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Last Updated: March 28, 2024

Claims for Patent: 6,862,470


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Summary for Patent: 6,862,470
Title: Cavity-filling biopsy site markers
Abstract:The invention provides materials, devices and methods for marking biopsy sites for a limited time. The biopsy-marking materials are ultrasound-detectable bio-resorbable powders, with powder particles typically between about 20 microns and about 800 microns in maximum dimension, more preferably between about 300 microns and about 500 microns. The powders may be formed of polymeric materials containing cavities sized between about 10 microns and about 500 microns, and may also contain binding agents, anesthetic agents, hemostatic agents, and radiopaque markers. Devices for delivering the powders include tubes configured to contain the powders and to fit within a biopsy cannula, the powders being ejected by action of a syringe. Systems may include a tube containing powder, and a syringe containing sterile saline. The tube may be configured to fit within a biopsy cannula such as a Mammotome.RTM. or SenoCor 360.TM. cannula.
Inventor(s): Burbank; Fred H. (San Juan Capistrano, CA), Lubock; Paul (Laguna Niguel, CA), Jones; Michael L. (Capistrano Beach, CA)
Assignee: SenoRx, Inc. (Aliso Viejo, CA)
Application Number:10/124,757
Patent Claims:1. An ultrasound-detectable biopsy marker mass which has a detectable in-vivo lifetime during which the marker mass remains readily detectable by ultrasound, and which is formed of particles of a bio-resorbable material having bubble cavities about 50 to about 200 microns in size and having a particle size between about 300 microns and about 500 microns.

2. The ultrasound-detectable biopsy marker mass of claim 1, wherein the bubble cavities have geometric centers and cavity sizes are measured by lengths through geometric centers of the cavities.

3. The ultrasound-detectable biopsy marker mass of claim 1, wherein said bio-resorbable material comprises a bio-resorbable polymeric material.

4. The ultrasound-detectable biopsy marker mass of claim 3, wherein said bio-resorbable polymeric material is selected from the group consisting of poly(esters), poly(hydroxy acids), poly(lactones), poly(amides), poly(ester-amides), poly(amino acids), poly(anhydrides), poly(ortho-esters), poly(carbonates), poly(phosphazines), poly(thioesters), poly(urethanes), poly(ester urethanes), polysaccharides, polylactic acids, polyglycolic acids, polycaproic acids, polybutyric acids, polyvaleric acids, and copolymers, polymer alloys, polymer mixtures, and combinations thereof.

5. The ultrasound-detectable biopsy marker mass of claim 3, wherein said bio-resorbable polymeric material is selected from the group consisting of polylactic acids, polyglycolic acids, polycaproic acids, and copolymers, polymer alloys, polymer mixtures, and combinations thereof.

6. The ultrasound-detectable biopsy marker mass of claim 5, wherein said bio-resorbable material comprises about 65% by weight polylactic acid and about 35% by weight polyglycolic acid.

7. The ultrasound-detectable biopsy marker mass of claim 5, wherein said bio-resorbable polymeric material comprises a polymeric material having an average molecular weight of less than about 60 kD selected from the group consisting of polylactic acid and polycaproic acid polymers, copolymers, polymer alloys, polymer mixtures, and combinations thereof.

8. The ultrasound-detectable biopsy marker mass of claim 5, wherein said bio-resorbable polymeric material comprises a polymeric material having an average molecular weight of greater than about 60 kD selected from the group consisting of copolymers of polylactic acid and polyglycolic acid, polymer alloys of polylactic acid and polyglycolic acid polymers, and polymer mixtures of polylactic acid polymers and polyglycolic acid polymers.

9. The ultrasound-detectable biopsy marker mass of claim 3, wherein said bio-resorbable polymeric material has a bulk density of between about 0.8 g/ml and about 1.5 g/ml.

10. The ultrasound-detectable biopsy marker mass of claim 1, wherein said detectable in-vivo lifetime is at least about 2 weeks.

11. The ultrasound-detectable biopsy marker mass of claim 1, wherein said detectable in-vivo lifetime is not greater than about 20 weeks.

12. The ultrasound-detectable biopsy marker mass of claim 1, wherein said detectable in-vivo lifetime is not greater than about 12 weeks.

