WO/1992/000710 | HEATING CATHETERS |
WO/2014/119391 | THERAPEUTIC TREATMENT DEVICE AND CONTROL METHOD THEREFOR |
WO/2007/067830 | RADIATION ABLATION TRACKING SYSTEM |
ASHLEY JOHN E (US)
MCGILL SCOTT (US)
MEHTA BANKIM H (US)
ASHLEY JOHN E (US)
MCGILL SCOTT (US)
US20070213735A1 | 2007-09-13 | |||
US20050149011A1 | 2005-07-07 | |||
US20050033201A1 | 2005-02-10 | |||
US6332089B1 | 2001-12-18 | |||
US5458596A | 1995-10-17 | |||
US6277116B1 | 2001-08-21 | |||
US67623007A | 2007-02-16 | |||
US20070081556W | 2007-10-16 | |||
US76403207A | 2007-06-15 | |||
US83254407A | 2007-08-01 | |||
US2592408A | 2008-02-05 | |||
US5961475A | 1999-10-05 |
CLAIMS
What is claimed is:
\ . A medical device for delivering energy from a power supply io tissue, the medical device comprising: a body having a tissue engaging surface; at least one probe extending from the tissue engaging surface, having a tip adapted to penetrate tissue, and where a sidcwall of the probe comprises an opening; an energy delivery element coupieablc to the power supply and positioned within the probe such that energy transmitted by the energy delivery element passes through the opening of the sidewali to treat tissue.
2. The medical device of claim 1. where the energy delivery element is rotatable.
3. The medical device of claim 1, where the probe is rotatable.
4. The medical device of claim i , where the energy delivery element is configured to produce sufficient energy through the opening to create a zone of treatment in the tissue.
5. The medical device of claim i , wherein the energy delivery element comprises an element selected from the group consisting of an acoustic transducer, an illumination source, a microwave energy supply, a resistive heat source, an RF energy probe, a cooling source.
6. The medical device of claim 1. where a portion of the energy delivery element is pivotable to allow for a change in an angular position of energy passing through the opening.
?. The medical device of claim 6, where the energy delivery element comprises an illumination source and a mirror, and wherein the mirror is adapted to be repositioned to change the angular position of the energy.
8. The medical device of claim 1 , further comprising a temperature sensor located within the probe and proximate to the opening.
9. The medical device of claim 1 , further comprising a temperature sensor located within the probe and advanceable from the probe.
10. The medical device of claim 9, where the temperature sensor is adapted to be advanced adjacent to the opening.
1 1. The medical CICλ ice of claim 1.
12. The medical
13. The medical device of claim K where the at least one probe comprises at least two rows of probes.
14. The medical device of claim 1. where the at least one probe comprises a plurality' of probes arranged in a circular pattern.
15. The medical dev ice of claim 1 , where the at least one probe forms an oblique angle relative to the tissue engaging surface.
Ui. The medical
17. The medical device of claim 1 , wherein the energy delivery element is adapted to heat tissue.
18. The medical device of claim 1 , wherein the energy delivery element is adapted to cool tissue.
IM. A method for applying energy treatment to a region of tissue beneath the epidermis, the method comprising; positioning at least a portion of at least one probe beneath the epidermis, where the probe comprises a body having an outer perimeter; and applying energy from the probe to create a zone of treatment, such that the exposure of energy to treat tissue is non-uniform about the outer perimeter of the probe and greatest in the zone of treatment.
20. The method of claim 19, where applying energy comprises applying an amount of energy to cause a therapeutic effect only in tissue within the zone of treatment.
21. The method of claim 19, further comprising rotating the probe to permit energy to tissue located about the outer perimeter of the probe.
22. The method of claim 19, wherein the probe includes at least one energy delivery clement located within a passageway of the probe.
3) 23 The method of claim 22, w herein the energy delrv cry element comprises an element selected from the group consisting of an acoustic transducer, an illumination source, a micros a\ c energy supply, a iesismc beat source, an Rl- energy probe, and a cooling source.
24 "
I he method of claim 22, furthci comprising articulating the energy
25 1 he method of claim 24, where the energy
26 ) he method of claim I 1 * further comprising measuring fcmpeiaturc beneath the epidermis and adjacent to the tissue receding energ>' from the probe with a temperature sensor
2 " ? ) he method of claim 26 further comprising ad\ aneing the tcmpcratiiie sensor from the probe and into the tissue.
28. The method of claim 26. further comprising ad\ aneing the tcmpcratuic sensor into a path of the energy.
29. ) he method of claim 1 ^. λvheicm the probe eompi iscs an opening \\ ithin (he oυtei perimeter such that the opening permits application of energ) in the selccme direction
30. 1 he method of claim 1 *->„ further comprising placing a plurality of probes beneath the epidermis
31. 1 he method of claim 30. further comprising placing at least two probes beneath the epidermis such mat me rcspecinc zones of treatment of at least too probes mterseci
32 The method of claim 31 , further comprising placing the plurality of probes m a circular pattern such that the respcctne /ones of treatment of the probes intersect
33. I he method of claim \ * ■ >. w here positioning at least one probe beneath the epidermis comprises positioning the zone of treatment w ithin dermal tissue
34. The method of elasm ? <■ >. where positioning at least one probe beneath the epidermis comprises positioning the zone of treatment w ithin a layer of subcutaneous fat
^2
35. The method of claim ! 9, further comprising placing a tissue engaging surface against an epidermal layer of tissue, and advancing the probe through the epidermis to position {he probe beneath the epidermis,
36. The method of claim 35, where advancing the probe comprises advancing the probe at an oblique angle relative to the tissue engaging surface.
37. The method of claim 19, wherein the energy causes heating of the tissue.
3H. The method of claim ! 9, wherein the energy causes cooling of the tissue.
• ^
9. A method for applying energy treatment to a region of tissue beneath the epidermis, the method comprising: positioning at least one probe beneath the epidermis, where the probe comprises an outer perimeter and at least one opening in a sidewall; and delivering a pressurized fluid through the sidewall to mechanically disrupt a region of tissue adjacent to the opening. |
DEVICES AND METHODS FOR PERClTAN EOl S ENERGY DELIVERY
CROSS-RLFf-RLNC F
J 0001] This application is a non-pi owsional of b S
BAC IvOROlAD OF FHL INVfcN FiON
[O0θ2J The svstcms md method discussed herein treat tissue in the hitman body In a patUcular x aπation, svstems and methods described below treat cosmetic conditions affecting the skin o{ \ aπo«s bod\ paits, including face, neck, and oihci atca* tudsUonallv ptone to wrinkling, lines sagging and other distortions of the s«kin
[0003] FXposuse of the skin to em uonmentai torees can, time cause the skm to sag wrinkle, form lines, ot develop othei undesuablc distentions
[0004] AccordmgK there is. uell known demand fot cosmetic psoccdures to reduce the \ isifaJe effects of such skin distottions Theie icinauis a large demand f oi "tightening" skin to i enio\ c sags and v. toiUeb cspccullv »i the regions of the face and neck
[0005] One method surgϊcaih resus faces facial skm b> ablating the outer laxer of the skin (from 200 μm to 600 μm), using lases or chemicals In time, a new skm susface
[0007] Utch et al L S Pat No 6,2 "
7,1 16 also teaches a v> stem fot shnnkmg collagen fot cosmetscalK henehαal piti poses In using on clcctt ode ait a\ cnnfigitiation [0008 j
example fabucation of an elects ode anas mav cause υndcsircd cross -cut tent paths forming between adjacent electrodes resulting in an increase m the amount of cnergs applied to tissue [00θ9J i hermage toe of Hax ward Califoima aiso holds patents and sells dex iees foi s\ stems foj capacitrve coupling of electϊodes to deln er a cπntxolled amount of
SC ViMARY OF ϊHb IWhM lON
[0013] ϊ hc ltncutiυn pjm idfs impiυx cd svstcms and methods of pcicutancouslv dtin enng enet
blemishes by application of a percutaneous treatment.
