IPC분류정보
국가/구분 |
United States(US) Patent
등록
|
국제특허분류(IPC7판) |
|
출원번호 |
US-0271013
(2008-11-14)
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등록번호 |
US-8298216
(2012-10-30)
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발명자
/ 주소 |
- Burger, Keith
- Elkins, Lisa
- Williams, Ronald
|
출원인 / 주소 |
|
대리인 / 주소 |
Kilpatrick Townsend and Stockton LLP
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인용정보 |
피인용 횟수 :
20 인용 특허 :
61 |
초록
▼
Medical devices, systems, and methods for pain management and other applications may apply cooling with at least one probe inserted through an exposed skin surface of skin. The cooling may remodel one or more target tissues so as to effect a desired change in composition of the target tissue and/or
Medical devices, systems, and methods for pain management and other applications may apply cooling with at least one probe inserted through an exposed skin surface of skin. The cooling may remodel one or more target tissues so as to effect a desired change in composition of the target tissue and/or a change in its behavior, often to interfere with transmission of pain signals along sensory nerves. Alternative embodiments may interfere with the function of motor nerves, the function of contractile muscles, and/or some other tissue included in the contractile function chain so as to inhibit muscle contraction and thereby alleviate associated pain. In some embodiments, other sources of pain such as components of the spine (optionally including herniated disks) may be treated.
대표청구항
▼
1. A method for treating pain associated with a nerve of a patient, the pain associated with a muscle spasm in a muscle of a patient and the nerve being disposed along a contractile chain of the muscle, the nerve underlying a tissue, the tissue having a surface, the method comprising:manually manipu
1. A method for treating pain associated with a nerve of a patient, the pain associated with a muscle spasm in a muscle of a patient and the nerve being disposed along a contractile chain of the muscle, the nerve underlying a tissue, the tissue having a surface, the method comprising:manually manipulating a body with a hand, the body supporting a needle, the body manipulated so as to penetrate a sharpened distal end of the needle through the surface and into the tissue to thermally couple the needle with the nerve, wherein the needle has a 22 gauge needle size or smaller so as to inhibit collateral tissue damage, and wherein the body supports a cooling fluid source; andtransmitting cooling fluid from the source through the surface within the needle so that the fluid cools the needle and the needle cools the nerve sufficiently that contraction of the muscle and the pain are inhibited. 2. The method of claim 1, wherein the cooling fluid cools the needle to a needle temperature in a target temperature range, the target temperature range determined in response to a desired duration of pain inhibition. 3. The method of claim 2, wherein the desired duration is permanent, and wherein the needle temperature is suitable to induce apoptosis of the nerve. 4. The method of claim 2, wherein the desired duration is less than permanent, and wherein the needle temperature is in a tissue stunning temperature range so that the nerve is capable of transmitting pain signals after the tissue warms. 5. The method of claim 1, wherein the needle is inserted in or adjacent to an epidural space near a spinal channel, and wherein the cooling of the needle inhibits pain transmission via the spinal channel. 6. The method of claim 1, wherein the body comprises a self contained hand-held body so that no power or material is transmitted along a flexible tether extending between a stationary structure and the hand-supported body during use. 7. The method of claim 1, wherein at least a portion of the cooling is performed through an electrically insulating surface of the needle, and wherein the needle has an electrically-conductive surface, and further comprising measurement of the nerve with the needle using an electro-myographic (“EMG”) system coupled to the electrically conductive surface of the needle. 8. The method of claim 1, wherein the surface of the tissue comprises a skin surface, and wherein the needle penetrates the skin surface of the patient overlying the nerve, and further comprising inhibiting visible scar formation along the skin surface by limiting cooling along the needle proximal of the nerve. 9. The method of claim 1, further comprising: cooling the nerve for a plurality of cooling cycles with at least one thaw therebetween, andwarming the probe or injecting warm fluid to speed the at least one thaw. 10. A method for treating pain associated with a nerve of a patient, the nerve underlying a tissue, the method comprising: manually manipulating a body with a hand, the body supporting a needle, the body manipulated so as to penetrate a sharpened distal end of the needle into the tissue to thermally couple the needle with the nerve, wherein the body supports a cooling fluid source;transmitting cooling fluid from the source to the needle so that the fluid cools the needle and the needle cools the nerve sufficiently that the pain is inhibited;detaching the needle from the body and mounting another needle to the body,inserting the other needle into the tissue to cool using cooling fluid from the cooling source,disposing of the body and cooling fluid source after treating only the patient, andinhibiting refilling of the cooling fluid source so as to inhibit use of the system with another patient. 11. A system for treating pain of a patient, the pain associated with a nerve of the patient, the nerve underlying a tissue, the system comprising: a body having a handle;a needle supported by the handle, the needle having a proximal end adjacent the body and a distal end with the distal end sharpened for penetrating distally into the tissue to thermally couple the needle with the nerve via manipulation of the handle, the needle having a 22 gauge needle size or less;a cooling fluid source mounted to the body and supported by the handle, the cooling fluid source coupled to the needle along a fluid path; anda fluid flow control system coupled to the fluid path so that fluid flowing from the source along the fluid path cools the needle and the needle effects cooling of the nerve to inhibit the pain, wherein the fluid flow control system comprises a length of tubing along the fluid path between the cooling fluid source and the needle;wherein the length of tubing of the fluid flow control system extends in cantilever within a lumen of the needle, and wherein the length of tubing of the fluid flow control system has an inner diameter of less than about 200 μm and a tolerance of about +/−10 μm or tighter so as to provide a majority of the metering of the fluid flowing into the needle. 