13. The ultrasound-detectable biopsy marker mass of claim 1, wherein said detectable in-vivo lifetime is between about 6 weeks and about 12 weeks.

14. The ultrasound-detectable biopsy marker mass of claim 1, further comprising a binding agent.

15. The ultrasound-detectable biopsy marker mass of claim 14, wherein said binding agent is selected from the group consisting of gelatin, polyethylene glycol, polyvinyl alcohol, glycerin, acrylic hydrogels, organic hydrogels, and combinations thereof.

16. The ultrasound-detectable biopsy marker mass of claim 14, wherein said biopsy marker mass comprises gelatin and bio-resorbable polymeric material having bubble cavities in the proportions (by weight) of about one part gelatin to between about two parts polymeric material to about five parts polymeric material.

17. The ultrasound-detectable biopsy marker mass of claim 14, wherein said biopsy marker mass comprises gelatin and bio-resorbable polymeric material having bubble cavities in the proportions (by weight) of about one part gelatin to about three parts polymeric material.

18. The ultrasound-detectable biopsy marker mass of claim 15, wherein said binding agent comprises gelatin selected from the group consisting of bovine collagen, porcine collagen, ovine collagen, equine collagen, synthetic collagen, agar, synthetic gelatin, and combinations thereof.

19. The ultrasound-detctable biopsy marker mass of claim 1, further comprising a material selected from the group consisting of a magnetic resonance imaging (MRI) agent, a colorant, a radioactive material, and a radiopaque material.

20. The ultrasound-detectable biopsy marker mass of claim 19, comprising a radiopaque material which comprises a marker formed in a recognizable shape not naturally found within a patient's body.

21. The ultrasound-detectable biopsy marker mass of claim 20, wherein said radiopaque marker is formed in a recognizable shape selected from the group of shapes consisting of star, square, rectangular, geometric, gamma, letter, coil and loop shapes.

22. The ultrasound-detectable biopsy marker mass of claim 20, comprising a radiopaque material selected from the group consisting of stainless steel, platinum, gold, iridium, tantalum, tungsten, silver, rhodium, nickel, bismuth, other radiopaque metals, alloys of radiopaque metals, mixtures of radiopaque metals, oxides of radiopaque metals, barium salts, iodine salts, iodinated materials, and combinations thereof.

23. A ready-to-use assembly for delivering a biopsy marker mass, comprising: a tube having an inner lumen and being configured to be received by a biopsy guide cannula; and a quantity of ultrasound-detectable bio-resorbable powder which is disposed within the inner lumen of said tube and which is formed of particulate having bubble cavities about 50 to about 200 microns in size and having a particle size between about 200 and 500 microns.

24. The assembly of claim 23, wherein said quantity of powder has a volume of between about 0.2 ml and about 1.2 ml of powder.

25. The assembly of claim 23, wherein the tube has a maximum transverse dimension of up to about 0.1 inch (2.54 mm).

26. The assembly of claim 23, wherein said tube is configured to engage with a syringe.

27. The assembly of claim 26, wherein said tube has a luer-look connection configured to engage with a syringe.

28. The assembly of claim 23, further comprising a material disposed within said tube that is selected from the group consisting of a magnetic resonance imaging (MRI) agent, a colorant, a radioactive material, and a radiopaque material.

29. The assembly of claim 23, comprising a radiopaque material disposed within said tube which comprises a marker formed in a recognizable shape not naturally found within a patient's body.

30. The assembly of claim 29, wherein said radiopaque marker is formed in a recognizable shape selected from the group of shapes consisting of star, square, rectangular, geometric, gamma, letter, coil and loop shapes.

31. A system for marking a biopsy site within a patient, comprising: a syringe having an elongated body, an inner cavity, a plunger slidably disposed within the cavity, and a discharge end; a delivery tube having a bore configured to be secured to the discharge end of the syringe; and a quantity of ultrasound-detectable bio-resorbable powder disposed within the delivery tube formed of particulate having bubble cavities about 50 to 200 microns in size and having a particle size between about 300 and 500 microns.

32. The system of claim 31, wherein said quantity of ultrasound-detectable bio-resorbable powder has a volume of between about 0.2 ml and about 1.2 ml of said powder.

33. The system of claim 31, wherein said quantity of ultrasound-detectable bio-resorbable powder is contained within said bore of said delivery tube.