[0014 j The invention includes methods for applying energy treating to a region of tissue beneath the epidermis to produce a therapeutic affect. Sy selectively applying energy percutaneously rather than through the epidermis, the amount of energy can be significantly reduced thereby avoiding collateral damage to tissue.
[00151 The methods include positioning at least a portion of at least one probe beneath the epidermis, where the probe comprises a body having an outer perimeter, and applying energy from the probe to create a zone of treatment, such that the exposure of energy to tissue is non-uniform about the outer perimeter of the probe and greatest in the zone of treatment. [0016 [ One or more of the probes can be configured to produce any number of zones of treatment. For example, a probe can be configured to have a number of zones along a length of the probe where the amount or intensiry of energy at each zone is specific to The region of Target tissue. In addition, the probe can be configured to produce zones that combine with adjacent probes to create a treatment size in the intersection of zones between adjacent probes. [0017j As noted above, the method can include an amount of energy to cause a therapeutic effect only in tissue within the zone of treatment, As such, the amount of energy will not be uniform about the perimeter of the probe.
[0018] The probes can employ a variety of energy types. For example, the probes can employ energy delivery element such as acoustic transducers, illumination sources, microwave energy- supplies, resistive heat sources, RF energy electrodes, as well as a cooling source. As noted herein, variations of the methods and devices include a variety of energy modalities combined in a single probe. Moreover, a variety of energy modalities can be combined in a single array of multiple probes.
[0019 j As shown herein, the application of energy can be manipulated to redirect the zone of treatment. For example, the energy source can be articulated to change an angular position of the selective direction of energy delivery. Alternatively, or in combination, the energy source or probe can be rotated to selectively apply the energy delivery in numerous directions about the probe. [0020] The systems and methods also include the use of various temperature measuring devices to monitor temperature above and/or beneath the epidermis and adjacent to the treatment site. In some variations, the temperature measuring device can be advanced into the zone of treatment and/or into a path of the energy being applied to the tissue.
[002J ] The invention also includes devices for percutaneous delivers' energy from a power supply to tissue. Such devices can include a body having at least one probe extending therefrom, where the probe has a tip adapted to penetrate tissue, and where a sidewall of the probe comprises an opening allowing for an energy delivery element coupSeabk to the power supply and positioned within the probe to transmit energy through the opening of the sidesvali to treat tissue. In some
additional variations, an opening in a probe wall is not required to provide treatment to the tissue. Moreover, the probe may also include shielding or insulation on certain areas so {hat the application of energy can be directed as needed.
[0022] In some variations, the devices include a tissue engaging surface on the body where the tissue engaging surface assists in uniform placement of the probe beneath a surface of the tissue. [00231 As noted above, the devices cars employ a variety of energy delivery modalities (including, but not limited io acoustic transducers, illumination sources, microwave energy conductors, resistive heat source, an RF energy probe, or a cooling source). [00241 The devices can also optionally include one or more temperature sensing elements located on a probe or on a body of the device. In some variations, the temperature sensing element can be advanced from the probe or device and into the region of tissue being treated. [0025J The devices and methods described Sierein may provide probe arrays provided in a cartridge body that is removably coupled to a treatment device, where a probe array of the cartridge device can penetrate tissue at an oblique angle or at a normal angle as discussed below. In addition, in those v ariations where the probe array enters at an oblique angle, the device may include a cooling surface that directly cools the surface area of tissue adjacent to the treated region of tissue. The cooling methods and apparatus described herein may be implemented regardless of whether the probes penetrate at an oblique angle or not.
[0026] In one variation of the device, the device comprises: a device body having a handle portion, a cartridge receiving surface, an actuator adjacent thereto and a plurality of electrically conductive leads on at least a portion of the cartridge receiving surface and being electrically eoupieable to the energy source, where the actuator is movcable relative to the device body; a cartridge body removably coupled to the dev ice body on the cartridge receiving surface, the cartridge body comprising a probe assembly in engagement with the actuator, the probe assembly having a plurality of probes arranged in an array and at least one of the probes having a connection portion, the probe assembly being moveable between a treatment position and a retracted position upon movement of the actuator, such that in the treatment position one or more probes can extend from the cartridge body and the respective connection portion engages one electrically conductive lead, and in the retracted position, one or more probe refracts into the cartridge and the respective connection portion moves out of engagement with the electrically conductive lead preventing delivery of energy.
[0027] fn additional variations, the cooling surface pre-cools the skin and underlying epidermis prior to delivering the therapeutic treatment Additional variations include application of cooling during and/or subsequent to the energy delivery where such cooling is intended to minimize undesired damage fo the epidermis, to maintain the epidermis temperature, and-'or to retain the epidermis in a normal condition.
[00281 Variations of {he invention include movement of the probes by use of a spring or other means to provide an impact force to the probes to penetrate tissue. The spring provides a spring force to mov e the probes at a velocity that allows for easier insertion of the probe array into tissue. [00291 Alternatively, or in combination, the probes may be coupled to an additional source of energy that imparts vibration in {he probes (e.g., an ultrasound energy generator). The same energy source may be used to generate the thermal effect in the dermis.
10030] " The methods and devices described herein may also use features to facilitate entry of the probes into tissue. For example, the surface tissue may he placed in traction prior to advancing probes through the surface tissue. The probes can comprise a curved shape, where advancing the curved probes through tissue can comprise rotating the probes into tissue. 100311 Another variation of the invention includes a cartridge and/or hand unit having any number of electronic storage units or memory (e.g.. SRAM. DRAM. Masked ROM, PROM, EPROM EEPROM. Plash memory, NVRAM, etc. or any combination thereof). Such memory capabilities can contain instructions or record communication between the cartridge and hand unit and/or controller to adjust treatment parameters, monitor usage, monitor sterility, or to record and convey other system or patient characteristics. In yet another variation, the cartridge and/or hand unit can include an RFID antenna/receiver configuration for preventing or permitting treatment given that the hand unit/controller recognizes a code embedded with the RFiD antenna. [0032] ϊt is expressly intended that, wherever possible, the invention includes combinations of aspects of the various embodiments described herein or even combinations of the embodiments themselves.
[0033 j In addition, the concepts disclosed herein can he combined with the following commonly assigned applications where such combinations are possible; U.S. Patent Application No,: \ 1/676,230 entitled "ME THODS AND DEVICES FOR HiEATlNG TISSUE filed on February 16, 2007; PCT application No : PCT/LJS2ϋO7/08ϊ 556 entitled "METHODS AND DEVICES FOR TREATING TISSUE filed on October 16, 2007; U.S. Patent Application No,: 1 1/764,032 entitled "METHODS AND DEVICES FOR TREATING TISSUE filed on June 15, 2007; and U.S. Patent Application No.; 1 ! • 832,544 entitled "METHODS AND DEVICES FOR TREATING TISSUE filed on August 01. 2007. Each of which is incorporated by reference herein.
