Adjustable implants

Abstract

1. A method comprising: providing an implant comprising at least one actuator configured to expand upon exposure to external energy; implanting the implant at an implantation site between at least one first tissue and at least one second tissue within a patient's body; selectively activating the at least one actuator; and shaping the at least one first tissue and / or the at least one second tissue in accordance with expansion of the activated at least one actuator.

Description

[Technical Field]

[0001] Related Applications This application claims the benefit of priority under 35 U.S.C. § 119(e) to U.S. Provisional Patent Application No. 63 / 408,120, filed September 20, 2022, the contents of which are incorporated herein by reference in their entirety. [Background technology]

[0002] The present invention, in some embodiments thereof, relates to tissue shaping, and more particularly to tissue shaping using adjustable implants.

[0003] US Patent No. US7722670B2 states, "According to one embodiment of the present invention, an implant device may be provided. The implant may be adapted to manipulate the position of an eyeball relative to a patient. The device comprises an insertion device having first and second portions. The first portion may include a first thickness and be adapted to elevate the position of the eyeball. The second portion may have a second thickness and / or a second position for moving the position of the eyeball forward relative to the first portion" (Abstract).

[0004] U.S. Patent No. US10779926B2 states that "a facial implant device includes a support structure adapted to be coupled to a bone surface within a facial region, an outer structure adapted to contour to a predetermined anatomical structure associated with the facial region, and an intermediate bladder structure positioned between the support structure and the outer structure. The intermediate bladder structure includes an internal volume that adjusts in response to adapting the outer structure to the predetermined anatomical structure associated with the facial region" (Abstract).

[0005] U.S. Patent No. US9572676B2 states, "We describe an inflatable balloon for the diagnosis and treatment of diseased intervertebral discs or fractured bones. The balloon is a multi-volume balloon consisting of a plurality of adjustable, expandable single volumes. Further, methods for forming, expanding, and implanting the multi-volume balloon for proper positioning and stabilization of diseased intervertebral discs or fractured bones are disclosed. Furthermore, kits for aligning and stabilizing bones, intervertebral discs, or spinal motion segments are disclosed" (Abstract).

[0006] U.S. Patent Application Publication No. US20070067041A1 states, "An inflatable facial implant includes a base having a first side and a second side. A bladder wall is secured to the first side of the base. The bladder wall is more flexible than the base. A surgical method for using such an implant is also disclosed" (Abstract).

[0007] U.S. Patent Application Publication No. US20100249946A1 describes, "Implantable tissue augmentation devices, methods, and related instruments. These devices include an inflatable body having a self-sealing membrane operably attached to a wall of the implant. The self-sealing membrane provides access for filling the device and includes a first layer comprising a fabric. The fabric has a first plurality of yarn bundles arranged in a first direction and a second plurality of yarn bundles arranged in a second direction. The first and second plurality of yarn bundles intersect to form a matrix pattern having cells defined by spaces between the yarn bundles. The membrane also includes a first elastomeric material configured to fill the cells and form a coating on the first and second plurality of yarn strands, and a second layer comprising a second elastomeric material. The second elastomeric material has a lower durometer hardness than the first elastomeric material. Kits and systems are also disclosed" (abstract).

[0008] Additional background art includes U.S. Patent Application Publication No. US20210369460A1, U.S. Patent Application Publication No. US20140128476A1, U.S. Patent No. 11,090,149B2, and U.S. Patent Application Publication No. US20170296243A1. Summary of the Invention

[0009] Several example embodiments of the present invention are provided below (embodiments may include features from more than one example and / or may not include all features of the examples).

[0010] Example 1. 1. A method for shaping tissue, comprising: providing an implant comprising at least one actuator configured to expand upon exposure to external energy; implanting the implant at an implantation site between at least one first tissue and at least one second tissue within a patient's body; selectively actuating the at least one actuator; shaping the at least one first tissue and / or the at least one second tissue in accordance with expansion of the actuated at least one actuator; A method comprising:

[0011] Example 2. 2. The method of Example 1, wherein the selectively actuating comprises remotely selectively actuating the at least one actuator from a remote location outside the body.

[0012] Example 3. 3. The method of any one of Examples 1 to 2, wherein the selectively actuating comprises selectively heating the at least one actuator to a temperature level that causes the at least one actuator to expand.

[0013] Example 4. 4. The method of example 3, wherein the selectively heating comprises selectively heating the at least one actuator using induction heating.

[0014] Example 5. 5. The method of any one of Examples 3 to 4, wherein the selectively heating comprises exposing the at least one actuator to an electromagnetic field generated outside the body.

[0015] Example 6. 4. The method of example 3, wherein the selectively heating comprises exposing the at least one actuator to at least one of ultrasonic energy, radio frequency energy, a laser, and infrared light.

[0016] Example 7. The method of any one of the preceding examples, wherein the selectively activating occurs during the implantation.

[0017] Example 8. The method of any one of the preceding examples, further comprising allowing the implantation site to heal prior to said selectively activating.

[0018] Example 9. The method of any one of the preceding examples, further comprising repeating the selectively actuating and the shaping if the shaped tissue does not acquire a target shape.

[0019] Example 10. The method of any one of the preceding examples, wherein the providing comprises providing the implant having at least one tissue interface, the at least one actuator coupled to the at least one tissue interface, and the embedding comprises positioning the at least one actuator in contact with the at least one second tissue and positioning the at least one tissue interface in contact with the at least one first tissue.

[0020] Example 11. The method of any one of the preceding examples, wherein the embedding comprises plastically or elastically bending the implant to conform to the surface of the at least one first tissue or the surface of the at least one second tissue.

[0021] Example 12. The method of any one of the preceding examples, further comprising selecting an implant having a target shape and / or target size that fits the implantation site prior to said providing.

[0022] Example 13. The method of any one of the preceding examples, comprising modifying the shape and / or size of the provided implant prior to and / or during implantation to fit the implantation site.

[0023] Example 14. 14. The method of example 13, wherein the modifying comprises changing a number of actuators of the implant.

[0024] Example 15. The method of any one of the preceding examples, wherein the at least one first tissue comprises soft tissue and the at least one second tissue comprises bony tissue, and wherein the shaping comprises shaping the soft tissue in accordance with expansion of the actuated at least one actuator.

[0025] Example 16. 15. The method of any one of Examples 1-14, wherein the at least one first tissue comprises a first soft tissue and the at least one second tissue comprises a second soft tissue, and the shaping comprises shaping the first soft tissue in accordance with expansion of the actuated at least one actuator.

[0026] Example 17. 10. The method of any one of the preceding examples, wherein the at least one actuator comprises a plurality of actuators, and wherein the selectively actuating comprises selectively actuating at least one actuator of the plurality of actuators.

[0027] Example 18. An intracorporeal implant, at least one tissue interface configured to be placed in contact with body tissue; a plurality of actuators coupled to the at least one tissue interface, at least one actuator of the plurality of actuators configured to expand and / or contract upon exposure to external energy; An implant in the body comprising:

[0028] Example 19. The body implant of Example 18, wherein the at least one tissue interface and / or the plurality of actuators are configured to flex.

[0029] Example 20. 20. The body implant of any one of Examples 18 or 19, wherein at least some of the plurality of actuators are coupled to one another by one or more connectors.

[0030] Example 21. 21. The intracorporeal implant of any one of Examples 18 to 20, wherein the actuators are configured to move laterally relative to one another when heated by the external energy.

[0031] Example 22. 22. The intracorporeal implant of any one of Examples 18 to 21, wherein each of the plurality of actuators comprises a shape memory material configured to expand when heated by the external energy.

[0032] Example 23. 23. The intracorporeal implant of Example 22, wherein the shape memory material comprises a shape memory alloy or a shape memory polymer.

[0033] Example 24. 24. The body implant of any one of Examples 22 or 23, wherein each of the plurality of actuators includes a spring formed from the shape memory material configured to expand when heated by the external energy.

[0034] Example 25. The body implant of Example 24, wherein the spring is formed in a spiral or helical shape.

[0035] Example 26. The body implant of Example 24 or 25, wherein each actuator comprises a base to which the spring is coupled, and the bases of two or more actuators are connected to one another to form an array of actuators coupled to the at least one interface.

[0036] Example 27. The body implant according to any one of Examples 18 to 26, wherein the at least one tissue interface comprises at least one soft and / or flexible portion configured to contact body tissue.

[0037] Example 28. The body implant of any one of Examples 18 to 27, wherein the at least one tissue interface includes at least one first surface configured to contact soft body tissue and at least one second surface configured to be coupled to the plurality of actuators.

[0038] Example 29. The intracorporeal implant according to Example 28, wherein the at least one first surface is soft and / or flexible.

[0039] Example 30. 30. The body implant of Example 28 or 29, wherein the at least one tissue interface and / or the at least one first surface comprises at least one expandable chamber.

[0040] Example 31. 30. The body implant of Example 28 or 29, wherein the at least one tissue interface comprises at least one chamber filled with a fluid or gel.

[0041] Example 32. 32. The intracorporeal implant of any one of Examples 18-31, wherein each of the plurality of actuators comprises an individual actuator cover isolating each actuator from the other actuators of the plurality of actuators.

[0042] Example 33. 33. The intracorporeal implant of Example 32, wherein the actuator cover comprises a bellows cover configured to move from a collapsed state to an unfolded state when the actuator is expanded.

[0043] Example 34. 34. The body implant of Example 32 or 33, wherein the actuator cover includes perforations shaped and sized to allow tissue growth through the cover and into the actuator.

[0044] Example 35. The intracorporeal implant according to Example 34, wherein the width of the perforations is within the range of 0.1 mm to 3 mm.

[0045] Example 36. An implant according to any one of Examples 18 to 35, wherein each of the actuators includes a first end coupled to the at least one tissue interface and an opposite second end, and the implant includes tissue contact pads each coupled to the second ends of the actuators, the tissue contact pads configured to contact bone tissue.

[0046] Example 37. An implant according to any one of Examples 18 to 31, comprising a base and an implant cover coupled between the at least one tissue interface and the base, the implant cover surrounding the implant and defining an implant cavity, and the plurality of actuators positioned within the cavity between the at least one tissue interface and the base.

[0047] Example 38. The implant of Example 37, wherein the implant cover includes a fold and is configured to move from a folded state to an unfolded state when at least one actuator of the plurality of actuators expands.

[0048] Example 39. 39. The body implant of Example 37 or 38, wherein the implant cover comprises perforations shaped and sized to allow tissue growth through the cover and into the implant.

[0049] Example 40. The intracorporeal implant according to any one of Examples 37 to 39, wherein the implant cover is integrated with the at least one tissue interface.

[0050] Example 41. An implant according to any one of Examples 37 to 40, comprising a filler material within the lumen, the filler material being configured to expand when at least one of the plurality of actuators expands.

[0051] Example 42. The body implant of any one of Examples 18 to 41, wherein the at least one tissue interface comprises at least one silicone-filled compartment.

[0052] Example 43. The implant of any one of Examples 18 to 42, wherein the implant is configured to move from a collapsed state to an expanded state when the at least one actuator expands, and wherein the thickness of the implant in the collapsed state is in the range of 1 mm to 4 mm.

[0053] Example 44. 1. An inflatable actuator comprising: at least one flexible tissue interface configured to contact tissue; at least one base; at least one expandable cell coupled between the at least one base and the at least one flexible tissue interface; at least one inflation port in the at least one inflatable cell, the at least one inflatable cell configured to expand when inflated through the at least one inflation port; 1. An inflatable actuator comprising:

[0054] Example 45. The expandable actuator of Example 44, wherein the at least one tissue interface comprises silicone.

[0055] Example 46. 46. ​​The inflatable actuator of Example 44 or 45, wherein the at least one tissue interface is dome-shaped.

[0056] Example 47. The body implant according to Example 44 or 46, wherein the inflation port is fluidly coupled to an inflation channel passing through the at least one flexible tissue interface.

[0057] Example 48. An inflatable actuator comprising a plurality of inflatable actuators according to example 44 coupled to one another by at least one connector.

[0058] Example 49. An implant according to Example 48, comprising at least one inflation channel having at least one inflation port, and the inflatable cells of the plurality of inflatable actuators are fluidly coupled to the at least one inflation channel.

[0059] Example 50. An intracorporeal implant, a base having at least one fluid flow path; a plurality of inflatable actuators coupled to the base; Each of the plurality of inflatable actuators comprises: at least one inflatable cell configured to move between a deflated state and an expanded inflated state; at least one inflation port fluidly coupled to the at least one inflatable cell; coupling each of the plurality of inflatable actuators to the base, thereby fluidly connecting the inflation port to the at least one fluid flow path of the base; Internal implants.

[0060] Example 51. The body implant of Example 50, wherein the plurality of expandable actuators are in contact with each other in an array arrangement on the base.

[0061] Example 52. The body implant of Example 50, wherein the plurality of inflatable actuators are spaced apart.

[0062] Example 53. 53. The body implant of any one of Examples 50 to 52, wherein each of the expandable actuators comprises at least one anchoring portion configured to anchor each expandable actuator to the base.

[0063] Example 54. An implant according to any one of Examples 50 to 53, wherein each of the inflatable actuators comprises at least one syringe coupled to the inflation port, and the syringe is inserted into at least one fluid flow path of the base, thereby fluidly connecting the at least one inflatable cell to the at least one fluid flow path.

[0064] Example 55. An intracorporeal implant, an array of actuators formed from shape memory alloy, the actuators being interconnected by shape memory alloy bridges; at least one of the actuators is configured to expand and contract when heated and move laterally relative to other actuators in the array; Internal implants.

[0065] Example 56. 56. The intracorporeal implant of Example 55, wherein the actuator comprises a spring formed from the shape memory alloy.

[0066] Example 57. 57. The body implant of Example 55 or 56, comprising at least one tissue interface having at least one first tissue contacting surface and at least one second surface.

[0067] Example 58. The body implant of Example 57, wherein the at least one tissue interface comprises at least one chamber filled with a fluid or gel.

[0068] Example 59. 1. A multi-unit intracorporeal implant comprising: a plurality of single-unit implants joined together, each single-unit implant comprising: at least one tissue interface configured to be placed in contact with body tissue; at least one expandable actuator coupled to the at least one tissue interface; and at least one connector configured to connect each single-unit implant to at least one different single-unit implant of the plurality of single-unit implants. Multi-unit intracorporeal implant.

[0069] Example 60. 60. The implant of Example 59, wherein the at least one tissue interface is part of the at least one expandable actuator.

[0070] Example 61. 61. The implant of Example 59 or 60, wherein the at least one expandable actuator comprises at least one inflatable chamber, and the at least one expandable actuator is configured to expand when the at least one inflatable chamber is inflated.

[0071] Example 62. 61. The implant of Example 59 or 60, wherein the at least one expandable actuator is formed from a shape memory alloy and configured to expand when heated above a predetermined temperature level.

[0072] Example 63. 63. The implant of any one of Examples 59-62, wherein the at least one connector includes a hinge portion configured to allow movement of the first single-unit implant relative to at least one second single-unit implant connected to the first single-unit implant.

[0073] Example 64. An implant as described in any one of Examples 59 to 63, wherein each single-unit implant comprises a base coupled to the at least one expandable actuator opposite the at least one tissue interface, the base configured to fixedly couple the single-unit implant to tissue.

[0074] Example 65. The implant of Example 64, wherein the base includes one or more openings shaped and sized to allow a screw or nail to pass through the base and enter the tissue to connect the single-unit implant to the body tissue.

[0075] Example 66. An intracorporeal implant, at least one implant cover having a tissue-contacting surface and at least one opposing surface, the at least one implant cover including at least one central portion, at least one edge portion configured to couple the intracorporeal implant to tissue, and at least one hinge portion between the central portion and the edge portion; at least one expandable actuator contacting the at least one opposing surface of the at least one central portion, the at least one expandable actuator configured to move from a collapsed state to an expanded state; the at least one expandable actuator obtains a continuous tissue contact surface of the at least one implant cover by using the hinge portion to press the at least one central portion against the at least one edge portion when the at least one expandable actuator is expanded. Internal implants.

[0076] Additional examples of some embodiments of the present invention are provided below (embodiments may include features from more than one example or may not include all features of the examples).

[0077] Example 1. 1. A method for shaping tissue, comprising: providing an implant comprising at least one actuator configured to expand upon exposure to external energy; implanting the implant at an implantation site between at least one first tissue and at least one second tissue within a patient's body; selectively actuating the at least one actuator; shaping the at least one first tissue and / or the at least one second tissue according to expansion of the at least one actuator actuated in response to the selectively actuating; A method comprising:

[0078] Example 2. 2. The method of Example 1, wherein the selectively actuating comprises remotely selectively actuating the at least one actuator from a remote location outside the body.

[0079] Example 3. 3. The method of any one of Examples 1 to 2, wherein the selectively actuating comprises selectively heating the at least one actuator to a temperature level that causes the at least one actuator to expand.

[0080] Example 4. 4. The method of example 3, wherein the selectively heating comprises exposing the at least one actuator to an electromagnetic field generated outside the body.

[0081] Example 5. 4. The method of example 3, wherein the selectively heating comprises exposing the at least one actuator to at least one of ultrasonic energy, radio frequency energy, a laser, infrared light, or a warm liquid.

[0082] Example 6. The method of any one of the preceding examples, wherein the selectively activating occurs before or during the implantation.

[0083] Example 7. The method of any one of the preceding examples, further comprising allowing the implantation site to heal prior to said selectively activating.

[0084] Example 8. The method of any one of the preceding examples, further comprising repeating the selectively actuating and the shaping if the shaped tissue does not acquire a target shape.

[0085] Example 9. The method of any one of the preceding examples, wherein the providing comprises providing the implant having at least one tissue interface, the at least one actuator coupled to the at least one tissue interface, and the embedding comprises positioning the at least one actuator in contact with the at least one second tissue and positioning the at least one tissue interface in contact with the at least one first tissue.

[0086] Example 10. The method of any one of the preceding examples, wherein the embedding comprises plastically or elastically bending the implant to conform to the surface of the at least one first tissue or the surface of the at least one second tissue.

[0087] Example 11. The method of any one of the preceding examples, comprising modifying the shape and / or size of the provided implant prior to and / or during implantation to fit the implantation site.

[0088] Example 12. 12. The method of example 11, wherein the modifying comprises changing a number of actuators of the implant.

[0089] Example 13. The method of any one of the preceding examples, wherein the at least one first tissue comprises soft tissue and the at least one second tissue comprises bony tissue, and wherein the shaping comprises shaping the soft tissue in accordance with expansion of the actuated at least one actuator.

[0090] Example 14. 13. The method of any one of Examples 1-12, wherein the at least one first tissue comprises a first soft tissue and the at least one second tissue comprises a second soft tissue, and the shaping comprises shaping the first soft tissue in accordance with expansion of the actuated at least one actuator.

[0091] Example 15. 10. The method of any one of the preceding examples, wherein the at least one actuator comprises a plurality of actuators, and wherein the selectively actuating comprises selectively actuating at least one actuator of the plurality of actuators.

[0092] Example 16. 1. An intracorporeal implant configured to be implanted at an implantation site within a body, comprising: at least one actuator positioning base including a plurality of spaced apart actuator coupling regions each configured to couple at least one actuator to the at least one actuator positioning base; a plurality of actuators coupled to the at least one actuator positioning base, at least one actuator of the plurality of actuators configured to expand and / or contract when exposed to energy; An implant in the body comprising:

[0093] Example 17. 17. The body implant of Example 16, wherein the plurality of actuators includes an actuator having an opening.

[0094] Example 18. 18. The body implant of Example 16 or 17, wherein the at least one actuator positioning base is configured to flex.

[0095] Example 19. An implant according to any one of Examples 16 to 18, wherein the actuator positioning base includes at least one opening in each of the plurality of spaced apart actuator coupling regions, and the at least one opening is configured to couple at least one of the plurality of actuators to the actuator positioning base via a snap connection.

[0096] Example 20. The intracorporeal implant according to any one of Examples 16 to 19, wherein at least some of the actuators are coupled to one another by one or more connectors.

[0097] Example 21. The body implant of any one of Examples 16 to 20, wherein the actuators are configured to move laterally relative to one another when heated by the energy.

