Replaceable and/or easily removable needle systems for dermal and transdermal cryogenic remodeling
View Patent ↗The present invention generally provides improved medical devices, systems, and methods. Some embodiments of the present invention 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. The cooling may remodel one or more target tissue so as to effect a desired change in a composition of the target tissue and/or a change in its behavior. Exemplary embodiments make use of replaceable needle probes supported by a probe body handle, with small needle probes often being replaced during treatment of a single patient. Careful control over the control of cryogenic cooling fluid into a needle probe can allow the length of the active cooling to be controlled through depletion of liquid from an evaporating cryogenic cooling flow.
1. A method for treating tissue of a patient using a device, the device comprising a handle, a fluid supply cartridge with a frangible seal, and a needle interface for rigidly receiving a needle, the method comprising;
rigidly attaching a first needle to the needle interface of the device;
penetrating the frangible seal of the fluid supply cartridge of the device;
inserting the first needle through a first insertion point and into a first target region of the tissue by manipulating the handle;
cooling the first target region with the first needle and removing the first needle from the patient;
removing the first needle from the needle interface;
rigidly attaching a second needle to the needle interface;
inserting the second needle through a second insertion point and into a second target region of the tissue by manipulating the handle;
cooling the second target region with the second needle; and
wherein the cooling of the first target region and second target region occur during a single treatment of the patient;
wherein the first and second cooling steps comprise:
inserting the attached needle distally through a collateral tissue and into the target tissue, the inserted needle having an outer lumen and a distal portion adjacent the target tissue and a proximal portion adjacent the collateral tissue;
introducing cooling fluid into the distal portion of the outer lumen;
controlling the introduction of the cooling fluid into the distal portion of the outer lumen such that the cooling fluid evaporates into gas and cools the target tissue sufficiently for treatment and such that the fluid is depleted sufficiently when gas passes through the proximal portion of the outer lumen to inhibit treatment of the collateral tissue
wherein the first needle and second needle each include a cooling fluid supply lumen extending distally to a port within the outer lumen, and wherein the cooling fluid is introduced into the distal portion of the outer lumen by metering the fluid out of the port of the cooling fluid supply lumen of the attached needle, the cooling fluid supply lumen having an inner diameter of less than 140 μm.
2. The method of claim 1 , wherein the first needle and second needle have a 20 gauge needle size or smaller.
3. The method of claim 2 , wherein at least one of the first needle and second needle have a 25 gauge needle size or smaller.
4. The method of claim 3 , wherein at least one of the first needle and second needle have a 30 gauge needle size or smaller.
5. The method of claim 1 , wherein the first needle and second needle are included in a first needle assembly and second needle assembly, respectively, and wherein the first needle assembly and second needle assembly include an engagement feature for fittingly mating with the needle interface of the device.
6. The method of claim 1 , wherein at least one of the first needle and the second needle does not have a circular cross-sectional shape.
7. The method of claim 1 , wherein the device comprises a battery.
8. The method of claim 1 , further comprising the steps of depleting the fluid supply cartridge and disposing the device so that the device and fluid supply cartridge are used to treat only the patient.
9. The method of claim 1 , wherein the target tissue along the distal portion of the outer lumen is cooled to a treatment temperature in a first temperature range, and wherein the collateral tissue along the proximal portion of the outer lumen is cooled to a collateral tissue temperature in a second temperature range, the second temperature range being warmer than the first temperature range.
10. The method of claim 9 , wherein the first temperature range is sufficient to freeze a portion of the target tissue.
11. A system for treating tissue of a patient, the system comprising:
a first needle having a proximal end, a distal tissue penetrating end, a lumen therebetween, and a cooling fluid supply lumen extending distally to a port within the lumen, the first needle having a 20 gauge needle size or smaller;
a second needle having a proximal end, a distal tissue penetrating end, a lumen therebetween, and a cooling fluid supply lumen extending distally to a port within the lumen, the second needle having a 20 gauge needle size or smaller;
a probe body having a handle supporting a cooling fluid source and a needle interface configured for sequentially receiving the first and second needles, the needle interface configured to rigidly attach a received needle such that the cooling fluid source is in communication with the cooling fluid supply lumen of a received needle;
wherein the cooling fluid source comprises a fluid supply cartridge and wherein the fluid supply cartridge comprises a frangible seal;
wherein the cooling fluid supply lumen of each of the first needle and the second needle meters fluid out of the port of the cooling fluid supply lumen, the cooling fluid supply lumen of each of the first needle and the second needle having an inner diameter of less than 140 μm.
12. The system of claim 11 , wherein the second needle has a 25 gauge needle size or smaller.
13. The system of claim 12 , wherein the second needle has a 30 gauge needle size or smaller.
14. The system of claim 11 , wherein the first needle and second needle include an engagement feature on the proximal end for fittingly mating with the needle interface of the probe body.
15. The system of claim 14 , wherein the engagement features of the first and second needles comprise a threaded engagement feature.
16. The system of claim 11 , wherein the first needle and second needle have the same configuration.
17. The system of claim 11 , wherein the first needle and second needle have a differing configuration.
18. The system of claim 11 , wherein the probe body comprises a pressure-regulated exhaust path configured to exhaust vaporized cooling fluid gas from the lumen of a received needle.
19. The system of claim 11 , wherein the probe body further comprises a cooling fluid valve disposed along a cooling fluid supply path between the cooling fluid source and the lumen of a received needle, wherein opening of the valve induces cooling via evaporation of cooling fluid within the lumen of a received needle.
20. The system of claim 11 , wherein the probe body further comprises a battery and a controller for controlling the cooling fluid flow from the cooling fluid source.
21. The system of claim 20 , wherein the first needle and second needle are configured to be inserted into the patient such that a proximal portion of the needle is adjacent a collateral tissue and the distal end is adjacent the target tissue, and wherein the cooling fluid flow is controlled such that evaporation of the cooling fluid in the distal end of an attached needle treats the target tissue and such that the cooling fluid is depleted sufficiently when the cooling fluid passes through the proximal portion of an attached needle to inhibit treatment of the collateral tissue.
22. The system of claim 11 , wherein the fluid supply cartridge is secured in a threaded cartridge support and wherein the frangible seal may be penetrated by the tightening of the threaded cartridge support.
23. A system for treating tissue of a patient, the system comprising:
a first needle having a proximal end, a distal tissue penetrating end, a lumen therebetween, and a cooling fluid supply lumen extending distally to a port within the lumen, the first needle having a 20 gauge needle size or smaller;
a second needle having a proximal end, a distal tissue penetrating end, a lumen therebetween, and a cooling fluid supply lumen extending distally to a port within the lumen, the second needle having a 20 gauge needle size or smaller;
a probe body having a handle supporting a cooling fluid source and a needle interface configured for sequentially receiving the first and second needles, the needle interface configured to rigidly attach a received needle such that the cooling fluid source is in communication with the cooling fluid supply lumen of a received needle;
wherein the cooling fluid source comprises a fluid supply cartridge and wherein the fluid supply cartridge contains a quantity in a range from 7 g to 30 g of liquid;
wherein the cooling fluid supply lumen of each of the first needle and the second needle meters fluid out of the port of the cooling fluid supply lumen, the cooling fluid supply lumen of each of the first needle and the second needle having an inner diameter of less than 140 μm.