CRYOLIPOLYSIS DEVICES AND METHODS THEREFOR

• US 20160058956A1
• Filed: 08/27/2015
• Published: 03/03/2016
• Est. Priority Date: 08/27/2014
• Status: Active Grant

• Current Assignee: TVA Medical, Inc. (Becton, Dickinson & Co)
• Original Assignee: TVA Medical, Inc. (Becton, Dickinson & Co)
• Inventors: COHN, William E., PATE, Thomas Diffley, BERMAN, Adam L.
• Granted Patent: US 10,646,666 B2
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61B 18/02 by cooling, e.g. cryogenic techniques devices for cooling specific reflex points of the body within cell-life limits A61H39/06
• CPC Class Codes: A61B 2018/00458 Deeper parts of the skin, e.g. treatment of vascular disorders or port wine stains
• CPC Class Codes: A61B 2018/0212 using an instrument inserted into a body lumen, e.g. catheter
• CPC Class Codes: A61B 2018/0231 Characteristics of handpieces or probes
• CPC Class Codes: A61B 2018/0275 using porous elements
• CPC Class Codes: A61M 2039/0258 for vascular access, e.g. blood stream access
• CPC Class Codes: A61M 2039/0291 method or device for implanting it in the body
• CPC Class Codes: A61M 5/14 Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
• CPC Class Codes: A61M 5/422 Desensitising skin
• CPC Class Codes: A61M 5/44 having means for cooling or heating the devices or media

Abstract

Described herein are cryolipolysis devices, systems, and methods for facilitating percutaneous access to a target blood vessel by performing cryolipolysis on subcutaneous adipose tissue obscuring the target blood vessel (e.g., a vessel used for hemodialysis treatment). Generally, the devices include a cooling member carrying a coolant that cools a selected portion of adipose tissue overlying the target blood vessel to reduce the selected portion of adipose tissue, thereby forming a depression in the adipose tissue and allowing the target blood vessel closer to the surface of the skin. In some variations, the cooling member is placed subcutaneously to directly cool the selected portion of adipose tissue. In other variations, the cooling member is placed external to the patient to indirectly cool the selected portion of adipose tissue through the skin.

Claims

1. A device for facilitating percutaneous access to a target blood vessel in a patient, comprising:

a subcutaneous probe to carry a coolant, the probe comprising an adipose tissue interface surface and a treatment segment, wherein the treatment segment defines a delivery lumen extending at least the length of the treatment segment to carry the coolant toward a distal end of the treatment segment and a return lumen to carry the coolant away from the distal end of the treatment segment.

2. The device of claim 1, wherein the treatment segment overlies and is substantially aligned with a treatment portion of the target blood vessel.

3. The device of claim 1, wherein the delivery lumen and the return lumen are in fluid communication with one another at the distal end of the treatment segment.

5. The device of claim 3, wherein at least a portion of the delivery lumen and at least a portion of the return lumen are separated by a porous wall.

6. The device of claim 5, wherein the probe further comprises a valve coupled to the return lumen to control a rate of a phase transformation of the coolant across the porous wall.

12. The device of claim 1, wherein the probe comprises a proximal probe portion directed along a first axis, and wherein the treatment segment is directed along a second axis that is oriented at a nonzero angle to the first axis.

14. The device of claim 1, further comprising a temperature sensor coupled to the treatment segment of the probe that measures at least one of the temperature of the treatment segment and the temperature of the coolant.

4. (canceled)

7-11. -11. (canceled)

13. (canceled)

15-20. -20. (canceled)

21. A system for facilitating percutaneous access to a target blood vessel in a patient, comprising:

a cooling device comprising a subcutaneous probe with an adipose tissue interface surface and a treatment segment defining a fluidic channel to carry a coolant; and

a cooling subsystem comprising a cooling mechanism and a fluid distributor, wherein the cooling mechanism modifies a temperature of the coolant, and the fluid distributor delivers the coolant from the cooling mechanism at a flow rate into the fluidic channel of the probe.

22. The system of claim 21, wherein the cooling mechanism comprises a closed fluidic system with a heat exchanger.

23. The system of claim 21, wherein the cooling mechanism comprises a coolant reservoir in fluid communication with the fluidic channel.

26. The system of claim 21, further comprising a control subsystem coupled to the cooling subsystem to control at least one of the flow rate and the temperature of the coolant.

29. The system of claim 21, further comprising a guide member to reposition the probe relative to a treatment portion of the target blood vessel.

24-25. -25. (canceled)

27-28. -28. (canceled)

30-52. -52. (canceled)

53. A method of facilitating percutaneous access to a target blood vessel in a patient, comprising:

inserting a subcutaneous probe into adipose tissue;

aligning the probe with a treatment portion of the target blood vessel; and

cooling a selected portion of adipose tissue surrounding the probe, thereby forming a depression in the selected portion of adipose tissue overlying the treatment portion of the target blood vessel.

54. The method of claim 53, wherein inserting the probe comprises inserting a distal end of the probe into the adipose tissue at a first location proximate the treatment portion of the target blood vessel.

55. The method of claim 54, wherein inserting the probe further comprises passing the distal end of the probe out of the adipose tissue at a second location different from the first location.

56. The method of claim 53, wherein cooling the selected portion of adipose tissue comprises circulating a coolant in the probe.

60. The method of claim 56, further comprising measuring a temperature of the probe and modulating at least one of a flow rate and a temperature of the coolant based on the measured temperature of the probe.

61. The method of claim 56, wherein circulating the coolant in the probe comprises allowing the coolant to absorb heat from the selected portion of the adipose tissue and vaporize from a liquid coolant into a gaseous coolant.

62. The method of claim 61, wherein circulating the coolant in the probe comprises allowing the gaseous coolant to enter a return lumen of the probe.

65. The method of claim 53, wherein cooling the selected portion of the adipose tissue comprises providing a solid or semi-solid coolant into the probe and allowing the solid or semi-solid coolant to undergo a phase transformation into a liquid or gas upon absorbing heat from the selected portion of the adipose tissue.

70. The method of claim 53, further comprising vasoconstricting vasculature in a skin of the patient overlying the selected portion of the adipose tissue.

71. The method of claim 70, wherein vasoconstricting vasculature comprises applying cold therapy to the skin of the patient overlying the selected portion of the adipose tissue.

72. The method of claim 70, wherein vasoconstricting vasculature comprises applying a vasoconstricting substance to the skin of the patient overlying the selected portion of the adipose tissue.

73. The method of claim 70, wherein vasoconstricting vasculature comprises applying positive pressure to the skin of the patient overlying the selected portion of the adipose tissue.

74. The method of claim 70, wherein vasconstricting vasculature comprises applying negative pressure to the skin of the patient overlying the selected portion of the adipose tissue.

57-59. -59. (canceled)

63-64. -64. (canceled)

66-69. -69. (canceled)

75-112. -112. (canceled)