Skin treatment systems, devices and methods

Abstract

Systems, devices, and methods for performing a cosmetic procedure on a patient are provided herein. A system includes at least one treatment device. Each treatment device having a set of multiple treatment modules. Each treatment module having at least one coring element and at least one actuation assembly. Each actuation assembly being operably attached to at least one treatment module of the set of multiple treatment modules and performing a microcoring procedure that includes the attached treatment module translating in a series of reciprocating motions. Each reciprocating motion includes each coring element of the attached treatment module being inserted into and withdrawn from target tissue of a patient.

Description

[0001] INTERNATIONAL PCT PATENT APPLICATION

[0002] SKIN TREATMENT SYSTEMS, DEVICES, AND METHODS

[0003] Inventors:

[0004] Shiv Sabesan, a citizen of the United States of America, residing at: 110 Johnson Hollow, Los Gatos, CA 95030

[0005] Monica Salas, a citizen of the United States of America, residing at: 130 Franklin Street, Apt. 2, Malden, MA 02148

[0006] Jared Floyd, a citizen of the United States of America, residing at: 5448 Elder Road, Ferndale, WA 98248

[0007] Jill Edgecombe, a citizen of the United States of America, residing at: 486 Mount Paran Road NW, Atlanta, GA 30327

[0008] Ashish Bhatia, a citizen of the United States of America, residing at: 2496 Stonehenge Drive, Aurora, IL 60502

[0009] Joel Willick, a citizen of the United States of America, residing at: 90 Ocean Ave, Unit 514, Revere, MA 02151

[0010] Assignee: Cytrellis Biosystems, Inc.

[0011] 299C Washington Street

[0012] Woburn, MA 01801

[0013] Entity: Small

[0014] SKIN TREATMENT SYSTEMS, DEVICES, AND METHODS

[0015] DESCRIPTION

[0016] RELATED APPLICATIONS

[0017]

[0001] This application claims the benefit of United States Provisional Patent Application Serial Number 63 / 546,808 (Docket No.: CYT-015-PR1), titled "Skin Treatment Systems, Devices and Methods", filed November 1, 2023, the content of which is incorporated herein by reference in its entirety for all purposes.

[0018]

[0002] This application claims the benefit of United States Provisional Patent Application Serial Number 63 / 555,134 (Docket No.: CYT-015-PR2), titled "Skin Treatment Systems, Devices and Methods", filed February 19, 2024, the content of which is incorporated herein by reference in its entirety for all purposes.

[0019]

[0003] This application is related to United States Provisional Patent Application Serial Number 61 / 766,937 (Docket No.: CYT-001-PR), titled "Methods and Devices for Skin Tightening", filed February 20, 2013, the content of which is incorporated herein by reference in its entirety for all purposes.

[0020]

[0004] This application is related to International Patent Application Serial Number PCT / US2014 / 016483 (Docket No.: CYT-001-PCT), titled "Methods and Devices for Skin Tightening", filed February 14, 2014, Publication Number WO2014 / 130359, published August 28, 2014, the content of which is incorporated herein by reference in its entirety for all purposes.

[0021]

[0005] This application is related to United States Patent Application Serial Number 14 / 764,866 (Docket No.: CYT-001-US), titled "Methods and Devices for Skin Tightening", filed July 30, 2015, United States Patent No. 10,543,127, issued January 18, 2020, the content of which is incorporated herein by reference in its entirety for all purposes.

[0022]

[0006] This application is related to United States Patent Application Serial Number 15 / 905,421 (Docket No.: CYT-001-US-CON1), titled "Methods and Devices for Skin Tightening", filed February 26, 2018, United States Patent No. 10,251,792, issued April 9, 2019, the content of which is incorporated herein by reference in its entirety for all purposes.

[0007] This application is related to United States Patent Application Serial Number 16 / 707,122 (Docket No.: CYT-001-US-DIV), titled "Methods and Devices for Skin Tightening", filed December 9, 2019, United States Patent No. 11,534,344, issued December 27, 2022, the content of which is incorporated herein by reference in its entirety for all purposes.

[0023]

[0008] This application is related to United States Patent Application Serial Number 17 / 987,190 (Docket No.: CYT-001-US-DIV-CON1), titled Methods and Devices for Skin Tightening”, filed November 15, 2022, United States Patent No. 12,023,226, issued July 2, 2024, the content of which is incorporated herein by reference in its entirety for all purposes.

[0009] This application is related to United States Patent Application Serial Number 18 / 655,705 (Docket No.: CYT-001-US-DIV-CON2), titled Methods and Devices for Skin Tightening”, filed May 6, 2024, United States Publication Number > , published , the content of which is incorporated herein by reference in its entirety for all purposes.

[0024]

[0010] This application is related to United States Provisional Patent Application Serial Number 61 / 819,190 (Docket No.: CYT-002-PR), titled "Microclosures and Related Methods for Skin Treatment", filed May 3, 2013, the content of which is incorporated herein by reference in its entirety for all purposes.

[0025]

[0011] This application is related to International Application Serial Number PCT / US14 / 036638 (Docket No.: CYT-002-PCT), titled "Microclosures and Related Methods for Skin Treatment", filed May 2, 2014, Publication No. WO2014 / 0179729, published November 6, 2014, the content of which is incorporated herein by reference in its entirety for all purposes.

[0026]

[0012] This application is related to United States Patent Application Serial Number 14 / 786,328 (Docket No.: CYT-002-US), titled "Microclosures and Related Methods for Skin Treatment", filed October 22, 2015, United States Publication No. 2016 / 0095592, published April 7, 2016, the content of which is incorporated herein by reference in its entirety for all purposes.

[0027]

[0013] This application is related to United States Patent Application Serial Number 17 / 207,172 (Docket No.: CYT-002-US-CON), titled "Microclosures and Related Methods for Skin Treatment", filed March 19, 2021, United States Publication No. 2021 / 0322005, published October 21, 2021, the content of which is incorporated herein by reference in its entirety for all purposes.

[0028]

[0014] This application is related to United States Provisional Patent Application Serial Number 61 / 864,281 (Docket No.: CYT-003-PR), titled "Methods and Apparatuses for Skin Treatment using Non-Thermal Tissue Ablation", filed March August 9, 2013, the content of which is incorporated herein by reference in its entirety for all purposes.

[0029]

[0015] This application is related to International Application Serial Number

[0030] PCT / US 14 / 050426 (Docket No.: CYT-003-PCT), titled "Methods and Apparatuses for Skin Treatment using Non-Thermal Tissue Ablation", filed August 8, 2014, Publication No.

[0031] WO2015 / 021434, published February 12, 2015, the content of which is incorporated herein by reference in its entirety for all purposes.

[0032]

[0016] This application is related to United States Patent Application Serial Number 14 / 910,767 (Docket No.: CYT-003-US), titled “Methods and Apparatuses for Skin Treatment using Non-Thermal Tissue Ablation”, filed February 8, 2016, United States Patent No. 10,555,754, issued February 11, 2020, the content of which is incorporated herein by reference in its entirety for all purposes.

[0033]

[0017] This application is related to United States Patent Application Serial Number 16 / 722,069 (Docket No.: CYT-003-US-DIV), titled “Methods and Apparatuses for Skin Treatment using Non-Thermal Tissue Ablation”, filed December 20, 2019, United States Publication No. 2020 / 0121354, published April 23, 2020, the content of which is incorporated herein by reference in its entirety for all purposes.

[0034]

[0018] This application is related to United States Patent Application Serial Number 18 / 921,404 (Docket No.: CYT-003-US-DIV-CON), titled “Methods and Apparatuses for Skin Treatment using Non-Thermal Tissue Ablation”, filed October 21, 2024, United States Publication No. , published , the content of which is incorporated herein by reference in its entirety for all purposes.

[0035]

[0019] This application is related to United States Provisional Patent Application Serial Number 61 / 918,271 (Docket No.: CYT-004-PR), titled "Methods and Devices for Manipulating Subdermal Fat", filed March December 19, 2013, the content of which is incorporated herein by reference in its entirety for all purposes.

[0036]

[0020] This application is related to International Application Serial Number PCT / US 14 / 071443 (Docket No.: CYT-004-PCT), titled "Methods and Devices for Manipulating Subdermal Fat", filed December 19, 2014, Publication No. WO2015 / 095675, published June 25, 2015, the content of which is incorporated herein by reference in its entirety for all purposes.

[0037]

[0021] This application is related to United States Patent Application Serial Number 15 / 106,036 (Docket No.: CYT-004-US), titled "Methods and Devices for Manipulating Subdermal Fat", filed June 17, 2016, United States Patent No. 10,953,143, issued March 23, 2021, the content of which is incorporated herein by reference in its entirety for all purposes.

[0022] This application is related to United States Patent Application Serial Number 17 / 166,543 (Docket No.: CYT-004-US-DIV), titled "Methods and Devices for Manipulating Subdermal Fat", filed February 3, 2021, United States Publication No. 2021 / 0178028, published June 17, 2021, the content of which is incorporated herein by reference in its entirety for all purposes.

[0038]

[0023] This application is related to United States Provisional Patent Application Serial Number 62 / 079,822 (Docket No.: CYT-005-PR), titled "Devices and Methods for Ablation of the Skin", filed March November 14, 2014, the content of which is incorporated herein by reference in its entirety for all purposes.

[0039]

[0024] This application is related to International Application Serial Number PCT / US 15 / 060685 (Docket No.: CYT-005-PCT), titled "Devices and Methods for Ablation of the Skin", filed November 13, 2015, Publication No. WO2016 / 077759, published May 19, 2016, the content of which is incorporated herein by reference in its entirety for all purposes.

[0025] This application is related to United States Patent Application Serial Number 15 / 526,299 (Docket No.: CYT-005-US), titled "Devices and Methods for Ablation of the Skin", filed May 11, 2017, United States Patent No. 11,324,534, issued May 10, 2022, the content of which is incorporated herein by reference in its entirety for all purposes.

[0040]

[0026] This application is related to United States Patent Application Serial Number 17 / 709,542 (Docket No.: CYT-005-US-CON1), titled "Devices and Methods for Ablation of the Skin", filed March 31, 2022, United States Patent No. 11,896,261, issued February 13, 2024, the content of which is incorporated herein by reference in its entirety for all purposes.

[0027] This application is related to United States Patent Application Serial Number 18 / 405,315 (Docket No.: CYT-005-US-CON2), titled "Devices and Methods for Ablation of the Skin", filed January 5, 2024, United States Publication No. , published , the content of which is incorporated herein by reference in its entirety for all purposes.

[0041]

[0028] This application is related to United States Design Patent Application Serial Number 29 / 509,219 (Docket No.: CYT-006-DES), titled "Device and Device Body for Mechanical Fractional Ablation of the Skin", filed November 14, 2014, United States Design Patent No. D797286, issued September 12, 2017, the content of which is incorporated herein by reference in its entirety for all purposes.

[0042]

[0029] This application is related to United States Provisional Patent Application Serial Number 62 / 314,748 (Docket No.: CYT-007-PR), titled "Devices and Methods for Cosmetic Skin Resurfacing", filed March 29, 2016, the content of which is incorporated herein by reference in its entirety for all purposes.

[0043]

[0030] This application is related to International Application Serial Number PCT / US 17 / 024752 (Docket No.: CYT-007-PCT), titled "Devices and Methods for Cosmetic Skin Resurfacing", filed March 29, 2017, Publication No. W02017 / 0172920, published October 5, 2017, the content of which is incorporated herein by reference in its entirety for all purposes.

[0044]

[0031] This application is related to United States Patent Application Serial Number 16 / 090,034 (Docket No.: CYT-007-US), titled "Devices and Methods for Cosmetic Skin Resurfacing", filed September 28, 2018, United States Patent No. 11,166,743, issued November 9, 2021, the content of which is incorporated herein by reference in its entirety for all purposes.

[0045]

[0032] This application is related to United States Patent Application Serial Number 17 / 491,691 (Docket No.: CYT-007-US-CON1), titled “Devices and Methods for Cosmetic Skin Resurfacing”, filed October 1, 2021, United States Publication No. 2022-0125477, published April 28, 2022, the content of which is incorporated herein by reference in its entirety for all purposes.

[0046]

[0033] This application is related to United States Provisional Patent Application Serial Number 62 / 397,869 (Docket No.: CYT-008-PR), titled “Devices and Methods for Cosmetic Skin Resurfacing”, filed September 21, 2016, the content of which is incorporated herein by reference in its entirety for all purposes.

[0047]

[0034] This application is related to International Patent Application Serial Number PCT / US 17 / 052528 (Docket No.: CYT-008-PCT), titled “Devices and Methods for Cosmetic Skin Resurfacing”, filed September 20, 2017, Publication No. 2018 / 057630, published March 29, 2018, the content of which is incorporated herein by reference in its entirety for all purposes.

[0048]

[0035] This application is related to United States Patent Application Serial Number 16 / 335,028 (Docket No.: CYT-008-US), titled "Devices and Methods for Cosmetic Skin Resurfacing", filed March 20, 2019, United States Patent No. 11,464,954, issued October 11, 2022, the content of which is incorporated herein by reference in its entirety for all purposes.

[0036] This application is related to United States Patent Application Serial Number 17 / 902,028 (Docket No.: CYT-008-US-CON1), titled " Devices and Methods for Cosmetic Skin Resurfacing", filed September 2, 2022, United States Publication No. 2023 / 0210552, published July 6, 2023, the content of which is incorporated herein by reference in its entirety for all purposes.

[0049]

[0037] This application is related to United States Provisional Patent Application Serial Number 62 / 397,865 (Docket No.: CYT-009-PR), titled "Rapid Skin Treatment Using Microcoring", filed September 21, 2016, the content of which is incorporated herein by reference in its entirety for all purposes.

[0050]

[0038] This application is related to International Patent Application Serial Number PCT / US17 / 052539 (Docket No.: CYT-009-PCT), titled "Rapid Skin Treatment Using Microcoring", filed September 20, 2017, Publication No. 2018 / 057637, published March 29, 2018, the content of which is incorporated herein by reference in its entirety for all purposes.

[0039] This application is related to United States Patent Application Serial Number 15 / 711,943 (Docket No.: CYT-009-US), titled "Rapid Skin Treatment Using Microcoring", filed September 21, 2017, United States Publication No. 2018 / 0078278, published March 22, 2018, the content of which is incorporated herein by reference in its entirety for all purposes.

[0040] This application is related to United States Patent Application Serial Number 16 / 857,801 (Docket No.: CYT-009-US-CON1), titled "Rapid Skin Treatment Using Microcoring", filed April 24, 2020, United States Publication No. 2020 / 0246039, published August 6, 2020, the content of which is incorporated herein by reference in its entirety for all purposes.

[0051]

[0041] This application is related to United States Provisional Patent Application Serial Number 62 / 756,694 (Docket No.: CYT-010-PR), titled "Systems and Methods for Skin Treatment", filed November 7, 2018, the content of which is incorporated herein by reference in its entirety for all purposes.

[0052]

[0042] This application is related to International Patent Application Serial Number PCT / US 19 / 060131 (Docket No.: CYT-010-PCT), titled "Systems and Methods for Skin Treatment", filed November 6, 2019, Publication No. 2020 / 097244, published May 14, 2020, the content of which is incorporated herein by reference in its entirety for all purposes.

[0043] This application is related to United States Patent Application Serial Number 17 / 291,235 (Docket No.: CYT-010-US), titled "Systems and Methods for Skin Treatment", May 4, 2021, United States Publication No. 2021 / 0401453, published December 30, 2021, the content of which is incorporated herein by reference in its entirety for all purposes.

[0053]

[0044] This application is related to United States Provisional Patent Application Serial Number 63 / 190,904 (Docket No.: CYT-012-PR1), titled "Skin Treatment Systems and Methods", filed May 20, 2021, the content of which is incorporated herein by reference in its entirety for all purposes.

[0054]

[0045] This application is related to International Patent Application Serial Number PCT / US22 / 030236 (Docket No.: CYT-012-PCT), titled “Skin Treatment Systems and Methods”, filed May 20, 2022, Publication No. 2022 / 0246185, published November 24, 2022, the content of which is incorporated herein by reference in its entirety for all purposes.

[0046] This application is related to United States Patent Application Serial Number 18 / 560,784 (Docket No.: CYT-012-US), titled "Systems and Methods for Skin Treatment", November 14, 2023, United States Publication No. 2024 / 0252200, published August 1, 2024, the content of which is incorporated herein by reference in its entirety for all purposes.

[0055]

[0047] This application is related to United States Provisional Patent Application Serial Number 63 / 248,562 (Docket No.: CYT-013-PR1), titled “Skin Treatment Systems, Devices and Methods”, filed September 27, 2021, the content of which is incorporated herein by reference in its entirety for all purposes.

[0056] This application is related to International Patent Application Serial Number PCT / US22 / 044862 (Docket No.: CYT-013-PCT), titled “Skin Treatment Systems and Methods”, filed September 27, 2022, Publication No. 2023 / 0049500, published June 8, 2023, the content of which is incorporated herein by reference in its entirety for all purposes.

[0048] This application is related to United States Patent Application Serial Number 18 / 695,869 (Docket No.: CYT-013-US), titled "Systems and Methods for Skin Treatment", filed March 27, 2024, United States Publication No. , published , the content of which is incorporated herein by reference in its entirety for all purposes.

[0057]

[0049] This application is related to United States Provisional Patent Application Serial Number 63 / 604,378 (Docket No.: CYT-014-PR1), titled "Skin Treatment Systems, Devices and Methods", filed November 30, 2023, the content of which is incorporated herein by reference in its entirety for all purposes.

[0058]

[0050] This application is related to United States Provisional Patent Application Serial Number 63 / 666,978 (Docket No.: CYT-016-PR1), titled "Skin Treatment Systems, Devices and Methods", filed July 2, 2024, the content of which is incorporated herein by reference in its entirety for all purposes.

[0059] TECHNICAL FIELD

[0060]

[0051] The embodiments disclosed herein relate generally to systems, devices, and methods for treatment of biological tissues.

[0061] BACKGROUND

[0062]

[0052] Many human health and other issues arise from damage, deterioration, or loss of tissue due to disease, advanced age, and / or injury. These issues can manifest themselves in a variety of alterations of tissue structure and / or function, including scarring, sclerosis, tightness, and laxity. In aesthetic medicine, elimination of excess tissue and / or skin laxity is an important concern that affects more than 25% of the U.S. population.

[0063] BRIEF SUMMARY

[0064]

[0053] There is a need for improved systems and methods that provide increased effectiveness over currently available techniques while maintaining convenience, affordability, and accessibility to individuals desiring tissue restoration.

[0065]

[0054] According to an aspect of the present inventive concepts, a system for performing a cosmetic procedure on a patient comprises: at least one treatment device, each treatment device comprising: a set of multiple treatment modules, each treatment module comprising at least one coring element; and at least one actuation assembly, each actuation assembly configured to operably attach at least one treatment module of the set of multiple treatment modules and configured to perform a microcoring procedure comprising the attached treatment module translating in a series of reciprocating motions, each reciprocating motion comprising each coring element of the attached treatment module being inserted into and withdrawn from target tissue of a patient.

[0055] In some embodiments, the system is configured to cause an increase in collagen (e.g., new collagen, immature collagen, and / or other collagen) in tissue within and / or otherwise proximate the target tissue. The system can be configured to cause an increase in collagen production of at least 5%, and / or at least 10%.

[0066]

[0056] In some embodiments, the system is configured to cause an increase in a collagen gene expression within and / or otherwise proximate the target tissue. The increase in the collagen gene expression can be an increase of at least 10%, at least 20%, or at least 30%.

[0057] In some embodiments, the system is configured to cool the target tissue and / or tissue proximate the target tissue prior to the insertion of each coring element into the target tissue. The tissue cooled can comprise a surface area of no more than 6cm2, 4cm2, 2cm2 or lcm2. The system can cool the tissue via a cooling spray and / or another skin surface treatment applied to target tissue and / or tissue proximate the target tissue.

[0067]

[0058] In some embodiments, the system is configured to perform microdermabrasion of the target tissue and / or tissue proximate the target tissue. The microdermabrasion can be configured to lower the insertion force of the at least one coring element into tissue. The microdermabrasion can be configured to reduce tenting that occurs during the insertion of the at least one coring element into tissue.

[0068]

[0059] In some embodiments, each coring element of the at least one coring element comprises a lumen including a distal portion with a first diameter and a proximal portion with a second diameter, and the second diameter is larger than the first diameter.

[0069]

[0060] In some embodiments, each coring element of the at least one coring element comprises a lumen with a diameter of at least 0.6mm or at least 0.75mm. Each coring element can comprise a gauge of no more than 18, 19, or 20.

[0070]

[0061] In some embodiments, each coring element of the at least one coring element comprises an insertion length of no more than 6.5mm or 6.0mm. Each coring element of the at least one coring element can comprise a tip with a bevel comprising two or more bevel portions, and each bevel portion can comprise a different bevel angle. Each bevel angle can comprise an angle of at least 1°, 5°, 10°, 15°, 20°, 25°, 30°, 35°, 40°, and / or 45°. Each bevel angle can comprise an angle of no more than 45°, 40°, 35°, 30°, 25°, 20°, 15°, 10°, 5°, or 1°. Each bevel angle can comprise an angle of at least 13° and no more than 17°. Each coring element can comprise a Franseen tip including three bevels.

[0071]

[0062] In some embodiments, each coring element of the at least one coring element comprises a Coumand tip. The tip can comprise an approximately 30° bevel. The tip can comprise an edge grind with a grind angle of approximately 15°.

[0063] In some embodiments, each coring element of the at least one coring element comprises a tip with an asymmetric bevel.

[0072]

[0064] In some embodiments, each coring element of the at least one coring element comprises a tip with a single, smooth cutting edge. The cutting edge can be sharpened to the inner diameter of the coring element.

[0073]

[0065] In some embodiments, each coring element of the at least one coring element comprises a barb comprising a laser-cut portion of the wall of the coring element. The barb can extend at least 0.05mm or 0.10mm into a lumen of the coring element.

[0074]

[0066] In some embodiments, each coring element of the at least one coring element comprises a coating. The coating can comprise a titanium nitride coating. The coring element can comprise a tip, and the coating can be configured to increase the hardness of at least the tip of the coring element.

[0075]

[0067] In some embodiments, the at least one coring element comprises a first set of coring elements configured for use in a first skin type and a second set of coring elements configured for use in a second skin type that is different than the first skin type. The first skin type and the second skin type can each comprise a skin type selected from the group consisting of: tissue of the medial cheek; tissue above boney areas, such as tissue of the jaw, chin, or cheekbone; tissue of the lower eyelids; tissue of the nasolabial fold; tissue of the neck and / or submentum; striae tissue; perioral tissue; soft tissue of the body that can be not part of the face; crepey tissue of the body that can be not tissue of the face; scar tissue; tattooed tissue; and combinations thereof.

[0076]

[0068] In some embodiments, the articulation assembly is further configured to vibrate one or more components of the attached treatment module. The system can be configured to vibrate the at least one coring element during insertion of the least one coring element into the target tissue, such as to reduce insertion force and / or reduce tenting of the skin.

[0077]

[0069] In some embodiments, the at least one treatment device further comprises a first housing, and each treatment module further comprises a second housing and a hub assembly. The second housing can be configured to operably attach to the first housing, and the hub assembly can be configured to operably attach to the at least one articulation assembly. Each coring element can be configured to articulate relative to the housing, and the hub assembly can comprise an array of coring elements that comprises the at least one coring element. The second housing can comprise a spacer assembly configured to be positioned on the skin of the patient and to position the hub assembly for the cosmetic procedure. The spacer assembly can comprise a frame including one or more walls surrounding a chamber, and the chamber can be configured to operably attach to a source of vacuum and to secure tissue to the spacer via vacuum applied by the source of vacuum. The spacer assembly can further comprise a gasket configured to provide a vacuum seal between the skin and the chamber. The chamber can comprise two or more chambers, and each chamber can be configured to be independently attached to the source of vacuum. The chamber can surround the hub assembly, and the chamber can be configured to transition to a fluid-tight chamber when the frame is vacuum sealed to the skin of the patient, and the hub assembly can be configured to translate within the fluid-tight chamber. The system can further comprise a guard configured to provide a physical stop that limits the skin penetration depth of the at least one coring elements. The guard can be removably attached to the hub assembly.

[0078]

[0070] The technology described herein, along with the attributes and attendant advantages thereof, will best be appreciated and understood in view of the following detailed description taken in conjunction with the accompanying drawings in which representative embodiments are described by way of example.

[0079] INCORPORATION BY REFERENCE

[0080]

[0071] All publications, patents, and patent applications mentioned in this specification are herein incorporated by reference to the same extent as if each individual publication, patent, or patent application was specifically and individually indicated to be incorporated by reference.

[0081] BRIEF DESCRIPTION OF THE DRAWINGS

[0082]

[0072] Fig. 1 illustrates a block diagram of a system for treating and / or diagnosing tissue, consistent with the present inventive concepts.

[0083]

[0073] Fig. 2 illustrates a side view of a coring element being introduced into the skin, consistent with the present inventive concepts.

[0084]

[0074] Fig. 3A, Fig. 3B, Fig. 3C, and Fig. 3D illustrate end, side, and sectional views of a needle, respectively, consistent with the present inventive concepts.

[0085]

[0075] Fig. 4 illustrates a block diagram of a system for treating and / or diagnosing tissue, consistent with the present inventive concepts.

[0086]

[0076] Figs. 5A-C illustrate side and perspective views of various embodiments of coring devices, consistent with the present inventive concepts.

[0077] Figs. 6 through 9E illustrate side and sectional views of coring elements with various tip geometries, consistent with the present inventive concepts.

[0087]

[0078] Figs. 10A-D illustrate side and sectional views of the distal portion of various coring elements, consistent with the present inventive concepts.

[0088]

[0079] Figs. 11A-F illustrate side views of various embodiments of a coring element, consistent with the present inventive concepts.

[0089]

[0080] Figs. 12A-C illustrate sectional views of various embodiments of a coring element comprising varying inner diameters, consistent with the present inventive concepts.

