Cellulite treatment systems and methods

Abstract

A system and method for treating cellulite including a device that applies separating septa to eliminate or reduce the appearance of cellulite. In one approach, an interventional tool is placed between tissue layers to engage and manipulate the septa that connect the tissue layers containing fat deposits.

Description

Technical Field

[0001] The present disclosure generally relates to systems and methods for treating cellulite. This application claims the benefit and priority of U.S. Patent Application No. 62 / 896,676, filed Sep. 6, 2019, 62 / 911,111, filed Oct. 4, 2019, and 63 / 049,705, filed Jul. 9, 2020, the entire contents of which are incorporated herein by reference.

Background Art

[0002] There is a continuing need for an effective approach for treating cellulite, also known as gynoid lipodystrophy, tuberous sclerosis, edematous fibrosis, panniculosis, edematous lipomatosis, dermopanniculosis deformans or status protensus cutis. Furthermore, there is a need for a simple, effective, and proactive treatment method to prevent future occurrence and recurrence of cellulite.

[0003] Since it has been reported that over 85% of women have cellulite, it is suggested that cellulite is rather a physiological condition than a pathological one. It is believed that cellulite does not occur simply due to the presence of fat in the reticular dermis. Cellulite is a hernia of subcutaneous fat within fibrous connective tissue, manifested as depressions in the skin. This fat load can lead to stress on the connective tissue located between the lobules of fat. Such depressions are more commonly seen in women than in men due to the orientation of the subcutaneous fibrous structure that defines the compartments containing adipocytes. In fact, this structure is thought to be the cause of cellulite appearance rather than excessive weight. Cellulite often occurs in pelvic areas such as the buttocks, lower limbs, and abdomen.

[0004] The subcutaneous fat layer beneath the epidermis is contained within the dermis, connected by septa that function as connective tissue between the dermis. In men, septa are more randomly and densely arranged in a cross shape, while in women, they are generally more parallel. Also, men have a thicker dermis, and the septa are at an angle to the skin surface, whereas women have a relatively thinner dermis, which thins with age, and the septa become perpendicular to the skin surface. Furthermore, in women with cellulite, the septa in the areas with cellulite are thicker, and the tension of the septa accentuates the cellulite. In women, the accumulation of fat in adipose tissue has a biological purpose: it is maximized to ensure sufficient calories for pregnancy and lactation. This increased fluid retention and proliferation of adipose tissue in the subcutaneous fat layer can further lead to the appearance of cellulite, where the septa maintain the initial distance between the dermis, resulting in depressions, while the pockets between the septa bulge. Over time, the septa stretch and then contract and harden, maintaining a certain distance between tissue layers. However, the pockets between the septa expand, which can exacerbate the appearance of cellulite.

[0005] Various approaches have been taken to treat or manage cellulite. Early treatments attempted to increase circulation and fat oxidation in areas exhibiting cellulite. Substances such as hyaluronic acid and aminophylline were injected into the targeted area to reduce cellulite. Other methods include electroporation followed by mesotherapy, or the application of dermatological creams and supplements to the cellulite. These approaches can be complemented by massage, or massage has been used alone to promote increased fat reabsorption or drainage of fluids and toxins from the treatment area. Ultrasound has also been proposed to break down subcutaneous tissue and fat and has been used in combination with liposuction. Low-pressure ultrasound combined with microbubble injection has also been employed to reduce the appearance of cellulite, as has the use of other energies such as lasers and radiofrequency. Such approaches are characterized by limited or unpredictable results. More recently, methods involving cutting septa in the subcutaneous region with blades or needles have been employed. Previous approaches have proven to be laborious, highly traumatic to tissue, leading to bleeding, bruising, tough tissue nodules, prolonged and painful recovery, and inconsistent results.

[0006] Therefore, there is a need for effective and efficient approaches to treat, minimize, or remove cellulite using a simple system that minimizes trauma. These approaches should be associated with predictable outcomes and be relatively easy to adopt.

[0007] This disclosure addresses these and other needs. [Overview of the project]

[0008] In concise and general terms, this disclosure relates to cellulite treatment systems and methods including devices that facilitate stretching, reorienting, breaking, cutting, slicing, and / or tearing septa or septa at the site of cellulite, depending on the system used and the force applied by the user. In one embodiment, the treatment approach includes a tissue cutting or slicing system.

[0009] In one embodiment, the cellulite treatment device is attached to the distal end of a shaft and is sized and shaped to allow it to be advanced between tissue layers. In one particular embodiment, the fibrous septa connecting the plateaus of the superior and inferior fascia within the skin can be traversed with the treatment device using one or more of an array of tools for engagement, and depending on the tool used and the force applied by the user, the septa can be stretched, readjusted, torn, destroyed, cut or incised. In doing so, the target subcutaneous connective tissue associated with the surface defect can be directly corrected with minimal impact on the surrounding vascular and lymphatic systems, the fat can be distributed more evenly, and the skin can present a smoother appearance.

[0010] In one or more embodiments, a cellulite treatment system embodies a tool that facilitates the ability to reach and treat all targeted cellulite-appearing areas through a single or limited number of entries (inlets) through the skin. In certain aspects, such a tool is sized, shaped, and configured (e.g., a diameter of approximately 2 mm or less and a blunt anatomical tip) so that it can be positioned within the tissue layers and advanced between tissue layers without the assistance of external skin stabilizing structures such as suction devices. Entry points penetrating the skin are employed in high positions on the buttocks where bikini or underwear straps are located, or along creases or transitions between the buttocks and thighs. Identification and evaluation of target septa are achieved by pressing, pulling, or otherwise stretching the septa in areas thought to be related to the appearance of cellulite on the outside of the skin. It is recognized that the septa that cause depressions and indentations are located at various angles and positions relative to the depressions and indentations observed in the skin, and are not necessarily directly beneath the appearance of such cellulite. Treatment systems and methods are designed to identify the septa involved in the appearance of cellulite imprinted on the skin, target these septa with treatment, and leave adjacent septa and blood vessels intact. Furthermore, a small subset or a larger area of ​​septa-like structures can be the structures that cause specific depressions or indentations.

[0011] In one method, an anesthetic is injected percutaneously or subcutaneously into the treatment site, and a cellulite treatment system is inserted subcutaneously across the treatment site and used to identify septa causing depressions or depressions by pushing or pulling on various septa to create depressions in the skin of the target area, and a cutting or slicing device or septum disruption structure is placed subcutaneously in the treatment site and employed to engage and cut, slice or destroy the septum tissue. In one particular embodiment, the patient is instructed to clench the muscles of the buttocks and / or legs to facilitate the identification of the target area and to confirm the release of the septa that will cause depressions or depressions after septum treatment. Alternatively, the physician may push the skin over the treatment target from the cranial direction towards the coccyx or pull from below the treatment target. Remote imaging, ultrasound or fluoroscopy energy may be employed to observe the procedure. Resizing or alternative configurations of the treatment structure may be employed to complete the treatment of a particular area. The treatment device is then repositioned to treat additional areas. The treatment device can be configured to treat multiple areas simultaneously or sequentially without being removed from the patient, and can also take a spot treatment approach. Langaline can be employed as a reference for directing treatment. Furthermore, various treatment trajectories can be directed through one or more inlets, and in certain applications, a maneuverable introducer is used to access the treatment area. In addition, anti-inflammatory agents, collagenases, deoxycholic acid, salicylic acid, glycolic acid, hyaluronic acid, or cellulite treatments can be administered separately or directly at the intervention site by the intervention device or other treatment instruments. Aspects of the present invention include identifying the septa that cause cellulite to appear, cutting or separating those septa, intraoperative confirmation that the separation of those septa has been achieved, and preventing the reappearance of cellulite.

[0012] In various embodiments, the therapeutic device may include one or more of the following for destroying, cutting, slicing, or dissecting tissue and / or controlling bleeding: blunt-tipped scissors, guillotine-type angled blades, protruding connectors, lateral opening hooks or V-shaped structures, internal hooks, bevel hooks, rotating structures or blades, cutting balloons or harmonic scalpels, selective cauterizing structures or energy transfer structures. In one particular approach, the therapeutic device includes a mechanical septum cutting element, such as a blade or sharp surface, which works in conjunction with a septum hook element to both hook and then cut, slice, tear, or destroy the septum. One or more of the septum hook elements and septum cutting elements are convertible from a hook configuration to a cutting configuration, from a cutting configuration to a hook configuration, or to a retractable configuration. In another particular approach, the therapeutic device may be embodied in an elongated member insertable through the skin, which can expand at least one area from a small state to a wide state, and when wide, can be configured to both hook and cut, slice, or destroy the target septum. In one or more alternative or additional aspects, cutting or destruction is achieved by a monopolar or bipolar structure or by an electrical or thermal means such as a hot wire, configured to deal with bleeding and facilitate cutting.

[0013] Cellulite treatment systems also include, in certain approaches, illumination such as bright light configured at or radiated through the tip of the treatment structure, or positioned along or strategically along the treatment structure, for the purpose of tracking the advance of the instrument to the treatment site and locating the position of the intracutaneous structure at the treatment site. In this way, direct observation of the treatment instrument by transmitted illumination through the skin is provided, and subcutaneous positioning and execution are readily available to the operator.

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

[0015] Furthermore, the disclosed devices and structures are employed for body sculpting, wrinkle removal, treatment of acne scars, and / or skin repositioning. Foam fillers or spacers of various lengths, and other structures such as subcutaneous implants that are absorbable or permanent, are used to achieve such purposes.

[0016] These and other features of this disclosure will become apparent to those skilled in the art upon reading the details of the system and method, which are described more fully below. [Brief explanation of the drawing]

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

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

[0019] [Figure 1D] Figure ID is a top view illustrating a cellulite treatment assembly and an approach for treating cellulite.

[0020] [Figure 1E] Figure 1E is a partial cross-sectional view showing an embodiment for treating septa under the skin surface. [Figure 1F] Figure 1F is a partial cross-sectional view showing an embodiment for treating septa under the skin surface. [Figure 1G] Figure 1G is a partial cross-sectional view showing an embodiment for treating septa under the skin surface. [Figure 1H] Figure 1H is a partial cross-sectional view showing an embodiment for treating septa under the skin surface. [Figure 1I] Figure 1I is a partial cross-sectional view showing an embodiment for treating septa under the skin surface. [Figure 1J] Figure 1J is a partial cross-sectional view showing an embodiment for treating septa under the skin surface. [Figure 1K] Figure 1K is a partial cross-sectional view showing an embodiment for treating septa under the skin surface. [Figure 1L] Figure 1L is a partial cross-sectional view showing an embodiment for treating septa under the skin surface. [Figure 1M] Figure 1M is a partial cross-sectional view showing an embodiment for treating septa under the skin surface. [Figure 1N] Figure 1N is a partial cross-sectional view showing an embodiment for treating septa under the skin surface. [Figure 10] Figure 1O is a partial cross-sectional view showing an embodiment for treating septa under the skin surface. [Figure 1P] Figure 1P is a partial cross-sectional view showing an embodiment for treating septa under the skin surface. [Figure 1Q] Figure 1Q is a partial cross-sectional view showing an embodiment for treating septa under the skin surface.

[0021] [Figure 1R] Figure 10-R is a partially cross-sectioned side view showing an alternative approach to transmitted illumination.

[0022] [Figure 1S] Figure 1S is a perspective view showing the use of a template in a treatment procedure. [Figure 1T] Figure 1T is a side view illustrating the use of a template in the treatment procedure.

[0023] [Figure 1U] Figure 1U is a top view illustrating an alternative approach to the use of templates in treatment procedures. [Figure 1V] Figure 1V is a side view illustrating an alternative approach to the use of templates in treatment procedures.

[0024] [Figure 1W] Figure 1W is a schematic diagram showing a subassembly of the approach to the photogenerating assembly. [Figure 1X] Figure 1X is a schematic diagram showing a subassembly of the approach to the photogenerating assembly. [Figure 1Y] Figure 1Y is a schematic diagram showing a subassembly of the approach to the photogenerating assembly.

[0025] [Figure 1Z] Figure 1Z is a partial cross-sectional view illustrating further steps in the processing method.

[0026] [Figure 1AA] Figure 1AA is a perspective view showing the placement of the processing strip over the processed area.

[0027] [Figure 2A] Figure 2A is a top view showing an alternative embodiment of the scissor device. [Figure 2B] Figure 2B is a top view showing an alternative embodiment of the scissor device. [Figure 2C] Figure 2C is a top view showing an alternative embodiment of the scissor device. [Figure 2AD] Figure 2D is a top view showing an alternative embodiment of the scissor device.

[0028] [Figure 3A]Figure 3A is a top view showing embodiments of a hook and V-structure for treating cellulite. [Figure 3B] Figure 3B is a top view showing embodiments of hooks and V-structures for treating cellulite. [Figure 3C] Figure 3C is a top view showing embodiments of a hook and V-structure for treating cellulite. [Figure 3D] Figure 3D is a top view showing embodiments of hooks and V-structures for treating cellulite. [Figure 3E] Figure 3E is a top view showing embodiments of hooks and V-structures for treating cellulite. [Figure 3F] Figure 3F is a top view showing embodiments of a hook and V-structure for treating cellulite.

[0029] [Figure 4A] Figure 4A is a top view and a perspective view showing the treatment structure that embodies the hook treatment structure. [Figure 4B] Figure 4B shows a top view and a perspective view illustrating the treatment structure that embodies the hook treatment structure. [Figure 4C] Figure 4C shows a top view and a perspective view illustrating the treatment structure that embodies the hook treatment structure. [Figure 4D] Figure 4D shows a top view and a perspective view illustrating the treatment structure that embodies the hook treatment structure. [Figure 4E] Figure 4E shows a top view and a perspective view illustrating the treatment structure that embodies the hook treatment structure. [Figure 4F] Figure 4F shows a top view and a perspective view illustrating the treatment structure that embodies the hook treatment structure. [Figure 4G] Figure 4G shows a top view and a perspective view illustrating the treatment structure that embodies the hook treatment structure.

[0030] [Figure 5A]Figure 5A is a top view showing the hook and slide approaches to the treatment structure. [Figure 5B] Figure 5B is a top view showing the hook and slide approaches to the treatment structure. [Figure 5C] Figure 5C is a top view illustrating the hook and slide approaches to the treatment structure. [Figure 5D] Figure 5D is a top view showing the hook and slide approaches to the treatment structure. [Figure 5E] Figure 5E is a top view showing hook and slide approaches to the treatment structure. [Figure 5F] Figure 5F is a top view showing the hook and slide approaches to the treatment structure. [Figure 5G] Figure 5G is a top view showing the hook and slide approaches to the treatment structure. [Figure 5H] Figure 5H is a top view showing the hook and slide approaches to the treatment structure. [Figure 5I] Figure 5I is a top view showing the hook and slide approaches to the treatment structure.

