Tissue augmentation methods using a medical injection apparatus

• US 20070078435A1
• Filed: 06/16/2006
• Published: 04/05/2007
• Est. Priority Date: 06/14/2001
• Status: Abandoned Application

• Current Assignee: Artes Medical USA Inc.
• Original Assignee: Artes Medical USA Inc.
• Inventors: Stone, Corbett, Anderson, Russell
• Application Number:
  US11/454,540
• Publication Number:
  US 20070078435A1
• Time in Patent Office: Days
• US Class Current: 604/507
• CPC Class Codes: A61M 25/0084 being one or more injection needles

Abstract

An injection apparatus that includes components that facilitate injection of relatively viscous materials into a subject is provided as well as methods of use. An injection apparatus may include a transition-bore needle apparatus, which has a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, in which the diameter of the proximal end is greater than the diameter of the distal end. An injection apparatus may include a hand-held injection facilitation apparatus, which may be coupled to a syringe. The hand-held injection facilitation apparatus can include a pivot arm and a body with a rod disposed within the body and coupled to the pivot arm. Movement of the pivot arm results in a proximal or distal movement of the rod within the body to effectively cause material to be expelled from the syringe. An injection apparatus may include a transition-bore needle apparatus and a hand-held injection facilitation apparatus in combination.

Claims

1. A method for placing an injectable therapeutic filler material to a targeted treatment location comprising:

inserting an injection apparatus wherein, said injection apparatus comprises

a transition-bore needle apparatus, which comprises a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein a diameter of the proximal end of the transition-bore needle apparatus is greater than a diameter of the distal end of the transition-bore needle apparatus, wherein a proximal portion of the transition-bore needle apparatus comprises a first needle having a first diameter, and a distal portion of the transition-bore needle apparatus comprises a second needle having a second diameter, and wherein the proximal end of the first needle defines a surface that is nonperpendicularly oriented to the lumen of the transition-bore needle apparatus; and

,

a surgical device suitable for insertion within a body lumen;

and,

delivering said injectable therapeutic filler material through said injection apparatus to said targeted treatment location.

2. The method of claim 1, wherein said injection apparatus is guided by an external imaging system.

3. The method of claim 2, wherein said external imaging system is radiography, fluoroscopy, computerized tomography, or ultrasound.

4. The method of claim 2, wherein said external imaging system includes the injection of an image contrast agent.

5. The method of claim 1, wherein said body lumen is an esophagus, a stomach or duodenum.

6. The method of claim 5, wherein said surgical device is a gastroscope.

7. The method of claim 1, wherein said body lumen is a urethra or ureter.

8. The method of claim 7, wherein said surgical device is a cytoscope.

9. The method of claim 1, wherein said body lumen is a vagina or fallopian tube.

10. The method of claim 9, wherein said surgical device is a laproscope.

11. The method of claim 1, wherein said body lumen is a rectum, colon, large intestine or small intestine.

12. The method of claim 11, wherein said surgical device is a proctoscope or endoscope.

13. The method of claim 1, wherein said body lumen is a blood vessel or duct.

14. The method of claim 13, wherein said surgical device is angioscope.

15. The method of claim 1, wherein said body lumen is a bronchus or lung.

16. The method of claim 15, wherein said surgical device is a bronchoscope.

17. The method of claim 1, wherein said body lumen is a nasal sinus.

18. The method of claim 17, wherein said surgical device is an otoscope.

19. The method of claim 1, wherein said body lumen is a joint.

20. The method of claim 19, wherein said surgical device is an arthroscope.

21. The method of claim 1, wherein said surgical device comprises a liquid crystal polymer.

22. The method of claim 1, wherein said injectable therapeutic filler material is injected into or adjacent to an anatomic structure.

23. The method of claim 22, wherein said anatomic structure is a sphincter muscle.

24. The method of claim 23, wherein said sphincter muscle is an esophageal sphincter, a urinary sphincter, a pyloric sphincter, an anal sphincter, or a bladder sphincter.

