulation of which functions to push outward a cutting blade installation that is sized and shaped to cut connective tissue. As shown in Figure 8E, a portion of the distal end of a localized treatment device can be equipped with a wire arranged so that it can advance to define a loop 832, the loop having a gauge that facilitates the structure used to cut tissue in a non-traumatic treatment procedure. Alternatively, RF energy can be used to cut septa.Figures 8F and 8G depict a deformable hypotube 834 that can be expanded so that two or more arms 836 project to define cutting blades for another non-atraumatic treatment procedure. Figure 8H illustrates a balloon structure 840 attached to a needle hypotube 842 that can be expanded beneath a dimple to eliminate or reduce the appearance of cellulite. Finally, in another non-atraumatic procedure (Figures 81 and 8J), a distal end portion of a localized treatment device can be fabricated with blades 850, one for cutting. MA / / U4 I004 -36 deployment and at least one that is configured to rotate and cut connective tissue. As shown in Figure 8K, a 410 dilator can be further equipped with longitudinally extending 853 blades that deploy when the 410 dilator expands. The 853 blades are configured to engage and cut target tissue or septa in an alternative treatment procedure. Such cutting is employed as an alternative to a non-traumatic procedure and is achieved by rotating, advancing, sweeping, or otherwise retracting the 410 dilator. The assembly does not expand and is withdrawn from the intervention site after use, such as through a tube. In another treatment procedure, a curved wire forming a loop 859 attached to a shaft 861 (Figures 8L to 80) can be deployed around the septa 350 within a target area 861. Pulling on the loop 859 to reduce the perimeter it defines results in the cutting of the septum 350 and the treatment of cellulite. In one aspect, the loop is formed from nitinol wire, or it is preformed wire or pieces thereof. The loop 859 encircles the target septa and, by tightening, cuts the septa. One procedure involves cutting a target area without movement of the shaft, thus providing a controlled treatment procedure. An atherectomy-style cutter 902 (see Figures 9A and 9B) can be configured to extract tissue through an opening 904 on the side of the instrument and can be used in certain more traumatic ancillary treatment procedures. 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 also provided as a conduit for applying suction to the intervention site, so that the cut or macerated tissue 912 can be removed. This device can be used to harvest fat for subsequent placement at a site treated with a dilator and used to fill the resulting space. The cutter 902 can also be used as a primary treatment device for cutting septa to treat cellulite. With reference again to Figures 4A to 4C, it should be recognized that the expandable dilator procedure for creating subcutaneous spaces has applications beyond the treatment of cellulite. That is, the manipulation of connective tissue, such as septa, can be applied to various other conditions or diseases. For example, the dilators described are used to Body sculpting, wrinkle reduction, acne scar treatment, and / or skin lifting and repositioning are all possible procedures. Foam fillers, stents, or spacers of varying lengths, along with other structures such as subcutaneous bonding devices that are either absorbable or permanent, are used to achieve these goals. Additionally, a diode laser can be used beneath the skin to tighten the skin in the targeted areas. This allows the skin to be smoothed to eliminate unwanted folds, scars, wrinkles, or stretch marks. Furthermore, the spaces created by the dilation can be filled with materials, such as the patient's own fat harvested from another location, or an expandable spacer contained within a shell can be released into the dilated space to provide a more youthful appearance or the desired resilience.Furthermore, by utilizing the spaces created by dilation, subcutaneous structures can be moved, repositioned, anchored, or pulled (as with a barbed suture) to create a desired external appearance. Therefore, these and other procedures for subcutaneous tissue treatments are included in this presentation. Various procedures and devices can be used to expand and contract dilators or balloons used in cellulite treatment systems. Many require two-handed