BRIEF DESCRIPTION OF THE DRAWINGS
[0034] FiG. 1 shows a representative cross sectional view of the skin composed of an outer stratum comeum covering the epidermal and dermal layers of skin and the underlying subcutaneous tissue;
[0035] FIG. 2A shows a sample variation of a system according to the principles of the invention having probes configured to provide percutaneous energy delivery;
[00361 FIG. 2B illustrates a partial view of a working end of a treatment unit engaging tissue such that the probes enters the tissue;
[00371 FiG. 2C shows another variation of a system having probes configured to apply percutaneous energy delivery;
[0038] FIGS. 3 A to ZB show variations of probes for use with the systems and methods described herein to create a zone of treatment;
[0039] FIGS. 4A to 4C show variations of probes for use with an illumination energy source and where {he energy source deliver)' can be articulated with respect to {he probe for re-directing a zone of treatment;
[004 ( Jj FIGS. 5A to 5B show a variation of a probe to move the zone of treatment around the probe to increase a treatment area;
[0041 j FIGS. 6A to 6E depict various probe array configurations for use in variations of {he systems and methods described herein;
[0042] FiG. ? shows a variation of a fluid delivery probe;
[0043] FIG. 8 shows a probe having a combination of treatment modalities;
[0044J FiG. 9 A illustrates a perspective view of a variation of a cartridge body for use with the present system;
[0045J FIGS. 9C to 9D show a perspective, side, and lop views respectively of an alternate cartridge body for use with the present system;
[0046] FiG. 10 shows a graph representing pulsed energy delivery and temperature measurements between pulses of energy;
[0047J FIGS. 1 IA to UB show variations of introducer members that assist in placing probes within tissue:
[0048 J FIG. 12A shows an additional variation of a device having an array of probes in a removable cartridge adjacent to a tissue engaging surface.;
(00491 FIG. 12B shows a magnified view of the probes and tissue engaging surface of the device of FiG. 12 A;
[0050] FiG. 12C shows an example of an probe entering tissue at an oblique angle adjacent to a tissue engaging surface;
[0051 { FIG. 13 shows another example of an probe entering tissue at an oblique angle underneath a skin anomaly;
[0052| FIG. 14A io 14C show cooling surfaces adjacent to the probes; and
[0053] FIGS. ISA to I 5D illustrate additional variations of probe for use with the systems and devices described herein.
DESCRIPTION OF THE PREFERRED EMBODIMENT
[0054] The systems and method discussed herein treat tissue in the human bad} . In one variation, the systems and methods treat cosmetic conditions affecting the skin of various body parts, including face, neck, and other areas traditionally prone Io wrinkling, lines, sagging and other distentions of the skin. The methods and systems described herein may also have application in other surgical fields apart from cosmetic applications.
[0055J The inventn e device and methods also include treatment of skin anomalies such as warts {Verruca plana, Verruca vulgaris), sebaceous hyperplasia or acne (Acne v ulgaris). Treatment of acne can be accomplished by the direct ablation of sebaceous glands or it can be accomplished by the delivery of thermal energy which will stimulate the body ' s immune system to eliminate the bacteria, Propiombncterium acnes, which is one of the causes of acne. The methods and devices can be used for the reroouil of unwanted hair (i.e., depilation) by applying energy or heat to permanently damage hair follicles thereby removing the skins ability to grow hair. Such treatment may be applied on areas of facial skin as well as other areas of the bod} .
[0056| Other possible uses include pain management (both in the use of heat to reduce pain in muscle {issue and by directly ablating nociceptive pain fibers K stimulation of cellular healing cascade via heat, treatment of the superficial muscular aponeurotic system ( SMAS), reproductive control by elevated heating of the testicles, and body modification such as piercing, scarification or tattoo a!
[0057 [ hi addition io therapeutic surface treatments of the skin, the current invention can be targeted to the underlying layer of adipose tissue or fai for Hpolysis or the breakdown of fat cells. Selecting probes having sufficient length to reach the subcutaneous fat layer allows for such probes to apply energy in the subcutaneous fat layer. Application of the energy can break down the fat ceils in that layer allowing the body to absorb the resulting free fatty acids into the blood stream. Such a process can allow for contouring of the body surface for improved appearance. Naturally, such an approach can be used in the reduction of ecllulitc.
[0058] Other possible uses include pain management (both in the use of heat to reduce pain in muscle tissue and by directly ablating nociceptive pain fibers), stimulation of cellular healing cascade via heat, reproductive control by elev ated heating of the testicles, and body modification such as scarification
[0059 j FIG . I shows a cross sectional \ iew of the skin 10 composed of an outer stratum eorneum 15 covering the epidermis 16. The skin also includes die dermis 18, subcutaneous tissue ' ' fai 12. " These layers cover muscle tissue 14 of within the body, in the face and neck areas, the skin 10 measures about 2mm in cross sectional depth, In the face and neck regions, the epidermis measures about UM) μm in cross sectional depth The skin 10 also includes a dermis ϊ8 layer that contains a layer of vascular tissue. In the face and neck regions, the dermis 18 measures
about 1900 μm in cross sectional depth.
[0060| The dermis 18 includes a papillary (upper) layer and a reticular (lower) layer, Most of the dermis 18 comprises collagen fibers. However, the dermis also includes various hair bulbs, sweat ducts, sebaceous glands and other glands.. " The subcutaneous tissue 12 region below the dermis 18 contains fat deposits as well as vessels and other tissue.
[00611 ϊn most cases, when applying cosmetic treatment to the skin for lightening or removal of wrinkles, it is desirable to deliver energy to the dermis layer rather than the epidermis, the subcutaneous tissue region 12 or the muscle 14 tissue. In fact, delivery of energy to the subcutaneous tissue region 12 or muscle 14 may produce pockets or other voids lending to further visible imperfections in the skin of a patient. Also, delivery of excessive energy to the epidermis can cause burns and/or sears leading to further visible imperfections.
[0062] The application of heat to the fibrous collagen structure in the dermis 18 causes the collagen to dissociate and contract along its length. It is believed that such disassociation and contraction occur when the collagen is heated to about 65 degree C. The contraction of collagen tissue causes the dermis 18 to reduce in size, which has an observable tightening effect. As the collagen contracts, wrinkles, lines, and other distortions become less visible, As a result, the outward cosmetic appearance of the akin 10 improves. Furthermore, the eventual wound healing response may further cause additional collagen production. This latter effect may further serve to tighten and bulk up the skin !0.
10063] Thermal energy is not the only method for treating collagen in the derroai layer to effect skin laxity and wrinkles. Mechanical disruption or cooling of tissue can also have a desirable therapeutic effect. As such, the devices and methods described herein are not limited to the percutaneous delivery of thermal energy, but also include the percutaneous delivery of mechanical energy or even reducing temperature of tissues beneath the epidermis (e.g., hypothermia effect on tissue).
10064 [ The treatment methods and device can also include the use of additives, medicines, bioactive substances, or other substances intended to create a therapeutic effect on their own or augment a therapeutic effect created by any one of the energy modalities discussed herein. [0065 j For example, autograph or allograph collagen can be delivered percutaneously to bulk up the dermal layer. Non-collagen fillers such as absorbable and non-absorbable polymers can also be delivered to increase the volume of the dermis and improve the surface appearance of the skin. Saline can be delivered to provide a diffuse path tor radio frequency current delivery or to add or remove thermal energy from the target tissue In addition, anesthetic or numbing agents can be delivered to reduce the patient ' s sensation of pain from the treatment. Botulinum Toxin type A (Botox.*) can also be delivered to the dermis or to the muscular layer below the dermis by further inserting the access probe 32. The delivery of Sotox^ can temporarily paralyze the underlying
musculature allowing for treatment of the target area with no muscle movement to move or disturb the treatment area.
[0066] The delivery of the substances described above can occur using the same delivery dcv ices that apply the energy based treatment. Alternatively, or in combination, a physician can administer such substances using a delivery means separate from the treatment devices [00671 FIG. 2A illustrates one variation of a treatment system according die principles described herein. The treatment system 200 generally includes a treatment unit 202 having a handpiece or device body 210 < or other member/feature that allows for manipulation of the system Io treat tissue 10) having one or more probes ϊ04 extending from the body 210. in some variations. the probes 104 arc coupled Io the body 210 via a removable cartridge 100. In the system 200 shown, the removable cartridge H ) O contains a plurality' of retractable probes J 04 arranged in an array 108. Hereafter, the term probes 104 is intended to include any electrode, energy transfer clement (e.g.. thermal, electrical, electromagnetic, microwave, mechanical, ultrasound, etc.). or source of therapeutic treatment. For sake of convenience, {he term probe shall be used to refer to any electrode, energy transfer element or source of therapeutic treatment unless specifically noted otherwise. As shown, the probes 104 can optionally extend from a front portion 112 of the cartridge 100. Alternatively, the probes ϊ04 can extend from a front face of the device body or from any surface of the device body/cartridge.
