Adjustable implant

Abstract

A method of tissue shaping, comprising: providing an implant comprising at least one actuator configured to expand upon exposure to an external energy; implanting the implant into an implantation site between at least one first tissue and at least one second tissue in the body of a patient; selectively energizing the at least one actuator; the at least one first tissue and / or the at least one second tissue is shaped as a function of expansion of the energized at least one actuator.

Description

[0001] Related Applications

[0002] This application claims the benefit of priority of U.S. Provisional Patent Application No. 63 / 408,120, filed on September 20, 2022, under 35 USC § 119(e), the content of which is incorporated herein by reference in its entirety.

[0003] Technical Field and Background Art

[0004] In some embodiments thereof, the present invention relates to shaping tissue, and more specifically, but not exclusively, to shaping tissue using adjustable implants.

[0005] U.S. Patent No. US7722670B2 describes that "according to one embodiment of the present invention, an implant device can be provided. The implant can be adapted to manipulate the position of the eyeball associated with a patient, whereby the device includes an insertion device that includes a first part and a second part. The first part can include a first thickness and can be adapted to lift the position of the eyeball. The second part can include a second thickness and / or a second position relative to the first part for moving the position of the eyeball in the forward direction" (abstract).

[0006] U.S. Patent No. US10779926B2 describes that "a facial implant device includes a support structure adapted to be connected to the surface of a bone within a facial region, an external structure adapted to a predefined anatomical contour associated with the facial region, and an intermediate airbag structure located between the support structure and the external structure. The intermediate airbag structure includes an internal volume that responds to adjustments to the external structure to adapt to the predefined anatomical contour associated with the facial region" (abstract).

[0007] U.S. Patent No. US9572676B2 describes that "an inflatable balloon for diagnosing and treating a diseased intervertebral disc or a fracture. The balloon is a multi-volume balloon composed of a plurality of adjustable and expandable individual volumes. Further disclosed are methods for forming, expanding, and implanting the multi-volume balloon to correctly position and stabilize the diseased intervertebral disc or the bone of the fracture. Also further disclosed is a kit for aligning and stabilizing bones, intervertebral discs, or spinal motion segments" (abstract).

[0008] U.S. Patent Application Publication No. US20070067041A1 describes that "an inflatable facial implant includes a base having a first side and a second side. An airbag wall is fixed to the first side of the base. The airbag wall is softer than the base. Also disclosed is a surgical method of using such an implant" (abstract).

[0009] U.S. Patent Application Publication No. US20100249946A1 describes "An implantable tissue augmentation device, method, and related tools are disclosed. The device includes an inflatable body having a self-sealing membrane operably attached to the wall of the implant. The self-sealing membrane provides an inlet for filling the device and includes a first layer that includes a fabric. The fabric has a first multi-strand yarn positioned in a first direction and a second multi-strand yarn positioned in a second direction. The first multi-strand yarn and the second multi-strand yarn intersect to form a matrix pattern having a plurality of cells defined by free spaces between the yarns. The membrane also includes a first elastic material and a second layer, the first elastic material being configured to fill the plurality of cells and form a coating on the first multi-strand yarn and the second multi-strand yarn, the second layer including a second elastic material. The hardness of the second elastomeric material is lower than that of the first elastic material. Kits and systems are also disclosed" (Abstract).

[0010] Other background arts include 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

[0011] Some examples of some embodiments of the present invention are listed below (one embodiment may include multiple features from multiple examples and / or fewer features than all of one example):

[0012] Example 1. A method of tissue shaping, the method comprising the steps of:

[0013] Providing an implant including at least one actuator configured to expand upon exposure to an external energy;

[0014] Implanting the implant at an implantation site between at least one first tissue and at least one second tissue within a patient's body;

[0015] Selectively energizing the at least one actuator;

[0016] Shaping the at least one first tissue and / or the at least one second tissue according to the expansion of the at least one actuator upon energization.

[0017] Example 2. The method according to Example 1, wherein the selectively energizing step includes remotely selectively energizing the at least one actuator from a remote location external to the body.

[0018] Example 3. The method according to any one of Example 1 or 2, wherein the selectively energizing step includes selectively heating the at least one actuator to a temperature level that causes the at least one actuator to expand.

[0019] Example 4. The method according to Example 3, wherein the selectively heating step includes selectively heating the at least one actuator.

[0020] Example 5. The method according to Example 3 or 4, wherein the selectively heating step includes exposing the at least one actuator to an electromagnetic field generated outside the body.

[0021] Example 6. The method according to Example 3, wherein the selectively heating step includes exposing the at least one actuator to at least one of the following: ultrasonic energy, radio frequency energy, laser, and infrared rays.

[0022] Example 7. The method according to any one of the foregoing examples, wherein the selectively energizing step is performed during the implanting step.

[0023] Example 8. The method according to any one of the foregoing examples, wherein the method includes allowing the implantation site to heal before the selectively energizing step.

[0024] Example 9. The method according to any one of the foregoing examples, wherein the method includes repeating the selectively energizing step and the shaping step if the shaping tissue does not obtain the target shape.

[0025] Example 10. The method according to any one of the foregoing examples, wherein the providing step includes providing at least one tissue interface for the implant, and the at least one actuator is connected to the at least one tissue interface, and the implanting step includes bringing the at least one actuator into contact with the at least one second tissue and bringing the at least one tissue interface into contact with the at least one first tissue.

[0026] Example 11. The method according to any one of the foregoing examples, wherein the implanting step includes plastically or elastically bending the implant to conform the implant to a surface of the at least one first tissue or a surface of the at least one second tissue.

[0027] Example 12. The method according to any one of the foregoing examples, wherein the method includes selecting an implant having a target shape and / or size that conforms to the implantation site before the providing step.

[0028] Example 13. The method according to any of the foregoing examples, the method comprising modifying the shape and / or dimensions of the provided implant before and / or during the implanting step to conform to the implant site.

[0029] Example 14. The method according to example 13, the modifying step comprising changing the number of actuators of the implant.

[0030] Example 15. The method according to any of the foregoing examples, the at least one first tissue comprising soft tissue, and the at least one second tissue comprising bone tissue, and the shaping step comprising shaping the soft tissue according to the expansion of the at least one actuator that is energized.

[0031] Example 16. The method according to any of examples 1 to 14, the at least one first tissue comprising a first soft tissue, and the at least one second tissue comprising a second soft tissue, wherein the shaping step comprises shaping the first soft tissue according to the expansion of the at least one actuator that is energized.

