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BR-112021001186-B1 - Device for the treatment of cellulite to treat cellulite expressions on a patient's skin associated with a septum treatment site.

BR112021001186B1BR 112021001186 B1BR112021001186 B1BR 112021001186B1BR-112021001186-B1

Abstract

APPARATUS AND SYSTEM FOR THE TREATMENT OF CELLULITE AND USE OF A SYSTEM FOR THE TREATMENT OF CELLULITE TO TREAT EXPRESSIONS OF CELLULITE ON A PATIENT'S SKIN. The present invention relates to systems for the treatment of cellulite, including an apparatus that is applied or the use of the apparatus involving the separation of septa to eliminate or reduce the appearance of cellulite. In one approach, an intervention tool is placed between the tissue layers to engage and treat the connective tissue layers of the septa between which the fat deposits are contained.

Inventors

  • Joshua Makower
  • Jonathan Podmore
  • Earl Bright
  • John Hanley
  • Pablo Acosta
  • Theodore Ketai
  • William Sauway Law
  • Michael Schaller
  • Bryan Hartley

Assignees

  • REVELLE AESTHETICS, INC

Dates

Publication Date
20260310
Application Date
20190722
Priority Date
20180723

Claims (18)

  1. 1. Apparatus for treating cellulite expressions on a patient's skin associated with a treatment site, comprising: a rod (222); a shaft (372) extending longitudinally from the rod (222); characterized by further comprising an engagement assembly (225) in a distal portion of the shaft (372), wherein the shaft (372) is configured to be inserted through the skin and advance the engagement assembly (225) between tissue layers to the treatment site, and the engagement assembly (225) has a rupture portion (353) and a blind portion (380); an actuator (908) on the shaft (222) configured to actuate the engagement assembly (225), wherein the actuator (908) is configured to position the engagement assembly (225) in at least one first configuration in which a rupture portion (353) is not exposed, a second configuration in which the blind portion (380) is presented to tension a septum (350) at the treatment site and the rupture portion (353) is covered, and a third configuration in which the rupture portion (353) is exposed. and configured to break the septum (350) at the treatment site.
  2. 2. Apparatus according to claim 1, characterized in that it additionally comprises a transillumination structure (352, 354).
  3. 3. Apparatus, according to claim 2, characterized in that the transillumination structure (352, 354) comprises a light positioned along the distal portion of the axis.
  4. 4. Apparatus, according to claim 3, characterized in that the light comprises one or more light-emitting diodes (LEDs) and/or a guide light.
  5. 5. Apparatus, according to claim 1, characterized in that the engagement assembly (225) includes a plurality of joints configured to project laterally from the axis (372).
  6. 6. Apparatus, according to claim 1, characterized in that the engagement assembly (225) includes an internal hook.
  7. 7. Apparatus according to claim 1, characterized in that the engagement assembly (225) includes a chamfered hook.
  8. 8. Apparatus, according to claim 1, characterized in that the engagement assembly (225) includes a rotating blade or structure.
  9. 9. Apparatus, according to claim 1, characterized in that the engagement assembly (225) includes a harmonic scalpel.
  10. 10. Apparatus, according to claim 1, characterized in that the engagement assembly (225) includes a selective cauterization structure or a power transmission structure.
  11. 11. Apparatus, according to claim 1, characterized in that the rupture portion (353) is configured to stretch, reorient, tear, rupture, cut and/or slice the septum (350) at the treatment site.
  12. 12. Apparatus, according to claim 11, characterized in that the rupture portion (353) is configured to cut the septum (350) at the treatment site.
  13. 13. Apparatus, according to claim 1, characterized in that the breaking portion (353) comprises a blade.
  14. 14. Apparatus, according to claim 1, characterized in that the engagement assembly (225) includes a first linkage (400) and a second linkage (402) rotatably fixed to the distal portion of the shaft (372), and the breaking portion (353) is in the first linkage (400) and the blind portion (380) is in the second linkage (402).
  15. 15. Apparatus, according to claim 14, characterized in that the first connection (400) is distal to the second connection (402).
  16. 16. Apparatus, according to claim 14, characterized in that the blind portion (380) comprises a concave surface at the first connection (400).
  17. 17. Apparatus, according to claim 1, characterized in that it further comprises a push rod (1407) connected to the actuator (908), wherein the actuator (908) is configured to advance the push rod (1407) to transition the engagement assembly (225) from the first configuration to the second configuration, and the actuator (908) is configured to advance or retract the push rod (1407) to transition the engagement assembly (225) from the second configuration to the first configuration.
  18. 18. Apparatus, according to claim 1, characterized in that the shaft (372) has a lateral opening, the engagement assembly (225) is retracted into the lateral opening in the first configuration, and the engagement assembly (225) is laterally projected from the shaft (372) in the second and third configurations.