operation and, in many cases, are operated by an assistant or other person. In the case of a cellulite procedure, the practitioner does not have regular contact with the balloon inflators and may need to perform the inflation themselves with one hand. Furthermore, conventional balloon inflators are designed for high pressure levels and are designed to allow the user to slowly approach the desired target pressure. Current inflators are typically designed to be a more universal tool for inflating different types of balloons to different pressures.There is a desire with cellulite procedures to streamline the process, both for training new practitioners and to allow for faster, more precise inflation during the procedure. An additional benefit of a syringe-based system is that current inflators are more oriented toward an operating room with a patient unfamiliar with their surroundings, so their appearance is very functional and conveys a sense of a medical procedure. The cellulite patient is likely to be conscious during the procedure, and all tools should resemble other equipment found in a similar environment or downplay the medical nature of the procedure to aid patient comfort. Unlike standard inflators, a professional... -38Cellulite will have experience with syringes. In addition, lower balloon pressures allow for a more direct inflation method since no mechanical advantage is needed. In one procedure (Figure 10A), a standard control syringe and a series of one-way valves are provided to allow the use of the syringe (of any size). A syringe 930 is retracted and saline solution is drawn from a reservoir 931 through a one-way valve 932. The syringe 930 is then pushed forward, propelling the saline solution forward through a second one-way valve 933 into a balloon 934. A first one-way valve 932 prevents the saline solution from syringe 930 from flowing back into reservoir 931. The syringe 930 can be retracted and filled from reservoir 931 and pushed forward into balloon 934, where balloon 934 has a larger volume than syringe 930. The one-way valve 933 prevents any backflow while the syringe is being refilled with saline solution from reservoir 931.As the balloon 934 approaches the target pressure, which can be monitored on the pressure gauge 938, it will reach a point where an optional release valve 939 engages at the target inflation pressure. This release valve 939 will maintain the balloon 934 at the target pressure. Should the user continue to advance the syringe 930 to inflate, the overflow will be redirected back to the reservoir 931 while maintaining the target pressure. Here, the path of the syringe 930 is uniform (unlike the rotary motion of the standard inflator), but as the septa in the cellulite targets are broken, there is a pressure change in the balloon as the septal structure is disrupted. This change can be detected by the user in the syringe 930, providing tactile feedback during treatment. To deflate the balloon 934, one or more stopcocks or valves 940 are rotated to reverse the original trajectory.When syringe 930 is withdrawn, it draws saline solution from balloon 934, and when advanced, it pushes the saline solution back into reservoir 931. This is repeated until balloon 934 is deflated. The saline solution in the system is then shut off to keep the field as dry as possible and ensure no residual saline solution remains in the treatment area. It is also noted that smaller syringes require more pumps, but higher pressures can be achieved with the same user input force. Reservoir 931 can also be a pre-filled syringe or a saline bag. MA / / U4 I004 -39In one respect, a simple syringe can provide the expansion and contraction of such members. In another procedure, an automated pump can provide the desired expansion and contraction. With reference to Figures 10B to 10D, the expansion and contraction of a balloon or other dilator can be achieved using a quick-pump assist device 950. The quick-pump assist device 950 includes a housing 952 incorporating an inlet installation 954 and an outlet installation 956. Two inlet squeeze valve installations 958 (see Figure 10B showing the device with a portion of the housing removed), each connected to a single one-way inlet valve 960, are associated with the inlet 954, and two outlet squeeze valve installations 962, each connected to a single one-way outlet valve 964, are associated with the outlet 956.Each squeeze