[00681 The device body 210 is not limited ω that shown. Instead, variations include device body shapes that are thinner in profile and can be held at a more vertical angle to the target tissue like a pencil or pointer. Variations also include a device body that has a loop or curved grip that facilitates one specific manner in which it can be grasped by the hand. Any number of variations is possible especially those that ensure the physician ' s hand does not contact of the distal end of the cartridge or the target tissue.
[0069] The devices according to the principles described herein can include any number of arrays depending upon the intended treatment site. Currently, the size of the array, as well as the number of arrays, can change depending on the v ariation of the invention needed, In most cases, the target region of tissue drives die array configuration. The present invention allows a physician to selectively change array configuration by attaching different cartridges 100. Alternatively, variations of the invention contemplate an probe assembly that is non-removable from the device body 200,
JOOTOj for example, a treatment unit 202 designed for relatively small treatment areas may only have a single pair of probes. On the other hand, a treatment unit 202 designed for use on the cheek or neck may have up to Hi probe pairs. However, estimates on {he size of {he probe array arc for illustrative purposes only, In addition, the probes on any given array may be the same shape and profile. Alternatively, a single array may hav e probes of varying shapes, profiles, and/or sizes
depending upon the intended application.
[0071 \ Furthermore, the array 108 defined by the individual probes 104 can have any number of shapes or profiles depending on the particular application. As described in additional detail herein, in those variations of the system 200 intended for skin resurfacing, the length of the probes
104 is generally selected so that the energy delivery occurs in the dermis layer of die skin 10 while the spacing of probes 104 may be selected to minimize delivery of energy between adjacent pairs of probes or ω minimize energy ω certain areas of tissue.
[0072] In those variations where the probes 104 are resistive, radiofrcqucncy, microwave, inductive, acoustic, or similar type of energy transfer elements, the probes can be fabricated from any number of materials, e.g., from stainless steel platinum, and other noble metals, or combinations thereof. Additionally, such probe may be placed on a non-conductive member (such as a polymeric member)
[0075] Additionally, the treatment unit 202 may or may not include an actuator as described below for driving the probe array ϊθS from {he cartridge 100 into the target region. Examples of such actuators include, but are not limited to, gas powered cylinders, springs, linear actuators, or other such motors. Alternative variations of the system 200 include actuators driven by the control system/energy supply unit 90.
10074 j FIG. 2A also shows an optional cooling device 234 coupled to the device body 210.
The cooling device 234 can be adjustable along the device body 210. The use of a cooling device
2J4 can also be desirable in those eases where energy or heat is applied to the tissue. In addition, a cooling device may have other beneficial effects even when a heat or energy treatment is not being used, in yet additional variations, the cooling device can be replaced with a heating device (such as when a cooling treatment is used to induce the therapeutic treatment within tissue).
J0075] Sn the illustrated variation, the cooling device 234 is in a retracted position where it is spaced away from probes 108 (and thus spaced from the surface of the target tissue). This retracted position can aid the user by allowing for visualization of proper placement of the probe array 108 into the target tissue. After the user places the device 202 on tissue, the user can advance the cooling device 234 (manually or automatically upon activation of the system) so that a cooling surface 216 of the cooling device 234 makes contact with the target tissue.
[0076 [ The cooling device can be an air or liquid type cooling device. Alternatively, the cooling device can include a Peltier cooling device. A Peltier cooling device can eliminate the need for a fluid source. Jn some eases, the cooling device can be powered using the same power supply that energizes the probes. Such a configuration provides a more compact design that is easier for a medical practitioner to manipulate.
|0077] The system 200 also includes an eoergy supply unit 90 coupled to the treatment unit
202 via a cable 96 or other means. The energy supply unit 90 may contain the software and
hat dw are required to control enemy deln erv AltematneSx the CPU, softw are and other hardware control systems røa\ reside m the hand piece 210 and or cable 96 It a, also noted that the cable 96 ma\ He pcrmanenrh affixed fo the supplj unit *><) and m the treatment unit 202 In additional
[0078] Sn one
generated to selectively destroy fat cells. In some cases, the multiple focused pressure pulses or shock waves can be directed at the target tissue to disrupt the cell membranes. Each individual pulse can have from 0, 1 to 2.5 Joules of energy.
|0081 ] The energy supply unit 90 may also include an input/output WO) device that allows the physician to input control and processing variables, to enable the controller to generate appropriate command signals. The I/O device can also receive real time processing feedback information from one or more sensors associated with the device, for processing by the controller, c g., to govern the application of energy and the delivery of processing fluid. The I/O device may also include a display, to graphically present processing information to the physician for viewing or analysis.
[0082] In sonic variations, the system 200 may also include an auxiliary unit 92 {where the auxiliary- unit may be a vacuum source, fluid source, ultrasound generator, medication source, etc.) Although the auxiliary unit is shown to be connected to the energy supply, variations of the system 200 may include one or more auxiliary 1 units 92 where each unit may be coupled to the power supply 90 and/or the treatment unit 202.
J 0083] FIG. 2B illustrates a partial view of a working end of a treatment unit 202 where the treatment unit 202 engages against tissue ϊ0 and the array 1OS extends from a cartridge 100 into the tissue 10. The cooling device 234 also engages tissue 10 so that a cooling surface 216 cools tissue directly above the area of treatment. The illustrated figure also demonstrates another feature of the system where the cartridge 100 includes a tissue engaging surface 106 having a plane that forms an angle A with a plane of the array of probes 108. As described below, this configuration permits a larger treatment area as well as direct cooling of the tissue surface. The devices of the present invention may have an angle A of 15 degrees. However, the angle can range from anywhere between perpendicular to parallel with respect to the tissue surface. The tissue engaging surface 106 can also include any number of features to ensure adequate contact with tissue. 10084] Although not shown, the tissue engagement surface may contain apertures or other features to allow improved engagement against tissue given the application of a vacuum. By drawing tissue against the tissue engaging surface the medical practitioner may better gauge the depth of the treatment. For example, given the relatively small sectional regions of the epidermis, dermis, and subcutaneous tissue, if a device is placed over an uneven contour of tissue, one probe pair may be not be placed at the sufficient depth. Accordingly, application of energy in such a case may cause a burn on the epidermis. Therefore, drawing tissue to the tissue engaging surface of die device increases the likelihood of driving the probes to a uniform depth in the tissue. [00851 In such an example, the tissue engagement surface 106 can include small projections, barbs, or even an elastic resin to increase friction against the surface of tissue. These projections or features can grip or prov ide friction relative to the tissue in proximity of the target tissue. This grip
or friction holds the tissue in place while the probes are inserted at an angle relative to the grip of the projections. In another variation, the tissue engaging surface can include contact or proximity sensors to ensure that any numbers of points along die tissue engaging surface are touching the surface of the target site prior to probe deployment and-'Or energy delivery, (0086] FIG. 2B also shows the treatment unit 202 havύig an extension actuator 240 and a retraction actuator 242 which extend and retract, the array !08 in the cartridge. The handle also contains a power control switch 244 that can start and stop delivery of energy. Clearly, the location, size, and construction of such actuators can vary, to addition, all actuators can be replaced by a single actuator. In yet another variation, actuation of the device can occur using a footswitch that is coupled to the control system.
