Ultrasonic Surgical Apparatus and Methods for Use Thereof

• US 20110040212A1
• Filed: 08/16/2010
• Published: 02/17/2011
• Est. Priority Date: 08/14/2009
• Status: Active Grant

• Current Assignee: Cilag Gmbh International (Johnson & Johnson)
• Original Assignee: Ethicon Endo-Surgery, Inc. (Johnson & Johnson)
• Inventors: Stulen, Foster B., Olson, William A., Dietz, Timothy G.
• Granted Patent: US 9,114,245 B2
• Time in Patent Office: Days
• US Class Current: 601/2
• CPC Class Codes: A61B 2017/22015 with details of the transmission member
• CPC Class Codes: A61B 2017/2253 using a coupling gel or liquid
• CPC Class Codes: A61B 2017/306 holding by means of suction
• CPC Class Codes: A61B 2017/320069 for ablating tissue
• CPC Class Codes: A61B 2017/32007 with suction or vacuum means
• CPC Class Codes: A61B 2017/320082 for incising tissue
• CPC Class Codes: A61B 2017/320089 node location
• CPC Class Codes: A61B 2017/320098 with transverse or torsional motion
• CPC Class Codes: A61N 2007/0034 Skin treatment
• CPC Class Codes: A61N 2007/0078 with multiple treatment transducers
• CPC Class Codes: A61N 2007/0082 Scanning 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: B06B 3/00 Methods or apparatus specially adapted for transmitting mechanical vibrations of infrasonic, sonic, or ultrasonic frequency

Abstract

Ultrasound surgical apparatus are disclosed, including: medical ultrasound handpieces with proximally mounted ultrasound radiators configured to create a distally-focused beam of ultrasound energy, in combination with distal guide members for control of focal point depth; medical ultrasound handpieces with proximally mounted ultrasound radiators configured to create a distally-focused beam of ultrasound energy, in combination with distal rolling members for manipulability and control of focal point depth; medical ultrasound handpiece assemblies with coupled end effectors providing a probe with a probe dilation region configured to have an average outside diameter that is equal to or greater than the average outside diameter of a probe tip and neck; as well as junctions to an ultrasonically inactive probe sheath; medical ultrasound handpiece assemblies with coupled end effectors having positionable, ultrasonically inactive probe sheath ends slidably operable to both cover and expose at least a probe tip; and ultrasound transducer cores including a transducing structure affixed to a longitudinally elongated, generally planar, single crystal or polycrystalline material waveguide.

Claims

1. An ultrasonic surgical apparatus comprising:

a medical ultrasound handpiece having a distal end and an ultrasound radiator mounted proximally from the distal end, wherein the ultrasound radiator is configured to create a beam of ultrasound energy having a focal point at a predetermined distance from the ultrasound radiator in the direction of the distal end, and has at least one monolithic ultrasound source with a focused emitting surface or at least one array ultrasound source configured as an electronically focusable array; and

a guide member for placement around a facial feature, whereupon the ultrasound handpiece is slidably engaged with the guide member to position the focal point within the skin.

2. The ultrasonic surgical apparatus of claim 1, wherein the predetermined distance is adjustable by one of the following mechanisms:

electrical adjustment of an array ultrasound source, mechanical adjustment of the thickness of the distal guide member, or mechanical adjustment of the position of the ultrasound radiator with respect to the distal end with a mechanical positioning system.

3. The ultrasonic surgical apparatus of claim 1, wherein the distal guide member is a locating ring to be positioned around a facial feature.

4. The ultrasonic surgical apparatus of claim 3, wherein the locating ring includes an adhesive backing.

5. The ultrasonic surgical apparatus of claim 3, wherein the medical ultrasound handpiece includes a vacuum port, the locating ring defines a chamber, and the locating ring is adhered to the surface of the skin surrounding the facial feature by a vacuum applied by the vacuum port within the chamber when the ultrasound handpiece is engaged with the guide member.

6. The ultrasonic surgical apparatus of claim 3, wherein the locating ring is constructed from a flexible foam sheet that is essentially incompressible for loads of up to 5 psi.

7. The ultrasonic surgical apparatus of claim 1, wherein the distal guide member is a locating base with a slidable, interlocking shuttle member configured to receive the distal end.

