Methods for vas-occlusive contraception and reversal thereof

Patent metadata

Field	Value
Publication number	US-10155063-B2
Application number	US-201615349824-A
Country	US
Kind code	B2
Filing date	Nov 11, 2016
Priority date	Nov 12, 2015
Publication date	Dec 18, 2018
Grant date	Dec 18, 2018

Abstract

Disclosed are methods of delivering an agent to the lumen of the vas deferens under guidance of ultrasound imaging. The methods include vas-occlusive contraception in which the vas deferens is non-surgically isolated and an occlusive substance is percutaneously administered into the lumen of the vas deferens under ultrasound. Also disclosed are methods of reversal of vas-occlusive contraception and methods of delivering an agent to the lumen of the vas deferens. Also disclosed are compositions for use in the methods of the invention.

First claim

What is claims is:

1. A method. of occluding an animal or human body lumen comprising:
puncturing the body lumen using a needle;
administering a first and second substance into the body lumen; and forming a mass in the body lumen by having the first and second substances crosslink with each other by way of a bioorthogonal reaction, wherein as a result of crosslinking an occlusion is formed in situ in the body lumen; and
wherein a plurality of pores having an average pore size in the range of about 0.1 nm to about 3 μm are formed in the occlusion from interaction between the first and second substances.

2. The method of claim 1 , wherein the occlusion is echogenic.

3. The method of claim 2 , wherein microbubbles are present in the first and/or second substances and are encapsulated in the occlusion and the microbubbles have an average size in the range from about 1 to about 1,000 μm in diameter.

4. The method of claim 3 , wherein the microbubbles have a shell comprising a polymer, a protein, a surfactant, a monosaccharide, a polysaccharide, or glass.

5. The method of claim 4 , wherein the polymer comprises one or more of natural or synthetic monomers, polymers, copolymers or block copolymers, biocompatible monomers, polymers, copolymers or block copolymers, polystyrene, neoprene, polyetherether 10ketone (PEEK), carbon reinforced PEEK, polyphenylene, PEKK, PAEK, polyphenylsulphone, polysulphone, PET, polyurethane, polyethylene, low-density polyethylene (LDPE), linear low-density polyethylene (LLDPE), high-density polyethylene (HDPE), polypropylene, polyetherketoneetherketoneketone (PEKEKK), nylon, TEFLON® TFE, polyethylene terephthalate (PETE), TEFLON® FEP, TEFLON® PFA, and/or polymethylpentene (PMP) styrene maleic anhydride, styrene maleic acid, polyurethane, silicone, polymethyl methacrylate, polyacrylonitrile, poly (carbonate-urethane), poly (vinylacetate), nitrocellulose, cellulose acetate, urethane, urethane/carbonate, polylactic acid, polyacrylamide (PAAM), poly (N-isopropylacrylamine) (PNIPAM), poly (vinylmethylether), poly (ethylene oxide), poly (ethyl (hydroxyethyl) cellulose), poly(2-ethyl oxazoline), polylactide (PLA), polyglycolide (PGA), poly(lactide-co-glycolide) PLGA, poly(e-caprolactone), polydiaoxanone, polyanhydride, trimethylene carbonate, poly(β-ydroxybutyrate), poly(g-ethyl glutamate), poly(DTH-iminocarbonate), poly(bisphenol A iminocarbonate), poly(orthoester) (POE), polycyanoacrylate (PCA), polyphosphazene, polyethyleneoxide (PEO), polyethylene glycol (PEG), polyacrylacid (PAA), polyacrylonitrile (PAN), polyvinylacrylate (PVA), polyvinylpyrrolidone (PVP), polyglycolic lactic acid (PGLA), poly(2-hydroxypropyl methacrylamide) (pHPMAm), poly(vinyl alcohol) (PVOH), PEG diacrylate (PEGDA), poly(hydroxyethyl methacrylate) (pHEMA), N-i sopropylacrylamide (NIPA), poly(vinyl alcohol) poly(acrylic acid) (PVOH-PAA), collagen, silk, fibrin, gelatin, hyaluron, cellulose, chitin, dextran, casein, albumin, ovalbumin, heparin sulfate, starch, agar, heparin, alginate, fibronectin, fibrin, keratin, pectin, elastin, ethylene vinyl acetate, polyethylene oxide, PEG or any of its derivatives, PLLA, PDMS, PIPA, PEVA, PILA, PEG styrene, Teflon RFE, FLPE, Teflon FEP, methyl palmitate, NIPA, polycarbonate, polyethersulfone, polycaprolactone, polymethyl methacrylate, polyisobutylene, nitrocellulose, medical grade silicone, cellulose acetate, cellulose acetate butyrate, polyacrylonitrile, PLCL, and/or chitosan.

6. The method of claim 1 , whereby a hydrogel occlusion is formed.

7. The method of claim 6 , wherein the first and/or second substance is a solution and the hydrogel occlusion is formed in situ and once formed comprises a plurality of pores sized to restrict passage of sperm cells but permit passage of fluids through the pores.

