INSTRUMENT AND METHOD FOR DIRECTLY APPLYING ENERGY TO A TISSUE BENEATH STRATUM CORNEUM TISSUE IN A PATIENT

This application claims the benefit of U.S. Provisional Application No. 60/797,206, filed May 3, 2006. This application is a continuation- in-part of Application No. 11/683,262, filed March 7, 2007, which claims the benefit of U.S. Provisional Application No. 60/780,139, filed March 8, 2006. The disclosures of Application No. 11/683,262, U.S. Provisional Application No. 60/780,139, and U.S. Provisional Application No. 60/797,206 are hereby incorporated herein by reference.

FIELD OF THE INVENTION

The present invention relates to a device utilizing energy to improve the appearance of skin in a patient.

BACKGROUND OF THE INVENTION

Currently, there are a variety of procedures in use for reducing the appearance of the aging signs in skin. Some of the common procedures employ muscle paralytics, injection fillers, microdermabrasion and dermabrasion, chemical peels, resurfacing and regeneration systems, or the application of direct energy. Common muscle paralytics are Botox®, Myobloc®, and Dysport®. These chemodenervating materials are injected through the skin at the subcutaneous level into select muscle groups and act to temporary paralyze select muscle groups, which create dynamic facial wrinkles. The temporary paralysis occurs as a result of blockage at the neural junction affecting the neurotransmitter to the muscle. This sort of treatment has a temporary effect and does not improve photo damaged skin, skin laxity, passive skin wrinkles, or the deep layers of skin.

Injection fillers, such as, Collagen (Cosmoderm®), hyaluronic acid (Restylane®, Juviderm™, Hylaform®, and Captique®), calcium hydroxyapatite (Radiesse®) and others, are selectively injected at various depths in or beneath the skin to "fill" the wrinkle and reduce the surface effect. They, in effect, plump up the skin to reduce the size of the wrinkle. The beneficial effects of these fillers are temporary, or, in the case of silicone or Artefill®, permanent. However, permanent fillers may lead to long term adverse side effects in humans.

In a microdermabrasion or dermabrasion process, the skin is abraded layer by layer to a selected depth. The abrasion promotes injury and healing of the tissue. The healing results in a somewhat favorable deposition of collagen into the dermis and the reduction of wrinkles. However, microdermabrasion is too superficial to cause a significant deep tissue effect and deep dermabrasion is invasive, resulting in side effects, which often lead to permanent unnatural lightening of the skin.

When chemical peeling is employed, acidic chemicals of various strengths and types are applied directly to the skin. Depending on the type of chemical utilized, the acids penetrate the skin to a varying degree. The penetration of the acid promotes injury and favorable healing of the tissue. However, light superficial chemical peels have limited beneficial effects on the skin and deep peels are invasive and result in side effects, which often lead to permanent unnatural lightening of the skin.

Resurfacing and regenerating systems employ energy in the form of heat, which is applied to the skin to create a deep healing response in the dermis. These systems use various technologies, such as, carbon dioxide, erbium, Nd- Yag (neodymium-doped yttrium aluminium garnet), nitrogen plasma gas, or the scanning, pulsing, or the application of fractionated energy to the skin to create a favorable response. These treatments heat the skin causing collagen shrinkage and deep tissue insult, resulting in a healing effect and the deposition of collagen into the dermis; thus, improving the surface appearance of skin. The superficial fractionated systems have limited beneficial aesthetic effects and the deep treatment lasers result in significant downtime, and often lead to permanent lightening of the skin.

The latest treatments of the signs of aging utilize direct energy, such as, light emitted diodes, ultrasound energy, and monopolar and bipolar radiofrequency, having unique and specific properties. During treatment, energy is applied to the skin by noninvasive hand pieces. The energy emitted by the hand pieces transmits through the top surface layer of the skin to promote a favorable response. Nonablative monopolar radiofrequency (MRF) treatment (ThermaCool™, Thermage Inc., Hayward, CA) is one nonablative rejuvenation modality. However, since these treatments are noninvasive, they have very limited beneficial aesthetic results.

The present invention is directed to a device configured to directly apply energy to specific sub-surface levels of the skin, to promote a favorable healing effect.