[0031] [Figure 6A] Figure 6A is a top view showing the segmented treatment structure. [Figure 6B] Figure 6B is a top view showing the segmented treatment structure.

[0032] [Figure 7A] Figure 7A is a top view showing a treatment device having a connecting hook and a cutting structure. [Figure 7B] Figure 7B is a top view showing a treatment device having a connecting hook and a cutting structure. [Figure 7C] Figure 7C is a top view showing a treatment device having a connecting hook and a cutting structure. [Figure 7D] Figure 7D is a top view showing a treatment device having a connecting hook and a cutting structure. [Figure 7E] Figure 7E is a top view showing a treatment device having a connecting hook and a cutting structure. [Figure 7F] Figure 7F is a top view showing a treatment device having a connecting hook and a cutting structure. [Figure 7G] Figure 7G is a top view showing a treatment device having a connecting hook and a cutting structure. [Figure 7H] Figure 7H is a top view showing a treatment device having a connecting hook and a cutting structure. [Figure 7I] Figure 7I is a top view showing a treatment device having a connecting hook and a cutting structure. [Figure 7J] Figure 7J is a top view showing a treatment device having a connecting hook and a cutting structure. [Figure 7K] Figure 7K is a top view showing a treatment device having a connecting hook and a cutting structure. [Figure 7L] Figure 7L is a top view showing a treatment device having a connecting hook and a cutting structure. [Figure 7M] Figure 7M is a top view showing a treatment device having a connecting hook and a cutting structure. [Figure 7N] Figure 7N is a top view showing a treatment device having a connecting hook and a cutting structure.

[0033] [Figure 7O] Figure 7O is a perspective view showing one embodiment of the processing system and processing apparatus. [Figure 7P] Figure 7P is a perspective view showing one embodiment of the processing system and processing apparatus.

[0034] [Figure 7R] Figure 7 is a top view, illustrating further features of the treatment device. [Figure 7S] Figure 7 is a top view, illustrating further features of the treatment device. [Figure 7T] Figure 7 is a top view, illustrating further features of the treatment device. [Figure 7U] Figure 7 is a cross-sectional view, illustrating further features of the treatment device. [Figure 7V] Figure 7 is a top view, illustrating further features of the treatment device. [Figure 7W] Figure 7 is a top view, illustrating further features of the treatment device. [Figure 7X] Figure 7 is a top view, illustrating further features of the treatment device.

[0035] [Figure 7Y] Figure 7Y is a side view illustrating yet another approach to the treatment device. [Figure 7Z] Figure 7Z is a side view illustrating yet another approach to the treatment device. [Figure 7AA] Figure 7AA is a side view illustrating yet another approach to the treatment device.

[0036] [Figure 7AB] Figure 7AB is a side view illustrating an alternative approach to the blade structure. [Figure 7AC] Figure 7AC is a side view illustrating an alternative approach to the blade structure. [Figure 7AD] Figure 7AD is a side view illustrating an alternative approach to the blade structure. [Figure 7AE] Figure 7AE is a side view illustrating an alternative approach to the blade structure.

[0037] [Figure 8A] Figure 8A is a perspective view showing the components of the spot treatment system. [Figure 8B] Figure 8B is a perspective view showing the components of the spot treatment system. [Figure 8C] Figure 8C is a perspective view showing the components of the spot treatment system.

[0038] [Figure 8D] Figure 8D is a side view illustrating an additional approach to the processing structure. [Figure 8E] Figure 8E is a side view illustrating an additional approach to the processing structure. [Figure 8F] Figure 8F is a side view showing an additional approach to the processing structure. [Figure 8G] Figure 8G is a side view showing an additional approach to the processing structure. [Figure 8H] Figure 8H is a side view showing an additional approach to the processing structure. [Figure 8I] Figure 8I is a side view illustrating an additional approach to the processing structure. [Figure 8J] Figure 8J is a side view showing an additional approach to the processing structure. [Figure 8K] Figure 8K is a side view illustrating an additional approach to the processing structure.

[0039] [Figure 8L] Figure 8L is a cross-sectional view showing various treatment approaches, including lassoing. [Figure M8] Figure 8M is a cross-sectional view showing various treatment approaches, including lassoing. [Figure 8N] Figure 8N is a cross-sectional view showing various treatment approaches, including lassoing. [Figure 8O] Figure 8O is a cross-sectional view showing various treatment approaches, including lassoing. [Figure 8P] Figure 8P is a cross-sectional view showing various treatment approaches, including lassoing. [Figure 8Q] Figure 8Q is a cross-sectional view showing various treatment approaches, including lassoing. [Figure 8R] Figure 8R is a cross-sectional view showing various treatment approaches, including lassoing. [Figure 8S] Figure 8S is a cross-sectional view showing various treatment approaches, including lassoing. [Figure 8T] Figure 8T is a cross-sectional view showing various treatment approaches, including lassoing. [Figure 8U]Figure 8U is a cross-sectional view showing various treatment approaches, including lassoing. [Figure 8V] Figure 8V is a cross-sectional view showing various treatment approaches, including lassoing.

[0040] [Figure 9A] Figure 9A is a cross-sectional view showing an atherectomy-type device and its use. [Figure 9B] Figure 9B is a cross-sectional view showing an atherectomy-type device and its use.

[0041] [Figure 10A] Figure 10A is a side view showing components of another treatment system. [Figure 10B] Figure 10B is a side view showing components of another treatment system. [Figure 10C] Figure 10C is a side view showing components of another treatment system.

[0042] [Figure 11] Figure 11 is a side view, showing yet another component of the treatment system.

[0043] [Figure 12A] Figure 12A is a top view illustrating a further approach to the processing system. [Figure 12B] Figure 12B is a top view illustrating a further approach to the processing system. [Figure 12C] Figure 12C is a top view illustrating a further approach to the processing system.

[0044] [Figure 13A] Figure 13A shows a bottom and top view illustrating yet another approach to the processing system. [Figure 13B] Figure 13B shows a bottom and top view illustrating yet another approach to the processing system. [Figure 13C] Figure 13C shows a bottom and top view illustrating yet another approach to the processing system. [Figure 13D] Figure 13D shows a bottom and top view illustrating yet another approach to the processing system. [Figure 13E] Figure 13E shows a bottom view and a top view illustrating yet another approach to the processing system. [Figure 13F] Figure 13F shows a bottom view and a top view illustrating yet another approach to the processing system. [Figure 13G] Figure 13G shows a bottom and top view illustrating yet another approach to the processing system. [Figure 13H] Figure 13H shows a bottom and top view illustrating yet another approach to the processing system. [Figure 13I] Figure 13I shows a bottom view and a top view illustrating yet another approach to the processing system. [Figure 13J] Figure 13J shows a bottom and top view illustrating yet another approach to the processing system.

[0045] [Figure 14A] Figure 14A is a bottom view showing another embodiment of the processing system. [Figure 14B] Figure 14B is a bottom view showing another embodiment of the processing system. [Figure 14C] Figure 14C is a bottom view showing another embodiment of the processing system. [Figure 14D] Figure 14D is a perspective view showing another embodiment of the processing system. [Figure 14E] Figure 14E is a perspective view showing another embodiment of the processing system. [Figure 14F] Figure 14F is a perspective view showing another embodiment of the processing system.

[0046] [Figure 15A] Figure 15A is a perspective view showing yet another embodiment of the processing system. [Figure 15B] Figure 15B is a perspective view showing yet another embodiment of the processing system. [Figure 15C] Figure 15C is a perspective view showing yet another embodiment of the processing system. [Figure 15D] Figure 15D is a top view showing yet another embodiment of the processing system. [Figure 15E] Figure 15E is a top view showing yet another embodiment of the processing system. [Figure 15F] Figure 15F is a top view showing yet another embodiment of the processing system.

[0047] [Figure 16A] Figure 16A is a perspective view showing alternative or additional features of the processing system. [Figure 16B] Figure 16B is a perspective view showing alternative or additional features of the processing system. [Figure 16C] Figure 16C is a perspective view showing alternative or additional features of the processing system.

[0048] [Figure 17A] Figure 17A is a perspective view illustrating further features of the processing system. [Figure 17B] Figure 17B is a perspective view showing further features of the processing system. [Figure 17C] Figure 17C is a perspective view illustrating further features of the processing system.

[0049] [Figure 18A] Figure 18A is a perspective view illustrating yet another feature of the processing system. [Figure 18B] Figure 18B is a perspective view illustrating yet another feature of the processing system. [Figure 18C] Figure 18C is a perspective view illustrating yet another feature of the processing system.

[0050] [Figure 19A] Figure 19A is a top view illustrating another alternative approach to the processing system. [Figure 19B]Figure 19B is a top view illustrating another alternative approach to the processing system. [Figure 19C] Figure 19C is a top view illustrating another alternative approach to the processing system.

[0051] [Figure 20A] Figure 20A is a partially cross-sectional side view showing alternative or additional features of the handle for the processing system. [Figure 20B] Figure 20B is a partially cross-sectional side view showing alternative or additional features of the handle for the processing system.

[0052] [Figure 21A] Figure 21A is a partial side cross-sectional view showing a further embodiment of the processing system. [Figure 21B] Figure 21B shows a partial side section view and a top view illustrating a further embodiment of the processing system. [Figure 21C] Figure 21C is a partial side cross-sectional view showing a further embodiment of the processing system. [Figure 21C] Figure 21C is a top view showing a further embodiment of the processing system. [Figure 21D] Figure 21D is a top view showing a further embodiment of the processing system. [Figure 21E] Figure 21E is a top view showing a further embodiment of the processing system.

[0053] [Figure 22A] Figure 22A is a side cross-sectional view showing another approach to the handle assembly for the processing system. [Figure 22B] Figure 22B is a side cross-sectional view showing another approach to the handle assembly for the processing system. [Figure 22C] Figure 22C is a side cross-sectional view showing another approach to the handle assembly for the processing system.

[0054] [Figure 23A] Figure 23A is a side section cross-sectional view showing yet another approach to the handle assembly for the processing system. [Figure 23B] Figure 23B is a side section view showing yet another approach to the handle assembly for the processing system. [Figure 23C] Figure 23C is a side section view showing yet another approach to the handle assembly for the processing system.

[0055] [Figure 24A] Figure 24A is a perspective view showing a preferred embodiment of the processing system. [Figure 24B] Figure 24B is a side view showing a preferred embodiment of the processing system. [Figure 24C] Figure 24C is a cross-sectional view showing a preferred embodiment of the processing system. [Figure 24D] Figure 24D is a side view showing a preferred embodiment of the processing system. [Figure 24E] Figure 24E is a side view showing a preferred embodiment of the processing system. [Figure 24F] Figure 24F is a cross-sectional view showing a preferred embodiment of the processing system. [Figure 24G] Figure 24G is a cross-sectional view showing a preferred embodiment of the processing system. [Figure 24H] Figure 24H is a cross-sectional view showing a preferred embodiment of the processing system.

[0056] [Figure 24I] Figure 24I is a perspective view showing an alternative chip assembly. [Figure 24J] Figure 24J is a perspective view showing an alternative chip assembly. [Modes for carrying out the invention]

[0057] Before describing the system and method, it should be understood that this disclosure is not limited to the specific embodiments described, as they may naturally differ. Furthermore, since the scope of this disclosure is limited only by the appended claims, it should be understood that the terms used herein are for the purpose of describing specific embodiments only and are not intended to limit them.

[0058] Where a range of values ​​is provided, unless the context clearly indicates otherwise, each intervention value between the upper and lower limits of that range, up to one-tenth of the lower limit, is also specifically disclosed. Each subrange between any stated value or intervention value within a stated range and any other stated value or intervention value within that stated range is included within this disclosure. The upper and lower limits of these subranges may independently be included in or excluded from the range, and each range in which either, both, or either of the upper limits are included is also included within the scope of this disclosure, subject to any particularly excluded limits within the stated range. Where a stated range includes one or both of the limit values, the range excluding one or both of the limit values ​​in which they are included is also included within this disclosure.

[0059] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as those generally understood by a person skilled in the art to which this disclosure belongs. Any methods and materials similar or equivalent to those described herein may be used in carrying out or testing the disclosure, but preferred methods and materials are described here.

[0060] It should be noted that, as used herein and in the appended claims, the singular forms "a," "an," and "the" include plural references unless the context clearly indicates otherwise. For example, a reference to "system" includes one or more systems and their equivalents known to those skilled in the art.

[0061] Referring to Figures 1A-B, a person is shown with cellulite 200 on his thighs and buttocks. In one approach to treatment, the dimples, linear depressions and / or other depressions characteristic of the cellulite 200 to be treated are preferably identified or circled with markings 204 while the patient is standing, as for most patients, the appearance of the cellulite disappears when lying prone because gravity pulls in a different direction. The patient may be asked to bulge or clench the tissue to help identify the treatment area. An area of ​​about 8 mm around the target depression, linear depression, or other depression is marked on the patient's skin to identify an area for the physician to confirm the fibrous septa that are causing the depression, linear depression, or other depression. Such a margin can be of various shapes indicated by the cellulite or depression formed in the patient's anatomical structure, and can be defined, for example, as a circular, elliptical, or D-shaped treatment margin, and the margin can encompass one or more target areas. In another embodiment, a computerized image processing device is used to locate and mark dimples and / or depressions. In Figures 1A-B, 44 dimples and depressions are marked for possible treatment. The physician treating the patient determines the instrument insertion sites 210 and pathways 212 that will most efficiently treat the cellulite while minimizing the amount of subcutaneous insertion sites and instrument pathways. Preferably, the instrument insertion sites are selected in locations that are not visible when the buttocks are in natural contact, such as where the buttocks meet the thighs, for improved cosmetics after the treatment healing period. In certain patients, the inner thigh is selected as the insertion site, which becomes less noticeable as it heals, or the outer area of ​​the thigh or the upper buttocks are used as alternative or additional insertion sites. Such treatment pathways can preferably be selected by the operator using straight edges that curve or contour to suit the patient, or they can be automatically generated by employing a computerized controller programmed to most efficiently address and measure the cellulite present in the predefined treatment sites.A computerized controller can be associated with a scanner that identifies specific depressions and areas for treatment, for example, by employing laser technology. In this regard, the computerized controller includes a program specific to cellulite treatment and is used in conjunction with electronic and mechanical devices, consisting of or including a non-transient computer-readable storage medium and a computer program mechanism embedded therein, for both identifying treatment areas and devising primary and alternative approaches to treatment. In another embodiment, a computerized visualization and treatment planning device is used to assist the physician in determining the location of the insertion site and the path toward the marked target.