[0090]

[0081] Figs. 13A-30D illustrate images of human tissue samples from subjects of a study performed by the applicant, consistent with the present inventive concepts.

[0091]

[0082] Figs. 31A-B and 32A-B illustrate before and after photographs of subjects of a study performed by the applicant, consistent with the present inventive concepts.

[0092]

[0083] Fig. 33 illustrates a method of performing a tissue treatment procedure including a microcoring procedure, consistent with the present inventive concepts.

[0093]

[0084] Figs. 34 and 35 illustrate a side view of a treatment device with a portion of a housing removed and a perspective view of a portion of a treatment device and a treatment assembly, consistent with the present inventive concepts.

[0094]

[0085] Figs. 36 - 39A illustrate perspective views of a treatment assembly and various embodiments of needle guards, consistent with the present inventive concepts.

[0095]

[0086] Figs. 40 and 40A-F illustrate various perspective and sectional views of a spacer assembly including a gasket, consistent with the present inventive concepts.

[0096]

[0087] Fig. 41 is a photograph illustrating a perspective view of a treatment assembly including a spacer assembly, consistent with the present inventive concepts.

[0097]

[0088] Figs. 42A and 42B illustrate perspective views of two embodiments of a spacer assembly including a dual vacuum chamber, consistent with the present inventive concepts.

[0098]

[0089] Figs. 43A-C illustrate a perspective view of the distal portion of a treatment assembly including multiple vacuum chambers, and a two-step process of skin presentation for microcoring, respectively, consistent with the present inventive concepts.

[0099]

[0090] Figs. 44A and 44B illustrate perspective views of two embodiments of a treatment assembly including a treatment chamber, consistent with the present inventive concepts.

[0100]

[0091] Figs. 45A-D illustrate sectional views of various embodiments of a treatment assembly including a treatment chamber, consistent with the present inventive concepts.

[0092] Figs. 46 and 46A-C illustrate a perspective view, top view, side view, and end view of a release mechanism, respectively, consistent with the present inventive concepts.

[0093] Figs. 47A through 47F illustrate an end, a side, a top, a sectional view, a magnified side view and a magnified sectional view of an embodiment of a coring element, respectively, consistent with the present inventive concepts.

[0101]

[0094] Figs. 48A and 48B illustrate perspective and side views of an embodiment of a coring element, respectively, consistent with the present inventive concepts.

[0102] DETAILED DESCRIPTION OF THE DRAWINGS

[0103]

[0095] Reference will now be made in detail to the present embodiments of the systems, devices, and methods (singly or collectively “technology” or “technologies” herein), examples of which are illustrated in the accompanying drawings. Similar reference numbers may be used to refer to similar components. However, the description is not intended to limit the present disclosure to particular embodiments, and it should be construed as including various modifications, equivalents, and / or alternatives of the embodiments described herein.

[0096] It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable sub-combination. For example, it will be appreciated that all features set out in any of the claims (whether independent or dependent) can be combined in any given way.

[0104]

[0097] It is to be understood that at least some of the figures and descriptions of the invention have been simplified to focus on elements that are relevant for a clear understanding of the invention, while eliminating, for purposes of clarity, other elements that those of ordinary skill in the art will appreciate may also comprise a portion of the invention. However, because such elements are well known in the art, and because they do not necessarily facilitate a better understanding of the invention, a description of such elements is not provided herein.

[0105]

[0098] Terms defined in the present disclosure are only used for describing specific embodiments of the present disclosure and are not intended to limit the scope of the present disclosure. Terms provided in singular forms are intended to include plural forms as well, unless the context clearly indicates otherwise. All of the terms used herein, including technical or scientific terms, have the same meanings as those generally understood by an ordinary person skilled in the related art, unless otherwise defined herein. Terms defined in a generally used dictionary should be interpreted as having meanings that are the same as or similar to the contextual meanings of the relevant technology and should not be interpreted as having ideal or exaggerated meanings, unless expressly so defined herein. In some cases, terms defined in the present disclosure should not be interpreted to exclude the embodiments of the present disclosure.

[0106]

[0099] It will be understood that the words "comprising" (and any form of comprising, such as "comprise" and "comprises"), "having" (and any form of having, such as "have" and "has"), "including" (and any form of including, such as "includes" and "include") and / or "containing" (and any form of containing, such as "contains" and "contain") when used herein, specify the presence of stated features, integers, steps, operations, elements, and / or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and / or groups thereof.

[0107]

[0100] It will be further understood that, although the terms first, second, third, etc. may be used herein to describe various limitations, elements, components, regions, layers and / or sections, these limitations, elements, components, regions, layers and / or sections should not be limited by these terms. These terms are only used to distinguish one limitation, element, component, region, layer or section from another limitation, element, component, region, layer or section. Thus, a first limitation, element, component, region, layer or section discussed below could be termed a second limitation, element, component, region, layer or section without departing from the teachings of the present application.

[0108]

[0101] It will be further understood that when an element is referred to as being "on", "attached", "connected" or "coupled" to another element, it can be directly on or above, or connected or coupled to, the other element, or one or more intervening elements can be present. In contrast, when an element is referred to as being "directly on", "directly attached", "directly connected" or "directly coupled" to another element, there are no intervening elements present. Other words used to describe the relationship between elements should be interpreted in a like fashion (e.g., "between" versus "directly between," "adjacent" versus "directly adjacent," etc.).

[0109]

[0102] It will be further understood that when a first element is referred to as being "in", "on" and / or "within" a second element, the first element can be positioned: within an internal space of the second element, within a portion of the second element (e.g., within a wall of the second element); positioned on an external and / or internal surface of the second element; and combinations of two or more of these.

[0103] As used herein, the term “proximate”, when used to describe proximity of a first component or location to a second component or location, is to be taken to include one or more locations near to the second component or location, as well as locations in, on and / or within the second component or location. For example, a component positioned proximate an anatomical site (e.g., a target tissue location), shall include components positioned near to the anatomical site, as well as components positioned in, on and / or within the anatomical site.

[0110]

[0104] Spatially relative terms, such as "beneath," "below," "lower," "above," "upper" and the like may be used to describe an element and / or feature's relationship to another element(s) and / or feature(s) as, for example, illustrated in the figures. It will be further understood that the spatially relative terms are intended to encompass different orientations of the device in use and / or operation in addition to the orientation depicted in the figures. For example, if the device in a figure is turned over, elements described as "below" and / or "beneath" other elements or features would then be oriented "above" the other elements or features. The device can be otherwise oriented (e.g., rotated 90 degrees or at other orientations) and the spatially relative descriptors used herein interpreted accordingly.

[0111]

[0105] The terms “reduce”, “reducing”, “reduction” and the like, where used herein, are to include a reduction in a quantity, including a reduction to zero. Reducing the likelihood of an occurrence shall include prevention of the occurrence. Correspondingly, the terms “prevent”, “preventing”, “prevention” and the like, where used herein, shall include the acts of “reduce”, “reducing”, and “reduction”, respectively.

[0112]

[0106] The term "and / or" where used herein is to be taken as specific disclosure of each of the two specified features or components with or without the other. For example "A and / or B" is to be taken as specific disclosure of each of (i) A, (ii) B and (iii) A and B, just as if each is set out individually herein.

[0113]

[0107] The term “one or more”, where used herein can mean one, two, three, four, five, six, seven, eight, nine, ten, or more, up to any number.

[0114]

[0108] The terms “and combinations thereof’ and “and combinations of these” can each be used herein after a list of items that are to be included singly or collectively. For example, a component, process, and / or other item selected from the group consisting of: A; B; C; and combinations thereof, shall include a set of one or more components that comprise: one, two, three or more of item A; one, two, three or more of item B; and / or one, two, three, or more of item C.

[0115]

[0109] In this specification, unless explicitly stated otherwise, “and” can mean “or”, and

[0116] “or” can mean “and”. For example, if a feature is described as having A, B, or C, the feature can have A, B, and C, or any combination of A, B, and C. Similarly, if a feature is described as having A, B, and C, the feature can have only one or two of A, B, or C.

[0117]

[0110] The expression “configured (or set) to” used in the present disclosure may be used interchangeably with, for example, the expressions “suitable for”, “having the capacity to”, “designed to”, “adapted to”, “made to” and “capable of’ according to a situation. The expression “configured (or set) to” does not mean only “specifically designed to” in hardware. Alternatively, in some situations, the expression “a device configured to” may mean that the device “can” operate together with another device or component.

[0118] [H l] As used herein, the term “threshold” refers to a maximum level, a minimum level, and / or range of values correlating to a desired or undesired state. In some embodiments, a system parameter is maintained above a minimum threshold, below a maximum threshold, within a threshold range of values, and / or outside a threshold range of values, such as to cause a desired effect (e.g., efficacious therapy) and / or to prevent or otherwise reduce (hereinafter “prevent”) an undesired event (e.g., a device and / or procedural adverse event). In some embodiments, a system parameter is maintained above a first threshold (e.g., above a first temperature threshold to cause a desired therapeutic effect to tissue) and below a second threshold (e.g., below a second temperature threshold to prevent undesired tissue damage). In some embodiments, a threshold value is determined to include a safety margin, such as to account for patient variability, system variability, tolerances, and the like. As used herein, “exceeding a threshold” relates to a parameter going above a maximum threshold, below a minimum threshold, within a range of threshold values and / or outside of a range of threshold values.

[0119]

[0112] As described herein, “room pressure” shall mean pressure of the environment surrounding the systems and devices of the present inventive concepts. “Positive pressure” includes pressure above room pressure or simply a pressure that is greater than another pressure, such as a positive differential pressure across a fluid pathway component such as a valve. “Negative pressure” includes pressure below room pressure or a pressure that is less than another pressure, such as a negative differential pressure across a fluid component pathway such as a valve. Negative pressure can include a vacuum but does not imply a pressure below a vacuum. As used herein, the term “vacuum” can be used to refer to a full or partial vacuum, or any negative pressure as described hereinabove.

[0120]

[0113] The term “diameter” where used herein to describe a non-circular geometry is to be taken as the diameter of a hypothetical circle approximating the geometry being described. For example, when describing a cross section, such as the cross section of a component, the term “diameter” shall be taken to represent the diameter of a hypothetical circle with the same cross-sectional area as the cross section of the component being described.

[0121]

[0114] The terms “major axis” and “minor axis” of a component where used herein are the length and diameter, respectively, of the smallest volume hypothetical cylinder which can completely surround the component.

[0122]

[0115] As used herein, the term “fluid” can refer to a liquid, gas, gel, or any flowable material, such as a material which can be propelled through a lumen and / or opening.

[0123]

[0116] As used herein, the term “material” can refer to a single material, or a combination of two, three, four, or more materials.

[0124]

[0117] As used herein, the term “conduit” or “conduits” can refer to an elongate component that can include one or more flexible and / or non-flexible filaments selected from the group consisting of: one, two or more wires or other electrical conductors (e.g., including an outer insulator); one, two or more wave guides; one, two or more hollow tubes, such as hydraulic, pneumatic, and / or other fluid delivery tubes; one or more optical fibers; one, two or more control cables and / or other mechanical linkages; one, two or more flex circuits; and combinations of these. A conduit can include a tube including multiple conduits positioned within the tube. A conduit can be configured to electrically, fluidically, sonically, optically, mechanically, and / or otherwise operably connect one component to another component.

[0125]

[0118] As used herein, the term “transducer” is to be taken to include any component or combination of components that receives energy or any input and produces an output. For example, a transducer can include an electrode that receives electrical energy and distributes the electrical energy to tissue (e.g., based on the size of the electrode). In some configurations, a transducer converts an electrical signal into any output, such as: light (e.g., a transducer comprising a light emitting diode or light bulb); sound (e.g., a transducer comprising one or more piezoelectric and / or CMUT transducers configured to deliver and / or receive ultrasound energy); pressure (e.g., an applied pressure or force); heat energy; cryogenic energy; chemical energy; mechanical energy (e.g., a transducer comprising a motor or a solenoid); magnetic energy; and / or a different electrical signal (e.g., different than the input signal to the transducer). Alternatively or additionally, a transducer can convert a physical quantity (e.g., variations in a physical quantity) into an electrical signal. A transducer can include any component that delivers energy and / or an agent to tissue, such as a transducer configured to deliver one or more of: heat energy to tissue; cryogenic energy to tissue; electrical energy to tissue (e.g., a transducer comprising one or more electrodes); light energy to tissue (e.g., a transducer comprising a laser, light emitting diode and / or optical component such as a lens or prism); mechanical energy to tissue (e.g., a transducer comprising a tissue manipulating element); sound energy to tissue (e.g., a transducer comprising one or more piezoelectric and / or CMUT transducers); chemical energy; electromagnetic energy; magnetic energy; and combinations of two or more of these. Alternatively or additionally, a transducer can comprise a mechanism, such as: a valve; a grasping element; an anchoring mechanism; an electrically-activated mechanism; a mechanically-activated mechanism; and / or a thermally activated mechanism.

[0126]

[0119] As used herein, the term “functional element” is to be taken to include one or more elements constructed and arranged to perform a function. A functional element can comprise one or more sensors and / or one or more transducers. In some embodiments, a functional element is configured to deliver energy to tissue, such as to treat and / or image tissue. In some embodiments, a functional element comprises one or more hollow filaments (e.g., one or more needles) that are configured to be inserted into tissue and / or withdrawn from tissue, such as to perform a microcoring treatment as described herein. In some embodiments, a functional element (e.g., comprising one or more sensors) can be configured to record one or more parameters, such as a patient physiologic parameter; a patient anatomical parameter (e.g., a tissue parameter); a patient environment parameter; and / or a system parameter (e.g., temperature and / or pressure within the system). In some embodiments, a sensor or other functional element is configured to perform a diagnostic function (e.g., to gather data used to perform a diagnosis). In some embodiments, a functional element is configured to perform a therapeutic function (e.g., perform a microcoring procedure, deliver therapeutic energy, and / or deliver a therapeutic agent). In some embodiments, a functional element comprises one or more elements constructed and arranged to perform a function selected from the group consisting of: core and / or remove tissue; deliver energy; extract energy (e.g., to cool a component); deliver a drug or other agent; manipulate a system component or patient tissue; record or otherwise sense a parameter such as a patient physiologic parameter or a patient anatomical parameter; and combinations of two or more of these. A “functional assembly” can comprise an assembly constructed and arranged to perform a function, such as are described hereinabove. In some embodiments, a functional assembly is configured to core tissue and / or otherwise treat tissue (e.g., a functional assembly configured as a treatment assembly or treatment module). Alternatively or additionally, a functional assembly can be configured as a diagnostic assembly that records one or more parameters, such as a patient physiologic parameter; a patient anatomical parameter; a patient environment parameter; and / or a system parameter. A functional assembly can comprise a deployable assembly, such as a robotically controlled assembly. A functional assembly can comprise one or more functional elements.

[0127]

[0120] As used herein, the term “agent” shall include but not be limited to one or more agents selected from the group consisting of: an agent configured to improve and / or maintain the health of a patient; a drug (e.g., a pharmaceutical drug); a hormone; a protein; a protein derivative; a small molecule; an antibody; an antibody derivative; an excipient; a reagent; a buffer; a vitamin; a nutraceutical; and combinations of these.

[0128]

[0121] As used herein, the term “target tissue” comprises one or more volumes of tissue of a patient to be diagnosed and / or treated, such as a treatment comprising a microcoring procedure as described herein. Similarly, a “treatment target” or “tissue target” comprises one or more volumes of tissue to be diagnosed and / or treated. “Safety margin tissue” comprises tissue whose treatment (e.g., receiving of a microcoring treatment) yields no significant adverse effect to the patient. “Non-target tissue” comprises tissue that is not intended to receive treatment (e.g., not intended to receive a microcoring treatment).

[0129]

[0122] As used herein, the term “system parameter” comprises one or more parameters of the system of the present inventive concepts. A system parameter can comprise one or more “tissue treatment parameters” (also referred to as “tissue treatment settings”), such as one, two or more tissue treatment parameters selected from the group consisting of: a “microcoring parameter” (also referred to as a “coring parameter” herein), such as a reciprocating motion parameter as described herein; a target level of a patient parameter such as a patient diagnostic parameter and / or a patient environment parameter as described herein; a tissue-type parameter; a tissue target area parameter; a tissue anatomical location area parameter; and combinations of these. Microcoring parameters include but are not limited to: depth of penetration of a coring element; duration and / or speed of penetration of a coring element such as rise time of speed of penetration of a coring element; penetration dwell time (also referred to as “hold time”); duration and / or speed of withdrawal of a coring element; time between penetrations; density of coring (also referred to as “microcoring density”); spacing between coring elements; coring diameter; location of penetration; coring suction force; skin suction force (e.g., vacuum pressure and contact area); vacuum “pinch” time (e.g., time to release skin suction); vacuum regeneration time (e.g., as dictated by tubing and / or filter volume and controlled leaks in the system); frequency of coring; inner diameter surface friction of coring element; and combinations of these. A system parameter can comprise a parameter selected from the group consisting of: a tissue treatment parameter; a microcoring parameter; an energy delivery parameter; a pressure level; a temperature level; an energy level; a power level; a frequency level; an amplitude level; a battery level; a threshold level for an alarm or other alert condition; and combinations of these. A system parameter can include one or more tissue targets identified to be treated (e.g., areas of skin tissue to be treated), such as tissue targets identified for treatment by an operator and / or by an algorithm of the system.

[0130]

[0123] As used herein, the term “patient parameter” comprises one or more parameters associated with the patient. A patient parameter can comprise a patient physiologic parameter, such as a physiologic parameter selected from the group consisting of: temperature (e.g., tissue temperature); pressure such as blood pressure or other body fluid pressure; pH; a blood gas parameter; blood glucose level; hormone level; heart rate; respiration rate; and combinations of these. Alternatively or additionally, a patient parameter can comprise a patient environment parameter, such as an environment parameter selected from the group consisting of: patient geographic location; temperature; pressure; humidity level; light level; time of day; and combinations of these.

[0131]

[0124] As used herein, the term “image data” comprises data created by one or more imaging devices. Image data can include data related to target tissue, safety margin tissue, and non-target tissue. Image data can also include data related to any implants or other nontissue objects that are proximate tissue being imaged. Image data can be processed by one or more algorithms of the present inventive concepts, such as to determine one or more locations to treat (e.g., target tissue identified to be ablated or otherwise receive microcoring or other treatment), and / or to determine one or more locations to which treatment (e.g., microcoring) is to be avoided (e.g., non-target tissue). Image data can comprise data produced by a single imaging component, or from multiple imaging components.

[0132]

[0125] As used herein, the term “transmitting a signal” and its derivatives shall refer to the transmission of power and / or data between two or more components, in any direction, such as via wired or wireless connections.

[0133]

[0126] As used herein, the term “patient use data” shall refer to data related to use of the tissue treatment systems of the present inventive concepts on a patient (e.g., use of the system in a diagnostic and / or therapeutic procedure performed on a patient). The data can include but is not limited to: operating parameters such as tissue treatment parameters; target tissue parameters such as location of target tissue and / or amount of target tissue to be treated; patient parameters such as patient physiologic parameters and / or patient location or other patient environment parameters; operator parameters; site parameters; and combinations of these. Patient use data can include data from multiple patients, such as data collected from multiple patients that interface with (e.g., receive a treatment from) one or more systems of the present inventive concepts. In some embodiments, an algorithm of the present inventive concepts uses patient use data from one or more patients to determine a system parameter to be used in performing a skin treatment procedure on a patient.

[0134]

[0127] As used herein, the term “critical structure” shall refer to a particular structure to which a treatment (e.g., a particular microcoring procedure) should be avoided.

[0135]

[0128] As used herein, the term “microcoring treatment plan” or simply a “treatment plan” shall refer to a set of treatment variables (e.g., reciprocating motion parameters and / or other microcoring parameters) and / or a set of treatment locations (e.g., microcoring treatment locations) that can be created to define a future microcoring treatment to be performed. In some embodiments, a system of the present inventive concepts produces one, two, or more microcoring treatment plans based on various data (e.g., patient data) recorded by the system, and / or data input into the system (e.g., by an operator of system 10).

[0136]

[0129] The systems, devices, and methods of the present inventive concepts can be configured for treating skin (e.g., eliminating tissue volume, tightening skin, lifting skin, reducing skin laxity, and / or otherwise providing a cosmetic effect), such as by selectively excising a plurality of microcores of patient tissue. In some embodiments, the tissue is treated without thermal energy being imparted to surrounding (e.g., non-excised) tissue. These systems, devices, and methods satisfy an unmet need for rapid and safe treatment of skin (“skin” or “skin tissue” herein), including, for example, faster pretreatment preparation and post-treatment healing times as compared to current surgical and thermal treatment methods.

[0137]

[0130] In general, the term “microcoring,” as used herein, refers to technologies that utilize one or more (in some embodiments, a plurality, e.g., an array) hollow needles, or other non-thermal treatment elements (e.g., blades, tubes, and / or drills) that remove and / or otherwise treat tissue of a patient. These treatment elements can be of sufficiently small dimension (e.g., comprise a sufficiently small diameter) to minimize the extent of bleeding and / or clotting within holes or slits, and / or to minimize scar formation, when used to excise (e.g., and optionally sequester) tissue from a site. In some embodiments, excising a tissue means forming a tissue portion (e.g., a “microcore”), such as by inserting a hollow needle into the site so that the tissue portion is formed inside the hollow needle and severed from surrounding tissue, whereby a microcore that is separated (e.g., physically separated) from other tissue is generated.

[0131] In some embodiments, microcoring elements, assemblies, and / or other components as described herein may include a component configured to perform sequestration of the excised tissue. As used herein, the term “sequestering”, when used in reference to tissue, means excising a microcore and then removing the excised microcore from the excision site. In certain embodiments, sequestered tissue may be permanently disposed. In certain embodiments, sequestered tissue may be used for diagnostic purpose, such as when used for biopsy and / or histology analyses, such as those known in the art. In some embodiments, technologies provided herein maximize removal and / or minimize risk of (partial or complete) re-insertion of extracted tissue.

[0138]

[0132] It should be understood that particular microcoring technologies using hollow needles specifically described herein serve for exemplary and / or illustrative purposes, and that other techniques and devices can be used to create microcores. Microcoring technologies described herein may include a number of advantageous features. For example, provided technologies may enable visualization of results in real time during the course of the treatment, such as through feedback (e.g., patient and / or operator feedback) and subsequent treatment adjustment in real time.

[0139]

[0133] Alternatively or additionally, the systems and devices of the present inventive concepts that are used for microcoring can include micro-sized features that may be beneficial for controlling extent of skin treatment and / or minimize adverse effects of the skin treatment.

[0140]

[0134] Still further, in some embodiments, technologies described herein may require less skill than that of a surgeon. Thus, in certain embodiments, a patient may be treated by a nonphysician professional and / or in an outpatient setting, rather than in an inpatient, surgical setting. In some embodiments, a patient may be treated at a spa, at a cosmetic salon, or at home. That is, the technologies of the present inventive concepts are amenable to and / or permit consistent and / or reproducible administration of skin treatment procedures in a variety of treatment settings, and with a broad range of clinicians, technicians and / or other operators (“operators” herein) performing the procedures.

[0141]

[0135] In some embodiments, the technologies described herein may have generally a lower risk profile and / or the technologies can provide more predictable results and / or risk factors than those for more invasive techniques (e.g., plastic surgery) or energy-based techniques (e.g., laser, radiofrequency (RF), or ultrasound), which may or may not be invasive.

[0136] In some embodiments, non-thermal fractional excision technologies described herein allow skin tightening, skin lifting, and / or reduction of skin laxity without (or with significant reduction of) one or more common side effects of thermal treatment methods (e.g., thermal ablation and / or other treatment methods that increase and / or otherwise modify the temperature of tissue in order to provide a treatment to that tissue). Thermal ablation techniques prevent and / or inhibit skin tightening by allowing coagulation of tissue and formation of rigid tissue cores that cannot be compressed. Thermal ablation techniques create a three-dimensional heat-affected zone (HAZ) surrounding an immediate treatment site. While fractional ablative lasers may be used on or near heat-sensitive sites (e.g., eyes, nerves), for example when the laser does not penetrate more than 1 mm into the skin (resulting in a comparatively small HAZ), other thermal ablation techniques (e.g., ultrasoundbased techniques and radiofrequency -based techniques) cannot be used in the vicinity of heatsensitive sites because the HAZ may extend to heat sensitive tissues potentially causing undesired damage (e.g., permanent undesired damage). As will be appreciated by those skilled in the art, a “heat-sensitive site” is a site where exposure to radiation and / or elevated temperature is associated with a relatively high risk of unacceptable cosmetic and / or physiologic outcomes. In any event, technologies of the present inventive concepts described herein have generally a lower risk profile than, for example, thermal methods, at least in part due to a zone of tissue injury that is smaller than the zone of injury (e.g., the HAZ) of thermal methods.

[0142]

[0137] In some embodiments, advantages of certain technologies described herein include a therapeutic benefit selected from the group consisting of: a particularly low (e.g., lesser than that observed with other techniques such as invasive techniques and / or thermal techniques) degree of erythema; faster resolution of erythema; lower percent incidence, severity, and / or term of skin discoloration (hyperpigmentation or hypopigmentation); low swelling and / or inflammation (e.g., as compared, with that observed with laser treatment and / or with ultrasound-based treatment); and combinations of these.

[0143]

[0138] In some embodiments, the technologies provided herein can allow for rapid closing of holes and / or slits after excising tissue (e.g., within a few seconds after treating skin, such as within ten seconds), thereby minimizing extent of bleeding and / or clotting within holes and / or slits, and / or minimizing the extent of scar formation.

[0144]

[0139] In some embodiments, the technologies provided herein may be useful for maximizing treatment effect while minimizing treatment time, such as by using rapid-fire reciprocating needles or needle arrays, and / or by using large needle arrays that allow for simultaneous excision of tens, hundreds, or even thousands of microcores.

[0145]

[0140] In some embodiments, the technologies described herein may be useful for maximizing tightening effect while minimizing healing time and / or minimizing the time in which a cosmetic effect occurs, such as by optimizing tightening (e.g., by controlling the extent of skin pleating, such as by increasing the extent of skin pleating for some applications or skin regions and / or by decreasing the extent of skin pleating for other applications or skin regions, as described herein).