[0032] Example 17. The method according to any of the foregoing examples, the at least one actuator comprising a plurality of actuators, and the selectively energizing step comprising selectively energizing at least one of the plurality of actuators.

[0033] Example 18. A body implant, the body implant comprising:

[0034] At least one tissue engagement portion configured to contact a body tissue;

[0035] A plurality of actuators connected to the at least one tissue engagement portion, wherein at least one of the plurality of actuators is configured to expand and / or contract when exposed to external energy.

[0036] Example 19. The body implant according to example 18, the at least one tissue engagement portion and / or the plurality of actuators being configured to be curved.

[0037] Example 20. The body implant according to any of examples 18 to 19, at least some of the plurality of actuators being connected to each other by one or more connectors.

[0038] Example 21. The body implant according to any of examples 18 to 20, the plurality of actuators being configured to move laterally relative to each other when heated by the external energy.

[0039] Example 22. The body implant according to any of examples 18 to 21, each of the plurality of actuators comprising a shape memory material configured to expand when heated by the external energy.

[0040] Example 23. The body implant as described in Example 22, wherein the shape memory material comprises a shape memory alloy or a shape memory polymer.

[0041] Example 24. The body implant as described in any one of Examples 22 to 23, wherein each of the plurality of actuators comprises a spring formed of the shape memory material, the spring being configured to expand when heated by the external energy.

[0042] Example 25. The body implant as described in Example 24, wherein the spring is in a helical shape or a helical body shape.

[0043] Example 26. The body implant as described in any one of Examples 24 or 25, wherein each actuator comprises a base connected to the spring, and wherein the bases of two or more actuators are connected together to form an array of a plurality of actuators connected to the at least one engagement portion.

[0044] Example 27. The body implant as described in any one of Examples 18 to 26, wherein the at least one tissue engagement portion comprises at least one of a soft portion and / or a bendable portion configured to contact body tissue.

[0045] Example 28. The body implant as described in any one of Examples 18 to 27, wherein the at least one tissue engagement portion comprises at least one first surface configured to contact soft body tissue and at least one second surface configured to be connected to the plurality of actuators.

[0046] Example 29. The body implant as described in Example 28, wherein the at least one first surface is soft and / or bendable.

[0047] Example 30. The body implant as described in any one of Examples 28 or 29, wherein the at least one tissue engagement portion and / or the at least first surface comprises at least one inflatable chamber.

[0048] Example 31. The body implant as described in any one of Examples 28 or 29, wherein the at least one tissue engagement portion comprises at least one chamber filled with a fluid or a gel.

[0049] Example 32. The body implant as described in any one of Examples 18 to 31, wherein each of the plurality of actuators comprises a separate actuator cover, the actuator cover isolating each actuator from the other actuators among the plurality of actuators.

[0050] Example 33. The body implant as described in Example 32, wherein the actuator cover comprises a bellows cover configured to move between a folded state and a non-folded state when the actuator expands.

[0051] Example 34. A body implant as described in any one of Examples 32 or 33, wherein the actuator cover includes a plurality of perforations, and the shape and size of the plurality of perforations allow tissue to grow inwardly through the cover into the actuator.

[0052] Example 35. The body implant of Example 34, wherein the width of the plurality of perforations is in the range of 0.1 mm to 3 mm.

[0053] Example 36. A body implant as described in any one of Examples 18 to 35, wherein each actuator of the plurality of actuators includes a first end and an opposite second end connected to the at least one tissue engagement portion, and the implant includes a plurality of tissue contact pads, each tissue contact pad being connected to the opposite second end of the actuator, and the plurality of tissue contact pads being configured to contact bone tissue.

[0054] Example 37. A body implant as described in any one of Examples 18 to 31, the body implant including a base and an implant cover connected between the at least one tissue engagement portion and the base, wherein the implant cover surrounds the implant and defines an implant lumen, and the plurality of actuators are located within the lumen, between the tissue engagement portion and the base.

[0055] Example 38. The body implant of Example 37, wherein the implant cover includes a plurality of folded portions and is configured to move between a folded state and a non-folded state when at least one of the plurality of actuators expands.

[0056] Example 39. A body implant as described in any one of Examples 37 or 38, wherein the implant cover includes a plurality of perforations, and the shape and size of the plurality of perforations allow tissue to grow inwardly into the implant.

[0057] Example 40. A body implant as described in any one of Examples 37 to 39, wherein the implant cover is integrated with the at least one tissue engagement portion.

[0058] Example 41. A body implant as described in any one of Examples 37 to 40, the body implant including a filler within the lumen, wherein the filler is configured to expand when at least one of the plurality of actuators expands.

[0059] Example 42. A body implant as described in any one of Examples 18 to 41, wherein the at least one tissue engagement portion includes at least one silicone-filled compartment.

[0060] Example 43. A body implant as described in any one of Examples 18 to 42, the body implant being configured to move between a collapsed state and an expanded state when the at least one actuator expands, and the thickness of the body implant in the collapsed state being in the range of 1 millimeter to 4 millimeters.

[0061] Example 44. An inflatable actuator, the inflatable actuator comprising:

[0062] At least one flexible tissue engaging portion configured to contact tissue;

[0063] At least one base;

[0064] At least one inflatable unit connected between the at least one base and the at least one flexible tissue engaging portion;

[0065] At least one inflation port in the at least one inflatable unit, wherein the at least one inflatable unit is configured to expand when inflated through the at least one inflation port.

[0066] Example 45. The inflatable actuator of Example 44, wherein the at least one flexible tissue engaging portion comprises silicon.

[0067] Example 46. The inflatable actuator of either Example 44 or 45, wherein the at least one tissue engaging portion is shaped as a dome.

[0068] Example 47. The inflatable actuator of any one of Examples 44 to 46, wherein the inflation port is in fluid communication with an inflation channel passing through the at least one flexible tissue engaging portion.

[0069] Example 48. A body implant, the body implant comprising:

[0070] A plurality of inflatable actuators as described in Example 44, the plurality of inflatable actuators being connected to each other by at least one connector.

[0071] Example 49. The body implant of Example 48, the body implant comprising at least one inflation channel having at least one inflation port, and the plurality of inflatable units of the plurality of inflatable actuators being in fluid communication with the at least one inflation channel.