[0062] Once a treatment approach is planned, the patient lies prone on the treatment table. Alternatively, due to the minimally invasive nature of the current approach, especially for a small number of patients, the patient can be treated standing, leaning forward on a support while standing, or somewhere between standing and leaning forward, allowing gravity to help identify the target septum and confirm treatment. The patient may also be asked to flex or clench their muscles to help pinpoint the treatment area. Furthermore, the device creates a complete 3D map of all cellulite relative to normal skin. By comparing the volume improvements of divots and dimples with the normal, idealized surface, the operator can calculate the overall and local volume effects of the treatment and track improvement over time.

[0063] In one specific approach, as shown in Figure 1C, cellulite treatment follows or references Langaline 214 present within the tissue. Langaline 214 is recognized to correspond to the natural orientation of tissue fibers present in humans and is roughly parallel to the orientation of muscle fibers. Langaline 214 can be used as a reference for treating cellulite. Notably, cellulite appears to be related to the location of Langaline and to fall along it. In one approach, multiple therapeutic targets along Langaline are treated from a single entry 216, and Langaline 214 provides a map along which the treatment is achieved. Thus, treatment can be directed along Langaline 214, as shown in the thigh for illustrative purposes to treat targeted septa, or, additionally or alternatively, laterally relative to Langaline 214, as shown in the buttocks for illustrative purposes to treat targeted septa. Treatment can also be directed to various locations relating to connective tissue or septa. In other words, the diaphragm can be engaged, stretched, reoriented, torn, cut, sliced, ruptured, or destroyed from various sides or angles relative to the diaphragm. Therefore, the diaphragm can be treated from above, below, or from the side to obtain the best results. For example, in certain situations, it has been observed that cellulite is most visible on a standing individual, so it may be most effective to perform treatment from above a particular connective tissue in order to utilize gravity to align the therapeutic force acting on the connective tissue with the direction of gravity or the direction in which it works best on a standing body. Furthermore, with limited femoral line treatment, rather than destroying or treating the entire lower diaphragm associated with the linear depression of the skin, the treatment involves approaching the linear depression perpendicular to or oblique to it, and releasing only a portion of the lower diaphragm. The treatment instrument is reheated and slightly repositioned, such as by a few millimeters, thereby leaving an area of ​​the diaphragm that has not been destroyed or treated, and then additional diaphragms are destroyed or treated, and if necessary, reheated, repositioned, and further destroyed or treated diaphragms are destroyed or treated.

[0064] Turning to Figure ID, we see a cellulite treatment assembly 220, which includes a handle 222 and a longitudinally extending elongated member or needle-sized structure, preferably a structure with a diameter of 2 millimeters or less, such as 224. A force gauge (electronic or mechanical) may be provided to ensure that a predetermined amount of force is applied to the tissue when testing the septum to prevent excessive or insufficient pulling. The distal end portion of the elongated member 224 comprises a treatment device 225 capable of performing one or more of the following actions on connective tissue: engaging, stretching, slicing, cutting, or destroying (e.g., Figures 1E-N). All cutting means can be combined with or further energized with RF, laser, ultrasound, or thermal energy to produce cutting and coagulation together or separately. Furthermore, the cutting means may include blades that are one or more of highly sharpened, hardened, or coated (e.g., titanium nitride or Teflon®). In certain embodiments, there may be a single or two intrusion sites on either side of the patient, one high on the buttocks and the other along the crease or transition between the buttocks and thigh, or on the inner thigh. Such sites are characterized by being easily concealed by nature or clothing. Treatment targets, depressions, and depressions marked on the skin surface while the patient is standing often disappear when the patient lies prone. The disclosed intervention device is configured so that the user approaches the target location and first uses the intervention device to press, pull, or otherwise stretch septa beneath the skin in the target area to identify specific septa affecting the target and / or septa that are causing the appearance of cellulite. In other words, septa beneath the skin are pulled or pressed to find septa that produce depressions or depressions on the skin surface. It should be noted that sufficient force is employed to pull or press the septa to create depressions or depressions in the skin, and an assessment is made to determine whether the created depressions or depressions correspond to target depressions or depressions marked for treatment. If so, the engaged partition is processed as described herein, and this method is repeated for all target processing areas.The operator also verifies that all target depressions or septa associated with depressions have been treated with the treatment device and that all target depressions or septa associated with depressions have been completely released. Septa define a complex network of connections between tissue layers beneath the skin within and around the cellulite target area, and it is recognized that septa include "webs," "trunks," and "branches from the trunks" that connect the tissue layers. Furthermore, septa are quite elastic and have been observed to stretch by about 10-20 mm before creating depressions associated with the target site. For this reason, multiple passes within the treatment area may be necessary to ensure that all septa associated with the treatment area have been cut, in order to confirm that the entire network of septa has been cut. Particular care is needed as secondary septa are difficult to confirm if the primary septa have not been cut. Secondary septa are septa that create depressions that are shallower or smaller than those of the primary septa. When the patient is standing, shallow depressions are not noticeable, but once the primary septa are cut and the deep depressions disappear, shallow and small depressions caused by secondary septa become more prominent. Furthermore, secondary septa and septal patterns are anticipated and subsequently searched for in areas where cellulite appears in multiple or closely spaced locations. This precisely addresses the resolution of connective septa by releasing hook-shaped septa that create depressions outside the treatment area without cutting, while cutting the septa associated with the target cellulite. By taking multiple precise passes under the target area, all primary and secondary cellulite-forming septa are treated.

[0065] For some treatment targets, a better approach may be taken by taking an entrance located below the treatment target, advancing the end of the intervention device beyond the treatment target, and then pulling it downward (effectively "down" if the patient is standing), for example, for treatment targets in the legs, while the patient is lying down. One or more strain gauges can be incorporated into the treatment device to help identify the target septum and to assess the progress and completion of treatment of the septum. This facilitates targeting of important septums in a less impactful way and, ideally, can minimize bruising or other problems associated with cutting or destroying a wide area around the target. Thus, various approaches for treating cellulite, which is expressed as depressions or depressions on the skin surface, are presented here. Furthermore, a handle portion can be employed to form depressions in the skin, allowing the intervention device to be inserted subcutaneously. The treatment regimen is selected for insertion of the intervention device based on the anatomical structure of the subject related to septa, which connect tissue layers that define chambers holding adipose tissue or other tissue. If desired, while under anesthesia and / or sedation, ultrasound can be used to evaluate the subcutaneous trajectories and depths of various connective tissue zones that cause surface irregularities. Ultrasound evaluation can assist in selecting specific trajectories for desired depths. Ultrasound evaluation also helps in strategically positioning the distal end of a treatment instrument at the connection point between the connective tissue and the dermis or facial tissue.

[0066] As shown in Figure IE, the target locations of cellulite to be treated are marked on the surface of the skin. This can be done when the patient is standing to best see the cellulite. As schematically shown in Figure IF, cellulite may decrease or disappear when the individual is lying down, and this should happen, with the marks identifying and confirming its location.

[0067] In one embodiment, a local anesthetic is applied to the subcutaneous treatment site. In one approach, a long anesthetic needle is tunneled through the marked treatment site, and the anesthetic is administered below the marked site along the tunneling pathway. It may be desirable to apply additional local anesthetic percutaneously using a shorter needle so that the anesthetic extends beyond the labeled target site. The distal end portion of the cellulite treatment assembly 220 is then inserted through the skin and guided to the vicinity of the dermis, as the blunt tip can be tracked as it is advanced toward a septum 350 (Figure 1G) near the marked position 204. Notably, the end of the cellulite treatment assembly 220 in any of the disclosed embodiments may also include a tapered nose cone configured to define a tapered profile and assist in advancing the device between tissue layers (see, for example, Figure 24B). The entry site is selected to minimize postoperative healing while limiting the use of anesthesia. The inventors found that, given the elasticity of the diaphragm 350, the distance from the marked position 204 to the position where the treatment assembly 220 is inserted into the skin is preferably at least about 2 cm, so as to be sufficient to pull and break the diaphragm 350 without the tip of the cellulite treatment assembly protruding from the skin in the process. Furthermore, the depth beneath the skin into which the diaphragm 350 is preferably engaged (i.e., cut, slice, tear, stretch, reorient (e.g., cruciate) or broken) is identified and determined. After determining the subcutaneous depth to be accessed for cutting, slicing, tearing, stretching, reorienting (e.g., cruciate) or breaking the diaphragm 350, a cellulite treatment assembly or other tool having a sharp or blunt tip is inserted through the skin, advanced between the layers of subcutaneous tissue, and advanced toward the diaphragm 350. In one approach, the distal end portion of the cellulite treatment assembly is configured with an illuminated tip 352 that is bright enough to be seen through the skin. The intensity of the light emitted by the tip 352 can be set to a specific constant level such that the light appearing at skin level as a circle or projection is of a predetermined size at a preferred depth below the skin for cutting or otherwise engaging the diaphragm 350. In this way, the treatment device is advanced to the target site. At the target site, the user adjusts the depth of the tip of the treatment device so that the circle or projection of light is of a predetermined size. Instead of having an illuminated tip, it is also possible to position the illumination element proximal to the treatment device 225. For example, a light source 354 (see Figure 10) can be the location of illumination. In this embodiment, the projection of light can be positioned below or to the side of the target site so that it is clear that the circle or projection of light is in a predetermined location and the treatment element is beyond the predetermined location. If the septum 350 is tested and confirmed to be a target for treatment, the septum 350 can be treated while maintaining the circle or projection at a predetermined size. The user can also use the size of the circle or projection of light to maintain the depth when advancing the tip of the treatment device subcutaneously to the target. In an alternative or different embodiment, a sharpened tip is employed to create access to the target tissue, and thus the tool can create a desired path not only within the tissue but also between tissue layers. The depth to which these instruments are advanced is expected to be between approximately 3 mm and 10 mm below the skin surface, although smaller and larger depths are also expected to be optimal for specific subjects. More superficial treatment depths are particularly effective in cutting all septa associated with the treatment site, and it is recognized that secondary septa can be cut in the initial pass within the treatment site. Thus, in a relatively superficial approach, the treatment device is advanced to a depth closer to the dermis than to the superficial fascia. In any case, the depth selected is chosen for cutting, slicing, fracturing, tearing, stretching, or reorienting the subject's septa 350. Furthermore, in one embodiment, it will be understood that the device 220 is formed from a substantially rigid material to access a consistent plane below the skin surface.

[0068] The treatment device is positioned by palpation, direct visualization (e.g., transmitted illumination or endoscopy) or non-invasive visualization (e.g., ultrasound or fluoroscopy), or other means of determining the position of the intervention device, such as marking along the length of the device and its path in the tissue, or by providing the intervention device with radiographic markers to position the device in the area below where cellulite (e.g., depressions) is observed on the subject's skin. The treatment device is advanced through the septum 350 until the treatment device 225 is optimally positioned to identify the target septum and achieve cellulite removal or minimization treatment. In one approach, as shown in Figures 1H-J, the treatment device 225 is passed over the septum 350, a hook is deployed, and then it is pulled proximal to tension the septum 350, for example (Figure IK). In an alternative approach, the treatment device 225 is extended several millimeters laterally beyond the target position, preferably about 1 to about 10 millimeters, more preferably about 3 to about 6 millimeters, the hook is deployed, then swept laterally toward the target, followed by pulling proximally, pulling and tensing the diaphragm. In one embodiment, during the initial deployment, the hook structure defines a relatively flat angle, i.e., the edge of the hook is at about 80 degrees with respect to the long axis of the elongated member 224, which results in providing substantial reach to the treatment instrument. Once it is time to cut or otherwise engage the diaphragm 350, the treatment instrument 225 is operated so that its blade or other cutting surface is exposed at a steeper angle suitable for cutting, such as about 70 degrees with respect to the long axis of the elongated member 224 (see also Figures 13A-B). During these and other steps, transmitted illumination may be employed to track the treatment device and guide the procedure. Mark 204 allows for easier targeting of the septum 350 while transmitted illumination is used to visualize the position of the treatment device 225. In another approach, a separate device may be employed to engage the septum 350 to determine whether such a septum is the cause of a depression or depression that has appeared on the surface of the skin.Such secondary devices can be positioned remotely from the target (i.e., the lesion) and are configured to apply tension to the skin surface in a predetermined direction to create the effect of gravity and visualize the lesion while the patient is lying down (i.e., a broad area of ​​adhesive attached to a spring mechanism so that a predetermined force is applied relatively parallel to the skin surface in the direction in which the skin would move when standing due to gravity). Using this additional device may further aid in confirming and locating the lesion and confirming that the treatment was effective. In addition, in various approaches, a portion of the elongated member can be configured to transition from a small state to a wide or large state, in which the wide or large state presents a cutting surface (i.e., a sharp blade or energy) for cutting tissue, and the device has a size and shape that allows it to be inserted through the skin and engage one or more areas of the subcutaneous septum.

[0069] It is noted that the septa causing the depression or indentation may not be directly beneath the depression or indentation, but may come from various angles and positions relative to the depression or indentation seen on the skin, and may be caused remotely by one or a few septa or many septa. Thus, engaging a certain septa in this way will reflect some change in the depression or indentation on the skin. A determination is made regarding the correspondence between the mark 204 made on the skin and the dimple that is formed or reformed. If the first septa 350 that the user pushes or pulls with the tool do not reproduce the dimple or indentation in the marked area 204, the user releases those first engaged septa, repositions the tool with a different septa, and pushes or pulls again. This is repeated until the septa causing the depression or indentation at the marked location is identified (Figure IK). Once the appropriate septum is identified, the tool 225 is manipulated to cut, slice, break, reorient, stretch, or tear the septum 350 connecting the tissue layers. In one approach, the blade 353 is deployed and presented for treatment (Figure 1L). In another approach, a balloon (not shown) is inflated to break the septum.

