Search

KR-20260068126-A - HYDROGELS AND METHOD OF MAKING THE SAME

KR20260068126AKR 20260068126 AKR20260068126 AKR 20260068126AKR-20260068126-A

Abstract

The present disclosure relates to a hydrogel and its use for the repair or replacement of body tissues. The hydrogel can be safely injected into a patient through a microgauge needle and is suitable for repairing, replacing, or replacing the nucleus pulposus of an intervertebral disc. The present disclosure also discloses a method for manufacturing the hydrogel of the present disclosure and a method for repairing or replacing tissues using said hydrogel.

Inventors

  • 브루어 에릭
  • 로우만 안토니
  • 쉐어 토마스 피.
  • 윌슨 피터
  • 스미스 나이젤 고든

Assignees

  • 레겔텍, 인코포레이티드

Dates

Publication Date
20260513
Application Date
20200107
Priority Date
20190107

Claims (17)

  1. As a method for manufacturing a hydrogel, (a) forming a mixture comprising polyvinyl alcohol, polyvinylpyrrolidone and water; (b) heating the mixture from step (a) to form a solution; (c) heating unfunctionalized polyethylene glycol (PEG) having an Mw of about 800 Da to about 2,000 Da; (d) Add the heated PEG from step (c) to the heated mixture of step (b); (e) Cool the mixture from step (d) to provide a hydrogel; (f) perform phase separation to provide an aqueous supernatant and a hydrogel; (g) Remove the aqueous supernatant to provide a hydrogel. A method comprising, wherein the hydrogel does not contain a chemically cross-linked polymer.
  2. In paragraph 1, A method in which the heating of step (b) is about 95°C to about 120°C.
  3. In paragraph 1 or 2, A method in which the heating of step (c) is about 95°C to about 120°C.
  4. In paragraph 1 or 2, A method in which phase separation is performed by centrifugation.
  5. In paragraph 4, A method in which centrifugation is performed for about 5 minutes to about 10 minutes at about 4,000 g to about 6,000 g.
  6. In paragraph 4, A method in which centrifugation is performed at approximately 4,300 g for about 10 minutes.
  7. In paragraph 1 or 2, A method in which centrifugation is performed at a rate and for a time sufficient to achieve phase separation but without forming a density gradient of the suspended contrast agent.
  8. In paragraph 1 or 2, A method in which the mixture of step (a) further includes a contrast agent.
  9. In paragraph 8, A method in which the contrast agent is barium sulfate.
  10. In paragraph 1 or 2, The mixture of step (e) About 7% by weight to about 17% by weight of polyvinyl alcohol; About 0.07 weight% to about 0.17% of polyvinylpyrrolidone; About 13 weight% to about 23 weight% of polyethylene glycol; About 3 weight% to about 13 weight% of barium sulfate; and About 57% by weight to about 67% by weight of water A method including
  11. In paragraph 1 or 2, The mixture of step (e) About 9% by weight to about 15% by weight of polyvinyl alcohol; About 0.09 weight% to about 0.15% of polyvinylpyrrolidone; About 15% by weight to about 21% by weight of polyethylene glycol; About 5 weight% to about 11 weight% of barium sulfate; and About 59% by weight to about 65% by weight of water A method including
  12. In paragraph 1 or 2, The mixture of step (e) About 11% by weight to about 13% by weight of polyvinyl alcohol; About 0.11 weight% to about 0.13% of polyvinylpyrrolidone; About 17 weight% to about 19 weight% of polyethylene glycol; About 7 weight% to about 9 weight% of barium sulfate; and About 61% by weight to about 63% by weight of water A method including
  13. In paragraph 1 or 2, A method in which polyethylene glycol has an Mw of about 800 Da to about 2000 Da.
  14. In paragraph 1 or 2, A method in which polyethylene glycol has an Mw of about 1000 Da.
  15. In paragraph 1 or 2, A method in which the weight percentage of the aqueous supernatant changes to less than about 5 weight percent when the hydrogel is stored at 23°C for 2 months.
  16. In paragraph 1 or 2, hydrogel About 12 weight% to about 22 weight% of polyvinyl alcohol; About 0.12 weight% to about 0.22 weight% of polyvinylpyrrolidone; Unfunctionalized polyethylene glycol having an Mw of about 800 Da to about 2,000 Da in an amount of about 12 wt% to about 22 wt%. A method comprising, wherein the hydrogel does not contain a chemically cross-linked polymer.
  17. Hydrogel produced by the method of claim 1 or 2.