[0072] Example 50. A body implant, the body implant comprising:

[0073] A base comprising at least one fluid channel;

[0074] A plurality of inflatable actuators, connected to the base;

[0075] Wherein each of the plurality of inflatable actuators includes:

[0076] At least one inflatable unit configured to move between a deflated state and an expanded inflated state;

[0077] At least one inflation port fluidly connected to the at least one inflatable unit;

[0078] Wherein the connection of each of the plurality of inflatable actuators to the base fluidly connects the inflation port to the at least one fluid channel of the base.

[0079] Example 51. The body implant according to Example 50, wherein the plurality of inflatable actuators are in contact with each other on the base in an array configuration.

[0080] Example 52. The body implant according to Example 50, wherein the plurality of inflatable actuators are spaced apart.

[0081] Example 53. The body implant according to any one of Examples 50 to 52, wherein each of the plurality of inflatable actuators includes at least one fastener configured to fasten each inflatable actuator to the base.

[0082] Example 54. The body implant according to any one of Examples 50 to 53, wherein each of the plurality of inflatable actuators includes at least one syringe connected to the inflation port, and the syringe penetrates into the at least one fluid channel of the base to fluidly connect the at least one inflatable unit to the at least one fluid channel.

[0083] Example 55. A body implant, the body implant comprising:

[0084] An array of a plurality of actuators formed of a shape memory alloy, the plurality of actuators being interconnected by a plurality of shape memory alloy bridge structures;

[0085] Wherein at least one of the plurality of actuators is configured to expand and contract and move laterally relative to other actuators in the array when heated.

[0086] Example 56. The body implant according to Example 55, wherein the plurality of actuators include a plurality of springs formed of the shape memory alloy.

[0087] Example 57. A body implant as described in Example 55 or 56, wherein the at least one tissue engaging portion has at least one first tissue contacting surface and at least one second surface.

[0088] Example 58. A body implant as described in Example 57, wherein the at least one tissue engaging portion includes at least one chamber filled with a fluid or a gel.

[0089] Example 59. A multi-unit body implant, the multi-unit body implant comprising:

[0090] A plurality of single-unit implants connected to each other, wherein each single-unit implant includes:

[0091] At least one tissue engaging portion configured to contact a body tissue;

[0092] At least one expandable actuator connected to the at least one tissue engaging portion;

[0093] At least one connector configured to connect each single-unit implant to at least one different single-unit implant among the plurality of single-unit implants.

[0094] Example 60. An implant as described in Example 59, wherein the at least one first tissue engaging portion is part of the at least one expandable actuator.

[0095] Example 61. An implant as described in Example 58 or 59, wherein the at least one expandable actuator includes at least one inflatable chamber, and the at least one expandable actuator is configured to expand when the inflatable chamber is inflated.

[0096] Example 62. An implant as described in Example 59 or 60, wherein the at least one expandable actuator is formed of a shape memory alloy and is configured to expand when heated to a predetermined temperature level or higher.

[0097] Example 63. An implant as described in any one of Examples 59 to 62, wherein the at least one connector includes a hub portion configured to allow movement of a first single-unit implant relative to at least one second single-unit implant connected to the first single-unit implant.

[0098] Example 64. An implant as described in any one of Examples 59 to 63, wherein each single-unit implant includes a base portion connected to the at least one expandable actuator relative to the at least one tissue engaging portion, the base portion being configured to fixedly connect the single-unit to the tissue.

[0099] Example 65. The implant as described in Example 64, wherein the base includes one or more openings, and the shape and size of the one or more openings allow a screw or a nail to pass through the base and into the tissue to connect the monomer unit implant to the tissue.

[0100] Example 66. A body implant, comprising:

[0101] At least one implant cover having a tissue contact surface and at least one opposite surface, wherein the at least one implant cover includes at least one intermediate portion, at least one edge portion, and at least one hinge portion between the at least one intermediate portion and the at least one edge portion, and the at least one edge portion is configured to connect the body implant to the tissue;

[0102] At least one expandable actuator in contact with the at least another opposite surface of the at least one intermediate portion, wherein the expandable actuator is configured to move from a collapsed state to an expanded state;

[0103] Wherein when the at least one expandable actuator expands, the at least one expandable actuator uses the hinge portion to push the at least one intermediate portion relative to the at least one edge portion to obtain a continuous tissue contact surface of the at least one implant cover.

[0104] Some additional examples of some embodiments of the present invention are listed below (one embodiment may include multiple features from multiple examples and / or fewer features than all of one example):

[0105] Example 1. A method for tissue shaping, the method comprising the steps of:

[0106] Providing an implant including at least one actuator configured to expand when exposed to an external energy;

[0107] Implanting the implant at an implant site between at least one first tissue and at least one second tissue in a patient's body;

[0108] Selectively energizing the at least one actuator;

[0109] In response to the selective energization, shaping the at least one first tissue and / or the at least one second tissue according to the expansion of the at least one actuator being energized.

[0110] Example 2. The method as described in Example 1, wherein the step of selectively energizing includes remotely selectively energizing the at least one actuator from a remote location external to the body.

[0111] Example 3. The method according to any one of Example 1 or 2, wherein the selectively energizing step includes selectively heating the at least one actuator to a temperature level that causes the at least one actuator to expand.

[0112] Example 4. The method according to Example 3, wherein the selectively heating step includes exposing the at least one actuator to an electromagnetic field generated outside the body.

[0113] Example 5. The method according to Example 3, wherein the selectively heating step includes exposing the at least one actuator to at least one of the following: ultrasonic energy, radio frequency energy, laser, infrared light, or a thermally insulating liquid.

[0114] Example 6. The method according to any one of the preceding examples, wherein the selectively energizing step is performed before or during the implanting step.

[0115] Example 7. The method according to any one of the preceding examples, wherein the method includes allowing the implant site to heal before the selectively energizing step.

[0116] Example 8. The method according to any one of the preceding examples, wherein the method includes repeating the selectively energizing step and the shaping step if the shaped tissue does not achieve the target shape.

[0117] Example 9. The method according to any one of the preceding examples, wherein the providing step includes providing at least one tissue interface for the implant, and the at least one actuator is connected to the at least one tissue interface, and the implanting step includes bringing the at least one actuator into contact with the at least one second tissue and bringing the at least one tissue interface into contact with the at least one first tissue.