[0087] As discussed below, the cooling device 234 includes a cooling plate or cooling surface 216. Optionally, the cooling surface cart have a disposable cover that prevents direct tissue contact between the actual cooling surface and the target tissue. The cover can be a disposable, sterilized component that is discarded after each treatment or after each patient.
J 0088] FIG. 2C shows another variation of a treatment system 200 according the principles described herein. The treatment system 200 generally includes a treatment unit 202 having a handpiece 2ϊ0 (or other member/feature that allows for manipulation of the system to treat tissue 10). The treatment unit 202 shown includes a faceplate 112 having a plurality of probes 104 * generally formed in an array SOS) that extend from openings in the faceplate 1 12. The devices may comprise probe arrays of only a single probe up to considerably larger arrays. As noted above, the size of the array is determined by the target region that is intended for treatment. Additionally, the treatment unit 202 may or may not include an actuator 128 for driving the electrode array 108 from the faceplate 112, Alternative variations of the system 200 include actuators driv en by the control system 90 or an auxiliary unit 92.
[0089] FIG. 3 A shows a cross sectional view of a variation of a probe 30 of a treatment device 200 when inserted into tissue. The probe 30 can be any probe disclosed herein (including those entering the tissue at an oblique angle). A single probe is shown for illustrative purposes only. Clearly, any configuration of probes as disclosed herein can be used. In addition, although the following probes are shown entering tissue in a direction that is normal to the surface of the tissue, variations of the devices and methods disclosed herein contemplate oblique entry of the probes into tissue as discussed in further detail below.
|0090| As illustrated, the probes 30 shown have an active surface that provide therapeutic treatment in a targeted direction resulting in a zone of treatment that contains the greatest amount of energy delivered to the tissue. In the variation illustrated in FiGS. 3 A and 3 B, probe 30 includes an outer wall 32 which has an opening 34 on at least a portion of that wall 32. The opening 34 allows an energy delivery element 36 to apply energy from die probe to create a zone of treatment
160, such that the exposure of energy to tissue is non-uniform about fhe outer perimeter of the probe and greatest in the zone of treatment 160. As described below , any energy modalιt> can be used fo create the targeted zone of neatmenr
|0091 ] λs shown m FKj. 3λ. the enetgj dclnerj element 36 comprises a piezoelectric erj _.tal \x ith a flexible transmitting cover membrane 40 The flexible membrane 40 can be coupled fo at kxst one powei
[0092J FIG 3λ also illustrates an optional temperature sensor 52 and temperature sensing lead 54 Temperature sensor 52 can be any t\γc of sensor such as a thermocouple, a thermistor a ferπfe bead, ot a fluorescing d>e. Fhe temperature sensing lead 54 can be part of the sensor 52 oi it can be a power supply Imc'wue from a pow er control module that transmits a signal to and from the sensor 52 In the case of a fluorescing d^e, fhe sensor and lead mav comprise a fiber opttc line that pro\ ides illumination to the dye and ttansratt the reflected fluorescence back to a power control mυduk. The use of the temperature sensot 52 and piobe 30 of the cuoent \ aπaUon pκn idc gjeat advantages other high fiequenev and ultra high fiequcncy acoustic energy systems which direct the energy into the skm from the surface.
10093] The use of the percutaneous probe 36 produces a desirable therapeutic effect with energy le\cls that are much lower than s> stems that aie requited to heat diteetly on the dermis iather than through the tough and i igid stiatum coπicum 15 and die scnsitnc epidermis Furthermore, m some v ariations there is no need to sequentially or simultaneously cool the surface of the tissue to present the epidetnm from heating too much as the eneigy is applied oiils to the dermis. In addition, the use of a temperature sensor 52 allow s foi a mcasuicmcnt of the adiaeent dermal tissue in ot near the treatment zone 160. This measurement provides a control mechanism for the power control module to adjust power
[0094| Ftgisie 3B shows an alternate variation of a probe 30 where a temperature sensor 52 is
In addition, any number of temperature sensors 52 can be placed along or adv anced from the probe treatment system.
[0095 j As noted above, the energy transfer element 36 delivers energy through an opening in a v. ait of the piobc 30, Io some variations, the opening can be cov ered
[00% I FlQ. 44 illustrates one such variation of a probe 30 of a treatment system 200 empiov ing an illumination cncxgy transfer somee. The illumination somee can include a laser source or other light energy source that directs encigy through the probe to the targeted tissue, As shown, the probe 30 contains an illumination source (e.g a fiber optic) and includes a lens assembly- 48 lor other deflection means) adjacent to an opening 34 m the ptobe 30. hi this v ariation, the opening 34 is at a beveled distal Up. Howes ei. the opening can also be in a
J0097J Furthermore, <& shown m FIGS 5λ and 5B the probe or the energy delivery element can be rotated such that a grcatet pottion of tissue can be targeted by the probe 30. In doing so, the zooc of treatment 160 can selcetiv el> ttcat tegions around the peπmetet of the probe 30 In an additional \ aπation, and as shown in Fig 5B the probe 30 can be rotated and the energv transfer element 36 can be articulated to αcaie a largei zone of treatment 160 or to selectively treat regions around the probe 30
|0098j ϊn anofhei variation of the device, an iliuromation source can be used to geneiate thermal energy that is applied to tissue rather than irradiate the tissue For example, the mirror of the prev ious variations can be replaced with an optical absorbing emitter that is mounted on the probe. This ermttα ss configured to heat as ss absorbs the light or laser energy. Fhe emittcx then conducts the heat to the tatget tissue via thermal conduction
[00991 ϊn additional variations the use of radio frequency, ultrasound, or microwave energy supplies can be directed towards an appropriate absorbing emitter that converts the delivered energy info thermal energy for treating the target tissue. Furthermore, the absorbing emitter can be composed of an inductive material which converts magnetic field energy into heat. This embodiment allows a smaller diameter delivery probe since the magnetic field can be produced outside of the target tissue and probe 30. In such a variation, there is no need to direct wires, antenna, fiber optics, transducers or other energy delivery methods through the inside of the probe 30 in order to apply the therapeutic treatment
[00 J OβJ FiGS. 6A to 6E depict various probe 30 configurations for use in variations of the device, As shown in FiG. 6A, one variation of the system includes a single probe 30. However, a single row array, as shown in FIG, 6B or a multiple row array, as shown in FlG. 6C are aiso within the scope of the disclosure. As discussed below, the probes may be staggered such that the treatment zones affect varying depths of tissue as well
[ 00! OtJ FIGS. 6D and 6E illustrate another variation of the system 200 where openings 34 with membranes 40 on adjacent probes 30 face one another so that the zone of treatment 160 from adjacent probes 30 intersects to treat tissue. One such benefit of this configuration is that the power generated by each probe alone can be reduced such that a region of tissue is only treated in the intersecting zone between adjacent probes. For example, the power from one probe 30 can be set sufficiently low to insufficiently heat the tissue to a therapeutic level. However, in the region of treatment created by intersecting treatment zones, the generated heat is sufficient to create the desired effect
[00102} In addition, FlG. 6E shows a circular array of probes 30 having openings M with membranes. 40 or energy directors that focus on the center of the array as shown in FlG, 6E. Again this configuration allows for the delivery of even lower levels of energy form any one probe 30. Accordingly, the device will only treat tissue when all of the probes are energized simultaneously so that the combined focused energy is sufficient to create a therapeutic effect. These array variations allow for even more precise energy delivery than is possible with surface delivered devices.