[0146]

[0141] In some embodiments, the technologies described herein may provide efficient clearance of sequestered and / or partially ablated tissue, and / or provide efficient clearance of debris from ablated tissue portions, thus reducing time for healing and / or improving the skin tightening treatment (e.g., relative to laser-based and / or other thermal technologies).

[0147]

[0142] In some embodiments, the technologies described herein may be configured to allow for efficient and effective positioning of skin prior to, during, and / or after tissue excision (e.g., excision including tissue sequestration). Positioning the skin can be critical to control skin-tightening direction, and it can ensure treatment occurs in the desired location and desired dimensions (e.g., thickness, width in a preferred direction, such as along or orthogonal to Langer lines).

[0148]

[0143] Among other things, the systems, devices, and methods of the present inventive concepts can include microcoring technologies that are configured to achieve desirable (e.g., reduced) procedure times and / or can significantly improve one or more aspects of healing from a tissue treatment procedure (e.g., a tissue removal procedure), such as when compared to thermal methods.

[0149]

[0144] Described herein are technologies, methods, and / or devices for treating skin, such as by selectively microcoring skin tissue. In particular, described herein are hollow needles or other hollow filaments (“needles” herein), as well as related systems (e.g., including kits), devices, and methods, capable of microcoring tissue portions by capturing and retaining the tissue portions inside a lumen of one or more hollow needles after insertion into and withdrawal from the skin. Microcored tissue portions can be removed from a lumen of a hollow needle and discarded. The process can be repeated to generate multiple microcored (also referred to as “cored” herein) skin tissue portions, in particular over a desired area of skin and located at chosen sites of the body of a patient. The hollow needles, kits, devices, methods, and other technologies described herein may provide increased effectiveness over currently available apparatuses and techniques while maintaining convenience, affordability, and accessibility to patients desiring tissue restoration.

[0150]

[0145] In some embodiments, technologies described herein include a treatment device, such as a handheld treatment device. An example treatment device may include a treatment module (e.g., a needle hub) comprising at least one hollow needle configured to remove a portion of the skin tissue (e.g., a microcore) when the hollow needle is inserted into and withdrawn from the skin tissue. In some embodiments, a treatment device may include an activation assembly (e.g., a translation and / or actuation assembly) connected to the treatment module, such as to translate (e.g., along one, two, and / or three axes) and / or actuate the treatment module in one or more directions relative to a surface of the skin tissue. In some embodiments, a treatment device may include a spacer to stabilize and / or maintain a constant position of the treatment device relative to the surface of the patient’s skin tissue. In some embodiments, a treatment device may include a hand piece including a hand piece shell, such as a housing that at least partially encases the activation assembly. In some embodiments, a hand piece and / or hand piece shell may include or may be connected to a spacer, such as a connection at a distal end of a treatment device (e.g., an end of a treatment device for contacting skin).

[0151]

[0146] Referring now to Fig. 1, a schematic view of a tissue treatment system is illustrated, consistent with the present inventive concepts. System 10 can be configured to perform a skin treatment procedure on a mammalian subject (also referred to as “patient” or “individual” herein). A skin treatment procedure performed using system 10 can include the performance of one or more procedures, such as one or more diagnostic procedures and / or one or more treatment procedures (e g., a tissue treatment procedure) performed on a mammalian subject. In some embodiments, system 10 is used by a clinician or other operator (“clinician” or “operator” herein) to perform one, two or more procedures, that are performed within a single day or over multiple days. System 10 can be configured to diagnose and / or treat one or more conditions of the subject to be treated (e.g., skin conditions, cosmetic issues, and / or other conditions of the subject to be treated). System 10 can be configured to treat and / or diagnose one or more portions (e.g., volumes) of patient tissue, “target tissue” herein. In some embodiments, system 10 comprises one, two or more devices that are configured to treat target tissue, such as to improve cosmesis of the patient (e.g., via microcoring as described herein). In some embodiments, system 10 is of similar construction and arrangement, and can include similar components, to the systems described in applicant’s co-pending United States Patent Application Serial Number 17 / 291,235, titled "Systems and Methods for Skin Treatment", May 4, 2021.

[0152]

[0147] System 10 can include one or more devices that are configured to gather various forms of patient information, patient data PD or data PD herein. For example, system 10 can include one or more devices or other components configured to collect patient data PD comprising patient diagnostic data, diagnostic data DD or data DD herein. Diagnostic data DD can comprise data related to a physiologic parameter of the patient, data related to the anatomy of the patient, data related to the environment of the patient (e.g., the current environment of the patient), and / or other patient-related data. Alternatively or additionally system 10 can include one or more devices or other components configured to collect patient use data (e.g., as defined herein). Alternatively or additionally, system 10 can include one or more devices or other components configured to collect patient data PD comprising patient image data, image data ID, which can comprise image data of tissue and / or one or more objects proximate tissue. Patient data PD can include data that is used in determining (e.g., by system 10 and / or an operator of system 10) a diagnosis and / or prognosis (either or both, “diagnosis” herein) for the patient. Alternatively or additionally, patient data PD can include patient data that is used in a tissue treatment procedure (e.g., by system 10 and / or an operator of system 10), such as to guide or otherwise affect a microcoring and / or other treatment performed on the patient. Image data ID can include image data related to: target tissue; safety margin tissue; non-target tissue; an implanted diagnostic and / or a treatment device; a foreign body (e.g., a splinter, tattoo, and the like); and combinations of these. System 10 can be configured to produce image data ID through the delivery of energy, such as X-ray energy, sound energy (e.g., ultrasound energy), and / or light energy that is delivered and whose reflections and / or other transmissions are collected in order to produce image data ID. In some embodiments, image data ID comprises data related to tissue comprising blood, such as when image data ID comprises blood flow data (e.g., as obtained using Doppler ultrasound).

[0153]

[0148] As used herein, a “tissue diagnostic procedure”, a “tissue diagnostic”, and their derivatives include but are not limited to: collection of diagnostic data DD; collection of image data ID (e.g., when system 10 records reflections and / or other transmissions of delivered X-ray, ultrasound, light, and / or other energy, and converts these recordings into image data ID); delivery of energy to tissue to characterize the tissue (e.g., when system 10 records one or more effects on the tissue due to the energy delivery, such as using spectroscopy); and / or recording of one or more tissue properties using one or more sensors and / or imaging devices of system 10. A tissue diagnostic procedure can also include a procedure in which various patient parameters are collected, such as patient environment parameters and / or a patient physiologic parameter, for example as described herein.

[0154]

[0149] As used herein, a “tissue treatment procedure”, a “tissue treatment”, and their derivatives include but are not limited to: microcoring of tissue; removal of tissue; ablation of tissue; causing the necrosis of tissue; reducing the volume of tissue (e.g., debulking tissue); stimulating tissue; improving the strength of tissue (e.g., muscle tissue); manipulating and / or otherwise applying a force to tissue; stiffening tissue; and / or otherwise providing a cosmetic enhancement and / or other therapeutic effect to tissue.

[0155]

[0150] System 10 includes treatment device 100 which can comprise one, two or more treatment devices that are configured to perform a treatment procedure on a patient (e.g., a microcoring or other tissue treatment procedure). Treatment device 100 can be configured to treat target tissue (e.g., perform a microcoring of target tissue). Alternatively or additionally, treatment device 100 can be configured to diagnose target tissue (e.g., gather diagnostic data DD and / or image data ID). Treatment device 100 can include one or more modules, treatment module 150 shown, each of which can be configured to perform a patient treatment (e.g., a microcoring treatment). Treatment module 150 can comprise one, two, three or more filaments for coring tissue, coring elements 155 shown. Treatment device 100 can include actuation assembly 120 shown, which can comprise one, two or more assemblies configured to interface with treatment module 150, such as is described herein. Treatment device 100 can include spacer assembly 180 shown, which can comprise one or more assemblies that are constructed and arranged to be positioned between a corresponding one or more treatment modules 150 and tissue.

[0156]

[0151] System 10 can include console 500 shown, which can comprise one, two or more discrete devices, where each of which can operably attach to one, two or more treatment devices 100, simultaneously and / or sequentially. Console 500 can include a connector, connector 505 as shown, which can be configured to operably attach (e.g., electrically, mechanically, fluidly, optically, sonically, and / or otherwise operably attach) to treatment device 100, such as via cable 103 of treatment device 100. Console 500 can be configured to allow an operator to control one or more treatment devices, such as via user interface 510 shown. Console 500 can comprise various assemblies and other components, as described herein, which singly or in combination are configured to provide to treatment device 100 one or more of: energy; mechanical, hydraulic, and / or pneumatic linkages; an agent (e.g., agent 60 described hereinbelow); and / or control signals. Console 500 can be configured to receive data from treatment device 100. In some embodiments, all or a portion of a console 500 is integrated into a treatment device 100 (e.g., the treatment device 100 is a relatively standalone device). Console 500, and / or another component of system 10, can comprise one or more algorithms, algorithm 25 shown. In some embodiments, treatment device 100 and / or another component of system 10 comprises all or a portion of algorithm 25.

[0157]

[0152] Algorithm 25 can analyze various information related to: microcoring procedures performed using system 10 (e.g., using treatment device 100); information uploaded into system 10; information obtained from healthcare records (e.g., electronic healthcare records) of a hospital, clinician’s office, and / or other clinical setting; information obtained from network 80 (e.g., the Internet); and / or combinations of these. In some embodiments, algorithm 25 is configured to determine one or more microcoring parameters for a particular patient, and the information analyzed by algorithm 25 to determine these parameters comprises data selected from the group consisting of: patient image data ID; patient skin type data; patient age data; patient body mass index data; patient lifestyle data; patient medical history data (e.g. data related to infections encountered by the patient); and combinations of these.

[0158]

[0153] In some embodiments, algorithm 25 is configured to be adjusted, such as by a clinician, such as to adjust an algorithm 25 configured to determine one or more microcoring parameters and / or one or more parameters associated with post-microcoring care.

[0159]

[0154] System 10 can include imaging device 50 shown, which can comprise one, two or more imaging devices. Imaging device 50 can be configured to collect image data ID. In some embodiments, imaging device 50 comprises one, two or more imaging devices selected from the group consisting of: a fluoroscope or other X-ray imaging device; an ultrasound imager; a CT scanner; an MRI; an OCT imaging device; a camera such as a visual light camera and / or an infrared camera; and combinations of these. Imaging device 50 can comprise a device configured to characterize and / or otherwise collect data related to one or more properties of tissue, such as a device (e.g., an ultrasound-based device) configured to measure elasticity of tissue and / or other tissue property (e.g., with or without collecting an image of the tissue). In some embodiments, image data ID provided by imaging device 50 can be used to determine a target area to treat with system 10, and / or a non-target area to which treatment should be avoided. For example, algorithm 25 can be configured to analyze image data ID and provide feedback (e.g., suggestions and / or requirements) for particular tissue areas to be classified as target areas and / or non-target areas. In some embodiments, algorithm 25 is configured to identify one or more implants or other objects present under the patient’s skin, to which treatment should be adjusted (e.g., avoided), such as an under-the- skin object comprising: an implant (e.g., implant 70 described hereinbelow) such as a cosmetic implant; a splinter; and / or tattoo ink. In these embodiments, algorithm 25 can be configured to identify a periphery of the under-the-skin object, such as to define a non -target zone including at least the area within the periphery (e.g., and also including a safety margin outside of the periphery).

[0160]

[0155] System 10 can include agent 60 shown, which can comprise one or more pharmaceuticals and / or other agents that can be delivered to the patient. Agent 60 can comprise an agent that is applied topically and / or an agent that is delivered systemically (e.g., orally). Agent 60 can comprise one, two, or more agents selected from the group consisting of hyaluronic acid; a moisturizer; an analgesic; a peptide; platelet rich plasma (PRP); arnica montana extract; a vasoconstrictor; methotrexate; minoxidil; stem cells; botulinum toxin; a corticosteroid; and combinations of these. Agent 60 can comprise an agent that is applied topically, and or inserted into the patient, such as into the dermis of the patient, such as when deposited in or otherwise proximate one or more target areas to be treated (e.g., premicrocoring), during treatment (e.g., when deposited via coring elements 155 or otherwise), and / or after treatment (e.g., after microcoring). In some embodiments, a functional element 99 (e.g., as described hereinbelow) comprises a delivery device configured to deliver agent 60, such as a syringe, needle, transdermal patch, microfluidic pump, and / or other delivery device configured to deliver agent 60 to the surface of the skin and / or to an internal location (e.g., into the dermis).

[0161]

[0156] In some embodiments, agent 60 comprises one or more binding agents, such as one or more organic compounds that are configured to bind to one or more tissue proteins, such as collagen. In these embodiments, agent 60 can comprise one or more bonding agents that are applied intradermally (e.g., via coring element 155 or otherwise) and / or topically, such as to improve collagen production and / or provide another cosmesis-improving effect. This application can be performed prior to microcoring, during microcoring, and / or after microcoring. In some embodiments, agent 60 comprises one or more xanthene compounds, such as Rose Bengal. Agent 60 can comprise a light-activated compound, such as a compound that is activated by light with a wavelength between 450nm and 600nm (e.g., green light). In some embodiments, functional element 99 and / or 199 comprise a light delivery element configured to deliver light (e.g. light with a wavelength between 450nm and 600nm) to activate an agent 60 comprising a light-activated compound. In some embodiments, a mechanism for protein-protein cross-linking is initiated by light absorption by molecules present in agent 60, which are promoted to excited high energy states. When sufficient oxygen is present, this energy is transferred to oxygen, generating singlet oxygen. These singlet oxygen molecules can then react with certain amino acids present in collagen, which can then initiate covalent bonds between protein molecules and promote cross-linking. Cross-linking of these protein molecules can increase the elastic modulus of skin. In some embodiments, this process (“photo-bonding”) can achieve wound closure (e.g., closure of wounds caused by a microcoring procedure) with short duration light-exposure times, for example less than five minutes, such as less than four minutes, three minutes, two minutes, or one minute.

[0162]

[0157] System 10 can include implant 70 shown, which can comprise one or more implants which can be implanted in the patient such as to improve cosmesis of the patient, and / or to treat a disease and / or disorder of the patient. In some embodiments, a treatment performed by system 10 includes the implantation of one or more implants 70, such as to further improve cosmesis of the patient. In some embodiments, a treatment performed by system 10 is adjusted due to the presence of an existing implant (e.g., implant 70), and / or due to a future implantation of an implant (e.g., implant 70).

[0163]

[0158] System 10 can include tissue collection assembly 600 shown (also referred to as “TCA 600” herein), which can comprise one or more assemblies configured to collect tissue which has been removed from the patient by treatment module 150. TCA 600 can comprise one or more containers for storing collected tissue. TCA 600 can comprise a vacuum pump and / or other low-pressure source, LPS 650 shown, such as to create a pressure differential which causes tissue extracted by treatment device 100 to be drawn into TCA 600.

[0164]

[0159] System 10 can include one or more functional elements, such as functional element 199 of treatment device 100, and / or functional element 599 of console 500, and / or functional element 99, each as shown. Functional elements 99, 199, and / or 599 can comprise one or more sensors and / or transducers, and / or an assembly that includes one or more sensors and / or transducers. Functional element 99, 199, and / or 599 can comprise a component (e.g., a sensor, or an assembly including a sensor) that is configured to collect patient data PD, such as diagnostic data DD and / or image data ID as described herein. In some embodiments, functional element 199 comprises at least one sensor, sensor 199a shown. In some embodiments, functional element 599 comprises at least one sensor, sensor 599a shown.

[0165]

[0160] Functional elements 99, 199, and / or 599 can comprise one, two or more sensors configured to collect diagnostic data DD of a patient, and / or image data ID of a patient.

[0161] Functional elements 99, 199, and / or 599 can comprise a sensor (e.g., sensor 199a and / or 599a) that is configured to produce a signal related to tissue being captured in a coring element 155. In some embodiments, lack of detection of tissue being captured in a coring element 155 results in system 10 automatically adjusting one or more microcoring parameters (e.g., depth of penetration of element 155, velocity of element 155 advancement and / or retraction, and / or acceleration of element 155 advancement or retraction). In some embodiments, detection of tissue being captured in a coring element 155 is used to determine (e.g., automatically determine) a minimum depth of penetration of element 155.

[0166]

[0162] Functional element 99, 199, and / or 599 can comprise a wireless element, such as a wireless transmitter that can send and / or receive power and / or data wirelessly. In some embodiments, a functional element 99, 199, and / or 599 comprises a sensor and / or a transducer that receives power wirelessly, and / or transmits signals (e.g., recorded sensor signals) wirelessly.

[0167]

[0163] Functional element 99, 199, and / or 599 can comprise one or more sensors selected from the group consisting of accelerometer; gravity-based sensor; strain gauge; acoustic sensor (e.g., a microphone or other acoustic sensor); electromagnetic sensor (e.g., a hall effect sensor); pressure sensor; vibration sensor; temperature sensor; vacuum sensor; GPS sensor; pH sensor; optical sensor; and combinations of these.

[0168]

[0164] Functional elements 99, 199, and / or 599 can comprise a patient “physiologic sensor” comprising one, two or more sensors configured to measure a patient physiologic parameter such as: body temperature; heart rate; blood pressure; respiration rate; perspiration rate; blood gas level; blood glucose level; brain and / or other neural activity such as measured by electroencephalogram (EEG), local field potential (LFP), and / or neuronal firing (e.g., single neuron firing activity); eye motion; EKG; and combinations of these.

[0169]

[0165] Functional elements 99, 199, and / or 599 can comprise a patient “environment sensor” comprising one, two or more sensors configured to measure a patient “environment parameter” such as: room temperature; room humidity; room pressure; room light level; room ambient noise level; room barometric pressure; and combinations of these.

[0170]

[0166] In some embodiments, functional elements 99, 199, and / or 599 comprise one or more sensors configured to measure a system 10 parameter, such as a system parameter selected from the group consisting of: temperature of at least a portion of a system 10 component; pressure and / or strain of a system 10 component; speed and / or acceleration of a system 10 component (e.g., speed and / or acceleration of a coring element 155 and / or other portion of treatment device 100); position and / or geometry of a system 10 component (e.g., position and / or geometry of a coring element 155 and / or other portion of treatment device 100); energy level; power level; and combinations of these.

[0171]

[0167] In some embodiments, system 10 is configured to operate in a closed loop mode, in which one or more parameters of treatment device 100 are adjusted based on one or more recorded parameters, such as system parameters, patient physiologic parameters, and / or patient environment parameters, each as described herein. For example, algorithm 25 can analyze (e.g., continuously and / or intermittently analyze) one or more signals provided by a functional element 99, 199, and / or 599, and adjust the treatment performed by system 10 based on the analysis.

[0172]

[0168] In some embodiments, functional elements 99, 199, and / or 599 comprise one or more transducers selected from the group consisting of: cooling element such as a Peltier element; heating element such as a Peltier element or a heat pump; vibrational transducer; light-producing element; a magnetic field-generating element; vacuum-generating element; and combinations of these.

[0173]

[0169] In some embodiments, functional elements 99, 199, and / or 599 comprise an assembly or other component configured to provide a vacuum to another component of system 10. For example, functional elements 99, 199, and / or 599 can comprise a tissueengaging port configured to receive a vacuum (e.g., from console 500) and to stabilize tissue, capture tissue (e.g., draw tissue toward the port) and / or otherwise engage tissue, when the vacuum is applied to the port. Functional elements 99, 199, and / or 599 can comprise a source of vacuum, such as vacuum that can be applied to such a tissue-engaging port.

[0174]

[0170] In some embodiments, functional elements 99, 199, and / or 599 comprise an adhesive, and / or an adhesive dispensing component, such as when an adhesive is used to temporarily (e.g., less than 1 day) and / or chronically (e.g., at least 1 week, 1 month, or 3 months) attach a component of system 10 to tissue of the patient, and / or to another component of system 10.

[0175]

[0171] In some embodiments, functional elements 99, 199, and / or 599 comprise a cooling fluid or cooling component (e.g., a thermoelectric cooling element) and / or an assembly configured to provide cooling (e.g., provide cooling to a system 10 component). In some embodiments, system 10 is configured to provide cooling to tissue and / or to a system 10 component during delivery of a tissue treatment and / or diagnosis, such as to avoid damage to non-target tissue and / or to avoid degradation of a system 10 component. Alternatively or additionally, system 10 can comprise a functional element comprising an assembly configured to provide a cooling fluid (e.g., in a recirculating arrangement) to another system 10 component.

[0176]

[0172] In some embodiments, functional elements 99, 199, and / or 599 comprise an assembly or other component configured to apply a force to tissue (e.g., a grasping component configured to place tissue in tension, and / or a pushing element configured to provide a compressive force to tissue), such as to apply a force (e.g., a tensioning and / or compressing force) to tissue (e.g., target tissue) while a microcoring procedure is being performed on target tissue by another component of system 10.

[0177]

[0173] Functional element 99, 199, and / or 599 can comprise an assembly configured to deliver agent 60 to the patient, as described herein. In some embodiments, agent 60 is delivered to the patient via one or more coring elements 155, where functional element 99, 199, and / or 599 comprises a pump or other fluid propulsion assembly that propels agent 60 through one or more conduits (e.g., fluid delivery tubes) such that agent 60 can be delivered into the patient (e.g., into the dermis of the patient) by one or more (e.g., all) coring elements 155 during a microcoring or other procedure performed via injection of elements 155 into the patient.

[0178]

[0174] Functional element 99 can comprise a cell phone, laptop, tablet, camera, and / or other operator-maintained device. In some embodiments, data collected during a treatment procedure performed by system 10 is provided by, stored, and / or analyzed by one of these devices.

[0179]

[0175] Functional element 99 can comprise a patient diagnostic device, such as a device configured to gather patient data PD (e.g., diagnostic data DD and / or image data ID).

[0180]

[0176] Treatment device 100 comprises various components such as conduits 101, nozzles 102, cable 103, and housing 110. These components can be of similar construction and arrangement to the similar components described in applicant’s co-pending United States Patent Application Serial Number 17 / 291,235, titled "Systems and Methods for Skin Treatment", May 4, 2021.

[0181]

[0177] Coring elements 155 can comprise one, two or more hollow filaments, such as coring element 155 described herein in reference to Figs. 3A-D. Each coring element 155 can comprise an elongate shaft (e.g., a hollow shaft), shaft 1551 shown, which can include a distal end. Each coring element 155 can comprise one or more projections, prong 1552 shown, that extend from the distal end of shaft 1551.

[0182]

[0178] Spacer assembly 180 can comprise a housing and other components that are configured to properly position treatment module 150 relative to the patient’s skin being treated. Spacer assembly 180 can include one or more sensors, sensor 181 shown, which can be configured to detect proper engagement of spacer assembly 180 with the patient (e.g., proper pressure level detected). In some embodiments, sensor 181 comprises a sensor configured to produce a signal that is used to determine the proximity and / or the orientation of a portion of spacer assembly 180 (e.g., a portion of device 100) relative to tissue of a target tissue location. For example, sensor 181 can comprise two or more sensors, such as an orientation sensor (e.g., an accelerometer) and a tissue proximity sensor (e.g., a contact sensor). In some embodiments, a portion of spacer assembly 180 can include two, three, or more sensors 181, such as three sensors 181 comprising three different contact sensors that are positioned on a distal surface of spacer assembly 180. Signals recorded from three sensors 181 can be analyzed to determine if a tissue surface is co-planar with a portion of spacer assembly 180 (e.g., co-planar with the plane of the three sensors 181).

[0183]

[0179] Actuation assembly 120 can be configured to interface with treatment module 150 by performing a function selected from the group consisting of control the motion of a treatment module 150 (e.g., translate treatment module 150 along one, two, or three axes); activate one or more components of treatment module 150 (e.g., advance and / or retract one or more coring elements 155 into and / or from tissue); rotate one or more components of treatment module 150 (e.g., rotate one or more coring elements 155 prior to, during, and / or after their insertion into tissue); vibrate one or more components of treatment module 150; and combinations of these. In some embodiments, actuation assembly 120 is configured to vibrate coring element 155 during insertion of the coring element into the target tissue, such as to reduce insertion force and / or reduce tenting of the skin. Actuation assembly 120 comprises actuator 121 shown. Actuator 121 and other components of actuation assembly 120 can be of similar construction and arrangement as the similar components described in applicant’s co-pending United States Patent Application Serial Number 17 / 291,235, titled "Systems and Methods for Skin Treatment", May 4, 2021.

[0184]

[0180] Console 500 can comprise user interface 510 as shown, which can comprise one or more user input and / or user output components, such as one, two or more components selected from the group consisting of display; touch screen display; button; switch; foot switch; lever; membrane keypad; mousejoystick; microphone; speaker; vibrational and / or other haptic transducer; light such as a light emitting diode; and combinations of these. Console 500 can comprise controller 520 as shown, which can include: one or more central processing units (CPUs), microprocessors and / or other microcontrollers, processor 521 shown; memory 522 shown (e.g., volatile or non-volatile memory); instructions 523 shown; signal processing and other electronic circuitry; oscillator circuitry such as voltage-controlled oscillator (VCO) circuitry; analog to digital circuitry; digital to analog circuitry; and / or other componentry configured to control or otherwise interface with one or more components of system 10. Controller 520 can comprise a power supply and / or energy storage component (e.g., a battery, a capacitor, and / or a power supply converted to receive “wall power” and convert it to an AC or DC voltage for use by system 10). Console 500 can further comprise drive module 550, and vacuum assembly 560, each as shown. Console 500 and its various components can be of similar construction and arrangement to those described in applicant’s co-pending United States Patent Application Serial Number 17 / 291,235, titled "Systems and Methods for Skin Treatment", May 4, 2021.

[0185]

[0181] System 10 can include one or more accessory components, accessories 90 shown. Accessories 90 can include one or more accessory components, such as those described in reference to Fig. 4 herein.