25. The method of claim 1, wherein said injectable therapeutic filler material is soft tissue filler.

26. The method of claim 25, wherein said soft tissue filler comprises polymethylmethacrylate microspheres.

27. The method of claim 26, wherein said soft tissue filler comprises approximately 20% by weight polymethylmethacrylate microspheres and approximately 80% by weight of a composition comprising 3.5% purified bovine collagen, 2.7% phosphate buffer, 0.9% sodium chloride, 0.3% lidocaine hydrochloride, and 92.6% water for injection.

28. The method of claim 1, further comprising the step of mixing a composition of at least one cell type with said filler material.

29. The method of claim 28, wherein said cells are autogenic.

30. The method of claim 28, wherein said cells are human.

31. The method of claim 28, wherein said cells are genetically engineered.

32. The method of claim 28, wherein said cell type acts synergistically with other cell types in the formation of tissue.

33. The method of claim 28, wherein said cell type is selected from the group consisting of fibroblast cells, smooth muscle cells, striated muscle cells, heart muscle cells, nerve cells, epithelial cells, endothelial cells, bone cells, bone progenitor cells, bone marrow cells, blood cells, brain cells, kidney cells, liver cells, lung cells, pancreatic cells, spleen cells, breast cells, foreskin cells, ovary cells, testes cells and prostate cells.

34. The method of claim 28, wherein said cells are fetal or adults stem cells.

35. The method of claim 34, wherein said stem cells are totipotent, multipotent, or pluripotent.

36. The method of claim 1, wherein said filler material is mixed with a composition of at least one of non-mammalian eukaryotic cells, prokaryotic cells or viruses.

37. The method of claim 1, wherein said filler material is mixed with at least one of a physiologically buffered salt solution, water, or glycerol.

38. The method of claim 1, wherein said filler material is mixed with at least one composition of serum, a growth factor, a hormone, a sugar, an amino acid, a vitamin, a metalloprotein, or a lipoprotein.

39. The method of claim 28, wherein said targeted treatment location is selected from the group consisting of a blood vessel, a duct, a bronchus, a lung, a sinus, an esophagus, a stomach, a duodenum, a small intestine, a large intestine, a colon, a rectum, a ureter, a urethra, a vagina, a fallopian tube, a sphincter muscle, a spine and a joint

120. The method of claim 1, wherein said distal needle includes a depth indicator.

40. A method for treating gastro-esophogeal reflux disease comprising:

inserting an injection apparatus into the esophagus of said subject, said injection apparatus comprising

a transition-bore needle apparatus, which comprises a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein a diameter of the proximal end of the transition-bore needle apparatus is greater than a diameter of the distal end of the transition-bore needle apparatus, wherein a proximal portion of the transition-bore needle apparatus comprises a first needle having a first diameter, and a distal portion of the transition-bore needle apparatus comprises a second needle having a second diameter, and wherein the proximal end of the first needle defines a surface that is nonperpendicularly oriented to the lumen of the transition-bore needle apparatus; and

,

a gastroscope;

and,

delivering an injectable therapeutic filler material through said injection apparatus around the lower esophageal sphincter to alter the biomechanical characteristics of said sphincter surrounding tissues to alleviate gastro-esophageal reflux.

41. The method of claim 40, wherein said injectable therapeutic filler material is soft tissue filler.

42. The method of claim 41, wherein said soft tissue filler comprises polymethylmethacrylate microspheres.

43. The method of claim 42, wherein said soft tissue filler comprises approximately 20% by weight polymethylmethacrylate microspheres and approximately 80% by weight of a composition comprising 3.5% purified bovine collagen, 2.7% phosphate buffer, 0.9% sodium chloride, 0.3% lidocaine hydrochloride, and 92.6% water for injection.

44. The method of claim 40, further comprising the step of mixing a composition of at least one type of cell with said filler material.

45. The method of claim 40, wherein said filler material is mixed with at least one of a physiologically buffered salt solution, water, or glycerol.

46. The method of claim 40, wherein said filler material is mixed with at least one composition of serum, a growth factor, a hormone, a sugar, an amino acid, a vitamin, a metalloprotein, or a lipoprotein.