[0070] After the appropriate septa have been cut, destroyed, stretched, or reoriented, the treatment element 225 is returned to its initial folded configuration. The treatment element is then advanced beyond the marked treatment site, the treatment element (e.g., a hook) is unfolded, and then pulled back below the marked treatment site to ensure that all septa that cause the marked depression or depression are separated intraoperatively. Again, multiple passes are made to ensure that all cellulite-generating septa, including secondary septa, are cut. If not, the tool is manipulated to cut, destroy, stretch, or realign additional septa. This procedure is repeated until all septa involved in the formation of the marked depression or depression are cut or sufficiently stretched and the depression or depression can no longer be reshaped intraoperatively using the tool. Furthermore, to ensure that the marked treatment area is sufficiently isolated, the treatment can be performed with the patient lying down, and then the patient can be asked to stand up from the treatment table to allow gravity to act and confirm that the marked treatment area has been treated. If the patient is standing, measures should be taken to maintain sterility and appropriate draping should be applied. If necessary, further treatment can be performed on untreated areas. Such a procedure results in the selective rupture, tearing, cutting or slicing of the targeted septum 350, as well as the removal or minimization of the appearance of depressions and cellulite on the skin (Figure 1M). The treatment elements (e.g., hook and / or blade) are then retracted inward (Figure IN partially folded), and the tool 220 is withdrawn from the body or removed from the site to be repositioned along and in any direction within the target tissue surface to treat additional areas.

[0071] Referring to Figure 10R, in an additional or alternative approach, a second light source 354, such as an LED (or other light source such as the tip of an optical fiber), may be configured along the cellulite treatment assembly 220 in close proximity to the irradiation tip 352, or, if the cellulite treatment assembly has a first light source in close proximity to the treatment element, the second light source may be located at the tip 352. In various approaches, the light source, such as an LED chip, may be configured at the tip of a treatment device having an electrical wire running proximal to it for control by an operator, or otherwise along it, or the light source may be generated by an LED or an optical fiber extending along or to the tip of a device in which the light source is configured within a proximal position such as the handle of the treatment device. By configuring such light sources 352, 354 in this manner, the depth of the cellulite treatment assembly 220 in the tissue and the position of the treatment element and / or tip can be assessed. Of note, the light source or source is positioned between tissue layers such that the structure configured to treat the septum is positioned distal to the target septum or laterally to the target, but at least adjacent to the target distance, so that the septum is efficiently and effectively hooked, engaged, and cut. When the cellulite treatment assembly 220 is placed within a first relatively shallow desired depth, as shown in Figure 10P, the light sources 352, 354 appear spaced apart and define a discrete pattern when viewed through transmitted illumination through the skin (Figure IP). When the cellulite treatment assembly 220 is placed deeper within the tissue (Figures 1Q-R), the light sources 352, 354 overlap due to the natural dispersion of light emitted from the light sources 352, 354 (Figure 1R). The operator of the treatment system can determine the depth of the cellulite treatment assembly 229 by paying attention to the discrete pattern of light or the degree of light overlap, the dispersion and intensity of light emitted from the light sources 352, 354. Therefore, the operator can guide the distal end of the treatment assembly to the desired treatment position while maintaining the desired depth beneath the skin. The light sources 352 and 354 can also be different colors to help determine the orientation of the cellulite treatment system 220 within the tissue through illumination.Furthermore, it should be noted that the second light source 354 can emit, for example, red light, while the illuminated tip 352 can emit white light, while any variation of color can be employed. Also, the color of the light can be varied according to the configuration of the treatment device, for example, the device may project white or a first color when sheathed or retracted, and change to a different or second color before and after use, such as when part of the device is deployed or tissue is cut. A strain gauge can be configured to sense the load on the treatment device during treatment, thereby facilitating a change in the color of the light source and indicating the progress or completion of targeted treatment. Furthermore, the second light source 354, or one light source located close to the treatment element, may be employed via transmitted illumination through the skin to position the cellulite treatment system relative to the treatment target area. Another advantage of the second light source, or one proximal light source, is that it can indicate to the user where the hook and blade are positioned relative to the target septum, so that the hook is properly positioned once deployed. In one embodiment, the second light source 354 is located between approximately 5 mm and 20 mm behind the first light source 352. In another embodiment, one proximal light source is located between approximately 1 mm and 25 mm behind the treatment element. Also, when the treatment instrument is being pulled proximal through the treatment target area, the illuminated tip 352 can inform the user that the hook and blade have been pulled through the target area. Furthermore, it should be noted that the light sources 352, 354 can be positioned in various alternative locations along the treatment device and can be spaced apart from each other by various amounts. Also, the cellulite treatment system may include more than two light sources of the same or different colors. In another embodiment, different colored lights can be used to indicate the state of the distal end of the instrument. For example, red light may be used to indicate that the hook and blade are inside the instrument for advancing under the skin, then white light may be used to indicate that the hook is deployed, and then red light may be used to indicate that the blade is deployed.

[0072] After treatment of one target area is completed, the procedure is repeated to treat other target areas. Thus, the same device can be employed to access tissue layers beneath depressions present in other areas or skin. Notably, in one embodiment, the device is capable of delivering anesthetic as needed or desired when progressing to additional or new sites. Thus, a system is provided configured to treat all target areas of the buttocks and thighs through a limited number of small entry points, such as through a single entry point. It is recognized that the system may further include a structure that allows the assembly to be maneuverable to the subcutaneous treatment site. In such embodiments, the device is configured to define a material that is flexible in the longitudinal direction, and the instrument will be maneuvered to the desired position in the tissue. Furthermore, in certain applications, the device has a rigidity that varies along its length. In another embodiment, the treatment device is embodied in a deflectable catheter.

[0073] Furthermore, in certain embodiments, the cellulite treatment system includes a squeezing tool that reproducibly applies lateral force to the skin to accentuate cellulite depressions or appearances, so that pre- and post-treatment effects can be obtained without requiring the patient to stand up and / or without removing the intervention tool. The squeezing tool may be embodied, for example, as a clamp having elongated legs on its opposite side, or as four fingers that are deployed on the surface of the skin and, when acted upon or adjacent to a target cellulite area, pull radially inward. In addition, the patient is instructed to clench the muscles of their buttocks and / or legs to identify the treatment site and confirm the treatment while lying or standing on the treatment table. In another embodiment, a skin stabilizer, such as a suction stabilizer, may be used to control the depth to which the cellulite treatment tool is advanced under the skin and to help maintain the target position as the tool is advanced.

[0074] In one or more approaches, the treatment system may additionally or alternatively include a template 500 to assist in locating and identifying the treatment site (see Figures 1S-U). In one approach (Figures 1S-T), the handle 222 of the treatment assembly 220 is configured to releasably engage with the proximal end 501 of the template 500, where the length of the template 500 matches and is parallel to the length of the elongated member 224 of the treatment assembly 220. The distal end portion of the template 500 includes an opening 502 having size and shape corresponding to the treatment device 225 configured at the end of the elongated member 224 of the treatment device. Thus, the opening 502 indicates where the treatment device 225 is deployed. One or more additional markings may also be included in the template 500 to locate other structures of the treatment assembly 220. In use, the elongated member 224 is positioned between tissue layers, the template 500 is positioned on the skin outside the body, and the opening 502 of the template 500 is positioned over a previously marked or otherwise wisely identified cellulite depression targeted for treatment. In this approach, the treatment assembly 220 may lack light to provide transmitted illumination, or this embodiment may be used in combination with transmitted illumination. Once positioned in this manner, the treatment assembly 220 is operated to cut through a septum associated with the targeted treatment site. In an alternative approach (Figures 1U-V), the template 500 may define a structure not connected to the treatment assembly 220, configured to be positioned outside the skin with its opening 502 positioned over the area targeted for treatment. The size of the opening 502 can additionally or alternatively be used to set or confirm the appropriate depth of the treatment device 225, i.e., when transmitted light fills the opening, the operator can know that the treatment device 225 is at the desired depth. Therefore, this approach is intended to include a treatment assembly 220 that includes a light 352 that provides transmitted illumination to assist in the proper positioning of the treatment device 225.Once light is transmitted and illuminated through the opening 501 of the template 500, the treatment device 225 can be operated to cut the target septum.

[0075] The light transmission assembly can be configured in various ways (see Figures 1W-Y). In one approach, the light source 354 is a 5mm red LED or another LED that provides light of the desired wavelength. As shown in Figure 1W, the light generated by the light source 354 transmits the light energy to the proximal end of the optical fiber 357 and is guided through a focusing spherical lens 355. The light fiber 357 is equipped with a ferrule 358 having an entrance chamfer that functions to guide the light transmitted from the spherical lens 355 (e.g., H-K9L glass) into the light fiber 357, thereby allowing light to be incident not only on the fiber end but also on the sides. Compared to other approaches, such an assembly is associated with less heat generation, less current draw, and reduced component costs, as well as optical output equal to or greater than that. That is, while generating significantly less heat, in one embodiment, the disclosed arrangement draws 100mAmps to generate 3.5mW of light while employing a 500 micron optical fiber. An alternative configuration is shown in Figure IX, which includes an assembly further comprising a collimating lens 359 to facilitate further focusing of the light energy from the light source 354 to the spherical lens 355. Here, the ferrule is not required as a guide because the collimating lens facilitates the necessary focusing.

[0076] As shown in Figure 1Y, in one embodiment, the optical fiber 357 is configured within a sheath 359 that extends substantially the length of the elongated member 224 of the treatment device. The distal end of the optical fiber 357 exits obliquely to the elongated member 224 and through a hole formed in the elongated member. A portion of the wall cut into the elongated member 224 provides support for the sheath 359. A clear epoxy or other adhesive or resin is employed to adhere the optical fiber 357 in place so that it is positioned to project light to the outside of the elongated member 224. An elongated working member 226 to which the treatment device (not shown) is attached is configured to provide space for the assembly of the sheath 359 and the optical fiber 357, and to facilitate and enable longitudinal movement thereto.

[0077] After or concurrently with treatment, an instrument 355 configured to stretch and temporarily hold the skin is placed over or on the treated septum 350 or the treated area (see Figures 1Z-1AA). Figure 1AA shows the buttocks of a subject after treatment, with the dimples gone from the skin. It should be noted that in some areas above the treated area, wrinkles may temporarily remain on the skin. In one approach, the skin stretch-holding instrument 355 is embodied in a rigid or inelastic strip containing adhesive, at least along its length or along spaced portions of the underside of the strip. The skin stretch-holding instrument has sufficient rigidity so that when the user bends the instrument along its length and releases the bending force, the instrument attempts to return to its full length. In use, the user slightly bends the instrument, bends the end of the instrument, and places the adhesive end of the instrument on the skin stretched over the treated dimple or treated area. The user then removes the instrument. When the device returns to its full length, it applies gentle tension to the entire skin, keeping the skin, including the previously indented area, in a smooth surface state over the treated dimple or treatment area during the tissue healing phase of the underlying tissue. The device is small enough to allow the patient to sit, stand, and walk normally while applying a gentle amount of tension to a small area (e.g., about 1 to 4 cm). Various different configurations of the device can be used, and the device can be positioned at various angles to the treatment site. For example, the strip can be positioned perpendicular to the length dimension of the dimple, along the length dimension of the dimple, at various angles thereto, or above or below it. Furthermore, the skin stretching retainer can specify a star shape or other configuration (not shown) that functions to stretch the skin by multiple dimensions relative to the dimple. The skin stretching retainer 355 is intended to be temporarily attached to the skin above the treatment site to aid in healing without leaving a dimple, and can be attached to the skin for several hours or several days. In another embodiment, the elastic strip can be positioned on the opposite side of the treated dimple or area.The elastic strip has adhesive at each end so that one end is placed on the skin surface near or central to the treatment site, then stretched slightly away from the treatment site, and the other end is positioned on the skin surface under tension so that when the elastic strip is released by the user, the light tension of the elastic strip gently pulls and smooths the skin. The second elastic strip can be applied in the same manner to the opposite side of the first elastic strip, or at other locations, to apply light tension in the opposite direction to smooth the skin between the first and second elastic strips. Additional elastic strips can be placed around the treated dimple or area as desired, for example, at 120 degrees apart, to apply light tension in three directions. Also, as described herein, fillers can be inserted or injected under the skin of the treatment site as desired and to further aid anatomical healing without leaving dimples in the skin.

[0078] Regarding Figures 2A-D, an approach to a blunt-tipped scissors 360, which constitutes the distal end portion of the cellulite treatment assembly 220, is shown. The blunt-tipped scissors 360 are advanced under the skin and used to engage a suspected septum. If the engagement of such a septum is to result in some change to a depression or depression expressed on the skin, as in each of the disclosed approaches and apparatus, the treatment structure, here the scissors 360, is operated to break, cut or slice the septum. Thus, the scissors 360 are opened and the septum is placed between its blades. The blades are then advanced against the septum or closed with respect to the septum, thereby cutting, slicing or severing the septum, and thus relieving tension between tissue layers and eliminating or minimizing the appearance of a depression or depression on the skin. The operation of the scissors is achieved from the proximal end of the treatment apparatus, for example, by pulling a wire or advancing and pushing an elongated member associated with the scissor arrangement. Illumination may be provided by a light 362 configured proximal to the scissors 360, such that transmitted illumination may be employed to track the position of the distal portion of the treatment assembly 220. In addition, or alternatively, in each disclosed embodiment, illumination may be provided via a light guide from an external light source or via one or more LEDs. The illumination assists the user in both locating the treatment device and proper depth placement, as transmitted illumination decreases as the depth of the tool increases. In one embodiment, the amount of illumination is set to ensure proper depth of the treatment device or structure, and the target illumination level is adjusted for skin type, thickness, and the presence of fat and pigment. As shown in Figures 2C–D, in one embodiment, the first scissor arm 363 is rotatably mounted on a curved link 364 which is rotatably mounted on a push rod 365 in turn. The second scissor arm 366 includes a curved slot 367 that receives a boss 368 extending from the pusher of the treatment device to guide the movement of the second scissor arm 366. Furthermore, the first and second scissor arms 363, 366 are rotatably mounted at the end of the treatment device to provide controlled scissor motion of the arms.The longitudinal movement of the push rod 365 via its connection to link 364, and the interaction between the curved slot 367 and boss 368, cause the scissor arms 363, 366 to be converted from a closed (Figure 2C) configuration to an open (Figure 2E) configuration and in between. In each of the disclosed approaches, once the selected or targeted septum is cut, sliced, or destroyed, the cellulite treatment device can be advanced or repositioned to treat additional target areas from the same or different skin insertion devices.

