High pressure pre-burst for improved fluid delivery

• US 10,548,659 B2
• Filed: 09/08/2009
• Issued: 02/04/2020
• Est. Priority Date: 01/17/2006
• Status: Active Grant

• Current Assignee: Ulthera Inc. (Merz Pharma GmbH & Company Kgaa)
• Original Assignee: Ulthera Inc. (Merz Pharma GmbH & Company Kgaa)
• Inventors: Chomas, James E., Deem, Mark E., Gifford, Hanson S., Sutton, Douglas S.
• Primary Examiner(s): Peffley, Michael F
• Assistant Examiner(s): Good, Samantha M
• Application Number:
  US12/555,746
• Publication Number:
  US 20090326439A1
• Time in Patent Office: 3,801 Days
• Field of Search: 606 41, 604 19- 22
• CPC Class Codes: A61B 18/1402 Probes for open surgery
• CPC Class Codes: A61B 18/1477 Needle-like probes
• CPC Class Codes: A61B 2018/0016 Energy applicators arranged in a two- or three dimensional array
• CPC Class Codes: A61B 2018/00452 Skin
• CPC Class Codes: A61B 2018/143 multiple needles
• CPC Class Codes: A61B 2018/1432 curved
• CPC Class Codes: A61B 2218/002 Irrigation
• CPC Class Codes: A61H 2201/0207 heated
• CPC Class Codes: A61H 2201/10 with further special therapeutic means, e.g. electrotherapy, magneto therapy or radiation therapy, chromo therapy, infrared or ultraviolet therapy
• CPC Class Codes: A61H 2201/105 with means for delivering media, e.g. drugs or cosmetics
• CPC Class Codes: A61H 2207/00 Anti-cellulite devices
• CPC Class Codes: A61H 23/0245 with ultrasonic transducers, e.g. piezoelectric
• CPC Class Codes: A61N 1/327 for enhancing the absorption properties of tissue, e.g. by electroporation
• CPC Class Codes: A61N 2005/0661 ultraviolet
• CPC Class Codes: A61N 2007/0008 Destruction of fat cells

Abstract

A needle with multiple injection ports is used in connection with a high-pressure injection system to infuse a treatment solution into a treatment area below the dermis of the skin. The needle has multiple tines that extend outwardly from the injection ports while inside the treatment area to disrupt tissue in the treatment area and to create multiple pathways of infusion. The tines are withdrawn and the needle is partially withdrawn, and solution is injected from the needle into the treatment area at high pressure to infuse the tissue within the treatment area. The burst, infusion, and a treatment such as an energy or third solution may be interleaved and repeated multiple times.

Claims

1. A device, comprising:

a hollow needle having a lumen and a plurality of injection ports comprising at least a first injection port, port A₁, a second injection port, port A₂, and a third injection port, port A₃,

wherein each of the plurality of injection ports increase in diameter from the proximal to the distal region of the needle, with said port A₃ having an area greater than an area of said port A₂ and the area of said port A₂ being greater than an area of said port A₁,

wherein Σ

A₁≥

A_needle, and A_needle is the cross-sectional area of the needle and A_i is the cross-sectional area of the plurality of injection ports,

a plurality of individual channels within the lumen of the needle, the plurality of individual channels being oriented substantially parallel to a central longitudinal axis of the needle, wherein each of the plurality of injection ports is in fluid communication with one of the plurality of individual channels disposed within the lumen of the needle.

2. The device of claim 1, wherein the plurality of injection ports are staggered.

3. The device of claim 1, wherein the plurality of injection ports are linearly disposed along the outer surface of the needle.

4. The device of claim 1, wherein the needle is flexible.

5. The device of claim 1, further comprising:

a plurality of elongated elements disposed within the needle and capable of movement from a first retracted configuration within the needle through the plurality of injection ports to a second extended configuration outside the needle, wherein the distal ends of the elongated elements are farther apart from each other in the extended configuration than in the retracted configuration.