SUMMARY OF THE INVENTION

The scope of the present invention is defined solely by the appended claims, and is not affected to any degree by the statements within this summary. Briefly stated, in one embodiment of the present invention, an instrument comprises a shaft that includes an insertable portion and a contact portion. The insertable portion is provided with means for directly applying energy to tissue beneath stratum corneum tissue in a patient whereby skin of the patient is tightened and rejuvenated. The contact portion is configured to receive energy of an energy source. Briefly stated, in another embodiment of the present invention, an instrument comprises a shaft including an insertable portion and a contact portion. The insertable portion is provided with means for directly applying energy to tissue beneath stratum corneum tissue in the patient whereby skin of the patient is tightened and rejuvenated. The contact portion connects to a conducting element and receives energy from the conducting element. The conducting element receives energy of an energy source. Briefly stated, in another embodiment of the present invention, a method for reducing the appearance of aging signs in a patient, comprises the step of providing an instrument that includes a shaft provided with an insertable portion and a contact portion, wherein the insertable portion includes a conductive material located on at least a portion of an outer surface of the insertable portion and the step of using the instrument to reduce the appearance of aging signs in a patient by applying energy to the contact portion of the shaft, inserting the conductive material into a tissue of a patient, wherein the tissue is located beneath stratum corneum tissue proximate to a skin defect caused by an aging process in the patient, and directly applying the energy to the tissue located beneath the stratum corneum tissue to reduce the appearance of aging signs in the patient.

Briefly stated, in another embodiment of the present invention an instrument, comprises a shaft including an insertable portion and a contact portion. The insertable portion is provided with a conductive material and an insulating material. The insulating material is applied semi-circumferentially on at least a portion of the shaft. The contact portion is configured to receive energy of an energy source.

Briefly stated, in another embodiment of the present invention an instrument comprises a shaft including an insertable portion and a contact portion. The insertable portion includes a plurality of first shaft sections and at least one second shaft section. The second shaft section includes an outer surface provided with an insulating material that extends circumferentially around the outer surface of the second shaft section. The first shaft sections include an outer surface, wherein at least a portion of the outer surface includes a conductive material. The contact portion is configured to receive energy of an energy source.

Briefly stated, in another embodiment of the present invention an instrument comprises a shaft including an insertable portion and a contact portion. The insertable portion includes at least one first shaft section and a plurality of second shaft sections. The second shaft sections include an outer surface provided with an insulating material that extends circumferentially around the outer surface of the second shaft sections. The first shaft section includes an outer surface, wherein at least a portion of the outer surface includes a conductive material. The contact portion is configured to receive energy of an energy source element.

ASPECTS

According to one aspect of the present invention, an instrument comprises: a shaft including an insertable portion and a contact portion; the insertable portion is provided with means for directly applying energy to tissue beneath stratum corneum tissue in a patient whereby skin of the patient is tightened and rejuvenated; and the contact portion is configured to receive energy of an energy source. Preferably, the insertable portion includes an insulating material located on a portion of an outer surface of the insertable portion.

Preferably, the instrument further includes a first shaft section included on the insertable portion, wherein the first shaft section includes the means for directly applying energy to the tissue beneath the stratum corneum tissue in the patient whereby the skin of the patient is tightened and rejuvenated and a second shaft section included on the insertable portion, wherein the second shaft section includes an outer surface that is provided an insulating material.

Preferably, the instrument further includes a first shaft section included on the insertable portion, wherein the first shaft section includes the means for directly applying energy to the tissue beneath the stratum corneum tissue in the patient whereby the skin of the patient is tightened and rejuvenated, another first shaft section included on the insertable portion, wherein the another first shaft section includes the means for directly applying energy to the tissue beneath the stratum corneum tissue in the patient whereby the skin of the patient is tightened and rejuvenated, a second shaft section included on the insertable portion, wherein the second shaft section includes an outer surface that is provided an insulating material, and the second shaft section is located between the first shaft section and the another first shaft section.

Preferably, the instrument further includes a first shaft section included on the insertable portion, wherein the first shaft section includes the means for directly applying energy to the tissue beneath the stratum corneum tissue in the patient whereby the skin of the patient is tightened and rejuvenated, a second shaft section included on the insertable portion, wherein the second shaft section includes an outer surface that is provided an insulating material, another second shaft section included on the insertable portion, wherein the second shaft section includes an outer surface that is provided the insulating material, and the first shaft section is located between the second shaft section and the another second shaft section. Preferably, the instrument further includes a first shaft section included on the insertable portion, wherein the first shaft section includes; means for directly applying energy to the tissue beneath the stratum corneum tissue in the patient whereby the skin of the patient is tightened and rejuvenated, insulating material applied semi- circumferentially on said first shaft section. Preferably, the instrument further includes a first shaft section included on the insertable portion, wherein the first shaft section includes, means for directly applying energy to the tissue beneath the stratum corneum tissue in the patient whereby the skin of the patient is tightened and rejuvenated, and insulating material applied hemi- circumferentially on said first shaft section. Preferably, the insertable portion includes an inner end and an outer end, the outer end includes a tip, and the tip includes insulating material, wherein said insulating material is applied semi-circumferentially on said tip.

