Method and apparatus for connective tissue treatment

• US 20030153849A1
• Filed: 04/24/2002
• Published: 08/14/2003
• Est. Priority Date: 02/06/1997
• Status: Active Grant

• Current Assignee: Exogen Inc. (Bioventus LLC)
• Original Assignee: Exogen Inc. (Bioventus LLC)
• Inventors: Cotton, Nicholas J., Carter, Andrew J., Walsh, William R., Scarborough, Nelson, Talish, Roger, Huckle, James William
• Granted Patent: US 7,789,841 B2
• Time in Patent Office: Days
• US Class Current: 601/2
• CPC Class Codes: A61B 17/16 Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans arthroscopic bone cutters A61B17/320016; dental implant drills potentially for other surgical use A61C8/0089; bone grinders A61F2/4644, A22C17/06; A61B17/1662 takes precedence over all other subgroups except A61B17/17
• CPC Class Codes: A61B 18/20 using laser
• CPC Class Codes: A61N 2007/0078 with multiple treatment transducers
• CPC Class Codes: A61N 7/00 Ultrasound therapy lithotripsy A61B17/22, A61B17/225; massage using supersonic vibration A61H23/00 ; using ultrasound for introducing media into the body A61M37/0092
• CPC Class Codes: A61P 19/04 for non-specific disorders of the connective tissue
• CPC Class Codes: A61P 43/00 Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00

Abstract

The invention relates to methods and apparatus for therapeutically treating connective tissue or increasing vascularization in tissue using ultrasound. More particularly, the present invention relates to methods and apparatus which use ultrasound to stimulate growth or healing, or to treating pathologies, of connective tissue, or to increase vascularization in ischaemic or grafted tissue using ultrasound.

Claims

1. A method for stimulating growth or healing, or treating pathologies, of connective tissue in mammals in need thereof, comprising:

subjecting the affected connective tissue to noninvasive, low intensity ultrasound of a frequency and duration sufficient to stimulate growth, healing, or repair of the connective tissue.

2. The method of claim 1, wherein the low intensity ultrasound has a frequency of between about 1 and about 2 MHz.

3. The method of claim 2, wherein the low intensity ultrasound has a frequency of around 1.5 MHz.

4. The method of claim 1, wherein the low intensity ultrasound is pulsed.

5. The method of claim 4, wherein the pulsed low intensity ultrasound has a pulse width of between about 10 and about 2,000 microseconds.

6. The method of claim 5, wherein the pulse width is about 200 microseconds.

7. The method of claim 4, wherein the pulse has a repetition frequency of about 0.10 to about 10 KHz.

8. The method of claim 7, wherein the repetition frequency is about 1 KHz.

9. The method of claim 1, wherein the connective tissue comprises tissue that has undergone or is undergoing degeneration as the result of osteoarthritis, tendonosis, or tendonitis, or a combination thereof.

10. The method of claim 9, wherein healing is stimulated without surgical repair or modification of the tissue.

11. The method of claim 1, wherein the connective tissue undergoing treatment has been subjected to surgery on or near the connective tissue.

12. The method of claim 11, wherein the surgery comprises repair of flexor or extensor tendons.

13. The method of claim 11, wherein the surgery comprises surgical transfer of a ligament or tendon or a ligament or tendon weave.

14. The method of claim 11, wherein the surgery comprises implantation of a scaffold capable of supporting tissue repair or regrowth.

15. The method of claim 14, wherein the scaffold comprises a material having a structure sufficiently porous to allow cell infiltration, and having a surface sufficient to allow cell adhesion and growth.

16. The method of claim 11, wherein the surgery comprises repair of a fibrocartilage.

17. The method of claim 16, wherein the fibrocartilage is selected from the group consisting of damaged lateral or medial meniscus, mandibular meniscus, spinal disc cartilage, and rib cartilage.

18. The method of claim 1, wherein the connective tissue undergoing treatment comprises one or more ligaments.

19. The method of claim 1, wherein at least one of the ligaments is located in the human knee.

20. The method of claim 19, wherein the ligaments include the anterior cruciate ligament or posterior cruciate ligament.

21. The method of claim 19, wherein the one or more ligaments include a genual ligament or a meniscofemoral ligament.

22. The method of claim 18, wherein the one or more ligaments include a lateral or collateral ligament.

23. The method of claim 1, wherein the connective tissue undergoing treatment comprises one or more tendons.

24. The method of claim 23, wherein at least one of the tendons is located in the human knee.

25. The method of claim 24, wherein the tendon is one or more of the tendon of quadriceps, gracilis tendon, sartorius tendon, semitendinosis tendon, popliteus tendon, or adductor magnus tendon.

26. The method of claim 23, wherein the tendon is in the human shoulder.

27. The method of claim 26, wherein the tendon is the supraspinatus tendon.

28. The method of claim 1, wherein the ultrasound is applied to connective tissue following a tissue shrinkage procedure.