47. A method for treating stress urinary incontinence comprising:

inserting an injection apparatus into the urethra of said subject, said injection apparatus comprising

a transition-bore needle apparatus, which comprises a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein a diameter of the proximal end of the transition-bore needle apparatus is greater than a diameter of the distal end of the transition-bore needle apparatus, wherein a proximal portion of the transition-bore needle apparatus comprises a first needle having a first diameter, and a distal portion of the transition-bore needle apparatus comprises a second needle having a second diameter, and wherein the proximal end of the first needle defines a surface that is nonperpendicularly oriented to the lumen of the transition-bore needle apparatus; and

,

a cytoscope;

and,

delivering a therapeutic filler material through said injection apparatus around the urinary sphincter to alter the biomechanical characteristics of said sphincter surrounding tissues to alleviate stress urinary incontinence.

48. The method of claim 47, wherein said injectable therapeutic filler material is soft tissue filler.

49. The method of claim 48, wherein said soft tissue filler comprises polymethylmethacrylate microspheres.

50. The method of claim 49, wherein said soft tissue filler comprises approximately 20% by weight polymethylmethacrylate microspheres and approximately 80% by weight of a composition comprising 3.5% purified bovine collagen, 2.7% phosphate buffer, 0.9% sodium chloride, 0.3% lidocaine hydrochloride, and 92.6% water for injection.

51. The method of claim 47, further comprising the step of mixing a composition of at least one type of cell with said filler material.

52. The method of claim 47, wherein said filler material is mixed with at least one of a physiologically buffered salt solution, water, or glycerol.

53. The method of claim 47, wherein said filler material is mixed with at least one composition of serum, a growth factor, a hormone, a sugar, an amino acid, a vitamin, a metalloprotein, or a lipoprotein.

54. A method for enabling contraception comprising:

inserting an injection apparatus into the fallopian tube of a subject, said injection apparatus comprising

a transition-bore needle apparatus, which comprises a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein a diameter of the proximal end of the transition-bore needle apparatus is greater than a diameter of the distal end of the transition-bore needle apparatus, wherein a proximal portion of the transition-bore needle apparatus comprises a first needle having a first diameter, and a distal portion of the transition-bore needle apparatus comprises a second needle having a second diameter, and wherein the proximal end of the first needle defines a surface that is nonperpendicularly oriented to the lumen of the transition-bore needle apparatus; and

,

a laproscope;

and,

delivering an injectable therapeutic filler material through said injection apparatus into said fallopian tube to provide a barrier and prevent fertilization.

55. The method of claim 54, wherein said injectable therapeutic filler material is soft tissue filler.

56. The method of claim 55, wherein said soft tissue filler comprises polymethylmethacrylate microspheres.

57. The method of claim 56, wherein said soft tissue filler comprises approximately 20% by weight polymethylmethacrylate microspheres and approximately 80% by weight of a composition comprising 3.5% purified bovine collagen, 2.7% phosphate buffer, 0.9% sodium chloride, 0.3% lidocaine hydrochloride, and 92.6% water for injection.

58. The method of claim 54, further comprising the step of mixing a composition of at least one type of cell with said filler material.

59. The method of claim 54, wherein said filler material is mixed with at least one of a physiologically buffered salt solution, water, or glycerol.

60. The method of claim 54, wherein said filler material is mixed with at least one composition of serum, a growth factor, a hormone, a sugar, an amino acid, a vitamin, a metalloprotein, or a lipoprotein.

61. A method for enabling contraception comprising:

inserting an injection apparatus into the vas deferens of a subject, said injection apparatus comprising

a transition-bore needle apparatus, which comprises a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein a diameter of the proximal end of the transition-bore needle apparatus is greater than a diameter of the distal end of the transition-bore needle apparatus, wherein a proximal portion of the transition-bore needle apparatus comprises a first needle having a first diameter, and a distal portion of the transition-bore needle apparatus comprises a second needle having a second diameter, and wherein the proximal end of the first needle defines a surface that is nonperpendicularly oriented to the lumen of the transition-bore needle apparatus; and

,

an angioscope;

and,

delivering an injectable therapeutic filler material through said injection apparatus into said vas deferns to provide a barrier and prevent sperm from entering the ejaculatory duct.