Preferably, the insertable portion includes an inner end and an outer end, the outer end includes a tip, and the tip includes insulating material, wherein said insulating material is applied hemi-circumferentially on said tip.

Preferably, the means for directly applying energy to the tissue beneath the stratum corneum tissue in the patient whereby the skin of the patient is tightened and rejuvenated provides means for directly applying energy to the subcutaneous tissue in the patient whereby the skin of the patient is tightened and rejuvenated.

According to another aspect of the present invention, an instrument comprises: a shaft including an insertable portion and a contact portion; the insertable portion is provided with means for directly applying energy to tissue beneath stratum corneum tissue in the patient whereby skin of the patient is tightened and rejuvenated; the contact portion connects to a conducting element and receives energy from the conducting element; and the conducting element receives energy of an energy source.

Preferably, the insertable portion includes an insulating material located on a portion of an outer surface of the insertable portion.

Preferably, the instrument further includes a first shaft section included on the insertable portion, wherein the first shaft section includes the means for directly applying energy to the tissue beneath the stratum corneum tissue in the patient whereby the skin of the patient is tightened and rejuvenated and a second shaft section included on the insertable portion, wherein the second shaft section includes an outer surface that is provided an insulating material.

Preferably, the instrument further includes a first shaft section included on the insertable portion, wherein the first shaft section includes the means for directly applying energy to the tissue beneath the stratum corneum tissue in the patient whereby the skin of the patient is tightened and rejuvenated, another first shaft section included on the insertable portion, wherein the another first shaft section includes the means for directly applying energy to the tissue beneath the stratum corneum tissue in the patient whereby the skin of the patient is tightened and rejuvenated, a second shaft section included on the insertable portion, wherein the second shaft section includes an outer

surface that is provided an insulating material, and the second shaft section is located between the first shaft section and the another first shaft section.

Preferably, the instrument further includes a first shaft section included on the insertable portion, wherein the first shaft section includes the means for directly applying energy to the tissue beneath the stratum corneum tissue in the patient whereby the skin of the patient is tightened and rejuvenated, a second shaft section included on the insertable portion, wherein the second shaft section includes an outer surface that is provided an insulating material, another second shaft section included on the insertable portion, wherein the second shaft section includes an outer surface that is provided the insulating material, and the first shaft section is located between the second shaft section and the another second shaft section.

Preferably, the instrument further includes a first shaft section included on the insertable portion, wherein the first shaft section includes the means for directly applying energy to the tissue beneath the stratum corneum tissue in the patient whereby the skin of the patient is tightened and rejuvenated and insulating material applied semi- circumferentially on said first shaft section.

Preferably, the instrument further includes a first shaft section included on the insertable portion, wherein the first shaft section includes the means for directly applying energy to the tissue beneath the stratum corneum tissue in the patient whereby the skin of the patient is tightened and rejuvenated and insulating material applied hemi- circumferentially on said first shaft section.

Preferably, the insertable portion includes an inner end and an outer end, the outer end includes a tip, and the tip includes insulating material, wherein said insulating material is applied semi-circumferentially on said tip. Preferably, the insertable portion includes an inner end and an outer end, the outer end includes a tip, and the tip includes insulating material, wherein said insulating material is applied hemi-circumferentially on said tip.

Preferably, the insertable portion includes an insulating material applied semi- circumferentially on at least a portion of the insertable portion and the instrument includes means for allowing an operator to orient the direction that the insulating material is facing when the insertable portion is inserted into the tissue of a patient.

Preferably, the insertable portion includes an insulating material applied semi- circumferentially on at least a portion of the insertable portion and the hand piece includes means for allowing an operator to orient the direction that the insulating material is facing when the insertable portion is inserted into the tissue of a patient. Preferably, the means for directly applying energy to the tissue beneath the stratum corneum tissue in the patient whereby the skin of the patient is tightened and rejuvenated provides means for directly applying energy to the subcutaneous tissue in the patient whereby the skin of the patient is tightened and rejuvenated.

According to another aspect of the present invention, a method for reducing the appearance of aging signs in a patient comprises the steps of: providing an instrument that includes: a shaft provided with an insertable portion and a contact portion; the insertable portion includes a conductive material located on at least a portion of an outer surface of the insertable portion; using the instrument to reduce the appearance of aging signs in a patient by: applying energy to the contact portion of the shaft; inserting the conductive material into a tissue of a patient, wherein the tissue is located beneath stratum corneum tissue proximate to a skin defect caused by the aging process in the patient; and directly applying the energy to the tissue located beneath the stratum corneum tissue to reduce the appearance of aging signs in the patient.