[0118] Example 10. The method according to any one of the preceding examples, wherein the implanting step includes plastically or elastically bending the implant to conform the implant to a surface of the at least one first tissue or a surface of the at least one second tissue.

[0119] Example 11. The method according to any one of the preceding examples, wherein the method includes modifying the shape and / or size of the provided implant before and / or during the implanting step to conform to the implant site.

[0120] Example 12. The method according to Example 11, wherein the modifying step includes changing the number of actuators of the implant.

[0121] Example 13. The method according to any of the foregoing examples, wherein the at least one first tissue includes soft tissue, and the at least one second tissue includes bone tissue, and the shaping step includes shaping the soft tissue according to the expansion of the at least one actuator powered.

[0122] Example 14. The method according to any of Examples 1 to 12, wherein the at least one first tissue includes a first soft tissue, and the at least one second tissue includes a second soft tissue, wherein the shaping step includes shaping the first soft tissue according to the expansion of the at least one actuator powered.

[0123] Example 15. The method according to any of the foregoing examples, wherein the at least one actuator includes a plurality of actuators, and the selectively powering step includes selectively powering at least one of the plurality of actuators.

[0124] Example 16. A body implant configured to be implanted in an implantation site in a body, the body implant comprising:

[0125] A positioning base of at least one actuator, the positioning base of the at least one actuator including a plurality of actuator connection regions spaced apart, each actuator connection region being configured to connect at least one actuator to the positioning base;

[0126] A plurality of actuators, connected to the positioning base of the at least one actuator, wherein at least one of the plurality of actuators is configured to expand and / or contract when exposed to energy.

[0127] Example 17. The body implant according to Example 16, wherein the plurality of actuators include a plurality of apertured actuators.

[0128] Example 18. The body implant according to Example 16 or 17, wherein the positioning base of the at least one actuator is configured to bend.

[0129] Example 19. The body implant according to any of Examples 16 to 18, wherein the positioning base of the actuator includes at least one opening in each of the plurality of spaced-apart actuator connection regions, the at least one opening being configured to connect at least one of the plurality of actuators to the positioning base of the actuator by a snap connection.

[0130] Example 20. The body implant according to any of Examples 16 to 19, wherein at least some of the plurality of actuators are connected to each other by one or more connectors.

[0131] Example 21. The body implant according to any one of Examples 16 to 20, wherein the plurality of actuators are configured to move laterally relative to each other when heated by the energy.

[0132] Example 22. The body implant according to any one of Examples 16 to 21, wherein each actuator of the plurality of actuators comprises a shape memory material configured to expand when heated by the energy.

[0133] Example 23. The body implant according to Example 22, wherein at least one actuator of the plurality of actuators is configured to expand in a direction substantially perpendicular to the positioning base of the plurality of actuators when heated.

[0134] Example 24. The body implant according to Example 22, wherein the at least one actuator of the plurality of actuators is configured to expand in a direction oriented at an angle between 10 degrees and 170 degrees relative to the positioning base of the plurality of actuators when heated.

[0135] Example 25. The body implant according to any one of Examples 22 to 24, wherein each actuator of the plurality of actuators comprises a spring formed of the shape memory material, the spring being configured to expand when heated by the energy.

[0136] Example 26. The body implant according to Example 25, wherein the spring is in a helical shape or a helical body shape.

[0137] Example 27. The body implant according to any one of Examples 25 or 26, wherein each actuator comprises a base connected to the spring, and wherein the bases of two or more actuators are connected together to form an array of the plurality of actuators connected to the positioning base of the actuators.

[0138] Example 28. The body implant according to any one of Examples 16 to 27, wherein the positioning base of the actuator comprises a tissue engaging portion having at least one of a soft portion and / or a bendable portion configured to contact body tissue.

[0139] Example 29. The body implant according to Example 28, wherein the tissue engaging portion comprises at least one first surface configured to contact soft body tissue and at least one second surface configured to be connected to the plurality of actuators, wherein the at least one first surface is soft and / or bendable.

[0140] Example 30. The body implant according to Example 29, wherein the at least one tissue engaging portion and / or the at least first surface comprises at least one inflatable chamber.

[0141] Example 31. The body implant as described in Example 29, wherein the at least one tissue engaging portion includes at least one chamber filled with a fluid or a gel.

[0142] Example 32. The body implant as described in any one of Examples 16 to 31, wherein each actuator of the plurality of actuators includes a separate actuator cover that isolates each actuator from the other actuators of the plurality of actuators.

[0143] Example 33. The body implant as described in any one of Examples 16 to 32, wherein the body implant includes a flexible cover connected to a positioning base of the plurality of actuators, wherein the plurality of actuators are located within an inner cavity between the flexible cover and the base.

[0144] Example 34. The body implant as described in any one of Examples 16 to 33, wherein the positioning base of the at least one actuator and the plurality of actuators form an array of a plurality of actuators, and the body implant includes a flexible closed cover that defines an inner cavity and has an outer surface and an inner surface, the outer surface being configured to contact body tissue, and wherein the actuator array is positioned within the inner cavity and connected to the inner surface of the flexible cover.

[0145] Example 35. The body implant as described in any one of Examples 33 or 34, wherein the flexible cover includes one or more perforations, the shape and size of the one or more perforations allowing tissue to grow inwardly into the implant and / or allowing fluid to be injected into the inner cavity.

[0146] Example 36. The body implant as described in any one of Examples 16 to 35, wherein each actuator of the plurality of actuators includes a first end and an opposite second end connected to a positioning base of the at least one actuator, and the implant includes a plurality of tissue contact pads, each tissue contact pad being connected to the opposite second end of the actuator, and the plurality of tissue contact pads being configured to contact bone tissue or soft tissue.

[0147] Example 37. The body implant as described in any one of Examples 16 to 36, wherein the body implant is configured to move between a collapsed state and an expanded state when the at least one actuator expands, and the thickness of the body implant in the collapsed state is in the range of 1 millimeter to 4 millimeters.

[0148] Example 38. A body implant, the body implant comprising:

[0149] An array of a plurality of perforated actuators, wherein each actuator is configured to expand when heated;

[0150] A cover body having a tissue contact outer surface, wherein the cover body surrounds the array of the plurality of perforated actuators.

[0151] Example 39. The body implant as described in Example 38, wherein the array of the plurality of perforated actuators is formed of a shape memory alloy configured to expand and apply a force on an inner surface of the cover body when the shape memory alloy expands.