[0079] Various approaches to laterally projecting tissue engagement and / or cutting structures are shown in Figures 3A–F. The distal end portion of the cellulite treatment assembly can embody a lateral opening hook arm 370 that rotates relative to the longitudinal shaft 372 to alternately display septum engagement and / or septum cutting structures (Figures 3A–B). The hook arm 370 is configured to swing out from a proximal-oriented longitudinal configuration parallel to the shaft 372 to a laterally projecting configuration in order to capture and tension the septum as the device is advanced beyond the target position and then retracted. Here again, such engagement with the septum is reflected in a physical change of the skin surface, so it can be confirmed that the septum responsible for creating depressions or indentations in the skin surface is being targeted. Destruction is brought about by tensioning the septum against the narrow edge of the hook arm 370 or against its cut or sharpened edge. The outer-facing portion of arm 370 can define a blunt structure, and the cutting edge can be positioned within the acute angle defined by arm 370. In this structure, when the partition is retracted within the acute angle defined by arm 370, increased tension can be employed to cooperate with the limited cutting edge. In Figures 3A-B, the transmitted illumination function is provided by a light 376 configured at the end of the device, while in the assembly shown in Figures 3C-D, a slit 378 formed in the shaft adjacent to the end allows for the dispersion of light energy.

[0080] In Figure 3E, the cutting and bulkhead engagement structure is embodied in a single moving arm 380, with illumination located near the hinge 382, ​​although the same could also be located at the end of the device. As in the previous embodiment, the exposed edge of the arm 380 can be blunt or sharp for cutting or slicing. Here, the arm 380 takes a distally oriented longitudinal configuration parallel to the shaft 383 for advancing between tissue layers, and the arm 380 is projected laterally outward to capture and cut or slice target bulkheads. Operation of the engagement and cutting structure can be achieved by operating a proximal lever or trigger connected to it via a wire or a longitudinally oriented shaft (not shown). Once a desired area has been treated, additional target areas can be treated. Referring to Figure 3F, the cutting and bulkhead engagement structure includes a pair of moving and rotating arms 381 that operate like scissors, rotating around the hinge 382 when a push rod 365 rotatably mounted to the first arm 381 advances in the shaft 383. The second arm 381 is mounted so as to be rotatable even at its distal point in the shaft 383. The arm 381 includes a sharp edge for cutting bulkheads. During the procedure, the bulkhead 350 is loaded laterally within the arm 381, thereby allowing tension to follow the cutting of the bulkhead 350 as the push rod 365 advances. In one embodiment, the bulkhead 350 is hooked by torque-hooking the procedure device so that the bulkhead 350 is captured within the arm 381 in an open scissor configuration in order to evaluate the bulkhead 350. Where the bulkhead 350 is identified for cutting, the arm 381 will be closed to complete the cutting. The arm 381 itself can be curved to capture the bulkhead and thus prevent the bulkhead from being pushed away before cutting.

[0081] The distal end portion of the cellulite treatment assembly 220 may optionally or additionally embody an internal static hook 388 (Figure 4A) to treat a target area from one or more skin insertion sites. The distal end portion of the assembly or the hook itself 388 may be positioned around tissue and employed to engage and test the tissue to identify target septa. Sharp edges within the hook may be used to engage and cut targeted and identified septa associated with the appearance of cellulite on the skin. As shown in Figure 4B, a concentric sliding tube 390, operable from the proximal end of the cellulite treatment assembly, may be additionally provided to move proximal and distal to the hook 392. The tube 390 may include selectively sharpened edges or may be blunted to thus cooperate with the hook 392 to capture, cut, slice, tear, or destroy septa. The assembly may further be advanced in a rotating manner to cut or slice septa. When tube 390 is used to cut the tissue, the cuts are made simultaneously and at intervals through the septum, resulting in a portion of the tissue being removed from the septum.

[0082] As shown in Figures 4B-C, the tube 390 may optionally or additionally include a hook cover or closer 399. The hook cover or closer 399 is attached to the end of the tube 390 and is advanceable to engage with the hook 392, closing the hook opening. In this configuration, the hook 392 can move within the patient's anatomical structure without snagging on tissue structures within the superficial adipose space. When the hook cover or closer 399 is disengaged from the hook structure 392, the hook 392 can present a structure for engaging with a target septum.

[0083] Referring to Figures 4E-F, an alternative approach to the stationary hook 388 is shown. Although not shown, the end of the stationary hook 388 can include a light source and may be deployable from the slide tube 390. The sharp edge 389 on the dorsal side of the hook 388 is used to engage and cut the targeted and identified diaphragm associated with the appearance of cellulite on the skin. Here, the diaphragm is hooked and the stationary hook 388 is twisted to cut the diaphragm. The device may also be used in combination with a slide tube (not shown) or another blade with a sharp edge for engaging and cutting the diaphragm.

[0084] Looking at Figure 4G, the hook 388 is not stationary but can be deployed from the tube 390. Here again, the hook 388 includes a cutting edge or longitudinally extending, protruding sharp structure 389 for cutting through the bulkhead. With the hook 388 deployed, the bulkhead is captured by twisting and pulling against the hook 388 and the sharp edge 389, and then cut.

[0085] As shown in Figures 5A-C, in a related approach to treating multiple treatment sites, the cutting, slicing, or destructive assembly additionally or alternatively includes a longitudinally retractable sheath 393 that alternatively covers and exposes the hook 392, and further comprises a retractable guillotine-shaped blade 394. The blade 394 slides within the opening defined by the hook 392 and has the size and shape for cutting the tissue snapped by the hook 392. Thus, at its distal position, the sheath 393 facilitates the assembly to define a structure suitable for advancement to the treatment site. When the sheath 393 is withdrawn through the operation of a structure connected to it located at the proximal end of the assembly, the hook structure 392 is exposed. The hook 392 is used to engage and capture target tissue to test whether the target tissue is related to the appearance of cellulite on the skin. While the hook holds the septum in a captured position, the guillotine blade 394 advances through the operation of a proximal actuator (not shown) to slice or cut the captured septum, thereby eliminating or minimizing the appearance of cellulite.

[0086] In an alternative approach (Figure 5D-I), the hook structure 392 is rotatably mounted on the shaft 383 or sheath 393 and configured to project laterally to capture and evaluate the bulkhead 350. A blade 394 of a size and shape that slides within the sheath 393 is configured to define an extendable guillotine-like blade arrangement for cutting the bulkhead captured by the hook 392. As shown in Figure 5D-F, the blade 394 is advanced distally, and upon reaching a gap or opening 395 within the sheath, the blade 394 projects laterally and engages laterally with the hook structure 394 (defined here by a linear projection member) beyond where the hook 394 captured the bulkhead 350. Further advancement of the blade 394 causes it to move along the hook 392, engaging and cutting the captured bulkhead. In another embodiment (Figure 5G-I), the hook 392 itself is curved or angled to effectively capture the bulkhead 350. In this approach, the blade 392 advances distally to engage with the hook 392 (Figure 5H), and then advances further along the hook 392 to cut the partition 350 captured by the hook 392 (Figure 51). The blade 392 can have a flexible or pivotable elongated end so as to protrude laterally from the sheath 393. Here, the end of the blade 394 exhibits a V-shape configured to facilitate capturing and precisely cutting the target partition 350.

[0087] Next, looking at Figures 6A-B, yet another approach to the distal end portion of the cellulite treatment system 220 is shown. Here, two-segment hook assemblies 396, 397 are held together by a tensile force (such as a spring or a wire or shaft connected thereto) on an angled surface 398. When one segment is rotated relative to the other, an angle is formed between the two segments. It will be recognized that the length of this hook-like structure can be adjusted to suit a particular need. Furthermore, the selected edges of the hook assembly can be sharpened or blunted. In one particular embodiment applicable to each of the disclosed embodiments, the hooks can be covered with an elastomer such that when the elastomer is stretched, the elastomer is displaced, and thus exposes the sharpened edge. When no tension is applied, the sharp edge is safely covered. It is also possible to use a spring-type shield instead of an elastomer. The operation of the two-segment hook assemblies 396, 397 within and between tissue layers enables engagement and identification of target septa as described herein, as well as slicing, cutting, or destroying of the target septa.

[0088] Referring here to Figures 7A–D, the cutting, slicing, or destruction treatment assembly is defined by a protruding link arrangement. The first link 400 includes a blade 401 and is rotatably attached at one end to the second link 402. Such positioning of the blade 401 proximal to the blocker second link 402 facilitates helping to minimize tissue adhesion to links 400, 402 and tissue discharge from the treatment device. That is, the operation of the blade away from the blocker functions not only to cut the target septum but also to keep tissue away from any gaps in the structure formed by the links of the treatment device or between the links. In each of the disclosed embodiments, the lengths of the first and second links, or the cutting, slicing, or destruction treatment assembly, are generally selected so that the target septum can engage, catch, and cut.

[0089] When the device is activated, the opposite end of the first link 400 slides relative to the longitudinal shaft 405. The second end of the second link 402 is rotatably fixed to a distal point on the shaft 405. In one embodiment, as the drive shaft 407, attached to the opposite end of the first link 400, advances, links 400 and 402 fully overlap (Figure 7C), creating a hook arrangement of size and shape to engage tissue and test the septum to determine if a septum is involved in the appearance of cellulite on the patient's skin. In this arrangement, the blade structure 401 is not exposed, but rather protected or covered by the second link 402. When a cutting or slicing operation is desired, such as when a selected septum is targeted, the drive shaft 407 is slightly retracted, thereby exposing the blade structure 401 to present a sharp edge for cutting hook-shaped septums (see Figure 7D). To accommodate links 400 and 402 for advancement or repositioning between organizational layers, shaft 407 is fully extended, so that links 400 and 402 are collinear and parallel to the shaft.

[0090] In a related approach, as shown in Figures 7E–G, the first link 400 defines a curved blade rotatably connected to a second link 402 which includes a generally triangular or pointed projection 408 having a size and shape such that it covers the blade 401 when the assembly is placed in a hook configuration (see Figure 7F). When the drive shaft 407 (shown as a hallucinated line) is operated so that the blade 401 is exposed (see Figure 7G), the blade 401 can be employed to cut through a partition. As the therapeutic device is advanced to and between intervention sites, the drive shaft 407 is drawn out so that the assembly defines a low profile in which the first 400 and the second link 402 are generally aligned longitudinally (Figure 7E). As shown in Figures 7H–K, the rotatable connection between the first 400 and the second link 402 may be additionally or alternatively characterized by a slot arrangement 409. Such a connection allows the projection 408 to be smaller, resulting in a smaller overall profile for the therapeutic device. Of note is that in the partition hook configuration (Figure 7J) after the drive shaft 407 is pulled slightly proximal, the end of the first link 400 is in a proximal position within the slot 409, and the small projection 408 of the second link 402 overlaps the blade 401. In the partition cutting configuration (Figure 7K), the end of the first link 400 is assumed to be in a distal position within the slot 409 so that the blade 401 is exposed for cutting. Referring to Figures 7L-N, in another embodiment, the first link 400 may also define a linear blade 401. In this approach, the projection 408 is therefore larger to provide the necessary coverage of the blade 401 when the apparatus is positioned in the hook configuration (Figure 7M). Each of the aforementioned apparatuses may also additionally or alternatively include other features of those disclosed herein, such as structures that provide transmitted illumination and high-frequency cutting and solidification.

[0091] Referring to Figures 70-7P, one embodiment of a cellulite treatment system 940 (described in more detail in relation to Figure 11) that can be employed to treat cellulite is shown. As shown (Figure 70), the distal end portion of the treatment system 940 comprises a treatment device 925, where the treatment devices in Figures 7L-7N are shown positioned at the distal end of the treatment device 940 in a hooking configuration (Figure 7P). Any of the disclosed treatment devices may be configured in this manner at the distal end of the treatment system 940.

[0092] As shown in Figures 7Q-7S, the treatment device may optionally or additionally include a wire 410 rotatably attached to a second link 402. Here, the proximal portion of the wire 410 functions as a structure that can be advanced and retracted to configure the treatment device in a closed position, a hooked position, and a cutting position. Furthermore, the wire 410 is formed into a coil 411 (see Figure 7S) that provides the strength and robustness necessary to move the wire 410 between the closed position (Figure 7Q) and the cutting position (Figure 7S). In the partition hooking configuration (Figure 7R), the second link 402 covers the wire 410, preventing the wire from being exposed to the target partition, and the coil 411 is aligned with the second blade 402. In its closed configuration (Figure 7Q), the treatment device defines a low profile suitable for advancing toward and between treatment targets. The proximal-facing edge of the wire can be sharpened to generate a cutting edge. In addition, or alternatively, the wire may be an electrode attached to a radio frequency generator so that the wire can be used for electrosurgical or RF cutting of target tissue.

[0093] In other alternative or additional embodiments, as shown in Figures 7T-U, the elongated member 224 of the cellulite treatment device can embody a tubular shape including a lumen 412 extending through it, the lumen providing space for an optical fiber 414. Notably, the remaining space not occupied by the optical fiber 414 defines a crescent shape in cross-sectional view. In one approach, the tubular portion terminates at the treatment device 225.

[0094] As shown in Figures 7V-X, in one or more embodiments, the lumen 412 of the elongated member 224 can be sized and shaped to individually receive one or more additional septal engagement, cutting, slicing, or disruption treatment devices 225, or for the injection of anesthetic, drugs, or other substances such as fillers or fat grafts before, during, or after treatment. In one approach, the treatment site can be drugged or filled with a substance simultaneously with or during the treatment procedure, rather than using separate devices and procedures to achieve the same thing. It should be noted that each of the disclosed embodiments can be combined in a similar manner to provide a combined cellulite treatment assembly.