According to another aspect of the present invention, an instrument comprises: a shaft including an insertable portion and a contact portion; the insertable portion is provided with a conductive material and an insulating material; the insulating material is applied semi-circumferentially on at least a portion of the shaft; and the contact portion is configured to receive energy of an energy source.

According to another aspect of the present invention, an instrument comprises: a shaft including an insertable portion and a contact portion;

the insertable portion includes a plurality of first shaft sections and at least one second shaft section; the second shaft section includes an outer surface provided with an insulating material that extends circumferentially around the outer surface of the second shaft section; the first shaft sections include an outer surface, wherein at least a portion of the outer surface includes a conductive material; the contact portion is configured to receive energy of an energy source. According to another aspect of the present invention, an instrument comprises: a shaft including an insertable portion and a contact portion; the insertable portion includes at least one first shaft section and a plurality of second shaft sections; the second shaft sections include an outer surface provided with an insulating material that extends circumferentially around the outer surface of the second shaft sections; the first shaft section includes an outer surface, wherein at least a portion of the outer surface includes a conductive material; the contact portion is configured to receive energy of an energy source.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 depicts a perspective view of an instrument of an embodiment of the present invention connected to a wire connected to an adaptor.

FIG. 2 depicts a perspective view of an instrument of an embodiment of the present invention. FIG. 3 depicts a perspective view of an instrument of an embodiment of the present invention.

FIG. 4 depicts a perspective view of a portion of an insertable portion of an instrument of an embodiment of the present invention.

FIG. 5 depicts a perspective view of a tip on an outer end on an insertable portion of an instrument of an embodiment of the present invention.

FIG. 6 depicts an instrument of an embodiment of the present invention showing how the instrument may be inserted at various angles and various locations on a patient.

FIG. 7 depicts an instrument, adaptor, and power source of an embodiment of the present invention.

FIG. 8 depicts various tissues in a patient and various angles which the instrument may be inserted into the tissues of a patient.

DETAILED DESCRIPTION OF THE PRESENTLY PREFERRED EMBODIMENTS

FIG. 1 depicts an instrument 15 according to an embodiment of the present invention. As shown, the instrument 15 is provided with an elongated shaft 20. The shaft 20 includes an insertable portion 25 extending between ends 26, 27. In the presently preferred embodiment, the insertable portion 25 is configured to insert into an incision in the skin of a patient and deliver energy to any number of subepidermal tissues in a patient, such as, for example dermal tissue 53 or subcutaneous tissue 59. Although in the presently preferred embodiment, the insertable portion 25 is configured to insert into an incision in the skin of a patient, it is within the scope of the present invention for the insertable portion 25 to pierce the skin of a patient.

According to one aspect of the presently preferred embodiment, the insertable portion 25 is provided with means for directly applying energy to a tissue or tissues beneath the stratum corneum in a patient, whereby the appearance of skin defects, such as wrinkles or lax skin, induced by the aging process, are reduced. According to another aspect of the presently preferred embodiment, the insertable portion 25 is provided with means for directly applying energy to a tissue or tissues beneath the stratum corneum in a patient, whereby the skin of the patient is tightened. According to yet another aspect of the presently preferred embodiment, the insertable portion 25 is provided with means for directly applying energy to a tissue or tissues beneath the stratum corneum in a patient, whereby wrinkles in the skin are reduced. According to yet a further aspect of the presently preferred embodiment, the insertable portion 25 is provided with means for directly applying energy to a tissue or tissues beneath the stratum corneum in a patient, whereby the skin is lifted. According to still a further aspect of the presently preferred embodiment, the insertable portion 25 is provided with means for directly applying energy to a tissue or tissues beneath the stratum corneum in a patient, whereby the skin is rejuvenated.