8. The ultrasonic surgical apparatus of claim 7, wherein the locating base includes an adhesive backing.

9. The ultrasonic surgical apparatus of claim 7, wherein the distal end provides a repositionable foot.

10. The ultrasonic surgical apparatus of claim 9, wherein one of a plurality of repositionable feet having varying thicknesses, each detachably affixable to the ultrasound handpiece, is detachably affixed to the medical ultrasound handpiece to vary the position of the ultrasound radiator with respect to the distal end.

11. The ultrasonic surgical apparatus of claim 9, wherein one of a plurality of repositionable feet having varying areal dimensions, each detachably affixable to the ultrasound handpiece, is detachably affixed to the medical ultrasound handpiece to control the application of diffuse ultrasound energy near the focal point to the skin.

12. The ultrasonic surgical apparatus of claim 1, wherein the medical ultrasound handpiece includes a registration system configured to monitor the location of the focal point with respect to the distal guide member.

13. The ultrasonic surgical apparatus of claim 1, wherein the medical ultrasound handpiece includes a registration system configured to monitor the track of the focal point with respect to the distal guide member.

14. A method of using an ultrasonic surgical apparatus comprising:

a medical ultrasound handpiece having a distal end and an ultrasound radiator mounted proximally from the distal end, wherein the ultrasound radiator is configured to create a beam of ultrasound energy having a focal point at a predetermined distance from the ultrasound radiator in the direction of the distal end, and has at least one monolithic ultrasound source with a focused emitting surface or at least one array ultrasound source configured as an electronically focusable array; and

a guide member for placement around a facial feature, whereupon the ultrasound handpiece is slidably engaged with the guide member to position the focal point within the skin;

the method comprising the steps of;

injecting a dermal filler into the dermis of a facial feature;

placing the distal guide member on the surface of the skin so as to surround the facial feature;

applying an acoustic gel to the skin over the facial feature;

engaging the distal end of the ultrasound handpiece with the emplaced guide member; and

slidably translating the ultrasound handpiece upon the emplaced guide member to position the focal point the ultrasound radiator within the injected dermal filler, then subsequently powering the ultrasound radiator to shear-thin the dermal filler.

15. The method of claim 14, wherein the distal guide member is a locating ring defining a chamber and the medical ultrasound handpiece includes a vacuum port for communication with the chamber, the method further comprising the step of:

applying a vacuum through the vacuum port and within the chamber when the ultrasound handpiece is engaged with the locating ring;

wherein the ultrasound radiator is subsequently powered as previously recited.

16. The method of claim 14, the method further comprising the step of:

placing the skin into tension, and subsequently adhering the distal guide member onto the tensioned surface of the skin.

17. An ultrasonic surgical apparatus comprising:

a medical ultrasound handpiece having a distal end, a distal rolling member for placement over a facial feature, and an ultrasound radiator mounted proximally from the distal end, wherein the ultrasound radiator is configured to create a beam of ultrasound energy having a focal point at a predetermined distance from the ultrasound radiator in the direction of the distal end, and has at least one monolithic ultrasound source with a focused emitting surface or at least one array ultrasound source configured as an electronically focusable array.

18. The ultrasonic surgical apparatus of claim 17, wherein the distal rolling member is a ring of bearings disposed at the distal end, and the distal end includes an acoustic head coupled to the ultrasound radiator through an internal acoustic coupling medium.

19. The ultrasonic surgical apparatus of claim 18, wherein the medical ultrasound handpiece includes a vacuum manifold in communication with the distal end.

20. The ultrasonic surgical apparatus of claim 17, wherein the distal rolling member is a ball, disposed at the distal end and externally coupled to the ultrasound radiator through an acoustic medium generally contained within the medical ultrasound handpiece.

21. The ultrasonic surgical apparatus of claim 20, wherein acoustic gel is dispensed from within the medical ultrasound handpiece as a coating on the surface of the ball.

22. The ultrasonic surgical apparatus of claim 17, wherein the distal rolling member is a ball mounted to the medical ultrasound handpiece for rotation about a predetermined axis, the ultrasound radiator is located within the ball, and the ball is internally coupled to the ultrasound radiator through an acoustic coupling fluid contained within the ball.

23. The ultrasonic surgical apparatus of claim 22, wherein the ball includes a stator, extending between axial ends of the axis of rotation of the ball, and one or more seals disposed about the interface between the stator and the axial ends.