[0152] Example 40. The body implant as described in any one of Example 38 or 39, wherein the plurality of perforated actuators are interconnected in the array.

[0153] Example 41. The body implant as described in any one of Example 38 to 40, wherein the array and the plurality of perforated actuators are formed as a single unit.

[0154] Example 42. The body implant as described in Example 41, wherein the array and the plurality of perforated actuators are formed as a single unit from a shape memory alloy.

[0155] Example 43. The body implant as described in any one of Example 38 to 42, wherein the cover body forms a bag that surrounds the array of the plurality of perforated actuators.

[0156] Example 44. The body implant as described in any one of Example 38 to 43, wherein one of the plurality of perforated actuators includes a plurality of openings passing through a body of the perforated actuator.

[0157] Example 45. The body implant as described in Example 44, wherein the perforated actuator is in the shape of an extensible spring.

[0158] Example 46. An inflatable actuator unit, the inflatable actuator unit comprising:

[0159] At least one flexible tissue engaging portion configured to contact tissue;

[0160] At least one base;

[0161] At least one inflatable unit connected between the at least one base and the at least one flexible tissue engaging portion;

[0162] At least one inflation port in the at least one inflatable unit, wherein the at least one inflatable unit is configured to expand when inflated through the at least one inflation port,

[0163] The base includes at least one connector configured to connect the inflatable actuator unit to at least one additional inflatable actuator unit and to permit movement of the inflatable actuator unit relative to an adjacent inflatable actuator unit.

[0164] Example 47. The inflatable actuator unit according to Example 46, wherein the at least one connector includes at least one of the following: a joint, a hub portion, and / or a rotary connector.

[0165] Example 48. The inflatable actuator unit according to Example 46 or 47, wherein an upper limit of a maximum dimension of the inflatable actuator unit is 20 millimeters.

[0166] Example 49. A body implant, the body implant comprising:

[0167] An array of a plurality of interconnected inflatable actuator units according to Example 46, wherein the array is configured to conform to a curvature of body tissue by movement of one or more inflatable actuator units relative to other inflatable actuator units in the array.

[0168] Example 50. A body implant, the body implant comprising:

[0169] An array of a plurality of actuators formed of a shape memory alloy, the plurality of actuators being interconnected by a plurality of shape memory alloy bridge structures;

[0170] Wherein at least one of the plurality of actuators is configured to expand and contract and to move laterally relative to other actuators in the array when heated.

[0171] Example 51. A multi-unit body implant, the multi-unit body implant comprising:

[0172] A plurality of single-unit implants connected to each other, wherein each single-unit implant includes:

[0173] At least one tissue engagement portion configured to contact a body tissue;

[0174] At least one expandable actuator connected to the at least one tissue engagement portion;

[0175] At least one connector configured to connect each single-unit implant to at least one different single-unit implant among the plurality of single-unit implants, wherein an upper limit of a maximum dimension of each single unit is 20 millimeters.

[0176] Example 52. The implant as described in Example 51, wherein the at least one expandable actuator includes at least one inflatable chamber, and the at least one expandable actuator is configured to expand when the inflatable chamber is inflated.

[0177] Example 53. The implant as described in Example 52, wherein the at least one expandable actuator is formed of a shape memory alloy and is configured to expand when heated above a predetermined temperature level.

[0178] Example 54. The implant as described in Examples 51 to 53, wherein each single-unit implant includes a base, the base is connected to the at least one expandable actuator relative to the at least one tissue engagement portion, the base includes one or more openings, and the shape and size of the one or more openings allow a screw or a nail to pass through the base and into the tissue to connect the single-unit implant to the tissue.

[0179] Example 55. A body implant, the body implant comprising:

[0180] At least one implant cover having a tissue contact surface and at least one opposite surface, wherein the at least one implant cover includes at least one intermediate portion, at least one edge portion, and at least one hinge portion between the at least one intermediate portion and the at least one edge portion, and the at least one edge portion is configured to connect the body implant to tissue;

[0181] At least one expandable actuator in contact with the at least another opposite surface of the at least one intermediate portion, wherein the expandable actuator is configured to move from a collapsed state to an expanded state;

[0182] Wherein when the at least one expandable actuator expands, the at least one expandable actuator uses the hinge portion to push the at least one intermediate portion relative to the at least one edge portion to obtain a continuous tissue contact surface of the at least one implant cover.

[0183] Unless otherwise defined, all technical and / or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the present invention, the exemplary methods and / or materials are described below. In case of conflict, the patent specification (including definitions) shall prevail. In addition, the materials, methods, and examples are illustrative only and are not intended to be limiting necessarily. Description of the Drawings

[0184] The present invention has been described by way of example only, with reference to the accompanying drawings and images, of some embodiments of the invention. Now, specifically referring to the accompanying drawings in detail, it should be emphasized that the details shown are by way of example and for illustrative discussion of embodiments of the invention. In this regard, the description using the accompanying drawings enables those skilled in the art to clearly know how to implement the embodiments of the invention.

[0185] In the drawings:

[0186] Figure 1 is a flowchart of a process for tissue remodeling according to some exemplary embodiments of the present invention;

[0187] Figures 2A to 2B is a schematic diagram showing the energy supply effect of a plurality of actuators of an implant according to some exemplary embodiments of the present invention;

[0188] Figures 2C to 2D is a schematic diagram showing tissue shaping using an implant having at least one solid actuator (e.g., a single actuator) according to some exemplary embodiments of the present invention;

[0189] Figures 3A to 3C is a block diagram of an implant according to some exemplary embodiments of the present invention;

[0190] Figure 3D is a flowchart of a process for installing an implant at a specific implantation site and / or for a specific treatment according to some exemplary embodiments of the present invention;

[0191] Figure 4 is a flowchart of a facial shaping process according to some exemplary embodiments of the present invention;

[0192] Figures 5A to 5D is an image of an actuator in the shape of a helical spring according to some exemplary embodiments of the present invention;

[0193] Figure 5E and 5F is a schematic diagram of an implant including a plurality of helical actuators according to some exemplary embodiments of the present invention;

[0194] Figures 6A to 6D is a schematic diagram of a plurality of solid actuators having a rectangular base according to some exemplary embodiments of the present invention;

[0195] Figures 7A to 7F is a schematic diagram of an array of a plurality of helical actuators according to some exemplary embodiments of the present invention;