[0095] Referring to Figure 7Y-AA, a relatively long therapeutic assembly can, for specific purposes, include, for example, an additional length of about 3 mm (or a total length in the range of about 5-10 mm), allowing therapeutic function to be achieved with less lateral movement of the longitudinal members supporting the therapeutic device. Here again, the first link 400 includes a blade 401, one end of which is rotatably attached to the second link 402. Positioning the blade 401 proximal to the blocker second link 402 facilitates minimizing tissue adhesion to links 400, 402 and tissue discharge from the therapeutic device, and the operation of the blade away from the blocker serves to cut the target septum as well as to keep tissue away from any gaps in the structure formed by or between the links of the therapeutic device. As shown in Figure 7Y, in a closed or retracted configuration, the links 400, 402 of the therapeutic device present a low-profile assembly. As the drive shaft attached to the first link 400 is advanced, the first and second links 400, 402 come to exhibit a hook structure (Figure 7Z) in which the second link 400 blocks the blade 401 of the first link 400. When the drive shaft is withdrawn by a predetermined amount, the blade 401 is exposed and comes to exhibit a cutting structure (Figure 7AA). When the drive shaft is fully withdrawn, the links 400, 402 return to a folded or retracted configuration. In each of the disclosed embodiments, the lengths of the first and second links or cutting, slicing or destroying assemblies are generally selected so that the target bulkhead engages, hooks, and cuts. Furthermore, as shown in Figures 7AB-AE, the cutting edge of the blade can be multi-edged, variable, and / or serrated along the length of the blade and can be configured on one or both sides of the member defining the blade in any particular embodiment to provide the desired cutting function.

[0096] In an alternative embodiment, spot treatment of septa is possible by employing a cellulite treatment system 800 configured to address one intervention site at a time. Thus, the cutting structure can be inserted perpendicular to the skin to achieve treatment, or advanced beneath the skin in a direction generally parallel to or at an angle to the skin surface. Furthermore, each structure of the disclosed tissue engagement and cutting device can be configured, alternatively or additionally, for use for treatment. In a particular embodiment, the cutting action is rotary in feature such that the cutter structure rotates at a controlled speed configured to cut the septum in a manner directed by the septum structure observed at the intervention site. The cutter can also be configured, alternatively or additionally, to achieve the cutting action by engaging or dragging the cutter against the target septum. Here again, the degree to which drag is performed is determined by the septum and the septum-specific structure. In one approach, the system 800 includes an elongated handle 802 provided for the operator to grasp (see Figures 8A-C). Extending longitudinally from the handle 802 is a needle assembly 804. The needle 804 is configured to create an insertion site adjacent to a specific cellulite target area, or to be inserted directly into a dimple cellulite area. Furthermore, to address and treat septa present beneath dimples or other depressions in the subject's skin, the intervention site instrument is advanced via the needle assembly 804. In addition, in one embodiment, the dilator may include or work with a harmonic scalpel, selective cauterizing structure, or energy-delivering structure for dissecting tissue and / or controlling bleeding. In one approach, once the correct depth is accessed, the cutting instrument is swung 360 degrees to cut the surrounding septa. Alternatively, an endoscope may be employed in an assembly including a cutter to cut the septa in a targeted manner; that is, the septa observed with the endoscope are the target of cutting with the cutter. Here, direct visual confirmation of the procedure is provided. In one embodiment, the needle 804 may be formed with a stop 810 that can be positioned along the needle 804 as desired or as indicated by a particular procedure or anatomy. The stop 810 is positioned so that when the needle 804 is placed in the tissue, its end is located at a desired depth, such as between tissue layers connected by septa. The end of the needle 804 is further provided with a lateral opening 822. It is through this lateral opening 822 that an intervention device, such as a cutter, scalpel, cauterizing structure, or energy transfer device, is advanced between the tissue layers. Such a device is then employed to selectively treat septa present beneath the skin for the purpose of removing or reducing the appearance of cellulite. Once the treatment is deemed successful, the spot cellulite treatment system 800 is then removed and employed at another location showing cellulite.

[0097] Next, looking at Figures 8D–J, further embodiments of instruments employed for the treatment of cellulite in alternative approaches are shown. Such structures may also be employed as distal end structures of the cellulite treatment assembly shown in Figure ID. Referring here to Figure 8D, the treatment device may comprise a wire including a coupling 830 operation that functions to push out the arrangement of cutting blades 831 having a size and shape for cutting connective tissue. As shown in Figure 8E, the distal end portion of the spot treatment device may comprise a wire arranged to be advanceable to define a loop 832, the loop having a gauge that facilitates the structure employed for cutting tissue. Alternatively, RF energy may be employed to cut the septa. Figures 8F-G show a deformable hypotube 834 expandable to define a cutting blade in another non-traumatic approach to treatment, with two or more arms 836 protruding. Figure 8H illustrates a balloon structure 840 attached to a needle hypotube 842 that can be expanded under depressions to remove or reduce the appearance of cellulite. Finally, in another non-external ear approach (Figure 81-J), the distal end portion of a spot treatment device may be formed with a blade 850 for cutting for deployment, and at least one configured to rotate to cut connective tissue.

[0098] As shown in Figure 8K, the dilator 410 can form the distal end portion of the cellulite treatment device and may further include a longitudinally extending blade 853 that unfolds when the dilator 410 is expanded. The blade 853 is configured to engage and cut target tissue or septa in an alternative approach to treatment. Such cutting is employed in an alternative to a non-traumatic approach and is achieved by rotating the dilator 410 or otherwise advancing, sweeping, or retracting it. The assembly is not expanded and is withdrawn from the intervention site after use, such as through a tube.

[0099] In yet another therapeutic approach, a lasso 859, forming the distal end portion of the cellulite treatment assembly, is a curved wire that can be advanced and retracted through a shaft 861 (Figure 8L~0) and deployed around a septum 350 in the target zone. Pulling the lasso 859 to contract the perimeter it defines results in cutting the septum 350 and treating the cellulite. In one embodiment, the lasso is formed from a nitinol wire or a pre-formed wire or fragment thereof. The lasso 859 surrounds the targeted septum and cuts the septum through constriction. One approach involves cutting the target area without moving the shaft and thus provides a controlled approach to treatment.

[0100] As shown in Figures 8P-T, the lasso 859 may additionally or alternatively define a tube, and the assembly may additionally include a wire 863 configured to slide within the tubular structure. After the bulkhead 350 is targeted, the lasso structure 859 is partially formed around the bulkhead 350 by being pushed out from the shaft 861. The wire 863 is then advanced within the lasso 859 and exited from the end of the lasso 859 (Figure 8Q). The wire 863 is then advanced towards a slot or opening 865 formed in the shaft 861 and held therein. The lasso 859 is then advanced further to the shaft 861 and engages with the shaft 861, thereby defining a completed hoop or loop (Figure 8R). The lasso 859 is then pulled tight around the target bulkhead 350 to cut, slice or break the bulkhead as desired (Figure 8T). Alternatively, the completed hoop may remain in its large hoop-shaped configuration, allowing the entire device to be pulled proximal to slice or break the surrounding diaphragm. After treating the target tissue, the lasso 859 and wire 863 are pulled proximal through the shaft 861 to detach from the slot 865, either fully or partially within the shaft 861, so that the treatment device may be used at additional locations.

[0101] In the associated lasso treatment approach (Figures 8U-V), a pair of elongated tubes 867, 868 are provided, which can be configured in a roughly parallel arrangement with respect to the target septum 350. The lasso 859 is advanced within the first tube 867 and exits from its end toward the second tube 868 (Figure 8U). The lasso 859 is then captured by the second tube 868 so that the treatment device surrounds the target septum 350. The assembly is then pulled proximal to cut, slice, or destroy the target tissue. After the treatment, the lasso 859 is withdrawn into the first tube 867 and released from engagement with the second tube 868. The assembly is then positioned as needed to treat additional areas.

[0102] An atherectomy-style cutter 902 (see Figures 9A-B) may also be alternatively or additionally configured to remove tissue through an opening 904 on the side of the instrument and can be used in certain auxiliary and more traumatic approaches to treatment. The cutting structure 906 is attached to an elongated actuator 908 via a block or other connector 910. Operation of the actuator 908 causes the cutting structure 906 to engage with the target tissue. A lumen 912 is further provided as a conduit for applying suction force to the intervention site so that the cut or eroded tissue 912 can be removed. The device may be employed to harvest fat for subsequent placement in the site treated with the dilator and to fill the resulting space. The cutter 902 may also be employed as a primary treatment device for cutting septa to treat cellulite.

[0103] Now, looking at Figures 10A-C, one preferred embodiment of a treatment system 920 is shown, which can be used in conjunction with one or more of the previously described devices for treating target tissue. The treatment system 920 includes a handle 922 and an elongated member 924 extending longitudinally from the handle 922. As described above, force gauges or sensors (electronic or mechanical) may be provided to ensure that a predetermined amount of force will be applied to the tissue when testing the septum to prevent excessive or insufficient pulling. Furthermore, the distal end portion of the elongated member 924 comprises a treatment device 925 capable of performing one or more of the following actions on connective tissue: engaging, slicing, cutting, or breaking. Thus, any one or more of the treatment devices described herein can define the treatment device 925. All cutting means may be combined with or further energized with RF, laser, ultrasound, or thermal energy to produce cutting and coagulation together or separately.

[0104] The handle 922 is equipped with a button or sliding trigger 926 configured to slide along the upper surface of the handle 922. The trigger 926 is attached to the proximal end portion of the shaft or wire 928, the distal end portion of which is associated with or attached to the treatment device 925. In a closed configuration, the trigger 926 is positioned at its most proximal position (Figure 10A), and the treatment device 925 maintains a configuration that is generally aligned longitudinally. Configured in this way, the treatment system 920 can be positioned or repositioned to achieve the desired cellulite treatment. Moving the trigger 926 to its most distal position causes the shaft or wire 928 to advance distally, positioning the treatment device 925 in a configuration for, for example, hooking target tissue (Figure 10B). Pulling the trigger 926 down to an intermediate position exposes a cutting structure (such as a blade or cutting wire), thereby configuring the treatment device 925 to cut, slice, or destroy target tissue (Figure IOC). A detent or other cooperative structure may be incorporated into the handle or trigger to fix the trigger in one or more positions while simultaneously providing tactile feedback regarding positioning. Furthermore, the system 925 may, alternatively or additionally, include any of the functionalities described above, such as structures for providing transmitted illumination and high-frequency cutting and solidification.

[0105] As shown in Figure 11, in another embodiment, the treatment system 940 includes a handle 942 and an elongated member 944 extending from the handle. A shaft or wire (not shown) configured within the elongated member 944 is attached to the treatment device 925, and alternatively or additionally, a rotatable trigger 946 is attached to the distal portion below the handle 942. Configured within the handle 942 is a slider 947 attached to the shaft or wire, which is associated with and cooperates with the trigger 946. A constant-force spring 950 is associated with and cooperates with the slider 947 to retract the cutting structure of the treatment device 925 when the trigger 946 is released. Furthermore, a transmitted illumination structure is configured within the handle 942 and includes a battery chamber 952 and an electrical switch 954 for turning on / off a light source (e.g., an LED) configured at the distal end of the treatment system 940.

[0106] When the trigger 946 is fully pulled, the treatment device 925 is configured in a hook configuration in which the cutting structure of the treatment device 925 is protected. When the trigger 946 is slightly released, the spring 950 retracts the shaft or wire associated with the treatment device 925, positioning the shaft or wire within the stopper on the slider 947, and informing the user with tactile feedback that the cutting structure of the treatment device 925 is exposed. When the trigger 946 is fully released, the spring 950 completely retracts the shaft or wire, thereby placing the treatment device 925 in the closed or unextended position. The treatment system 940 can then be repositioned and operated to treat additional areas.

[0107] Various additional embodiments of the processing apparatus are shown in Figures 12A–18C. Referring to Figures 12A–C, the cutting, slicing, or destruction processing assembly is again defined by a protruding link arrangement. The first link 1400 includes the blade 1401 and is rotatably attached at one end to the second link 1402. The opposite end of the first link 1400 slides against a longitudinal shaft 1405 (shown as at least partially transparent). The shaft 1405 defines a housing for supporting and accommodating the link arrangement. The second end of the second link 1402 is rotatably fixed to a distal point on the shaft 1405. The drive shaft or push rod 1407 is rotatably or pivotably attached to the opposite end of the first link 1400, and the second link 1402 includes a roughly triangular or pointed projection 1408 of a size and shape that shields the blade 1401 from contact with tissue when the assembly is in the hooking configuration. When the push rod 1407 is fully retracted (Figure 12A), the blade 1401 is sheathed within the body of the longitudinal shaft 1405. Note that in the fully retracted configuration, the first and second links 1400, 1401 form an obtuse angle, and the projection 1408 extends a relatively small distance from the opposite side of the longitudinal shaft. When the push rod 1407 is fully advanced and stopped, the projection 1408 contacts the push rod 1407, and the blade 1401 is again protected by the projection 1408 (Figure 12B). With this configuration, the treatment device can be used to hook onto a target septum, test the septum, and determine whether such a septum is associated with the appearance of cellulite on the patient's skin. When the push rod 1407 is withdrawn from its fully advanced position by an order of approximately 0.070 inches in one embodiment (see Figure 12C, where the blade 1401 is shown transparently for illustrative purposes), the blade 1401 is exposed and presented to engage with the target septum to cut, slice, or destroy. The treatment device also has a blunt, intact tip 1406 that allows the treatment device to be advanced through subcutaneous tissue with minimal trauma. In all embodiments, the blunt tip 1406 may house a light-emitting diode, or the tip of an optical fiber, to facilitate transmitted illumination through the skin, for use as guidance for the user to know the position of the tip of the treatment device.

[0108] Additionally or alternatively, the tip in any of the disclosed embodiments may be formed to feature or relate to low entry and advancement forces through the patient's skin and anatomical structures, while simultaneously presenting a low likelihood of tissue damage. Thus, the tip may envision a bullet-like point or short dilator tip shape, or a sharp profile or trocar-type configuration may be defined to facilitate advancement or tracking. Furthermore, the tip may be retractable, reconfigurable, or sharp only when presented with a predetermined level of resistance. In a particular approach, a spring-loaded cover or shield is configured over the tip, and upon encountering a defined resistance, the cover or shield is removed to expose a sharp tip configured to facilitate advancement of the treatment device or reduce the force traversing the patient's anatomical structures.

[0109] In the alternative approach (Figures 13A-D), the second link 1402 includes a blade 1401 with a sharp projection 1403, and the first link 1400 acts as a blocker to shield the main portion of the blade 1401 from contact with tissue when the treatment device is in a hooking configuration. When the treatment device is in a hooking configuration, the sharpened projection 1403 extends proximal to the pivot between the first link 1400 and the second link 1402, and when the treatment device is pulled proximal by the user, the pivot position as the leading part of the device during retraction does not catch on the tissue but rather cuts through it, so that the user can feel the resistance of the diaphragm catching on the main portion of the first link 1400. Notably, in the fully retracted position (Figure 13A), the first and second links 1400, 1401 define an obtuse angle, and when the push rod 1407 is almost fully advanced (Figure 13B), the majority of the blade 1401 is protected by the second link 1402. Thus, the structure is presented in a hook configuration to facilitate hook capture while simultaneously providing an unprotected portion of the blade 1403 near the connection between the first and second links 1400, 1402. When the push rod 1407 is fully advanced, the blade 1401 is fully exposed to cut, slice, or destroy the target partition (see Figures 13C-D; Figure 13D shows the first blade as transparent for illustrative purposes) when the treatment device is retracted proximal by the user.