Description

Description Field [001] The present description relates in a general way to systems and methods for the treatment of cellulite. This application claims the benefit and priority of U.S. Patent Applications Nos. 62/702,314, filed July 23, 2018; 62/736,016, filed September 25, 2018; 62/798,515, filed January 30, 2019; 62/802,368, filed February 7, 2019; and 62/8254,447, filed March 28, 2019, the full contents of which are incorporated herein by reference. Background of the Description [002] There is a continuing need for an effective approach to the treatment of cellulite, also known as gynoid lipodystrophy, nodular liposclerosis, edematofibrosclerotic panniculopathy, panniculosis, edematous adipose tissue, deforming demopaniculosis or status protrusus cutis. In addition, there is a need for proactive treatment modalities that prevent future or recurrent cellulite and that are easy and effective to use. [003] It has been reported that more than 85% of women have cellulite, thus suggesting that cellulite is a physiological and not a pathological condition. It is believed that the existence of fat only in the reticular dermis does not cause cellulite. Cellulite can be described as the herniation of subcutaneous fat within the fibrous connective tissue, which manifests as ripples in the skin. This fat load can cause stress on the connective tissue located between the fat lobules. These ripples are more common in women than in men due to the orientation of the subcutaneous fibrous structures that define the chambers containing fat cells. In fact, it is believed that this structure causes the appearance of cellulite more than excess weight. Frequently, cellulite appears in the pelvic region, including the buttocks, lower limbs, and abdomen. [004] The subdermal fat layers beneath the epidermis are contained between the dermal layers connected by septa that act as connective tissue between the dermal layers. In men, the septa are arranged more randomly and densely oriented in a more crisscrossing configuration, whereas the septa in women are generally more parallel in their arrangement. [005] Furthermore, men have thicker dermis and more angular septa relative to the skin surface, while women have relatively thinner dermis, which thins with age, and septa that are perpendicular to the skin surface. Additionally, women with cellulite exhibit thickening of the septa in the cellulite regions, and tension in the septa highlights the cellulite. In women, fat storage in adipose tissue has a biological purpose, as it is maximized to ensure adequate caloric availability for pregnancy and lactation. An increase in fluid retention or proliferation of adipose tissue in such subdermal fat layers can further result in the appearance of cellulite where the septa maintain an initial distance between the dermal layers, thus creating dimples, while pockets between the septa protrude. Over time, the septa can stretch and then eventually contract and harden, thus retaining the tissue layers at fixed distances, but the pockets between these septa can expand, thus increasing the appearance of cellulite. [006] Several approaches have been taken to treat or combat cellulite. Early treatments involved attempts to increase circulation and fat oxidation in areas exhibiting cellulite. Here, substances such as hyaluronic acid and aminophylline were injected into the target areas to reduce cellulite. Other approaches involved electroporation of the target areas, followed by mesotherapy, or the application of dermatological creams or other cellulite supplements. These approaches could be complemented by massage, or massage was used alone to promote increased fat reabsorption or drainage of fluids and toxins in the treated areas. Ultrasound has also been proposed to break down subcutaneous tissue and fat, and has been used in combination with liposuction. Low-pressure acoustic therapy in combination with microbubble infiltration has also been employed to reduce the appearance of cellulite, as has the use of other energies such as lasers and radiofrequency. These approaches have been characterized by limited or unpredictable results. More recently, cutting septa with blades or needles in the subdermal region has been employed. Previous approaches were considered laborious and very traumatic to the tissue, leading to bleeding, hematomas, hard tissue nodules, long and painful recoveries, and inconsistent results. [007] Therefore, there is a need for effective and efficient approaches to treat, minimize or eliminate cellulite with simple systems that minimize trauma. These approaches should be associated with predictable results and be relatively easy to employ. [008] The present description meets these and other needs. Summary of the Description [009] In summary and in general terms, the present description is directed to systems and methods of cellulite treatment involving a device that facilitates and methods that involve, depending on the system u