62. The method of claim 61, wherein said injectable therapeutic filler material is soft tissue filler.

63. The method of claim 62, wherein said soft tissue filler comprises polymethylmethacrylate microspheres.

64. The method of claim 63, wherein said soft tissue filler comprises approximately 20% by weight polymethylmethacrylate microspheres and approximately 80% by weight of a composition comprising 3.5% purified bovine collagen, 2.7% phosphate buffer, 0.9% sodium chloride, 0.3% lidocaine hydrochloride, and 92.6% water for injection.

65. The method of claim 64, further comprising the step of mixing a composition of at least one type of cell with said filler material.

66. The method of claim 65, wherein said filler material is mixed with at least one of a physiologically buffered salt solution, water, or glycerol.

67. The method of claim 65, wherein said filler material is mixed with at least one composition of serum, a growth factor, a hormone, a sugar, an amino acid, a vitamin, a metalloprotein, or a lipoprotein.

68. A method for treating bladder incontinence comprising:

inserting an injection apparatus into the bladder of said subject, said injection apparatus comprising

a transition-bore needle apparatus, which comprises a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein a diameter of the proximal end of the transition-bore needle apparatus is greater than a diameter of the distal end of the transition-bore needle apparatus, wherein a proximal portion of the transition-bore needle apparatus comprises a first needle having a first diameter, and a distal portion of the transition-bore needle apparatus comprises a second needle having a second diameter, and wherein the proximal end of the first needle defines a surface that is nonperpendicularly oriented to the lumen of the transition-bore needle apparatus; and

,

a cytoscope;

and,

delivering an injectable therapeutic filler material through said injection apparatus around the bladder sphincter to alter the biomechanical characteristics of said sphincter surrounding tissues to alleviate bladder incontinence.

69. The method of claim 68, wherein said injectable therapeutic filler material is soft tissue filler.

70. The method of claim 69, wherein said soft tissue filler comprises polymethylmethacrylate microspheres.

71. The method of claim 70, wherein said soft tissue filler comprises approximately 20% by weight polymethylmethacrylate microspheres and approximately 80% by weight of a composition comprising 3.5% purified bovine collagen, 2.7% phosphate buffer, 0.9% sodium chloride, 0.3% lidocaine hydrochloride, and 92.6% water for injection.

72. The method of claim 68, further comprising the step of mixing a composition of at least one type of cell with said filler material.

73. The method of claim 68, wherein said filler material is mixed with at least one of a physiologically buffered salt solution, water, or glycerol.

74. The method of claim 68, wherein said filler material is mixed with at least one composition of serum, a growth factor, a hormone, a sugar, an amino acid, a vitamin, a metalloprotein, or a lipoprotein.

75. A method for treating fecal incontinence comprising:

inserting an injection apparatus into the rectum of said subject, said injection apparatus comprising

a transition-bore needle apparatus, which comprises a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein a diameter of the proximal end of the transition-bore needle apparatus is greater than a diameter of the distal end of the transition-bore needle apparatus, wherein a proximal portion of the transition-bore needle apparatus comprises a first needle having a first diameter, and a distal portion of the transition-bore needle apparatus comprises a second needle having a second diameter, and wherein the proximal end of the first needle defines a surface that is nonperpendicularly oriented to the lumen of the transition-bore needle apparatus; and

,

a proctoscope;

and,

delivering an injectable therapeutic filler material through said injection apparatus around the anal sphincter to alter the biomechanical characteristics of said sphincter surrounding tissues to alleviate fecal incontinence.

76. The method of claim 75, wherein said injectable therapeutic filler material is soft tissue filler.

77. The method of claim 76, wherein said soft tissue filler comprises polymethylmethacrylate microspheres.

78. The method of claim 77, wherein said soft tissue filler comprises approximately 20% by weight polymethylmethacrylate microspheres and approximately 80% by weight of a composition comprising 3.5% purified bovine collagen, 2.7% phosphate buffer, 0.9% sodium chloride, 0.3% lidocaine hydrochloride, and 92.6% water for injection.

79. The method of claim 75, further comprising the step of mixing a composition of at least one type of cell with said filler material.

80. The method of claim 75, wherein said filler material is mixed with at least one of a physiologically buffered salt solution, water, or glycerol.