According to one aspect of the presently preferred embodiment, the insertable portion 25 may be provided with means for directly applying energy to a tissue or tissues beneath the stratum corneum in a patient and indirectly applying energy to a tissue or tissues beneath, above, or around the tissue to which the energy is directly applied, whereby the appearance of aging signs, such as wrinkles or lax skin, induced by the aging process, are reduced. According to another aspect of the presently preferred embodiment, the insertable portion 25 is provided with means for directly applying energy to a tissue or tissues beneath the stratum corneum in a patient and indirectly applying energy to a tissue or tissues beneath, above, or around the tissue to which the energy is directly applied, whereby the skin of the patient is tightened. According to yet another aspect of the presently preferred embodiment, the insertable portion 25 is provided with means for directly applying energy to a tissue or tissues beneath the stratum corneum in a patient and indirectly applying energy to a tissue or tissues beneath, above, or around the tissue to which the energy is directly applied, whereby wrinkles in the skin are reduced. According to yet a further aspect of the presently preferred embodiment, the insertable portion 25 is provided with means for directly applying energy to a tissue or tissues beneath the stratum corneum in a patient and indirectly applying energy to a tissue or tissues beneath, above, or around the tissue to which the energy is directly applied, whereby the skin is lifted. According to still a further aspect of the presently preferred embodiment, the insertable portion 25 is provided with means for directly applying energy to a tissue or tissues beneath the stratum corneum in a patient and indirectly applying energy to a tissue or tissues beneath, above, or around the tissue to which the energy is directly applied, whereby the skin is rejuvenated. The specific tissue below the stratum corneum to which the energy is directly applied may vary according to the desired course of cosmetic treatment. It is within the scope of the present invention for the means to directly apply energy to a tissue or tissues within the epidermis that are located beneath the stratum corneum. In one embodiment of the present invention, the means directly applies energy to the stratum lucidum. In another embodiment of the present invention, the means directly applies energy to the stratum granulosum. In yet another embodiment of the present invention,

the means directly applies energy to the stratum spinosum. In still another embodiment of the present invention, the means directly applies energy to the stratum germinativum.

It is within the scope of the present invention for the means to directly apply energy to a tissue or tissues within the dermis. In one embodiment of the present invention, the energy is directly applied to papillary tissue. In another embodiment of the present invention, the energy is directly applied to reticular tissue.

It is within the scope of the present invention for the means to directly apply energy to the subcutaneous tissue. In one embodiment of the present invention, the energy is directly applied to adipose tissue within the subcutaneous tissue. The specific tissue below the stratum corneum to which the energy is indirectly applied may vary according to the desired course of cosmetic treatment. It is within the scope of the present invention for the means to indirectly apply energy to a tissue or tissues within the epidermis that are located beneath the stratum corneum. In one embodiment of the present invention, the means indirectly applies energy to the stratum lucidum. In another embodiment of the present invention, the means indirectly applies energy to the stratum granulosum. In yet another embodiment of the present invention, the means indirectly applies energy to the stratum spinosum. In still another embodiment of the present invention, the means indirectly applies energy to the stratum germinativum. It is within the scope of the present invention for the means to indirectly apply energy to a tissue or tissues within the dermis. In one embodiment of the present invention, the energy is indirectly applied to papillary tissue. In another embodiment of the present invention, the energy is indirectly applied to reticular tissue.

It is within the scope of the present invention for the means to indirectly apply energy to the subcutaneous tissue. In one embodiment of the present invention, the energy is indirectly applied to adipose tissue within the subcutaneous tissue.

It is within the scope of the present invention for the means to directly apply energy to any one or more of the aforementioned tissues and indirectly apply energy to any one or more of the aforementioned tissues. In the preferred embodiment, the energy is applied in any number of forms. By way of example, and not limitation, then energy may be in the form of thermal energy, ultrasound energy, microwave energy, electrical energy, optical radiation energy, light

emitted diode energy, electromagnetic energy, monopolar radiofrequency energy, and bipolar radiofrequency energy. In the presently preferred embodiment the energy is delivered as radiofrequency energy that is received by the probe 15. In the presently preferred embodiment, the energy is delivered in an amount to cause ionic agitation and factional heat so that the tissue is heated to an elevated temperature that is sufficient to induce denaturation of protein, such as, for example, but not limitation, a temperature at least above about 50 ⁰ C, preferably at least above about 68°C.

According to one aspect of the presently preferred embodiment, the means for directly applying energy to the means for directly applying energy includes a conductive material 28 on an outer surface of the insertable portion 25. The conductive material 28 may be any material that is capable of directly applying selected energy to the desired tissue or tissues in a patient, such as, for example, and not limitation, a metal, including a stainless steel.

In the presently preferred embodiment, the conductive material 28 is included on a first shaft section 29 of the insertable portion 25. As shown in FIG. 1, the first shaft section 29 may extend from an outer end 27 of the insertable portion 25. As shown, in the presently preferred embodiment, the outer end 27 of the insertable portion 25 is blunt; however, in alternative embodiments, the instrument 15 may be a needle and the end 26 may be pointed, as disclosed in Application No. 11/683,262. Furthermore, the instrument 15 may include any of the features of the needle disclosed in Application No. 11/683,262 and may be used in any of the manners disclose in Application No. 11/683,262.