valve assembly includes a rotating portion 965 configured to engage the first arm 966 and the second arm 967 as it rotates from a first to a second position. When in these positions, the arms 966 and 967 are deflected against the inlet tube 968 or outlet tube 969 to squeeze the tube closed or allow it to remain open. Connected to one end of the housing 952 is a first T-adapter 970 having a first port 972, a second port 974, and a third port 976. The first port 972 is sized and shaped to connect to a syringe pump 980. The second port 974 and the third port 976 are associated with the inlet and outlet functions, respectively.At the opposite end of housing 952 is a second T-adapter 982 having ports 984, 986, and 988. The first port 984 is sized and shaped to connect to a tube in fluid communication with a balloon or other dilator (not shown). The second port 986 and the third port 988 of the second T-adapter 982 are in fluid communication with the inlet and outlet, respectively. As shown in Figure 10A, a knob 990 connects to a rotating part 965, providing a structure for a user to grip and turn. A reservoir 992 connects to the system via a third adapter 993 (Figure 10C) and is associated with the inlet 954 and outlet 956.Pressure relief valves (not shown) are also provided in fluid communication with the 992 reservoir and the dilator, the relief valves having different burst pressure ratings so that there is control of the maximum pressures provided by the dilator. MA / / U4 I004 -40 the ball. Inflation of the balloon or expansion of the dilator is achieved with the inlet squeeze valves 958 in a passive state, leaving an inlet line 954 open while closing an outlet line 956 such that the outlet squeeze valves 962 are in an active state. Deflation or contraction is achieved by turning knob 990 to close the inlet line 954 and open the outlet line 956. Control of inflation or deflation is provided by activating knob 990. Note that, in an alternative procedure, the one-way valves and squeeze valves can be replaced by turning the one-way valves to achieve the desired functionality. Turning now to Figures 11A to 11D, another procedure for the treatment of cellulite is shown. Here, crossing the superficial fat space 1002 beneath the dermis is achieved with sharp tools or with blunt or tapered dissecting tools 1004. In one aspect, the cutting or slicing structure may be attached to the end of an elongated instrument that is sized and shaped to advance beneath the skin to engage and cut the septa. In a particular procedure, such a cutting or slicing structure as described above is configured to pull or push against the connective tissue to achieve the cut, and the treatment may involve a stabilizer or be achieved without one.In another aspect, a blunt-tipped device or 410 balloon is attached to the elongated tool, such as near its terminal end, and is used to track and target cellulite sites without a stabilizer, along the lower portion of the dermis. 350 septa are often characterized by a tree-like structure and a main trunk of the 350 tensor septa that creates a dimpled location of cellulite. With dermal tracking and inflation of a 410 balloon, this would ensure optimal depth and placement, and the user could interrupt the direct connection between the branches of the 350 tensor septa right at the intersection with the dermis. This facilitates the use of smaller balloons or more targeted / effective therapy. Therefore, several procedures for cellulite treatment methods and devices are presented. The described procedures are designed to provide an effective and focused approach to treating, minimizing, and preventing cellulite. The described procedures can also be used for - 41. Repair and reduce the appearance of cellulite in a targeted and atraumatic way. Furthermore, the proactive treatment modalities described are easy and effective to use. Although this exposition has been described with reference to its five specific modalities, those skilled in the art should understand that various changes may be made and equivalents substituted without departing from the true spirit and scope of the exposition. Furthermore, many modifications may be made to adapt a particular situation, material, composition of matter, process, or process stage(s) to the objective, spirit, and scope of this exposition. It is intended that all such modifications remain within the scope of this exposition.