6. The device of claim 5, wherein the plurality of elongated elements, at least one elongated element is an electrode, and wherein the at least one electrode is at least partially electrically insulated.

7. The device of claim 5 wherein at least one of the plurality of elongated elements is one of a cutting element and a harmonic scalpel.

8. A device, comprising:

a hollow needle having a lumen and a plurality of injection ports comprising at least a first injection port, port A₁, a second injection port, port A₂, and a third injection port, port A₃,

wherein said port A₁ is positioned in a proximal region of the needle, said port A₃ is positioned in a distal region of the needle, said port A₂ is positioned between said port A₁ and said port A₃, each of the plurality of injection ports extending through an outer surface of the needle and in fluid connection with the lumen, and said port A₃ is the distal-most port that extends through the outer surface of the needle; and

wherein each of the plurality of injection ports increase in diameter from the proximal to the distal region of the needle, with said port A₃ having an area greater than an area of said port A₂ and the area of said port A₂ being greater than an area of said port A₁,

wherein Σ

A_i≥

A_needle, and A_needle is the cross-sectional area of the needle and A_i is the cross-sectional area of the plurality of injection ports;

a compressor system in fluidic connection with the needle and configured to pressurize a fluid to be delivered to a destination via the plurality of injection ports,

wherein a placement and cross-sectional area of the plurality of injection ports relative to the needle enables delivery of a volume of the fluid of between 0.1 mL and 20 mL at a pressure between 1 to 200 pounds per square inch and in a plane parallel to a skin surface, when the needle is inserted percutaneously and parallel to the overall surface of the skin, and

a plurality of individual channels within the lumen of the needle, wherein each of the plurality of injection ports is in fluid communication with a corresponding one of the plurality of channels and wherein the plurality of individual channels are each oriented substantially parallel to a central longitudinal axis of the needle.

9. The device of claim 8, wherein the plurality of injection ports are linearly disposed along the outer surface of the needle.

10. A device, comprising:

a hollow needle having a lumen and a plurality of injection ports comprising at least a first injection port, port A₁, a second injection port, port A₂, and a third injection port, port A₃,

wherein said port A₁ is positioned in a proximal region of the needle, said port A₃ is positioned in a distal region of the needle, said port A₂ is positioned between said port A₁ and said port A₃, each of the plurality of injection ports extending through an outer surface of the needle and in fluid connection with the lumen, and said port A₃ is the distal-most port that extends through the outer surface of the needle; and

wherein each of the plurality of injection ports increase in diameter from the proximal to the distal region of the needle, with said port A₃ having an area greater than an area of said port A₂ and the area of said port A₂ being greater than an area of said port A₁,

wherein Σ

A₁≥

A_needle, and A_needle is the cross-sectional area of the needle and A_i is the cross-sectional area of the plurality of injection ports; and

a plurality of individual channels within the lumen of the needle,

wherein each one of the plurality of individual channels is in fluid communication with a corresponding one of the plurality of injection ports, and

wherein each one of the plurality of individual channels is oriented substantially parallel to a central longitudinal axis of the needle.

11. The device of claim 10, wherein the plurality of injection ports are linearly disposed along the outer surface of the needle.

12. The device of claim 10, wherein the plurality of individual channels is grouped in an array about the central longitudinal axis of the needle.

13. The device of claim 12, wherein individual channels of the array that are located closer to the central longitudinal axis of the needle terminate at a more distal location along the needle as compared to those individual channels of the array that are located farther from the central longitudinal axis of the needle.

14. The device of claim 10, wherein the plurality of injection ports are aligned along the needle to allow a fluid released from said needle to be released at a specified angle relative to the central longitudinal axis of the needle.

15. The device of claim 10, wherein the needle is flexible.

16. The device of claim 10, further comprising:

a plurality of elongated elements disposed within the needle and capable of movement from a first retracted configuration within the needle through the plurality of injection ports to a second extended configuration outside the needle, wherein the distal ends of the elongated elements are farther apart from each other in the extended configuration than in the retracted configuration.