[001031 FIG. 7 shows yet another alternative variation for delivering energy to the targeted tissue. In this variation the probe 30 includes openings 34 that permit delivery of a fluid. Clearly, the probe can include one or more additional openings located anywhere along the probe. The probe 30 can be configured to produce a jet of fluid when pressurized. This jet or jets of fluid create a treatment zone ϊ60 to produce a therapeutic effect in tissue. Any fluid, such as sterile saline, when delivered at a sufficient velocity and pressure can mechanically disrupt the collagen of the dermal layer creating a therapeutic effect. Although the probe 30 can directly deliver the fluid, other configurations are possible. For example, the probe can include a fluid delivery member 58
located within a body of the probe 30.
[00104} FIG. 8 shows another alternative variation of a probe for use with devices and methods disclosed herein. The illustrated probe 30 two lumens 77 and 79. The first lumen 77 includes a source of ultrasound energy. Specifically the probe is composed of an outer wall 32 which has an opening 34 on at least a portion of die wall 32. As described above, the probe can include a piezo electric crystal 38 with a flexible transmitting cover membrane 40* The flexible membrane is coupled to one of the power delivery 1 leads 44 and the other lead 44 is coupled to a conductive cpoxy bed 42. The epoxy bed 42 secures the crystal 38 to an interior of the probe and transmits power to the crystal 38 Delivery of power to the crystal 38 causes the flexible membrane 40 to osculate direct acoustic energy into the target tissue. The variation also can include a temperature sensor 52 and temperature sensing lead 54 for monitoring target tissue temperature and controlling energy delivery.
[00105} The second lumen 79 of the probe can include a second type of energy delivery device, hi this variation, the second lumen 79 includes elements for delivering laser or light energy to the targeted tissue- The lumen 79 contains a fiber optic 46 which has a lens as&ernbly 48 at the distal tip. Distal of the lens assembly 48 can be a digital micromirror device (DMD). The lens assembly 48 can direct the light or laser energy out of the cannula opening 34 and into the target tissue as discussed above.
[00106} The combination of the two energy modalities, laser and ultrasound, directed to the target tissue can provided an enhanced therapeutic effect to the target tissue. Clearly any number of energy modalities can be combined within a single probe 30. Furthermore, the probe can include two separate zones of treatment given each energy modality.
[00107| FIG. 9 A illustrates one variation of a removable cartridge body 100 for use with the present system. As shown, the cartridge body 100 includes retention fasteners 114 allowing for coupling with the device body as well as removal from the device body. Again, any number of structures can be incorporated into the device to permit removable coupling of the cartridge body 100 to a treatment unit. " The probes described above can be combined into the various cartridge bodies 100 shown herein.
[00108J The cartridge body 100 further includes a probe assembly ϊ02 that is moveable or shdabie within the cartridge body S(MK The mode of movement of the actuator can include those modes that are used in such similar applications. Examples of these modes include, sliding, rotation, incremental indexing (via a raehet-rype system), stepping (via an step-motor) Accordingly, the probe assembly 102 can include a coupling portion or structure 118 that mates with an actuating member in the device body, In the illustrated example, the probe assembly 102 is in a treatment position (e.g., the array 108 extends from the cartridge 100 allowing for treatment). The probe assembly 102 includes any number of probes 104 mat form an array 108 and are
extendable and retractable from a portion 104 of the cartridge .100 (as noted above, the probes can alternatively extend from the device body, or other parts of the system). As noted above, although the illustrated example shows an array 108 of 1x6 probes 104, the array can comprise any dimension of M x N " probes where the limits are driven by the nature of the treatment site as well as the type of energy' delivery required.
[QOJ 09] FKJ. 9A also shows the probes 104 in the probe assembly 102 as having connection or contact portions 116 that couple io a connection board on a treatment unit to prov ide an electrical pathway from the power supply to the probes 1(14. In the illustrated variation, the probe assembly 102 as well as the connection portions 116 moves. Such a feature allows for selective connection of the probes with the power supply. For example, in certain variations of the system, the probes arc only coupled to the power supply when in a treatment position and arc incapable of delivering energy when in a retracted position, in another variation, the probe assembly and connection board are configured to permit temperature detection at all times but only energy delivery in the treatment position. Such customization can prevent energy delivery in an unintended location, for example, when the probes have an insulation that only allows energy delivery at the distal tip and the intended location of energy delivery is at specific depth in the target tissue that corresponds to the length of the extended probe the probe cannot delivers' energy to an unintended shallower location when it is not fully extended. However, any number of v ariations is possible. For example, the system can be configured so that the probes can be energized whether in the treatment or retracted positions.
[00110} The connection portions ϊ 16 can be fabricated in any number of configurations as well. For example, as shown, {he connection portions 116 comprise spring contacts or spring pins of the type shown. Accordingly, the connection portions 116 can maintain contact with a corresponding contact point trace on a connection board during movement of the probe assembly 102 [ 00111 J FIG. 9 A shows the front portion 112 of the cartridge 100 as having multiple guiding channels 120. These channels 126 can support and guide the probes 104 as they advance and retract relative to the cartridge 100. " The channels 120 can also be configured to provide alternate energy treatments to the surface of the tissue as well as suction or other fluids as may be required by a procedure One benefit is that a single cartridge design can be configured to support a variety of probe array configurations. For example rather than the array of six (6) probes as shown, the channels 120 can support any number of probes (the illustrated example shows a maximum of sixteen 06) but such a number is for exemplary purposes only). Furthermore, the channels 120 need not be only in a linear arrangement as shown, but could be in 1 , 2, 3 or more rows or in a random configuration.
Jθθ112J FIG. 9B shows a perspective view of another variation of a probe assembly. Sn this variation, the probes f 04 are staggered or offset such that adjacent probe pairs 105 do not form a
linear pattern. One such benefit of this configuration is to
[00115} Commonly assigned IλS. Patent application No. 12 025,924 filed υn February 1 , 2*108 entitled CARlRIDGH LLHCTRODt DHViCF, the entirety of w hich is incorporated by reference herein, includes additional details of removable cartridge assemblies for use with the systems described herein.
[00116| The present systems may apply treatments based upon sensing tissue tempeiatωe conditions as a form of acm e process feedback control. Alternately, those systems reiving on conduction of energy through the tissue can monitor changes in impedance of the tissue being treated and ultimately stop the treatment when a desired
caused by thermal!) denaturing the collagen in the dermal la> cr of a target area As noted herein, s\ sterns according to the present invention are able Io provide a desirable effect in the target area though
[QOJ ϊ 9] Sn one mode, the s> stein can simply monitoi the amount υf energy being applied to the target Mtc. This process imoKes applying energy aod maintaining that energy at a certain predetermined This treatment can be based on a total amount of energy applied and or application of a specific amount of energx ox er a set period of time. In addition, the
to tissue by placing probes into target areas without thermal treatment to induce a healing response in the targeted area. Accordingly, the invention is not limited to application of energy via the probes.
[00122| The low energy requirements of the system present an additional advantage since the components on the system undergo less stress than those systems needing higher amounts of energy. Io those systems requiring higher energy. RF energy is often delivered in a pulsed fashion or for a specific duty cycle to prevent stressing the components of that system. In contrast, the reduced energy requirements of the present system allow for continual delivery of RF energy during a treatment cycle In another variation, the duty cycle of variations of the present system can be pulsed so that temperature measurements can be taken between the pulsed deliveries of energy. Pulsing the energy delivery allows for an improved temperature measurement in the period between energy deliveries and provides precise control of energy delivery when the goal of the energy' delivery is to reach a pre-determined temperature for a pre-determined time [00123} FIG. 10 illustrates a graph of energy delivery and temperature versus time. As shown, the pulses or cycles of energy are represented by the bars 302, 304, 306, 308, 310, 312, Each pulse has a parameter, including amount of energy, duration, maximum energy deliv ered, energy wave form or profile (square wave, sinusoidal, triangular, etc), current, voltage, amplitude, frequency, etc. As shown in the graph, measurements are taken between pulses of energy. Accordingly. between each pulse of energy delivery one or more temperature seasons) near the probe obtains a temperature measurement 402, 404, 406, 408. 410, 412. The controller compares the measured temperature to a desired temperature (illustrated by 400). Based on the difference, the energy parameters arc adjusted for the subsequent energy pulse. Measuring temperature between pulses of energy allows for a temperature measurement that is generally more accurate than measuring during the energy deliv ery pulse. Moreover, measuring between pulses allows for minimizing the amount of energy applied to obtain the desired temperature at the target region |00124} FϊG, 1 1 A illustrates an aspect for use with the variations of the devices described herein that eases insertion of probes into tissue, In this example, the probes 304 advance through an introducer member or cannula 130 located on die front face 112 of a cartridge. The eannu!al30 places tissue 10 in a state of tension (also called "traction"). In this variation the introducer/eannula 130 is located about each channel 120 in the cartridge.