Claims

1. A cellulite treatment system, comprising: a cellulite treatment stabilizer configured with a plurality of suction ports arranged to stabilize the tissue and including a tissue hooking structure defining a proximal lower portion arranged to facilitate the creation of a tissue insertion site.

2. The system of claim 1, wherein the lower portion is configured to apply downward pressure to facilitate the creation of a tissue insertion site.

3. A cellulite treatment system, comprising: a balloon on a shaft configured to advance between tissue layers; and a cellulite treatment stabilizer configured to be arranged parallel to the balloon on a shaft, the stabilizer including a structure configured to extend longitudinally along the outside of the skin and a lower proximal portion configured to create a tissue insertion site.

4. A cellulite treatment system, comprising: a cellulite treatment instrument; and a cellulite treatment stabilizer including a plurality of channels for receiving the cellulite treatment instrument.

5. The system of claim 4, wherein the channels are arranged to facilitate access to a plurality of tissue depths.

6. A cellulite treatment system, comprising: a balloon on a shaft configured to be placed between layers of tissue; and an elongated stabilizer for cellulite treatment configured to be arranged parallel to the balloon on a shaft configured to be placed between layers of tissue, a lower surface of the stabilizer being configured with a friction structure to engage and stabilize the tissue.

7. A cellulite treatment system, comprising: a cellulite treatment balloon installed on a shaft and sized and shaped to advance between tissue layers; and a generally parallel stabilizer that stabilizes the tissue during the advancement of the balloon.

8. The cellulite treatment system of claim 7, wherein the -43 stabilizer is configured to be removed once the balloon is placed at a treatment site prior to treatment.

9. A method for treating cellulite, comprising: placing a stabilizer on the outside of the subject's skin; introducing a balloon on a shaft into the tissue in a parallel relationship to the stabilizer; and expanding the balloon to treat cellulite.

10. The method of claim 9, further comprising stretching, breaking, reorienting or altering the tissue associated with cellulite.

11. A cellulite treatment system that accesses septum-joined tissue layers, comprising: a tissue-engaging device including a plurality of suction ports, at least one guide channel, and one or more guide channel positions; an elongated guide sized and configured to be inserted into the at least one guide channel and to create an insertion site within the tissue; and an expandable dilator sized and shaped to be placed across the insertion site and between the tissue layers to stretch or tear the subcutaneous connective tissue.

12. The system of claim 11, wherein the elongated guide is a needle and further comprises an introducer sized and shaped to screw onto the needle.

13. The system of claim 12, further comprising a guide wire sized and shaped to be inserted through the introducer.

14. The system of claim 11, wherein the expandable dilator is sized and shaped to advance over the guide rod.

15. The system of claim 11, wherein the expander is a balloon.

16. The system of claim 11, wherein the expandable dilator is not adaptable.

17. The system of claim 11, wherein the guide channel is slidable and lockable in its position.

18. The system of claim 11, wherein the expander includes a plurality of separate expander portions.

19. The system of claim 11, wherein the expandable dilator is a balloon with rigid members on its surface. ML / I / U4I004 20. The system of claim 11, wherein the expandable dilator is a stent.

21. The system of claim 11, wherein the expandable dilator is a filling material.

22. The system of claim 11, further comprising a light source.

23. The system of claim 11, further comprising means for anchoring the system at a distal location at the subcutaneous intervention site.

24. The system of claim 11, further comprising a target measuring device that scans the target areas and creates a complete three-dimensional map of the cellulite in relation to normal skin surfaces.

25. The system of claim 11, further comprising an anesthetic and an anesthetic injection sub-installation.

26. The system of claim 11, further comprising a dilator subcision device that controls the deployment of the expandable dilator.

27. The system of claim 11, further comprising a port inlet device, the port inlet device including an expandable structure.

28. The system of claim 11, wherein the introducer is orientable.

29. The system of claim 11, wherein the expandable dilator is coated with medication.

30. The system of claim 11, wherein the system is configured to deliver drug to the treatment site.

31. A cellulite treatment system that accesses septum-bound tissue layers, comprising: a tissue-engaging device including at least one guide channel and one or more guide channel positions; a needle sized and shaped to be inserted into the at least one guide channel and to create an insertion site within the tissue; and an expandable dilator sized and shaped to be placed within the insertion site and between the tissue layers to stretch or tear the septa; wherein the tissue-engaging device functions to provide a stable base by holding a tissue plane firmly while the needle is employed to create an insertion opening.

32. The system of claim 31, wherein the attachment device is configured to apply suction force. MA / E / ZuZu / U4 I004 33. The system of claim 31, wherein the engagement device is configured to employ adhesion to provide counter-traction to the insertion and advancement of the needle.

34. The system of claim 31, wherein the dilator is arranged to drain fluids.

35. The system of claim 31, wherein the system is configured to administer anti-inflammatory drugs, collagenase, deoxycholic acid, salicylic acid, glycolic acid, hyaluronic acid, or drugs for the treatment of cellulite.