[0196] Figures 7G to 7J is a schematic diagram of an array of a plurality of helical actuators according to some exemplary embodiments of the present invention;

[0197] Figure 7K and 7L is a schematic diagram showing the shaping of multiple implants according to some exemplary embodiments of the present invention;

[0198] Figures 8A to 8D is a schematic diagram of an implant including multiple screw actuators according to some exemplary embodiments of the present invention;

[0199] Figure 8E is a schematic diagram of a screw actuator and a screw passing through an opening in the screw actuator according to some exemplary embodiments of the present invention;

[0200] Figures 9A to 9G is a schematic diagram showing a spring actuator attachment and a cover according to some exemplary embodiments of the present invention;

[0201] Figures 10A to 10C is a schematic diagram of an implant having a single actuator according to some exemplary embodiments of the present invention;

[0202] Figures 11A to 11D is a schematic diagram of an implant having multiple three - dimensional figures according to some exemplary embodiments of the present invention;

[0203] Figures 12A to 12B is a schematic diagram of a modular implant formed from single - unit implants according to some exemplary embodiments of the present invention;

[0204] Figures 12C to 12F is a schematic diagram of an implant in the body according to some exemplary embodiments of the present invention, wherein the tissue - contacting surface of the implant cover obtains a uniform and smooth shape after the cover expands;

[0205] Figures 13A to 13B is a schematic diagram of a waveform spring actuator according to some exemplary embodiments of the present invention;

[0206] Figures 14A to 14E is a schematic diagram of a closed - type expandable implant according to some exemplary embodiments of the present invention;

[0207] Figures 15A to 15G is a schematic diagram of a flexible implant according to some exemplary embodiments of the present invention;

[0208] Figure 16 is a schematic diagram of a flexible implant located in the cranial chin region according to some exemplary embodiments of the present invention;

[0209] Figures 17A to 17D is a schematic diagram of an implant according to some exemplary embodiments of the present invention, the implant including multiple actuators connected between two layers of material (such as a mesh material);

[0210] Figures 18A to 18D is a schematic diagram of an implant including a plurality of isolated actuators according to some exemplary embodiments of the present invention;

[0211] Figures 19A to 19C is a schematic diagram of an implant including a plurality of isolated spring actuators according to some exemplary embodiments of the present invention;

[0212] Figures 20A to 20C is a schematic diagram of an implant according to some exemplary embodiments of the present invention, the implant including a plurality of isolated spring actuators within a plurality of sockets located in a tissue interface;

[0213] Figures 21A to 21G is a schematic diagram of an implant including a plurality of thin expandable actuators according to some exemplary embodiments of the present invention;

[0214] Figures 22A to 22B is a schematic diagram of an implant according to some exemplary embodiments of the present invention, the implant including an inflatable chamber in a collapsed deflated state (22A) and an expanded inflated state (22B);

[0215] Figures 22C to 22E is a schematic diagram of an implant including a plurality of inflatable actuators according to some exemplary embodiments of the present invention;

[0216] Figures 23A to 23E is a schematic diagram of a modular implant including a plurality of monomer unit actuators or implants according to some exemplary embodiments of the present invention;

[0217] Figures 24A to 24C is a schematic diagram of an implant according to some exemplary embodiments of the present invention, the implant including a plurality of inflatable actuators optionally configured in an array;

[0218] Figures 24D to 24E is a schematic diagram showing the assembly of expandable actuators to form an implant according to some exemplary embodiments of the present invention;

[0219] Figures 25A to 25C is a schematic diagram showing the assembly of an actuator array according to some exemplary embodiments of the present invention;

[0220] Figure 25D is a schematic diagram showing an actuator (e.g., by snap connection) connected to a single base according to some exemplary embodiments of the present invention;

[0221] Figure 25E is a schematic diagram showing the head-to-tail orientation arrangement of actuators on a base according to some exemplary embodiments of the present invention;

[0222] Figures 26A to 26E is a schematic view showing an implant assembly according to some exemplary embodiments of the present invention;

[0223] Figures 27A to 27C is a schematic view showing an implant assembly according to some additional exemplary embodiments of the present invention;

[0224] Figures 28A to 28D is a schematic view showing an implant including a chamber and an internal actuator array according to some exemplary embodiments of the present invention; and

[0225] Figure 28E is a view showing the use of the implant shown according to some exemplary embodiments of the present invention Figures 28A to 28D as a temple implant. DETAILED DESCRIPTION

[0226] In some embodiments, the present invention relates to tissue shaping, and more specifically, but not exclusively, to using adjustable implants for tissue shaping.

[0227] One aspect of some embodiments of the present invention relates to selectively powering at least one actuator (e.g., a three-dimensional actuator) within a body implant (e.g., a filler implant) by exposing at least one actuator to external energy from outside the body, thereby shaping body tissue. In some embodiments, the implant includes a plurality of actuators, and at least one of the plurality of actuators is selectively powered. In some embodiments, the powering step includes delivering energy to at least one three-dimensional actuator within the implant, which causes the actuator to expand and / or contract. In some embodiments, the expansion or collapse deformation (e.g., local deformation) of the actuator causes a change in the shape of the tissue in contact with the implant. In some embodiments, the powering step includes delivering energy through the skin surface to at least one actuator without physically penetrating the skin. In some embodiments, the energy is applied directly to the three-dimensional actuator or is delivered to the three-dimensional actuator through the tissue in contact with the three-dimensional actuator. In some embodiments, the energy is transmitted through the body in the form of waves to the actuator or the tissue in contact with the actuator.

[0228] According to some exemplary embodiments, the actuator is a perforated actuator including one or more openings. In some embodiments, the one or more openings pass through the body of the actuator. In some embodiments, the shape of the actuator is a spring having pores passing through the spring body.

[0229] According to some embodiments, the energy for powering the actuator is transmitted in the form of waves, such as ultrasonic waves, radio frequency waves, electromagnetic fields, and electromagnetic waves. In some embodiments, the energy is transmitted from at least one energy source located outside the body and / or from at least one energy source located inside the body (e.g., within a body cavity or a lumen of the body). In some embodiments, the term external energy refers to energy generated from an energy source located outside the body.

[0230] According to some exemplary embodiments, the transmitted energy includes thermal energy transmitted by heating, such as inductive heating, magnetic induction, and electromagnetic induction. Alternatively, at least one of the following is used to transmit energy: ultrasonic waves, radio frequency, and infrared rays.