[0186]

[0182] As described hereinabove, the term “microcoring treatment plan” or simply “treatment plan” can refer to a set of treatment variables (e.g., reciprocating motion parameters and / or other microcoring parameters) and / or a set of treatment locations (e.g., microcoring treatment locations) that can be created to define a future microcoring treatment to be performed. A “microcoring treatment plan” or a “treatment plan” can comprise a set of parameters that are used in treating target tissue of the patient using system 10. A treatment plan can include a set of treatment settings, such as one, two or more microcoring parameters (e.g., reciprocating motion parameters, target tissue parameters, patient parameters, and / or other microcoring parameters). A treatment plan can include a set of different skin treatment or other procedures (e.g., one, two or more microcoring procedures and / or other treatment procedures). A treatment plan can include a desired and / or recommended order for performing a set of multiple skin treatment or other procedures (e.g., where the treatment plan provides multiple procedures to be performed in a particular order, where in some instances sufficient efficacy is achieved when a subset of the procedures is performed). In some embodiments, system 10 is configured to automatically and / or semi-automatically (“automatically” herein) generate a treatment plan (e.g., one or more treatment plans made available to an operator of system 10). System 10 can generate a treatment plan using an algorithm, such as algorithm 25 described herein. A treatment plan can be developed by algorithm 25 using at least image data ID, such as by using image data ID comprising: ultrasound-based image data (e.g., Doppler data and / or other image data produced using ultrasound); CT-based image data; MRI-based image data; and / or X-ray-based image data (e.g., fluoroscopic data and / or other image data produced using X-ray). Alternatively or additionally, algorithm 25 can develop a proposed treatment plan based on parameters selected from the group consisting of: patient age; patient race; patient gender; patient skin type; patient skin condition; volume of target tissue to be treated; cellulite and / or fat content of target tissue; geometry of target tissue; tissue type, geometry and / or other characteristic of non-target tissue proximate the target tissue; and combinations of these. In some embodiments, a treatment plan includes a methodology to ensure treatment of target tissue, while avoiding damage to neighboring non-target tissue. In some embodiments, system 10 (e.g., via algorithm 25) is configured to produce a prediction of outcome (e.g., an estimation of likelihood of efficacy and / or an assessment of any risks) associated with one or more treatment plans.

[0187]

[0183] As described herein, system 10 can comprise one or more algorithms, algorithm 25 shown. Algorithm 25 can comprise one or more algorithms that are performed by a processor (e.g., a processor of a system component, such as processor 521 of controller 520). The processor can perform algorithm 25 using instructions (e.g., instructions 523 of controller 520 and / or instructions of another component of system 10), such as instructions that are stored in memory of that component (e.g., instructions 523 that are stored in memory 522 of controller 520). All or a portion of algorithm 25 can be integrated into one, two or more of various components of system 10, such as server 20, console 500, treatment device 100, imaging device 50, TCA 600, and / or functional element 99. Algorithm 25 can comprise one or more machine learning, neural network, and / or other artificial intelligence algorithms (“Al algorithm” herein).

[0188]

[0184] Algorithm 25 (e.g., an Al algorithm) can be configured to determine and / or modify one or more microcoring parameters, such as to effectively treat target tissue (e.g., improve cosmesis of the patient) and / or avoid damage to non-target tissue. For example, algorithm 25 can be configured to determine a volume of target tissue to be treated (e.g., treated with a microcoring procedure), such as to effectively enhance cosmesis of the patient and / or otherwise provide a therapeutic benefit to the patient, while avoiding or at least minimizing damage to non-target tissue. In these embodiments, algorithm 25 can be further configured to determine and / or modify one or more microcoring parameters (e.g., at least based on the determined volume), such as to effectively treat the target tissue volume determined, while avoiding damage to non-target tissue, as described hereinabove.

[0189]

[0185] Algorithm 25 can be configured to perform a “microcoring analysis” comprising using an analysis of one or more types of information by algorithm 25 to assess the level of microcoring (e.g., the current level of microcoring) of target tissue. The results of this analysis can be used by system 10 to perform microcoring in a closed loop mode. Microcoring data produced in the microcoring analysis can be stored as image data ID (e.g., and correlated with one or more tissue locations). In some embodiments, system 10 (e.g., treatment device 100 and / or imaging device 50) delivers and / or receives energy (e.g., light energy and / or ultrasound energy or other imaging-capable energy) to and / or from tissue, and algorithm 25 performs a microcoring analysis based on the delivered and / or received energy.

[0190]

[0186] Algorithm 25 can be configured to adjust tissue treatment parameters (e.g., microcoring parameters) based on sensor signals, such as when sensor 199a provides feedback to algorithm 25 regarding a microcoring procedure.

[0191]

[0187] In some embodiments, algorithm 25 is configured to perform an analysis on patient data PD (e.g., patient use data from a single patient, or a group of patients upon which system 10 has performed a treatment procedure), such as to modify a future treatment provided by system 10.

[0192]

[0188] In some embodiments, algorithm 25 is configured to provide a treatment plan, such as when algorithm 25 performs analysis on patient data PD comprising data collected during treatment of the patient with system 10 in a previous treatment procedure, and / or based on patient data PD collected from use of system 10 on multiple patients (e.g., a large number of patients treated with system 10).

[0193]

[0189] System 10 can include network 80 as shown, which can comprise one or more computer networks such as the Internet, a local area network, cellular network, and / or other data sharing, storage, and / or transmitting platform. In some embodiments, patient data PD, and / or other data collected during the use of system 10 is transmitted from one location to another location over network 80. In some embodiments, one or more central data storage areas are used to store the data, such as when an algorithm 25 analyzes the data to provide a treatment plan and / or provide system 10 parameters for a future treatment of one or more patients.

[0194]

[0190] Treatment device 100 and / or another component of system 10 can be configured to perform a treatment (e.g., a microcoring treatment) in a “closed loop” mode (i.e. a closed loop mode of microcoring and / or other closed loop mode of operation), such as when one or more sensors of system 10 (e.g., a sensor-based functional element 99, 199, and / or 599), provide patient and / or system information that is used to continuously and / or intermittently adjust the treatment being delivered by treatment device 100 (e.g., adjust the microcoring parameters and / or other parameters of the treatment). For example, microcoring can be adjusted in a closed loop mode based on a system 10 parameter and / or based on a patient parameter (e.g., a patient physiologic parameter, patient anatomical parameter, and / or a patient environment parameter, each as described herein). Microcoring by treatment device 100 can be adjusted based on image data ID described herein, such as to redirect and / or otherwise adjust microcoring (e.g., due to detected patient motion and / or undesired treatment device 100 motion) and / or to change one or more microcoring parameters (e.g., as determined by algorithm 25 using image data ID or other data). In some embodiments, image data ID is used to determine when a treatment (e.g., a microcoring amount) is sufficient, such as when algorithm 25 analyzes image data ID to confirm sufficient change in tissue characteristics have occurred.

[0195]

[0191] As described herein, system 10 can be configured to perform a series of skin treatment procedures on a patient, such as a patient desiring improved cosmesis of the face or other body location, as described herein. In some embodiments, system 10 is configured to be used to: perform a first procedure and a second procedure, in which the two procedures are performed at least 24 hours apart. The first procedure can include microcoring, the second procedure can include microcoring, or both can include microcoring. In some embodiments, the first procedure does not include microcoring, while the second procedure does include microcoring. In some embodiments, two, three, four, or more microcoring procedures of the present inventive concepts are performed, such as over a period of months and / or years. In some embodiments, the treatment plan for a subsequent procedure using system 10 is based on the data collected and / or results of one or more previous treatment procedures performed using system 10.

[0196]

[0192] System 10 can be configured to perform a treatment on a patient (e.g., a patient desiring improved cosmesis of the face or other body location) that includes the performance of multiple, sequential treatment plans, such as a sequence of treatment plans that each may use one, two or more components of system 10 (e.g., one, two or more of treatment devices 100) that are used to perform one or more diagnostic procedures, and / or one or more therapeutic procedures. Performance of an “initial treatment plan” performed using system 10, can be configured based on current physiologic state (e.g., current undesired state of tissue) of the patient, as well as any previous treatments performed (e.g., using system 10 or otherwise). Each “subsequent treatment plan”, can also be based on the current physiologic state, as well as all previous treatments performed, as described herein.

[0197]

[0193] In some embodiments, the one or more coring elements 155 (e.g., three coring elements 155) comprise a dimension selected from the group consisting of: an outer diameter of no more than 0.050in, or no more than 0.040in, such as approximately 0.028in; an inner diameter of no more than 0.030in, or no more than 0.025in, such as approximately 0.016in; a core length of at least 0.5mm and / or no more than 5.0mm; a penetration depth of no more than 6.0mm; a cutting depth of no more than 5.0mm; and combinations of these.

[0198]

[0194] In some embodiments, one or more coring elements 155 comprise a doublebeveled needle geometry (e.g., as shown in Figs. 3 A-D), such as to minimize effective insertion depth and / or resist wear during use.

[0199]

[0195] In some embodiments, system 10 is configured to precisely control insertion speed of the one or more coring elements 155 (e.g., simultaneous insertion of all of coring elements 155). In these embodiments, the dwell time can comprise a time of no more than 60msec, such as no more than 45msec, no more than 30msec, and / or no more than 20msec. System 10 (e.g., console 500 and / or treatment device 100) can comprise a proportional integral derivative (PID) controller that provides closed loop control of coring element 155 advancement and position that results in accurate core depth, such as while minimizing impact forces on the patient’s skin (e.g., thus improving healing response and core hole precision).

[0200]

[0196] In some embodiments, multiple coring elements 155 are positioned in an array (e.g., a linear arrangement of three or four elements 155) in which the coring elements 155 are separated by a distance of at least 0.2mm, such as at least 0.5mm, at least 1.0mm, at least 2.0mm, and / or approximately 3.33mm.

[0201]

[0197] System 10 can include tissue collection assembly 600 for clearing tissue cores captured by coring elements 155. In some embodiments, LPS 650 comprises a single source of low pressure (e.g., vacuum) that provides multiple (e.g., two) functions. System 10 can be configured to control the flow rate (e.g., the pressure) proximate the coring elements 155, such as to remove tissue cores without impacting low pressure applied to spacer assembly 180 (e.g., spacer assembly 180 using suction to stabilize treatment module 150 relative to the patient’s skin). The flow channels into which the tissue cores are extracted can include a funnel portion that increases the flow velocity at locations where the tissue is extracted from the back ends of the coring elements 155.

[0202]

[0198] Treatment device 100 can comprise spacer assembly 180, which can provide a stabilizing force to treatment device 100 during use, as described herein. For example, spacer assembly 180 can utilize a suction force that allows effective treatment of target tissue areas comprising various surface contours. System 10 can include an automated pinch valve in line with vacuum conduits provided to spacer assembly 180, such as to provide enhanced stabilization of treatment module 150 with the patient’s skin between patterns of deployment of one or more coring elements 155. For example, the pinch valve can be activated to allow easy repositioning of treatment module 150 (e.g., and spacer assembly 180) at the end of a pattern of microcoring, such as to improve ease and speed of a treatment.

[0203]

[0199] Treatment device 100 can comprise a “treatment window” that is sized to accommodate various ranges of suction force to be applied. In some embodiments, spacer assembly 180 provides a treatment window of at least 100mm2, such as no more than 2,000mm2, such as approximately 640mm2, such as to provide a nominal holding force of treatment module 150 (e.g., spacer assembly 180) of at least 10. ON, such as at least 18. ON, such as approximately 28.5N with the patient’s skin.

[0204]

[0200] System 10 can be configured to detect (e.g., and quantify) deceleration of coring elements 155, such as to minimize damage to the coring elements 155 and / or to detect damage to at least one coring element 155.

[0205]

[0201] System 10 can include various features that enhance positioning accuracy (e.g., during deployment) of coring elements 155, such as positioning accuracy in X and Y directions, and / or positioning accuracy in the Z dimension (e.g., insertion direction). Such features include but are not limited to: 1: 1 gearing and / or direct drive-in actuation assembly 120; sensor detection of position (e.g., hall sensors and / or optical sensors such as optical encoders); linear bearings (e.g., that minimize undesired motion and / or creep from a desired position); and combinations of these.

[0206]

[0202] System 10 can be configured to provide variable patterns for microcoring (e.g., varied microcoring density), such as to achieve a skin removal percentage (also referred to as “areal fraction”) of no more than 20%, and / or no less than 0.5%, such as at least 1%, and / or at most 10% (e.g., between 1% and 10%).

[0207]

[0203] Actuation assembly 120 can comprise one or more actuators (e.g., solenoids) that are configured to precisely control movement of one or more coring elements 155 such as to achieve variable depth control within 0.8mm, such as within 0.5mm, while accommodating variability in skin thickness, skin toughness, and / or other varying skin parameters.

[0208]

[0204] System 10 can comprise a calibration routine such as to store calibration information created during manufacturing of one or more components of system 10, and / or information collected at a site (e.g., prior to, during, and / or after use of system 10). Calibration data can be stored in a treatment module 150, actuation assembly 120, and / or other component of treatment device 100. System 10 can be configured to improve accuracy of needle deployment (e.g., in the Z direction), based on the calibration data (e.g., to accommodate variability in manufacturing processes).

[0209]

[0205] Coring elements 155 can comprise a bevel angle of no more than 30 degrees, such as no more than 25 degrees, and / or no more than 20 degrees, such as to improve healing and / or minimize scarring of the patient.

[0210]

[0206] System 10 can be configured to control the speed and / or frequency (e.g., repetition rate) of the deployment of the coring elements 155 into the patient’s skin, such as to deploy the elements 155 (e.g., three elements 155 in unison) at a rate of at least 1Hz, or 3Hz, or approximately 8Hz. Alternatively or additionally, system 10 can be configured to deploy the elements 155 (e.g., three elements 155 in unison) at a rate of no more than 30Hz, such as no more than 20Hz, such as approximately 8Hz.

[0211]

[0207] Applicant has conducted various studies using the systems, devices, methods, and other technologies of the present inventive concepts, such as system 10 and its components as described herein. Applicant has conducted studies using the systems of the present inventive concepts in mammalian subjects, including multiple studies in porcine models as well as human patients. Results of these studies are described in applicant’s co-pending International Patent Cooperation Treaty Patent Application Serial Number PCT / US2022 / 030236, titled "Skin Treatment Systems and Methods", filed May 20, 2022.

[0212]

[0208] System 10 can be configured to remove skin via microcoring, such as without use of thermal energy (e.g., avoiding damage to cells from heating) during the microcoring procedure. Energy -based devices such as fractional laser and radiofrequency ablation lead to epidermal and dermal cell necrosis from thermal injury that may inhibit rapid wound closure, an adverse effect that can be avoided via use of system 10. Although fractional lasers and radiofrequency devices have shown acceptable results in rejuvenation of skin, data on skin tightening is inconclusive. It is suspected that coagulation necrosis of the cells surrounding fractional laser cores prevent early wound closure and therefore limit reduction of skin surface area and skin tightening. System 10 avoids coagulation necrosis and can achieve both early wound closure, and enhanced skin tightening, as described herein. The coring elements 155 and other components of system 10 provide numerous benefits including limited side effects, and fast (e.g., expedited) patient recovery. By removing tissue, significant skin tightening can be achieved, as demonstrated by data gained in skin treatment procedures performed on human subjects.

[0213]

[0209] System 10 can be configured to both tighten skin and reduce skin wrinkles and / or folds of the patient’s skin. Use of system 10 in human patients has achieved skin tightening as well as reduction in skin wrinkles and / or folds, via removal of skin without the use of thermal energy, while also reducing (e.g., preventing or resulting in minimal) scar formation.

[0214]

[0210] Referring now to Fig. 2, a side view of a coring element being introduced into the skin is illustrated, consistent with the present inventive concepts. A coring element 155 can be safely introduced into the skin, such as to subsequently be withdrawn to remove a microcore of tissue, such that the remaining tissue heals with no scarring or at most minimal scarring. The treatment provided by system 10 also provides near-immediate closure along the relaxed skin tension lines (RSTLs), with no thermal energy.

[0215]

[0211] Referring now to Figs. 3A-D, various views of a coring element are illustrated, consistent with the present inventive concepts. Typical dimensions of a coring element 155 are shown. In some embodiments, coring element 155 comprises a penetrating portion with an outer diameter of at least 0.0203” and / or an outer diameter of no more than 0.050”. In some embodiments, coring element 155 comprises a penetrating portion with an inner diameter of at least 0.0103” and / or an inner diameter of no more than 0.0207”.

[0216]

[0212] Referring now to Fig. 4, a block diagram of a tissue treatment system is illustrated, consistent with the present inventive concepts. As shown, system 10 of Fig. 4 includes treatment device 100, console 500, tissue collection assembly 600, and other components as shown, each of which can be of similar construction and arrangement to the similar components described in reference to system 10 of Fig. 1 described herein.

[0217]

[0213] Treatment device 100 can be configured as a handheld device, comprising a “handpiece” geometry.

[0218]

[0214] Console 500 can comprise user interface 510 as shown. In some embodiments, at least a portion of user interface 510 is integral to treatment device 100. User interface 510 can be configured to allow a user (e.g., a technician) to set one or more microcoring parameters, such as depth of penetration of coring elements 155, density of coring (e.g., density of coring created by an array of one, two, three or more elements 155 of treatment module 150), and / or other coring and / or system 10 parameters. In some embodiments, system 10, via user interface 510, is configured to provide an automated presentation of: pretreatment setup steps of system 10; intra-treatment use of system 10; and / or post-treatment steps of system 10.

[0215] Treatment device 100 can include one or more treatment modules 150, which can include a single coring element 155 or multiple coring elements 155 (e.g., three coring elements 155). In some embodiments, treatment device 100 includes a kit 1500 of multiple treatment modules 150, such as a kit including at least one treatment module 150a each with a single coring element 155, and at least one treatment module 150b each with multiple (e.g., three) coring elements 155. For example, a treatment module 150a with a single coring element 155 can be used to perform microcoring in one or more “hard to reach areas”, while treatment module 150b can be used to perform microcoring in skin surface areas that are larger (e.g., to reduce treatment time than that achievable via a treatment module 150a with a single coring element 155). Treatment module 150b can comprise an assembly of multiple (e.g., three) coring elements 155 that are positioned at least 1mm, at least 2mm, at least 3mm, and / or approximately 3.33mm apart (e.g., to reduce likelihood of skin “tenting” and / or to reduce slicing of skin). In some embodiments, treatment module 150b can comprise an assembly of multiple (e.g., three) coring elements 155 that are positioned no more than 7mm apart, such as no more than 6mm apart, no more than 5mm apart, and / or no more than 4mm apart.

[0219]

[0216] In some embodiments, treatment module 150b comprises an assembly of multiple (e.g., three) coring elements 155, where each element 155 comprises opposing lateral sides that terminate at the distal end of each element 155 in one or more sharpened edges that each define a cutting axis. In some embodiments, the cutting edges axes of the cutting edges of multiple (e.g., 3) coring elements 155 are arranged in a non-linear arrangement, such as to prevent slicing and / or tearing of skin positioned between coring elements 155 during microcoring (e.g., slicing and / or tearing that might result from multiple linearly aligned cutting edges of relatively close proximity being inserted through the skin simultaneously).

[0220]

[0217] Treatment module 150 can comprise a single assembly that is attached to the remaining portion of treatment device 100, and it can include one or more mechanisms to prevent undesired movement of coring elements 155 when not attached.

[0221]

[0218] Treatment device 100 can include actuation assembly 120 which can include one or more actuators, such as x-actuator 121x, y-actuator 12 ly, and / or z-actuator 121z as shown. In some embodiments, actuation assembly 120 includes x-actuator 121x and y-actuator 12 ly for positioning the coring elements 155 relative to one or more locations on the patient’s skin, and z-actuator 121z is configured to advance the elements 155 into the skin, such as is described in detail hereinbelow. This x-y positioning, and z-advancement can be repeated multiple times until a desired microcoring pattern is achieved. Actuators 121 (e.g., x-actuator 121x and y-actuator 12 ly) can comprise motors, such as brushless DC motors, as well as a fine-pitched lead screw (e.g., a lead screw with a M3C0.5-6g thread). The lead screw can comprise a brass or other metal lead screw with a PEEK or other plastic projection that rides on the screw threads. Actuators 121 (e.g., x-actuator 121x and y-actuator 12 ly) can comprise a motor with at least a 3 : 1 or 4: 1 gear ratio. Actuators 121 can comprise one or more position sensors (e.g., functional elements 199a configured as position sensors), such as hall effect sensors. In some embodiments, x-actuator 121x and / or y-actuator 12 ly include an optical gate-based position sensor. In some embodiments, z-actuator 121z comprises a position sensor (e.g., a functional element 199a configured as a position sensor), such as a linear magnetic and / or optical encoder configured to determine the change in position of a translating component of actuator 121z (e.g., determine the change in position of the translating component of actuator 121z, such as to determine the acceleration, speed, and / or absolute position of advancement and / or retraction of coring elements 155 by actuator 12 Iz). In some embodiments, z-actuator 121z comprises a position sensor that includes or is integral to a linear bearing, such as to ensure unimpeded motion of z-actuator 12 Iz.

[0222]

[0219] System 10 can be configured to perform a microcoring of tissue by the clinician or other operator positioning a skin contacting surface (e.g., a frame as described herein) of treatment device 100 at a first tissue surface location. Activation of coring (e.g., via a footswitch or other control of system 10) is initiated by the operator, and the following sequence of events occur: (1) treatment module 150 (e.g., including one or more coring elements 155, such as three coring elements 155) is advanced into tissue (e.g., via z-actuator 121z to a target depth); (2) treatment module 150 is withdrawn from the tissue (e.g., via z- actuator 12 Iz); and (3) treatment module 150 is repositioned to a new location (e.g., via x- actuator 121x and / or y-actuator 12 ly). Steps 1 through Step 3 can be performed a single time, or multiple times, such as at least 3, 8, 12, 17, and / or 20 times (e.g., with a three coring element 155 assembly), in order to perform a “treatment event”. After a first treatment event is performed, one or more subsequent treatment events can be initiated. In each event, the operator positions the skin contacting surface (e.g., a frame as described herein) at a desired (e.g., new) tissue location, and one or more series of Steps 1 through 3 are repeated.

[0223]

[0220] In some embodiments, a switch (e.g., a footswitch) and / or other control that is activated by an operator to initiate a treatment event, must remain activated (e.g., a footswitch must continue to be depressed) in order for the treatment event to continue to completion (e.g., of the one or more series of Steps 1 thru 3 that are repeated). If the control is not maintained in an active state (e.g., a footswitch pedal is released), system 10 can be configured in the following arrangement: if Step 1 or Step 2 is in process, the treatment procedure continues thru completion of Step 2 (i.e. completion of needle withdrawal), and an additional coring element 155 advancement of Step 1 is prevented; otherwise (e.g., if Step 3 is in process), the treatment procedure stops. This configuration provides a safe mode of operation as well as allowing an operator to treat a portion of a proposed treatment area of a treatment event.

[0224]

[0221] System 10 can include a limit on depth of travel of actuator 12 Iz (e.g., limit depth of travel of a translating component of actuator 121z that translates along the z-axis), such as to limit depth of penetration of one or more coring elements 155 into skin (e.g., such as to avoid contact of a coring element 155 with a nerve, blood vessel, and / or bone). In some embodiments, this depth of penetration is input by an operator (e.g., input into user interface 510), such as a depth of 3mm, 4mm, and / or 5mm of penetration into the patient’s skin. In some embodiments, a titration or other iterative adjustment procedure is performed by an operator, in which depth of penetration is adjusted, such as to increase depth of penetration to achieve sufficient coring, and / or a decrease in depth of penetration (e.g., when treating an area in which element 155 contact with bone might otherwise result). System 10 can be configured to decelerate actuator 12 Iz as the one or more coring elements 155 are approaching a target depth.

[0225]

[0222] Actuator 12 Iz can be controlled by one or more algorithms of system 10 (e.g., algorithm 25) via one or more sets of instructions. Ranges of positions of a translating portion of actuator 121z range from a -zmaxto zmax, with a rise time tr. The translating component of actuator 12 Iz has a velocity, v, and a maximum velocity vmax, and an acceleration, a. The acceleration a of the translating component of actuator 12 Iz can be controlled to approximate a smooth continuous function. The translating component of actuator 121z can have a zmaxequal to approximately 0.007m (0.7cm), and vmaxcan be equal to approximately l.Om / sec. The translating component of actuator 12 Iz can have a velocity function as follows: The mfeum velocity occurs at t, = Q

[0226] Integrating gives the position:

[0227]

[0223] Treatment device 100 can be void of any surface, projection, and / or other mechanical stop that is contacted by treatment module 150 during advancement of coring elements 155 in a microcoring procedure (e.g., no mechanical stop is used to limit advancement of coring elements 155 during a microcoring procedure). Avoidance of such a mechanical stop can provide numerous advantages, such as avoiding the vibration that occurs when a moving assembly makes contact with a mechanical stop (e.g., a vibration that can cause a degradation of tissue cores removed during a microcoring procedure).

[0228]

[0224] Treatment device 100 can comprise one or more sensors, such as sensor 199a shown. Console 500 can comprise one or more sensors, such as sensor 599a shown. In some embodiments, sensor 199a and / or 599a comprise one or more sensors. Sensor 199a and / or 599a can comprise a pressure sensor, such as a pressure sensor configured to monitor a pressure level (e.g., a vacuum pressure level) of one or more conduits or other cavity portions of system 10. Sensor 199a and / or 599a can comprise one, two, or more sensors configured to monitor (e.g., constantly monitor during use) the position (e.g., the x, y, and / or z position) of actuation assembly 120 (e.g., monitor the position of an actuator 121). Sensor 199a and / or 599a can comprise one, two or more sensors configured to monitor the position of a component of system 10, such as the position of a component of an actuator 121. For example, sensor 199a and / or 599a can comprise an encoder (e.g., a magnetic and / or optical encoder), such as an encoder that monitors the position of a component of actuator 121. In some embodiments, sensor 199a and / or 599a comprises a position sensor (e.g., an encoder) which monitors a position of a component with a resolution of 0.5mm or less. For example, sensor 199a and / or 599a can comprise one or more position sensors (e.g., one or more encoders) that monitor the one or more positions of actuator 121x and / or 12 ly with a greater precision than 60pm (e.g., a resolution of 60pm or less), such as greater precision than 40pm, such as a resolution of approximately 20pm. Alternatively or additionally sensor 199a and / or 599a can comprise one or more position sensors (e.g., one or more encoders) that monitor one or more positions of actuator 121z with a greater precision than 5pm (e.g., a resolution of 5pm or less), such as a greater precision than 4pm, 3pm, and / or 2pm, such as a resolution of approximately 1pm.