36. The system of claim 31, wherein the system is configured to deliver an anesthetic at the treatment site transcutaneously or subcutaneously.

37. The system of claim 31, wherein the hooking device includes a handle and an elongated portion extending from the handle, the elongated portion being sized and shaped to hook the skin.

38. The system of claim 31, wherein the attachment device includes a plurality of suction ports configured within the elongated portion.

39. The system of claim 31, wherein the adhesive is attached to the elongated portion.

40. The system of claim 31, wherein the loop portion is used to create an indentation in the skin through which intervention devices can be inserted subcutaneously.

41. The system of claim 31, wherein there is a pair of locking devices connected in parallel.

42. The system of claim 31, further comprising a target measuring device that scans target areas and creates a complete three-dimensional map of cellulite in relation to normal skin surfaces.

43. The system of claim 32, wherein the target measuring device cooperates with a controller to automatically create a treatment pathway.

44. The system of claim 31, further comprising a structure that administers an anesthetic subcutaneously.

45. The system of claim 31, further comprising a guide wire sized and shaped to be placed through the stabilizer and within an MA / / U4 I004 -46 intervention site.

46. ​​The system of claim 31, further comprising a hypotube sized and shaped to advance through the stabilizer and into an intervention site.

47. The system of claim 46, wherein the hypotube has variable stiffness.

48. The system of claim 47, further comprising an introducer assembly that is sized and shaped to advance over the hypotube.

49. The system of claim 31, wherein the expandable dilator is configured to stretch, break, and reorient the septa.

50. The system of claim 45, further comprising a proximal guidewire anchor assembly that can be attached to the skin, wherein the anchor assembly includes a pair of adjustable protrusions configured to releasably engage the guidewire.

51. The system of claim 45, further comprising a structure that anchors a distal end portion of the guide wire.

52. The system of claim 45, further comprising a sleeve sized and shaped to receive the guide wire, wherein the translation of the sleeve functions to deploy the anchoring structure attached to a distal end portion of the guide wire.

53. The system of claim 45, wherein a terminal end portion of the guide wire is curved.

54. The system of claim 45, further comprising a clamp that attaches to a terminal end of a guide wire emerging from the skin.

55. The system of claim 45, wherein the guide wire includes a pair of curved portions configured at its end.

56. The system of claim 45, wherein a terminal end of the guide wire includes a deployable V-hook structure.

57. The system of claim 45, wherein a terminal end of the guide wire is configured with an expandable balloon or cage.

58. The system of claim 45, wherein a terminal end of the guide wire is magnetized and held in a stable position by a magnet.

59. The system of claim 45, wherein a terminal end of the guide wire is configured with a coil.

60. The system of claim 45, wherein a terminal end of the guide wire is configured with a plurality of curved structures configured to resist proximal and distal translation of the guide wire.

61. The system of claim 45, wherein the expandable dilator is a balloon.

62. The system of claim 61, wherein the balloon is smoothly tapered at the proximal and distal ends.

63. The system of claim 61, wherein the balloon includes an elongated distal taper.

64. The system of claim 61, wherein the ball has a graduated profile.

65. The system of claim 61, wherein the ball extends laterally rather than vertically when expanded to define an overall flattened appearance.

66. The system of claim 11, further comprising fixed lights along at least a portion of the dilator, the lights being configured to provide transillumination during an intervention procedure.

67. The system of claim 11, further comprising an elongated member attached to the expandable dilator and lights attached to the elongated member configured to provide transillumination during an intervention procedure.

68. The system of claim 11, wherein the expandable dilator is located in a quick-exchange catheter.

69. The system of claim 11, wherein the expandable dilator includes a plurality of separate balloon portions covered with a membrane.

70. The system of claim 11, wherein the system is housed in a single device, the single device including a handle and an elongated portion extending from the handle, the elongated portion being sized and shaped to retain the expandable dilator installed on the needle, the elongated portion being advanceable and retractable over the expandable dilator.