81. The method of claim 75, wherein said filler material is mixed with at least one composition of serum, a growth factor, a hormone, a sugar, an amino acid, a vitamin, a metalloprotein, or a lipoprotein.

82. A method for treating obesity comprising:

inserting an injection apparatus into the stomach of said subject, said injection apparatus comprising

a transition-bore needle apparatus, which comprises a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein a diameter of the proximal end of the transition-bore needle apparatus is greater than a diameter of the distal end of the transition-bore needle apparatus, wherein a proximal portion of the transition-bore needle apparatus comprises a first needle having a first diameter, and a distal portion of the transition-bore needle apparatus comprises a second needle having a second diameter, and wherein the proximal end of the first needle defines a surface that is nonperpendicularly oriented to the lumen of the transition-bore needle apparatus; and

,

a gastroscope;

and,

delivering an injectable therapeutic filler material through said injection apparatus around the pyloric sphincter to alter the biomechanical characteristics of said sphincter surrounding tissues to restrict gastric emptying.

83. The method of claim 82, wherein said injectable therapeutic filler material is soft tissue filler.

84. The method of claim 83, wherein said soft tissue filler comprises polymethylmethacrylate microspheres.

85. The method of claim 84, wherein said soft tissue filler comprises approximately 20% by weight polymethylmethacrylate microspheres and approximately 80% by weight of a composition comprising 3.5% purified bovine collagen, 2.7% phosphate buffer, 0.9% sodium chloride, 0.3% lidocaine hydrochloride, and 92.6% water for injection.

86. The method of claim 82, further comprising the step of mixing a composition of at least one type of cell with said filler material.

87. The method of claim 82, wherein said filler material is mixed with at least one of a physiologically buffered salt solution, water, or glycerol.

88. The method of claim 82, wherein said filler material is mixed with at least one composition of serum, a growth factor, a hormone, a sugar, an amino acid, a vitamin, a metalloprotein, or a lipoprotein.

89. A method for treating joint cartilage damage comprising:

inserting an injection apparatus into the damaged joint of said subject, said injection apparatus comprising

a transition-bore needle apparatus, which comprises a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein a diameter of the proximal end of the transition-bore needle apparatus is greater than a diameter of the distal end of the transition-bore needle apparatus, wherein a proximal portion of the transition-bore needle apparatus comprises a first needle having a first diameter, and a distal portion of the transition-bore needle apparatus comprises a second needle having a second diameter, and wherein the proximal end of the first needle defines a surface that is nonperpendicularly oriented to the lumen of the transition-bore needle apparatus; and

,

an arthroscope;

and,

delivering an injectable therapeutic filler material through said injection apparatus into the joint to alter the biomechanical characteristics of said joint cartilage surrounding tissues to alleviate joint damage.

90. The method of claim 89, wherein said injectable therapeutic filler material is soft tissue filler.

91. The method of claim 90, wherein said soft tissue filler comprises polymethylmethacrylate microspheres.

92. The method of claim 91, wherein said soft tissue filler comprises approximately 20% by weight polymethylmethacrylate microspheres and approximately 80% by weight of a composition comprising 3.5% purified bovine collagen, 2.7% phosphate buffer, 0.9% sodium chloride, 0.3% lidocaine hydrochloride, and 92.6% water for injection.

93. The method of claim 89, further comprising the step of mixing a composition of at least one type of cell with said filler material.

94. The method of claim 89, wherein said filler material is mixed with at least one of a physiologically buffered salt solution, water, or glycerol.

95. The method of claim 89, wherein said filler material is mixed with at least one composition of serum, a growth factor, a hormone, a sugar, an amino acid, a vitamin, a metalloprotein, or a lipoprotein.

96. A method for embolotherapy comprising:

inserting an injection apparatus into the blood vessel of said subject, said injection apparatus comprising

a transition-bore needle apparatus, which comprises a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein a diameter of the proximal end of the transition-bore needle apparatus is greater than a diameter of the distal end of the transition-bore needle apparatus, wherein a proximal portion of the transition-bore needle apparatus comprises a first needle having a first diameter, and a distal portion of the transition-bore needle apparatus comprises a second needle having a second diameter, and wherein the proximal end of the first needle defines a surface that is nonperpendicularly oriented to the lumen of the transition-bore needle apparatus; and

,

an angioscope;

and,

delivering an injectable therapeutic filler material through said injection apparatus into said blood vessel to interrupt or diminish blood flow.