34. The system of claim 31, wherein said delivery tube is configured to be received within a biopsy cannula.

35. The system of claim 31, wherein said delivery tube has a width not greater than about 0.1 inch (2.54 mm).

36. The system of claim 31, further comprising a supply of biocompatible liquid disposed within the inner cavity of the syringe.

37. The system of claim 36, wherein said biocompatible liquid comprises a liquid selected from the group consisting of sterile saline, sterile saline containing an pharmaceutical agent, sterile saline containing an anesthetic agent, sterile saline containing a hemostatic agent, sterile saline containing a colorant, sterile saline containing a radio contrast agent, sterile saline containing an osmotic agent, sterile sugar solution, sterile sugar solution containing a pharmaceutical agent, sterile sugar solution containing an anesthetic agent, sterile sugar solution containing a hemostatic agent, sterile sugar solution containing a colorant, sterile sugar solution containing a radio contrast agent, biocompatible oils, biocompatible oils containing an pharmaceutical agent, biocompatible oils containing an anesthetic agent, biocompatible oils containing a hemostatic agent, biocompatible oils containing a colorant, biocompatible oils containing a radio contrast agent, and combinations thereof.

38. The system of claim 31, wherein said quantity of ultrasound-detectable bio-resorbable powder comprising a material selected from the group consisting of a magnetic resonance imaging (MRI) agent, a colorant, a radioactive material, and a radiopaque material.

39. The system of claim 38, comprising a radiopaque material which comprises a radiopaque marker formed in a recognizable shape not naturally found within a patient's body.

40. The system of claim 39, wherein said radiopaque marker is formed in a recognizable shape selected from the group of shapes consisting of star, square, rectangular, geometric, gamma, letter, coil and loop shapes.

41. A method of making an ultrasound-detectable biopsy marker mass, comprising: providing an ultrasound-detectable bio-resorbable polymeric material having bubble cavities, wherein said bubble cavities have geometric centers and cavity sizes measured along lengths across said cavities through geometric centers of said cavities, said cavity sizes generally being about 50 to 200 microns in size and having a particle size between about 300 and 500 microns; comminuting the ultrasound-detectable bio-resorbable material effective to reduce said material to an aggregation of finely-divided ultrasound-detectable bio-resorbable particles; and sieving said aggregation of finely-divided particles with a sieve having a sieve size of not more than about 2000 microns.

42. The method of claim 41, wherein providing an ultrasound-detectable bio-resorbable polymeric material having bubble cavities comprises a method selected from the group consisting of extruding a polymeric material and a blowing agent effective to create a polymeric rod having gas bubbles entrained therein; whipping a gas into a polymeric material; including salt particles within a polymeric material; and including a non-miscible liquid within a polymeric material.

43. The method of claim 42, wherein said polymeric material is selected from the group consisting of poly(esters), poly(hydroxy acids), poly(lactones), poly(amides), poly(ester-amides), poly(amino acids), poly(anhydrides), poly(ortho-esters), poly(carbonates), poly(phosphazines), poly(thioesters), poly(urethanes), poly(ester urethanes), polysaccharides, polylactic acids, polyglycolic acids, polycaproic acids, polybutyric acids, polyvaleric acids, and copolymers, polymer alloys, polymer mixtures, and combinations thereof.

44. The method of claim 42, wherein said method of providing comprises extruding a polymeric material and a blowing agent effective to create a polymeric rod having gas bubbles entrained therein, further wherein said blowing agent is selected from the group of blowing agents consisting of sodium bicarbonate, ammonium carbonate, sodium boron hydride, silicon oxy-hydride, hydrochlorofluorocarbon compounds, chlorofluorocarbon compounds, mixtures of sodium bicarbonate, ammonium carbonate, sodium boron hydride, silicon oxy-hydride, hydrochlorofluorocarbon compounds, and chlorofluorocarbon compounds, hexane, heptane, heptene, propyl alcohol, isopropyl alcohol, mixtures of hexane, heptane, heptene, propyl alcohol, and isopropyl alcohol.

45. The method of claim 41, wherein providing an ultrasound-detectable bio-resorbable polymeric material having bubble cavities comprises providing a mixture of a copolymer of poly-lactic acid and poly-glycolic acid and up to about 5% by weight sodium bicarbonate.