[0229]

[0225] In some embodiments, system 10 is configured to constantly (e.g., always) determine and / or otherwise know the position of treatment module 150 and / or its coring elements 155 (e.g., constantly determine and / or otherwise know the x, y, and / or z positions of each element 155 during use). Alternatively or additionally, sensor 199a and / or 599a can comprise one, two, or more sensors configured to monitor (e.g., constantly monitor during use) the speed and / or the acceleration of actuation assembly 120 (e.g., monitor the speed and / or acceleration of an actuator 121). System 10 can comprise one or more position, speed, and / or acceleration limits (e.g., threshold above or below which operation is prevented or at least requires additional attention from an operator). System 10 can include a set of position, speed, and / or acceleration thresholds, such as for any actuator 121. Detection of any of these parameters outside of an expected range can result in system 10 entering a warning state, such as a state in which further operation is limited (e.g., microcoring is prevented) until further action is taken. For example, system 10 can be configured to alarm if one of the following conditions are detected (e.g., as determined by signals provided by sensor 199a and / or 599a): intended depth of penetration of a coring element 155 not achieved; velocity profile of a coring element 155 motion outside of an intended window (e.g., element 155 does not reach an intended location within a time window); a coring element 155 at an undesired position; acceleration of a coring element 155 is above a threshold ; and combinations of these. Sensor 199a and / or 599a can comprise one or more sensors configured to monitor current, such as current applied to an actuator 121 (e.g., x-actuator 121x, y-actuator 12 ly, and / or z-actuator 121z). System 10 can be configured to monitor the current value of current, peak current, and / or amount of current over time. Current above a threshold can correlate to an actuator 121 having to exert an undesired amount of force, and / or an actuator 121 being in a “stuck” position. Sensor 199a and / or 599a can comprise one or more sensors configured to detect a “locked” or “unlocked” status of treatment module 150, such as to prevent use (e.g., prevent microcoring) if treatment module 150 is not properly positioned in treatment device 100.

[0230]

[0226] System 10 can be configured to monitor repeated use of treatment module 150, such as when an upper limit of uses is applied by system 10. For example, each treatment module 150 can comprise a unique identifier (e.g., an RFID or other identifier as described herein), and system 10 can keep track of uses of treatment module 150 such as to prevent repeated use above a threshold.

[0231]

[0227] In some embodiments, system 10 is configured to monitor deceleration of actuator 12 Iz, such as, to reduce the likelihood of damage to one or more coring elements 155.

[0232] Sensor 199a and / or 599a can comprise one or more sensors to detect a deceleration “fault”, in other words a detected level of deceleration that is outside of an expected range, and / or has repeatedly transitioned above one or more deceleration thresholds. A deceleration fault can indicate damage (e.g., hooked end, bent shaft, and the like) to one or more coring elements 155 may have occurred (e.g., due to hitting bone or other hard surface during advancement). System 10 can be configured to prevent further use until inspection by an operator is performed (e.g., and treatment module 150 is replaced or confirmation of no damage is provided by the operator). In some embodiments, system 10 is configured to monitor the deceleration of a translating component of actuator 121z (e.g., the component causing coring elements 155 to advance into and retract from tissue), and if the monitored deceleration exceeds (e.g., at any time) a maximum threshold, DMAX, cause system 10 to enter an alarm state in which the operator is required to perform an action, such as: replacement of all or a portion of treatment module 150; inspection of treatment device 100 and / or another component of system 10; and / or performance of a safety and / or efficacy related task. In some embodiments, DMAX comprises a deceleration level of no more than 75g, such as no more than 60g, such as a deceleration limit of approximately 50g. In some embodiments, system 10 has multiple deceleration thresholds, such as a DMAX (e.g., as described hereinabove), as well as one, two or more other, lower thresholds, such as a Di, and / or a D2 deceleration threshold, such as when D2 is greater than DI. System 10 (e.g., algorithm 25) can be configured to record the number of times actuator 12 Iz exceeds either or both thresholds, and to enter an alarm state (e.g., a state in which use of system 10 is stopped until further action is performed as described hereinabove), and / or to enter an alert state (e.g., a state in which use of system 10 can continue, but the operator is notified of the exceeding of the threshold). In some embodiments, DI comprises a threshold of no more than 40g, such as no more than 35g, or approximately 32g, and system 10 enters an alert state if deceleration of actuator 121z exceeds DI. In some embodiments, system 10 enters an alert and / or an alarm state (e.g., as described hereinabove) if a difference in deceleration (e.g., between two or more advancements of actuator 12 Iz) exceeds a threshold (e.g., a one advancement has a deceleration that exceeds a previous advancement by a threshold level). In some embodiments, monitoring of deceleration of actuator 121z is used to automatically adjust the depth of penetration (e.g., depth of advancement) of element 155.

[0233]

[0228] In some embodiments, system 10 includes one or more sensors configured to monitor for inadequate communication (e.g., loss of communication) between two or more components of system 10 (e.g., between treatment device 100 and console 500).

[0234]

[0229] System 10 (e.g., console 500 and / or treatment device 100) can be configured to operate in a closed loop mode, such as via a PID or other control module. In some embodiments, system 10 is configured to adjust (e.g., automatically adjust) the depth of penetration of coring elements 155 based on deceleration of actuator 121z (e.g., such as when system 10 records, stores, and / or otherwise monitors the deceleration of actuator 12 Iz).

[0235]

[0230] Accessories 90 can include various accessory components, such as a power cord (e.g., to attach to wall power), one or more filters, suction tubing, and / or other accessory components. Accessories 90 can include a footswitch, such as an operator-controlled footswitch configured to initiate and / or stop microcoring or other functions of system 10.

[0236]

[0231] Functional element 599 of console 500 and / or functional element 199 of treatment device 100 can comprise a data transmission module, such as a cellular or other wireless transceiver, and / or a wired connection transceiver. System 10 can be configured to transmit system 10 use and / or other recorded information (e.g., data logs) to a remote site (e.g., the cloud, the system 10 manufacturer’s location, a data collection service, and the like) via the transceiver, such as to collect, process, and / or analyze data collected by one or more systems 10 that are in use at one or more settings in which system 10 is used.

[0237]

[0232] In some embodiments, and as described herein, system 10 comprises a treatment module 150 comprising one or more coring elements 155, and an actuation assembly 120 that is operably attached to treatment module 150. Actuation assembly 120 and one or more other components of system 10 can be configured to perform a microcoring procedure comprising the treatment module 150 translating in a series of “reciprocating motions”, each reciprocating motion comprising each coring element 155 being inserted into and withdrawn from tissue of the patient, such as to provide a cosmetic effect to the patient.

[0238]

[0233] In some embodiments, the series of reciprocating motions comprises at least one reciprocating motion. The series of reciprocating motions can comprise at least two reciprocating motions, such as multiple reciprocating motions that are performed in a similar or dissimilar fashion (e.g., with similar and / or dissimilar levels of reciprocating motion parameters, respectively).

[0234] In some embodiments, actuation assembly 120 is further configured to translate the treatment module 150 in one or more directions relative to a surface of skin tissue of the patient, such as in two orthogonal directions (e.g., in an x-y positioning arrangement as described herein, in which after each x-y positioning, the one or more coring elements are advanced and retracted along a z-axis in a reciprocating motion).

[0239]

[0235] In some embodiments, system 10 is configured to perform the series of reciprocating motions based on one, two, or more parameters associated with the reciprocating motion. These one, two, or more “reciprocating motion parameters” can comprise parameters selected from the group consisting of: insertion speed; insertion acceleration; insertion rise time; insertion dwell time; insertion fall time; insertion force; withdrawal speed; withdrawal acceleration; withdrawal force; core diameter; depth of insertion; microcoring density; microcoring pattern; lateral movement speed; lateral movement direction; lateral movement vector; lateral movement height; microcoring location; microcoring location tolerance; deceleration threshold; undershoot threshold; overshoot threshold; vacuum actuation release delay; vacuum release duration; and combinations thereof. System 10 can comprise reciprocating motion parameters, and at least one reciprocating motion parameter can be adjustable by an operator. In some embodiments, at least one reciprocating motion parameter can be automatically adjusted by system 10.

[0240]

[0236] In some embodiments, system 10 is configured to assess coring depth. Assessment can comprise an assessment of the depth of a previously captured core, and / or a core to potentially be captured in the future. System 10 can comprise a sensor (e.g., one, two, or more sensor-based functional elements 99 and / or 199) that can be configured to produce a signal, and system 10 can be configured to assess the coring depth based on the sensor signal. The sensor can comprise one, two, or more sensors selected from the group consisting of: optical sensor; camera; impedance sensor, such as a tissue impedance sensor; acoustic sensor; ultrasound sensor; doppler ultrasound sensor; accelerometer; strain gauge; magnetic sensor; density sensor; pressure sensor; temperature sensor; pH sensor; blood sensor; blood gas sensor; and combinations thereof. As described herein, system 10 can comprise controller 520 and a memory storage component, memory 522, coupled to controller 520, and memory 522 can store instructions 523 for controller 520 to perform (e.g., via processor 521) an algorithm, algorithm 25 shown, and algorithm 25 can be configured to perform the coring depth assessment. Algorithm 25 can comprise one or more machine learning, neural network, and / or other artificial intelligence algorithms (“Al algorithm” herein). The assessment can comprise providing an optimized depth for coring. System 10 can be configured to automatically adjust the coring depth based on the assessment. Alternatively or additionally, system 10 can be configured to provide coring depth feedback to the operator based on the assessment. The coring depth feedback can comprise a suggested depth for coring. The feedback can comprise a “too deep” warning when the assessment indicates depth of coring has been above a threshold.

[0241]

[0237] In some embodiments, system 10 is configured to detect whether a core has been captured in at least a first coring element of the one or more coring elements 155. System 10 can be configured to detect whether a core has been captured in each of the one or more coring elements 155. System 10 can comprise a sensor (e.g., one, two, or more sensorbased functional elements 99 and / or 199) that can be configured to produce a signal, and system 10 can be configured to detect whether a core has been captured based on the sensor signal. The sensor can comprise one, two, or more sensors selected from the group consisting of optical sensor; camera; impedance sensor, such as a tissue impedance sensor; acoustic sensor; ultrasound sensor; doppler ultrasound sensor; accelerometer; strain gauge; magnetic sensor; density sensor; pressure sensor; temperature sensor; pH sensor; blood sensor; blood gas sensor; and combinations thereof. As described herein, system 10 can comprise controller 520 and a memory storage component, memory 522, coupled to controller 520, and memory 522 can store instructions 523 for controller 520 to perform (e.g., via processor 521) algorithm 25, and algorithm 25 can be configured to perform the determination of whether the core has been captured. System 10 can comprise one or more reciprocating motion parameters, and algorithm 25 can be further configured to correlate the likelihood of future core captures to a reciprocating motion parameter. In these embodiments, algorithm 25 can comprise an Al-based algorithm, as described herein. System 10 can be configured to automatically adjust a reciprocating motion parameter if a sufficient core cannot be detected as having been captured. The one, two, or more reciprocating motion parameters that are adjusted can comprise parameters selected from the group consisting of insertion speed; insertion acceleration; insertion rise time; insertion dwell time; insertion fall time; insertion force; withdrawal speed; withdrawal acceleration; withdrawal force; core diameter; depth of insertion; microcoring density; microcoring pattern; lateral movement speed; lateral movement direction; lateral movement vector; lateral movement height; microcoring location; microcoring location tolerance; deceleration threshold; undershoot threshold; overshoot threshold; vacuum actuation release delay; vacuum release duration; and combinations thereof.

[0238] In some embodiments, system 10 is configured to assess the quality of a captured core. System 10 can comprise a sensor (e.g., one, two, or more sensor-based functional elements 99 and / or 199) that can be configured to produce a signal, and system 10 can be configured to assess the quality of the captured core based on the sensor signal. The sensor can comprise one, two, or more sensors selected from the group consisting of optical sensor; camera; impedance sensor, such as a tissue impedance sensor; acoustic sensor; ultrasound sensor; doppler ultrasound sensor; accelerometer; strain gauge; magnetic sensor; density sensor; pressure sensor; temperature sensor; pH sensor; blood sensor; blood gas sensor; and combinations thereof. System 10 can comprise a handpiece that includes actuation assembly 120, and the sensor can be positioned in the handpiece. Alternatively, system 10 can include sensing device 40 as shown, such as a sensing device that does not include actuation assembly 120, and where the sensor (e.g., functional element 99) configured to detect the captured core is positioned in sensing device 40. As described herein, system 10 can comprise controller 520 and a memory storage component, memory 522, coupled to controller 520, and memory 522 can store instructions 523 for controller 520 to perform (e.g., via processor 521) algorithm 25, and algorithm 25 can be configured to perform the assessment of the core quality. In these embodiments, algorithm 25 can comprise an Al-based algorithm, as described herein. Algorithm 25 can be configured to provide a coring score representing the quality of the captured core (e.g., a coring score provided to an operator of system 10, such as via a display of console 500, display 511 shown, or other display, speaker, and / or other output component of system 10).

[0242]

[0239] In some embodiments, system 10 is configured to identify the tissue type and / or a tissue property of tissue of a captured core, tissue of a target tissue location, or both. System 10 can comprise a sensor (e.g., one, two, or more sensor-based functional elements 99 and / or 199) that can be configured to produce a signal, and system 10 can be configured to identify the tissue type and / or tissue property based on the sensor signal. The sensor can comprise one, two, or more sensors selected from the group consisting of optical sensor; camera; impedance sensor, such as a tissue impedance sensor; acoustic sensor; ultrasound sensor; doppler ultrasound sensor; accelerometer; strain gauge; magnetic sensor; density sensor; pressure sensor; temperature sensor; pH sensor; blood sensor; blood gas sensor; and combinations thereof. As described herein, system 10 can comprise controller 520 and a memory storage component, memory 522, coupled to controller 520, and memory 522 can store instructions 523 for controller 520 to perform (e.g., via processor 521) algorithm 25, and algorithm 25 can be configured to perform the identification of the tissue type and / or tissue property. In these embodiments, algorithm 25 can comprise an Al-based algorithm, as described herein. System 10 can be configured to identify one, two, or more tissue types selected from the group consisting of skin tissue; fat tissue; muscle tissue; blood vessel wall tissue; blood; scar tissue; and combinations thereof. System 10 can comprise one or more reciprocating motion parameters, and system 10 can be configured to adjust a reciprocating motion parameter based on the identified tissue type and / or tissue property. The one, two, or more reciprocating motion parameters that are adjusted can comprise parameters selected from the group consisting of insertion speed; insertion acceleration; insertion rise time; insertion dwell time; insertion fall time; insertion force; withdrawal speed; withdrawal acceleration; withdrawal force; core diameter; depth of insertion; microcoring density; microcoring pattern; lateral movement speed; lateral movement direction; lateral movement vector; lateral movement height; microcoring location; microcoring location tolerance; deceleration threshold; undershoot threshold; overshoot threshold; vacuum actuation release delay; vacuum release duration; and combinations thereof. System 10 can be configured to reduce insertion depth if the identified tissue type can be fat tissue. System 10 can be configured to increase insertion force if the identified tissue type can be scar tissue. System 10 can be configured to modify a reciprocating motion parameter if an undesired and / or unexpected tissue type and / or tissue property is identified. The one, two, or more reciprocating motion parameters that are adjusted can comprise parameters selected from the group consisting of insertion speed; insertion acceleration; insertion rise time; insertion dwell time; insertion fall time; insertion force; withdrawal speed; withdrawal acceleration; withdrawal force; core diameter; depth of insertion; microcoring density; microcoring pattern; lateral movement speed; lateral movement direction; lateral movement vector; lateral movement height; microcoring location; microcoring location tolerance; deceleration threshold; undershoot threshold; overshoot threshold; vacuum actuation release delay; vacuum release duration; and combinations thereof. System 10 can be configured to enter an alert state if an undesired and / or unexpected tissue type and / or tissue property can be captured and / or identified in a target tissue location.

[0243]

[0240] In some embodiments, system 10 is configured to detect the force of an insertion of a coring element 155, the force of a withdrawal of a coring element 155, or both. System 10 can comprise a sensor (e.g., one, two, or more sensor-based functional elements 99 and / or 199) that can be configured to produce a signal, and system 10 can be configured to detect the force based on the sensor signal. The sensor can comprise one, two, or more sensors selected from the group consisting of optical sensor; camera; impedance sensor, such as a tissue impedance sensor; acoustic sensor; accelerometer; strain gauge; magnetic sensor; density sensor; pressure sensor; temperature sensor; and combinations thereof. As described herein, system 10 can comprise controller 520 and a memory storage component, memory 522, coupled to controller 520, and memory 522 can store instructions 523 for controller 520 to perform (e.g., via processor 521) algorithm 25, and algorithm 25 can be configured to perform the force detection. In these embodiments, algorithm 25 can comprise an Al-based algorithm, as described herein. System 10 can be configured to adjust the depth of insertion if an undesired force is detected. System 10 can be configured to enter an alert state if the detected force exceeds a threshold. System 10 can be configured to perform an initial insertion and / or withdrawal and detect the associated force, and then adjust the insertion and / or withdrawal force in subsequent reciprocating motions of coring elements 155.

[0244]

[0241] In some embodiments, system 10 is configured to set a depth of insertion of the one or more coring elements 155. The depth of insertion can be set based on a tissue analysis performed by system 10. System 10 can comprise a sensor (e.g., one, two, or more sensorbased functional elements 99 and / or 199) that can be configured to produce a signal, and system 10 can be configured to perform the tissue analysis based on the sensor signal. The sensor can comprise one, two, or more sensors selected from the group consisting of: optical sensor; camera; impedance sensor, such as a tissue impedance sensor; acoustic sensor; ultrasound sensor; doppler ultrasound sensor; accelerometer; strain gauge; magnetic sensor; density sensor; pressure sensor; temperature sensor; pH sensor; blood sensor; blood gas sensor; and combinations thereof. As described herein, system 10 can comprise controller 520 and a memory storage component, memory 522, coupled to controller 520, and memory 522 can store instructions 523 for controller 520 to perform (e.g., via processor 521) algorithm 25, and algorithm 25 can be configured to perform the tissue analysis. In these embodiments, algorithm 25 can comprise an Al-based algorithm, as described herein.

[0245]

[0242] In some embodiments, system 10 is configured to detect the presence of a critical structure at a target tissue location. System 10 can comprise a sensor (e.g., one, two, or more sensor-based functional elements 99 and / or 199) that can be configured to produce a signal, and system 10 can be configured to perform the detection of the presence of the critical structure based on the sensor signal. The sensor can comprise one, two, or more sensors selected from the group consisting of: optical sensor; camera; impedance sensor, such as a tissue impedance sensor; acoustic sensor; ultrasound sensor; doppler ultrasound sensor; accelerometer; strain gauge; magnetic sensor; density sensor; pressure sensor; temperature sensor; pH sensor; blood sensor; blood gas sensor; and combinations thereof. The sensor can comprise an imaging device (e.g., imaging device 50 described herein), and the imaging device can comprise one, two, or more devices selected from the group consisting of: ultrasound imaging device; X-ray imaging device, such as a fluoroscope; OCT imaging device; and combinations thereof. As described herein, system 10 can comprise controller 520 and a memory storage component, memory 522, coupled to controller 520, and memory 522 can store instructions 523 for controller 520 to perform (e.g., via processor 521) algorithm 25, and algorithm 25 can be configured to perform the detection of the presence of the critical structure. In these embodiments, algorithm 25 can comprise an Al-based algorithm, as described herein. The critical structure can comprise a structure selected from the group consisting of: blood vessel tissue; bone; scar tissue; damaged tissue, such as burned tissue; and combinations thereof. System 10 can comprise one or more reciprocating motion parameters, and system 10 can be configured to adjust a reciprocating motion parameter to avoid inserting the one or more coring elements 155 into the detected critical structure. System 10 can be configured to automatically reduce the depth of insertion based on the detection of the critical structure. System 10 can be configured to enter an alert state when a critical structure can be detected.

[0246]

[0243] In some embodiments, system 10 is configured to mark tissue, such as target tissue, non-target tissue, and / or safety margin tissue. System 10 can comprise marking element 91 shown, such as a marking element that is configured to mark tissue. Marking element 91 can comprise one, two, or more marking elements configured to mark tissue with ink, dye, and / or energy such as laser energy. System 10 can be configured to mark tissue to identify a no coring area (e.g., a non-target tissue area), and the no coring area can comprise a tissue surface portion to which microcoring should be avoided. The no coring area can comprise a first tissue surface portion and a second tissue surface portion, such as portions to which microcoring should be avoided. System 10 can be configured to prevent coring in tissue locations marked as non-target tissue by system 10. The treatment module 150 can comprise a spacer, spacer assembly 180 described herein, that includes a window, window 182 shown, and system 10 can be configured to perform multiple reciprocating motions of the one or more coring elements 155 within window 182 of spacer assembly 180. System 10 can be further configured to avoid inserting the coring elements 155 in tissue that has been marked by system 10 as non-target tissue that should not be cored. System 10 can be configured to mark the tissue with a marking pattern that is indicative of non-target tissue. System 10 can be configured to core tissue that has been marked by system 10 as target tissue. System 10 can be configured to perform multiple reciprocating motions of the one or more coring elements 155 within window 182 of spacer assembly 180, and system 10 can be further configured to insert the coring elements 155 in tissue that has been marked by system 10 for coring (e.g., marked as target tissue). System 10 can be configured to mark the tissue with a marking pattern that is indicative of target tissue. In some embodiments, system 10 is configured to mark target tissue with a first marking pattern and to mark non-target tissue with a second marking pattern different than the first marking pattern. In these embodiments, system 10 can be configured to perform multiple reciprocating motions of the one or more coring elements 155 within window 182 of spacer assembly 180, and system 10 can be further configured to insert the coring elements 155 in tissue that has been marked by system 10 with the first pattern and to avoid inserting the coring elements 155 in tissue that has been marked by system 10 with the second pattern.

[0247]

[0244] In some embodiments, treatment device 100 is configured to insert coring elements 155 into target tissue at an angle that is selected (e.g., selected by the operator and / or automatically by system 10) based on the tissue to be treated. For example, the angle at which treatment device 100 inserts coring elements 155 into tissue (e.g., the “angle of attack”, relative to the skin surface being treated) can be adjustable, for example adjustable between 90° (e.g., where the angle of attack is perpendicular to the surface of the skin), andl° (e.g., where the angle of attack is nearly parallel with the surface of the skin. In some embodiments, the angle of attack is adjustable between 30° and90°, such as between 45° and 90°. In some embodiments, spacer assembly 180 comprises an adjustable member configured to articulate to adjust the angle of attack. In some embodiments, the insertion depth of coring elements 155 can be adjusted (e.g., automatically adjusted by system 10) based on the angel of attack selected.

[0248]

[0245] In some embodiments, system 10 is configured to record skin surface data. The skin surface data can comprise photographs and / or other images of the skin surface (e.g., images that are produced by one or more components of system 10). System 10 can be configured to record skin surface data prior to a microcoring procedure and / or after a microcoring procedure. In some embodiments, system 10 is configured to record skin surface data both prior to a microcoring procedure and after a microcoring procedure. As described herein, system 10 can comprise controller 520 and a memory storage component, memory 522, coupled to controller 520, and memory 522 can store instructions 523 for controller 520 to perform (e.g., via processor 521) algorithm 25, and algorithm 25 can be configured to perform an analysis of microcoring effectiveness based on a comparison of the skin surface data recorded prior to the microcoring procedure and after the microcoring procedure. System 10 can be configured to record skin surface data prior to a microcoring procedure, and algorithm 25 can be configured to produce a microcoring treatment plan (e.g., an initial treatment plan) based on the skin surface data recorded prior to the microcoring procedure. In these embodiments, algorithm 25 can comprise an Al-based algorithm, as described herein.

[0249]

[0246] In some embodiments, system 10 comprises diagnostic assembly 30 shown, such as a diagnostic assembly configured as a self-diagnostic assembly that performs a diagnostic on one or more components of system 10. Diagnostic assembly 30 can be configured to detect damage to a component of system 10. Diagnostic assembly 30 can comprise one or more sensors, sensor 39 shown, such as an acceleration sensor, impact sensor, and / or other sensor configured to produce a signal representative of damage to the component of system 10 being monitored for damage.

[0250]

[0247] In some embodiments, system 10 comprises a user interface, such as user interface 510 and / or another user interface of system 10, and the user interface is configured to allow an operator to select a microcoring pattern to be used in a microcoring procedure. In these embodiments, the microcoring pattern can be selected from a set of microcoring patterns made available by system 10, such as microcoring parameters presented on display 511 or other display of system 10.

[0251]

[0248] In some embodiments, system 10 comprises one or more user interfaces, collectively including a first input device, input device 512 shown (e.g., a touch screen of user interface 510) and a second input device. The second input device can comprise input device 104 of treatment device 100 and / or input device 513 of user interface 510, each as shown. In these embodiments, system 10 can be configured to receive commands from an operator from either or both of first input device 512 (e.g., a touch screen), as well as input device 104 and / or input device 513. Input device 104 and / or input device 513 can comprise a microphone (e.g., a microphone configured to receive commands from an operator of system 10). System 10 can comprise a handpiece (e.g., housing 110 comprises a hand-held housing) comprising treatment module 150, and input device 104 can be positioned on the handpiece (e.g., on housing 110). System 10 can comprise one or more reciprocating motion parameters, and one, two, or all of input device 512 (e.g., a touch screen), input device 104 and / or input device 513, can be configured to allow an operator to adjust one or more (e.g., all) of the adjustable reciprocating motion parameters.