[0098] Example 22. 22. The body implant of any one of Examples 16 to 21, wherein each of the plurality of actuators comprises a shape memory material configured to expand when heated by the energy.

[0099] Example 23. 23. The intracorporeal implant of Example 22, wherein at least one actuator of the plurality of actuators is configured to expand in a direction substantially perpendicular to the actuator positioning base when heated.

[0100] Example 24. 23. The body implant of Example 22, wherein at least one of the plurality of actuators is configured to expand when heated in a direction oriented at an angle between 10 degrees and 170 degrees relative to the actuator positioning base.

[0101] Example 25. An implant according to any one of Examples 22 to 24, wherein each of the plurality of actuators includes a spring formed from the shape memory material configured to expand when heated by the energy.

[0102] Example 26. The body implant of Example 25, wherein the spring is formed in a spiral or helical shape.

[0103] Example 27. 27. The body implant of Example 25 or 26, wherein each actuator comprises a base to which the spring is coupled, and the bases of two or more actuators are connected to one another to form an array of actuators coupled to the actuator positioning bases.

[0104] Example 28. An implant according to any one of Examples 16 to 27, wherein the actuator positioning base includes a tissue interface having at least one soft and / or flexible portion configured to contact body tissue.

[0105] Example 29. The body implant of Example 28, wherein the tissue interface includes at least one first surface configured to contact soft body tissue and at least one second surface configured to be coupled to the plurality of actuators, and the at least one first surface is soft and / or flexible.

[0106] Example 30. 30. The intracorporeal implant of Example 29, wherein the at least one tissue interface and / or the at least one first surface comprises at least one expandable chamber.

[0107] Example 31. 30. The body implant of Example 29, wherein the at least one tissue interface comprises at least one chamber filled with a fluid or gel.

[0108] Example 32. 32. The intracorporeal implant of any one of Examples 16-31, wherein each of the plurality of actuators comprises an individual actuator cover isolating each actuator from the other actuators of the plurality of actuators.

[0109] Example 33. An implant according to any one of Examples 16 to 32, further comprising a flexible cover coupled to the actuator positioning base, the plurality of actuators being positioned within an internal cavity between the flexible cover and the actuator positioning base.

[0110] Example 34. An implant according to any one of Examples 16 to 33, wherein the at least one actuator positioning base and the plurality of actuators form an array of actuators, the implant comprises a flexible surrounding cover defining an internal cavity, the flexible surrounding cover having an inner surface and an outer surface configured to contact body tissue, and the array of actuators is positioned within the internal cavity and coupled to the inner surface of the flexible cover.

[0111] Example 35. The body implant of Example 33 or 34, wherein the flexible cover includes one or more perforations shaped and sized to allow tissue growth into the body implant and / or fluid injection into the lumen.

[0112] Example 36. An implant according to any one of Examples 16 to 35, wherein each of the actuators includes a first end coupled to the at least one actuator positioning base and an opposite second end, and the implant includes tissue contact pads each coupled to the second ends of the actuators, the tissue contact pads configured to contact bone tissue or soft tissue.

[0113] Example 37. The implant of any one of Examples 16 to 36, wherein the implant is configured to move from a collapsed state to an expanded state when the at least one actuator expands, and wherein the thickness of the implant in the collapsed state is in the range of 1 mm to 4 mm.

[0114] Example 38. An intracorporeal implant, an array of actuators having apertures, each actuator configured to expand when heated; a cover having a tissue-contacting outer surface, the cover enclosing the array of actuators having the openings; An implant in the body comprising:

[0115] Example 39. 39. The body implant of Example 38, wherein the actuator having the opening is formed from a shape memory alloy configured to expand and applies a force to the inner surface of the cover when the shape memory alloy expands.

[0116] Example 40. The body implant of Example 38 or 39, wherein the actuators having the openings are interconnected in the array.

[0117] Example 41. The implant according to any one of Examples 38 to 40, wherein the array and the actuator having the opening are formed as a single unit.

[0118] Example 42. 42. The intracorporeal implant of Example 41, wherein the array and the actuator having the opening are formed as a single unit from a shape memory alloy.

[0119] Example 43. The implant according to any one of Examples 38 to 42, wherein the cover forms a pocket surrounding the array of actuators having the openings.

[0120] Example 44. 44. The body implant according to any one of Examples 38 to 43, wherein any of the opening-containing actuators includes an opening through the body of the opening-containing actuator.

[0121] Example 45. 45. The body implant of Example 44, wherein the actuator having the opening is formed as a stretchable spring.

[0122] Example 46. an inflatable actuator unit, at least one flexible tissue interface configured to contact tissue; at least one base; at least one expandable cell coupled between the at least one base and the at least one flexible tissue interface; at least one inflation port in the at least one inflatable cell, the at least one inflatable cell configured to expand when inflated through the at least one inflation port; the base includes at least one connector configured to connect the inflatable actuator unit to at least one additional inflatable actuator unit and to allow movement of the inflatable actuator unit relative to an adjacent inflatable actuator unit. Inflatable actuator unit.

[0123] Example 47. 47. The inflatable actuator unit of Example 46, wherein the at least one connector comprises at least one of a joint, a hinge, and / or a swivel connector.

[0124] Example 48. 48. The inflatable actuator unit of example 46 or 47, wherein the maximum dimension of the inflatable actuator unit is up to 20 mm.

[0125] Example 49. An intracorporeal implant, 47. An array of a plurality of inflatable actuator units coupled to one another according to Example 46, wherein the array is configured to conform to the curvature of body tissue by movement of one or more inflatable actuator units relative to other inflatable actuator units in the array. Internal implants.

[0126] Example 50. An intracorporeal implant, an array of actuators formed from shape memory alloy, the actuators being interconnected by shape memory alloy bridges; at least one of the actuators is configured to expand and contract when heated and move laterally relative to other actuators in the array; Internal implants.

[0127] Example 51. 1. A multi-unit intracorporeal implant comprising: a plurality of single-unit implants joined together, each single-unit implant comprising: at least one tissue interface configured to be placed in contact with body tissue; at least one expandable actuator coupled to the at least one tissue interface; at least one connector configured to connect each single-unit implant to at least one different single-unit implant of the plurality of single-unit implants; The maximum dimension of each single unit is 20 mm. Multi-unit intracorporeal implant.

[0128] Example 52. 52. The implant of Example 51, wherein the at least one expandable actuator comprises at least one inflatable chamber, and the at least one expandable actuator is configured to expand when the at least one inflatable chamber is inflated.

[0129] Example 53. 53. The implant of Example 52, wherein the at least one expandable actuator is formed from a shape memory alloy and configured to expand when heated above a predetermined temperature level.

[0130] Example 54. An implant as described in any one of Examples 51 to 53, wherein each single-unit implant comprises a base coupled to the at least one expandable actuator opposite the at least one tissue interface, the base including one or more openings shaped and sized to allow screws or nails to penetrate the base into the body tissue so as to couple the single-unit implant to the body tissue.

[0131] Example 55. An intracorporeal implant, at least one implant cover having a tissue-contacting surface and at least one opposing surface, the at least one implant cover including at least one central portion, at least one edge portion configured to couple the intracorporeal implant to tissue, and at least one hinge portion between the central portion and the edge portion; at least one expandable actuator contacting the at least one opposing surface of the at least one central portion, the at least one expandable actuator configured to move from a collapsed state to an expanded state; the at least one expandable actuator obtains a continuous tissue contact surface of the at least one implant cover by using the hinge portion to press the at least one central portion against the at least one edge portion when the at least one expandable actuator is expanded. Internal implants.

[0132] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used to practice or test embodiments of the present invention, exemplary methods and / or materials are described below. In case of conflict, the patent specification, including definitions, will prevail. In addition, the materials, methods, and examples are merely illustrative and are not necessarily intended to be limiting.

[0133] Some embodiments of the present invention will now be described, by way of example only, with reference to the accompanying drawings and images. It is emphasized that the details shown below, with particular reference to the drawings, are for the purposes of illustration and for the purpose of providing a detailed description of embodiments of the present invention. Similarly, from viewing the description in conjunction with the drawings, it will become apparent to those skilled in the art how embodiments of the present invention may be practiced. [Brief explanation of the drawings]

[0134] [Figure 1] 1 is a flowchart of a tissue reshaping process, according to some exemplary embodiments of the present invention. [Figure 2A] 10A-10C are schematic diagrams illustrating the effect of actuation of actuators of implants, according to some exemplary embodiments of the present invention. [Figure 2B] 10A-10C are schematic diagrams illustrating the effect of actuation of actuators of implants, according to some exemplary embodiments of the present invention. [Figure 2C] 1A-1C are schematic diagrams illustrating tissue shaping using an implant having at least one solid-state actuator, according to some exemplary embodiments of the present invention. [Figure 2D] 1A-1C are schematic diagrams illustrating tissue shaping using an implant having at least one solid-state actuator, according to some exemplary embodiments of the present invention. [Figure 3A] 1 is a block diagram of an implant, according to some exemplary embodiments of the present invention. [Figure 3B] 1 is a block diagram of an implant, according to some exemplary embodiments of the present invention. [Figure 3C] 1 is a block diagram of an implant, according to some exemplary embodiments of the present invention. [Figure 3D] 1 is a flowchart of a process for adapting an implant to a particular implantation site and / or a particular treatment, according to some exemplary embodiments of the present invention. [Figure 4] 10 is a flowchart of a facial shaping process according to some exemplary embodiments of the present invention. [Figure 5A] 1 is an image of a spiral spring actuator according to some exemplary embodiments of the present invention. [Figure 5B] 1 is an image of a spiral spring actuator according to some exemplary embodiments of the present invention. [Figure 5C] 1 is an image of a spiral spring actuator according to some exemplary embodiments of the present invention. [Figure 5D]1 is an image of a spiral spring actuator according to some exemplary embodiments of the present invention. [Figure 5E] 1A-1C are schematic illustrations of implants comprising multiple spiral actuators, according to some exemplary embodiments of the present invention. [Figure 5F] 1A-1C are schematic illustrations of implants comprising multiple spiral actuators, according to some exemplary embodiments of the present invention. [Figure 6A] 1A-1C are schematic diagrams of solid-state actuators with rectangular bases, according to some exemplary embodiments of the present invention. [Figure 6B] 1A-1C are schematic diagrams of solid-state actuators with rectangular bases, according to some exemplary embodiments of the present invention. [Figure 6C] 1A-1C are schematic diagrams of solid-state actuators with rectangular bases, according to some exemplary embodiments of the present invention. [Figure 6D] 1A-1C are schematic diagrams of solid-state actuators with rectangular bases, according to some exemplary embodiments of the present invention. [Figure 7A] 1 is a schematic diagram of an array of spiral actuators, according to some exemplary embodiments of the present invention; [Figure 7B] 1 is a schematic diagram of an array of spiral actuators, according to some exemplary embodiments of the present invention; [Figure 7C] 1 is a schematic diagram of an array of spiral actuators, according to some exemplary embodiments of the present invention; [Figure 7D] 1 is a schematic diagram of an array of spiral actuators, according to some exemplary embodiments of the present invention; [Figure 7E] 1 is a schematic diagram of an array of spiral actuators, according to some exemplary embodiments of the present invention; [Figure 7F] 1 is a schematic diagram of an array of spiral actuators, according to some exemplary embodiments of the present invention; [Figure 7G] 1 is a schematic diagram of an array of spiral actuators, according to some exemplary embodiments of the present invention; [Figure 7H]1 is a schematic diagram of an array of spiral actuators, according to some exemplary embodiments of the present invention; [Figure 7I] 1 is a schematic diagram of an array of spiral actuators, according to some exemplary embodiments of the present invention; [Figure 7J] 1 is a schematic diagram of an array of spiral actuators, according to some exemplary embodiments of the present invention; [Figure 7K] 1A-1C are schematic diagrams illustrating shaping of an implant, according to some exemplary embodiments of the present invention. [Figure 7L] 1A-1C are schematic diagrams illustrating shaping of an implant, according to some exemplary embodiments of the present invention. [Figure 8A] 1A-1C are schematic illustrations of implants comprising multiple spiral actuators, according to some exemplary embodiments of the present invention. [Figure 8B] 1A-1C are schematic illustrations of implants comprising multiple spiral actuators, according to some exemplary embodiments of the present invention. [Figure 8C] 1A-1C are schematic illustrations of implants comprising multiple spiral actuators, according to some exemplary embodiments of the present invention. [Figure 8D] 1A-1C are schematic illustrations of implants comprising multiple spiral actuators, according to some exemplary embodiments of the present invention. [Figure 8E] 1A-1C are schematic diagrams of a spiral actuator and a screw passing through an opening in the spiral actuator, according to some exemplary embodiments of the present invention. [Figure 9A] 10A-10C are schematic diagrams illustrating the mounting and cover of a spring actuator according to some exemplary embodiments of the present invention. [Figure 9B] 10A-10C are schematic diagrams illustrating the mounting and cover of a spring actuator according to some exemplary embodiments of the present invention. [Figure 9C] 10A-10C are schematic diagrams illustrating the mounting and cover of a spring actuator according to some exemplary embodiments of the present invention. [Figure 9D] 10A-10C are schematic diagrams illustrating the mounting and cover of a spring actuator according to some exemplary embodiments of the present invention. [Figure 9E] 10A-10C are schematic diagrams illustrating the mounting and cover of a spring actuator according to some exemplary embodiments of the present invention. [Figure 9F] 10A-10C are schematic diagrams illustrating the mounting and cover of a spring actuator according to some exemplary embodiments of the present invention. [Figure 9G] 10A-10C are schematic diagrams illustrating the mounting and cover of a spring actuator according to some exemplary embodiments of the present invention. [Figure 10A] 1A-1C are schematic diagrams of implants with a single actuator, according to some exemplary embodiments of the present invention. [Figure 10B] 1A-1C are schematic diagrams of implants with a single actuator, according to some exemplary embodiments of the present invention. [Figure 10C] 1A-1C are schematic diagrams of implants with a single actuator, according to some exemplary embodiments of the present invention. [Figure 11A] 1 is a schematic diagram of an implant having multiple solid implants, according to some exemplary embodiments of the present invention. [Figure 11B] 1 is a schematic diagram of an implant having multiple solid implants, according to some exemplary embodiments of the present invention. [Figure 11C] 1 is a schematic diagram of an implant having multiple solid implants, according to some exemplary embodiments of the present invention. [Figure 11D] 1 is a schematic diagram of an implant having multiple solid implants, according to some exemplary embodiments of the present invention. [Figure 12A] 1A-1C are schematic diagrams of modular implants formed from single-unit implants, according to some exemplary embodiments of the present invention. [Figure 12B] 1A-1C are schematic diagrams of modular implants formed from single-unit implants, according to some exemplary embodiments of the present invention. [Figure 12C] 1A-1C are schematic illustrations of an implant within a body, where the tissue contacting surface of the implant cover attains a uniform, smooth shape as the cover expands, according to some exemplary embodiments of the present invention. [Figure 12D] 1A-1C are schematic illustrations of an implant within a body, where the tissue contacting surface of the implant cover attains a uniform, smooth shape as the cover expands, according to some exemplary embodiments of the present invention. [Figure 12E] 1A-1C are schematic illustrations of an implant within a body, where the tissue contacting surface of the implant cover attains a uniform, smooth shape as the cover expands, according to some exemplary embodiments of the present invention. [Figure 12F] 1A-1C are schematic illustrations of an implant within a body, where the tissue contacting surface of the implant cover attains a uniform, smooth shape as the cover expands, according to some exemplary embodiments of the present invention. [Figure 13A] 1 is a schematic diagram of a wave spring actuator, according to some exemplary embodiments of the present invention; [Figure 13B] 1 is a schematic diagram of a wave spring actuator, according to some exemplary embodiments of the present invention; [Figure 14A] 1A-1C are schematic illustrations of enclosed expandable implants, according to some exemplary embodiments of the present invention. [Figure 14B] 1A-1C are schematic illustrations of enclosed expandable implants, according to some exemplary embodiments of the present invention. [Figure 14C] 1A-1C are schematic illustrations of enclosed expandable implants, according to some exemplary embodiments of the present invention. [Figure 14D] 1A-1C are schematic illustrations of enclosed expandable implants, according to some exemplary embodiments of the present invention. [Figure 14E] 1A-1C are schematic illustrations of enclosed expandable implants, according to some exemplary embodiments of the present invention. [Figure 15A] 1A-1C are schematic diagrams of flexible implants, according to some exemplary embodiments of the present invention. [Figure 15B] 1A-1C are schematic diagrams of flexible implants, according to some exemplary embodiments of the present invention. [Figure 15C] 1A-1C are schematic diagrams of flexible implants, according to some exemplary embodiments of the present invention. [Figure 15D]1A-1C are schematic diagrams of flexible implants, according to some exemplary embodiments of the present invention. [Figure 15E] 1A-1C are schematic diagrams of flexible implants, according to some exemplary embodiments of the present invention. [Figure 15F] 1A-1C are schematic diagrams of flexible implants, according to some exemplary embodiments of the present invention. [Figure 15G] 1A-1C are schematic diagrams of flexible implants, according to some exemplary embodiments of the present invention. [Figure 16] 1A-1C are schematic diagrams of a flexible implant positioned in the jaw region of the skull, according to some exemplary embodiments of the present invention. [Figure 17A] 1A-1C are schematic illustrations of implants comprising multiple actuators coupled between two layers of material, for example, mesh material, according to some exemplary embodiments of the present invention. [Figure 17B] 1A-1C are schematic illustrations of implants comprising multiple actuators coupled between two layers of material, for example, mesh material, according to some exemplary embodiments of the present invention. [Figure 17C] 1A-1C are schematic illustrations of implants comprising multiple actuators coupled between two layers of material, for example, mesh material, according to some exemplary embodiments of the present invention. [Figure 17D] 1A-1C are schematic illustrations of implants comprising multiple actuators coupled between two layers of material, for example, mesh material, according to some exemplary embodiments of the present invention. [Figure 18A] 1A-1C are schematic illustrations of implants with multiple independent actuators, according to some exemplary embodiments of the present invention. [Figure 18B] 1A-1C are schematic illustrations of implants with multiple independent actuators, according to some exemplary embodiments of the present invention. [Figure 18C] 1A-1C are schematic illustrations of implants with multiple independent actuators, according to some exemplary embodiments of the present invention. [Figure 18D] 1A-1C are schematic illustrations of implants with multiple independent actuators, according to some exemplary embodiments of the present invention. [Figure 19A] 1A-1C are schematic diagrams of implants with multiple independent spring actuators, according to some exemplary embodiments of the present invention. [Figure 19B] 1A-1C are schematic diagrams of implants with multiple independent spring actuators, according to some exemplary embodiments of the present invention. [Figure 19C] 1A-1C are schematic diagrams of implants with multiple independent spring actuators, according to some exemplary embodiments of the present invention. [Figure 20A] 1A-1C are schematic illustrations of implants with multiple independent spring actuators positioned in sockets at the tissue interface, according to some exemplary embodiments of the present invention. [Figure 20B] 1A-1C are schematic illustrations of implants with multiple independent spring actuators positioned in sockets at the tissue interface, according to some exemplary embodiments of the present invention. [Figure 20C] 1A-1C are schematic illustrations of implants with multiple independent spring actuators positioned in sockets at the tissue interface, according to some exemplary embodiments of the present invention. [Figure 21A] 1A-1C are schematic illustrations of implants comprising multiple low-profile expandable actuators, according to some exemplary embodiments of the present invention. [Figure 21B] 1A-1C are schematic illustrations of implants comprising multiple low-profile expandable actuators, according to some exemplary embodiments of the present invention. [Figure 21C] 1A-1C are schematic illustrations of implants comprising multiple low-profile expandable actuators, according to some exemplary embodiments of the present invention. [Figure 21D] 1A-1C are schematic illustrations of implants comprising multiple low-profile expandable actuators, according to some exemplary embodiments of the present invention. [Figure 21E] 1A-1C are schematic illustrations of implants comprising multiple low-profile expandable actuators, according to some exemplary embodiments of the present invention. [Figure 21F]1A-1C are schematic illustrations of implants comprising multiple low-profile expandable actuators, according to some exemplary embodiments of the present invention. [Figure 21G] 1A-1C are schematic illustrations of implants comprising multiple low-profile expandable actuators, according to some exemplary embodiments of the present invention. [Figure 22A] 1A-1C are schematic diagrams of implants with expandable chambers in a collapsed state, according to some exemplary embodiments of the present invention. [Figure 22B] 1A-1C are schematic illustrations of implants with expandable chambers in an expanded state, according to some exemplary embodiments of the present invention. [Figure 22C] 1A-1C are schematic illustrations of implants with multiple inflatable actuators, according to some exemplary embodiments of the present invention. [Figure 22D] 1A-1C are schematic illustrations of implants with multiple inflatable actuators, according to some exemplary embodiments of the present invention. [Figure 22E] 1A-1C are schematic illustrations of implants with multiple inflatable actuators, according to some exemplary embodiments of the present invention. [Figure 23A] 1 is a schematic diagram of a modular implant including multiple single-unit actuators or implants, according to some exemplary embodiments of the present invention. [Figure 23B] 1 is a schematic diagram of a modular implant including multiple single-unit actuators or implants, according to some exemplary embodiments of the present invention. [Figure 23C] 1 is a schematic diagram of a modular implant including multiple single-unit actuators or implants, according to some exemplary embodiments of the present invention. [Figure 23D] 1 is a schematic diagram of a modular implant including multiple single-unit actuators or implants, according to some exemplary embodiments of the present invention. [Figure 23E] 1 is a schematic diagram of a modular implant including multiple single-unit actuators or implants, according to some exemplary embodiments of the present invention. [Figure 24A] 1A-1C are schematic illustrations of implants with multiple inflatable actuators, optionally arranged in an array, according to some exemplary embodiments of the present invention. [Figure 24B] 1A-1C are schematic illustrations of implants with multiple inflatable actuators, optionally arranged in an array, according to some exemplary embodiments of the present invention. [Figure 24C] 1A-1C are schematic illustrations of implants with multiple inflatable actuators, optionally arranged in an array, according to some exemplary embodiments of the present invention. [Figure 24D] 1A-1C are schematic diagrams illustrating the assembly of an inflatable actuator to form an implant, according to some exemplary embodiments of the present invention. [Figure 24E] 1A-1C are schematic diagrams illustrating the assembly of an inflatable actuator to form an implant, according to some exemplary embodiments of the present invention. [Figure 25A] 1A-1C are schematic diagrams illustrating the assembly of an actuator array, according to some exemplary embodiments of the present invention. [Figure 25B] 1A-1C are schematic diagrams illustrating the assembly of an actuator array, according to some exemplary embodiments of the present invention. [Figure 25C] 1A-1C are schematic diagrams illustrating the assembly of an actuator array, according to some exemplary embodiments of the present invention. [Figure 25D] 10A-10C are schematic diagrams illustrating coupling of actuators to a single base, for example via a snap connection, according to some exemplary embodiments of the present invention. [Figure 25E] 1A-1C are schematic diagrams illustrating craniocaudal placement of actuators on a base, according to some exemplary embodiments of the present invention. [Figure 26A] 1A-1C are schematic diagrams illustrating assembly of an implant, according to some exemplary embodiments of the present invention. [Figure 26B] 1A-1C are schematic diagrams illustrating assembly of an implant, according to some exemplary embodiments of the present invention. [Figure 26C]1A-1C are schematic diagrams illustrating assembly of an implant, according to some exemplary embodiments of the present invention. [Figure 26D] 1A-1C are schematic diagrams illustrating assembly of an implant, according to some exemplary embodiments of the present invention. [Figure 26E] 1A-1C are schematic diagrams illustrating assembly of an implant, according to some exemplary embodiments of the present invention. [Figure 27A] 10A-10C are schematic diagrams illustrating the assembly of an implant, according to some additional exemplary embodiments of the present invention. [Figure 27B] 10A-10C are schematic diagrams illustrating the assembly of an implant, according to some additional exemplary embodiments of the present invention. [Figure 27C] 10A-10C are schematic diagrams illustrating the assembly of an implant, according to some additional exemplary embodiments of the present invention. [Figure 28A] 1A-1C are schematic diagrams illustrating implants including chambers and internal actuator arrays, according to some exemplary embodiments of the present invention. [Figure 28B] 1A-1C are schematic diagrams illustrating implants including chambers and internal actuator arrays, according to some exemplary embodiments of the present invention. [Figure 28C] 1A-1C are schematic diagrams illustrating implants including chambers and internal actuator arrays, according to some exemplary embodiments of the present invention. [Figure 28D] 1A-1C are schematic diagrams illustrating implants including chambers and internal actuator arrays, according to some exemplary embodiments of the present invention. [Figure 28E] 28A-28D are images illustrating the use of the implant shown in FIGS. 28A-28D as a temple implant, according to some exemplary embodiments of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0135] The present invention, in some embodiments thereof, relates to tissue shaping, and in particular to tissue shaping using adjustable implants.