46. A method of marking a biopsy site within a patient's body, comprising depositing at the biopsy site a quantity of an ultrasound-detectable bio-resorbable particulate material having bubble cavities about 50 to 200 microns in size and having a particle size between about 300 and 500 microns.

47. The method of claim 46, wherein depositing said quantity of particulate material having bubble cavities comprises the application of pressure, wherein said pressure is selected from the group consisting of gas pressure, acoustic pressure, hydraulic pressure, and pressure from direct contact with a plunger.

48. The method of claim 47, wherein said application of pressure comprises the application of hydraulic pressure effective to produce fluid flow adjacent said quantity of ultrasound-detectable bio-resorbable particulate material.

49. The method of claim 48, wherein said application of hydraulic pressure comprises depressing a plunger disposed within an elongated chamber containing a fluid.

50. The method of claim 48, wherein said fluid flow comprises the flow of a biocompatible liquid through a tube containing said quantity of ultrasound-detectable bio-resorbable particulate material, wherein said biocompatible liquid is selected from the group consisting of sterile saline, sterile saline containing an pharmaceutical agent, sterile saline containing an anesthetic agent, sterile saline containing a hemostatic agent, sterile saline containing a colorant, sterile saline containing a radio contrast agent, sterile saline containing an osmotic agent, sterile sugar solution, sterile sugar solution containing a pharmaceutical agent, sterile sugar solution containing an anesthetic agent, sterile sugar solution containing a hemostatic agent, sterile sugar solution containing a colorant, sterile sugar solution containing a radio contrast agent, biocompatible oils, biocompatible oils containing an pharmaceutical agent, biocompatible oils containing an anesthetic agent, biocompatible oils containing a hemostatic agent, biocompatible oils containing a colorant, biocompatible oils containing a radio contrast agent, and combinations thereof.

51. The method of claim 46, wherein said quantity comprises between about 0.2 ml and about 1.2 ml of ultrasound-detectable bio-resorbable particulate material.

52. The ultrasound-detectable biopsy marker mass of claim 1, wherein said bio-resorbable material is effective to form a gel upon introduction within the body of an animal.

53. The system of claim 31, wherein said delivery tube has an outer surface configured to engage a cannula, and further comprising a cannula configured to receive a delivery tube.

54. The system of claim 53, wherein said cannula is configured to engage a delivery tube received within said cannula.

55. The system of claim 54, wherein at least one of said cannula and said delivery tube comprise an engagement feature selected from the group consisting of a pin, a slot, a wedge, a bump, a band, and a luer-lock fitting.

56. The system of claim 36, wherein said biocompatible liquid comprises a hemostatic agent selected from the group consisting of adrenochrome, algin, alginic acid, aminocaproic acid, batroxobin, carbazochrome salicylate, cephalins, cotarmine, ellagic acid, epinephrine, ethamsylate, factor VIII, factor IX, factor XIII, fibrin, fibrinogen, naphthoquinone, oxamarin, oxidized cellulose, styptic collodion, sulamrin, thrombin, thromboplastin (factor III), tolonium chloride, tranexamic acid, and vasopression.

