Fat grafting for plantar fasciitis

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A patent has just been granted for this (attached):

This application claims the benefit of U.S. Provisional Patent Application No. 62/550,966, filed Aug. 28, 2017, which is incorporated herein by reference.
The plantar fascia is a fibrous band that originates at the heel bone and inserts into the heads of the metatarsal bones at the bottom of one's foot. Acute plantar fasciitis develops as a result of an excessive amount of traction on the ligament during stance and ambulation. Classic symptoms of plantar fasciitis include pain at the heel when first rising from a resting position. In acute plantar fasciitis the pain will improve on ambulation as the plantar fascia warms up and becomes more flexible. The heel may throb at the end of a day as well.
When there is no resolution of acute plantar fasciitis pain, chronic plantar fasciitis or fasciosis may develop. In response to the long term presence of an inflammatory process, the plantar fascia may become thickened and develop fragmentation and degeneration at its heel attachment. Plantar fasciosis may develop as early as 6-10 months after the initial plantar fasciitis presentation. We used ultrasonography to quantify the size of the plantar fascia. A thickness of less than 0.4 cm is considered a normal plantar fascia measurement. The thickness of greater than 0.4 cm is considered pathologic and confirms the presence of plantar fasciosis/chronic plantar fasciitis. Plantar fasciitis is the most common cause of heel pain and accounts for 116%-15% of all foot problems requiring medical attention. Most cases of acute plantar fasciitis (90%) can be managed conservatively with stretches, ice, anti-inflammatory medications, and night splints, amongst other therapies. However, for 10% of the population with plantar fasciitis, it can become recurrent and traditional therapy options fail to help the heel pain. Chronic plantar fasciitis is also called plantar fasciosis. Current treatments for chronic plantar fasciitis include extra corporeal shock wave therapy (ultrasound), platelet rich plasma injections, open plantar fasciotomy, endoscopic plantar fasciotomy, and other invasive procedures. Satisfaction with these techniques range from 50-95%, but complications from surgical release of the plantar fascia can include a long recovery, nerve damage and numbness, wound infection, deep vein thrombosis from immobilization, calcaneal cuboid syndrome (lateral foot pain), metatarsal stress fractures, scar formation, and recurrent plantar fasciitis.
Fat grafting is a developing technology finding utility in filling of soft tissues, with over 70,000 such procedures in 2015. Fat grafting specialties include: plastic surgery; ear, nose, throat (ENT) and facial plastic surgery; ophthalmology or oculoplastic surgery; dermatology and cosmetic dermatology; oral and maxillofacial surgery; and aesthetic medicine. In fat grafting, autologous fat is obtained, for example, by liposuction techniques. The fat, obtained by liposuction or otherwise, is then separated into oil, fat, and aqueous fractions, with the fat fraction being used for therapeutic purposes. In one example, strainers are used to separate the fat fractions. In another, the fat is rolled in gauze, e.g., TELFA®. In further examples, the fat is fractionated by centrifugation. These current fractionation processes are costly, labor-intensive, and/or expose the fat to the environment, thereby increasing the risk of infection. LIPIVAGE® is a vacuum filtration unit that is an improvement on the open-air systems, but requires a vacuum system and subsequent transfer to a delivery system. There is a need for rapid, easy-to-use, and inexpensive devices and techniques for harvesting and that minimize environmental exposure and exposure to multiple devices where each step adds expense, labor costs, and risk of contamination.
SUMMARY

According to one aspect of the invention, a fat grafting device is provided. The device comprises:

• • a rotatable internal body having a lumen, an axis of rotation, a first end comprising a central outlet from the lumen, a porous wall configured to retain fat tissue or cells within the lumen and pass liquids through the wall, and a second end opposite the first end, having an opening;
  • an external body surrounding and rotatably retaining the internal body, the external body having a first end comprising a cannula adaptor, such as a Luer adaptor, aligned with and optionally surrounding at least a portion of the central outlet of the internal body, and a second end opposite the first end, having an opening;
  • a piston slidably disposed within the internal body and having a peripheral seal engaging an inner surface of the porous wall of the internal body;
  • an internal plunger body attached to the piston and defining a central cavity;
  • an external plunger body rotatably retaining the internal plunger body and disposed at the second end of the external body; and
  • a drive assembly attached to the internal plunger body and comprising within the internal plunger body, either:
    • a cylindrical plunger having spiral threads, a ratchet configured to engage the spiral threads of the plunger, and a retainer attached to the internal plunger body configured to engage the ratchet, or
    • spiral threads on an inside surface of the internal plunger body, a plunger, and a ratchet affixed to the plunger so as to rotate in only one direction, the ratchet engaging the spiral threads on the inside surface of the internal plunger body,
  • wherein the piston engages the internal body, so that when the internal plunger body and piston is rotated, the internal body rotates.

According to another aspect of the invention, a guide device adapted to a human foot, for use in identifying one or more plantar fascia landmarks is provided, comprising:

• • a support member, comprising,
    • a curved first portion adapted to or configured to receive a posterior surface of a heel, for example with a major surface on the inside of the curve, and having a lateral and a medial end;
    • a second portion connected to and extending in an anterior direction from the medial end of the first portion, optionally having a major surface facing laterally or adapted to or configured to a medial side of a foot extending from the heel to the arch of the foot;
    • a third portion connected to and extending from an anterior end of the second portion, adapted to or configured to the arch of a foot, e.g. comprising a twist in which the major surface of the support member rotates from facing in a lateral direction towards a side of the foot to facing in a superior direction towards the plantar surface of the foot; and
    • a fourth portion connected to an end of the third portion opposite the second portion and extending towards toes of a foot, in an anterior direction from the third portion and optionally having a first major surface adapted to or configured to face a plantar surface of a foot, e.g. facing in a superior;
  • a heel guide adapted to or configured to cross a plantar surface of a heel, e.g., extending laterally from an inferior side of the first or second portion of the support member, and optionally wherein the heel guide is arcuate with an anterior concave side;
  • a guide member strip having a first end attached to the heel guide and a second end fastened to the fourth portion of the support member and defining a guide opening adapted to or configured to center over a landmark of the plantar fascia when the guide member is aligned over the planter fascia, optionally, with the guide member strip passing over the distal metatarsal head and calcaneus bone, wherein the landmark is an injection site on the plantar fascia, for example, an injection site for a corticosteroid, PRP (platelet-rich plasma), SVF (stromal vascular fraction), or fat cells or tissue.

In yet another aspect of the invention, a method of separating live fat cells and tissue from liquids is provided, comprising:

• • drawing live fat cells or fat tissue into the internal body of the device described above, or a syringe device according to any aspect described herein, by moving the piston axially away from the first end of the external body;
  • rotating the internal body of the device by moving the cylindrical plunger in an axial direction relative to the ratchet, thereby rotating the ratchet; and
  • ejecting the fat cells or tissue from the internal body by moving the piston axially toward the first end of the external body.

According to a further aspect of the invention, a method of grafting live fat cells and tissue in a patient is provided, comprising:

• • drawing live fat cells or fat tissue through a cannula and into the internal body of the device described above, or a syringe device according to any aspect described herein, by moving the piston axially away from the first end of the external body;
  • rotating the internal body of the device by moving the cylindrical plunger in an axial direction relative to the ratchet, thereby rotating the ratchet; and
  • injecting the fat cells or tissue from the internal body by moving the piston axially toward the first end of the external body.

According to another aspect of the invention, a method of treating plantar fasciitis in a patient, comprising injecting fat cells into the plantar fascia of the patient in an amount effective to treat plantar fasciitis in a patient. The method optionally utilized the device described above, or a syringe device according to any aspect described herein, and/or the guide device adapted to a human foot, for use in identifying one or more plantar fascia landmarks, according to any aspect described herein.

 

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