[0136] An aspect of some embodiments of the present invention relates to shaping body tissue by selectively activating at least one actuator (e.g., a solid-state actuator) within an internal implant (e.g., a filled implant) by exposing the at least one actuator to external energy from outside the body. In some embodiments, the implant comprises multiple actuators, and at least one of the multiple actuators is selectively activated. In some embodiments, activating includes providing energy to at least one solid-state actuator within the implant, causing the actuator to expand and / or contract. In some embodiments, the expansion or collapse of the actuator reshapes the filled implant, for example, locally, changing the shape of tissue in contact with the implant. In some embodiments, activating includes transmitting energy to the at least one actuator beyond the skin surface without physically penetrating the skin. In some embodiments, energy is applied directly to the solid-state actuator or is delivered to the solid-state actuator via tissue in contact with the solid-state actuator. In some embodiments, energy is delivered to the actuator or tissue in contact with the actuator in the form of waves throughout the body.

[0137] According to some exemplary embodiments, the actuator is an apertured actuator and includes one or more apertures. In some embodiments, the one or more apertures traverse the body of the actuator. In some embodiments, the actuator is formed as a spring with an aperture traversing the body of the spring.

[0138] According to some embodiments, the energy used to actuate the actuator is provided in the form of, for example, ultrasound, radio frequency waves, electromagnetic fields, and electromagnetic waves. In some embodiments, the energy is provided from at least one energy source located outside the body and / or at least one energy source located inside the body, for example, in a body cavity or duct. In some embodiments, the term external energy refers to energy generated from an energy source located outside the body.

[0139] According to some exemplary embodiments, the supplied energy includes thermal energy supplied by, for example, induction heating, magnetic induction, and electromagnetic induction. Alternatively, the energy is supplied using at least one of ultrasound, radio frequency, and infrared.

[0140] In some embodiments, induction heating parameters include generating magnetic induction at a frequency in the range of 25 Khz to 1000 Khz, e.g., 25 Khz to 200 Khz, 100 Khz to 400 Khz, 200 Khz to 600 Khz, 500 Khz to 1000 Khz, 50 Khz, 100 Khz, or any intermediate, lesser, or greater frequency or frequency range. In some embodiments, magnetic induction is generated to induce heating for 40 seconds, 60 seconds, 100 seconds, or any intermediate, lesser, or greater value or range of values ​​within a time period in the range of 15 seconds to 120 seconds (e.g., 15 seconds to 50 seconds, 30 seconds to 100 seconds, 70 seconds to 120 seconds).

[0141] According to some embodiments, the actuators are arranged in an array within the implant, e.g., a two-dimensional array, a linear array, or a circular array. In some embodiments, the implant is modular, and the actuators are configured to be assembled or disassembled from the array, e.g., to fit the size and / or shape of the implantation site. In some embodiments, the modular implant includes multiple similar and / or different units assembled to form a single implant. In some embodiments, each unit includes at least one exposed actuator (e.g., an aperture or inflatable actuator), at least one covered or enclosed actuator, a unit including an actuator and a base, or a unit including an actuator coupled to a base and at least partially enclosed within a cover. In some embodiments, the modular implant is formed by placing two or more units side by side or one above the other. Furthermore, in a modular implant, two or more units are coupled to shared elements of the implant, e.g., a shared base, a shared cover, a shared inflation tube. In some embodiments, in a modular implant, two or more units are reversibly assembled to form the modular implant, e.g., reversibly coupled in a manner that allows for separation without irreversibly deforming the implant or the units.

[0142] According to some exemplary embodiments, two or more units are connected to one another, e.g., side-by-side, via at least one connector on one or both units. In some embodiments, the connector is configured to allow movement of each unit relative to adjacent connected units. In some embodiments, the connector includes at least one of a joint, a hinge, and / or a swivel connector.

[0143] According to some embodiments, the maximum dimension, e.g., maximum width, thickness, and / or length, of each unit is at most 20 mm, e.g., at most 15 mm, at most 10 mm, at most 7 mm, at most 5 mm, at most 3 mm, at most 2 mm, or any intermediate, smaller, or larger value. In some embodiments, the maximum dimension is the dimension of the unit when the unit is in a compressed, e.g., maximally compact, state.

[0144] In some embodiments, the actuators are spaced apart from other actuators in the array, hi some embodiments, each actuator, or at least some of the actuators in the array, are configured to expand and / or contract independently of the other actuators.

[0145] An aspect of some embodiments relates to an inflatable actuator including at least one inflatable cell configured to expand upon inflation. In some embodiments, the at least one inflatable cell is disposed between at least one flexible tissue interface configured to contact soft tissue and at least one base. In some embodiments, the base of the inflatable actuator is configured to be coupled to bone tissue using, for example, at least one screw, pin, or nail.

[0146] According to some exemplary embodiments, the inflatable actuator includes at least one inflation port in the at least one inflatable cell, hi some embodiments, inflating the at least one inflatable cell through the at least one inflation port expands the at least one inflatable cell, thereby increasing the distance between the at least one flexible tissue interface and the base.

[0147] According to some exemplary embodiments, the at least one inflation port is fluidly connected to at least one fluid passageway, for example, a fluid passageway passing through the at least one flexible interface. Alternatively or additionally, the at least one passageway passes through the base of the actuator.

[0148] According to some exemplary embodiments, an intracorporeal implant includes multiple inflatable actuators connected to one another using at least one connector or at least one anchor, hi some embodiments, at least one connector includes a hinge configured to allow at least one inflatable actuator to move relative to other actuators of the implant, such as adjacent actuators.

[0149] One aspect of some embodiments relates to an intracorporeal implant including a base and a plurality of inflatable actuators connected to the base. In some embodiments, the base includes at least one inflation channel fluidly connected to at least one inflatable cell of each inflatable actuator. In some embodiments, the at least one inflation channel is configured to allow fluid to enter the inflatable cell, e.g., to allow inflation and expansion of the inflatable actuator. Alternatively, each inflatable cell includes a separate inflation port to allow inflation of each inflatable cell independently of other inflatable cells of the implant.

[0150] According to some exemplary embodiments, each inflatable actuator includes at least one locking portion, for example, to enable securing of the inflatable actuator to the implant base, hi some embodiments, the at least one locking portion includes an interference lock or a snap-fit ​​locking portion.

[0151] According to some exemplary embodiments, each inflatable actuator includes a plug-in portion connected to the inflatable cell configured to allow easy connection of the inflatable cell to at least one inflation channel of the implant base, hi some embodiments, the plug-in portion includes a syringe.

[0152] One aspect of some embodiments relates to an array of expandable compartments, each having at least one solid-state actuator. In some embodiments, actuation of at least one solid-state actuator in an expandable state causes each expandable compartment to move between a collapsed state and an expanded state. In some embodiments, the array comprises a two-dimensional array (2D array) or linear array of expandable compartments. In some embodiments, the array comprises a substrate, e.g., a flexible substrate, to which the expandable compartments or at least one solid-state actuator are connected.

[0153] According to some embodiments, the expandable compartments are configured to expand and contract along a similar axis, or alternatively, at least some of the expandable compartments are configured to expand along a different axis relative to other expandable compartments of the array.

[0154] According to some embodiments, the array is a modular array, where one or more expandable compartments can be reversibly assembled to form and / or disassembled from the array. In some embodiments, the expandable compartments of the array are movable relative to one another, e.g., at least one expandable compartment is configured to move laterally relative to at least one different expandable compartment of the same array.

[0155] An aspect of some embodiments relates to a modular implant (e.g., an adjustable implant for shaping tissue, including multiple single-unit expandable implants). In some embodiments, each single-unit implant includes at least one expandable actuator and at least one tissue interface connected to the at least one expandable actuator. In some embodiments, the multiple single-unit implants are connected to one another using at least one connector (e.g., a hinge). In some embodiments, the multiple single-unit implants are reversibly connected to one another, for example, to allow for disassembly of the modular implant. Alternatively, the multiple single-unit implants are irreversibly connected to one another.

[0156] According to some exemplary embodiments, the actuator of the single-unit implant comprises a solid-state actuator, such as an actuator formed from a shape memory alloy. Alternatively or additionally, the actuator of the single-unit implant includes an expandable cell, such as a balloon.

[0157] One aspect of some embodiments relates to an intracorporeal implant that includes an array of actuators formed from a shape memory alloy. In some embodiments, the actuators are interconnected by shape memory alloy bridges configured to allow lateral movement relative to other actuators in the array, e.g., when heated above a predetermined temperature level. In some embodiments, heating the actuator array causes the actuators to expand along an axis perpendicular to the longitudinal axis of the array.

[0158] One aspect of some embodiments relates to an intracorporeal implant having at least one implant cover. The cover includes a central portion and an edge portion interconnected by a hinge portion (e.g., a hinge portion of the cover). In some embodiments, when the intracorporeal implant is in a collapsed state, the tissue-contacting surface of the cover is non-uniform, for example, including at least one indentation in the hinge portion. In some embodiments, when the implant expands, the central portion moves relative to the edge portion to create a uniform, continuous, and / or smooth tissue-contacting surface.

[0159] According to some exemplary embodiments, the cover surrounds at least one expandable actuator disposed within the implant, optionally in contact with a central portion of the cover. In some embodiments, expansion of the at least one actuator expands the implant and moves the central portion relative to an edge portion of the cover. In some embodiments, the edge portion of the cover is used to secure the implant to tissue (e.g., bone tissue). In some embodiments, the edge portion bends inward toward an implant cavity defined by the cover, allowing the implant to be connected to bone tissue, for example, through one or more openings in the edge portion.

[0160] In some embodiments, the thickness of the intracorporeal implant in a compact, e.g., folded, state is a value in the range of 0.5 mm to 4 mm (e.g., 0.5 mm to 2 mm, 1 mm to 3 mm, 1 mm to 4 mm, 2 mm to 4 mm), or any intermediate, smaller, or larger value or range of values. In some embodiments, the thickness of the intracorporeal implant in a fully expanded state is a value in the range of 3 mm to 25 mm (e.g., 3 mm to 7 mm, 5 mm to 10 mm, 7 mm to 17 mm, 12 mm to 25 mm), or any intermediate, smaller, or larger value or range of values. In some embodiments, the maximum width and / or maximum length of the intracorporeal implant is a value in the range of 10 mm to 80 mm (e.g., 10 mm to 30 mm, 10 mm to 20 mm, 15 mm to 40 mm, 20 mm to 70 mm, 40 mm to 100 mm), or any intermediate, smaller, or larger value or range of values. In some embodiments, the weight of the internal implant is a value in the range of 0.1 g to 50 g (eg, a range of 10 g to 30 g, 15 g to 40 g, 20 g to 50 g), or any intermediate value or range of values.

[0161] Before describing at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of elements and / or methods set forth in the following description and / or illustrated in the drawings and / or examples. The invention is capable of other embodiments and of being practiced or carried out in various ways.

[0162] Exemplary General Tissue Shaping Process According to some exemplary embodiments, tissue shaping is performed for aesthetic and / or functional reasons. In some embodiments, tissue shaping is performed, for example, in the face, to correct congenital defects, defects caused by surgical removal of tissue, such as when a tumor is removed, defects caused by trauma to tissue, such as accidents resulting in changes in bone structure and / or soft tissue changes. In some embodiments, tissue shaping is performed to correct aesthetic defects, such as age-related aesthetic defects or aesthetic defects that cause interference to the patient. In some embodiments, tissue shaping is performed to correct age-related changes, such as age-related changes in the face or any body part.

[0163] Reference is made to FIG. 1, which illustrates a general process for tissue shaping according to some exemplary embodiments of the present invention.

[0164] According to some exemplary embodiments, an implant, e.g., a fillable implant, is implanted into the body at block 102. In some embodiments, the implant comprises a plurality of actuators. In some embodiments, the plurality of actuators are arranged in an array, optionally spaced apart from one another. In some embodiments, each actuator, or at least one actuator, is configured to expand and / or contract along at least one axis. In some embodiments, each actuator, or at least one actuator, is configured to expand and / or contract to a similar extent in all directions. Alternatively, each actuator, or at least one actuator, is configured to expand and / or contract to a greater extent in at least one first direction relative to at least one second direction.

[0165] According to some exemplary embodiments, the tissue is allowed to heal in block 103. In some embodiments, the tissue is allowed to heal after implantation of the implant in block 102 and before actuating the at least one implant actuator in block 104. Alternatively, the at least one implant actuator is actuated during the implantation procedure and / or while the patient is still in the operating room, or in the clinic after implantation in block 102.

[0166] According to some exemplary embodiments, in block 104, one or more actuators within the implant are selectively activated. In some embodiments, the one or more actuators are activated by providing energy through the skin surface. In some embodiments, activating the one or more actuators includes heating the one or more actuators. Alternatively or additionally, activating includes providing energy to the one or more actuators, for example, in the form of ultrasound or a magnetic field. In some embodiments, the energy is provided from outside the body, optionally without physically penetrating the skin surface to reach the one or more actuators. In some embodiments, the energy is provided using at least one of ultrasound, radio frequency (RF), and light (e.g., infrared or laser). In some embodiments, activating includes heating the one or more solid-state actuators by induction heating, for example, by exposing the one or more solid-state actuators to a magnetic field. In some embodiments, the magnetic field is an alternating magnetic field, optionally generated outside the body. Optionally, the energy is provided from within the body, for example, by placing an energy generating device within a body cavity.

[0167] According to some exemplary embodiments, actuation of one or more actuators causes expansion or contraction of the one or more actuators, resulting in localized shaping of tissue.

[0168] According to some exemplary embodiments, the shape of the tissue over time is optionally monitored at block 106. In some embodiments, the shape of the tissue is monitored over time, for example, to identify changes caused by at least one of body healing, bone growth, bone movement, soft tissue growth, and / or tissue loss.

[0169] According to some exemplary embodiments, the actuation of one or more actuators of the implant is repeated in block 108. In some embodiments, the actuation is repeated, for example, to reshape the tissue according to the tissue changes identified in block 108. In some embodiments, for example, the one or more actuators are actuated to expand or contract, or to increase or decrease a previous expansion or contraction.

[0170] Exemplary Tissue Shaping Reference is made to Figures 2A-2B, which illustrate the effect of actuation on the operation of an implant actuator in some exemplary embodiments of the present invention.

[0171] According to some exemplary embodiments, implant 202 includes multiple actuators, such as actuators 204, 206, and 208, configured to expand or contract in response to energy provided to the actuators. In some embodiments, the actuators are solid-state actuators, e.g., in the form of spiral or wave springs. In some embodiments, the actuators are spaced apart from one another and configured to expand or contract independently upon exposure to energy. In some embodiments, the actuators are aligned within the implant and are configured to expand and contract in the same direction, e.g., along the same axis. Alternatively, at least some of the actuators within the implant are configured to expand and contract in a different direction than the other actuators.

[0172] According to some exemplary embodiments, the actuator includes a shape memory alloy (eg, Nitinol) configured to change shape when heated.

