Dermal and transdermal cryogenic microprobe systems
원문보기
IPC분류정보
국가/구분
United States(US) Patent
등록
국제특허분류(IPC7판)
A61B-018/02
A61B-017/00
A61B-018/00
출원번호
US-0614887
(2006-12-21)
등록번호
US-9254162
(2016-02-09)
발명자
/ 주소
Burger, Keith
Williams, Ronald
Elkins, Lisa
출원인 / 주소
MyoScience, Inc.
대리인 / 주소
Kilpatrick Townsend and Stockton LLP
인용정보
피인용 횟수 :
1인용 특허 :
71
초록▼
Medical devices, systems, and methods optionally treat dermatological and/or cosmetic defects, and/or a wide range of additional target tissues. Embodiments apply cooling with at least one small, tissue-penetrating probe, the probe often comprising a needle having a size suitable for inserting throu
Medical devices, systems, and methods optionally treat dermatological and/or cosmetic defects, and/or a wide range of additional target tissues. Embodiments apply cooling with at least one small, tissue-penetrating probe, the probe often comprising a needle having a size suitable for inserting through an exposed surface of the skin of a patient without leaving a visible scar. Treatment may be applied along most or all of the insertable length of an elongate needle, optionally by introducing cryogenic cooling fluid into the needle lumen through a small, tightly-toleranced lumen of a fused silica fluid supply tube, with the supply tube lumen often metering the cooling fluid. Treatment temperature and/or time control may be enhanced using a simple pressure relief valve coupled to the needle lumen via a limited total exhaust volume space.
대표청구항▼
1. A system for treating a target tissue of a patient, the system comprising: a first having a proximal end, an axially sealed distal tissue penetrating end, and a lumen therebetween, the first needle comprising a 16 gauge or smaller needle size;a first cooling fluid supply lumen extending distally
1. A system for treating a target tissue of a patient, the system comprising: a first having a proximal end, an axially sealed distal tissue penetrating end, and a lumen therebetween, the first needle comprising a 16 gauge or smaller needle size;a first cooling fluid supply lumen extending distally within the first needle lumen to a distal portion of the first needle lumen, the first supply lumen defined by a first supply tube comprising fused silica and wherein the first supply tube within the needle further includes a polymer over the fused silica;a cooling fluid source coupleable to the first supply lumen to direct cooling fluid flow into the first needle lumen so that liquid from the cooling flow vaporizes within the target tissue when the first needle extends into the target tissue;a handpiece body supporting the needle;at least one distally oriented skin engaging surface supported by the handpiece body so as to engage the skin surface before, during and/or after cooling of the target tissue; andwherein the skin-engaging surface comprises a cooled tissue engaging surface. 2. The system of claim 1, wherein an outer diameter of the polymer is less than 800 μm. 3. The system of claim 1, wherein the supply tube extends in cantilever distally into the needle lumen, and wherein the supply tube has sufficient stiffness to inhibit flow induced buckling of the supply tube within the needle lumen. 4. The system of claim 1, wherein the skin engaging surface inhibits heat transfer to or from the skin surface engaged thereby. 5. The system of claim 1, wherein an insertable length of the needle between the distal end of the needle and the at least one skin engaging surface is selectably alterable, the at least one skin engaging surface comprising a plurality of alternative skin engaging surfaces disposed on associated alternative spacer bodies, the spacer bodies having differing thicknesses between their skin engaging surfaces and an opposed handpiece engaging surface so that a user can alter the insertable length of the needle by selection from among the spacer bodies. 6. The system of claim 1, wherein the skin-engaging surface is thermally coupled to a skin cooling chamber, and wherein a skin cooling port directs cooling fluid from the fluid source into the skin cooling chamber, the skin cooling chamber having a higher operating pressure than the needle lumen. 7. The system of claim 1, wherein the skin engaging surface is configured to cool the skin to inhibit inflammation, and wherein the needle is configured to cool the target tissue to below 0° C. to induce necrosis. 8. The system of 1, wherein a controller is coupled with the needle lumen by a valve, the controller having a first configuration for providing an initial cooling state and a second configuration for providing a treatment temperature in a target range by establishing a target treatment pressure in the lumen, the initial cooling state configured to induce gradual cooling of the needle using an intermediate treatment pressure in the needle lumen that is higher than the target treatment pressure so as to allow osmotic effects to inhibit intracellular ice formation and necrosis of the tissue. 9. The system of claim 1, wherein the cooling fluid, when vaporizing within the needle lumen cools an outer surface of the needle to a temperature in a treatment temperature range throughout an insertable length of the needle between the distal end and the proximal end such that a target tissue extending to the skin surfaces can be treated. 