57. The system of claim 36, wherein said biocompatible liquid comprises a pharmaceutical agent selected from the group consisting of penicillins, cephalosporins, vancomycins, aminoglycosides, quinolones, polymyxins, erythromycins, tetracyclines, streptomycins, sulfa drugs, chloramphenicols, clindamycins, lincomycins, sulfonamides, paclitaxel, docetaxel, acetyl sulfisoxazole, alkylating agents, antimetabolites, plant alkaloids, mechlorethamine, chlorambucil, cyclophosphamide, melphalan, ifosfamide, methotrexate, 6-mercaptopurine, 5-fluorouracil, cytarabine, vinblastine, vincristine, etoposide, doxorubicin, daunomycin, bleomycin, mitomycin, carmustine, lomustine, cisplatin, interferon, asparaginase, tamoxifen, flutamide, amantadines, rimantadines, ribavirins, idoxuridines, vidarabines, trifluridines, acyclovirs, ganciclovirs, zidovudines, foscarnets, interferons, prochlorperzine edisylate, ferrous sulfate, aminocaproic acid, mecamylamine hydrochloride, procainamide hydrochloride, isoproterenol sulfate, phenmetrazine hydrochloride, bethanechol chloride, methacholine chloride, isopropamide iodide, tridihexethyl chloride, phenformin hydrochloride, methylphenidate hydrochloride, theophylline cholinate, cephalexin hydrochloride, diphenidol, meclizine hydrochloride, prochlorperazine maleate, phenoxybenzamine, thiethylperzine maleate, anisindone, diphenadione erythrityl tetranitrate, isoflurophate, acetazolamide, methazolamide, bendroflumethiazide, chloropromaide, tolazamide, chlormadinone acetate, phenaglycodol, allopurinol, aluminum aspirin, hydrocortisone, hydrocorticosterone acetate, cortisone acetate, dexamethasone and its derivatives such as betamethasone, triamcinolone, methyltestosterone, 17-S-estradiol, ethinyl estradiol, ethinyl estradiol 3-methyl ether, prednisolone, 17-hydroxyprogesterone acetate compounds, 19-nor-progesterone, norgestrel, norethindrone, norethisterone, norethiederone, progesterone, norgesterone, norethynodrel, aspirin, indomethacin, naproxen, fenoprofen, sulindac, indoprofen, nitroglycerin, isosorbide dinitrate, propranolol, timolol, atenolol, alprenolol, cimetidine, clonidine, imipramine, dihydroxyphenylalanine, theophylline, calcium gluconate, ketoprofen, ibuprofen, cephalexin, haloperidol, zomepirac, ferrous lactate, vincamine, diazepam, phenoxybenzamine, milrinone, capropril, mandol, quanbenz, hydrochlorothiazide, ranitidine, flurbiprofen, fenufen, fluprofen, tolmetin, alclofenac, mefenamic, flufenamic, difuinal, nizatidine, sucralfate, etintidine, tetratolol, minoxidil, chlordiazepoxide, diazepam, amitriptyline, imipramine, prostaglandins, coagulation factors, analogs of these compounds, derivatives of these compounds, and pharmaceutically acceptable salts of these compounds, analogs and derivatives.

58. The method of claim 50, wherein said biocompatible liquid comprises a hemostatic agent selected from the group consisting of adrenochrome, algin, alginic acid, aminocaproic acid, batroxobin, carbazochrome salicylate, cephalins, cotarmine, ellagic acid, epinephrine, ethamsylate, factor VIII, factor IX, factor XIII, fibrin, fibrinogen, naphthoquinone, oxamarin, oxidized cellulose, styptic collodion, sulamrin, thrombin, thromboplastin (factor III), tolonium chloride, tranexamic acid, and vasopression.

59. The method of claim 50, wherein said biocompatible liquid comprises a pharmaceutical agent selected from the group consisting of penicillins, cephalosporins, vancomycins, aminoglycosides, quinolones, polymyxins, erythromycins, tetracyclines, streptomycins, sulfa drugs, chloramphenicols, clindamycins, lincomycins, sulfonamides, paclitaxel, docetaxel, acetyl sulfisoxazole, alkylating agents, antimetabolites, plant alkaloids, mechlorethamine, chlorambucil, cyclophosphamide, melphalan, ifosfamide, methotrexate, 6-mercaptopurine, 5-fluorouracil, cytarabine, vinblastine, vincristine, etoposide, doxorubicin, daunomycin, bleomycin, mitomycin, carmustine, lomustine, cisplatin, interferon, asparaginase, tamoxifen, flutamide, amantadines, rimantadines, ribavirins, idoxuridines, vidarabines, trifluridines, acyclovirs, ganciclovirs, zidovudines, foscarnets, interferons, prochlorperzine edisylate, ferrous sulfate, aminocaproic acid, mecamylamine hydrochloride, procainamide hydrochloride, isoproterenol sulfate, phenmetrazine hydrochloride, bethanechol chloride, methacholine chloride, isopropamide iodide, tridihexethyl chloride, phenformin hydrochloride, methylphenidate hydrochloride, theophylline cholinate, cephalexin hydrochloride, diphenidol, meclizine hydrochloride, prochlorperazine maleate, phenoxybenzamine, thiethylperzine maleate, anisindone, diphenadione erythrityl tetranitrate, isoflurophate, acetazolamide, methazolamide, bendroflumethiazide, chloropromaide, tolazamide, chlormadinone acetate, phenaglycodol, allopurinol, aluminum aspirin, hydrocortisone, hydrocorticosterone acetate, cortisone acetate, dexamethasone and its derivatives such as betamethasone, triamcinolone, methyltestosterone, 17-S-estradiol, ethinyl estradiol, ethinyl estradiol 3-methyl ether, prednisolone, 17-hydroxyprogesterone acetate compounds, 19-nor-progesterone, norgestrel, norethindrone, norethisterone, norethiederone, progesterone, norgesterone, norethynodrel, aspirin, indomethacin, naproxen, fenoprofen, sulindac, indoprofen, nitroglycerin, isosorbide dinitrate, propranolol, timolol, atenolol, alprenolol, cimetidine, clonidine, imipramine, dihydroxyphenylalanine, theophylline, calcium gluconate, ketoprofen, ibuprofen, cephalexin, haloperidol, zomepirac, ferrous lactate, vincamine, diazepam, phenoxybenzamine, milrinone, capropril, mandol, quanbenz, hydrochlorothiazide, ranitidine, flurbiprofen, fenufen, fluprofen, tolmetin, alclofenac, mefenamic, flufenamic, difuinal, nizatidine, sucralfate, etintidine, tetratolol, minoxidil, chlordiazepoxide, diazepam, amitriptyline, imipramine, prostaglandins, coagulation factors, analogs of these compounds, derivatives of these compounds, and pharmaceutically acceptable salts of these compounds, analogs and derivatives.