97. The method of claim 96, wherein said injectable therapeutic filler material is soft tissue filler.

98. The method of claim 97, wherein said soft tissue filler comprises polymethylmethacrylate microspheres.

99. The method of claim 98, wherein said soft tissue filler comprises approximately 20% by weight polymethylmethacrylate microspheres and approximately 80% by weight of a composition comprising 3.5% purified bovine collagen, 2.7% phosphate buffer, 0.9% sodium chloride, 0.3% lidocaine hydrochloride, and 92.6% water for injection.

100. The method of claim 96, further comprising the step of mixing a composition of at least one type of cell with said filler material.

101. The method of claim 96, wherein said filler material is mixed with at least one of a physiologically buffered salt solution, water, or glycerol.

102. The method of claim 96, wherein said filler material is mixed with at least one composition of serum, a growth factor, a hormone, a sugar, an amino acid, a vitamin, a metalloprotein, or a lipoprotein.

103. The method of claim 96, wherein said blood flow is to a tumor.

104. The method of claim 103, wherein said tumor is carcinogenic.

105. The method of claim 96, wherein said blood vessel has an aneurysm, arteriovenous fistulae (AVF), arteriovenous malformation (AVM), or traumatic bleeding.

106. The method of claim 96, wherein said blood vessel comprises a venous malformation (VM), lymphatic malformation (LM), or hemangioma.

107. The method of claim 96, wherein said blood vessel is hemorrhaging.

108. The method of claim 107, wherein said hemorrhaging is from a pseudoaneurysm.

109. The method of claim 107, wherein said hemorrhaging is from gastrointestinal (GI) tract, pelvic, posttraumatic, epistaxis, or hemoptysis bleeding.

110. The method of claim 96, wherein said blood vessel is a varicocele.

111. The method of claim 96, wherein said blood vessel feeds an organ.

112. The method of claim 96, wherein said blood vessel feeds a uterine leiomyomata or fibroid.

113. A method for treating spinal disc injury comprising:

inserting an injection apparatus into the nucleus pulposus, or space vacated from the removal thereof, of said subject, said injection apparatus comprising

a transition-bore needle apparatus, which comprises a proximal end, a distal end, and a lumen extending from the proximal end to the distal end, wherein a diameter of the proximal end of the transition-bore needle apparatus is greater than a diameter of the distal end of the transition-bore needle apparatus, wherein a proximal portion of the transition-bore needle apparatus comprises a first needle having a first diameter, and a distal portion of the transition-bore needle apparatus comprises a second needle having a second diameter, and wherein the proximal end of the first needle defines a surface that is nonperpendicularly oriented to the lumen of the transition-bore needle apparatus; and

,

endoscopic discectomy equipment;

and,

delivering an injectable therapeutic filler material through said injection apparatus into the nucleus pulposus, or space vacated from the removal thereof, to restore the biomechanical characteristics of said spinal surrounding tissues.

114. The method of claim 113, wherein said injectable therapeutic filler material is soft tissue filler.

115. The method of claim 114, wherein said soft tissue filler comprises polymethylmethacrylate microspheres.

116. The method of claim 115, wherein said soft tissue filler comprises approximately 20% by weight polymethylmethacrylate microspheres and approximately 80% by weight of a composition comprising 3.5% purified bovine collagen, 2.7% phosphate buffer, 0.9% sodium chloride, 0.3% lidocaine hydrochloride, and 92.6% water for injection.

117. The method of claim 113, further comprising the step of mixing a composition of at least one type of cell with said filler material.

118. The method of claim 113, wherein said filler material is mixed with at least one of a physiologically buffered salt solution, water, or glycerol.

119. The method of claim 113, wherein said filler material is mixed with at least one composition of serum, a growth factor, a hormone, a sugar, an amino acid, a vitamin, a metalloprotein, or a lipoprotein.