[0252]

[0249] In some embodiments, system 10 comprises a display, display 511 shown, and system 10 is configured to provide “microcoring feedback information” on the display. This feedback information can comprise data selected from the group consisting of: core size data, such as detected core size data; coring element 155 reciprocating motion data; target tissue data; non-target tissue data; and combinations thereof. System 10 can be configured to provide the microcoring feedback information as video on display 511. System 10 can be configured to allow an operator to: play, play in slow motion, pause, rewind, and / or zoom the video.

[0253]

[0250] In some embodiments, the one or more coring elements 155 comprise multiple coring elements 155 arranged in a grid of at least one row and at least two columns. Each pair of neighboring columns can be separated by a distance LI, and actuation assembly 120 can be configured to: perform a first reciprocating motion of the multiple coring elements 155; translate the multiple coring elements 155 a distance LT that is a distance less than LI; and then perform a second reciprocating motion of the multiple coring elements 155. System 10 can be configured to translate the multiple coring elements 155 in a direction approximately 45 degrees relative to the axis of the columns. System 10 can be configured to translate the multiple coring elements 155 in a direction relatively orthogonal to the axis of the columns. The orthogonal distance translated can comprise a distance of approximately half of LI. After performing the second reciprocating motion of the multiple coring elements 155, system 10 can be configured to translate the multiple coring elements 155 a distance (e.g., an orthogonal distance) of approximately 1.5 times LI, and then perform a third reciprocating motion of the multiple coring elements 155. After performing the third reciprocating motion of the multiple coring elements 155, system 10 can be configured to translate the multiple coring elements 155 a distance (e.g., an orthogonal distance) of approximately half of LI, and then perform a fourth reciprocating motion of the multiple coring elements 155. The grid can comprise at least two rows, where each pair of neighboring rows can be separated by a distance L2, and the distance LT can comprise a distance that can be greater than LI and greater than L2. The number of columns of the grid can comprise a quantity that can be at least three times the number of rows of the grid.

[0254]

[0251] In some embodiments, the one or more coring elements 155 comprises an array of at least ten coring elements 155. In some embodiments, the one or more coring elements 155 comprises an array of at least 100 coring elements 155.

[0255]

[0252] As described herein, system 10 can comprise a spacer, such as spacer assembly 180 described herein, and spacer assembly 180 can apply a vacuum (e.g., via vacuum assembly 560 shown) to a tissue surface being treated by system 10. System 10 can be configured to: apply the vacuum while spacer assembly 180 can be positioned on the patient’s skin at a first location LI; deliver a series of multiple reciprocating motions of the one or more coring elements 155; wait a pre-determined time period Tl; and then release the vacuum for a pre-determined time period T2. Spacer assembly 180 can be configured to be repositioned at a second patient skin location L2 during time period T2. Alternatively or additionally, spacer assembly 180 can be configured to be repositioned at a second patient skin location L2 after time period T2 has elapsed. System 10 can comprise a first vacuum source and a second vacuum source, and the first vacuum source can apply a vacuum to spacer assembly 180, and the second vacuum source can apply a vacuum that removes cores from the one or more coring elements 155. System 10 can be configured to provide the vacuum to spacer assembly 180 at a first level, a second level, or both. Vacuum assembly 560 can comprise a first vacuum source 560a configured to provide vacuum at a first level, and a second vacuum source 560b configured to provide vacuum at a second level, and the second level can be different than the first level. The first vacuum source 560a and the second vacuum source 560b can be each configured to be detached from, and / or operably attached to, the treatment module 150. Spacer assembly 180 can comprise: a curved skincontacting surface; a compressible skin-contacting surface; and / or a flexible skin contacting surface. In some embodiments, spacer assembly 180 and one or more other components of system 10 can be configured to treat the neck of the patient. In these embodiments, the one or more coring elements 155 can comprise a single coring element 155.

[0256]

[0253] In some embodiments, system 10 comprises a console, console 500 shown and described herein, that operably attaches to the treatment module 150 and / or actuation assembly 120. Console 500 can comprise a motion detection sensor, such as a sensor that produces a signal indicative of console 500 being moved (e.g., between rooms of an office, a hospital, and / or other setting in which system 10 is used, in a desired or undesired fashion).

[0257]

[0254] In some embodiments, system 10 comprises a projection assembly, projection assembly 93 shown, which can be configured to project an image of a microcoring pattern onto a skin surface portion of the patient (e.g., onto the face, neck, or other body portion of a patient). Projection assembly 93 can be integral to the treatment module 150, actuation assembly 120, or both. Projection assembly 93 can comprise a discrete component of system 10. Projection assembly 93 can comprise a laser configured to produce the image of the microcoring pattern. In some embodiments, projection assembly 93 projects an image representing target tissue, safety margin tissue, and / or non-target tissue onto a skin surface of the patient.

[0255] In some embodiments, system 10 comprises a skin scanning assembly, scanner 94 shown, configured to scan the surface of one or more skin surface portions of the patient. System 10 can comprise a display, display 511 shown, and the scanner 94 can be configured to provide one or more images of the one or more skin surface portions on display 511. System 10 can be configured to allow an operator to mark target tissue to be treated and / or non-target tissue not to be treated, on at least one image provided by scanner 94 on display 511. System 10 can be configured to prevent microcoring in the tissue marked as non-target tissue. System 10 can be configured to automatically perform microcoring in the tissue marked as target tissue.

[0258]

[0256] In some embodiments, system 10 comprises a coring element position tracking assembly, tracking assembly 95 shown, and tracking assembly 95 can be configured to track the translation of the treatment module 150 (e.g., coring elements 155) along a skin surface. Tracking assembly 95 can comprise one or more sensors (e.g., an optical sensor and / or other sensor-based functional element 99) that can be configured to detect texture changes in a skin surface. Tracking assembly 95 can be configured to determine when a desired translation distance and / or a translation distance threshold has been reached.

[0259]

[0257] In some embodiments, system 10 comprises one or more skin treatment and / or other treatment devices, skin treatment device 900 shown. In some embodiments, skin treatment device 900 comprises a skin-compressing dressing, such as is described in applicant’s co-pending United States Patent Application Serial Number 17 / 987,190, titled “Methods and Devices for Skin Tightening”, filed November 15, 2022. Such a skincompressing dressing can be used prior to, during, and / or after a microcoring procedure is performed using treatment device 100.

[0260]

[0258] In some embodiments, system 10 comprises an agent delivery assembly, agent delivery assembly 200 shown, and agent delivery assembly 200 can be configured to deliver an agent (e.g., agent 60 described herein) to one or more target tissue locations. Agent delivery assembly 200 can comprise one or more agent delivery elements, agent delivery element 201 shown. The one or more agent delivery elements 201 can comprise one or more elements selected from the group consisting of needle; fluid jet; iontophoretic element; and combinations thereof. System 10 can comprise a first cartridge, cartridge 2011 shown, that includes the one or more agent delivery elements 201. Cartridge 2011 can be configured to operably attach to the treatment module 150. In some embodiments, cartridge 2011 also includes the one or more coring elements 155 of treatment module 150. Alternatively or additionally, system 10 can further comprise a second cartridge (not shown but such as a cartridge of treatment module 150) that includes the one or more coring elements 155. At least one of the one or more coring elements 155 can comprise at least one of the one or more agent delivery elements 201 (e.g., a single needle or other component both cores tissue and delivers an agent). The one or more coring elements 155 can comprise at least two coring elements 155, and the at least two coring elements 155 can comprise all of the one or more agent delivery elements 201. System 10 can be configured to insert the one or more coring elements 155 at a first insertion rate profile and to insert the at least one agent delivery element 201 at a second insertion rate profile, and the first insertion rate profile can be different than the second insertion rate profile. For example, the two insertion rate profiles can comprise different velocities, accelerations, wait times, and the like. System 10 can be configured to insert the at least one agent delivery element 201 into tissue, wait for a time period Tl, and withdraw the at least one agent delivery element 201 from tissue. The at least one agent delivery element 201 can comprise an elongate shaft with a distal end, and the at least one agent delivery element 201 can comprise one or more agent delivery openings positioned at the distal end and / or proximal to the distal end (e.g., a side hole of the shaft). System 10 can comprise an agent (e.g., agent 60 described herein) to be delivered by the agent delivery assembly 200. In these embodiments, agent 60 can comprise one, two, or more agents selected from the group consisting of: an analgesic agent, such as lidocaine; epinephrine; an antibiotic agent; an antifungal agent; a cooling agent; a warming agent; a dye; a radiographic agent; an ultrasonically visible agent; and combinations thereof. In some embodiments, the agent 60 comprises a dermal filler to be delivered by agent delivery assembly 200.

[0261]

[0259] In some embodiments, system 10 comprises tissue cooling assembly 92 shown, such as an assembly configured to reduce the temperature of one or more surfaces and / or volumes of tissue of the patient. System 10 can be configured to cool (e.g., via tissue cooling assembly 92) at least a target tissue location at a time prior to performing a microcoring procedure, during a microcoring procedure, and / or after a microcoring procedure. The treatment module 150 and / or actuation assembly 120 can comprise tissue cooling assembly 92. Tissue cooling assembly 92 can comprise a separate component, such as a mask configured to be placed on the patient’s face and extract heat from tissue. Alternatively or additionally, the mask can be configured to compress tissue of the patient. In some embodiments, tissue cooling assembly 92 is configured to at least reduce the use of analgesics in performing the procedure on the patient.

[0260] In some embodiments, skin presentation and / or skin preparation is an important aspect of effective microcoring treatments of the present inventive concepts. When a needle or other coring element, for example coring element 155, is advanced into the skin, the skin surface deflects a certain distance before the needle cuts through the surface of the skin. Various pre-treatments can be provided by system 10 and used to manipulate the skin to become more rigid, such as to minimize this deflection. For example, as described herein, chemical and / or physical methods of skin treatment can be used (e.g., solely or in combination) with (e.g., in advance of) the microcoring performed using treatment device 100, such as to improve the outcome of the microcoring treatment (e.g., to improve the quality of the capture of tissue cores). In some embodiments, a temperature-reducing skin surface treatment can be performed prior to a microcoring procedure, such as a cryogenic or other temperature-reducing treatment performed using tissue cooling assembly 92. In some embodiments, tissue cooling assembly 92 delivers a cryogenic spray to cool tissue. Tissue becomes more rigid when it is cooled, such as to decrease the amount of deflection achieved at a given applied force, therefore microcoring procedures can be more effective when performed on temperature-reduced tissue (e.g., tissue cooled below 37°C). In some embodiments, a two-step treatment procedure comprising cooling the tissue and then microcoring the tissue is performed, such as by first cooling a tissue area with tissue cooling assembly 92 (e.g., a cooling assembly comprising a cooling jet). Tissue cooling assembly 92 can be configured to cool the tissue area to approximately -10°C. The pre-treated (e.g., cooled) tissue area can comprise a relatively small area, such as an area of no more than 6cm2, such as no more than 4cm2, 2cm2, or 1cm2. Soon after the cooling of the tissue (e.g., within three seconds of cooling the tissue, such as within two seconds), a microcoring procedure can be performed on the cooled tissue area with treatment device 100. In some embodiments, the cooling and microcoring therapies are alternated, such as on adjacent tissue areas, until the entire treatment area is treated. These methods for skin pre-treatment to assist with microcoring can also provide enhanced healing and treatment technique benefits. For example, pre-treating tissue with a cooling procedure, blood vessels in the treatment area will vasoconstrict. This vasoconstriction provides an additional benefit of preventing and / or at least limiting bleeding (e.g., immediate bleeding) of the treatment area, which would improve physician visibility of the treatment area. Tissue cooling can also reduce bleeding and / or inflammation of the treated tissue immediately post procedure.

[0262]

[0261] In some embodiments, treatment module 150 and actuation assembly 120 comprise a first system 10a, and system 10 further comprises: a second system 10b, not shown but comprising: a second treatment module 150’ comprising a one or more coring elements 155’; and a second actuation assembly 120’ operably attached to the second treatment module 150’ and configured to perform a microcoring procedure comprising the second treatment module 150’ translating in a series of reciprocating motions, each reciprocating motion comprising each coring element 155’ being inserted into and withdrawn from tissue of a patient. A server 20 (e.g., a server connected to network 80 described herein, such as the Internet or privately maintained network) can be configured to receive information from the first system 10a and the second system 10b. System 10 can be configured to update the first system 10a based on at least information received from the second system 10b.

[0263]

[0262] Referring now to Figs. 5A-C, side and perspective views of various embodiments of coring devices are illustrated, consistent with the present inventive concepts. Coring element 155 and / or other components of system 10 described in Figs. 5A-C can be of similar construction and arrangement as the similar components described in reference to Fig. 1 and otherwise herein. In some embodiments, each coring element 155 is configured to remove multiple tissue cores, for example as the coring element is repeatedly inserted into and removed from tissue (e.g., when coring element 155 is repositioned at a new tissue location between each insertion). Coring element 155 can include one or more recesses, lumens, or other openings, such as lumen 1555 shown. Lumen 1555 can extend from the distal end of coring element 155 to a proximal portion of coring element 155, such as when lumen 1555 extends the length of coring element 155 from the proximal end to the distal end. In some embodiments, a first portion of tissue excised by coring element 155 remains within lumen 1555 and is “pushed” proximally through lumen 1555 by a subsequent portion of tissue to be excised as coring element 155 is inserted into tissue (e.g., the excised portions of tissue “stack up” within lumen 1555). In some embodiments, excised portions of tissue remain within lumen 1555 until they are forced out of the proximal end of lumen 1555.

[0264] Alternatively, or additionally, a source of negative pressure (e.g., a vacuum) can be applied to the proximal end of lumen 1555 to draw the excised tissue portions through lumen 1555. In some embodiments, the distal portion of lumen 1555 comprises a first diameter, and the proximal portion of lumen 1555 comprises a second diameter, where the second (proximal) diameter is larger than the first (distal) diameter. For example, coring element 155 can comprise a swaged coring needle with a larger proximal inner diameter than distal inner diameter (i.e., a needle with a lumen that has a larger proximal diameter than distal diameter). In some embodiments, the outer diameter of coring element 155 varies correspondingly with the internal diameter of lumen 1555, such as when the wall thickness of coring element 155 is relatively constant along the length of the coring element. In some embodiments, the distal portion of coring element 155 comprises approximately a 22GA needle. In some embodiments, the proximal portion of coring element 155 comprises a lumen with a diameter of at least 0.60mm, such as at least 0.75mm, for example when the proximal portion of coring element 155 comprise a gauge of no more than 18GA, such as no more than 19GA or 20GA. In some embodiments, the distal portion of coring element 155 comprises the length of coring element 155 that is inserted into tissue, such as approximately the distal 6.0mm of coring element 155, or approximately the distal 6.5mm of coring element 155 (e.g., each coring element 155 comprises an insertion length of no more than 6.5mm, or 6.0mm). Portions of excised tissue can stack up within the distal portion of lumen 1555, as described herein, and can be removed from the proximal portion of lumen 1555 via vacuum applied to the proximal end of lumen 155. In some embodiments, coring element 155 comprises one or more openings, slot 1556 shown in Fig. 5C, through the wall of coring element 155 into lumen 1555, such as an opening located at the distal end of the proximal portion of lumen 1555 that allows air to be drawn into lumen 1555 by a vacuum applied to the proximal end of lumen 1555 (e.g., such as to increase airflow through the proximal portion of lumen 1555).

[0265]

[0263] In some embodiments, coring element 155 comprises a two-part design (e.g., a design comprising two distinct components), such as when coring element 155 includes a distal portion comprising a first shaft that is partially located within the lumen of a proximal portion comprising a second shaft (e.g., where the proximal portion of the first shaft is fixedly positioned within the distal portion of the lumen of the second shaft).

[0266]

[0264] Referring now to Figs. 6 through 9E, side and sectional views of coring elements with various tip geometries are illustrated, consistent with the present inventive concepts. Coring element 155 and / or other components of system 10 described in Figs. 6 through 9E can be of similar construction and arrangement as the similar components described in reference to Fig. 1 and otherwise herein. In some embodiments, coring element 155 comprises a tip (i.e., a distal end portion) comprising one or more bevels, such as one or more bevels extending from the outer wall of coring element 155 toward the central axis of coring element 155. Each bevel of coring element 155 can comprise two or more bevel portions (e.g., a compound bevel), where each bevel portion can comprise a different bevel angle. For example, and as shown in Fig. 9, coring element 155 can include a bevel comprising a first bevel portion angle extending from the outer wall of coring element 155 inward at a first bevel angle, and a second bevel portion extending from the first bevel portion inward towards the central axis of coring element 155 at a second bevel angle.

[0267] Coring element 155 of Fig. 9 comprises two bevels, each bevel comprising two bevel portions, where the two bevels meet at the central axis of coring element 155. In some embodiments, coring element 155 can comprise a circumferential bevel, for example where the wall of coring element 155 is beveled from the outer surface of the wall to the inner surface of the wall, such as is shown in Fig. 8.

[0268]

[0265] One or more bevels of coring element 155 can comprise a bevel angle of at least 1°, such as at least 5°, 10°, 15°, 20°, 25°, 30°, 35°, 40°, or 45°. Additionally or alternatively, one or more bevels of coring element 155 can comprise a bevel angle of no more than 45°, such as no more than 40°, 35°, 30°, 25°, 20°, 15°, 10°, 5°, or 1°.

[0269]

[0266] Figs. 6 and 6A-C show a coring element 155 comprising a Franseen tip. In some embodiments, the bevels of the tip of coring element 155 (e.g., the three bevels of the Franseen tip) can comprise a bevel angle of at least 13° and / or no more than 17°, such as approximately 15°. Lumen 1555 of coring element 155 can comprise an inner diameter of approximately 0.0170” or 0.0155” (e.g., at least 0.0150”, no more than 0.0175”, or both).

[0270]

[0267] Fig. 7 and Figs. 7A-D show another embodiment of a coring element 155 comprising a Franseen tip. In some embodiments, coring element 155 comprises one or more inward projections, barb 1553 shown. Barb 1553 can extend into lumen 1555 and can be configured to provide a pulling force to portions of tissue within lumen 1555 to be excised (e.g., to provide a pulling force that is generated while coring element 155 is retracted from surrounding tissue). In some embodiments, barb 1553 comprises a laser cut portion of the wall of coring element 155.

[0271]

[0268] Fig. 8 and Figs. 8A-C show a coring element 155 comprising a single bevel and an edge grind (e.g., a Menghini tip comprising circumferential edge grind). For example, coring element 155 can comprise a Coumand tip. In some embodiments, the bevel of coring element 155 comprises an approximately 30° bevel (e.g., at least a 20° bevel, no more than a 40° bevel, or both), as shown. The edge grind can comprise a grind angle of approximately 15° (e.g., a grand angle of at least 10°, no more than 20°, or both). In some embodiments, coring element 155 comprises an asymmetric bevel, as shown. Coring element 155 can comprise a single, smooth cutting edge, such as a single cutting edge that is sharpened to the internal diameter of coring element 155, as shown. A single cutting edge of coring element 155 comprising an asymmetric bevel, such as is shown in Fig. 8, can require a lower insertion force than similar geometries comprising symmetric bevels and / or multiple cutting edges.

[0272]

[0269] Fig. 9 and Figs. 9A-E show coring element 155 comprising a varying diameter along its length and a double bevel. In some embodiments, coring element 155 can comprise a varying diameter, such as is described in reference to Figs. 5A-C and otherwise herein. In some embodiments, coring element 155 can comprise a double tip bevel, as shown. For example, coring element 155 can comprise a first bevel of approximately 20° (e.g., a bevel of at least 18°, no more than 22°, or both), and a second bevel of approximately 40° (e.g., at least 37°, no more than 43°, or both), as shown.

[0273]

[0270] The distal tip of coring element 155 can comprise a tip geometry selected from the group consisting of: a lancet tip; an asymmetric tip; an axisymmetric tip; and combinations of these. In some embodiments, the distal end of coring element 155 comprises a bevel selected from the group consisting of: a bias bevel; a Cournand bevel; a back bevel; a Franseen bevel; and combinations of these.

[0274]

[0271] In some embodiments, coring element 155 comprises a hypodermic-needle-like coring element comprising a double bevel tip, for example as shown in Figs. 9 and 9A-9E. The sharpness of the tip of coring element 155 can be configured to balance treatment efficacy versus durability, such as to withstand the approximately 5,000 punctures that can be required by each coring element 155 in a microcoring treatment (e.g., coring element 155 can be configured to withstand at least 5,000 punctures without significant dulling). Coring element 155 can comprise a compound bevel, such as a compound bevel comprising a shallow (approximately 20°) leading edge and a sharper (approximately 10°) following edge. Having a shallow leading edge makes the coring element 155 more resistant to dulling (e.g., dulling from curling of the leading edge of coring element 155) as a result of repeated punctures throughout a treatment. The shallow leading edge can also reduce the overall insertion depth of coring element 155 required to excise the tissue core as the cutting edge of the coring element 155 is closer to the needle tip. In some embodiments, the coring element 155 must have a length greater than the desired core depth to be captured with each puncture, since the core is not fully encapsulated within the coring element 155 beyond the base of the cutting edge. A sharper (e.g., steeper) following edge can benefit the treatment efficacy as it reduces the force required to puncture the coring element 155 through the skin, which can reduce skin deflection with each puncture, and therefore improve the precision of the needle depth penetration. A sharper bevel angle can provide a benefit to the treatment healing profile because it causes less trauma to the skin and creates a cleaner cut edge of the hole left behind by the needle.

[0275]

[0272] Referring additionally to Figs. 10A-D, side and sectional views of the distal portion of various coring elements are illustrated, consistent with the present inventive concepts. Coring element 155 and / or other components of system 10 described in Figs. 10A- D can be of similar construction and arrangement as the similar components described in reference to Fig. 1 and otherwise herein. Figs. 10A-D show coring element 155 comprising a Franceen tip comprising three symmetric bevels (e.g., a multi-plane symmetric bevel tip). Fig. 10B shows a sectional view of coring element 155 including multiple tissue engaging features, ribs 1554. In some embodiments, ribs 1554 extend into lumen 1555. Alternatively or additionally, ribs 1554 can comprise reliefs (e.g., recesses or openings) into the wall of coring element 155. For example, ribs 1554 can comprise reliefs that are machined into the wall of coring element 155.

[0276]

[0273] Fig. 10C shows a side view of coring element 155 comprising one or more barbs, barb 1553 shown. Barb 1553 can comprise a laser cut portion of the wall of coring element 155 that has been deformed (e.g., in a manufacturing process of coring element 155) inward into lumen 1555. In some embodiments, barb 1553 comprises one or more barbs that are configured to extend into lumen 1555, such as to extend at least 0.05mm, such as at least 0.10mm. Fig. 10D shows a side view of coring element 155 comprising multiple reliefs, slots 1556 shown. Slots 1556 can comprise laser cut reliefs in the wall of coring element 155. In some embodiments, coring element 155 comprises one or more “crimps” (e.g., reduced diameter portions along its length), such as one or more crimps created during a manufacturing process of coring element 155 configured to reduce the ID of a portion of coring element 155.

[0277]

[0274] Referring now to Figs. 11A-F, side views of various embodiments of a coring element are illustrated, consistent with the present inventive concepts. Coring element 155 and / or other components of system 10 described in Figs. 11 A-F can be of similar construction and arrangement as the similar components described in reference to Fig. 1 and otherwise herein.

[0278]

[0275] Fig. 11 A shows an embodiment of a coring element 155 comprising a swaged coring element, for example as described in reference to Figs. 5A-C herein. Coring element 155 of Fig. 11 A comprises a compound bevel, for example as described in reference to Fig. 9 and otherwise herein.

[0279]

[0276] Fig. 1 IB shows an embodiment of a coring element 155 comprising a three-bevel tip (e.g., a Franseen tip), for example as described in reference to Fig. 6 and otherwise herein.

[0280]

[0277] Fig. 11C shows another embodiment of a coring element 155 comprising a compound bevel.

[0281]

[0278] Fig. 1 ID shows another embodiment of a coring element 155 comprising a three- bevel tip. Coring element 155 of Fig. 1 ID includes barb 1553, for example as described in reference to Fig. IOC and otherwise herein.

[0282]

[0279] Fig. 1 IE shows another embodiment of a coring element 155 comprising a swaged coring element. Coring element 155 of Fig. 1 IE comprises a compound bevel, and an opening, slot 1556 shown, for example as described in reference to Fig. 5C and otherwise herein.

[0283]

[0280] Fig. 1 IF shows an embodiment of a coring element 155 comprising a single bevel and an edge grind, for example a Menghini tip, such as is described in reference to Fig. 8 and otherwise herein.

[0284]

[0281] In some embodiments, the distal portion of lumen 1555 of coring element 155 (e.g., the portion of lumen 1555 within the portion of coring element 155 that is inserted into tissue) comprises an inner diameter of at least 0.0065”, and / or no more than 0.1700”, such as approximately 0.017”. In some embodiments, the distal portion of coring element 155 comprises a wall thickness of at least 0.001”, and / or no more than 0.006”, such as approximately 0.003”. In some embodiments, at least the distal portion of coring element 155 comprises a needle gauge of no more than 22GA, such as approximately 22GA, 24GA, and / or 28GA.

[0285]

[0282] Referring additionally to Figs. 12A-C, sectional views of various embodiments of a coring element comprising varying inner diameters are illustrated, consistent with the present inventive concepts. Coring element 155 and / or other components of system 10 described in Figs. 11 A-F can be of similar construction and arrangement as the similar components described in reference to Fig. 1 and otherwise herein. Figs. 12A-C show various embodiments of coring element 155 where lumen 1555 comprises a varying inner diameter (e.g., a stepped and / or sloped inner diameter). Fig. 12A shows an embodiment of a coring element 155 where lumen 1555 comprises a counter-bore (e.g., a counter-bore that is machined or otherwise created during a manufacturing process of coring element 155), such as a counter-bore that extends from the proximal end of lumen 1555, such that the proximal portion of lumen 1555 comprises a greater inner diameter than the distal portion, as shown. In Fig. 12B, coring element 155 comprises a swaged coring element, where the proximal portion of lumen 1555 has been swaged (e.g., during a manufacturing process of coring element 155) to increase the proximal inner diameter of lumen 1555. Fig. 12C shows an embodiment of a coring element 155 comprising a two-piece construction comprising a distal hypotube that is received within and bonded to the distal portion of a proximal hypotube, as shown. For example, coring element 155 can include a distal shaft comprising a 22GA needle that is bonded to a 19GA hypotube. In some embodiments, lumen 1555 of coring element 155 comprises a tapered profile, such as a relatively continuous taper from the proximal end to the distal end of lumen 1555 (e.g., where the distal end of lumen 1555 comprises a smaller inner diameter than the proximal end).