24. The ultrasonic surgical apparatus of claim 23 wherein the stator is user-adjustably fixed in orientation with respect to a handle portion of the medical ultrasound handpiece by a pin-and-plug connection, and wherein the pin may be conformably received in a plurality of positions within the plug.

25. The ultrasonic surgical apparatus of claim 22, wherein one of a plurality of rings having varying material thicknesses, each removably attachable to the ball, is removeably attached to the ball to mechanically vary the position of the ultrasound radiator with respect to the distal end.

26. A method of using an ultrasonic surgical apparatus comprising:

a medical ultrasound handpiece having a distal end, a distal rolling member for placement over a facial feature, and an ultrasound radiator mounted proximally from the distal end, wherein the ultrasound radiator is configured to create a beam of ultrasound energy having a focal point at a predetermined distance from the ultrasound radiator in the direction of the distal end, and has at least one monolithic ultrasound source with a focused emitting surface or at least one array ultrasound source configured as an electronically focusable array;

the method comprising the steps of;

injecting a dermal filler into the dermis of the facial feature;

placing the distal rolling member on the surface of the skin over the facial feature;

applying an acoustic gel to the skin over the facial feature; and

rollingly translating the distal rolling member over the skin to position the focal point of the ultrasound radiator within the injected dermal filler, then subsequently powering the ultrasound radiator to shear-thin the dermal filler.

27. The method of claim 26, further comprising the step of:

depowering the ultrasound radiator, and subsequently rollingly translating the distal rolling member over the skin to manipulate the dermal filler from the surface of the skin while in a shear-thinned state.

28. An ultrasonic surgical apparatus comprising:

a medical ultrasound handpiece assembly having an ultrasound transducer; and

an end effector coupled to the ultrasound transducer, the end effector having, in order, a distal probe tip, a probe neck, a probe dilation region, and an ultrasonically active shaft, with the shaft being coaxially held within an ultrasonically inactive probe sheath;

wherein the probe dilation region is configured to have an average outside diameter that is equal to or greater than the average outside diameter of the probe tip and the average outside diameter of the probe neck; and

wherein the probe sheath is configured to have an outside diameter that is approximately equal to the outside diameter of the probe dilation region so as to create a uniform junction between the probe sheath and the probe dilation region.

29. The ultrasonic surgical apparatus of claim 28, wherein the distal probe tip has a distal-most blade portion.

30. The ultrasonic surgical apparatus of claim 28, wherein the probe dilation region is located proximate the first anti-node proximal from the distal probe tip.

31. The ultrasonic surgical apparatus of claim 30, wherein the probe dilation region and the ultrasonically inactive probe sheath form a junction, with the junction located at a node proximal from the proximal anti-node.

32. The ultrasonic surgical apparatus of claim 30, wherein the probe dilation region and the ultrasonically inactive probe sheath form a junction, with the junction located at said first anti-node.

33. The ultrasonic surgical apparatus of claim 28, wherein the distal probe tip has an undulating periphery in cross-section.

34. The ultrasonic surgical apparatus of claim 33, wherein the distal probe tip has a high aspect ratio, with portions of the probe tip being wider than the width of the probe dilation region.

35. The ultrasonic surgical apparatus of claim 28, wherein the probe neck an undulating periphery in cross-section.

36. The ultrasonic surgical apparatus of claim 35, wherein a portion of the probe neck is configured to include a plurality of longitudinally extending, circumferentially arrayed slats with openings to an internal lumen.

37. The ultrasonic surgical apparatus of claim 35, wherein a proximal portion of the probe neck is configured as a solid rod defining a plurality of longitudinally extending, circumferentially arrayed ribs alternating with a plurality of longitudinally extending, circumferentially arrayed indentations.

38. The ultrasonic surgical apparatus of claim 28, wherein the medical ultrasound handpiece assembly includes at least one fluid lumen in fluid communication with the end effector, and the ultrasonically active shaft includes an internal lumen, with the at least one fluid lumen of the medical ultrasound handpiece assembly in fluid communication with the internal lumen.

39. The ultrasonic surgical apparatus of claim 38, wherein the medical ultrasound handpiece assembly has an oppositely projecting portion of the ultrasonically active shaft which projects from a proximal end of the ultrasound transducer and within a handpiece port of the medical ultrasound handpiece assembly.