Description

Hydrogels and Method of Making the Same Cross-reference regarding related applications The present application claims priority to U.S. Application No. 16/241,510 filed January 7, 2019 and U.S. Application No. 16/673,123 filed November 4, 2019, the contents of which are incorporated herein by reference in their entirety. Field of invention The present disclosure relates to hydrogels and their use for repairing or supplementing body tissues. Hydrogels can be safely injected into a patient through a microgauge needle using the delivery system described herein and are suitable for repairing or supplementing the nucleus pulposus of an intervertebral disc. According to the extensive 2011 Institute of Medicine Report on chronic pain, approximately 100 million American adults suffer from some form of chronic pain, with back pain being the most common cause. The lifetime incidence of back pain in adults is estimated at 70–80%, making it the second leading cause of doctor visits. In the United States, back pain is the most common workers' compensation claim; in 1999, it was estimated that 149 million workdays were lost annually due to back pain, with the total cost estimated at $50 billion to $60 billion per year. In the United Kingdom, which has one-fifth the population of the U.S., over 100 million workdays are lost annually. The global burden of back pain is estimated to be in the range of hundreds of billions of dollars. While there are numerous causes of back pain, the most prevalent is degenerative disc disease. Human intervertebral discs consist of two main structures: an outer or peripheral tendon structure and an inner gelatinous nucleus pulposus located in the central region. Degeneration of the nucleus pulposus, typically associated with natural aging, can lead to disc degeneration and loss of function. Many patients experience chronic low back pain due to injury or age-related disc degeneration. Current treatments range from conservative therapy to invasive surgical procedures, including discectomy, spinal fusion, and total disc replacement. Conservative therapy often consists of a combination of rest, physical therapy, exercise, weight loss, yoga, and pain medication (e.g., opioids). Some patients with chronic low back pain receive steroid and/or analgesic injections. Unfortunately, no conservative treatment option addresses the underlying degeneration of the discs, and options for patients who have failed conservative treatment are limited, aside from surgical interventions such as discectomy, spinal fusion, and total disc replacement. Although numerous studies have indicated that opioid analgesics are ineffective in relieving chronic low back pain, approximately half of all opioid prescriptions are for chronic low back pain. There is a need for percutaneous treatment options to address disc degeneration in patients with chronic low back pain who have failed conservative therapy. Replacement or replacement of the nucleus pulposus can alleviate pain, restore the healthy physiological function of the disc, and/or prevent further wear or deterioration of the disc annulus. Currently, there are very few minimally invasive techniques or materials available to replace or replace the nucleus pulposus of a vertebral disc with selected mammalian sites. A much smaller number of techniques or materials provide the physiological and mechanical properties to restore a damaged disc to its maximum capacity. Conventional hydrogel techniques for replenishing or restoring the nucleus pulposus often require injecting a preheated solid hydrogel into the intervertebral space through a large needle. The resulting hole can cause severe discomfort to the patient and may provide a hole through which the resulting implant can be expelled. The accompanying drawings, incorporated herein and constituting a part of this specification, illustrate embodiments of the present invention and are provided to explain the features of the present invention together with the general description provided above and the detailed description provided below. In the drawings: FIG. 1 is a schematic example of a hydrogel delivery assembly according to one embodiment. FIG. 2 is a top view of a hydrogel delivery assembly according to one embodiment. FIG. 3 is a perspective view of a hydrogel delivery assembly according to one embodiment. Figure 4 is a partially enlarged perspective view of the hydrogel delivery assembly of Figure 3. FIG. 5 is a front view of a hydrogel delivery device included in the hydrogel delivery assembly of FIG. 3. Fig. 6 is an enlarged perspective view of the hydrogel delivery device of Fig. 5. FIGS. 7A and 7B are cross-sectional views of the hydrogel delivery assembly of FIG. 3 taken along line 7A-7A, and are illustrated as the first arrangement and the second arrangement, respectively. FIG. 8A illustrates a method of the present disclosure for replacing the nucleus of an intervertebral disc. FIG. 8B illustrates a method of the p