[0110] When employing one or more of the disclosed embodiments in a therapeutic procedure, it is anticipated that it may be preferable not to destroy the hook septum, and in such cases, it is desirable to release or disengage the hook septum. Certain approaches involve moving the instrument forward away from the hook septum or twisting it to release or disengage it. Thus, it is recognized that there are challenges, such as the presence of additional septa or other tissues in the area that may be unintentionally re-engaged by the therapeutic device when in the hook configuration, and that the retraction of the therapeutic device may be hindered by the anatomy of the adjacent patient. Referring to Figures 13E-F, a therapeutic device including a hinge link arrangement 1400, 1402 or similar structure that pivots relative to a longitudinal shaft 1405 to transition from a hook configuration (Figure 13E) to a retracted configuration (Figure 13F) has the advantage that when the therapeutic device is retracted or stored in a sheath, the interlocking link 1400 (or similar structure) moves to push the septum 350 or other tissue away from the therapeutic device. This action does not require additional advancement of the treatment device within the patient's anatomical structure and ensures that the diaphragm 350 or other tissues are not undesirably entangled. Furthermore, when retracted, links 1400 and 1402 release any tissue that may have been trapped within the longitudinal shaft 1405, and links 1400 and 1402 ultimately occupy such space within the longitudinal shaft 1405.

[0111] In additional or alternative embodiments (see Figures 13G-J), the treatment device comprises a first link 1400 that defines a curved or angled structure that obstructs the blade 1401 formed on the second link 1402. By adopting such a curved or angled configuration, the first link 1400 obscures or allows to exist the space that would exist between the first link 1400 and the longitudinal axis 1405 when the first link 1400 and the second link 1402 are positioned in the hooking position (Figures 13G and I) and / or cutting position (Figures 13H and J). The curved or angled link 1400 thus blocks tissue from accumulating in the space between the link and the longitudinal shaft that would obstruct the operation of the link during use and when attempting to retract the link. A pair of such blockers may, alternatively, be configured on each side of the second link to assist in tissue removal.

[0112] Recognizing the need to eliminate gaps where tissue may become trapped in an undesirable manner, various elastomer sheaths can be configured between links to occupy such gaps or spaces. The sheaths will extend during the projection and movement of the links and retract into place when the links are retracted, as the treatment device is advanced or retrieved. Furthermore, to assist in removing unwanted tissue trapped between the rotating links, it is possible to employ high-pitch helices in the hinges between the links so that the space between the rotating links changes or increases when the links are retracted, thereby dislodging any previously trapped tissue. The projections 1403 can, alternatively or additionally, extend to cover the pivot between the links to prevent tissue from becoming trapped in or at the pivot. In addition, the links can be formed from nitinol or other highly plastically deformable materials to create a single-piece, hingeless structure that can be formed into a cutting and hooking configuration. Furthermore, the sheath can be configured inside or outside the longitudinal shaft to wipe tissue from the link, and the shaft can include a longitudinally extending wiper configured around a slot in which the link is housed and deployed, similar to a wiper configured within a car window slot.

[0113] Next, looking at Figures 14A-F, yet another approach to the treatment device is shown. Here, two parallel and articulated first links 1420, 1422 are provided, positioned to block or shield the blade 1401 that is attached to or formed on the edge of the second link 1402. Each of the first links 1420, 1422 defines a curved or yoke-shaped member with a distinctive profile designed to selectively shield the second link 1402, with a first end 1424 rotatably or pivotably attached to the pusher 1407 and a second end 1426 rotatably or pivotably attached to the second link 1402. The parallel-positioned first links 1420, 1422 provide additional strength for the hooking and cutting positions. When the push rod 1407 is fully retracted (Figures 14A and 14D), the curved portions of the first links 1420, 1422 protrude from the opposite side (at least partially shown as transparent) of the longitudinal axis 1405 from which the links extend when deployed for hooking or cutting, slicing or destroying a septum. To present a tissue hooking structure, the push rod 1407 is advanced so that the first links 1420, 1422 completely shield or block the blade 1401 (see Figures 14B and 14E; one of the first links 1420 is shown as transparent for illustrative purposes in Figure 14E) from contact with the tissue. Fully advancing the push rod 1405 acts to fully expose the blade 1401 (see Figures 14C and 14F), thus presenting the blade 1401 for cutting, slicing or destroying target tissue.

[0114] As shown in Figures 15A-F, the treatment device may optionally or additionally include first and second push rods 1430, 1432, the first push rod 1430 being configured to operate an articulated or pivotal first link 1434, and the second push rod 1432 being configured to operate an articulated or pivotal second link 1436 containing the blade surface 1401. When the push rods 1430, 1432 are in their fully advanced position (Figures 15A and 15D), the first link 1434 and the second link 1436 are generally parallel and housed within the longitudinal shaft 1405 (shown at least partially transparent). When the push rods 1430, 1432 are withdrawn, they act to cause the first 1434 and second 1436 links to protrude from their housed positions (see Figures 15B, C, E, F). When the push rods are pulled out equally, the first link 1436 is fully exposed, overlapping the blade 1401 (Figures 15C, 15F) to cut, slice, or destroy the target tissue. However, when the push rod 1430 associated with the first link 1434 is advanced to a different degree than the second push rod 1432, the first link 1434 can shield or block a portion of the blade 1401 (Figure 15B), thereby presenting a structure for hooking the target tissue, or shielding a portion of the blade 1401 (Figure 15E), thereby presenting a structure for both hooking and cutting. This embodiment may also have a blunt tip 1406.

[0115] In additional or alternative embodiments, the robustness of the blade mechanism of the treatment device can be enhanced by reinforcing the pivot point, increasing the strength of the longitudinal shaft, and improving blade concealment during insertion and advancement into tissue and during tissue engagement. As shown in Figure 16A, a welding pin or swaged tube 1450 can be used at the connection between the first link 1400 and the second link or link 1402. Alternatively, a mechanical joint such as a welding pin or swaged tube can form a connection between the second link or link 1402 and the distal portion of the longitudinal shaft 1405. In one or more embodiments, such a pivot point may be defined, for example, by a pin or tube with a diameter of about 0.025 inches and can be used at one or more rotational or pivotal connections in the treatment system. Furthermore, as is most commonly seen in Figures 16B-C, the first link 1400 containing the blade 1401 may be configured between a pair of second links 1402 (one of which is shown as transparent) rather than being hidden by or cooperating with a single first link 1400.

[0116] As shown in Figures 17A-C, in an alternative or additional approach, the processing system lacks a protruding structure when links 1400 and 1402 are fully retracted and housed within the longitudinal shaft 1405 (Figure 17A). The first link 1400, acting as a blocking or blunting element, can be spring-loaded so that the blade 1401 formed on the second link 1402 is shielded until a critical force is achieved (Figure 17B), after which the blade 1401 is presented to cut, slice, or break the target bulkhead (Figure 17C). After cutting or slicing, the blade 1401 can be configured to automatically re-sheath, or an actuator such as a button can be provided to re-sheath the blade 1401. In this approach, the link has two positions: retracted and deployed. Similarly, the overall force requirement can be reduced because there is no state in which the user engages the hooking structure with excessive force. Thus, the blade 1401 is either fully retracted into its sheath during navigation or housed within the longitudinal shaft 1405 and deployed when needed. In this way, the longitudinal shaft 1405 can be formed from, for example, a hypotube, and it is possible to reduce the cuts required for ejecting and retracting the links 1400, 1402. Such a structure or related functionality can be incorporated into any of the disclosed embodiments, thus making it possible to provide a spring-loaded cutter that requires a constant, controlled amount of force to expose the blade for cutting. This embodiment may also have a blunt tip 1406.

[0117] In the related approach (see Figures 18A-C), the blocking or hooking function is provided by a pair of curved or angled first links 1400. In the retracted configuration, the curved or angled links 1400 protrude from the longitudinal shaft 1405 opposite the deployment or treatment side (Figure 18A). However, as in the preceding approach, the blocking or shielding first links 1400 remain on the opposite side, shielding the blade 1401 until a critical force is achieved (Figure 18B), after which the blade is spring-loaded so that it is exposed to cut, slice, or break the target bulkhead (Figure 18C). Here again, after cutting or slicing, the blade 1401 can be configured to automatically resheath, or an actuator such as a button can be provided to resheath the blade 1401, and there are two positions of the link, namely sheathed and deployed.

[0118] As shown in Figures 19A-B, the treatment device includes a first link 1400, one end of which is rotatably attached to the end of the pusher 1407, and the other end of which is rotatably attached to the midpoint of the second link 1402. The action of the push rod 1407 converts the links 1400 and 1402 from a closed configuration (Figure 19A) to an open configuration (Figure 19B), and in between. The second link 1402 itself takes an obtuse angle, and the portion of the second link 1402 extending beyond its connection to the first link 1400 presents a structure for hooking onto a partition and may further include a sharp edge defining a blade 1401. It should be noted that the blade may also be omitted. Thus, the advance of the pusher 1407 results in the extension of the links 1400 and 1402, forming a proximal scissor-type mechanism. During use, the deployed structure captures a targeted partition for evaluation. When it is determined that the captured bulkhead should be cut, the push rod 1407 is retracted, and the two links 1400 and 1402 pass each other so as to have a cutting action via their sharpened edges or by the overlapping interference of their blunt edges. Furthermore, as shown in Figure 19C, the blade edge 1401 can extend only a portion of the length of the second link 1402. In this way, when partially extended, the second link 1402 presents a structure for cutting bulkheads, but when fully extended, the second link 1402 includes a length of structure close to the connection point of the second link 1402 to the first link 1400, which is designed to catch the captured bulkhead but not cut it.

[0119] Referring here to Figures 20A-B, a handle 1922 of a therapeutic device is shown, which includes a trigger or slider assembly 1926 containing a pushable button 1928. The handle 1922 includes a track 1929 along which the button 1928 is registered. Such an arrangement can be incorporated into one or more of the previously disclosed therapeutic systems. As shown in Figure 20A, in one embodiment, the button 1928 is biased against the track 1929 by a helical spring 1930. The slider assembly 1926 is connected to a therapeutic device (not shown) and mounted on a drive shaft or pusher 1407 to facilitate its operation. The button 1928 is pushable to release a lock or other engagement between the button 1928 and the track 1929, thereby allowing the slider assembly 1926 to slide relative to the handle 1922. Releasing button 1928 results in the button engaging with track 1929 and allowing it to slide to lock-engage with one of a series of cutouts 1932 formed in track 1929. Note that when not locked to track 1929, button 1928 of the slider assembly can engage and slide along track 1929 between locked positions. Such cutouts 1932 are positioned and oriented so that when slider assembly 1926 is locked to track 1929, the treatment device is positioned in tissue and relative to the target diaphragm in one or more of the sheathing, hooking, and cutting positions. Secure engagement between slider assembly 1926 and handle 1922 is thus provided as a tactile feel to the user regarding the positioning and state or configuration of the treatment device. As shown in Figure 20B, instead of a helical spring, button 1930 is biased by a leaf spring 1934. Furthermore, here, the button 1928 is configured to be independently operable and is defined as a structure that can be pressed independently of the sliding structure of the slider assembly 1926, thereby providing an alternative discrete control of the sliding and locking functions.

[0120] Further approaches to the processing system are shown in Figures 21A–23C. As shown in Figures 21A–C, the processing system 1940 includes a handle assembly 1942 containing a slider 1943 biased by a spring 1944, the slider 1943 configured to translate along a portion of the body 1946 of the handle assembly 1942. A button 1947 protrudes vertically from the top surface of the slider 1943, and the button 1947 is connected to or associated with a boss 1948 that sits in a slot formed in the slider 1942. The boss 1948 is also configured to slide along and register along a ramp 1949 or other engagement structure formed in the handle body 1946. Additionally, a lever 1950 rotatably mounted on the slider 1943 includes a curved slot 1951 that receives a boss 1952 protruding from a bracket 1953. Each of the slider 1943 and bracket 1953 is attached to one or more longitudinally extending members 1954 associated with / related to the treatment device 1956 attached to its end portion (see Figures 21D-F). Attached to the proximal end of the handle assembly 1942 is an optional light and energy source unit 1995, such as a light-emitting diode and battery. Extending through the longitudinal shaft of the handle assembly 1942 and the treatment device 1956 to the distal portion of the longitudinal shaft is an optical fiber (not shown) that transmits light from the light and energy source unit 1995 to the distal portion of the treatment device 1956, providing transmitted illumination through the skin to the user.

[0121] In the treatment device storage position (see Figures 21A and D), the slider 1943 is in its closest position and the spring 1944 is almost compressed. As the slider 1943 translates forward (Figures 2IB and E), the spring 1944 extends, and the slider boss 1948 becomes temporarily fixedly registered along the ramp 1949. This action causes the longitudinally extending member 1954 to advance in order to operate the treatment device 1956. In this configuration, the treatment device 1956 is in an deployed but covered configuration intended to hook or otherwise engage with the target bulkhead. Subsequently, by pressing down the rotatable lever 1950, the longitudinally extending member 1956 advances slightly distally through the interaction between the lever 1950 and the bracket 1953, exposing the treatment device sharpening link or blade 1957 (see Figures 21C and F), which is configured to cut, slice, or break the partition. Notably, a spring (not shown) is configured between the lever 1950 and the bracket 1953 to bias the lever 1950, returning the treatment device 1956 to a locked hook configuration. After the desired operation of the treatment device 1956 at the intervention site, the slider button 1947 is pressed down to disengage the slider boss 1948 and the ramp 1949, thereby allowing the spring 1944 to return the slider 1943 to its most proximal position, storing the treatment device 1956 for further use or removal from the intervention site. In an alternative approach, system 1940 would lack lever 1950, and an additional spring (not shown) would be configured to allow the bracket 1953 to advance only when the treatment device 1956 is presented with a predetermined resistance, at which point exposure of the blade 1957 would be permitted. This would make the tool easier to use and less likely to omit the cutting step following the hooking of the partition.