60. The method of claim 46, wherein said quantity of ultrasound-detectable bio-resorbable particulate material comprises a slurry of ultrasound-detectable bio-resorbable particles in a biocompatible liquid.

61. The method of claim 60, wherein said slurry is formed within a delivery tube.

62. The method of claim 60, wherein said slurry is formed within a syringe.

63. The ultrasound-detectable biopsy marker mass of claim 1, further comprising a radioactive material.

64. The ultrasound-detectable biopsy marker mass of claim 63, wherein said radioactive material comprises a brachytherapy seed.

65. The ultrasound-detectable biopsy marker mass of claim 19, comprising a radioactive material, wherein said radioactive material comprises a brachytherapy seed.

66. The assembly of claim 28, comprising a radioactive material, wherein said radioactive material comprises a brachytherapy seed.

67. The system of claim 38, comprising a radioactive material, wherein said radioactive material comprises a brachytherapy seed.

68. The assembly of claim 23, further comprising a plunger configured to slide within said inner lumen effective to push material therein.

69. A system for marking a biopsy site within a patient, comprising: a delivery tube having a bore with a proximal portion and a distal portion, a plunger slidably disposed within said bore proximal portion, and a discharge end on said distal portion; and a quantity of ultrasound-detectable bio-resorbable powder disposed within said bore distal portion formed of particulate having bubble cavities about 10 to about 500 microns in size.

70. The system of claim 69, wherein said delivery tube is configured to be received within a biopsy cannula.

71. The system of claim 69, wherein said delivery tube has a width not greater than about 0.1 inch (2.54 mm).

72. An ultrasound-detectable marker mass for a biopsy cavity site which has a ultrasound detectable in-vivo lifetime of at least two weeks at the site, and which is formed of bioresorbable particles from about 300 to less than 2000 microns and having bubble cavities about 10 to 500 microns in size.

73. The ultrasound-detectable biopsy marker mass of claim 72, wherein the bubble cavities have geometric centers and cavity sizes are measured by lengths through geometric centers of the cavities.

74. The ultrasound-detectable biopsy marker mass of claim 72, wherein the bubble cavity size is between about 50 microns and about 200 microns.

75. The ultrasound-detectable biopsy marker mass of claim 72 wherein the bio-resorbable material is a bio-resorbable polymeric material.

76. The ultrasound-detectable biopsy marker mass of claim 75, wherein the bio-resorbable polymeric material is selected from the group consisting of poly(esters), poly(hydroxy acids), poly(lactones), poly(amides), poly(ester-amides), poly(amino acids), poly(anhydrides), poly(ortho-esters), poly(carbonates), poly(phosphazines), poly(thioesters), poly(urethanes), poly(ester urethanes), polysaccharides, polylactic acids, polyglycolic acids, polycaproic acids, polybutyric acids, polyvaleric acids, and copolymers, polymer alloys, polymer mixtures, and combinations thereof.