10. The system of claim 1, wherein the supply lumen is defined by a non-metallic tubular supply tube. 11. The system of claim 1, wherein the system has a first configuration and a second configuration, the skin engaging surface in the first configuration disposed distally of the needle so as to engage the skin before penetrating the target tissue, the needle in the second configuration extending distally of the skin engaging surface. 12. The system of claim 11, further comprising an articulatable support coupling the skin engaging surface to the needle so the skin engaging surface applies a pain inhibiting pressure to the skin before, during, and/or after skin penetration by the needle. 13. The system of claim 1, wherein, when the flow is initiated and when an outer surface of the needle engages the target tissue, the outer surface of the needle engaging the target tissue cools at a rate of more than about 25° C./sec so as to promote intracellular ice formation and necrosis of the target tissue. 14. The system of claim 13, further comprising an array of needles coupled to the fluid source, each needle, when the flow is initiated, having an outer surface that cools at a rate of more than about 25° C./sec so as to promote intracellular ice formation and necrosis of the target tissue between the needles when the flow is initiated and when an outer surface of the needle engages the target tissue. 15. The system of claim 1, wherein an outer surface of the needle has an elongate cross-section. 16. The system of claim 15, wherein a proximal cross-section of the needle is circular to limit cooling adjacent the skin, the elongate cross-section comprising an elliptical cross-section to enhance heating along the target tissue, and wherein the distal end of the needle has a sharpened cutting edge. 17. The system of claim 1, wherein the needle is metallic. 18. The system of claim 17, further comprising: a second needle having a proximal end, an axially sealed distal tissue penetrating end, and a lumen therebetween, the second needle comprising a 16 gauge or smaller needle size;a second cooling fluid supply lumen extending distally within the second needle lumen to a distal portion of the second needle lumen, the second supply lumen defined by a second supply tube comprising fused silica and wherein the second supply tube further has a polymer over the fused silica; andwherein the cooling fluid source is coupleable to the second supply lumen simultaneously with the first supply lumen. 19. The system of claim 18, further comprising a handpiece body for housing the cooling fluid source and for supporting the first needle and second needle, the first needle spaced apart from the second needle, and wherein the first and second needle are removably supported by the handpiece body. 20. The system of claim 19, wherein the first and second cooling fluid supply lumens have an inner diameter of less than 50 μm. 21. The system of claim 1, wherein the needle comprises a 25 gauge or smaller needle size. 22. The system of claim 21, wherein the supply lumen has an inner diameter of less than 100 μm. 23. The system of claim 21, wherein an aspect ratio defined by an insertable length of the needle to an outer size of the needle is more than 20. 24. The system of claim 21, further comprising a handle supporting the needle, the supply lumen, and the fluid source for manual manipulation during treatment. 25. The system of claim 21, further comprising a supply valve disposed between the supply lumen and the fluid source, the system having a cooling fluid supply volume between the needle lumen and the supply valve, the valve having a first configuration and a second configuration, the valve in the first configuration providing fluid communication between the fluid source and the supply volume, the valve in the second configuration inhibiting the cooling flow and venting the supply volume so as to limit cooling fluid vaporization within the needle lumen after the valve moves from the first configuration to the second configuration. 26. The system of claim 21, further comprising a pressure relief valve in fluid communication with the needle lumen so as to control a pressure of the vaporizing cooling flow within the needle such that a temperature of the target tissue is within a desired treatment temperature range. 27. The system of claim 26, wherein an exhaust volume of the device between the supply lumen and the pressure relief valve is less than about 0.05 in3. 28. The system of claim 26, wherein the flow is metered primarily by a flow resistance of the supply lumen, and the metered flow inhibits temperature fluctuation by maintaining a liquid/gas mixture within the needle lumen. 29. The system of claim 28, wherein the flow is not actively modulated between the fluid source and the needle lumen during cooling, wherein the pressure relief valve comprises a biasing spring mechanically urging a valve member against a valve seat so as to maintain pressure within the needle lumen within a desired pressure range, and wherein the biasing spring is disposed outside an exhaust volume extending from the supply lumen to the valve seat.
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