In the presently preferred embodiment, the insertable portion 25 is provided with means for preventing or limiting the direct application of energy to certain tissues in a patient. However, it is within the scope of the present invention to fabricate the instrument 15 without means for preventing or limiting the direct application of energy to tissue beneath the stratified squamous epithelial cells of a patient. By way of example, and not limitation, the insertable portion 25 may be fabricated without means for preventing or limiting the direct application of energy to certain tissues in a patient whereat, an insulating sleeve is inserted into the tissue of a patient to prevent or limit the direct application of energy to certain tissues in a patient. Depending on the course of treatment, the protected tissue may be epidermal tissue 50, dermal tissue 53,

subcutaneous tissue 59, and/or critical soft tissue structures, such as, for example, and not limitation, neuro vascular structures.

According to one aspect of the presently preferred embodiment, the means for preventing or limiting the direct application of energy to certain tissues in a patient includes an insulating material 31. The insulating material 31 may be any material, such as, for example, and not limitation, Teflon®, that prevents or limits the application of energy. Those of ordinary skill in the art will appreciate that other suitable insulating materials may be used and that it is within the scope of the present invention to use other insulating materials. As shown in FIGS. 1, in the presently preferred embodiment, the insulating material 31 is located at least on an outer surface of a second shaft section 30 of the insertable portion 25. In embodiments wherein the second shaft section 30 conducts energy to a first shaft section, the second shaft section 30 preferably includes the conductive material 28 and the insulating material 31 is preferably applied as a coating on the conductive material.

Although the insertable portion 25 is shown as being generally straight, it is within the scope of the present invention to vary the shape and size of the insertable portion 25 according to the desired treatment. The length, diameter, and shape of the insertable portion 25 may be varied according to the treatment area and the patient. It is within the scope of the present invention to provide the insertable portion 25 with any of the shape, such as a curved or angulated shape or any shape disclosed in connection with the shaft and needle in Application No. 11/683,262.

Although the embodiment in FIG. 1 shows the second shaft section 30 extending from the outer end 26 and the first shaft section 29 extending from the inner end 27 of the insertable portion 25, the first and second shaft sections 29, 30 may be arranged in any fashion in order to deliver energy to desired tissue or tissues and, if desired, to prevent or limit the direct application of energy to desired tissue or tissues. By way of example, FIG. 2 depicts an instrument 15 of an alternative embodiment of the present invention. As shown therein, the instrument 15 is provided with a plurality of first shaft sections 29 and a plurality of second shaft sections 30. As shown, the shaft sections 29, 30 may be positioned along the shaft 20 in alternating fashion. The shaft sections 29, 30 may be of equal length or may be of unequal length. Each or some of the plurality of

shaft sections 29 may be of equal length or unequal length. Each or some of the plurality of shaft sections 30 may be of equal length or unequal length. As shown, a second shaft section 30 may extend from the end 26; however, in alternative embodiments, a first shaft section 29 may extend from the end 26. As shown, a first shaft section 29 may extend from the end 27; however, in alternative embodiments, a second shaft section 30 may extend from the end 27. It is within the scope of the present invention to provide the insertable portion 25 with any number of first shaft sections 29 and second shaft sections 30 arranged in any fashion.

It is within the scope of the present invention to fabricate the instrument 15 with or without the insulating material 31; furthermore, it is within the scope of the present invention to locate the insulating material 31 at a variety of locations on the insertable portion 25. By way of example, although in the embodiments depicted in FIGS. 1 and 2, the first shaft sections 29 are fabricated without the insulating material 31, it is within the scope of the present invention to provide at least a portion of the first shaft sections 29 with the insulating material 31.

FIGS. 3-5 depict instruments 15 of further alternative embodiments of the present invention, wherein the first shaft section 29 includes an insulating material 31, preferably as a coating. As shown, another portion of the first shaft section 29 is exposed to deliver energy. In the embodiments depicted in FIGS. 3-5, the insulating material 31 is applied semi-circumferentially, including hemi-circumferentially, as shown. As shown in FIGS. 4-5, the end 27 is provided with a tip 23 that may include the insulating material 31, which may be applied semi-circumferentially, including hemi-circumferentially; or alternatively, as shown in FIG. 3, the tip 23 may be exposed. Although the first shaft sections 29 in the embodiments depicted in FIGS. 3-5 are provided with an insulating material 31 applied semi-circumferentially, including hemi- circumferentially, along the entire length of the first shaft section 29, it is within the scope of the present invention to apply the insulating material 31 semi- circumferentially, including hemi-circumferentially, along a portion or portions of the length of the first shaft section 29. Those of ordinary skill in the art will appreciate that the insulating material 31 may be applied semi-circumferentially, including hemi-circumferentially, to at least a portion or portions of the first shaft section 29 of the embodiment depicted in FIG. 1 or