12. The system of claim 11, wherein the flow control system is configured to direct sufficient cooling fluid along the path so that the cooling fluid cools the needle to a needle temperature in a desired temperature range, the desired temperature range determined in response to a desired duration of pain inhibition, the needle temperature being sufficiently warm to inhibit ablation of the nerve. 13. The system of claim 12, wherein the desired duration is permanent, and wherein the needle temperature is suitable to induce apoptosis of the nerve. 14. The system of claim 12, wherein the desired duration is less than permanent, and wherein the nerve is cooled to a temperature in a stunned tissue temperature range, so that the nerve is capable of transmitting pain signals after the tissue warms. 15. The system of claim 11, wherein the needle comprises an epidural needle. 16. The system of claim 11, wherein the body comprises a hand-held body so that no power or material need be transmitted along a flexible tether extending between a stationary structure and the hand-supported body during use. 17. The system of claim 11, wherein the needle has an electrically insulating surface of the needle, the electrically insulating surface being disposed so that at least a portion of the cooling of the nerve is performed therethrough, and wherein the needle also has an electrically-conductive surface, and further comprising an electromyography (EMG) connector accessible from the body and coupled to the electrically conductive surface of the needle so as to facilitate measurement of the nerve with the needle using an EMG system coupled to the connector. 18. The system of claim 11, wherein the tissue comprises a skin surface, and wherein the needle is configured to penetrate the skin surface of the patient overlying the nerve, and wherein the fluid flow control system limits flow of the cooling fluid so as to limit cooling along the needle proximal of the nerve sufficiently to inhibit visible scar formation along the skin surface. 19. A system for treating pain of a patient, the pain associated with a nerve of the patient, the nerve underlying a tissue, the system comprising: a body having a handle;a needle supported by the handle, the needle having a proximal end adjacent the body and a distal end with the distal end sharpened for penetrating distally into the tissue to thermally couple the needle with the nerve via manipulation of the handle;a cooling fluid source mounted to the body and supported by the handle, the cooling fluid source coupled to the needle along a fluid path;a fluid flow control system coupled to the fluid path so that the fluid cools the needle and the needle effects cooling of the nerve to inhibit the pain; anda warm fluid source, the fluid flow control system configured to alternate between the flow of cooling fluid to effect cooling of the nerve and warm fluid flow from the warm fluid source in a plurality of cooling cycles with at least one thaw therebetween. 20. A system for treating pain of a patient, the pain associated with a nerve of the patient, the nerve underlying a tissue, the system comprising: a body having a handle;a needle supported by the handle, the needle having a proximal end adjacent the body and a distal end with the distal end sharpened for penetrating distally into the tissue to thermally couple the needle with the nerve via manipulation of the handle;a cooling fluid source mounted to the body and supported by the handle, the cooling fluid source coupled to the needle along a fluid path;a fluid flow control system coupled to the fluid path so that the fluid cools the needle and the needle effects cooling of the nerve to inhibit the pain;an interface releasably coupling the needle to the body,another needle coupleable to the body via the interface, andwherein a cooling fluid path coupling the cooling fluid source to the needle inhibits refilling of the cooling fluid source, a size of the cooling fluid source being less than sufficient for treating a plurality of patients to inhibit use of the system with another patient, the body and cooling fluid source being disposable after treating only the patient. 21. The method of claim 1, wherein the cooling fluid cools the needle to a needle temperature in a target temperature range, the target temperature range determined in response to a desired duration of pain inhibition. 22. The method of claim 21, wherein the desired duration is permanent, and wherein the needle temperature is suitable to induce ablation of the nerve. 23. The method of claim 1, further comprising inhibiting visible lesion formation along the surface by limiting cooling along the needle proximal of the nerve. 24. The method of claim 1, wherein the manipulating of the body with the hand is performed so as to position the needle using neurostimulation by stimulating the nerve with an electrically conductive surface of the needle. 25. The system of claim 11, wherein the length of tubing of the fluid flow control system has an outer diameter of less than about 1000 μm and sufficient strength to avoid collapsing or excessive blow back during injection of the fluid therethrough during vaporization of the fluid within the needle around the length of tubing. 26. The system of claim 11, wherein the length of tubing of the fluid flow control system comprises a length of silica tubing extending within a lumen of the needle. 27. The system of claim 11, wherein the needle has a 25 gauge needle size or smaller. 28. The system of claim 11, wherein the needle has a 26 gauge needle size or smaller. 29. The system of claim 11, wherein the needle includes an electrically conductive surface configured for use as an electrode to effect neurostimulation of the nerve.
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