[00125} As shown, once the introducer member 130 engages tissue 10, the tissue first elasticaUy deforms as shown. Eventually, the tissue can no longer deflect and is placed in traction by the introducer members 130 As a result, the probes ϊ04 more readily penetrate the tissue. [00126} FIG. 1 1 B illustrates another variation of the introducer member 130 that is tapered inwards toward the probes so that die opening at the distal end closely fits around the probe. J00127J Sn another variation, insertion of the array 108 can consist of 2 or more steps, In die
first step the actuation of the extension presses the channels 120 against the target tissue to create a state of traction. Further actuation advances the array 108 through the channels 120 and into the target tissue Since the target tissue is under traction, the array requires less foxcc to penetrate the tissue. In another
[00128 j In those
100129 j FICi. 12A illustrates another variation of a system 200 for use in accordance with the principles discussed heteiπ Jn this \ ai iation, the s> stern 20ft includes a ti eatment unit 202
[00131 } The treatment unit 202 of the device 200 may also include a handle portion 210 that allows the user to manipulate the device 200. In this variation, the handle portion 210 includes a lever or lever means 240 that actuates the probes info the tissue (as discussed in further detail below).
[00132} As discussed above, the device 200 can be coupled to a power supply 96 with or without an auxiliary unit 94 via a connector or coupling member 9€. Io some variations of the device, a display or user interface can be located on the body of the device 200 as discussed below. [00133} FIG. 12B illustrates a partial side view of the probes 104 and tissue engaging surface .106 of the probe device of FIG. 12A. As shown, the probes 104 extend from the cartridge 1θ0 through the introducer 130, In alternate variations, the probes can extend directly from the body of the device or through extensions on the device.
[00134} As shown, the probes 104 are advanceable from the cartridge fin this case through the introducers 130) at an oblique angle A as measured relative to the tissue engagement surface 106. The tissue engagement surface 106 allows a user to place the device on the surface of tissue and adv ance the probes 104 to the desired depth of tissue. Because the tissue engagement surface 106 provides a consistent starting point for the probes, as the probes 104 advance from the device 202 they are driven to a uniform depth in the tissue
[00135] For instance, without a tissue engagement surface, the probe ϊ04 may be advanced too far or may not be adv anced far enough such that they would partially extend out of the skm, As discussed above, either case presents undesirable outcomes when attempting to treat the dermis layer for cosmetic effects In cases where the dev ice is used for tumor ablation, inaccurate placement may result in insufficient treatment of the target area.
[00136| FIG. 12C illustrates a magnified view of the probe entering tissue 20 at an oblique angle A with the tissue engaging surface 106 resting on the surface of the tissue 20. As is shown, the probe if 04 can include an active area 122, Generally, the term ' " active area" refers to die part of the probe through which energy is transferred to or from the tissue. For example, the active area could be a conductive portion of an probe, it can be a resistivcly heated portion of the probe, or even comprise a window through which energy transmits to the tissue. Although this variation shows the active area 122 as extending over a portion of the probe, variations of the device include probes 104 having larger or smaller active areas 122,
J00137J In any ease, because the probes f 04 enter the tissue at an angle A, the resulting region of treatment 152. corresponding to the active area 122 of the probe is larger than if the needle were driven perpendicular to the tissue surface. This configuration permits a larger treatment area with fewer probes 104, In addition, the margin for error of locating the active region 122 in the desired tissue region is greater since the length of the desired tissue region is greater at angle A than if the probe were deployed perpendicularly to the tissue.
25
[00138} As noted herein, the probes 104 may be inserted into the tissue m either a single motion where penetration of the tissue and advancement into the tissue arc part of the same movement or act. However, variations, include the use of a spring mechanism or impact mechanism to dme the probes 104 into the tissue. Dm my the probes 104 w ith such a spring-force increases the momentum of the probes as they approach tissue and facilitates improv ed penetration into the tissue. AN shown below, variations of the devices discussed herein may be fabricated to pun idc for a dual action to insert the ptobes. For example, the first action may comprise use of a spring or impact mechanism to initially dm e the probes to sjmpiy penetrate the tissue Use of the spring force or impact mechanism to driv e the probes may overcome die initial resistance in puncturing the tissue. The next action would then be an adv ancement of the probes so that they reach their intended target site. The impact mechanism ma\ be spring dm en. fluid driv en or v ia other means known by those skilled in the art. One possible configuration is to use an impact or spring mechanism to full) drive the probes to their intended depth.
[00139} FIG. 13 illustrates an example of the benefit of oblique entry when the device is used to treat the dermis IS. λs shown, the length of the dermis IS along the activ e region 122 is greater than a deptli of the dermis IS. Accordingly when trying to insert the probe in a perpendicular manner, the shorter depth provides less of a margin for error when trying to selectively treat the dermis tcgion 18 As discussed herein, although the figure illustrates treatment of the dermis to tighten skin or reduce winkles, the dev ice and methods ma> be used to affect skm anomalies 153 such as acne. w aits, sebaceous glands, tattoos, oi other structures oi blemishes In addition, the probe may be inserted to apply energv to a tumor, a hair follicle, a fat layer, adipose tissue. SMAS, a nerve or a pain fiber or a blood vessel As noted hercm, the probes shown can include any variation of probe disclosed abov e
Jθθ14θJ Inserting the probe at angle A also allows for direct cooling of the surface tissue, As shown in FIG 12€\ fhc area of tissue on the surface ϊ56 that is directly adjacent or above the treated region !52 (i.e., the region treated by the active aiea 122 of the piobe !04) is spaced frøm the entry point by a distance or gap 154. This gap 154 allows for direct cooling of the entire surface f 56 adjacent to the treated region ϊS2 without interference b> the pxobe or the pxobe mounting structure. In contrast, if the probe were driven perpendicularly to the tissue surface, then cooling must occm at or around the perpendicular entry point.