[0231] In some embodiments, the inductive heating parameters include generating a magnetic induction with 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, a frequency of 50 Khz, 100 Khz, or any intermediate, smaller, or larger frequency or a range of multiple frequencies). In some embodiments, the magnetic induction is generated to inductively heat within a time period between 15 seconds and 120 seconds (e.g., within 15 seconds to 50 seconds, 30 seconds to 100 seconds, 70 seconds to 120 seconds, 40 seconds, 60 seconds, 100 seconds, or any intermediate, smaller, or larger value or a range of multiple values).

[0232] According to some embodiments, the actuators are arranged in an array within the implant, such as 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, for example, to conform to the size and / or shape of the implantation site. In some embodiments, the modular implant includes multiple similar and / or different units that are assembled to form a single implant. In some embodiments, each unit is at least one uncovered actuator, such as a perforated or inflatable actuator, at least one covered or enclosed actuator, a unit including an actuator and a base, or a unit including an actuator connected to a base and at least partially enclosed within a cover body. In some embodiments, the modular implant is formed by aligning two or more units side by side, or one on top of the other. Additionally, in the modular implant, two or more units are connected to a shared element of the implant, such as a shared base, a shared cover body, a shared inflation tube. In some embodiments, in the modular implant, two or more units can be reversibly assembled to form the modular implant, for example, by a reversible connection that allows disassembly without causing irreversible deformation to the implant or the units.

[0233] According to some exemplary embodiments, two or more units are connected to each other by at least one connector of one or two units, for example, connected side by side. In some embodiments, the connector is configured to allow each unit to move relative to an adjacent interconnected unit. In some embodiments, the connector includes at least one of the following: a joint, a hub portion, and / or a rotary connector.

[0234] According to some embodiments, the maximum size of each unit, such as the maximum width, maximum thickness, and / or maximum length, is up to 20 millimeters, for example, up to 15 millimeters, up to 10 millimeters, up to 7 millimeters, up to 5 millimeters, up to 3 millimeters, up to 2 millimeters, or any intermediate, smaller, or larger value. In some embodiments, the maximum size is the size of the unit when the unit is in a compressed state (e.g., maximum compact state).

[0235] In some embodiments, the actuator is spaced apart from other actuators within the array. In some embodiments, each actuator or at least some of the actuators within the array is configured to expand and / or contract independently of other actuators.

[0236] One aspect of some embodiments relates to an inflatable actuator including at least one inflatable unit configured to expand upon inflation. In some embodiments, at least one inflatable unit is located between at least one flexible tissue engagement portion configured to contact soft tissue and at least one base. In some embodiments, the base of the inflatable actuator is configured to be connected to bone tissue, for example, using at least one screw, pin, or nail.

[0237] According to some exemplary embodiments, the inflatable actuator includes at least one inflation port in at least one inflatable unit. In some embodiments, the at least one inflatable unit is inflated through the at least one inflation port, causing the at least one inflatable unit to expand, thereby increasing the distance between at least one flexible tissue engagement portion and the base.

[0238] According to some exemplary embodiments, the at least one inflation port is fluidly connected to at least one channel, such as a fluid channel passing through at least one flexible engagement portion. Alternatively or additionally, at least one channel passes through the base of the actuator.

[0239] According to some exemplary embodiments, a body implant includes a plurality of inflatable actuators connected to each other using at least one connector or at least one fastener. In some embodiments, the at least one connector includes a hub portion configured to allow at least one inflatable actuator to move relative to different actuators of the implant, for example, relative to an adjacent actuator.

[0240] One aspect of some embodiments relates to a body 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 unit of each of the plurality of inflatable actuators. In some embodiments, the at least one inflation channel is configured to allow fluid to flow into the inflatable unit, such as to allow inflation and expansion of the inflatable actuator. Alternatively, each inflatable unit includes a separate inflation port, such as to allow each inflatable unit to be inflated independently of the remaining inflatable units of the implant.

[0241] According to some exemplary embodiments, each inflatable actuator includes at least one fastener, such as to allow the inflatable actuator to be fastened to the implant base. In some embodiments, the at least one fastener includes an interference lock or a snap-fit fastener.

[0242] According to some exemplary embodiments, each inflatable actuator includes a plug-in portion connected to the inflatable unit, the plug-in portion being configured to allow an easy connection between the inflatable unit and at least one inflation channel in the implant base. In some embodiments, the plug-in portion includes a syringe.

[0243] One aspect of some embodiments relates to an array of a plurality of expandable compartments, each expandable compartment having at least one three-dimensional actuator. In some embodiments, when at least one three-dimensional actuator in an expandable state is energized, each of the plurality of expandable compartments in the array moves between a collapsed state and an expanded state. In some embodiments, the array includes a two-dimensional (2D array) or a linear array of a plurality of expandable compartments. In some embodiments, the array includes a base layer, such as a flexible base layer, to which the plurality of expandable compartments or at least one three-dimensional actuator is connected.

[0244] According to some embodiments, the plurality of expandable compartments are configured to expand and contract along similar axes. Alternatively, at least some of the expandable compartments are configured to expand along different axes relative to other expandable compartments in the array.

[0245] According to some embodiments, the array is a modular array, in which one or more expandable compartments can be reversibly assembled to form the array and / or can be disassembled from the array. In some embodiments, the plurality of expandable compartments of the array are movable relative to each other, for example, at least one expandable compartment is configured to move laterally relative to at least one different expandable compartment of the same array.

[0246] One aspect of some embodiments relates to modular implants, such as adjustable implants for tissue shaping, which include multiple monomer units of expandable implants. In some embodiments, each monomer unit implant includes at least one expandable actuator and at least one tissue engagement portion, and the at least one tissue engagement portion is connected to the at least one expansion actuator. In some embodiments, multiple monomer unit implants are connected to each other using at least one connector (such as a hub portion). In some embodiments, multiple monomer unit implants are reversibly connected to each other, such as allowing disassembly of the modular implant. Alternatively, multiple monomer unit implants are irreversibly connected to each other.

[0247] According to some exemplary embodiments, the actuator of the monomer unit implant includes a three-dimensional actuator, such as an actuator formed of a shape memory alloy. Alternatively or additionally, the actuator of the monomer unit implant includes an inflatable unit, such as a balloon.