[0122] In an alternative approach (Figures 22A-C), the treatment system 1960 includes a handle assembly 1962 containing a slider 1963 biased by a spring 1964, the slider 1963 also configured to translate along a portion of the body 1966 of the handle assembly 1962. Here, instead of providing a button to unlock the slider 1963, the slider 1963 is configured to rotate relative to the body 1966, and the slider 1963 itself includes a boss 1968 configured to slide and register along a ramp 1969 or other engagement structure formed within the handle body 1966. Also here, a lever 1970 rotatably mounted on the slider 1962 includes a curved slot 1971 that receives the boss 1972 protruding from a bracket 1973. Each of the slider 1962 and bracket 1973 is attached to a treatment device associated with / one or more longitudinally extending members 1976 attached to its end portion (not shown, but such as the structures shown in Figures 21D-F).

[0123] When the treatment device is in its retracted position (see Figure 22A), the slider 1962 is in its closest position and the spring 1964 is almost compressed. As the slider 1962 translates forward (Figure 22B), the spring 1964 extends, the slider boss 1968 becomes temporarily fixedly registered along the ramp 1969, and the longitudinally extending member 1976 moves forward to operate the treatment device. In this configuration, the treatment device is in an deployed but covered configuration intended to hook or otherwise engage with the target septum. Subsequently, by pressing down the rotatable lever 1970, the longitudinally extending member 1976 is advanced slightly distally through the interaction between the lever 1970 and the bracket 1973, exposing the sharpened link or blade of the treatment device (see Figure 22C). In this configuration, the treatment device is configured to cut, slice, or destroy the target septum. A spring (not shown) is configured between the lever 1970 and the bracket 1973 to bias the lever 1970 and return the treatment device to a lock and hook configuration. After the desired operation of the treatment device at the intervention site, the slider 1962 is pushed down and rotated to disengage the slider boss 1968 and the ramp 1969, thereby allowing the spring 1964 to return the slider 1962 to its most proximal position and retract the treatment device.

[0124] As shown in Figures 23A-C, the treatment device 1980 may additionally or alternatively include a handle assembly 1982, which includes a slider 1984 configured to slide along the body of the handle assembly 1982. When the slider 1984 is in its most proximal position (Figure 23A), the treatment device (not shown) is in its retracted position. The slider 1984 is attached to a pair of rotatable angled members 1986, 1987, the ends of which are rotatably attached to the handle body and the slider 1984, respectively. The forward-positioned rotatable member 1986 further includes an extension 1988, which is rotatably attached to a rotatable bracket 1989, and this extension is, in turn, rotatably attached to a longitudinally extending member 1990 having a treatment device (not shown) attached to its distal end. A button 192 protrudes vertically from the slider 1984 and is associated with a boss 1993 configured to register along a portion of the body of the handle assembly 1982 (see Figure 23B). When the slider 1984 is advanced along the handle body and positioned so that the boss 1993 is registered within a recess 1994 formed in the handle body, the treatment device is deployed but at least partially covered to present a structure for hooking or engaging with a target septum. By pressing down the button 1992, the boss 1993 of the slider 1984 can be disengaged from the recess 1994, thereby allowing the slider 1992 to be advanced further distally. In doing so, the longitudinally extending member 1990 can be advanced further to expose the cutting portion of the treatment device for cutting, slicing, or engaging tissue and achieving the desired interventional treatment. The slider 1992 can then be returned, as desired, to either a retracted position or an deployed but covered position for further interventional steps. Therefore, this approach provides a mechanism to scale up small movements of the handle assembly so that the configuration of the treatment device (e.g., the receiving position, hook position, or cutting position) is more obvious to the user.

[0125] In the previously described embodiment, a “ballpoint pen” type mechanism can be used in the handle assembly such that, after the hook and / or sharp blade tears or cuts the bulkhead, the link automatically restores itself if the force on the link decreases sharply when tearing or cutting the bulkhead.

[0126] In another embodiment, a coil is deployed from the distal part of the treatment device, the septum is wrapped around the coil and rotated to recreate the target cellulite on the skin surface, the coil is then pulled by the user to break or cut the septum, or the septum is cut using a cutter.

[0127] Referring here to Figures 24A-H, a processing system is shown that embodies the specific functionality and selected number of features described above. The treatment system includes a handle assembly 2000 from which an elongated member 2002 extends. The handle assembly 2000 defines a contour profile whose size and shape are determined to fit conveniently in the operator's hand. Various actuating members 2004 are provided on the handle assembly 2000, and their operation achieves the deployment of a processing device 2010, which is employed to engage, test, and / or cut partitions. The elongated member 2002 has a length and cross-sectional shape configured to be positioned between tissue layers and advances and extends to partitions present within the target treatment area. The distal end 2012 of the treatment system (Figure 24B) includes a treatment device 2010. In various embodiments, any number of treatment devices described can be configured at the end of the elongated member 2002, but Figure 24B shows treatment devices similar to those shown in Figures 13A-B. Furthermore, the end of the elongated member 2002 is provided with a nose cone 2014 of a size and shape that facilitates the atraumatically advancing of the treatment system through the subcutaneous tissue in the subepidermal space. Such a nose cone may be incorporated in any one of the described treatment devices or systems.

[0128] The distal end portion 2012 of the treatment system (Figure 24B) also includes an exit port 2020 for the optical fiber 2022, which provides the transmitted illumination function described above. As shown in the cross-sectional view of the treatment system (Figure 24C), the optical fiber 2022 extends distally from the optical energy source and focusing assembly 2030, which is configured within the handle assembly 2000. The optical fiber 2022 extends distally through the handle and within the elongated member 2002 to the exit port 2020 (see also Figures 24D-E). Referring to Figure 24D, the battery 2032 supplies energy to the LED 2034, which generates optical energy through the spherical lens 2036, in the arrangement shown in Figure 1W, and sends it to the optical fiber 2022. As best seen in Figure 24E, the optical fiber 2022 is routed laterally through the exit port 2020 so as to be positioned to provide selective transmitted illumination. Of particular note is that the optical fiber 2022 is positioned adjacent to the pusher member 2038, which is configured to operate the treatment device 2010.

[0129] Next, looking at Figures 24F-H, the operation of the actuator of the handle assembly 2000 is described. The actuator 2004 is configured to slide within a gap 2040 formed on the upper surface of the handle assembly 2000. The first actuator subassembly 2042 includes a lower section that is operably connected to the pusher member 2038, which in turn is connected to the treatment device. The second actuator subassembly 2044 includes a lower slot area 2046 that slidably receives a boss 2048 attached to the pusher member 2010. When the treatment device 2010 is in a sheathed configuration (see, for example, Figures 24F and 13A), the first and second actuator subassemblies 2042, 2044 are positioned within the proximal portion of the handle gap 2040. To remove the sheath and configure the treatment device 2010 in the hooked position (see, for example, Figures 24G and 13B), the first and second actuator subassemblies 2042, 2044 are slid to their distal positions within the handle gap 2040. As the first and second actuator subassemblies are advanced distally, the pusher member 2038 moves distally, thereby rotating the blunt and sharpened links at the distal end into the hooked position. Pressing down and holding the second actuator subassembly 2044 moves the pusher member 2028 slightly distally, passing through the boss 2048 which slides along the angled slot 2046, resulting in the treatment device 2010 being placed in the cutting configuration (see, for example, Figures 24H and 13C). The treatment device is reset to either the sheathed or hooked configuration with the help of a retraction spring in the handle and positioned as deemed necessary by the operator during the cellulite treatment procedure.

[0130] In alternative or additional features of any disclosed embodiment (Figures 241-J), the distal end of the treatment system may be equipped with a retractable knife 2050 of a size and shape for puncturing the skin. Thus, the knife 2050 is sized and shaped to form a desired minimal traumatic opening in the skin, instead of the physician making a small puncture wound using a scalpel blade. In one approach, the knife 2050 is employed when the treatment device is in a sheathed position 2052. In use, the operator deploys the knife 2050 to create an incision in the skin. The knife 2050 is then retracted into the nose cone by the physician using a button on the handle, and the treatment system is used as described herein. Alternatively, the knife 2050 may be configured like a laparoscopic safety trocar so that once employed to penetrate the skin, the knife 2050 automatically retracts into the tip of the device. The knife 2050 may also be configured to be selectively deployed to achieve intra- and inter-tissue cutting functions.

[0131] Accordingly, various approaches to cellulite treatment methods and devices are presented. The disclosed approaches are configured to provide effective and intensive approaches to treat, minimize, and prevent cellulite. The disclosed approaches can also be used to repair and reduce the appearance of cellulite in a targeted manner. Furthermore, the disclosed active treatment methods are easy to use and effective.

[0132] Some particular aspects of this disclosure include one or more of the following: focused treatment of only septa causing skin depressions or depressions; minimizing birthmarks; accessing all treatment targets through a limited, cosmetically acceptable entrance; capturing and retaining septa while separating them; intraoperative confirmation of treatment targets; needle-diameter-sized tools for small openings; and transmitted-illumination identification of tool tip positions.

[0133] While this disclosure has been described with reference to its specific embodiments, those skilled in the art will understand that various modifications may be made and equivalents may be substituted without departing from the true spirit and scope of this disclosure. Furthermore, many modifications may be made to adapt specific circumstances, materials, material compositions, processes, process steps, or steps to the purposes, spirit, and scope of this disclosure. All such modifications are intended to be within the scope of this disclosure.

Claims

1. A cellulite treatment system for treating cellulite on the skin of a patient related to the septal treatment site, wherein the cellulite treatment system is An elongated member configured to be inserted subcutaneously, comprising a first shaft (1405) and a second shaft (1407) supported by the first shaft (1405) and configured to move longitudinally along the first shaft (1405), A treatment device provided at the end of the elongated member, The treatment device includes a first link (1400) having a first end and a second end, and a second link (1402) having a first end and a second end. The first end of the first link (1400) is pivotably connected to the end of the second shaft (1407), The first end of the second link (1402) is pivotably connected to the end of the first shaft (1405), The second end of the first link (1400) is pivotably connected to the second end of the second link (1402), This allows the treatment device to be changed between a septa hooking structure and a septa cutting structure by moving the second shaft (1407) longitudinally relative to the first shaft (1405). An optical transmission assembly comprising an optical transmission assembly including a light source (354), a spherical lens (355), and an optical fiber (357), In the scepter cutting structure, the first end of the first link (1400) takes a first position close to the first end of the second link (1402), and the base end side edge (1401) of the second link (1402) is exposed from the base end side of the base end side of the first link (1400). In the scepter hooking structure, the first end of the first link (1400) takes a second position away from the first end of the second link, and the base end side edge (1401) of the second link (1402) is not exposed on the base end side from the base end side edge of the first link (1400). A cellulite treatment system wherein the proximal end edge (1401) of the second link (1402) is formed with a sharp cutting blade (1401) for cutting septa.

2. The cellulite treatment system according to claim 1, wherein when the treatment device is in the form of the septa hooking structure, the septa cutting structure, and a structure intermediate between the septa hooking structure and the septa cutting structure, the second link (1402) is inclined such that the first end of the second link (1402) is located on the terminal side of the second end of the second link (1402).

3. The cellulite treatment system according to claim 1, wherein when the treatment device is in the form of the septa hooking structure, the septa cutting structure, and a structure intermediate between the septa hooking structure and the septa cutting structure, the first link (1400) is inclined such that the first end of the first link (1400) is located on the distal side of the second end of the first link (1400).

4. The treatment device is configured to have a structure in which the second shaft (1407) is retracted by moving it toward the proximal end relative to the first shaft (1405). The cellulite treatment system according to claim 1, wherein in the retracted structure, the first link (1400) and the second link (1402) are aligned with the first shaft (1405).

5. The cellulite treatment system according to claim 1, wherein the proximal end edge of the first link is curved convexly toward the terminal end.

6. The cellulite treatment system according to claim 1, wherein the proximal end edge of the first link is bent convexly toward the terminal end.

7. A cellulite treatment system for treating cellulite on the skin of a patient related to the septal treatment site, wherein the cellulite treatment system is An elongated member (224) configured to be inserted subcutaneously, comprising a first shaft (405) and a second shaft (407) supported by the first shaft (405) and configured to move longitudinally along the first shaft (405), A treatment device (225) provided at the end of the elongated member, The treatment device (225) has a first link (400) having a first end and a second end, and a second link (402) having a first end and a second end. The first end of the first link (400) is pivotably connected to the end of the second shaft (407), The first end of the second link (402) is pivotably connected to the end of the first shaft (405), The second end of the first link (400) is pivotably connected to the second end of the second link (402), This allows the treatment device (225) to be changed between a septum hooking structure and a septum cutting structure by moving the second shaft (407) longitudinally relative to the first shaft (405). An optical transmission assembly comprising an optical transmission assembly including a light source, a spherical lens, and an optical fiber, In the scepter hooking structure, the first end of the first link (400) takes a first position close to the first end of the second link (402), and the base end edge of the first link (400) is not exposed from the base end edge of the second link (402) toward the base end. In the scepter cutting structure, the first end of the first link (400) takes a second position away from the first end of the second link (402) toward the base end, and the base end edge of the first link (400) is exposed toward the base end from the base end edge of the second link (402), A cellulite treatment system wherein the proximal edge of the first link (400) is formed with a sharp cutting blade (401) for cutting septa.

8. The cellulite treatment system according to claim 7, wherein when the treatment device (225) is in the form of the septa hooking structure, the septa cutting structure, and a structure intermediate between the septa hooking structure and the septa cutting structure, the second link (402) is inclined such that the first end of the second link (402) is located on the terminal side of the second end of the second link (402).

9. The cellulite treatment system according to claim 7, wherein when the treatment device (225) is in the form of the septa hooking structure, the septa cutting structure, and a structure intermediate between the septa hooking structure and the septa cutting structure, the first link (400) is inclined such that the first end of the first link (400) is located further abutmentally than the second end of the first link (400).

10. The treatment device (225) is configured to have a structure in which the second shaft is retracted by moving it toward the proximal end relative to the first shaft from the septa hooking structure. The cellulite treatment system according to claim 7, wherein in the retracted structure, the first link (400) and the second link (402) are aligned with the first shaft (405).

11. The cellulite treatment system according to claim 7, wherein the proximal end edge of the first link is curved convexly toward the terminal end.

12. The cellulite treatment system according to claim 7, wherein the proximal end edge of the second link is bent convexly toward the proximal end.

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