[0286]

[0283] In some embodiments, one or more portions of coring element 155 includes a surface treatment, coating, and / or other modification, coating 1557, such as a coating that can be applied to the tip and / or other portions of coring element 155. Coating 1557 can comprise a titanium nitride coating. Coating 1557 can be configured to increase the hardness of a portion of coring element 155, such as to harden the tip of coring element 155, such as to limit dulling of coring element 155 during use in a clinical procedure (e.g., to increase the durability of coring element 155). In some embodiments, coating 1557 is applied to coring element 155 after a grinding and / or other sharpening process that is used to manufacture coring element 155.

[0287]

[0284] In some embodiments, system 10 includes kit 1500, not shown but described in reference to Fig. 1 and otherwise herein. Kit 1500 can include various treatment modules 150 that each include coring elements 155 of varying designs. For example, differently configured coring elements 155 can be intended for use in different clinical scenarios, for example different sets of coring elements 155 configured to each be used on different tissue types (e.g., tissue of different anatomical locations, tissue of different ethnicities or other varying patient parameter, and / or other tissue differences). System 10 can be configured to treat (e.g., perform a microcoring procedure on) various tissue anatomical location types, such as tissue types selected from the group consisting of: tissue of the medial cheek; tissue above boney areas, such as the tissue of the jaw, chin, or cheekbone; tissue of the lower eyelids; tissue of the nasolabial fold; tissue of the neck and / or submentum; striae tissue; perioral tissue; soft tissue of the body (e.g., not the face); crepey tissue of the body (e.g., not the face); scar tissue; tattooed tissue; and combinations of these. Design variables of coring element 155 that are customized or otherwise configured for treating a particular tissue type can be selected from the group consisting of the inner diameter of lumen 1555; the outer diameter of coring element 155; the wall thickness; the tip geometry; the type of applied coating and / or the coating process; the material of coring element 155; inclusion of skin capturing features, such as ribs and / or barbs; and combinations of these. For example, in some embodiments, for tissue over boney structures (e.g., skin above the cheekbone), coring element 155 can comprise a shallower grind than coring elements 155 configured to treat tissue in less boney areas (e.g., the skin of the medial cheek). In some embodiments, a first set of coring elements 155 is configured to treat one, two, or more tissue types, and a second set of coring elements 155, different than the first set, is configured to treat a different one, two, or more tissue types.

[0288]

[0285] Referring now to Figs. 13A-30D, images of human tissue samples from subjects of clinical studies performed by the applicant are shown, consistent with the present inventive concepts. Applicant performed clinical studies to investigate histological changes in skin treated with a microcoring procedure, such as a microcoring procedure performed using the systems and methods described herein (e.g., a microcoring procedure performed using system 10). The aim of these studies was to evaluate the histopathology and immunochemistry of the skin and subcutaneous tissue after a single and multiple treatments with microcoring technology of the present inventive concepts (MCT; Ellacor® System). Data generated demonstrated safety at coring depths up to 7mm, as well as the histological effect of this microcoring on human tissue following 1, 2, or 3 treatments.

[0289]

[0286] In a single center-study conducted by applicant, study SI, six female patients scheduled to undergo abdominoplasty were divided into two cohorts. Patients in cohort 1 (safety cohort) received one microcoring treatment of the present inventive concepts that was administered at three treatment depths (4mm, 5mm and 7mm; each depth was administered at a unique test area) and was harvested at 30 days after treatment. Patients in cohort 2 received one, two, or three treatments at a single treatment depth (4mm), with multiple treatments administered at 30-day intervals. At 90 days post initial treatment, tissue sampling and abdominoplasty were performed and histologic evaluations were carried out for all treatment areas. Histopathology of the excised abdominal tissue was performed at a central pathology laboratory and biopsies were evaluated using H&E, Herovici, and Movat stains by blinded evaluators.

[0287] System 10 can be configured to cause in increase (e.g., a clinically significant increase) in new collagen deposition, In study SI, a robust increase in new collagen deposition is observed for one to three treatments using system 10 compared to the untreated control in all subjects. Herovici stain highlighted magenta-staining mature collagen fibers within the reticular dermis and revealed an appreciable increase in new collagen compared to the control tissue in the papillary dermis. Importantly, there was no evidence of inflammation or scarring, consistent with earlier preclinical and clinical histology. All treatment-related adverse events were typical and expected reactions (flaking skin, and redness) and were mild in severity.

[0290]

[0288] Prior to applicant’s studies, the histologic response for various core depths was not completely understood. In study SI, the histological changes that occur following microcoring treatment of the present inventive concepts in human subjects undergoing abdominoplasty surgery are examined and findings confirmed that in addition to skin removal, the microcoring treatment of the present inventive concepts using system 10 results in an increase in collagen in the treated area. For example, at least a 5%, or at least a 10% increase in collagen production (e.g., production of new collagen, immature collages, and / or any collagen) can result when performing a microcoring procedure using system 10 (up to a 20% increase in collagen production was observed in this study). In some embodiments, an increase in collagen can be measured using machine learning and / or other artificial intelligence techniques, such as via an analysis of images of the stained slides, such as to analyze a percentage of purple stain relative to blue stain. For example, a machine learning model can be trained with images of tissue stained using a standard Movat stain. The model can be trained to identify anomalies in images of tissue stained using the Herovici stain, and / or the model can be trained to subtract the two images from the two stains, and to threshold the difference to determine the percentage of new collagen that’s being produced.

[0291]

[0289] Figs. 13 A through 15D show images of stained sections of tissue from various microcoring treatment areas of a first subject of applicant’s study SI, Subject 1 (01-01). Tissue from Subject 1 was harvested 28 days post microcoring treatment. Subject 1 had a microcoring procedure of the present inventive concepts performed using system 10, in three microcoring treatment areas. Treatment area 1 was treated to a depth of 4mm, treatment area 2 was treated to a depth of 5mm, and treatment area 3 was treated to a depth of 7mm. Figs. 13A-D show pictures of hematoxylin and eosin (H&E) stained sections of treatment area 1, treatment area 2, treatment area 3, and a control area, respectively. Figs. 14A-D show pictures of Herovici stained sections of treatment area 1, treatment area 2, treatment area 3, and a control area, respectively. Figs. 15A-D show pictures of Movat stained sections of treatment area 1, treatment area 2, treatment area 3, and a control area, respectively. A substantial increase in new (i.e., immature) collagen deposition is observed in all three microcoring treatment areas compared to the untreated control. Herovici stain highlights magenta-staining mature collagen fibers within the reticular dermis and reveals an appreciable increase in blue-staining immature collagen compared to control tissue, as shown in Figs. 14A-D. This increase in immature collagen is observed in the entire thickness of the reticular dermis and is most prominent in the papillary dermis. Movat stain demonstrates preserved elastic fiber distribution militating against any scar formation, as shown in Figs. 15A-D. No inflammation is seen in these tissue samples.

[0292]

[0290] Figs. 16A through 18D show images of stained sections of tissue from various microcoring treatment areas of a second subject of applicant’s study SI, Subject 2 (01-02). Tissue from Subject 2 was harvested 28 days post microcoring treatment. Subject 2 had a microcoring procedure of the present inventive concepts performed using system 10 in three areas. Treatment area 1 was treated to a depth of 4mm, treatment area 2 was treated to a depth of 5mm, and treatment area 3 was treated to a depth of 7mm. Figs. 16A-D show pictures of hematoxylin and eosin (H&E) stained sections of treatment area 1, treatment area 2, treatment area 3, and a control area, respectively. Figs. 17A-D show pictures of Herovici stained sections of treatment area 1, treatment area 2, treatment area 3, and a control area, respectively. Figs. 18A-D show pictures of Movat stained sections of treatment area 1, treatment area 2, treatment area 3, and a control area, respectively. A substantial increase in immature collagen deposition is observed in all three microcoring treatment areas compared to the untreated control. Herovici stain highlights magenta-staining mature collagen fibers within the reticular dermis and reveals an appreciable increase in blue-staining immature collagen compared to control tissue, as shown in Figs. 17A-D. This increase in immature collagen is observed in the entire thickness of the reticular dermis and is most prominent in the papillary dermis. Movat stain demonstrates preserved elastic fiber distribution militating against any scar formation, as shown in Figs. 18A-D. No inflammation is seen in these tissue samples.

[0293]

[0291] Figs. 19A through 2 ID show images of stained sections of tissue from various microcoring treatment areas of a third subject of applicant’s study SI, Subject 3 (01-03). Tissue from Subject 3 was harvested 28 days post microcoring treatment. Subject 3 had a microcoring procedure of the present inventive concepts performed using system 10 in three areas. Treatment area 1 was treated to a depth of 4mm, treatment area 2 was treated to a depth of 5mm, and treatment area 3 was treated to a depth of 7mm. Figs. 19A-D show pictures of hematoxylin and eosin (H&E) stained sections of treatment area 1, treatment area 2, treatment area 3, and a control area, respectively. Figs. 20A-D show pictures of Herovici stained sections of treatment area 1, treatment area 2, treatment area 3, and a control area, respectively. Figs. 21 A-D show pictures of Movat stained sections of treatment area 1, treatment area 2, treatment area 3, and a control area, respectively. A substantial increase in immature collagen deposition is observed in all three microcoring treatment areas compared to the untreated control. Herovici stain highlights magenta-staining mature collagen fibers within the reticular dermis and reveals an appreciable increase in blue-staining immature collagen compared to control tissue, as shown in Figs. 20A-D. This increase in immature collagen is observed in the entire thickness of the reticular dermis and is most prominent in the papillary dermis. Movat stain demonstrates preserved elastic fiber distribution militating against any scar formation, as shown in Figs. 21 A-D. No inflammation is seen in these tissue samples.

[0294]

[0292] Figs. 22A-24D show images of stained sections of tissue from various microcoring treatment areas performed using system 10 of a fourth subject of applicant’s study SI, Subject 4 (01-04). Tissue from treatment area 1 of Subject 4 was harvested 82 days post microcoring treatment after receiving three separate microcoring treatments, tissue from treatment area 2 of Subject 4 was harvested 41 days post microcoring treatment after receiving two separate microcoring treatments, and tissue from treatment area 3 of Subject 4 was harvested 19 days post microcoring treatment after receiving one microcoring treatment. Figs. 22A-D show pictures of hematoxylin and eosin (H&E) stained sections of treatment area 1, treatment area 2, treatment area 3, and a control area, respectively. Figs. 23 A-D show pictures of Herovici stained sections of treatment area 1, treatment area 2, treatment area 3, and a control area, respectively. Figs. 24A-D show pictures of Movat stained sections of treatment area 1, treatment area 2, treatment area 3, and a control area, respectively. A substantial increase in immature collagen deposition is observed in all three microcoring treatment areas compared to the untreated control. Herovici stain highlights magenta-staining mature collagen fibers within the reticular dermis and reveals an appreciable increase in bluestaining immature collagen compared to control tissue, as shown in Figs. 23 A-D. This increase in immature collagen is observed in the entire thickness of the reticular dermis and is most prominent in the papillary dermis. Movat stain demonstrates preserved elastic fiber distribution militating against any scar formation, as shown in Figs. 24A-D. No inflammation is seen in these tissue samples.

[0293] Figs. 25A-27D show images of stained sections of tissue from various microcoring treatment areas treated using system 10 of a fifth subject of applicant’s study SI, Subject 5 (01-05). Tissue from treatment area 1 of Subject 5 was harvested 89 days post microcoring treatment after receiving three separate microcoring treatments, tissue from treatment area 2 of Subject 5 was harvested 52 days post microcoring treatment after receiving two separate microcoring treatments, and tissue from treatment area 3 of Subject 5 was harvested 31 days post microcoring treatment after receiving one microcoring treatment. Figs. 25A-D show pictures of hematoxylin and eosin (H&E) stained sections of treatment area 1, treatment area 2, treatment area 3, and a control area, respectively. Figs. 26A-D show pictures of Herovici stained sections of treatment area 1, treatment area 2, treatment area 3, and a control area, respectively. Figs. 27A-D show pictures of Movat stained sections of treatment area 1, treatment area 2, treatment area 3, and a control area, respectively. A substantial increase in immature collagen deposition is observed in all three microcoring treatment areas compared to the untreated control. Herovici stain highlights magenta-staining mature collagen fibers within the reticular dermis and reveals an appreciable increase in bluestaining immature collagen compared to control tissue, as shown in Figs. 26A-D. This increase in immature collagen is observed in the entire thickness of the reticular dermis and is most prominent in the papillary dermis. Movat stain demonstrates preserved elastic fiber distribution militating against any scar formation, as shown in Figs. 27A-D. No inflammation is seen in these tissue samples.

[0295]

[0294] Figs. 28A-30D show images of stained sections of tissue from various microcoring treatment areas treated using system 10 of a sixth subject of applicant’s study SI, Subject 6 (01-06). Tissue from treatment area 1 of Subject 6 was harvested 77 days post microcoring treatment after receiving three separate microcoring treatments, tissue from treatment area 2 of Subject 6 was harvested 42 days post microcoring treatment after receiving two separate microcoring treatments, and tissue from treatment area 3 of Subject 6 was harvested 24 days post microcoring treatment after receiving one microcoring treatment. Figs. 28A-D show pictures of hematoxylin and eosin (H&E) stained sections of treatment area 1, treatment area 2, treatment area 3, and a control area, respectively. Figs. 29A-D show pictures of Herovici stained sections of treatment area 1, treatment area 2, treatment area 3, and a control area, respectively. Figs. 30A-D show pictures of Movat stained sections of treatment area 1, treatment area 2, treatment area 3, and a control area, respectively. A substantial increase in immature collagen deposition is observed in all three microcoring treatment areas compared to the untreated control. Herovici stain highlights magenta-staining mature collagen fibers within the reticular dermis and reveals an appreciable increase in bluestaining immature collagen compared to control tissue, as shown in Figs. 29A-D. This increase in immature collagen is observed in the entire thickness of the reticular dermis and is most prominent in the papillary dermis. Movat stain demonstrates preserved elastic fiber distribution militating against any scar formation, as shown in Figs. 30A-D. No inflammation is seen in these tissue samples.

[0296]

[0295] Referring now to Figs. 31A-B and 32A-B, before and after photographs of subjects of a study performed by the applicant are shown, consistent with the present inventive concepts. Applicant performed a study, study S2, to evaluate the effectiveness of a microcoring treatment procedure (MCT), such as a microcoring procedure performed using the systems and methods described herein (e.g., a microcoring procedure performed using system 10). The study s2 also investigated a therapeutic mechanism of action using gene marker analysis. The aim of this study S2 was to evaluate the efficacy of the microcoring procedure of the present concepts using system 10 for minimally invasive skin tightening (MIST) in the mid to lower face and submental area in adult patients. An exploratory endpoint was to characterize the therapeutic mechanism of action using gene marker analysis. The study S2 population included patients with diverse Fitzpatrick skin types from I-V.

[0297]

[0296] In this single-center study, study S2, all patients were treated with three courses of microcoring using system 10. The data described herein comprise interim data from

[0298] 10 patients who have completed the study as of November 2, 2023. Endpoints include gene expression and histologic analysis of microcores removed during day 0 microcoring treatment (baseline sample), as well as those removed at day 45 and 90 following initial microcoring treatment. The qPCR-based gene expression panel comprises 107 target genes, each with established roles in skin biology (anti-aging, cell renewal and regeneration, hydration, wound healing, extracellular matrix integrity, and inflammation, among others). Clinical endpoints are assessed at 90 days following the last of three treatments.

[0299]

[0297] Data from 10 patients comparing genetic markers at baseline to levels at 45 and 90 days are presented. There were substantial and positive responses recorded for collagen and elastin genes in all test subjects compared to baseline versus day 45 and day 90, based on analysis of tissue cores captured using system 10 and examined from the same subject. Subjects also saw upregulation of genes contributing to extracellular matrix integrity including collagen subtypes, elastin, and fibrillin at both 45 and 90 days, with a more robust response at 90 days. System 10 can be configured to perform a microcoring procedure in which these gene modifications (e.g., upregulations) are caused, as demonstrated by study S2.

[0300]

[0298] These interim data captured to date provide a picture of a molecular response to microcoring of the present inventive concepts, showing the first glimpse into mechanism of action on cellular level. In some embodiments, system 10 is configured to perform at least a microcoring procedure as described herein, where at least a 10%, 20%, and / or 30% increase in collagen gene expression results (e.g., increase in COL3A1, Collagen Type Ill Alpha 1 Chain). In this interim data captured to date, there were remarkable increases in collagen gene markers spanning from a 30% to 656% increase in COL3A1 (Collagen Type Ill Alpha 1 Chain) gene expression. These data, coupled with images of clinical response have the potential to identify the molecular hallmarks of clinical response to MIST and to understand the relative contribution of skin excision and induction of neocollagenesis. By understanding the genetic profile of response in a range of patients, and examining the pathways stimulated, this study S2 paves the way for using biomarkers to measure outcomes of intervention and predict response for microcoring-eligible patients.

[0301]

[0299] Referring now to Fig. 33, a method of performing a tissue treatment procedure including a microcoring procedure is illustrated, consistent with the present inventive concepts. Method 1000 of Fig. 33 can be performed with treatment device 100 and / or other devices and / or components of system 10 described in reference to Fig. 1 and otherwise herein. In Step 1010, a pre-coring procedure is performed, such as a procedure configured to prepare the target tissue (e.g., an area of the skin of the patient) for a microcoring procedure. In Step 1020, a microcoring procedure is performed, such as a microcoring procedure performed using treatment device 100 as described herein. In Step 1030, a post-coring procedure is performed, such as a procedure configured to promote healing and / or enhance the efficacy of the microcoring procedure of Step 1020.

[0302]

[0300] In some embodiments, a treatment procedure comprises treating multiple tissue areas, for example, two, three, or more treatment areas, where each tissue area is treated with a single microcoring step (e.g., each Step 1020 treats one tissue area of multiple tissue areas to be treated by the tissue treatment procedure of method 1000). In some embodiments, Steps 1010, 1020, and / or 1030 are performed serially for multiple treatment areas, for example when Step 1010 is performed on a first treatment area, followed by Step 1020 performed on the same treatment area, followed by Step 1030 performed on the same treatment area, prior to Step 1010 and / or Step 1020 being performed on a subsequent treatment area. Alternatively or additionally, Steps 1010, 1020, and / or 1030 can be performed in any sequence, and / or repeatedly for multiple treatment areas sequentially. For example, Steps 1010 and 1020 (e.g., a Step 1010 comprising a tissue cooling procedure and Step 1020 comprising a microcoring procedure, each as described herein) can be performed in an alternating manner for a series of treatment areas, followed by a single Step 1030 configured to treat two or more (e.g., all) of the series of treatment areas treated by Steps 1010 and 1020. In some embodiments, Step 1030 comprises application of an agent (e.g., topical application and / or an intra-dermally injected application), such as agent 60 described herein, to one or more of the treatment areas. In these embodiments, agent 60 can comprise an agent selected from the group consisting of one or more binding agents; an organic compound configured to bind to collagen and / or other tissue protein; Rose Bengal and / or one or more other xanthene compounds; and combinations of these.

[0303]

[0301] As described above and otherwise herein, Step 1010 can comprise a tissue cooling procedure, such as a cryogenic or other cooling procedure configured to reduce the tenting of skin that results when a coring element 155 begins to penetrate a tissue surface, such as when the skin is stiffened by the cooling, such as to reduce the tenting during microcoring. Alternatively, or additionally, Step 1010 can comprise a tissue “softening” procedure, such as a procedure configured to lower the force required for coring element 155 to puncture the tissue. In some embodiments, Step 1010 comprises the application of a topical agent (e.g., agent 60) configured to soften the tissue to lower the puncture force. In some embodiments, Step 1010 comprises a microdermabrasion procedure, such as an abrasion procedure configured to lower the insertion force and / or reduce the skin tenting of coring element 155 insertion into tissue (e.g., by removing a surface layer of the skin prior to microcoring).

[0304]

[0302] Referring now to Figs. 34 and 35, a side view of a treatment device with a portion of a housing removed for illustrative clarity, and a perspective view of a portion of a treatment device and a treatment assembly are illustrated, consistent with the present inventive concepts. Treatment device 100 and / or other components of system 10 described in Figs. 34 and 35 can be of similar construction and arrangement as the similar components described in reference to Fig. 1 and otherwise herein. Treatment device 100 can comprise a handheld and / or otherwise clinician manipulatable portion, housing 110. Housing 110 can encase assemblies and / or other components of treatment device 100, such as at least a portion of actuation assembly 120. In some embodiments, treatment device 100 includes one or more on-board controllers, such as controller 130 shown, that is located within housing 110. Controller 130 can be configured to operably connect and communicate with console 500 (not shown but described herein), for example controller 520 and / or drive module 550 of console 500. Controller 130 can communicate wirelessly and / or with a wired connection to console 500. Controller 130 can include one or more processors and / or microcontrollers, such as an FPGA and / or ASIC microcontroller. In some embodiments, controller 130 is configured to control the movement of actuation assembly 120, for example to control x-y actuation and / or z actuation as described herein.

[0305]

[0303] In some embodiments, housing 110 of treatment device 100 is configured to interchangeably attach to one or more treatment modules 150, for example as shown in Fig. 35. Housing 110 can include connecting portion 160, such as a connecting portion 160 that includes receiving portion 161 and is configured to physically engage a portion of a treatment module 150 (e.g., a “male” receiving portion configured to be slidingly received within a portion of treatment module 150). Receiving portion 161 can include one or more mating and / or alignment features, projections 1611 shown. Actuation assembly 120 can include a motion transfer assembly, shaft assembly 122 shown, that is configured to operably attach to a movable portion of treatment module 150, such that actuation assembly 120 can control the position of the movable portion, as described herein (e.g., to control the position of the movable portion in the x, y, and / or z directions relative to housing 110).

[0306]

[0304] Treatment module 150 can include a structural member, housing 151. Housing 151 can be configured to removably attach to housing 110 of treatment device 100, such that one or more treatment modules 150 (e.g., similar or dissimilar treatment modules 150) can be interchangeably attached to housing 110. In some embodiments, a movable portion of treatment module 150 includes a hub assembly 152 that is movably attached to housing 151, such that hub assembly 152 can translate in one, two, and / or three directions relative to housing 151 and housing 110 (e.g., when treatment module 150 is operably attached to housing 110). Shaft assembly 122 of actuation assembly 120 can be configured to removably attach to hub assembly 152, for example when treatment module 150 is removably attached to housing 110.

[0307]

[0305] In some embodiments, treatment module 150 includes spacer assembly 180, for example when a portion of housing 151 comprises a spacer assembly 180 that is configured to be positioned on the skin of the patient such as to properly position hub assembly 152 relative to the skin for a coring procedure to be performed, for example as described herein. Hub assembly 152 can include an array 1550 of one, two, three, or more coring elements 155. In some embodiments, a portion of housing 151 comprises a frame of spacer assembly 180, frame 185, that surrounds one or more openings, such as window 182 shown. To perform a microcoring treatment, treatment device 100 can be positioned proximate tissue to be treated (e.g., target tissue), such that spacer assembly 180 (e.g., the bottom portion of frame 185) is in contact with the tissue surrounding the target tissue, and the target tissue is located within window 182.

[0308]

[0306] Referring now to Figs. 36-39A, perspective views of a treatment assembly and various embodiments of needle guards are illustrated, consistent with the present inventive concepts. Treatment device 100 and / or other components of system 10 described in Figs. 36- 39A can be of similar construction and arrangement as the similar components described in reference to Fig. 1 and otherwise herein. In some embodiments, treatment module 150 includes a coring element depth limiter, needle guard 153 shown. Needle guard 153 can be configured to provide a physical stop that limits the skin penetration depth of coring elements 155. In some embodiments, needle guard 153 is removably attached to treatment module 150. For example, needle guard 153 can be directly attached to a portion of coring elements 155, such as shown in Figs. 37 and 38, and / or needle guard 153 can removably attach to a portion of hub assembly 152, such as shown in Figs. 36 and 39. In some embodiments, treatment module 150 can include two, three, or more interchangeable needle guards 153, such as interchangeable guards that allow different coring depths. In some embodiments, various needle guards 153 are color coded, such as color coded to indicate the maximum coring depth allowed with each guard in place.

[0309]

[0307] Needle guard 153 can include a spacing element, spacer 1531 shown, that surrounds at least a portion of coring elements 155. Spacer 1531 can comprise a depth Ds that extends in the direction of coring elements 155. Needle guard 153 can limit the penetration depth of coring elements 155 to a depth equal to the length of coring elements 155 less the depth Ds of the guard. Spacer 1531 can include one or more openings, openings 1532 shown, that at least partially surround coring elements 155 when needle guard 153 is positioned on treatment module 150. In some embodiments, opening 1532 comprises one or more slots configured to laterally receive a proximal segment of coring elements 155, such that needle guard 153 can be positioned around and / or removed from coring elements 155 without passing over the distal end of coring elements 155 (e.g., such that the distal ends of coring elements 155 do not need to pass through openings 1532 when needle guard 153 is installed and / or removed from treatment module 150). In some embodiments, needle guard 153 includes one or more mating and / or alignment features, such as clip 1534 shown in Figs. 36 and 36A, and / or projection 1535 shown in Figs. 39 and 39A. For example, clip 1534 can be configured to provide a “snap-fit” connection to hub assembly 152, as shown in Fig. 36. In another example, projection 1535 can be configured to mate with a corresponding recess in hub assembly 152, as shown in Fig. 39.