to at least a portion or portions of one or more of the first shaft sections 29 depicted in FIG. 2. The insulating material 31 may be applied semi-circumferentially, including hemi-circumferentially, to the first shaft sections 29 along their entire length or along part of their lengths. Furthermore, the insulating material 31 may be applied circumferentially or semi-circumferentially, including hemi-circumferentially, to the tips 23 of the embodiments depicted in FIGS. 1 and 2.

As shown in FIG. 7, in embodiments that include the insulating material 31, the insulating material 31 on the shaft sections 29, 30 extends for a predetermined length 34 between an inner end 32 and an outer end 33 of the insulating material 31. The length 34 is dimensioned according to a length of tissue or tissues that are desired to be protected. The length 34 is preferably dimensioned to be greater than or equal to the length of tissue or tissues desired to be protected from the application of energy. By way of example, the length 34 may be dimensioned according to at least a portion of the tissue length 51 (shown in FIG. 8) of epidermal tissue 50 (shown in FIG. 8) in a typical patient. Where protection of epidermal tissue 50 is desired, the length 34 is preferably dimensioned to be greater than or equal to the tissue length 51 of the epidermal tissue 50. By way of example, the length 34 may be dimensioned according to at least a portion of the tissue length 54 (shown in FIG. 8) of dermal tissue 53 (shown in FIG. 8). Where protection of dermal tissue 53 is desired, the length 34 is preferably dimensioned to be greater than or equal to the tissue length 54 of the dermal tissue 53. By way of example, the length 34 may be dimensioned according to at least a portion of the tissue length 60 (shown in FIG. 8) of subcutaneous tissue 59 (shown in FIG. 8). Where protection of subcutaneous tissue 59 is desired, the length 34 is preferably dimensioned to be greater than or equal to the tissue length 60 of the subcutaneous tissue 59. As shown in FIG. 7, in embodiments that include the insulating material 31, the outer end 33 of the insulating material 31 on the shaft sections 29, 30 extends a distance 35 from the inner end 26 of the insertable portion 25. The distance 35 is dimensioned according to a depth of tissue or tissues desired to be protected from the application of energy. The distance 35 is preferably dimensioned to be greater than or equal to the depth of tissue or tissues desired to be protected from the application of energy. By way of example, the distance 35 may be dimensioned according to at least a portion of the tissue depth 52 of epidermal tissue 50 in a typical patient. Where protection of

epidermal tissue 50 is desired, the distance 35 is preferably dimensioned to be greater than or equal to the tissue depth 52 of the epidermal tissue 50. By way of example, the distance 35 may be dimensioned according to at least a portion of the tissue depth 55 of dermal tissue 53. Where protection of dermal tissue 53 is desired, the distance 35 is preferably dimensioned to be greater than or equal to the tissue depth 55 of the dermal tissue 53. By way of example, the distance 35 may be dimensioned according to at least a portion of the tissue depth 61 of subcutaneous tissue 59. Where protection of subcutaneous tissue 59 is desired, the distance 35 is preferably dimensioned to be greater than or equal to the tissue depth 61 of the subcutaneous tissue 59. In the presently preferred embodiment, the shaft 20 is provided with means for receiving energy. According to one aspect of the presently preferred embodiment, the means includes a portion of the shaft 20, such as, for example, and not limitation, a contact portion 36, that contacts a conductive element, such as, for example, and not limitation, conductive element 62, that receives energy from an energy source, such as, for example, and not limitation, energy source 100. It is preferred, but not required, that the means includes a portion of the shaft 20, such as, for example, and not limitation, the contact portion 36, that connects to a conductive element, such as, for example, and not limitation, conductive element 62, that receives energy from an energy source, such as, for example, and not limitation, energy source 100. Alternatively, the contact portion 36 may connect to another structure which connects to the conductive element 62, whereby the contact portion 36 contacts the conductive element 62.