29. The method of claim 28, wherein the tissue shrinkage procedure is selected from the group consisting of capsulorraphy and spinal disc shrinkage.

30. The method of claim 1, wherein the connective tissue pathology is tendonitis or tendonosis.

31. The method of claim 1, wherein the connective tissue has suffered an acute tear or chronic overuse injury.

32. The method of claim 1, wherein the connective tissue is located in the elbow joint.

33. The method of claim 32, wherein the pathology is tennis elbow.

34. The method of claim 1, wherein the connective tissue is located in the foot.

35. The method of claim 34, wherein the pathology is plantar fascitis.

36. The method of claim 1, wherein the connective tissue comprises fascia.

37. The method of claim 1, wherein the connective tissue undergoing treatment is located in the human knee.

38. The method of claim 37, wherein the connective tissue comprises the lateral or medial meniscus.

39. The method of claim 1, further comprising administering to the mammal a pharmacological agent.

40. The method of claim 39, wherein the pharmacological agent is a drug or growth factor.

41. The method of claim 39, wherein the growth factor is administered in sufficient dosage to increase the rate of repair, the quality of repair, or both.

42. The method of claim 39, wherein the growth factor is selected from the group consisting of the Transforming Growth Factor β

superfamily, Bone Morphogenetic Proteins, Cartilage Derived Morphogenic Proteins and Growth Differentiation Factors, angiogenic factors, platelet-derived cell growth factor (PD-ECGF), Platelet Derived Growth Factors (PDGF), Vascular Endothelial Growth Factor (VEGF), the Epidermal Growth Factor family, Transforming Growth Factor Alpha (TGFα

), Platelet Derived Growth Factors, e.g. PDGF-A, PDGF-B, PDGF-BB, Fibroblast Growth Factors, e.g. BFGF, Hepatocyte Growth Factors (HGF), Insulin-like Growth Factors, Growth Hormones (GH), Interleukins, Connective Tissue Growth Factors (CTGF), Parathyroid Hormone Related Proteins (PTHrp), autologous growth factors, and mixtures of at least two of these materials.

43. The method of claim 1, wherein the ultrasound is generated by a plurality of ultrasonic transducers placed in the vicinity of the skin the tissue to be treated.

44. The method of claim 43, wherein the ultrasonic transducers emit ultrasound simultaneously.

45. The method of claim 43, wherein the ultrasonic transducers emit ultrasound sequentially.

46. A method for increasing vascularization in connective tissues, ischaemic tissues or grafted tissue in mammals in need thereof, comprising:

subjecting the affected tissue to noninvasive, low intensity ultrasound of a frequency and duration sufficient to stimulate an increase in vascularization in the ischaemic or grafted tissue.

47. The method of claim 46, further comprising administering to the mammal a therapeutic treatment for promoting angiogenesis.

48. The method of claim 47, wherein the therapeutic treatment for promoting angiogenesis comprises administering endothelial cell growth factor (EGF), fibroblast growth factor (FGF), angiogenin, transforming growth factor beta (TGF beta), or prostaglandins.

49. The method of claim 46, wherein the therapeutic treatment comprises prophylactic treatment of a connective tissue to promote angiogenesis to increase the speed of recovery, repair, or both, post injury.

50. An apparatus for positioning one or more ultrasonic transducers with respect to a joint for delivery of ultrasonic therapy thereto, comprising:

a covering member adapted to cover at least a portion of the joint or adjacent body members and be secured thereto in a fixed position, wherein the covering member comprises one or more receiving areas adapted to receive and hold one or more ultrasonic transducer assemblies in one or more fixed positions relative to the joint or adjacent body member.

51. The apparatus of claim 50, wherein the covering member comprises a flexible fabric layer.

52. The apparatus of claim 51, wherein the receiving area comprises one or more transducer receiving ports disposed within the covering member.

53. The apparatus of claim 52, wherein the fabric layer comprises an elastic material surrounding the joint or adjacent body member.

54. The apparatus of claim 50, wherein the receiving areas comprise one or more covering member attachment areas adapted to secure the ultrasonic transducer assembly.

55. The apparatus of claim 54, wherein the ultrasonic transducer assembly comprises a strap comprising a port adapted to receive an ultrasonic transducer and one or more strap attachment areas adapted to securely attach to a covering member attachment area, whereby the ultrasonic transducer port is securely positioned relative to the joint or adjacent body member.

56. The apparatus of claim 55, further comprising a rigid strut adapted to secure the joint in a fixed position during treatment.

57. The apparatus of claim 56, wherein the rigid strut comprises an adjustment mechanism for varying the strut orientation or position.

58. The apparatus of claim 57, wherein the adjustment mechanism comprises a lockable pivot or hinge.

59. The apparatus of claim 50, wherein the joint is the knee, and the transducer assemblies are positioned relative to the interarticular space or the cruciate ligament bone tunnels.