[0310]

[0308] Referring now to Figs. 40 and 40A-F, various perspective and sectional views of a spacer assembly including a gasket are illustrated, consistent with the present inventive concepts. Spacer assembly 180 and / or other components of system 10 described in Figs. 40 and 40A-F can be of similar construction and arrangement as the similar components described in reference to Fig. 1 and otherwise herein. Fig. 40 shows a partial cut away view of frame 185 of spacer assembly 180. In some embodiments, spacer assembly 180 is configured to stabilize the target tissue within window 182 and / or to stabilize treatment module 150 (e.g., and treatment device 100) relative to the target tissue. For example, spacer assembly 180 can be configured to apply a vacuum to tissue to stabilize the target tissue within window 182 and / or to stabilize treatment module 150.

[0311]

[0309] Frame 185 can include one or more walls surrounding a hollow void, vacuum chamber 183 shown. Vacuum chamber 183 can at least partially surround window 182, for example such that when vacuum is applied to vacuum chamber 183, the tissue (e.g., skin) surrounding the target tissue positioned within window 182 (“surrounding tissue” herein), is secured to frame 185 via the vacuum force. In some embodiments, vacuum chamber 183 can operably attach to a source of vacuum (e.g., negative pressure), such as a source of vacuum provided by console 500, not shown but described herein. In some embodiments, treatment device 100 is configured to provide a source of negative pressure to vacuum chamber 183, for example when functional element 199 of treatment device 100 (not shown) comprises a vacuum pump or other negative pressure source that can be operably attached to vacuum chamber 183. In some embodiments, spacer assembly 180 includes one or more vacuum connection ports and / or conduits, port 186 shown. Port 186 can operably attach to a source of vacuum via one or more vacuum lumens (e.g., one or more tubes fluidly attached to console 500) not shown.

[0312]

[0310] In some embodiments, vacuum chamber 183 comprises a depth Dv and a width Wv, as shown. Depth Dv can comprise an average depth, a maximum depth, and / or a first depth of vacuum chamber 183 (e.g., the depth from the edge of vacuum chamber 183 to a first inward projection, as shown). Width Wv can comprise a minimum width, for example when various portions of vacuum chamber 183 comprise different widths (as shown), an average width, and / or the width of a majority of vacuum chamber 183. Depth Dv can comprise a depth of at least 2mm, such as at least 4mm or at least 6mm. Width Wv can comprise a width of at least 0.5mm, such as at least 1mm, 2mm, 3mm, or 4mm. Width Wv can comprise a width of no more than 10mm, such as no more than 8mm, 6mm, or 4mm. In some embodiments, vacuum chamber 183 provides a break force (e.g., the force required to break the vacuum seal between vacuum chamber 183 and tissue) of at least 6N, such as at least 9N or at least ION.

[0313]

[0311] In some embodiments, spacer assembly 180 includes one or more sealing elements, gasket 184. Figs. 40A and 40B show a perspective view and a cutaway perspective view of a portion of spacer assembly 180 including an embodiment of gasket 184. Gasket 184 can be configured to improve the vacuum seal formed between the skin of the patient and the edges of vacuum chamber 183. In some embodiments, gasket 184 is further configured to manipulate the skin, such as to stretch the target tissue (e.g., skin of the patient) located within window 182. Gaskey 184 can comprise a material, such as a rubber, configured to grip the surface of the skin (e.g., to enhance manipulation of the skin). As shown in Figs. 40A and 40B, gasket 184 can include one or more projections, wings 1841a, b shown, configured to grip the surface of the skin. Wings 1841a,b can be configured to first contact tissue (e.g., the surface of the skin) as frame 185 is positioned (e.g., by the clinician) to be in contact with the tissue, and to deflect outward (e.g., away from window 182), such as to stretch the tissue between wings 1841a, b. In other embodiments, gasket 184 can include a projection, flange 1842, that surrounds at least a portion of gasket 184, for example flange 1842 can fully surround gasket 184 as shown in Figs. 40C-F. Figs. 40C and 40D show perspective views of a portion of spacer assembly 180 and gasket 184, respectively. Figs. 40E and 40F show perspective cutaway views of spacer assembly 180 and gasket 184, respectively. Flange 1842 can be configured to first contact tissue as frame 185 is positioned to be in contact with the tissue, and to deflect outward (e.g., away from window 182 in all directions), such as to stretch the tissue within the perimeter of flange 1842. In some embodiments, gasket 184 is configured to provide a sealing element to the inside, the outside, or both inside and outside edges of vacuum chamber 183. For example, and as shown in Figs. 40A and 40B, gasket 184 can be positioned about the outer edge of vacuum chamber 183. In some embodiments, gasket 184 comprises two or more gaskets each configured to provide a sealing element to an edge of vacuum chamber 183, such as a first gasket 184 that is positioned about the outer edge of vacuum chamber 183 and a second gasket 184 (not shown) that is positioned about the inner edge of vacuum chamber 183. Alternatively or additionally, gasket 184 can comprise an insert that is configured to be positioned within vacuum chamber 183, forming a secondary chamber, vacuum chamber 1843, that is defined within a portion of gasket 184, for example as shown in Figs. 40C-40F. In some embodiments, gasket 184 includes one or more openings, holes 1844 shown in Figs. 40C and 40D. Holes 1844 can be configured to allow vacuum pressure to pass from vacuum chamber 183, through gasket 184, and into vacuum chamber 1843. In some embodiments, gasket 184 includes at least 10 holes 1844. In some embodiments, one or more holes 1844 comprise a diameter of at least 0.5mm. In some embodiments, gasket 184 includes one or more recesses, such as recess 1845a,b shown in Fig. 40F, on the top (skin facing) and bottom (frame facing) sides, respectively. Recess 1845a can be configured to increase the depth of vacuum chamber 1843, such as to a depth at least equal to depth Dv of vacuum chamber 183 described herein. Recess 1845b can be configured to prevent and / or at least limit the likelihood of gasket 184 preventing vacuum from reaching each of holes 1844 (e.g., to prevent gasket 184 from unintentionally sealing a portion of vacuum chamber 183 and not allowing the vacuum source to effectively seal gasket 184 to the skin). In some embodiments, flange 1842 extends from gasket 184 at an angle from the surface normal of the bottom of gasket 184, angle a. Angle a can comprise an angle of no more than 55°, such as no more than 45°, or 35°. In some embodiments, when frame 185 is engaged with the tissue (e.g., gasket 184 is in contact with the tissue and vacuum is applied to create a seal), flange 1842 deflects (e.g., to stretch the target tissue, as described herein) such that angle a approaches 90° (e.g., such that flange 1842 is near-parallel with the surrounding tissue).

[0314]

[0312] Referring additionally to Fig. 41, a photograph showing a perspective view of a treatment assembly including a spacer assembly is illustrated, consistent with the present inventive concepts. Spacer assembly 180 and / or other components of system 10 described in Fig. 41 can be of similar construction and arrangement as the similar components described in reference to Fig. 1 and otherwise herein. Fig. 41 shows gasket 184 comprising an insert that has been positioned within vacuum chamber 183. A vacuum lumen, tube 1831, is shown attached to port 186.

[0315]

[0313] Referring now to Figs. 42A and 42B, perspective views of two embodiments of a spacer assembly including a dual vacuum chamber are illustrated, consistent with the present inventive concepts. Spacer assembly 180 and / or other components of system 10 described in Figs. 42A and 42B can be of similar construction and arrangement as the similar components described in reference to Fig. 1 and otherwise herein. In some embodiments, vacuum chamber 183 comprises multiple independent vacuum chambers, such as two separate chambers 183a and 183b shown in Figs. 42A and 42B. Each chamber 183a, b can be independently fluidly attached to a source of vacuum, such as via ports 186a,b shown that can each controllably attach to one or more vacuum sources, such as via vacuum lumens (e.g., tubes fluidly attached to console 500), not shown.

[0316]

[0314] In some embodiments, treatment device 100 is configured to manipulate tissue (e.g., a skin surface) to maintain a portion of target tissue in an optimized condition for receiving a microcoring treatment (to “present the target tissue” herein). The presentation of target tissue is a critical component to effective microcoring treatments. When a needle (e.g., coring element 155) is punctured into the skin, the skin can deflect a certain amount before the needle cuts through the surface of the skin. This deflection makes it challenging to control the exact puncture depth of the needle relative to the skin surface. An effective way to control skin deflection during microcoring treatments can be for system 10 to tension skin within the treatment area (e.g., to tension the target tissue). In some embodiments, a clinician can manually stretch and tension skin by hand before applying a microcoring treatment using system 10.

[0317]

[0315] In some embodiments, a first vacuum chamber, for example chamber 183a, can be sealed to a portion of surrounding tissue (e.g., by applying vacuum to the chamber). After chamber 183a is sealed to the portion of surrounding tissue, frame 185 can be translated along the tissue (e.g., translated along the plane of the surface of the tissue, in the direction of chamber 183a away from the target tissue), such as to stretch, apply tension to, and / or otherwise manipulate the target tissue positioned within window 182. After the target tissue has been manipulated, a second vacuum chamber, for example chamber 183b, can be sealed to a second portion of surrounding tissue by applying vacuum to the second chamber. In some embodiments, after both chambers 183a,b are sealed to the surrounding tissue (e.g., skin surface), a microcoring procedure can be performed, for example as described herein. In some embodiments, and as shown in Fig. 42B, chamber 183a can comprise a bottom surface that is angled upward from the plane of window 182. In these embodiments, frame 185 can first be positioned near target tissue (e.g., in contact with surrounding tissue) such that vacuum chamber 183a is aligned with the tissue surface, and vacuum chamber 183b (and window 182) is angled relative to and offset from the tissue surface. After a portion of surrounding tissue is sealed to vacuum chamber 183a, frame 185 can be tilted to align vacuum chamber 183b with the tissue surface, positioning the target tissue within window 182. This tilting process can be similar to the process described in reference to Figs. 43 A-C herebelow.

[0318]

[0316] Referring additionally to Figs. 43A-C, a perspective view of the distal portion of a treatment assembly including multiple vacuum chambers, and a two-step process of skin presentation for microcoring, respectively, are illustrated, consistent with the present inventive concepts. Spacer assembly 180 and / or other components of system 10 described in Figs. 43 A-C can be of similar construction and arrangement as the similar components described in reference to Fig. 1 and otherwise herein. In some embodiments, the use of the dual chamber frame shown in Fig. 43 A is configured to allow the clinician to seal the lower chamber (e.g., vacuum chamber 183a) against the skin first. Then the clinician can use frame 185 to stretch the skin (e.g., to stretch the target tissue), thus introducing tension of the skin surface in the treatment area, as shown in Fig. 43B. To maintain this tension in the treatment area, the clinician can then tilt treatment device 100 such that window 182 is flat against the skin, as shown in Fig. 43C, and second chamber 183b can be sealed against the surrounding tissue. When both chambers are sealed, skin tension in the treatment area can be maintained by the constant flow of a vacuum to chamber 183b or chamber 183a and 183b.

[0319]

[0317] In some embodiments, housing 151 of treatment module 150 surrounds hub assembly 152 (not shown but described herein) and is configured to form a fluid-tight seal (e.g., a full or near-fluid-tight seal) to a portion of housing 110, such as to form a fluid-tight chamber (e.g., a full or near-fluid-tight chamber) within housing 151 when frame 185 is positioned on tissue. In these embodiments, vacuum chamber 183b can comprise the fluid- tight chamber within housing 151. In some embodiments, the treatment chamber formed by housing 151 can be similar to treatment chamber 156 described in reference to Figs. 44A and 44B and otherwise herein. In some embodiments, window 182 comprises one or more projections or other tissue manipulating features, not shown, but configured to limit tenting of the tissue that may be caused by the application of vacuum within vacuum chamber 183b.

[0320]

[0318] Referring now to Figs. 44A and 44B, perspective views of two embodiments of a treatment assembly including a treatment chamber are illustrated, consistent with the present inventive concepts. Treatment module 150 and / or other components of system 10 described in Figs. 44A and 44B can be of similar construction and arrangement as the similar components described in reference to Fig. 1 and otherwise herein. In some embodiments, treatment module 150 comprises a chamber surrounding at least coring elements 155 and configured to seal to tissue surrounding target tissue, treatment chamber 156. Some portions and / or components of treatment module 150 can be positioned within treatment chamber 156 (e.g., not shown in Figs. 44A and / or 44B but described herein). In some embodiments, treatment chamber 156 is configured to create a fluid-tight seal (e.g., a full or near-fluid-tight seal) to tissue, such that target tissue is presented within the fluid-tight chamber 156 (e.g., a full or near-fluid-tight chamber 156). In some embodiments, chamber 156 comprises a vacuum chamber, such as a vacuum chamber configured to present the target tissue under vacuum pressure, such as is described herein, for example when chamber 156 comprises vacuum chamber 183.

[0321]

[0319] Chamber 156 can extend from hub assembly 152 to frame 185 of spacer assembly 180, for example as shown in Figs. 44A and 44B. Chamber 156 can include side walls surrounding the chamber between hub assembly 152 and frame 185, such as bellows 1561 shown. Bellows 1561 can extend from a proximal portion of hub assembly 152, as shown in Fig. 44A, and / or from a distal portion of hub assembly 152, as shown in Fig. 44B (e.g., extending from a distal portion of hub assembly 152 proximate coring elements 155, not shown, but positioned on the distal portion of hub assembly 152, as described herein). Bellows 1561 can comprise a fluid-tight seal to a portion of hub assembly 152 and a fluid- tight seal to frame 185, for example such that when frame 185 is sealed to tissue (e.g., when vacuum chamber 183 is sealed to tissue), chamber 156 comprises a fluid-tight chamber surrounding coring elements 155, where the portion of chamber 156 comprising window 182 is sealed with target tissue.

[0322]

[0320] Bellows 1561 can be configured to allow hub assembly 152 to translate in one or more axis (e.g., three axes) relative to frame 185. For example, bellows 1561 can comprise a flexible material configured to allow relative motion between hub assembly 152 and frame 185. Additionally, bellows 1561 can comprise a material that is rigid enough to prevent bellows 1561 from collapsing under vacuum pressure when vacuum is applied to chamber 156. In some embodiments, bellows 1561 includes one or more rigid structural members, such as one or more rigid hoops positioned in the pleats of the bellows to provide structural support to prevent collapse under vacuum.

[0323]

[0321] Referring now to Figs. 45A-D, sectional views of various embodiments of a treatment assembly including a treatment chamber are illustrated, consistent with the present inventive concepts. Treatment module 150 and / or other components of system 10 described in Figs. 45A-D can be of similar construction and arrangement as the similar components described in reference to Fig. 1 and otherwise herein. Fig. 45A shows an embodiment of chamber 156 where bellows 1561 is configured to slidingly attach to hub assembly 152, such that hub assembly 152 can translate in x and y directions relative to bellows 1561. Hub assembly 152 can translate in the z direction (e.g., relative to frame 185) as bellows 1561 expands and contracts to accommodate the translation.

[0324]

[0322] Fig. 45B shows an embodiment of chamber 156 where bellows 1561 is configured to attach to a proximal portion of hub assembly 152, for example as shown in Fig. 44A. Bellows 1561 of Figs. 44A and 45B comprises a longer flexible portion than bellows 1561 of Fig. 44B that attaches to a distal portion of hub assembly 152. The increased length of bellows 1561 can increase the flexibility of bellows 1561 to accommodate translation of hub assembly 152 in the x and y directions relative to frame 185.

[0325]

[0323] Fig. 45C shows an embodiment of chamber 156 where bellows 1561 comprises a diaphragm configured to accommodate translation of hub assembly 152 in the z direction relative to frame 185.

[0326]

[0324] Fig. 45D shows an embodiment of chamber 156 where a portion of hub assembly 152 is slidingly received within chamber 156, such that hub assembly 152 can translate in the z direction relative to frame 185.

[0327]

[0325] Referring now to Figs. 46 and 46A-C, a perspective view, top view, side view, and end view of a release mechanism are illustrated, respectively, consistent with the present inventive concepts. Treatment device 100 and / or other components of system 10 described in Figs. 46 and 46A-C can be of similar construction and arrangement as the similar components described in reference to Fig. 1 and otherwise herein. In some embodiments, as described herein, treatment module 150 is configured to removably and interchangeably attach to housing 110 of treatment device 100. Housing 151 of treatment module 150 and / or connecting portion 160 of housing 110 (each described herein) can comprise a releasing locking mechanism, such as locking mechanism 165 shown in Figs. 46 and 46A-C. Locking mechanism 165 can include slot 1651 shown, which can be configured to slidingly receive a mating portion of an attaching device. Locking mechanism 165 can include a securing portion, clip 1652 shown, including a recess 1653 that is configured to secure to a projection of the mating portion of the attaching device. In some embodiments, clip 1652 is configured to be deflected upward (as shown) to release the projection from recess 1653, allowing the attaching device to be released from the locking mechanism.

[0326] Referring now to Figs. 47A through 47F, an end view, a side view, a top view, a sectional view, a magnified side view and a magnified sectional view of an embodiment of a coring element, respectively, are illustrated, consistent with the present inventive concepts. Coring element 155 and / or other components of system 10 described in Figs. 47A through 47F can be of similar construction and arrangement as the similar components described in reference to Fig. 1 and otherwise herein. As described herein, coring element 155 can comprise a tip (i.e., a distal end portion) comprising one or more bevels, such as one or more bevels from the outer wall of coring element 155 toward the central axis of coring element 155. Each bevel of coring element 155 can comprise two or more bevel portions (e.g., a compound bevel), where each bevel portion can comprise a different bevel angle. For example, as shown in Figs. 47A through 47F, coring element 155 can comprise a Francine tip including three bevels which meet at three points, prongs 1552 shown.

[0328]

[0327] Coring element 155 can include shaft 1551 with lumen 1555 therethrough. One or more portions of shaft 1551 can include a surface modification or a coating, coating 1557 shown and described herein. In some embodiments, coring element 155 includes one or more inward projections, such as barbs 1553, projecting inward into lumen 1555 (for example as shown in Figs. 47D and 47F). Barbs 1553 can comprise: projections that extend no more than 50% into lumen 1555; projections that extend at least 5% into lumen 1555; or both.

[0329]

[0328] Referring now to Figs. 48A and 48B, perspective and side views of an embodiment of a coring element, respectively, are illustrated, consistent with the present inventive concepts. Coring element 155 and / or other components of system 10 described in Figs. 48A and 48B can be of similar construction and arrangement as the similar components described in reference to Fig. 1 and otherwise herein. Coring element 155 can comprise a Francine tip, and can include three bevels which meet at three points, prongs 1552 shown, and as described herein. Coring element 155 can include barb 1553, such as a barb formed from a portion of shaft 1551 that is deformed into lumen 1555. For example, a portion of shaft 1551 can be defined by a laser cut or other relief that is manufactured into the shaft, allowing barb 1553 to be deformed (e.g., bent) inward into lumen 1555, such as shown and as described herein. Barbs 1553 can comprise: projections that extend no more than 50% into lumen 1555; projections that extend at least 5% into lumen 1555; or both.

[0330]

[0329] The above-described embodiments should be understood to serve only as illustrative examples; further embodiments are envisaged. Any feature described herein in relation to any one embodiment may be used alone, or in combination with other features

Claims

described, and may also be used in combination with one or more features of any other of the embodiments, or any combination of any other of the embodiments. Furthermore, equivalents and modifications not described above may also be employed without departing from the scope of the invention, which is defined in the accompanying claims.WHAT IS CLAIMED IS:

1. A system for performing a cosmetic procedure on a patient, the system comprising: at least one treatment device, each treatment device comprising: a set of multiple treatment modules, each treatment module comprising at least one coring element; and at least one actuation assembly, each actuation assembly configured to operably attach at least one treatment module of the set of multiple treatment modules and configured to perform a microcoring procedure comprising the attached treatment module translating in a series of reciprocating motions, each reciprocating motion comprising each coring element of the attached treatment module being inserted into and withdrawn from target tissue of a patient.

2. The system according to claim 1 and / or any one or more other claims herein, wherein the system is configured to cause an increase in collagen in tissue within and / or otherwise proximate the target tissue.

3. The system according to claim 2 and / or any one or more other claims herein, wherein the system is configured to cause an increase in collagen production of at least 5%, and / or at least 10%.

4. The system according to claim 1 and / or any one or more other claims herein, wherein the system is configured to cause an increase in a collagen gene expression within and / or otherwise proximate the target tissue.

5. The system according to claim 4 and / or any one or more other claims herein, wherein the increase in the collagen gene expression is an increase of at least 10%, at least 20%, or at least 30%.

6. The system according to claim 1 and / or any one or more other claims herein, wherein the system is configured to cool the target tissue and / or tissue proximate the target tissue prior to the insertion of each coring element into the target tissue.

7. The system according to claim 6 and / or any one or more other claims herein, wherein the tissue cooled comprises a surface area of no more than 6cm2, 4cm2, 2cm2or 1cm2.

8. The system according to claim 6 and / or any one or more other claims herein, wherein the system cools the tissue via a cooling spray and / or another skin surface treatment applied to target tissue and / or tissue proximate the target tissue.

9. The system according to claim 1 and / or any one or more other claims herein, wherein the system is configured to perform microdermabrasion of the target tissue and / or tissue proximate the target tissue.

10. The system according to claim 9 and / or any one or more other claims herein, wherein the microdermabrasion is configured to lower the insertion force of the at least one coring element into tissue.

11. The system according to claim 9 and / or any one or more other claims herein, wherein the microdermabrasion is configured to reduce tenting that occurs during the insertion of the at least one coring element into tissue.

12. The system according to claim 1 and / or any one or more other claims herein, wherein each coring element of the at least one coring element comprises a lumen including a distal portion with a first diameter and a proximal portion with a second diameter, and wherein the second diameter is larger than the first diameter.

13. The system according to claim 1 and / or any one or more other claims herein, wherein each coring element of the at least one coring element comprises a lumen with a diameter of at least 0.6mm or at least 0.75mm.

14. The system according to claim 13 and / or any one or more other claims herein, wherein each coring element comprises a gauge of no more than 18, 19, or 20.

15. The system according to claim 1 and / or any one or more other claims herein, wherein each coring element of the at least one coring element comprises an insertion length of no more than 6.5mm or 6.0mm.

16. The system according to claim 1 and / or any one or more other claims herein, wherein each coring element of the at least one coring element comprises a tip with a bevel comprising two or more bevel portions, wherein each bevel portion comprises a different bevel angle.

17. The system according to claim 16 and / or any one or more other claims herein, wherein each bevel angle comprises an angle of at least 1°, 5°, 10°, 15°, 20°, 25°, 30°, 35°, 40°, and / or 45°.

18. The system according to claim 16 and / or any one or more other claims herein, wherein each bevel angle comprises an angle of no more than 45°, 40°, 35°, 30°, 25°, 20°, 15°, 10°, 5°, or 1°.

19. The system according to claim 16 and / or any one or more other claims herein, wherein each bevel angle comprises an angle of at least 13° and no more than 17°.

20. The system according to claim 19 and / or any one or more other claims herein, wherein each coring element comprises a Franseen tip including three bevels.

21. The system according to claim 1 and / or any one or more other claims herein, wherein each coring element of the at least one coring element comprises a Coumand tip.

22. The system according to claim 21 and / or any one or more other claims herein, wherein the tip comprises an approximately 30° bevel.

23. The system according to claim 21 and / or any one or more other claims herein, wherein the tip comprises an edge grind with a grind angle of approximately 15°.

24. The system according to claim 1 and / or any one or more other claims herein, wherein each coring element of the at least one coring element comprises a tip with an asymmetric bevel.

25. The system according to claim 1 and / or any one or more other claims herein, wherein each coring element of the at least one coring element comprises a tip with a single, smooth cutting edge.

26. The system according to claim 25 and / or any one or more other claims herein, wherein the cutting edge is sharpened to the inner diameter of the coring element.

27. The system according to claim 1 and / or any one or more other claims herein, wherein each coring element of the at least one coring element comprises a barb comprising a laser-cut portion of the wall of the coring element.

28. The system according to claim 27 and / or any one or more other claims herein, wherein the barb extends at least 0.05mm or 0.10mm into a lumen of the coring element.

29. The system according to claim 1 and / or any one or more other claims herein, wherein each coring element of the at least one coring element comprises a coating.

30. The system according to claim 29 and / or any one or more other claims herein, wherein the coating comprises a titanium nitride coating.

31. The system according to claim 29 and / or any one or more other claims herein, wherein the coring element comprises a tip, and wherein the coating is configured to increase the hardness of at least the tip of the coring element.

32. The system according to claim 1 and / or any one or more other claims herein, wherein the at least one coring element comprises a first set of coring elements configured for use in a first skin type and a second set of coring elements configured for use in a second skin type that is different than the first skin type.

33. The system according to claim 32 and / or any one or more other claims herein, wherein the first skin type and the second skin type each comprise a skin type selected from the group consisting of: tissue of the medial cheek; tissue above boney areas, such as tissue of the jaw, chin, or cheekbone; tissue of the lower eyelids; tissue of the nasolabial fold; tissue of the neck and / or submentum; striae tissue; perioral tissue; soft tissue of the body that is not part of the face; crepey tissue of the body that is not tissue of the face; scar tissue; tattooed tissue; and combinations thereof.

34. The system according to claim 1 and / or any one or more other claims herein, wherein the articulation assembly is further configured to vibrate one or more components of the attached treatment module.

35. The system according to claim 34 and / or any one or more other claims herein, wherein the system is configured to vibrate the at least one coring element during insertion of the least one coring element into the target tissue, such as to reduce insertion force and / or reduce tenting of the skin.

36. The system according to claim 1 and / or any other claim herein, wherein the at least one treatment device further comprises a first housing, and each treatment module further comprises a second housing and a hub assembly, wherein the second housing is configured to operably attach to the first housing, and the hub assembly is configured to operably attach to the at least one articulation assembly, wherein each coring element is configured to articulate relative to the housing, and wherein the hub assembly comprises an array of coring elements that comprises the at least one coring element.

37. The system according to claim 36 and / or any other claim herein, wherein the second housing comprises a spacer assembly configured to be positioned on the skin of the patient and to position the hub assembly for the cosmetic procedure.

38. The system according to claim 37 and / or any other claim herein, wherein the spacer assembly comprises a frame including one or more walls surrounding a chamber, and wherein the chamber is

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