[00141 } FIG 14A illustrates one example of a cooling surface 216 placed on body structme or tissue 20 As shown, the probe 104 enters at an oblique angle A such that the actne region 122 of the probe 104 is directly adjacent or below the cooling surface 216. In certain v ariations, the cooling surface 216 may extend to the entry point (or beyond) of the probe ϊ04. However, it is desirable to have the cooling surface 216 over the probe's activ e region 122 because the heat generated by rhe active region f 22 w ill have its greatest effect on the surface at the surface location
156 In some λ aπations de\ ices and methods deses ibed herein max also incorporate a cooling source in the tissue engagement suiface
[00142| I he eoohng surface 2ϊ6 and coolmg deuce mav be am cooling mechanism known in those skilled m the an Jror example, it raaj be a manifold fjpe block
[00143} In one appiicatjon, the cooling surface lib is mamtamed at or near bod\ temperature Accordingly . as {he cncrg\ transfer occuis causing the iempeuture of the surface 156 to mcrcase, contact between the coolmg sui face 216 and the tissue 20 shall cause the coolmg sus face to uietease m tcmpcratujc as the interface ) caches a tcmpetatuie equihbπuni λceoidmgK , as the
|00144| When trcaUiig the skin, it is bciiexed {hat {he dermis should be heated to a psedeteinnned temper atuie condition, at or about 65 degree C without increasing the tempeiatuie of the epidermic bey oncl 42 degtce C Since the aetn e area of the prohe designed to tcmain beneath the epidermic, the ptcsciit svstcni applies cneigj to the deimis in a targeted, ^clcctne fashion to dissociate and contract collagen tissue Bv attempting to limit enei g) dcln cry to the dcmxis, the coπtlguiauoo ol the present s> s>tem also mu»mu;cs damage to the epidemus [00145} W hile the coohng sudace ma\ compute any commonly known thcmialh conducts e material, metal or compound (e g coppci, steel, aluminum, etc } \ aiiations of the
(AKOj). The benefit of the single crystal aluminum oxide is a high thermal conductivity optical clarity, ability to withstand a large temperature range, and the ability to fabricate the single crystal aluminum oxide into various shapes. A number of other optically transparent or translucent substances could be used as wet! (e.g., diamond, other crystals or glass).
(00147] FTCl. 14Fi illustrates another aspect tor use with variations of the devices and methods described herein, ϊn this variation, the cartridge lβø includes two arrays of probes 104, 126. As shown, the first plurality !04 is spaced evenly apart from and parallel to the second plurality 126 of probes, in addition, as shown, the first set of probes 1(14 has a first length while the second set of probes 126 lias a second length, where the length of each probe is chosen such that the sets of probes 164, 126 extend into the tissue 20 by the same vertical distance or length 158, Although only two arrays of probes arc shown, variations of the invention include any number of arrays as required by the particular application In some variations, the lengths of the probes 104, 126arc the same. However, the probes will be inserted or advanced by different amounts so that their active regions penetrate a uniform amount into the tissue. As shown, the cooling surface may include more than one temperature detecting clement 218,
|00!48| FIG. 14B also illustrates a cooling surface 216 located abov e the active regions 122 of the probes, in such a variation, it may be necessary for one or more of the probe arrays to pass through a portion of the cooling surface 216, Alternative variations of the device include probes that pass through a portion of the cooling device.
|00149j FIG. 14B also shows a variation of the device having additional energy transfer elements ϊ05 located in the cooling surface 216. As noted above, these energy transfer elements can include sources of radiant energy that can be applied either prior to the cooling surface contacting the skin, during energy treatment or cooling, or after energy treatment |00!50| FIG. 14C shows an aspect for use with methods and devices of the invention that allows marking of the treatment site. As shown, the cartridge 100 may include one or more marking lumens 226, 230 that are coupled to a marking ink 98. During use, a medical practitioner may be unable to see areas once treated. The use of marking allows the practitioner to place a mark at the treatment location to avoid excessive treatments. As shown, a marking lumen 226 may be placed proximate to the probe 104. Alternatively, or in combination, marking may occur at or near the cooling surface 216 since the cooling surface is directly above the treated region of tissue. The marking lumens may be combined with or replaced by marking pads. Furthermore, any type of medically approved dye may be used to mark. Alternatively, the dye may comprise a substance that is visible under certain wavelengths of light. Naturally, such a feature permits marking and visualization by the practitioner given illumination by the proper light source but prevents the patient from seemy the dye subsequent to the treatment, |00!5J| FIG. 15 A shows an alternative variation of a probe that includes a resistive heating
element 50 to supply therapeutic treatment to the tissue. The resistive heater 50 can be made of any number of typical nickel chrome alloys that produce thermal heat via electrical resistance. The heat produced by the heater 50 conducts through the the probe walls 32 and into the dermal tissue. A temperature sensor 52 can be positioned anywhere as shown herein. However, in the illustrated variation, the sensor 52 is placed on the outer surface of the probe 30. This sensor 52 can provide temperature feedback to the system to adjust power delivery to the resistive heater 50 for producing desired energy delivery to the targeted derma! tissue 152.
JO0152J FlG. 15B shows an alternative probe configuration. Jn this embodiment an energy clement CiO advances out of the probe 30. The energy element 60 can be a resistive heater, an RF electrode, a cryoprohe, or any energy modality discussed herein were direct contact with the target tissue is beneficial. This variation allows the energy delivery clement 60 to more directly contact the target tissue without having to transfer energy through the probe wall 32. Accordingly, this design allows for use of lower energy levels to achieve the same therapeutic effect. In those therapies where the tissue is heated, the targeted temperature can be reached in a shorter time period given the direct contact. So addition, the variation of FlG, 15B can employ a temperature sensor 52 as shown above.
(001531 FIG. 15C shows an additional variation of a probe 30 configuration. This variation contains a coaxial central conductor 74 and an outer conductor 78. It also contains insulators 76 that create a dipole for directing electrical energy in the microwave spectrum from the device into the tissue to heat the tissue 152. This microwave heater can also be used to treat dermal tissue and can rely on a temperature sensor 52 to adjust delivered power. In an alternate variation, the probe 30 can include shielding to direct the microwave energy in a particular direction to create a zone of treatment as described above.
J00154J FIG. 151) shows a variation of a cryogenic probe device. Typically, the device will produce a hypothermia effect within tissue. In one configuration, the probe 30 includes a delivery lumen 342 and return lumen 344 and a coiled heat exchanger 346. Cooled liquid or gas can he delivered through the delivery lumen 342 to the coiled heat exchanger 346 where it will cool fee surrounding target tissue before exiting the probe 30 through the return lumen 344. The fluid or gas delivers 1 can be controlled by measuring the target tissue temperature with temperature sensor 52 that is coupled to a control source (not shown) via conducting wires 54.
[00155} Clearly, any number of different cooling devices can be incorporated into the probe to produce a percutaneous hypothermia effect within tissue. For example, a percutaneous hypothermia treatment device can include a thermal electric cooler, TEC, such as a pettier device. Electric current can he delivered to the TEC to reduce its temperature such that it will cool the surrounding target tissue. The efficiency of the TEC can be optionally improved by providing a cooling device to remove heat generated by the side of the TEC that is riot in contact with the target
tissue This cooling dev ice can rciy on the flow of a fluid or gas on the side of the TFC not in contact with the target tissue, or through a heat exchanger which ss attached to the side of the TEC not m contact v. tth die target tissue
|00!56| In any of the above \ anation, the energy sources can be coπfigiocd as dixectioxiai energy sources \ ia the use of the appropriate insulation to direct energy to produce die treatment zon.es as> described
[00157} Although the systems dcscπbed herein may be used by themselves, the inv ention includes the methods: and devices described above m combination with substances such as moisturizers, ointments, etc that increase the resisfix it> of the epidermis Accordingly, pπor to the treatment, the medical practitioner can prepare the patient by increasing the resistivity of the cμidcums Dutiug the treatment, because of the increased resistrvit) of the epidermis, energy would fend to flow in the dermis
[θθl 58J In addition, such substances can be combined \\ ith λ anous other energs deln cry modalities to prov ide enhanced collagen production in the targeted tissue or other affects as described herein,
[00159| In one example,
of the facial muscles after energy dclhery. This max be provide a significant
|00!6J| Another means fo enhance the tissue's therapeutic response is the use of mechanical energy through massage Such an application of mechanical energy can be combined with the methods and systems described herein. Previously, devices have used massaging techniques to treat adipose tissue. For example. Patent No 5,961.475 discloses a massaging device that applies negative pressure as well as massage to the skin. Massage both increases blood circulation to the tissue and breaks done connections between die adipose and surrounding tissue. For example, these effects combined with energy treatment of the tissue to enhance the removal of fat cells, [0θ162| The above variations arc intended to demonstrate the v arious examples of embodiments of the methods and devices of the