[0173] According to some exemplary embodiments, as shown in FIGS. 2A and 2B , implant 202 includes multiple actuators, such as actuators 204, 206, 208, 210, and 212. In some embodiments, at least some of the actuators (e.g., actuators 204, 206, 208, and 210) are positioned and aligned along a similar axis. In some embodiments, at least some of the actuators, e.g., actuator 212, are positioned in a different direction relative to other actuators on the implant. In some embodiments, the actuators are coupled to a material layer, e.g., base layer 216 or tissue-interface layer 218. In some embodiments, the material layer is flexible, e.g., allowing the implant to conform to the shape and / or anatomical structure of body tissue. In some embodiments, as shown in FIGS. 2A and 2B , implant 202 is implanted under a fat or muscle layer 220 located beneath skin 222. Alternatively, the implant is implanted just beneath the skin. In some embodiments, base layer 216 of the implant is positioned in contact with body tissue 217, e.g., bone tissue.

[0174] According to some exemplary embodiments, as shown in FIGURE 2A, energy 224 delivered from an energy source 226 located outside the body to implant 202 selectively activates one or more actuators within the implant. In some embodiments, energy 224 selectively activates actuators 206, 208, 210, 212 without affecting or minimally affecting other actuators of the implant, such as actuator 204. In some embodiments, energy 224 selectively heats one or more actuators, such as actuators 206, 208, 210, 212.

[0175] According to some exemplary embodiments, for example, as shown in FIG. 2B , selective activation, e.g., selective heating, of the actuators causes the actuators 206, 208, 210, 212 within the implant to expand, pushing against surrounding tissue in contact with the implant, e.g., fat and / or muscle tissue 220 and / or skin tissue 220, causing a reshaping of the external body surface (e.g., changing the curvature of the external surface of the implant or skin over the activated actuators).

[0176] Reference is made to Figures 2C and 2D, which illustrate tissue shaping using an implant comprising at least one solid-state actuator, according to some exemplary embodiments of the present invention.

[0177] According to some exemplary embodiments, implant 250 includes one or more solid-state actuators in the form of springs, such as actuators 252, 254, and 256. In some embodiments, the springs are configured to move between an expanded state and a compressed state. In some embodiments, the springs are configured to expand in a relaxed state.

[0178] According to some exemplary embodiments, springs 252, 254, 256 are coupled to a body interface 258, e.g., a soft body interface. In some embodiments, for example, as shown in FIG. 2C , implant 250 is implanted under skin 262 and optionally under fat and / or muscle tissue 260. In some embodiments, implant 250 is positioned to place the springs in contact with body tissue 264, e.g., bone, and body interface 258 is in contact with skin 262, muscle and / or fat tissue 260.

[0179] According to some exemplary embodiments, the supply of energy 268 to the spring, e.g., from an energy source 270, causes the spring to expand. In some embodiments, the energy source 270 includes a source of a magnetic field (e.g., an alternating magnetic field). In some embodiments, the energy 268 includes a magnetic field. In some embodiments, the spring includes a conductive material and heats when exposed to the magnetic field. In some embodiments, the induction of heating relaxes the spring, moving the heated spring to an expanded state, as shown, for example, in FIG. 2D .

[0180] According to some exemplary embodiments, selectively exposing one or more of the springs, such as spring 258, to energy 268 causes expansion of spring 258. In some embodiments, the expansion of the selected spring or springs is a relative expansion compared to the expansion of other springs in the implant.

[0181] According to some exemplary embodiments, the relative expansion of one or more springs compared to other springs in the implant is achieved by using springs with different characteristics than the other springs. For example, one or more springs can be formed to have at least one of a different cross-sectional thickness, a different radius, and / or a different number of spiral turns. Thus, by applying the same energy 268 to the springs, each different characteristic provides a different expansion relative to the other springs. In some embodiments, the different expansion of the different springs is facilitated by locally supplying different amounts of energy to each spring.

[0182] According to some exemplary embodiments, for example, as shown in FIG. 2D , expansion of the one or more springs presses the body interface 258 against at least one of the skin 262, fat and / or muscle layers, causing a change in the shape of the tissue, for example, a change in the curvature of the outer surface of the tissue.

[0183] In some embodiments, expansion of one or more springs between hard body tissues and soft body tissues, such as skin, fat and muscle tissue, results in the soft tissues being pushed outward from the hard body tissues.

[0184] Exemplary Implants According to some exemplary embodiments, the implant is used to shape tissue, such as facial tissue or other body tissue. In some embodiments, tissue shaping includes altering the external curvature or contour of the tissue. Alternatively or additionally, the implant is used to fill a volume of missing tissue within the body created by at least one of bodily trauma, removal of neoplastic tissue, and removal of inflammatory tissue. In some embodiments, tissue removal results in a change in body contour due to collapse of the skin surface into the formed cavity. In some embodiments, the implant is used to fill the formed cavity and reshape the body's outer surface distal to the filled cavity by pressing externally against the skin. Optionally, the implant is used to restore the shape of the body's outer surface to the shape of the body's outer surface prior to cavity formation.

[0185] Reference is made to Figures 3A and 3B, which illustrate an implant, according to some exemplary embodiments of the present invention.

[0186] According to some exemplary embodiments, for example, as shown in FIG. 3A , implant 302 includes at least one actuator or two or more actuators, e.g., actuators 304, 306, 308, 310. In some embodiments, each actuator is configured to move between a compressed state and an expanded state. In some embodiments, each actuator, or at least some of the actuators, is configured to expand or compress along a selected axis, e.g., the actuator's major axis 305. In some embodiments, the expansion or compression of each actuator, or at least some of the actuators, of the implant is greater in a particular axis (e.g., the major axis 305) compared to the expansion or compression in a different axis (e.g., the actuator's minor axis 307).

[0187] According to some exemplary embodiments, at least some or all of the actuators are solid-state actuators. In some embodiments, at least some or all of the actuators include or are spring-shaped. In some embodiments, the actuators (e.g., springs) are formed from shape memory materials (SMMs), including shape memory alloys (SMAs) and / or shape memory polymers (SMPs), as described, for example, in Huang et al. (2010). In some embodiments, the actuators, e.g., springs, are configured to recover their original shape after significant apparent plastic deformation when a specific stimulus is applied.

[0188] According to some exemplary embodiments, when the actuator is exposed to a stimulus, for example in the form of energy, the actuator expands and optionally returns to its original shape. Alternatively, when the actuator is exposed to a stimulus, for example in the form of energy, the actuator contracts.

[0189] According to some exemplary embodiments, at least some or all of the actuators 304, 306, 308, 310 are formed from a shape memory alloy (e.g., copper-aluminum-nickel alloy, nickel-titanium (NiTi) alloy (nitinol)). In some embodiments, when an actuator formed from a shape memory alloy is heated, it expands and optionally regains its original shape. Alternatively or additionally, at least some or all of the actuators 304, 306, 308, 310 are formed from a different shape memory material, such as a shape memory polymer.

[0190] According to some exemplary embodiments, each actuator is disposed within an individual insulating sleeve configured to isolate the actuator (e.g., a spring) from the surrounding environment. In some embodiments, the insulating sleeve is configured to thermally isolate the actuator from the surrounding environment, for example, from tissue surrounding the implant after the implant is implanted in the body.

[0191] According to some exemplary embodiments, implant 302 includes a tissue interface 312 that is placed in contact with bodily tissue, e.g., bodily soft tissue. In some embodiments, bodily soft tissue includes at least one of skin, muscle, and fat tissue. In some embodiments, tissue interface 312 includes a pad or cushion. In some embodiments, tissue interface 312 is soft and / or flexible, e.g., conforms to the shape of the bodily soft tissue. Optionally, tissue interface 312 is filled with a fluid or viscous material, e.g., a gel.

[0192] According to some exemplary embodiments, the tissue interface 312, e.g., the first tissue interface, includes at least one first surface 314 configured to contact a body tissue, e.g., a soft body tissue, and at least one second surface 316. Optionally, the at least one second surface is opposite the at least one first surface 314. In some embodiments, an actuator is coupled to the at least one second surface 316. In some embodiments, applying a force toward the at least one second surface (e.g., when one or more actuators expand) presses the at least one surface 314 against the tissue. In some embodiments, the applied force changes the shape of the tissue interface 312, e.g., changes the shape or curvature of the at least one surface 314 at a level relative to the force applied to the at least one second surface 318. Optionally, applying a force locally to the at least one second surface 316 locally deforms the shape of a region of the tissue interface 312 aligned with the direction of the applied force.

[0193] According to some exemplary embodiments, each actuator, e.g., a spring, includes a first end 318 and an opposite second end 320. In some embodiments, the actuators are coupled to at least one second surface 316 of the tissue interface 312 by the first end 318 of each actuator.

[0194] According to some exemplary embodiments, the actuator comprises an inflatable chamber, such as a balloon, in some embodiments, inflation of the inflatable chamber expands the chamber and exerts a force against surface 316, bending tissue interface 312 upward.

[0195] According to some exemplary embodiments, the implant 302 includes a separate base 322 for each actuator, coupled to at least one second end 320 of each actuator. In some embodiments, the base 322 is configured to enable stable contact between the actuator and bodily tissue, e.g., bodily hard tissue. In some embodiments, the bodily hard tissue includes bone tissue. In some embodiments, the base 322 is configured to secure the actuator to the hard tissue, e.g., via openings in the base and / or one or more actuators suitable for receiving screws or nails. Alternatively or additionally, the cover, e.g., tissue interface 312, extends to the bone tissue and is secured to the bone tissue using nails or screws that penetrate the cover and are secured to the bone. Alternatively, the implant (e.g., at least one of the base, actuators, or cover) is attached to the bone tissue using an adhesive, e.g., glue.

[0196] According to some exemplary embodiments, the base 322 is stiffer than the tissue interface 312. In some embodiments, the implant 302 is anchored within the body by coupling the actuator to the tissue.

[0197] According to some exemplary embodiments, the actuators are spaced apart from one another, for example, to allow tissue to grow into the implant in the areas between adjacent actuators.

[0198] 3B, implant 330 includes a hollow body 332 with at least one actuator or multiple actuators, e.g., actuators 304, 306, 308, and 310, disposed within body 322. In some embodiments, the actuators are disposed at tissue interface 312 and a common base 334 configured to contact hard tissue of the body, e.g., bone. In some embodiments, base 334 is configured to secure implant 330 to the body, e.g., to hard tissue of the body.

[0199] According to some exemplary embodiments, hollow body 332 is an enclosed hollow body configured to isolate the actuator from surrounding tissue when implant 330 is implanted within the body. Alternatively, hollow body 332 is at least partially perforated (e.g., at base 334) to allow tissue to grow into the interior of the implant.

[0200] According to some exemplary embodiments, at least one or all of the actuators are substantially perpendicular to the tissue interface, or at least one or all of the actuators are positioned at an angle selected from the range of 30 degrees to 90 degrees relative to the tissue interface 312, such as an angle selected from the range of 40 degrees to 90 degrees, an angle selected from the range of 40 degrees to 50 degrees, or any intermediate, smaller, or larger angle.

[0201] Reference is made to FIG. 3C, which illustrates an implant having a tissue interface coupled to two or more expandable chambers, according to some exemplary embodiments of the present invention.

[0202] According to some exemplary embodiments, an implant, e.g., implant 350, includes a tissue interface 312 and two or more inflatable actuators, e.g., actuators 352, 354, 356, and 358, coupled to a surface 316 opposite the skin-contacting surface 314, e.g., as illustrated in FIG. 3A. In some embodiments, at least one or all of the inflatable actuators include one or more inflatable chambers configured to inflate upon introduction of fluid thereto, and optionally to deflatate upon, e.g., removal of fluid from the inflatable chambers.

[0203] According to some exemplary embodiments, fluid is introduced to the inflatable actuators via a fluid flow path, e.g., flow path 360. In some embodiments, the flow path connects all or at least one of the inflatable actuators to at least one opening 362 and optionally includes a valve, e.g., a duckbill valve. In some embodiments, at least one opening 362 is located within the tissue interface, e.g., at the tissue-contacting surface of the tissue interface, allowing easy access to the flow path 360, e.g., from outside the body. In some embodiments, fluid, e.g., gas or liquid, is introduced to and / or removed from the inflatable actuators using a needle that penetrates opening 362. Optionally, each inflatable actuator is connected to a separate flow path and a separate opening, e.g., allowing selective introduction or removal of fluid from each inflatable actuator.

[0204] According to some exemplary embodiments, the implant includes only solid actuators, such as springs, or only inflatable actuators, or the implant includes a combination of solid and inflatable actuators.

[0205] According to some exemplary embodiments, the implant is positioned such that the tissue interface contacts tissue beneath the skin and the actuators directly or indirectly contact hard tissue, such as bone, or alternatively, the implant is positioned such that the tissue interface contacts bone and at least one or more actuators coupled to the tissue interface press against the tissue beneath the skin.

[0206] Exemplary Implant Fitting to Target Implantation Site According to some exemplary embodiments, prior to implantation of an adjustable implant, the implant must be adapted to a particular implantation site, with specific characteristics, optionally taking into account the location, shape, and / or size of the implantation site, and / or the target shape of the soft tissue after implantation and healing. In some embodiments, to adapt the implant to a particular implantation site, a professional can select from a variety of pre-formed implants. Alternatively, the professional can modify an existing pre-formed implant. Alternatively, the professional can form a new implant that matches the implantation site and / or the future target shape of the tissue.

[0207] Reference is now made to FIG. 3D , which illustrates a process of adapting an implant according to at least one of the size and / or shape of the implantation site, the target shape of the body tissue after implantation, and / or the implant's ability to adjust during recovery to reach the target tissue shape, according to some exemplary embodiments of the present invention.

[0208] According to some exemplary embodiments, a target implantation site is identified at block 370. In some embodiments, the target implantation site is a site on the head, limbs, torso, and / or back, or anywhere else on the subject's body. In some embodiments, the target implantation site is identified during or after surgery, such as surgery to remove a tumor or mass.

[0209] According to some exemplary embodiments, one or more parameters of the target implantation site are determined at block 372. In some embodiments, the one or more parameters include size, shape, volume, composition of surrounding tissue, and / or proximity to different tissues. In some embodiments, the different tissues include at least one of neural tissue, blood vessels, bone tissue, and / or skin tissue.

[0210] According to some exemplary embodiments, a desired tissue shape after implantation is optionally determined at block 374. In some embodiments, a desired tissue shape after recovery from the implantation procedure is determined at block 374. In some embodiments, the desired tissue shape includes external body curvature and / or tissue volume at the implantation site.

[0211] According to some exemplary embodiments, at block 376, one or more parameters of the adjustable implant are determined. In some embodiments, the one or more parameters are determined based on one or more parameters of the implantation site and / or the desired shape after treatment. In some embodiments, the one or more implant parameters include at least one of the shape, size, volume, expansion ability, type of material forming the implant, implant porosity, type of actuator, shape of actuator, type of actuator spiral, distribution of actuators within the implant, and / or number of actuators.

[0212] According to some exemplary embodiments, an existing implant, e.g., an already pre-formed implant, is selected at block 378. In some embodiments, the existing implant is selected from at least two existing implants, each having one or more different implant parameters. In some embodiments, the existing implant is selected according to the adjustable implant parameters determined at block 376. Optionally, the existing implant is a commercially available product.

[0213] According to some exemplary embodiments, alternatively, an existing adjustable implant is modified at block 380. In some embodiments, the existing implant is modified according to the implant parameters determined at block 376. In some embodiments, the existing implant is modified, for example, by cutting the implant according to a particular shape.

[0214] According to some exemplary embodiments, alternatively, a new implant is assembled at block 382. In some embodiments, the implant is assembled according to the determined implant parameters at block 376. In some embodiments, the implant is assembled in the operating room, for example, before or during the implantation procedure. Alternatively, the implant is assembled outside the operating room, before the implantation procedure.

[0215] According to some exemplary embodiments, after obtaining an implant having target parameters or characteristics, as described in block 102, the implant is implanted at the implantation site. Optionally, one or more actuators are selectively activated, for example, prior to implantation. In some embodiments, one or more actuators are activated prior to implantation by heating the actuators, for example, by injecting a hot liquid into the implant and / or by exposing the one or more actuators to energy.

[0216] Exemplary facial and body remodeling According to some exemplary embodiments, implants are used to shape the skin for aesthetic reasons, to treat defects caused by trauma to the body, or congenital defects. In some embodiments, the implant is implanted under the skin and, optionally, under at least one additional tissue layer of the body, such as, for example, muscle and fat tissue layers. In some embodiments, the implant is configured to be implanted in one or more regions of the body, such as, for example, the facial region, the head region, the neck region, one or more limb regions, the abdominal region, the chest region, the back region, or any region of the body. In some embodiments, the implant is used to shape a region of the body, such as the region of the body into which it is implanted.

[0217] According to some exemplary embodiments, the implant is controllably and / or selectively expanded to press against the skin in selected areas, for example, to shape the surface and / or contours of the skin to a desired shape. Additionally or optionally, the implant is used to fill a cavity or lumen in the body caused by trauma, a surgical procedure, or a cavity or lumen that is a congenital defect.

[0218] Reference is now made to FIG. 4, which illustrates a process of facial sculpting, eg, facial remodeling, according to some exemplary embodiments of the present invention.

[0219] According to some exemplary embodiments, facial remodeling is determined at block 402. In some embodiments, facial remodeling is determined to achieve a desired facial shape. In some embodiments, determining to undergo facial remodeling includes determining portions of the face to remodel, such as the chin, forehead, or cheeks.

[0220] According to some example embodiments, a target facial shape is determined at block 404. In some embodiments, determining the target shape includes determining the shape of a portion of the face selected for remodeling after healing following facial remodeling surgery.

[0221] According to some exemplary embodiments, an implant is selected at block 406. In some embodiments, the implant is selected based on the determined target face shape and / or the current shape of the facial portion selected for remodeling. In some embodiments, at block 406, an implant having a desired shape, size, and / or function is selected.

[0222] According to some exemplary embodiments, the implant is optionally modified in block 408. In some embodiments, at least one of the shape, structure, and / or composition of the implant is optionally modified to match the current shape of the facial portion selected for remodeling and / or the determined target facial shape in block 408. In some embodiments, the implant is a modular implant and can be optionally modified in block 408, for example, by adding or removing actuators from the implant.

[0223] According to some exemplary embodiments, at block 410, an implant is implanted into facial tissue. In some embodiments, the implant includes only two or more actuators coupled to one another and implanted within the body. Optionally, each of the two or more actuators includes a separate tissue interface configured to press against the skin. Alternatively, the actuators are coupled to at least one tissue interface, such as a single shared interface, as shown, for example, in FIGS. 3A-3C.

[0224] According to some exemplary embodiments, the implant and / or the actuator or at least one actuator is anchored, for example to bone tissue, during implantation of the implant in block 410. Optionally, anchoring the implant or at least one actuator to bone tissue fixes the position of the implant within the body and optionally prevents the implant from migrating from the implantation site.

[0225] According to some exemplary embodiments, the skin is closed after implantation of the implant at block 412. In some embodiments, the skin is closed over the implant.

[0226] According to some exemplary embodiments, one or more of the implant's actuators are activated in block 414. In some embodiments, activating at least one actuator expands the actuator, optionally pressing against the skin surface. In some embodiments, one or more actuators are activated while the patient is still in surgery and optionally before the skin is closed in block 412. In some embodiments, one or more actuators are selectively activated after the skin is closed while the patient is still undergoing the implantation procedure. Alternatively, one or more actuators are selectively activated after a healing period following the implantation procedure. For example, the actuators are activated after a healing period of at least 12 hours, at least 24 hours, at least 48 hours, at least 72 hours, at least one week, at least two or three weeks, at least one month, or after an intermediate, shorter, or longer period.

[0227] According to some exemplary embodiments, selectively activating one or more actuators in block 414 includes heating the actuators using at least one of inductive heating, ultrasound that penetrates the skin toward the implant, radio frequency (RF), and injecting a warm fluid into the implant. Alternatively, if the actuators include at least one expandable chamber, selectively activating the actuators includes inflating the at least one expandable chamber, for example, by introducing a fluid into the at least one expandable chamber.

[0228] According to some exemplary embodiments, at block 416, the shape of the tissue is determined after the selective actuation and, optionally, after a healing period. In some embodiments, at block 416, a relationship between the shape of the tissue after the selective actuation and, optionally, after a healing period and a target shape, e.g., a target facial shape, is determined. Optionally, at block 416, the shape of the tissue after the selective actuation and, optionally, after a healing period, is compared to the target facial shape. In some embodiments, if the shape of the tissue is the target shape, the facial remodeling process ends.