8. The method of claim 1 , wherein the first and the second substance crosslink with each other by way of a Click reaction.

9. The method of claim 8 , wherein the first substance and the second substance are each a polymer chosen from one or more of natural or synthetic monomers, polymers, copolymers or block copolymers, biocompatible monomers, polymers, copolymers or block copolymers, polystyrene, neoprene, polyetherether 10 ketone (PEEK), carbon reinforced PEEK, polyphenylene, PEKK, PAEK, polyphenylsulphone, polysulphone, PET, polyurethane, polyethylene, low-density polyethylene (LDPE), linear low-density polyethylene (LLDPE), high-density polyethylene (HDPE), polypropylene, polyetherketoneetherketoneketone (PEKEKK), nylon, TEFLON® TFE, polyethylene terephthalate (PETE), TEFLON® FEP, TEFLON® PFA, and/or polymethylpentene (PMP) styrene maleic anhydride, styrene maleic acid, polyurethane, silicone, polymethyl methacrylate, polyacrylonitrile, poly (carbonate-urethane), poly (vinylacetate), nitrocellulose, cellulose acetate, urethane, urethane/carbonate, polylactic acid, polyacrylamide (PAAM), poly (N-isopropylacrylamine) (PNIPAM), poly (vinylmethylether), poly (ethylene oxide), poly (ethyl (hydroxyethyl) cellulose), poly(2-ethyl oxazoline), polylactide (PLA), polyglycolide (PGA), poly(lactide-co-glycolide) PLGA, poly(e-caprolactone), polydiaoxanone, polyanhydride, trimethylene carbonate, poly(β-hydroxybutyrate), poly(g-ethyl glutamate), poly(DTH-iminocarbonate), poly(bisphenol A iminocarbonate), poly(orthoester) (POE), polycyanoacrylate (PCA), polyphosphazene, polyethyleneoxide (PEO), polyethylene glycol (PEG), polyacrylacid (PAA), polyacrylonitrile (PAN), polyvinylacrylate (PVA), polyvinylpyrrolidone (PVP), polyglycolic lactic acid (PGLA), poly(2-hydroxypropyl methacrylamide) (pHPMAm), poly(vinyl alcohol) (PVOH), PEG diacrylate (PEGDA), poly(hydroxyethyl methacrylate) (pHEMA), N-isopropylacrylamide (NIPA), poly(vinyl alcohol) poly(acrylic acid) (PVOH-PAA), collagen, silk, fibrin, gelatin, hyaluron, cellulose, chitin, dextran, casein, albumin, ovalbumin, heparin sulfate, starch, agar, heparin, alginate, fibronectin, fibrin, keratin, pectin, elastin, ethylene vinyl acetate, polyethylene oxide, PEG or any of its derivatives, PLLA, PDMS, PIPA, PEVA, PILA, PEG styrene, Teflon RFE, FLPE, Teflon FEP, methyl palmitate, NIPA, polycarbonate, polyethersulfone, polycaprolactone, polymethyl methacrylate, polyisobutylene, nitrocellulose, medical grade silicone, cellulose acetate, cellulose acetate butyrate, polyacrylonitrile, PLCL, and/or chitosan, wherein the first substance comprises a thiol end group and the second substance comprises a maleimide end group.

10. The method of claim 1 , wherein imaging is used to identify the animal or human body lumen during and/or after forming the mass.

11. The method of claim 1 , wherein the occlusion comprises a plurality of pores sized to restrict passage of sperm cells, but the occlusion absorbs and allows passage of fluids through.

12. The method of claim 1 , wherein the first and second substance each have a viscosity less than or equal to 7 Pa*s.

13. The method of claim 1 , wherein the first and/or second substance includes one or more of a contraceptive, an occlusive device, a therapeutic agent, an imaging agent, an echogenic agent, microbubbles, spermicide, antimicrobials, vasodilators, and/or a composition or device for increasing or decreasing motility, viability, and/or fertility of sperm or ova.

14. The method of claim 1 , wherein the first and/or second substance comprises an imaging agent.

15. The method of claim 1 , wherein the body lumen is chosen from one or more of a vas deferens, fallopian tube, aneurysm, blood vessel, ducts, tumors, and organs.

16. The method of claim 1 , wherein after the occlusion is formed, the occlusion swells to secure itself wi

Assignees

• Univ Virginia Patent Foundation

Inventors

• Herr John C
• Klibanov Alexander L
• Eisenfrats Kevin Simon

Classifications

• A61L24/0036

  Porous materials, e.g. foams or sponges · CPC title

• A61L24/0015

  Medicaments; Biocides · CPC title

• A61L24/0031

  Hydrogels or hydrocolloids · CPC title

• A61L2300/626

  Liposomes, micelles, vesicles · CPC title

• A61B8/481

  involving the use of contrast agents, e.g. microbubbles introduced into the bloodstream · CPC title