71. The system of claim 11, wherein the system defines a localized treatment device, including the needle a lateral opening through which the intervention instrumentation is deployed and recaptured.

72. The system of claim 11, further comprising a harmonic scalpel, a selective cauterization structure or an energy transmission structure for dissecting tissue and / or controlling bleeding.

73. A method of cellulite treatment comprising: identifying a treatment site; selecting the depth to which access is made between tissue layers; holding or stabilizing the tissue; creating an insertion site; after creating an insertion site releasing tissue; advancing the intervention instrumentation within the insertion site to an intervention site; and stretching, reorienting or breaking at least one septum at the intervention site.

74. The method of claim 73, further comprising the creation of a treatment regimen that involves employing the insertion site to treat multiple areas.

75. The method of claim 73, wherein a hooking device functions to provide a stable base without lifting a fabric plane.

76. The method of claim 73, wherein the hooking device functions to provide a stable base without lifting a tissue plane and in such a way that the needle can be used to create an insertion site.

77. The method of claim 73, further comprising advancing a needle to the intervention site.

78. The method of claim 73, further comprising advancing a hypotube over the needle.

79. The method of claim 73, further comprising advancing a guide wire inside the hypotube.

80. The method of claim 73, further comprising advancing an expandable dilator over the guide wire.

81. The method of claim 73, further comprising manipulating the expandable dilator to stretch, reorient, or break the septa connecting the tissue layers.

82. The method of claim 73, further comprising scanning a subject's skin to identify treatment areas and create a treatment regimen, storing the scan date to evaluate the effectiveness of the treatment.

83. A system for treating a target region of skin tissue having a subcutaneous region beneath the target region, comprising: a guide tool configured to be positioned at a relatively fixed distance below the skin, the guide tool defining a toolpath; a tool that stabilizes and flattens the target region of tissue to allow the guide to be inserted beneath the skin; and one or more expandable dilator devices configured to be inserted along the toolpath to permanently expand the subcutaneous region beneath the target region.

84. A method for treating a tissue region having a skin surface and a subcutaneous region beneath the skin surface, comprising: placing a stabilizing device on the skin surface and applying a force capable of flattening the skin surface beneath the stabilizing device; advancing a guide or tool into the skin surface a predetermined distance beneath the skin such that the guide or tool is introduced along a path parallel to the flattened skin; removing the stabilizing device; and passing an expandable treatment tool along the path of the predetermined guide or tool into the subcutaneous region to be treated.

85. A system for treating a target region of skin tissue having a subcutaneous region beneath the target region, comprising: a guide tool configured to be positioned at a relatively fixed distance beneath the skin, the guide tool defining a toolpath; a tool that stabilizes and flattens the target region of tissue to allow the guide to be inserted beneath the skin, the stabilizer including an arm and a frame, the arm being rotatable with respect to the frame; and one or more expandable dilator devices configured to be inserted along the toolpath to permanently expand the subcutaneous region beneath the target region; wherein the arm and frame cooperate to form one or more channels for receiving interventional instrumentation.

86. The system of claim 85, further comprising at least one magnet configured within one or more of the frame or arm, the at least one magnet being configured to maintain a coupling between the frame and the arm.

87. A system for treating a target region of skin tissue having a superficial fat space beneath the dermis and septa connected to the dermis, comprising: 5 an elongated tool sized and shaped to access and advance along a superficial fat space beneath the dermis, the elongated tool including a terminal end portion defining one or more of a sharp, blunt, or tapered dissecting structure; and one or more expandable dilator devices associated with or attached to the 10 elongated tool and configured to permanently alter the superficial fat space beneath a target region.

88. The system of claim 87, wherein the tool is configured to provide dermal tracking without a stabilizer and inflation of the dilator ensures optimal depth and placement to alter the 15 connections between the target septa at an intersection with the dermis.

Images