[0229] According to some exemplary embodiments, if the shape of the tissue is not the target shape, the shape of the implant is modified in block 418. In some embodiments, the shape of the implant is modified by actuating at least one actuator, optionally using an actuator different from the one actuated in block 414. Alternatively or additionally, the shape of the implant is modified by applying a force to the implant, for example, by pushing the implant. In some embodiments, a force is applied to the implant during or after selective actuation of one or more actuators.

[0230] According to some exemplary embodiments, when the actuator comprises at least one inflatable chamber, the shape of the implant is modified, for example, by deflating the at least one inflatable chamber and / or by inflating the at least one inflatable chamber.

[0231] Exemplary spiral springs and implants According to some exemplary embodiments, the implant includes one or more solid-state actuators, e.g., a plurality of solid-state actuators. In some embodiments, the actuators include springs that can move between a contracted (e.g., collapsed) state and an expanded state when exposed to energy. In some embodiments, the energy can heat the springs, moving them to a relaxed, exposed state. In some embodiments, each spring is formed from a shape memory alloy, e.g., nitinol. In some embodiments, heating the springs causes them to return to their undeformed, expanded shape.

[0232] Reference is made to Figures 5A-5D, which illustrate an actuator of an implant, according to some exemplary embodiments of the present invention, where the actuator is in the form of a spiral spring.

[0233] According to some exemplary embodiments, as shown, for example, in Figures 5A-5C, the solid-state actuator includes at least one spring, for example, a spiral spring 502. In some embodiments, the spiral spring 502 includes a base 504 and a movable portion 506 integral with the base. In some embodiments, the movable portion 506 moves between a collapsed state, as shown, for example, in Figure 5A, and an expanded state, as shown, for example, in Figure 5B. In some embodiments, the expansion of the movable portion is an axial expansion along an axis substantially perpendicular to the base 504.

[0234] According to some exemplary embodiments, the spiral spring 502, e.g., the movable portion 506, has a double spiral structure. In some embodiments, the double spiral structure is formed by wrapping two metal parts, e.g., wires or strips, around the longitudinal axis of the spiral spring in opposite directions until they are joined, e.g., at the apex of the spiral spring. In some embodiments, the metal parts are joined using welding or soldering. In some embodiments, the spiral spring 502 is optionally formed from a shape memory alloy and expands to its pre-deformed, expanded shape when heated to a temperature level between 37°C and 65°C (e.g., when heated to a temperature level between 37°C and 45°C, e.g., when heated to a temperature level between 40°C and 60°C, or when heated to any temperature level in an intermediate, smaller, or larger temperature range).

[0235] According to some exemplary embodiments, a spiral spring, such as spiral spring 502, is formed by cutting (e.g., laser cutting) a NiTi plate / sheet with the desired pattern of a flat coil. In some embodiments, the flat coil is then formed into its pre-deformed shape using a mold and heat treatment at approximately 500°C to achieve its final shape, thereby achieving shape memory. In some embodiments, laser cutting of NiTi tubes and / or 3D printing of NiTi are used as additional manufacturing options.

[0236] According to some exemplary embodiments, spiral springs, such as those shown in FIG. 5D, can be assembled together to form an array of spiral springs. In some embodiments, the spiral springs are attached to one another, for example, by at least one anchor, to form the array. Alternatively, the spiral springs are attached to one another and coupled to a common base. Alternatively or additionally, the spiral springs are attached to one another and coupled to a common tissue interface configured to contact soft tissue of the body, such as skin, fat, and muscle tissue.

[0237] According to some exemplary embodiments, a single solid-state actuator (e.g., a spiral spring actuator) is in contact with two or more solid-state actuators, e.g., two, three, four, five, six, or any greater number, as shown in FIG. 5D . In some embodiments, actuator 502 is in contact with actuators 508, 510, 512, and 514. In some embodiments, the geometric polygonal shape of base 504 allows for contact with multiple actuators on the sides of the polygon, e.g., forming an array of actuators. In some embodiments, as shown in FIG. 5D , actuator base 504 is hexagonally shaped, allowing a single actuator to contact up to six actuators, e.g., through the sides of the hexagonal base.

[0238] Reference is made to Figures 5E and 5F, which illustrate an implant comprising a plurality of spiral actuators coupled to an implant base and a tissue interface, according to some exemplary embodiments of the present invention.

[0239] According to some exemplary embodiments, as shown in FIG. 5E, an array of polygon-shaped spiral actuators, e.g., actuators 516, 518, 520, and 522, is coupled to an implant base 524. In some embodiments, each base of the actuators is coupled to the implant base. In some embodiments, as shown in FIG. 5F, an implant 530 includes an implant base 524 and a tissue interface 532 coupled to a movable portion of each actuator (e.g., movable portion 506). In some embodiments, tissue interface 532 is a soft tissue interface and is optionally filled with a fluid, e.g., a viscous fluid, or a gel, e.g., a silicone gel. In some embodiments, tissue interface 532 is coupled to the apex of the movable portion of the actuator. In some embodiments, tissue interface 532 is in the form of a cap that sits on top of the actuator.

[0240] Reference is made to Figures 6A-6D, which illustrate solid state actuators (eg, actuator springs with rectangular bases), according to some exemplary embodiments of the present invention.

[0241] According to some exemplary embodiments, as shown, for example, in Figures 6A-6C, a solid-state actuator, e.g., spring actuator 602, comprises a rectangular base 604 and a movable portion 606. In some embodiments, movable portion 606 is integral with base 604. In some embodiments, spring actuator 602 is similar to spring actuator 502, with a hexagonal base, as compared to the rectangular (e.g., square) base of actuator 602.

[0242] According to some exemplary embodiments, as shown, for example, in Figure 6D, the rectangular base 604 allows for up to four actuators to be attached to a single actuator via the sides of the actuator's rectangular base, thereby forming an array of actuators. In some embodiments, as shown, for example, in Figure 6C, the actuator base 604 includes one or more openings, such as opening 608, for mechanically coupling the base 604 to a tissue interface (e.g., a soft tissue interface of an implant) or body tissue (e.g., bone tissue).

[0243] Exemplary Actuator Array According to some exemplary embodiments, the actuators of the implant are arranged in an array, e.g., to increase the contact area of ​​the implant with the soft tissue interface or, e.g., to enable efficient anchoring of the implant to bone tissue. In some embodiments, the position of each actuator (e.g., a spiral actuator) or at least some of the actuators in the array is fixed relative to other actuators in the array, e.g., adjacent actuators. Alternatively, each actuator or at least some of the actuators are movable, e.g., laterally movable, relative to other actuators in the array. In some embodiments, the actuators move laterally within the array upon exposure to energy, e.g., energy that heats the actuator above a certain temperature level. In some embodiments, the actuators are connected to each other by a connector that allows one or more actuators to be detached from the array to tailor the shape and / or size of the array or implant to a particular implantation site in the body.

[0244] Reference is made to Figures 7A and 7B, which illustrate an array of coupled actuators, for example spiral actuators, according to some exemplary embodiments of the present invention.

[0245] According to some exemplary embodiments, implant 702 includes a plurality of actuators, e.g., spiral actuators 704, 706, and 708, arranged in an array. In some embodiments, spiral actuators 704, 706, and 708 are coupled to a base or tissue interface 710, which is optionally made of a soft material such as silicon. In some embodiments, at least some of the spiral actuators in the array, e.g., actuators 708, 712, and 714, are coupled to each other via the spiral body or windings forming the spiral body of each spiral actuator. Optionally, two or more spiral actuators are formed via at least one shared winding of material forming the spiral shape of each actuator. Optionally, spiral actuators 708, 712, and 714 are arranged in a row, e.g., linearly, sequentially, within the array.

[0246] According to some exemplary embodiments, applying energy to, and optionally heating, the actuators allows for relative lateral movement of actuators coupled together within a row of actuators. Alternatively, the applied energy allows for lateral movement of groups of coupled actuators relative to different groups of actuators within the same array or the same implant. In some embodiments, the lateral movement of the actuators deforms, for example, stretching, the base or tissue interface 710. Optionally, selectively heating and / or deforming a single spiral actuator of a group of directly coupled actuators heats and / or deforms other spiral actuators in the array.

[0247] Reference is now made to Figures 7C-7E, which illustrate additional actuator arrays, such as spiral actuators, coupled together, according to some exemplary embodiments of the present invention.

[0248] According to some exemplary embodiments, actuators, such as spiral actuators, are interconnected to form a two-dimensional (2D) array of actuators, as shown in Figures 7C, 7D, and 7E. In some embodiments, actuators 720, 722, and 724 are interconnected by at least one connector 726, such as a wire or strip of material. In some embodiments, at least one connector 726 is formed from a thermally and / or electrically insulating material. Alternatively, at least one connector 726 is formed from a thermally and / or electrically conductive material, such as a metal. In some embodiments, the actuators are interconnected through the base of each actuator using at least one connector 726.

[0249] Reference is made to FIG. 7F, which illustrates an array of actuators interconnected by deformable connectors, according to some exemplary embodiments of the present invention.

[0250] According to some exemplary embodiments, at least two actuators, e.g., actuators 720, 722, and 724, are interconnected via at least one deformable connector, e.g., connector 742. In some embodiments, the at least one deformable connector 742 is configured to move from a collapsed state to an expanded state, e.g., when heated. In some embodiments, the at least one deformable connector 742 is formed from a shape memory material, e.g., a shape memory alloy or a shape memory polymer. In some embodiments, the shape memory alloy comprises nitinol. In some embodiments, deformation of connector 742 connecting two actuators in an array changes the distance between the two actuators, thereby deforming the array. In some embodiments, deformation of the connector causes the actuators to move laterally relative to each other.

[0251] According to some exemplary embodiments, two or more spiral-type solid actuators are directly interconnected, for example, via the base of the actuator or the spring or spiral portion of the actuator. Alternatively, each actuator includes at least two extensions extending from the actuator and configured to allow the two actuators to be coupled to one another. In some embodiments, a single actuator includes two, three, four, five, six, or more extensions configured to allow the actuator to be coupled to other actuators in the array.

[0252] A potential advantage of forming an array of actuators interconnected by extensions is that the array can be easily shaped to a desired shape or size by detaching (optionally cutting) the actuators from the array at the extensions with no or minimal damage to the actuators themselves. In some embodiments, this allows for having a modular implant or modular actuator array that can be easily modified as needed.

[0253] Reference is made to Figures 7G-7J, which illustrate an array of interconnected spiral actuators, according to some exemplary embodiments of the present invention.

[0254] According to some exemplary embodiments, as shown in, for example, FIG. 7G, an array 760, e.g., a grid, of actuators includes two or more actuators, e.g., actuators 762 and 764, interconnected with one or more extensions, e.g., extensions 766 and 768. In some embodiments, each actuator is formed with at least one extension configured to interconnect with at least one different actuator. In some embodiments, the actuators are coupled to one another, e.g., by coupling an extension of a first actuator with an extension of a second actuator. Optionally, as shown in, for example, FIGS. 7I and 7J, the entire array is formed as a single unit, with all actuators and extensions formed from the same material, e.g., a deformable material, optionally a shape memory alloy. According to some exemplary embodiments, actuator 770 includes at least one extension, e.g., extension 772, extending outward from a base 774 of the actuator. Optionally, each actuator includes at least three extensions. In some embodiments, the extensions are evenly distributed around the circumference of the actuator or the actuator base. Alternatively, the extensions are unevenly distributed around the circumference of the actuator. In some embodiments, all actuators in the array have the same or different number of extensions. In some embodiments, the actuators are formed with at least one extension. Alternatively, at least one extension is coupled to at least one actuator after the actuator is formed, optionally during formation of the array.

[0255] According to some exemplary embodiments, at least one extension is planar. In some embodiments, at least one extension interconnecting two actuators has at least one narrow portion that is narrower than the width of the other portions along the length of the extension. Optionally, the at least one narrow portion represents a cut point to enable separation between the two actuators by cutting the extension, e.g., by cutting at the narrow portion of the extension. A potential advantage of having a narrow portion is that it allows for easy cutting of the at least one extension, and thereby easy disconnection between the two actuators. Optionally, the extension is formed as a single, integral unit from the same material as the actuators, as shown, for example, in Figures 7I-7J.

[0256] According to some exemplary embodiments, as shown in FIG. 7H , for example, an array 776 comprises two or more actuators interconnected by at least one torsional extension 782. In some embodiments, the at least one torsional extension is formed from a deformable material configured to deform when exposed to energy. In some embodiments, the material comprises a shape memory alloy. In some embodiments, deformation of the extension allows the actuators to move laterally relative to one another within the array. Alternatively or additionally, deformation of the extension allows for lateral elasticity of the array in the plane of the actuators.

[0257] According to some exemplary embodiments, at least one twisted extension forms and / or indicates a disconnection region between adjacent actuators in the array.

[0258] According to some exemplary embodiments, as shown in FIG. 7I, an array 784 of actuators includes actuators connected to each other via the base of each actuator, optionally formed by precision cutting, e.g., laser cutting. In some embodiments, the actuators are connected to each other as tiles. In some embodiments, at least some of the or each actuator includes a polygonal base that can be attached to other adjacent actuator bases on at least one side. In some embodiments, the base is triangular, quadrilateral, rectangular, hexagonal, or any polygonal shape that can optionally be tiled. A potential advantage of having a polygonal shape is that it allows for a larger surface area when the actuator contacts a surface, such as a polymer or silicon surface, to which it is bonded, and optionally prevents the surface from collapsing when the actuator expands in the opposite direction.

[0259] According to some exemplary embodiments, as shown, for example, in Figure 7I, actuator 786 includes a hexagonal base 788 that is shaped and sized to be coupled to at least one actuator, for example, actuator 790, via a side of the base. In some embodiments, actuator 786 is configured to be coupled to up to six actuators via a side of the hexagonal base.

[0260] According to some exemplary embodiments, each actuator, e.g., actuator 786, includes a base 788 and at least three spiral extensions, each extension having a first end coupled or integral with base 788 and a second end located away from base 788. In some embodiments, the spiral extensions are optionally helically twisted between the first and second ends to form a spring-like structure for the actuator. In some embodiments, the spring-like structure is configured to extend in a direction substantially perpendicular to and away from the base when the actuator or spiral extension is deformed. Optionally, the spiral extensions extend in response to energy applied to the actuator, optionally in response to energy that heats the spiral extensions.

[0261] According to some exemplary embodiments, as shown, for example, in FIG. 7J , array 792 includes two or more actuators, e.g., actuators 794 and 796, coupled to each other via a spiral extension of each actuator, e.g., spiral extension 798 of actuator 794 and spiral extension 799 of actuator 796. In some embodiments, as described above with respect to actuator 786, for example, an actuator includes at least two or at least three spiral extensions twisted together to form a spring-like, expandable portion of the actuator.

[0262] Exemplary Implant Forming According to some exemplary embodiments, at least a portion of an existing implant can be adjusted to a desired shape and / or size depending on the shape and / or size of a target implantation site within a subject's body. A potential advantage of having an implant that is shapeable prior to implantation is that it allows fewer implants to be used for more implantation sites, thereby allowing for maximum customization and ease of use while optionally reducing manufacturing costs. An additional advantage of having an implant that is shapeable prior to implantation is that it allows the implant to conform to newly created cavities within the body that have non-traditional shapes, sizes, and / or volumes, for example, due to trauma or tumor removal.

[0263] Reference is made to Figures 7K and 7L, which illustrate a shapeable (eg, cuttable to be shaped to have a desired shape, area, volume and / or size) implant, according to some exemplary embodiments of the present invention.

[0264] According to some exemplary embodiments, the implant includes multiple actuators, e.g., solid-state actuators, coupled to a surface, e.g., a base. In some embodiments, as shown, for example, in FIG. 7K, implant 719 includes, e.g., two or more actuators 721 and 723, coupled to surface 725. In some embodiments, the base of each actuator is coupled to a common surface 725. Alternatively, the apex of a spring portion of the actuator, e.g., the apex of a telescoping portion of the actuator, is coupled to surface 725. In some embodiments, the surface is a surface opposite the tissue-contacting surface of the sheet material.

[0265] According to some exemplary embodiments, the base is formed from a polymeric material and is optionally elastic. In some embodiments, the base to which the one or more actuators are coupled is thin, e.g., has a maximum thickness in the range of 0.01 mm to 10 mm, e.g., 0.01 mm to 5 mm, 0.5 mm to 3 mm, 1 mm to 10 mm, or any intermediate, smaller, or larger thickness. In some embodiments, the base is bendable, e.g., flexible. Optionally, the base is elastic. In some embodiments, the base is formed from a cuttable material. Optionally, the base includes one or more cut lines and / or cut areas, such as a narrowing in the thickness of the base and / or including an opening, to allow for easy separation between portions of the base.

[0266] According to some exemplary embodiments, the actuators are evenly spaced on surface 725, and the distance between the actuators is also uniform. Alternatively, or additionally, the distance between at least some of the actuators varies. In some embodiments, the sheet material extends beyond one or more actuators. In some embodiments, actuators 721 and 723 are directly coupled to surface 725 (e.g., the surface of the sheet material), as shown, for example, in FIG. 7K. Alternatively, actuator 727, for example, is coupled to a surface extending from each actuator or at least some of the actuators, e.g., surface 725, via one or more extensions 729 and 731, as shown, for example, in FIG. 7L. In some embodiments, the actuators are connected to each other via one or more extensions and coupled to the surface via the extensions, as shown, for example, in FIGS. 7G and 7H. Alternatively, the actuators are spaced apart and separated from each other, as shown, for example, in FIGS. 7K and 7L.

[0267] According to some exemplary embodiments, as shown, for example, in Figures 7K and 7L, the implant is formed by cutting along lines 733 between the surface and the actuators, for example, to form the implant according to a desired shape, size and / or contour.

[0268] According to some exemplary embodiments, the surface of the implant to which the actuator is coupled is made from a material that is easily cut using, for example, scissors, a blade, a knife, or any cutting edge.

[0269] Exemplary Implant with Spring Actuator Reference is made to Figures 8A-8D, which illustrate an implant including an array of spring actuators, according to some exemplary embodiments of the present invention.

[0270] According to some exemplary embodiments, implant 802 comprises an array of actuators, including, for example, spiral actuators 804, 806, and 808, and is coupled to a first tissue interface 810, for example, a soft tissue interface. In some embodiments, each actuator is separately coupled to a second tissue interface, for example, a hard tissue interface. In some embodiments, the soft tissue interface is an interface between the implant (e.g., one or more actuators of the implant) and soft tissue of the body (e.g., muscle, ligament, tendon, connective tissue, adipose tissue, skin tissue). In some embodiments, the hard tissue interface is an interface between the implant and, for example, one or more actuators of the implant and hard tissue of the body, for example, bone tissue.

[0271] According to some exemplary embodiments, the soft tissue interface 810 comprises a soft interface, such as an inflated or inflatable interface, a cushion, etc. In some embodiments, the soft tissue interface is filled with a fluid, such as a liquid, a gel, a viscous gel, and / or a viscous fluid. In some embodiments, the soft tissue interface 810 is configured to protect the body's soft tissue from damage when one or more actuators of the implant press the soft tissue interface against the body's soft tissue, e.g., to lift the skin surface.

[0272] According to some exemplary embodiments, actuators 804, 806, and 808 of the implant move between a collapsed state, as shown, for example, in FIG. 8A, and an expanded state, as shown, for example, in FIG. 8B. In some embodiments, implant 802 is introduced into the body when the actuators are in a compressed state, providing a low-profile implant that can be inserted into the body, for example, through a thin and / or small incision. In some embodiments, actuation of one or more actuators causes the actuated actuators to expand to the expanded state.

[0273] According to some exemplary embodiments, the implant 802 is implanted into bone tissue 814 and soft tissue 816 (e.g., the soft tissue beneath the skin tissue), as shown, for example, in Figures 8C and 8D. In some embodiments, the tissue interface 812 is used, for example, to secure the implant 802 to the hard tissue, e.g., the bone tissue 814.