77. The ultrasound-detectable biopsy marker mass of claim 75, wherein the bio-resorbable polymeric material is selected from the group consisting of polylactic acids, polyglycolic acids, polycaproic acids, and copolymers, polymer alloys, polymer mixtures, and combinations thereof.

78. The ultrasound-detectable biopsy marker mass of claim 75, wherein the bio-resorbable polymeric material comprises about 65% by weight polylactic acid and about 35% by weight polyglycolic acid.

79. The ultrasound-detectable biopsy marker mass of claim 75, wherein the bio-resorbable polymeric material has an average molecular weight of less than about 60 kD and is selected from the group consisting of polylactic acid and polycaproic acid polymers, copolymers, polymer alloys, polymer mixtures, and combinations thereof.

80. The ultrasound-detectable biopsy marker mass of claim 75, wherein the bio-resorbable polymeric material has an average molecular weight of greater than about 60 kD and is selected from the group consisting of copolymers of polylactic acid and polyglycolic acid, polymer alloys of polylactic acid and polyglycolic acid polymers, and polymer mixtures of polylactic acid polymers and polyglycolic acid polymers.

81. The ultrasound-detectable biopsy marker mass of claim 75, wherein the bio-resorbable polymeric material has a bulk density of between about 0.8 g/ml and about 1.5 g/ml.

82. The ultrasound-detectable biopsy marker mass of claim 72, wherein the detectable in-vivo lifetime is at least about 2 weeks.

83. The ultrasound-detectable biopsy marker mass of claim 72, wherein the detectable in-vivo lifetime is not greater than about 20 weeks.

84. The ultrasound-detectable biopsy marker mass of claim 72, wherein the detectable in-vivo lifetime is not greater than about 12 weeks.

85. The ultrasound-detectable biopsy marker mass of claim 72, wherein the detectable in-vivo lifetime is between about 6 weeks and about 12 weeks.

86. The ultrasound-detectable biopsy marker mass of claim 75, wherein the polymeric material includes a binding agent.

87. The ultrasound-detectable biopsy marker mass of claim 86, wherein the binding agent is selected from the group consisting of gelatin, polyethylene glycol, polyvinyl alcohol, glycerin, acrylic hydrogels, organic hydrogels, and combinations thereof.

88. The ultrasound-detectable biopsy marker mass of claim 72, wherein the biopsy marker mass comprises gelatin and bio-resorbable polymeric material having bubble cavities in the proportions (by weight) of about one part gelatin to between about two parts polymeric material to about five parts polymeric material.

89. The ultrasound-detectable biopsy marker mass of claim 86, wherein the biopsy marker mass comprises gelatin and bio-resorbable polymeric material having bubble cavities in the proportions (by weight) of about one part gelatin to about three parts polymeric material.

90. The ultrasound-detectable biopsy marker mass of claim 86, wherein said binding agent comprises one or more gelatins selected from the group consisting of bovine collagen, porcine collagen, ovine collagen, equine collagen, synthetic collagen, agar, synthetic gelatin, and combinations thereof.

91. The ultrasound-detectable biopsy marker mass of claim 72, further comprising a material selected from the group consisting of a magnetic resonance imaging (MRI) agent, a colorant, a radioactive material, and a radiopaque material or element.

92. The ultrasound-detectable biopsy marker mass of claim 72 including a marker element formed in a recognizable shape not naturally found within a patient's body.

93. The ultrasound-detectable biopsy marker mass of claim 92, wherein said radiopaque marker is formed in a recognizable shape selected from the group of shapes consisting of star, square, rectangular, geometric, gamma, letter, coil and loop shapes.

94. The ultrasound-detectable biopsy marker mass of claim 93, wherein the radiopaque material is selected from the group consisting of stainless steel, platinum, gold, iridium, tantalum, tungsten, silver, rhodium, nickel, bismuth, other radiopaque metals, alloys of radiopaque metals, mixtures of radiopaque metals, oxides of radiopaque metals, barium salts, iodine salts, iodinated materials, and combinations thereof.

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