40. The ultrasonic surgical apparatus of claim 39, wherein the handpiece port is configured for connection to a syringe having a syringe tip, and the oppositely projecting portion is configured to project at least within the syringe tip.

41. The ultrasonic surgical apparatus of claim 28, wherein the medical ultrasound handpiece assembly includes at least one fluid lumen in fluid communication with the end effector;

and wherein an interstitial space between the ultrasonically inactive probe sheath and the ultrasonically active shaft serves as a fluid lumen, with the at least one fluid lumen of the medical ultrasound handpiece assembly in fluid communication with the proximal end of the ultrasonically inactive probe sheath and the interstitial space.

42. A method of using an ultrasonic surgical apparatus comprising:

a medical ultrasound handpiece assembly having an ultrasound transducer; and

an end effector coupled to the ultrasound transducer, the end effector having, in order, a distal probe tip, a probe neck, a probe dilation region, and an ultrasonically active shaft, with the shaft being coaxially held within an ultrasonically inactive probe sheath;

wherein the probe dilation region is configured to have an average outside diameter that is equal to or greater than the average outside diameter of the probe tip and the average outside diameter of the probe neck; and

wherein the probe sheath is configured to have an outside diameter that is approximately equal to the outside diameter of the probe dilation region so as to create a uniform junction between the probe sheath and the probe dilation region;

the method comprising the steps of;

injecting a dermal filler into a facial feature;

inserting at least the distal probe tip beneath the surface of the skin;

powering the ultrasound transducer to operate the probe tip; and

inserting at least the distal probe tip into the injected dermal filler.

43. The method of claim 42, further including the step, following the powering step, of:

inserting the probe dilation region beneath the surface of the skin to protect the surface of the skin from unintended contact with ultrasonically active portions of the probe.

44. A method of using an ultrasonic surgical apparatus comprising:

a medical ultrasound handpiece assembly having an ultrasound transducer; and

an end effector coupled to the ultrasound transducer, the end effector having, in order, a distal probe tip, a probe neck, a probe dilation region, and an ultrasonically active shaft, with the shaft coaxially held within an ultrasonically inactive probe sheath;

wherein the probe dilation region is configured to have an average outside diameter that is equal to or greater than the average outside diameter of the probe tip and the average outside diameter of the probe neck; and

wherein the probe sheath is configured to have an outside diameter that is approximately equal to the outside diameter of the probe dilation region so as to create a uniform junction between the probe sheath and the probe dilation region;

the method comprising the steps of;

inserting the distal probe tip beneath the surface of the skin above a periorbital fat pad;

powering the ultrasound transducer to operate the distal probe tip;

advancing the distal probe tip into the periorbital fat pad;

inserting the probe dilation region and the ultrasonically inactive probe sheath beneath the surface of the skin as the distal probe tip is advanced so as to isolate the skin from ultrasonically active portions of the probe; and

manipulating the distal probe tip within the periorbital fat pad while the ultrasound transducer is powered.

45. An ultrasonic surgical apparatus comprising:

a medical ultrasound handpiece having an ultrasound transducer; and

an end effector coupled to the ultrasound transducer, the end effector having, in order, a distal probe tip, a probe neck, and an ultrasonically active shaft, with the shaft coaxially held within an ultrasonically inactive probe sheath;

wherein the probe sheath is configured such that the distal end of the probe sheath is slidably operable to both cover and expose at least the probe tip.

46. The ultrasonic surgical apparatus of claim 45, wherein at least a portion of the ultrasonically inactive probe sheath is longitudinally flexible, includes an S-shaped crease, and is adapted to allow the distal end of the probe sheath to slidably retract in response to a longitudinal resistance to advancement of the probe sheath.

47. The ultrasonic surgical apparatus of claim 46, wherein the stiffness of the portion of the ultrasonically inactive probe sheath is adapted such that portions of the probe sheath distally adjacent to the crease will not fold into the crease as the probe tip and probe sheath are is advanced into soft tissue.

48. The ultrasonic surgical apparatus of claim 45, wherein the distal end of the ultrasonically inactive probe sheath includes a spring-biased mechanism configured to slidably retract a distal-most segment of the probe sheath within a proximal segment of the probe sheath in response to a longitudinal resistance to advancement of the probe sheath.