[0274] According to some exemplary embodiments, implant 802 is implanted within the body, e.g., with one or more or all of the implant actuators compressed, as shown, e.g., in Figure 8C. In some embodiments, after selective activation of at least one actuator or actuators of implant 802, the activated actuators expand, increasing the distance between bone tissue 814 and soft tissue 816, as shown, e.g., in Figure 8D. In some embodiments, activation of the actuators lifts soft tissue 816 relative to bone 814.

[0275] According to some exemplary embodiments, selective activation of at least one actuator is achieved by selectively supplying energy to the at least one actuator. In some embodiments, the selective supply of energy heats the at least one actuator and optionally moves the heated actuator to an expanded state. In some embodiments, each actuator or at least one actuator, e.g., a prong actuator, is pre-formed to expand when heated to a particular extent and / or to a predetermined temperature. In some embodiments, the degree of expansion of at least one actuator of an implant is different from at least one other actuator of the same implant.

[0276] According to some exemplary embodiments, as shown, for example, in FIG. 8E , at least one tissue interface of the actuator, e.g., tissue interface 812, includes at least one opening shaped and sized to receive a nail or screw 811, e.g., to enable fixation of the actuator and / or implant to body tissue, e.g., bone tissue.

[0277] According to some exemplary embodiments, as shown in, for example, FIGS. 9A and 9B , the actuator is covered with a thermally insulating coating, such as a silicone coating. In some embodiments, an actuator 902, e.g., a spiral actuator, includes a helical body 904 covered with a bellows 906, e.g., a conical bellows. In some embodiments, the bellows 906, optionally formed from a metal or shape memory alloy, thermally insulates the helical body from body tissue and / or adjacent actuators of the implant. In some embodiments, as shown in, for example, FIG. 9B , an end 908 of the actuator body 904 is covered with or coupled to a cushion or pad, optionally filled with a fluid. In some embodiments, the end 908 is an apex, e.g., a narrow portion of the actuator's helical body 904.

[0278] In some embodiments, as shown in FIGS. 9C-9G, the implant, e.g., the tissue interface 910 of the implant, includes an undercut, e.g., an undercut opening 912. In some embodiments, as shown in FIGS. 9E and 9F, the undercut is shaped and sized to receive the base 909, e.g., the wide end of the body 904. In some embodiments, the undercut is shaped and sized to at least partially surround the base 909, e.g., to prevent the body 904 from disengaging from the implant, e.g., from the tissue interface 910 of the implant. Optionally, the tissue interface 910 is a soft tissue interface. Optionally, the tissue interface 910 is formed from a thermally insulating material, e.g., to thermally insulate the actuator, which may be made from a metal, from the tissue. A potential advantage of having a thermally insulating tissue interface is that it can prevent tissue damage (e.g., tissue burns or coagulation) when the actuator is heated.

[0279] Reference is made to Figures 10A-10C, which illustrate an implant with a single actuator, according to some exemplary embodiments of the present invention.

[0280] According to some exemplary embodiments, implant 1002 includes an actuator 1004 coupled to a tissue interface 1006, e.g., a soft tissue interface, optionally within an undercut in the tissue interface. In some embodiments, tissue interface 1006 is a rectangular tissue interface, optionally square in shape, as shown, for example, in FIG. 10B. In some embodiments, rectangular tissue interface 1008 has rounded corners, e.g., to prevent damage to tissue contacting tissue interface 1008. Alternatively, tissue interface 1010 is rounded, as shown, for example, in FIG. 10C.

[0281] Reference is made to Figures 11A-11D, which illustrate an implant having an array of actuators, according to some exemplary embodiments of the present invention.

[0282] 11A and 11B, implant 1102 includes a rectangular tissue interface 1104 (e.g., a square tissue interface) and a plurality of actuators (e.g., actuators 1106, 1108, 1110, and 1112) arranged in an array of actuators. In some embodiments, an even number of actuators are arranged in each row or column of the array.

[0283] According to some exemplary embodiments, as shown, for example, in FIGS. 11C and 11D, the implant 1120 includes a round or triangular tissue interface 1122.

[0284] Reference is now made to Figures 12A and 12B, which illustrate a multi-unit implant formed from multiple single-unit or multi-unit implants, according to some exemplary embodiments of the present invention.

[0285] According to some exemplary embodiments, multi-unit implant 1202 includes two single-unit implants, such as implants 1204 and 1206, coupled to one another by connectors 1208 and 1210. In some embodiments, the connectors, e.g., connectors 1208 and 1210, at least partially bridge the gap between the two units 1204 and 1206. In some embodiments, connectors 1208 and 1210 are formed from a soft material (e.g., a soft polymer), a hard material (e.g., a hard polymer), and / or a metallic material. In some embodiments, the multi-unit implant is modular and can include any number of single-unit implants connected to one another by connectors. In some embodiments, the connectors are configured for reversible assembly into the single-unit implants, allowing for easy disassembly, e.g., to form multi-unit implants of various shapes and sizes. In some embodiments, the connectors are configured to enable the creation of modular implants, e.g., modular multi-unit implants.

[0286] According to some exemplary embodiments, as shown in FIG. 12B , the connectors are configured to be reversibly coupled to one another, for example, to enable modular formation of multi-unit implants. In some embodiments, implant units 1202 and 1205 are coupled to one another to form a quadruple-unit implant by interconnecting connectors 1208 and 1214. In some embodiments, connecting single units of the actuator to form a multi-unit implant allows, for example, the implant to conform to the shape of the implantation site. In some embodiments, the single units have a round, rectangular, hexagonal, or any geometric shape.

[0287] Exemplary implants with non-folding edge portions According to some exemplary embodiments, the implant includes one or more actuators covered by a cover, which optionally functions as a tissue interface and is configured to be placed in contact with tissue. In some embodiments, the cover includes at least one portion at an end of the implant that remains unfolded when the actuators of the implant are collapsed. In some embodiments, when the actuators of the implant expand, a central portion of the cover is stretched by the actuator. In some embodiments, stretching the central portion of the cover aligns with the unfolded portion of the edge of the implant, for example, to form a uniform, smooth outer surface of the implant.

[0288] See Figures 12C and 12D, which show an implant with unfolded edges when the implant's actuator is in a collapsed state (Figure 12C) and when the actuator is in an expanded state (Figure 12D).

[0289] According to some exemplary embodiments, implant 1220 includes at least one actuator, e.g., actuators 1222 and 1224. In some embodiments, implant 1220 further includes cover 1226, which is optionally formed from a soft, compressible, and / or flexible material (e.g., silicone). In some embodiments, cover includes at least one central portion 1228 and at least one edge portion 1230. In some embodiments, central portion 1228 is located over the actuator and optionally contacts an end of the actuator. In some embodiments, edge portion 1230 is located at an edge of implant 1220. In some embodiments, central portion 1228 is thicker than edge portion 1230 of the cover. Optionally, edge portion is located at a periphery of implant 1220. In some embodiments, central portion 1228 is connected to the edge portion via hinge portion 1232 of cover 1226.

[0290] According to some exemplary embodiments, the edge 1230 includes one or more openings shaped and sized to receive screws 1234 or nails to secure the edge of the implant 1220 to tissue, such as bone tissue. Optionally, the edge 1230 of the cover is tapered.

[0291] According to some exemplary embodiments, the edges 1230 of the cover 1226 are not folded, e.g., the edges 1230 remain unfolded when the actuators 1222 and 1224 are in a folded state and the central portion 1228 is folded. In some embodiments, for example, when the actuators expand to an expanded state, the actuators push against the central portion 1226, aligning the central portion 1228 against the edges 1230 and creating a uniform, smooth tissue-contacting surface of the cover 1226. In some embodiments, the expansion of one or more actuators elevates tissue 1240, e.g., soft tissue, in contact with the cover, while anchoring the implant 1220 to the bone with a uniform, smooth surface and edges that contact the bone tissue 1236.

[0292] According to some exemplary embodiments, the cover 1226 includes a plurality of holes that are shaped and sized to allow fluid and / or tissue to penetrate the implant, for example, into voids between the actuators and / or into voids in the cover 1226 and bone 1236.

[0293] According to some exemplary embodiments, as shown in, for example, FIGS. 12E and 12F , the implant includes a cover 1226 and a filler material 1244 in the bone tissue 1236. In some embodiments, the filler material is flexible, optionally an elastic filler material, and is configured to expand and fill voids formed within the implant when the actuator is expanded. In some embodiments, if the implant includes a filler material, the cover is sealed to prevent fluids and / or tissue from entering the implant. Alternatively, the cover includes pores that allow fluids and / or tissue to enter the implant and the filler material 1244. In some embodiments, the filler material 1244 includes a sponge-like material. Optionally, the filler material 1244 is formed from a shape memory material, such as a shape memory polymer or a shape memory material, such as nitinol.

[0294] Exemplary Wave Spring Actuator Reference is made to Figures 13A-13B, which illustrate a wave spring actuator according to some exemplary embodiments of the present invention.

[0295] According to some exemplary embodiments, the implant includes one or more wave spring actuators, such as wave spring actuator 1302. In some embodiments, wave spring actuator 1302 is formed from a shape memory alloy (e.g., nitinol (NiTi)) or a copper-aluminum-nickel alloy. In some embodiments, a spring actuator formed from a shape memory alloy, such as wave spring actuator 1302, is configured to move between a compressed state, such as a martensitic state (optionally upon cooling), and an expanded state, such as an austenitic state (optionally upon heating).

[0296] According to some exemplary embodiments, the spring actuator is configured to transition to a martensitic state, such as the compressed state shown in FIG. 13A, when the shape memory alloy is cooled below a predetermined temperature, e.g., below 38°C, below 37°C, below 35°C, or any intermediate, lower, or higher temperature level. In some embodiments, the spring actuator transitions to the martensitic state when cooled and forced to remain in a compressed state by applying an external force to the actuator. Alternatively, the spring actuator has two shape memory states, and simply cooling the spring is sufficient to transition from the first memory state to the second memory state without actively compressing the actuator.

[0297] According to some exemplary embodiments, when the shape memory alloy is heated to a temperature above a predetermined value, e.g., 40°C or above, 38°C or above, 37°C or above, 35°C or above, or any intermediate, lower, or higher temperature level, the spring actuator is configured to acquire an austenite state, e.g., the expanded state shown in FIG. 13B. In some embodiments, the actuator, e.g., the spring actuator, acquires a fully expanded state, which represents when the transition from the martensite phase to the austenite phase is complete, i.e., Af (austenite finish), and to reach this Af state, the transition temperature value must be high (e.g., 50°C-60°C) compared to As (austenite start 35°C-38°C). The phase transition temperature value is predetermined according to the desired transition temperature.

[0298] In some embodiments, a plurality of spring actuators, for example wave spring actuators, are arranged in an array within the implant.

[0299] Potential advantages of using wave spring actuators are that they can be made in increasing height and force and in different diameter sizes.

[0300] In some embodiments, a single wave spring formed from NiTi exerts a compressive force selected from the range of 700 to 1100 grams (gr) in the austenitic state, and a single wave spring formed from NiTi exerts a compressive force selected from the range of 300 to 600 grams (gr) in the martensitic state.

[0301] In some embodiments, the shape and / or size of the actuator is designed based on the expansion force required to lift the tissue. In some embodiments, the force / strength of the actuator depends on the geometry of the element, i.e., the width of the material and / or the length of the element structure.

[0302] In some embodiments, adding actuators to the implant increases the force delivered to the tissue proportionally. Optionally, the compressive force is proportional to the total area of ​​the implant depending on the number of actuators supporting the implant.

[0303] Exemplary Surrounded Implant According to some exemplary embodiments, the implant includes an enclosed body having a base configured to couple the implant body to hard tissue (e.g., bone) and a soft tissue interface configured to allow contact between the implant body and soft tissue. In some embodiments, the implant comprises one or more actuators enclosed within the body. In some embodiments, the enclosed body is configured to isolate the actuators and / or the implant lumen from body tissue after implantation. In some embodiments, the implant body is an expandable body configured to move between a collapsed state and an expanded state. In some embodiments, the body is configured to expand, optionally axially, for example, according to alignment of the actuator, after heating of the actuator.

[0304] Reference is made to Figures 14A-14E, which illustrate enclosed expandable implants, according to some exemplary embodiments of the present invention.

[0305] According to some exemplary embodiments, an implant, e.g., implant 1402, includes an expandable body 1404 having an internal lumen 1406. In some embodiments, implant 1402 includes a base 1408 configured to attach implant 1402 to hard tissue (e.g., bone). In some embodiments, the base is formed from a hard material. Alternatively, base 1408 is formed from a flexible material. In some embodiments, body 1404 includes a tissue interface 1410, e.g., a soft tissue interface. In some embodiments, tissue interface 1410 includes a layer of soft material, optionally including a fluid, e.g., liquid, air, gas, or gel. Optionally, the tissue interface layer is thick, e.g., thicker than base 1408.

[0306] According to some exemplary embodiments, implant 1402 includes a plurality of actuators, e.g., actuators 1410 and 1412, optionally arranged in an array and positioned within lumen 1406 of implant 1402. In some embodiments, the actuators are positioned and aligned between base 1408 and the inner surface of tissue interface 1410, as shown, for example, in Figures 14B and 14C. In some embodiments, a first end of each actuator is coupled to base 1408 and a second end of each actuator is coupled to the inner surface of tissue interface 1410.

[0307] According to some exemplary embodiments, the actuators, e.g., actuators 1408, 1410, and 1412, are expandable actuators, e.g., comprising wave spring actuators as shown in Figures 13A-13B. In some embodiments, the actuators are configured to move between a collapsed state, e.g., as shown in Figures 14D and 14E, and an expanded state, e.g., as shown in Figures 14B and 14C. In some embodiments, expansion of one or more actuators causes the implant body 1404 to expand, e.g., as shown in Figures 14B and 14C. In some embodiments, expansion of the implant body causes the tissue interface 1410 to push against the soft tissue, changing the curvature and shape of the outer surface of the skin, as shown in Figures 2D and 8C.

[0308] According to some exemplary embodiments, body 1404 is shaped like a collapsible bellows, for example, allowing body 1404 to collapse and expand.

[0309] Exemplary Flexible Implant According to some exemplary embodiments, the implant is flexible, allowing the implant to contact and / or secure to, for example, non-planar, e.g., curved, hard tissue. In some embodiments, non-planar hard tissue, e.g., bone tissue, is found in the skull. In some embodiments, the implant is flexible enough to contact and optionally secure to the skull.

[0310] According to some exemplary embodiments, the flexible implant is configured to bend in one or more directions and / or along one or more axes of the implant. In some embodiments, the flexible implant comprises a flexible tissue interface and / or an array of flexible actuators. See Figures 15A-15F, which illustrate flexible implants according to some exemplary embodiments of the present invention.

[0311] According to some exemplary embodiments, implant 1502 is flexible, e.g., capable of bending in one or more directions. In some embodiments, implant 1502 comprises a tissue interface 1512 and a plurality of actuators coupled to the tissue interface, e.g., actuators 1504, 1506, and 1508. In some embodiments, each actuator includes a first end 1503 coupled to tissue interface 1512 and a second end 1505 distal to tissue interface 1512, as shown in, for example, FIG. 15A .

[0312] According to some exemplary embodiments, each actuator includes a spring 1510, for example formed from a shape memory alloy, and is optionally configured to move between a compressed and an extended state upon heating.

[0313] According to some exemplary embodiments, the actuators are positioned on the surface of the tissue interface 1512, with adjacent actuators spaced apart evenly or unevenly. In some embodiments, the actuators are spaced apart on the surface of the tissue interface. In some embodiments, each actuator includes a cover 1514 (e.g., a spring cover that isolates the actuator's spring from adjacent actuators and / or tissue surrounding the implant). In some embodiments, the cover 1514 is flexible and optionally includes a bellows cover. In some embodiments, the cover is configured to stretch with actuator expansion (e.g., when the spring within the actuator expands). In some embodiments, the bellows cover is formed from a sheet material (e.g., a coated fabric) in a folded accordion shape. In some embodiments, the bellows cover is shaped to fold and unfold with the movement of the actuator, e.g., the actuator spring. In some embodiments, the bellows cover is made from a polymer layer (e.g., silicone, polyurethane).

[0314] According to some exemplary embodiments, each bellows cover 1514 is optionally perforated, for example, to allow tissue to grow into the actuator after implantation (e.g., after activation of the actuator has ended). Alternatively, the bellows cover is impermeable to tissue. In some embodiments, the spaces between the actuators of the implant allow tissue to grow between the actuators. In some embodiments, the bellows are made of a biodegradable material, allowing tissue growth several months after implantation.

[0315] According to some exemplary embodiments, the tissue interface 1512 is soft and / or flexible. In some embodiments, the tissue interface 1512 comprises one or more layers of a soft and / or flexible material. Optionally, the tissue interface 1512 is coated or covered with an actuator cover, e.g., the tissue interface 1512 is covered with a bellows cover or the tissue interface 1512 cover is integrated with the bellows cover, as shown, for example, in FIGS. 15D-15F .

[0316] According to some exemplary embodiments, as shown in, for example, Figures 15D-15G, a flexible implant, e.g., implant 1530, is configured to bend about the implant's major axis 1533 and / or minor axis 1535. In some embodiments, as shown in, for example, Figure 15E, bending of implant 1530 changes the distance between the second ends 1505 of each actuator that are not connected to a user interface (e.g., tissue interface 1532). In some embodiments, flexible implant 1530 bends when one or more actuators are in a compressed state, as shown in, for example, Figure 15D, and / or when one or more actuators are in an extended state, as shown in, for example, Figures 15E and 15F.

[0317] According to some exemplary embodiments, the flexibility of the implant 1530 allows the actuator to conform to the curved surface of the bone 1540 and bring the tissue interface 1532 into contact with the soft tissue of the body, as shown, for example, in FIG. 15G.

[0318] According to some exemplary embodiments, the implant 1530 is attached to the jawbone, as shown, for example, in Figure 16. In some embodiments, the second end 1505 of one or more actuators of the implant 1530 is connected to the jawbone using adhesive, screws, or nails.

[0319] According to some exemplary embodiments, the tissue interface (e.g., tissue interface 312 in FIGS. 3A and 3B) includes one or more holes that allow tissue to grow through the tissue interface into one or more actuators. In some embodiments, the holes are positioned to allow energy to be delivered to the actuators through the tissue interface. In some embodiments, the holes are configured to provide an opening for delivering other energy sources, such as lasers, that can be used to selectively (e.g., via focused optical delivery) or uniformly (e.g., via collimated or wide beam optical delivery) induce heat in the actuators.

[0320] Exemplary Mesh Implants According to some exemplary embodiments, the implant comprises a body formed from a mesh material and one or more actuators disposed within the body. Alternatively or optionally, each of the distal and proximal ends of the actuators is connected to at least one layer of mesh material. In some embodiments, the actuators are disposed between at least two opposing layers of mesh material, for example, to allow tissue growth into the implant and optionally the actuators.

[0321] Reference is now made to Figures 17A-17D, which illustrate an implant having an actuator connected to two mesh layers, one on each side of the actuator, according to some exemplary embodiments of the present invention.

[0322] According to some exemplary embodiments, implant 1702 includes at least one actuator (e.g., spring actuators 1704 and 1706) and at least two layers of mesh material (e.g., at least one first mesh layer 1708 and at least one second mesh layer 1710). In some embodiments, a first end of the actuators is connected to at least one first mesh layer 1708 of the implant, and a second end of each actuator is connected to at least one second mesh layer 1710 of the implant.

[0323] According to some exemplary embodiments, the implant is disposed in two tissue layers: a first tissue layer 1712, e.g., a soft tissue layer, and a second tissue layer 1714, e.g., a bone layer. In some embodiments, mesh layer 1710 is secured to, e.g., bone layer 1714, and mesh layer 1708 is disposed in contact with soft tissue layer 1712. Optionally, the implant is disposed between two body layers when the actuator, or at least a portion of the actuator, is in a collapsed state, as shown, e.g., in FIG. 17A .