As shown in FIG. 3, in the preferred embodiment an inner end 22 of the shaft 20 is provided with the contact portion 36 of conductive material. In the presently preferred embodiment, the contact portion 36 connects to a conducting element 62 that receives and delivers energy to the instrument 15. In the presently preferred embodiment, the conducting element 62 includes a hand piece 63. According to one aspect of the presently preferred embodiment, the hand piece 63 is shaped so that an operator may handle the instrument 15. According to another aspect of the presently preferred embodiment, the hand piece 63 is shaped to allow an operator to position the instrument 15. According to yet another aspect of the presently preferred embodiment, the hand piece 63 is shaped to allow an operator to operate the instrument 15. As shown, in the presently preferred embodiment, the hand piece 63 is connected to a wire

64 that receives energy from an energy source 100. The hand piece 63 preferably includes an insulating material that insulates the operator from exposure to the energy.

In the embodiments depicted, the contact portion 36 is threaded and screwed into the hand piece 63. In such an embodiment, the shaft 20 may include a stop 67 that contacts the hand piece 63 when the shaft 20 is fully secured to the hand piece 63.

Although in the presently preferred embodiment, the contact portion 36 is threaded and screwed into the hand piece 63it is within the scope of the present invention to connect the contact portion 36 to the conducting element 62 via other arrangements. By way of example, and not limitation, the contact portion 36 may connect to the conducting element 62 via a twist lock connection, such as, for example, via a twist lock connection to a hand piece 63.

The conducting element 62 or instrument 15 may be provided with an orientation indictor 66. As shown in FIG. 7, the orientation indicator 66 may be included on the hand piece 63; alternatively the orientation indicator 66 may be included on any portion of the instrument 15 that is not inserted into the tissue of a patient. According to one aspect of the presently preferred embodiment, the orientation indicator 66 allows an operator to orient the direction of the insertable portion 25 faces when the insertable portion 25 is inserted into the tissue of a patient. According to another aspect of the presently preferred embodiment, the orientation indicator 66 allows an operator to orient the direction of the insulating material 31 applied semi-circumferentially faces when the insertable portion 25 is inserted into the tissue of a patient. It is within the scope of the present invention for the orientation indicator 66 to be provided in any form, including, but not limited to, a mark, a sign, a symbol, an indentation, and/or a protrusion.

The wire 64 connects the instrument 15 to an energy source 100 such as, for example, and not limitation, a thermal energy source, an electrical energy source, an ultrasound energy source, an electro-magnetic energy source, or a radiofrequency energy source. As shown in FIG. 7, the wire 64 may include an adaptor 65. The adaptor 65 may connected to the energy source 100. The quantity of energy generated by the energy source 100 is preferably regulated by a controller (not shown), such as a footplate (not shown). The energy may be administered in pulses, pulsed cycles, or continuously. Accordingly, an operated may selectively supply a desired controlled amount of energy to the instrument 15.

As shown in FIGS. 6 and 8, the instrument 15 may be inserted perpendicularly or at various angles A, underneath specific wrinkles or other skin conditions of a patient. The instrument 15 may be left in place or moved in and out of the patient while treatment is occurring. The instrument 15 allows a controlled amount of energy to be directly and/or indirectly applied to various levels of tissue or tissues beneath the stratum corneum. The effect is to stimulate and activate the tissue and promote collagen contracture, such as, for example, thermal collagen contracture, and soft tissue denaturation, including adipose tissue. The treatment results in secondary collagen stimulation, production, deposition, realignment and eventual skin and soft tissue tightening. The treatment stimulates fibroblast activity, neocollagen production, collagen and soft tissue contraction, collagen deposition, collagen realignment, adipose dissolution, and subsequent wrinkle reduction and tissue tightening for aesthetic improvement of the patient's skin. The instruments 15 can be used to effect tissue and skin rejuvenation, tightening, reduction, and lifting in specific regions of the face, neck, and the body. In the preferred embodiment, while certain tissue or tissues receive energy, the insulating material 31 may be included on the second shaft section 30 to prevent or limit the direct application of energy to other tissue or tissues of the patient, which depending on the type of energy and amount of energy applied could damage such tissue or tissues. The instrument 15 is preferably, although not required to be, disposable and used for a single treatment on a patient.

While this invention has been particularly shown and described with references to various embodiments thereof, it will be understood by those skilled in the art that various changes in form and details may be made therein without departing from the spirit and scope of the invention as defined by the appended claims. For the purpose of teaching preferred principles, some conventional aspects have been simplified or omitted. Those skilled in the art will appreciate variations from these examples that fall within the scope of the invention. Those skilled in the art will appreciate that the features described above can be combined in various ways to form multiple variations of the invention. As a result, the invention is not limited to the specific examples described above, but only by the claims and their equivalents.