49. The ultrasonic surgical apparatus of claim 48, wherein the spring-biased mechanism includes at least two circumferentially opposing elastic dogbones having opposing ends anchored to the distal-most segment and the proximal segment, respectively.

50. The ultrasonic surgical apparatus of claim 48, wherein the spring force of the spring-biased mechanism is adapted such that the distal-most segment will not appreciably expose proximal portions of the distal probe tip as the probe tip and the ultrasonically inactive probe sheath are advanced into soft tissue.

51. The ultrasonic surgical apparatus of claim 45, wherein a proximal portion of the ultrasonically inactive probe sheath is coupled to an adjustment mechanism configured to positively position the distal end of the ultrasonically inactive probe sheath over at least the distal probe tip.

52. The ultrasonic surgical apparatus of claim 51, wherein the adjustment mechanism includes an internally threaded drive member that is rotatably coupled to external threads on the proximal portion of the ultrasonically inactive probe sheath.

53. The ultrasonic surgical apparatus of claim 51, wherein the adjustment mechanism includes a slide member that is fixed to the proximal portion of the ultrasonically inactive probe sheath.

54. The ultrasonic surgical apparatus of claim 51, wherein the adjustment mechanism is a component of the medical ultrasound handpiece.

55. The ultrasonic surgical apparatus of claim 45, wherein the probe neck includes a plurality of slots opening into an internal lumen.

56. The ultrasonic surgical instrument of claim 55, wherein the plurality of slots is configured as a longitudinal array of slots.

57. The ultrasonic surgical instrument of claim 55, wherein the plurality of slots is configured as a plurality of longitudinally elongated, circumferentially arrayed slots alternating with a plurality of longitudinally elongated, circumferentially arrayed bridges.

58. The ultrasonic surgical instrument of claim 57, wherein said plurality of slots are located at a node.

59. The ultrasonic surgical instrument of claim 45:

wherein the ultrasonically active shaft, probe neck, and distal probe tip include an internal lumen;

wherein the ultrasonically active shaft and the ultrasonically inactive probe sheath form an interstitial space; and

wherein a proximal portion of probe neck includes a lateral aperture for fluid communication between the internal lumen and the interstitial space, and a seal disposed proximally from the lateral aperture.

60. The ultrasonic surgical apparatus of claim 59, wherein at least one cannula penetrates the seal and extends distally beyond the lateral aperture.

61. The ultrasonic surgical apparatus of claim 59, wherein the proximal portion of the probe neck is configured as a distally-opening bell, and the lateral aperture is positioned in the narrowing portion of the bell.

62. A method of using an ultrasonic surgical apparatus comprising:

a medical ultrasound handpiece having an ultrasound transducer; and

an end effector coupled to the ultrasound transducer, the end effector having, in order, a distal probe tip, a probe neck, and an ultrasonically active shaft, with the shaft coaxially held within an ultrasonically inactive probe sheath and operatively connected to the probe neck;

wherein the probe sheath is configured such that the distal end of the probe sheath is slidably operable to both cover and expose at least the probe tip;

the method comprising the steps of;

inserting at least the distal probe tip beneath the surface of the skin;

powering the ultrasound transducer to operate the probe tip;

inserting the distal end of the ultrasonically inactive probe sheath beneath the surface of the skin while the ultrasound transducer is powered;

advancing the probe tip while the ultrasound transducer is powered; and

retracting the distal end of probe sheath to expose a greater length of at least the distal probe tip.

63. The method of claim 62, further comprising the steps of:

injecting a dermal filler into a facial feature; and

inserting at least the distal probe tip into the injected dermal filler;

64. The method of claim 62, wherein distal probe tip is inserted beneath the surface of the skin above a periorbital fat pad, and further comprising the step of manipulating at least the distal probe tip within the periorbital fat pad while the ultrasound transducer is powered.

65. The method of claim 62, wherein the distal end of the ultrasonically inactive probe sheath is separable from the ultrasonic surgical apparatus, and further comprising the steps of:

separating the distal end of the ultrasonically inactive probe sheath from the ultrasonic surgical apparatus; and

withdrawing the ultrasonic surgical apparatus while the separated distal end of the ultrasonically inactive probe sheath remains in place beneath the surface of the skin.