[0324] According to some exemplary embodiments, upon actuation, one or more actuators, e.g., actuator 1704, expand, pushing against mesh layer 1708 and moving tissue (e.g., soft tissue 1712) contacting or resting against mesh layer 1708 away from bone tissue 1714, as shown, for example, in FIG. 17C . In some embodiments, following a healing period following implant surgery, body tissue migrates into the implant through the pores of the mesh. In some embodiments, if the actuators are not covered with a coating that prevents tissue ingress, body tissue optionally enters the actuators before the actuation process begins. Alternatively, if the actuators are covered with a coating, body tissue can invade into and between the implant, improving support and anchoring of the actuators and improving the biological healing response with the implant, as shown, for example, in FIG. 17D .

[0325] In some embodiments, the mesh material comprises at least one of a fabric, a perforated polymer or other biomaterial, a metal net, and / or a metal mesh. In some embodiments, the mesh material allows for dispersing or spreading a force applied to tissue, for example, by an actuator, such as a spring actuator. Additionally or optionally, the mesh material allows for tissue in-growth or biological fluid crossing, for example, through the implant. Optionally, one or more or all of the actuators are coated or sealed. Alternatively, one or more or all of the actuators are left uncoated.

[0326] Exemplary Implants with Isolated Actuators According to some exemplary embodiments, the implant includes one or more isolation layers configured to isolate one or more actuators of the implant from the surrounding environment. In some embodiments, the one or more isolation layers surround the one or more actuators. In some embodiments, the one or more isolation layers include folds (e.g., peripheral folds surrounding each actuator to allow free expansion without interference from the isolation layer). In some embodiments, isolating the actuators of the implant allows, for example, tissue intrusion between adjacent actuators and prevents tissue intrusion into the actuator body. Optionally, tissue intrusion into the actuator body, e.g., spring body, may impede, for example, axial spring expansion and collapse movement.

[0327] Reference is now made to Figures 18A-18D, which illustrate implants with isolated actuators, according to some exemplary embodiments of the present invention.

[0328] According to some exemplary embodiments, the implant includes two or more spaced-apart actuators disposed within hollow bellows (e.g., bellows 1806 and 1808). In some embodiments, the hollow bellows are interconnected, e.g., forming at least one covering or coating layer that isolates the actuators from the surrounding environment. In some embodiments, the bellows include or are at least partially formed from silicon. In some embodiments, the bellows surrounding the actuators are interconnected by a sleeve, e.g., a silicone rubber bellows sleeve. In some embodiments, the bellows are formed from a material configured to prevent cells and / or tissue from passing through the bellows, e.g., into the actuators. In some embodiments, the bellows are formed from a solid material or from a perforated material with pores too narrow for cells to penetrate. In some embodiments, the pores have a maximum width value in the range of 30 μm (microns) to 5 microns, e.g., 30 microns to 10 microns, 15 microns to 3 microns, or values ​​in intermediate, smaller, or larger ranges. In some embodiments, the holes have a maximum width value in the range of 0.1 mm to 1 mm, e.g., 0.1 mm to 0.4 mm, 0.6 mm to 0.9 mm, or any intermediate, smaller, or larger range. In some embodiments, the bellows is formed from a material that prevents tissue in-growth into or out of the bellows.

[0329] According to some exemplary embodiments, as shown in, for example, FIGS. 18B-18D , implant 1803 includes tissue contact layer 1810, e.g., a soft tissue contact layer. In some embodiments, tissue contact layer 1810 is the tissue interface of the implant and is optionally formed from silicone and / or rubber. In some embodiments, as shown in, for example, FIG. 18B , the implant is embedded in two tissue layers, e.g., bone tissue 1812 and soft tissue 1814. In some embodiments, the collapsed state comprises a collapsed bellows with folds around it. In some embodiments, actuator 1802 expands within bellows 1806 after actuator actuation. In some embodiments, expansion of actuator 1802 unfolds bellows 1806, e.g., straightening out folds around the bellows.

[0330] According to some exemplary embodiments, as shown, for example, in FIG. 18D, the bellows define gaps between the isolated actuators, which allows tissue to penetrate between adjacent isolated actuators and into the implant, e.g., into the implant body.

[0331] According to some exemplary embodiments, the bellows is configured to thermally isolate the actuator from the surrounding environment, e.g., to prevent heat loss to the surrounding environment after actuation of the actuator. Additionally or alternatively, the bellows is configured to reduce air volume and / or reduce vacuum pressure on the spring actuator.

[0332] According to some exemplary embodiments, as shown in, for example, Figures 19A-19C, spring actuators of the implant, such as spring actuators 1902 and 1904, are disposed within hollow bellows 1906 and 1908, respectively. In some embodiments, the hollow bellows are configured to reduce collapsed volume and are optionally formed from silicone or a different polymer.

[0333] According to some exemplary embodiments, hollow bellows 1906 and 1908 and / or spring actuators 1902 and 1904 are connected to an interface, such as cover 1910. In some embodiments, the cover is optionally formed from a thermally insulating material and configured to reduce heat transfer to surrounding tissue and / or reduce heat loss from the heated spring actuators after actuation of the spring actuators. Optionally, hollow bellows 1906 and 1908 are integral with cover 1910. Optionally, cover 1910 has a foldable shape.

[0334] According to some exemplary embodiments, as shown in, for example, Figures 20A-20C, an interface, e.g., cover 2002, includes at least one socket 2004. In some embodiments, the at least one socket 2004 is located on a surface opposite the tissue-contacting surface of cover 2002. In some embodiments, the at least one socket is configured to receive at least one of a hollow bellows and a spring actuator within the bellows.

[0335] In some embodiments, when the spring actuator is in a compressed state, e.g., when the implant is inserted into the body, the spring does not protrude from the at least one socket, maintaining a thin cross-section of the implant, e.g., so as not to interfere with inserting the implant into the body through a thin incision and / or implanting the implant at the implantation site.

[0336] Exemplary Expansion Actuator Reference is made to Figures 21A-21G, which illustrate an implant with at least one low-profile, expandable actuator, according to some exemplary embodiments.

[0337] According to some exemplary embodiments, an implant, such as implant 2102, includes at least one low-profile, expandable actuator 2104 formed as a thin plate or grid. In some embodiments, the low-profile, expandable actuator 2104 is formed from a shape memory alloy, such as nitinol. In some embodiments, the low-profile, expandable actuator is located between a base 2106 and a cover 2107 of the implant 2102, optionally surrounding the low-profile, expandable actuator. In some embodiments, the cover is a tissue-contacting interface, and is optionally soft.

[0338] According to some exemplary embodiments, the low-profile expandable actuator includes multiple expandable segments, e.g., bridges 2108, 2110, and 2112. In some embodiments, the bridges are configured to move from a collapsed state to an expanded state when energy is applied, e.g., when heated. In some embodiments, in the collapsed state, the bridges are compressed and the actuator is flat, optionally planar, as shown, for example, in FIG. 21C. In some embodiments, when the bridges are in the compressed state, the implant 2102 has a thin cross-section, optionally allowing the implant to be inserted into the body through a thin or narrow incision.

[0339] In some embodiments, the thickness of implant 2102 in the collapsed state is in the range of 0.5 mm to 3 mm, e.g., 0.5 mm to 1 mm, 0.5 mm to 2 mm, 1 mm to 2 mm, 1 mm to 3 mm, or any intermediate value or range of values, smaller or larger value or range of values.

[0340] According to some exemplary embodiments, the bridges expand when heated, as shown, for example, in FIGS. 21C-21E. In some embodiments, the amount of bridge expansion depends on the temperature of the low-profile expandable actuator 2104 and / or the temperature of each bridge. In some embodiments, the bridges expand uniformly, for example, if the bridges are thermally connected and / or have similar properties. Alternatively, at least one bridge may be pre-formed to expand to a different extent than one or more other bridges in the implant, resulting in non-uniform expansion of the implant 2102. Alternatively, at least one bridge may be thermally isolated from the other bridges and heated to a different temperature than the other bridges, resulting in non-uniform expansion of the implant 2102.

[0341] According to some exemplary embodiments, the bridge is sealed within the implant 2102, for example, by a cover 2107, as shown, for example, in FIG. 21F.

[0342] According to some exemplary embodiments, as shown, for example, in FIG. 21G, bridges 2108 and 2110 are formed by laser cutting and can optionally be formed in any shape and / or size.

[0343] Exemplary Expanding Implants Reference is now made to Figures 22A-22E, which illustrate an inflatable actuator, according to some exemplary embodiments of the present invention.

[0344] According to some exemplary embodiments, the implant comprises one or more inflatable actuators, e.g., inflatable actuator 2202. In some embodiments, inflatable actuator 2202 comprises at least one inflatable chamber 2204 disposed between a base 2206 (e.g., a first tissue-contacting interface) and a second tissue-contacting interface 2208. In some embodiments, base 2206 is optionally planar and configured to be placed in contact with body tissue, e.g., bone. In some embodiments, interface 2208 comprises a compressible, optionally soft, interface, e.g., a cushion, configured to press against body soft tissue when the implant is expanded.

[0345] According to some exemplary embodiments, implant 2202 comprises at least one flow path (e.g., flow path 2210 connected to chamber 2204 and configured to allow fluid flow between chamber 2204 and at least one fluid source). Optionally, a flow path, e.g., flow path 2212, traverses interface 2208. Optionally, at least one flow path (e.g., flow paths 2210 and 2212) includes at least one valve (e.g., a one-way valve) to control the flow of fluid through the flow path.

[0346] According to some exemplary embodiments, as shown, for example, in FIG. 22B, inflation of chamber 2204 by introducing fluid into chamber 2204 via the flow channel expands implant 2202.

[0347] According to some exemplary embodiments, as shown in, for example, FIG. 22C , an implant, e.g., implant 2214, comprises a series of inflatable actuators, e.g., actuators 2216, 2218, and 2220. In some embodiments, the series of actuators are fluidly connected by at least one fluid path. In some embodiments, the at least one fluid path comprises at least one valve for controlling the flow of fluid to and / or from a single chamber of at least one inflatable actuator of the implant or all chambers of the inflatable actuators of the implant. Optionally, each inflatable actuator includes a fluidically separated fluid path to at least one inflatable chamber of the actuator, e.g., allowing for individual inflation of at least one inflatable chamber.

[0348] According to some exemplary embodiments, one or more tissue-contacting interfaces 2208 of the implant have a rounded and / or curved outer surface facing the tissue, e.g., a rounded and / or curved tissue-contacting surface, as shown, for example, in FIG. 22D. In some embodiments, the interface 2208 is dome-shaped, as shown, for example, in FIG. 22D. Alternatively, the interface 2208 of the implant 2232 has a rectangular shape, as shown, for example, in FIG. 22E. Optionally, the interface 2208 has a flat tissue-contacting surface or outer surface, as shown, for example, in FIG. 22E. Optionally, the interface 2208 has a flat tissue-contacting surface or outer surface, as shown, for example, in FIG. 22E.

[0349] Exemplary Modular Implants According to some exemplary embodiments, the implant comprises two or more, e.g., a plurality of, single actuators coupled together. In some embodiments, coupling the single actuators can create a modular implant, e.g., having a predetermined size and / or shape. Additionally or alternatively, coupling the single actuators can form an implant that conforms to a selected implantation site within the body.

[0350] Reference is made to Figures 23A-23E, which illustrate a modular implant, according to some exemplary embodiments of the present invention.

[0351] According to some exemplary embodiments, an implant, e.g., a modular implant, comprises two or more single-unit expandable actuators, e.g., actuator 2302. In some embodiments, for example as shown in FIG. 23B , actuator 2302 comprises at least one expandable portion (e.g., expandable chamber 2304 configured to move between a compressed state and an expanded state upon actuation or inflation). In some embodiments, the chamber is connected to a base 2306. Optionally, base 2306 is formed like a plate. Optionally, base has a customized 3D shape to fit / replace / accommodate the shape of a particular anatomical bone. Optionally, base 2306 is rigid.

[0352] According to some exemplary embodiments, base 2306 includes one or more openings or holes, e.g., opening 2308, configured to allow coupling of base 2306 to bone tissue. Additionally, base includes one or more openings or holes configured to allow coupling of a base of at least one first actuator unit to a base of at least one second actuator unit. In some embodiments, the at least one first actuator unit is connected to the at least one second actuator unit via a hinge. In some embodiments, the at least one first actuator unit is movably connected to the at least one second actuator unit, e.g., allowing the first actuator unit to move relative to the second actuator unit.

[0353] According to some exemplary embodiments, an implant, e.g., a modular implant, comprises an array 2310 of actuator units that can be assembled or disassembled from the array, as shown, for example, in Figure 23C. In some embodiments, the array is positioned between a first tissue (e.g., bone tissue) and a second tissue (e.g., soft tissue) such that the chamber 2304 contacts the soft tissue, as shown, for example, in Figure 23D.

[0354] Alternatively, the implant comprises an array of single actuator units connected to a single tissue interface, or two or more tissue interfaces each covering two or more actuators.

[0355] According to some exemplary embodiments, the array of actuator units that are movable relative to adjacent actuators in the array is flexible, e.g., bendable, to conform to the curvature of the tissue within the body, e.g., at the implantation site, as shown in Figure 23E. In some embodiments, the flexible array bends to conform to the curvature of the skull tissue, such as the jaw region of the head, the temple region of the head, or the cheek region of the head, as shown in Figure 23E.

[0356] Exemplary Actuator Array According to some exemplary embodiments, the implant comprises an array of actuators, for example as described above in Figures 23C and 23D. In some embodiments, the actuators in the array are assembled together. Alternatively, the actuators of the array are connected to a base layer. See Figures 24A and 24B, which illustrate an array of actuators connected to a base, according to some exemplary embodiments of the invention.

[0357] According to some exemplary embodiments, as shown in, for example, FIG. 24A , implant 24A comprises an array of spaced apart actuators, e.g., actuators 2404, 2406, 2408, and 2410 connected to a single base structure 2412. In some embodiments, the base (e.g., base 2412) comprises one or more openings or anchors (e.g., screws 2414) configured to secure base 2412 to body tissue (e.g., bone tissue). In some embodiments, as shown in, for example, FIG. 24B , implant 2440 comprises a plurality of actuators, e.g., actuators 2442 and 2444, arranged in an array, e.g., a compact array. In some embodiments, actuators 2442 and 2444 in the array contact each other and optionally have a polygonal shape, allowing for a compact arrangement of actuators that contact each other via sides of the polygonal shape.

[0358] 24C , the base 2450 of the implant 2440 includes one or more fluid flow paths, e.g., a channel 2452. In some embodiments, the implant 2440 includes at least one valve 2454 on the channel 2452 configured to control flow into and / or out of the channel 2452. Optionally, the valve 2454 is a one-way valve. Optionally, the valve 2454 includes a check valve.

[0359] According to some exemplary embodiments, each actuator, e.g., actuators 2442 and 2444, is configured to be assembled to base 2450. Optionally, the actuators are configured to be irreversibly assembled to base 2450. Alternatively, the actuators are configured to be reversibly assembled to base 2450.

[0360] According to some exemplary embodiments, as shown in FIG. 24D , for example, the actuator 2442 includes at least one expandable cell 2460 connected to an actuator base 2462. In some embodiments, the actuator base is rigid and optionally includes one or more locking features 2464 configured to secure the actuator 2442 to the implant base 2450. In some embodiments, each actuator includes a piercing element, such as a needle 2466, fluidly coupled to a cell 2460. In some embodiments, as shown in FIGS. 24A-24E , for example, the actuator 2442 is secured by inserting the end of the needle into a channel 2452, using the locking feature 2464, to form a flow path between the channel 2452 and the expandable cell 2460. In some embodiments, as shown in FIG. 24D , for example, the expandable cells of the implant are inflated via the channel 2452 in the implant base to which each actuator is fluidly coupled.

[0361] Alternatively or additionally, as shown, for example, in FIG. 24E, each cell of the actuator includes at least one valve 2480, for example, for individually inflating each cell separately from other cells of the implant actuator.

[0362] Exemplary Actuator Assembly According to some exemplary embodiments, the implant is modular and can be assembled on demand, for example, as described in block 382 of FIG. 3D. In some embodiments, the implant is assembled by placing a desired number of actuators, such as the spiral springs shown in FIGS. 5A-5D, 6A-6D, and 7A-7J, at selected locations using actuator positioning bases. In some embodiments, the base is a layer of material, for example, a sheet.

[0363] Reference is now made to Figures 25A-25C, which illustrate placement of an actuator using an actuator positioning base, according to some exemplary embodiments of the present invention.

[0364] According to some exemplary embodiments, actuator assembly 2502 includes a positioning base (e.g., layer 2504 having at least one, e.g., at least two, predetermined placement locations distributed therein). In some embodiments, each placement location is configured to directly or indirectly couple at least one actuator to layer 2504, e.g., via an adapter. In some embodiments, as shown in FIG. 25A , for example, each placement location includes an extension 2506 (e.g., a pin) extending from layer 2504. In some embodiments, an actuator adapter, e.g., adapter 2508, is configured to couple to extension 2508. Further, the adapter is configured to couple to an actuator, such as, for example, a spiral spring. In some embodiments, each adapter includes a first opening 2510 shaped and sized to receive extension 2506 and a second opening 2512 shaped and sized to receive actuator 2514. Alternatively, the actuator is directly coupled to the extension, e.g., via an opening in the actuator.

[0365] According to some exemplary embodiments, as shown, for example, in FIG. 25B, base 2516 includes an opening 2518 at each placement location. In some embodiments, the opening is configured to receive a portion of an adapter, such as, for example, a pin 2522. In some embodiments, each adapter is configured to be coupled to an actuator 2514, optionally via the opening in the adapter, as shown, for example, already in FIG. 25A.

[0366] According to some exemplary embodiments, as shown in Figures 25A and 25B, each actuator is positioned at a desired location on the base using an adapter coupled to the base using, for example, a snap-fit ​​mechanism, and positioned at a specific, predetermined location within the base. Optionally, each actuator is reversibly or irreversibly coupled to the adapter using, for example, a snap-fit ​​or interference lock. Optionally, each adapter is reversibly or irreversibly coupled to the base using, for example, a snap-fit ​​or interference lock. Optionally, the actuator is reversibly or irreversibly coupled directly to the base using, for example, a snap-fit ​​or interference lock mechanism.

[0367] A potential advantage of using an adapter to couple an actuator to a base may be the ability to couple a standard actuator to a base or to couple different sized bases or actuators with expandable portion heights that are expandable at different temperatures, for example.

[0368] According to some exemplary embodiments, as shown, for example, in FIG. 25C, a base 2524 with predetermined actuator attachment locations allows actuators to be placed in specific locations, either via adapters 2528 or directly, to form a customized assembly 2530 with a specific distribution on the base 2524.

[0369] According to some exemplary embodiments, the base is flexible, e.g., bendable, and includes multiple coupling regions, each configured to couple at least one actuator to the base. In some embodiments, the base is formed from at least one of a polymeric material, silicon or its derivatives, plastic, and / or metal. A potential advantage of having the base formed from a different material than the actuators, e.g., a polymeric material, may be that the base can be easily cut without damaging the actuators. In some embodiments, as shown in FIG. 25D , the base 2540 includes multiple spaced openings, such as openings 2542 and 2544. In some embodiments, openings 2542 and 2544 are shaped and sized to allow coupling of the actuator 2548 to the base 2540, optionally via an adapter 2550. In some embodiments, the actuator 2548 or the actuator adapter 2550 is configured to be coupled to the base 2540 via a snap connection, optionally using at least one snap-fit ​​connector. Optionally, the actuator includes a portion configured to be coupled to the base via a snap connection.

[0370] According to some exemplary embodiments, base 2540 includes at least two types of openings, one type for coupling an adapter or actuator to the base in a first orientation, e.g., for directly or indirectly coupling an actuator base to base 2540, and another type of opening, e.g., opening 2546, for coupling an adapter or actuator in a second, optionally opposite orientation.

[0371] According to some exemplary embodiments, coupling the actuators in opposite orientations relative to the base allows for a head-to-tail arrangement, with the base 2554 of at least one first actuator 2556 adjacent to the tip 2558 of the expandable portion of at least one second actuator 2580, as shown in Figure 25E for example. A potential advantage of arranging the actuators in a head-to-tail orientation is that it makes efficient use of space in the base, allowing as many actuators as possible to be coupled to a single shared base.

[0372] Reference is now made to Figures 26A-26E, which illustrate implant assemblies, according to some exemplary embodiments of the present invention.

[0373] According to some exemplary embodiments, the implant assembly includes an actuator positioning base, such as base 2602. In some embodiments, base 2602 is a grid including one or more actuator couplings (e.g., connectors 2604 and 2606), each configured to couple to, for example, a solid, spiral-shaped actuator 2608. In some embodiments, each actuator is reversibly or irreversibly coupled to base 2602, for example, via connectors 2604 and / or 2606. In some embodiments, base 2602 includes one or more tissue anchors for coupling base 2602 to body tissue, for example, hard body tissue optionally including bone tissue. In some embodiments, one or more tissue anchors include openings 2610 shaped and sized to receive screws for coupling the base to tissue.

[0374] According to some exemplary embodiments, the base 2602 is formed in a grid, with the actuator couplings 2604 and 2606 connected to one another via at least one bridge 2603. In some embodiments, the shape of the base 2602 can be changed by cutting or disconnecting the bridges.

[0375] According to some exemplary embodiments, the assembly comprises an array of caps, e.g., array 2612 includes at least one or more caps, e.g., caps 2614 and 2616. In some embodiments, the caps are spaced apart from one another. In some embodiments, the distance between the centers of adjacent caps is comparable to the distance between the centers of adjacent actuator couplings.

[0376] According to some exemplary embodiments, the concave side (e.g., dome) of each cap is configured to couple to an actuator, and the opposite convex side of the cap is optionally configured to contact soft tissue. In some embodiments, adjacent caps in the cap array are connected to one another via one or more connecting bridges or portions 2618. In some embodiments, the cap array includes one or more connectors for connecting the cap array to the actuator array. Optionally, the one or more connectors include openings 2620 that align with openings 2610 when cap array 2612 is coupled to actuator base 2602. In some embodiments, openings 2610 and 2620 allow for insertion of screws 2622 across implant 2630 and into hard tissue, e.g., bone 2632, of the body, as shown, for example, in FIG. 26E .

[0377] FIG. 26D shows an underside view of the implant assembly 2630.

[0378] Reference is now made to Figures 27A-27C, which illustrate an implant assembly in which an actuator is sandwiched between a base layer and a cover layer, the actuator mating with the base layer and the cover layer, according to some exemplary embodiments of the present invention.

[0379] According to some exemplary embodiments, implant assembly 2702 comprises an actuator base 2704 including one or more actuator coupling locations 2706 and 2708, and one or more actuators or actuator housings 2710 and 2712. In some embodiments, the actuator housing comprises an actuator optionally irreversibly coupled to an adapter.

[0380] According to some exemplary embodiments, implant assembly 2702 includes cover 2714. In some embodiments, an actuator, e.g., an actuator housing or adapter, is coupled between base 2704 and cover 2714. In some embodiments, cover layer 2714 is coupled to the actuator via intermediate bonding layer 2716, as shown, for example, in FIGS. 27A-27C . In some embodiments, actuators 2710 and 2712 and cover 2714 mate with intermediate bonding layer 2716 from both sides, optionally using mating mechanisms, e.g., one or more snap-fit ​​connectors. Optionally, the actuator or actuator housing mates with base 2704 via mating mechanisms, e.g., mating connector 2722, e.g., a snap-fit ​​connector.

[0381] Exemplary Implants with Internal Actuator Arrays Reference is now made to Figures 28A-28D, which illustrate an implant having an internal actuator array, according to some exemplary embodiments of the present invention.

[0382] According to some exemplary embodiments, implant 2802 comprises a chamber 2804 having walls surrounding and defining a lumen. In some embodiments, chamber 2804 includes at least one opening 2806 to the lumen. In some embodiments, the chamber is formed from a resilient material, and at least one tissue-contacting surface of the chamber is soft or smooth. In some embodiments, chamber 2804 is formed as a single unit. Alternatively, the chamber is assembled from two or more separate units joined together.

[0383] According to some exemplary embodiments, as shown, for example, in Figure 28B, implant 2802 comprises an internal actuator array 2808. In some embodiments, as shown, for example, in Figure 28C, actuator array 2808 comprises a base 2814 and at least one actuator or multiple actuators, e.g., actuators 2812 and 2810, coupled to base 2814 using at least one adapter, at least one lock, adhesive, and / or locking portion.

[0384] According to some exemplary embodiments, actuator array 2808 is formed by disposing one or more actuators, e.g., actuators 2810 and 2812, at predetermined actuator placement locations within the base or on at least one surface of the base. In some embodiments, the base includes one or more grooves or sockets at each placement location, such as groove 2813 shown in the transparent view of the implant in FIG. 28A . In some embodiments, groove 2813 is shaped and sized to receive at least a portion of the actuator, e.g., the actuator base. In some embodiments, the shape of the groove matches the shape of the actuator portion, e.g., the actuator base. In some embodiments, the shape of the groove is circular, round, oval, quadrilateral, polygonal, triangular, or any geometric shape that matches the portion of the actuator configured to be disposed within groove 2813.

[0385] According to some exemplary embodiments, one or more grooves in the implant are empty. In some embodiments, the grooves are spaced apart such that the minimum distance between them is between 0.1 mm and 10 mm, e.g., between 0.1 mm and 1 mm, between 0.5 mm and 3 mm, between 0.5 mm and 5 mm, or any intermediate, smaller, or larger distance or distance value range.

[0386] According to some exemplary embodiments, as shown, for example, in Figure 28C, implant 2802 is assembled by inserting actuator array 2808 into the chamber lumen, for example, through at least one opening 2806. In some embodiments, after insertion, the actuator array is bonded to the chamber, e.g., the inner surface of the chamber wall, using an adhesive or using one or more pins or staples that extend at least partially through chamber 2804 and array 2808.

[0387] According to some exemplary embodiments, as shown in Figure 28D, the chamber 2804 has a tapered edge 2816 that at least partially surrounds the chamber 2804. In some embodiments, the chamber 2804 includes a lumen 2818 surrounded by a wall 2820.

[0388] According to some exemplary embodiments, as shown in FIG. 28E , an implant, e.g., implant 2802, includes one or more holes or openings, e.g., opening 2822, in the chamber. In some embodiments, the openings are configured to allow cells to enter the implant cavity, e.g., lumen 2818, during the healing process. In some embodiments, as shown in FIG. 28E , implant 2802 is used as a temporal implant in temporal bone surgery. In some embodiments, the implant is placed in the temple region of skull 2824 and used to create volume between the skull and the skin. Alternatively, the implant is implanted in the jaw region, cheek region, chin region, or any other region of the face or head.

[0389] A potential advantage of having an implant formed from an enclosed flexible compartment with an array of actuators within the compartment lumen, as shown, for example, in Figure 28B, is that it has a more uniform design in which the actuators are held within the chamber and do not come into direct contact with tissue, which may optionally allow for longer tissue growth around the implant and a longer post-operative implant adjustment period. An additional advantage is that the implant with actuators may be easily extracted from the body as a single unit, if desired.

[0390] It is anticipated that many related actuators will be developed during the life of the patent that matures from this application, and the scope of the term actuator is intended to pre-emptively include all such new technologies.

[0391] As used herein, "about" in reference to an amount or value means "within ±10%."

[0392] The words "comprises," "comprising," "includes," "including," "has," "having" and their conjugations mean "including but not limited to."

[0393] The term "consisting of" means "including and limited to."

[0394] The term "consisting essentially of" means that a composition, method, or structure may include additional components, steps, and / or moieties, provided that the additional components, steps, and / or moieties do not materially alter the basic and novel characteristics of the claimed composition, method, or structure.

[0395] As used herein, the singular forms "a," "an," and "the" include plural references unless the context clearly dictates otherwise. For example, "a compound" or "at least one compound" includes a plurality of compounds, and may also include mixtures thereof.

[0396] Throughout this application, various embodiments of the invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and is not an inflexible limitation on the scope of the invention. Thus, the description of a range should be considered to specifically disclose all of the possible subranges and individual numerical values ​​within that range. For example, description of a range such as 1 to 6 specifically discloses subranges such as 1 to 3, 1 to 4, 1 to 5, 2 to 4, 2 to 6, 3 to 6, etc., as well as individual numerical values ​​within that range, e.g., 1, 2, 3, 4, 5, and 6. This applies regardless of the magnitude of the range.

[0397] When a range of values ​​is provided herein (e.g., any pair of numbers connected by "10-15," "10 to 15," or other range designations), it is intended to include any number (fractional or integer) within the limits of the range provided, unless the context clearly dictates otherwise. The phrases "range between" a first designated number and a second designated number, and "range," "range to," "range to," or "range including" (or other similar range terminology) "from" a first designated number to a second designated number, are used interchangeably herein and are meant to include the first and second designated numbers and all fractional and integer values ​​therebetween.

[0398] Unless otherwise indicated, numbers used herein, and any numerical ranges based thereon, are approximations within the accuracy of reasonable measurement and rounding errors, as will be understood by one of ordinary skill in the art.

[0399] It will be understood that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in any combination of these features in a single embodiment. Conversely, multiple 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 subcombination or with respect to other described embodiments as appropriate. A given feature described in the context of various embodiments should not be construed as essential to that embodiment, unless the particular embodiment is inoperable without that element.

[0400] While the present invention has been described in conjunction with specific embodiments thereof, many alternatives, modifications, and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications, and variations that fall within the spirit and broad scope of the appended claims.

[0401] It is the intention of the applicants that all publications, patents, and patent applications mentioned in this specification be incorporated herein by reference in their entirety to the same extent as if each individual publication, patent, and patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application should not be construed as an admission that such reference is available as prior art to the present invention. Nor should it necessarily be construed as limiting, to the extent that section headings are used. In addition, the priority document of this application, if any, is incorporated herein by reference in its entirety.

Claims

1. 1. A method for shaping tissue, comprising: providing an implant comprising at least one actuator configured to expand upon exposure to external energy; implanting the implant at an implantation site between at least one first tissue and at least one second tissue within a patient's body; selectively actuating the at least one actuator; shaping the at least one first tissue and / or the at least one second tissue according to expansion of the at least one actuator actuated in response to the selective activation; A method comprising:

2. the selectively activating includes remotely selectively activating the at least one actuator from a remote location outside the body. The method of claim 1.

3. the selectively activating includes selectively heating the at least one actuator to a temperature level that causes the at least one actuator to expand. The method according to claim 1 or 2.

4. the selectively heating includes exposing the at least one actuator to an electromagnetic field generated outside the body. The method of claim 3.

5. the selectively heating includes exposing the at least one actuator to at least one of ultrasonic energy, radio frequency energy, a laser, infrared light, or a warm liquid; The method of claim 3.

6. the selective activation occurs before or during the implantation. The method according to any one of claims 1 to 5.

7. allowing the implantation site to heal prior to said selectively activating. The method according to any one of claims 1 to 6.

8. If the shaped tissue does not acquire a target shape, repeating the selectively activating and the shaping. The method according to any one of claims 1 to 7.

9. providing the implant with at least one tissue interface; the at least one actuator is coupled to the at least one tissue interface; the implanting includes placing the at least one actuator in contact with the at least one second tissue and placing the at least one tissue interface in contact with the at least one first tissue. The method according to any one of claims 1 to 8.

10. the embedding includes plastically or elastically bending the implant to conform to the surface of the at least one first tissue or the surface of the at least one second tissue; The method according to any one of claims 1 to 9.

11. modifying the shape and / or size of the provided implant prior to and / or during implantation to adapt it to the implantation site. The method according to any one of claims 1 to 10.

12. modifying includes changing a number of actuators of the implant. The method of claim 11.

13. the at least one first tissue comprises soft tissue and the at least one second tissue comprises bony tissue, and the shaping comprises shaping the soft tissue in accordance with expansion of the actuated at least one actuator. The method according to any one of claims 1 to 12.

14. the at least one first tissue comprises a first soft tissue, the at least one second tissue comprises a second soft tissue, and the shaping comprises shaping the first soft tissue in accordance with expansion of the actuated at least one actuator. The method according to any one of claims 1 to 12.

15. the at least one actuator comprises a plurality of actuators, and the selectively activating comprises selectively activating at least one actuator of the plurality of actuators. The method according to any one of claims 1 to 14.

16. 1. An intracorporeal implant configured to be implanted at an implantation site within a body, comprising: at least one actuator positioning base including a plurality of spaced apart actuator coupling regions each configured to couple at least one actuator to the at least one actuator positioning base; a plurality of actuators coupled to the at least one actuator positioning base, at least one actuator of the plurality of actuators configured to expand and / or contract upon exposure to energy; Internal implants.

17. the plurality of actuators includes an actuator having an opening; 17. The body implant of claim 16.

18. the at least one actuator positioning base is configured to flex; The body implant according to claim 16 or 17.

19. the actuator positioning base includes at least one opening in each of the plurality of spaced apart actuator coupling regions, the at least one opening configured to couple at least one actuator of the plurality of actuators to the actuator positioning base by a snap connection. The intracorporeal implant according to any one of claims 16 to 18.

20. At least some of the plurality of actuators are coupled to one another by one or more connectors. The body implant according to any one of claims 16 to 19.

21. the plurality of actuators are configured to move laterally relative to one another when heated by the energy; The intracorporeal implant according to any one of claims 16 to 20.

22. each of the plurality of actuators includes a shape memory material configured to expand when heated by the energy; The intracorporeal implant according to any one of claims 16 to 21.

23. At least one actuator of the plurality of actuators is configured to expand in a direction substantially perpendicular to the actuator positioning base when heated.

23. The body implant of claim 22.

24. At least one actuator of the plurality of actuators is configured to expand when heated in a direction oriented at an angle between 10 degrees and 170 degrees relative to the actuator positioning base.

23. The body implant of claim 22.

25. each of the plurality of actuators includes a spring formed from the shape memory material configured to expand when heated by the energy; The intracorporeal implant according to any one of claims 22 to 24.

26. The spring is formed in a spiral or helical shape.

26. The body implant of claim 25.

27. each actuator having a base to which the spring is coupled, the bases of two or more actuators being connected to one another to form an array of actuators coupled to the actuator positioning base; 27. The body implant of claim 25 or 26.

28. the actuator positioning base includes a tissue interface having at least one soft and / or flexible portion configured to contact body tissue; The body implant according to any one of claims 16 to 27.

29. the tissue interface includes at least one first surface configured to contact soft body tissue and at least one second surface configured to be coupled to the plurality of actuators, the at least one first surface being soft and / or flexible; 29. The body implant of claim 28.

30. the at least one tissue interface and / or the at least one first surface comprises at least one inflatable chamber; 30. The body implant of claim 29.

31. the at least one tissue interface comprises at least one chamber filled with a fluid or gel; 30. The body implant of claim 29.

32. each of the plurality of actuators includes a respective actuator cover isolating each actuator from other actuators of the plurality of actuators; The intracorporeal implant according to any one of claims 16 to 31.

33. further comprising a flexible cover coupled to the actuator positioning base; the plurality of actuators are positioned within a lumen between the flexible cover and the actuator positioning base; The intracorporeal implant according to any one of claims 16 to 32.

34. the at least one actuator positioning base and the plurality of actuators form an array of actuators; the body implant comprises a flexible, surrounding cover defining an internal cavity, the flexible, surrounding cover having an inner surface and an outer surface configured to contact body tissue; the array of actuators is positioned within the lumen and coupled to the inner surface of the flexible cover; The body implant according to any one of claims 16 to 33.

35. The flexible covering includes one or more perforations shaped and sized to allow tissue growth into the interior of the body implant and / or fluid infusion into the lumen.

35. The body implant of claim 33 or 34.

36. each of the actuators includes a first end coupled to the at least one actuator positioning base and an opposite second end; the internal implant includes tissue contact pads each coupled to the second end of the actuator; The tissue contact pad is configured to contact bone tissue or soft tissue. The body implant according to any one of claims 16 to 35.

37. the intracorporeal implant is configured to move from a collapsed state to an expanded state when the at least one actuator expands, and a thickness of the intracorporeal implant in the collapsed state is in a range of 1 mm to 4 mm; The body implant according to any one of claims 16 to 36.

38. An intracorporeal implant, an array of actuators having apertures, each actuator configured to expand when heated; a cover having a tissue-contacting outer surface, the cover enclosing the array of actuators having the openings; An implant in the body comprising:

39. the actuator having the opening is formed from a shape memory alloy configured to expand and applies a force to an inner surface of the cover when the shape memory alloy expands; 39. The body implant of claim 38.

40. the apertured actuators are interconnected within the array; 40. The body implant of claim 38 or 39.

41. the array and the actuator having the aperture are formed as a single unit; The intracorporeal implant according to any one of claims 38 to 40.

42. the array and the actuator having the aperture are formed as a single unit from a shape memory alloy; 42. The body implant of claim 41.

43. the cover forms a pocket surrounding the array of actuators having the openings. The body implant according to any one of claims 38 to 42.

44. any of the apertured actuators includes an aperture through the body of the apertured actuator; The body implant according to any one of claims 38 to 43.

45. The actuator having the opening is formed as a stretchable spring.

45. The body implant of claim 44.

46. an inflatable actuator unit, at least one flexible tissue interface configured to contact tissue; at least one base; at least one expandable cell coupled between the at least one base and the at least one soft tissue interface; at least one inflation port in the at least one inflatable cell, the at least one inflatable cell configured to expand when inflated through the at least one inflation port; the base includes at least one connector configured to connect the inflatable actuator unit to at least one additional inflatable actuator unit and to allow movement of the inflatable actuator unit relative to an adjacent inflatable actuator unit; Inflatable actuator unit.

47. the at least one connector includes at least one of a joint, a hinge, and / or a swivel connector; 47. An inflatable actuator unit according to claim 46.

48. The maximum dimension of the inflatable actuator unit is up to 20 mm.

48. An inflatable actuator unit according to claim 46 or 47.

49. An intracorporeal implant, 45. An array of a plurality of inflatable actuator units according to claim 44 coupled together, the array being configured to conform to the curvature of body tissue by movement of one or more inflatable actuator units relative to other inflatable actuator units in the array. Internal implants.

50. An intracorporeal implant, an array of actuators formed from shape memory alloy, the actuators being interconnected by shape memory alloy bridges; at least one of the actuators is configured to expand and contract when heated and move laterally relative to other actuators in the array; Internal implants.

51. 1. A multi-unit intracorporeal implant comprising: a plurality of single-unit implants joined together; Each single unit implant: at least one tissue interface configured to be placed in contact with body tissue; at least one expandable actuator coupled to the at least one tissue interface; at least one connector configured to connect each single-unit implant to at least one different single-unit implant of the plurality of single-unit implants; The maximum dimension of each single unit is up to 20 mm; Multi-unit intracorporeal implant.

52. the at least one expandable actuator comprises at least one inflatable chamber, the at least one expandable actuator configured to expand when the at least one inflatable chamber is inflated; 52. The implant of claim 51.

53. the at least one expandable actuator is formed from a shape memory alloy and is configured to expand when heated above a predetermined temperature level; 53. The implant of claim 52.

54. each single-unit implant comprising a base coupled to the at least one expandable actuator opposite the at least one tissue interface; the base includes one or more openings shaped and sized to allow a screw or nail to penetrate the base into the body tissue so that the single-unit implant can be attached to the body tissue; An implant according to any one of claims 51 to 53.

55. An intracorporeal implant, at least one implant cover having a tissue-contacting surface and at least one opposing surface, the at least one implant cover including at least one central portion, at least one edge portion configured to couple the body implant to tissue, and at least one hinge portion between the central portion and the edge portion; at least one expandable actuator contacting the at least one opposing surface of the at least one central portion, the at least one expandable actuator configured to move from a collapsed state to an expanded state; the at least one expandable actuator obtains a continuous tissue contact surface of the at least one implant cover by using the hinge portion to press the at least one central portion against the at least one edge portion when the at least one expandable actuator is expanded. Internal implants.

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