[0248] One aspect of some embodiments relates to a body implant, including an array of multiple actuators formed of a shape memory alloy. In some embodiments, the actuators are interconnected by a shape memory alloy bridge structure configured to allow the actuators to move laterally relative to other actuators within the array when heated (such as heated to a temperature higher than a predetermined temperature level). In some embodiments, heating of the actuator array causes the actuators to expand along an axis perpendicular to the long axis of the array.

[0249] One aspect of some embodiments relates to a body implant, including at least one implant cover, and the at least one implant cover includes an intermediate portion and an edge portion interconnected by a hub portion of the cover (such as a hub portion). In some embodiments, when the body implant is in a collapsed state, the tissue contact surface of the cover is uneven and includes at least one indentation, such as in the hub portion. In some embodiments, when the implant expands, the intermediate portion moves relative to the edge portion to produce a uniform, continuous, and / or smooth tissue contact surface.

[0250] According to some exemplary embodiments, the cover surrounds at least one expandable actuator located within the implant and optionally contacts the intermediate portion of the cover. In some embodiments, expansion of the at least one actuator causes the implant to expand and the intermediate portion to move relative to the edge portion of the cover. In some embodiments, the edge portion of the cover is used to connect (such as anchor) the implant to tissue (such as bone tissue). In some embodiments, the edge portion curves inwardly toward the implant lumen defined by the cover, such as to allow the implant to be connected to bone tissue through one or more openings in the edge portion.

[0251] In some embodiments, the thickness of the body implant in the compact state (e.g., collapsed state) is a value in the range of 0.5 mm to 4 mm, such as 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 body implant in the fully expanded state is a value in the range between 3 mm and 25 mm, such as between 3 mm and 7 mm, between 5 mm and 10 mm, between 7 mm and 17 mm, between 12 mm and 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 body implant is a value in the range between 10 mm and 80 mm, such as between 10 mm and 30 mm, between 10 mm and 20 mm, between 15 mm and 40 mm, between 20 mm and 70 mm, between 40 mm and 100 mm, or any intermediate, smaller or larger value or range of values. In some embodiments, the weight of the body implant is a value in the range between 0.1 gram (gr) and 50 grams, such as between 10 grams and 30 grams, between 15 grams and 40 grams, between 20 grams and 50 grams, or any intermediate value or range of values.

[0252] Before explaining in detail at least one embodiment of the invention, it should be understood that the invention in its application is not necessarily limited to the components and / or methods and / or the construction and setting details shown in the following description, in the drawings and / or in the embodiments. The invention is capable of having other embodiments or of being practiced or carried out in various ways.

[0253] Exemplary overall tissue shaping process

[0254] According to some exemplary embodiments, tissue shaping is performed for aesthetic and / or functional reasons. In some embodiments, for example, tissue shaping is performed on the face to correct birth defects, defects caused by surgical resection of tissue (e.g., when removing a tumor), and defects caused by tissue trauma (e.g., an accident that results in changes in bone structure and / or soft tissue). In some embodiments, tissue shaping is performed to correct aesthetic defects, such as age-related aesthetic defects or aesthetic defects that interfere with 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.

[0255] Now refer to Figure 1 , which depicts an overview process of tissue shaping according to some exemplary embodiments of the present invention.

[0256] According to some exemplary embodiments, at block 102, an implant (e.g., a filler implant) is implanted into the body. In some embodiments, the implant includes a plurality of actuators. In some embodiments, the plurality of actuators are arranged in an array and optionally spaced apart from each other. In some embodiments, each or at least one actuator is configured to expand and / or contract along at least one axis. In some embodiments, each or at least one actuator is configured to expand and / or contract to a similar extent in all directions. Alternatively, each 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.

[0257] According to some exemplary embodiments, at block 103, the tissue is allowed to heal. In some embodiments, after implanting the implant at block 102 and before energizing at least one implant actuator at block 104, the tissue is allowed to heal. Alternatively, at block 102, during the implantation procedure and / or when the patient is still in the operating room or during an outpatient visit after implantation, at least one implant actuator is energized.

[0258] According to some exemplary embodiments, at block 104, one or more actuators within the implant are selectively energized. In some embodiments, energy is transferred through the skin surface to energize one or more actuators. In some embodiments, energizing one or more actuators includes heating one or more actuators. Alternatively or additionally, energizing includes transferring energy (e.g., in the form of ultrasonic waves or magnetic fields) to one or more actuators. In some embodiments, the energy is transferred from outside the body and optionally without physically penetrating the skin surface to reach one or more actuators. In some embodiments, at least one of the following is used to transfer energy: ultrasonic waves, radio frequency (RF), and light (e.g., infrared or laser). In some embodiments, energizing includes heating one or more three-dimensional actuators by inductive heating, e.g., by exposing one or more three-dimensional 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 transferred from within the body, e.g., by placing an energy generating device in a body cavity.

[0259] According to some exemplary embodiments, energizing one or more actuators causes the one or more actuators to expand or contract, thereby causing local shaping of the tissue.

[0260] According to some exemplary embodiments, at block 106, optionally, the shape of the tissue is monitored over time. In some embodiments, the shape of the tissue is monitored over time, e.g., to identify changes in the tissue shape, e.g., caused by at least one of the following: body healing, bone growth, bone movement, soft tissue growth, and / or tissue loss.

[0261] According to some exemplary embodiments, powering of one or more actuators of the implant is repeated at block 108. In some embodiments, the powering is repeated, for example, to reshape tissue in accordance with tissue changes identified at block 108. In some embodiments, one or more actuators are powered, for example, to expand or collapse one or more actuators, or to increase or decrease a previous expansion or a previous collapse of the one or more actuators.

[0262] Exemplary tissue shaping

[0263] Now refer to Figures 2A to 2B , which depicts a schematic illustration of the powering effect of multiple actuators of an implant in accordance with some exemplary embodiments of the present invention.

[0264] According to some exemplary embodiments, the implant 202 includes a plurality of actuators, such as actuators 204, 206, and 208, which are configured to expand or contract in response to energy delivered to the plurality of actuators. In some embodiments, the plurality of actuators are solid actuators, such as in the form of springs having a helical or sinusoidal spring shape. In some embodiments, the plurality of actuators are spaced apart from each other and are configured to expand or contract independently when exposed to energy. In some embodiments, the plurality of actuators are aligned within the implant to expand and contract in the same direction, such as along the same axis. Alternatively, the orientation of at least some of the plurality of actuators within the implant allows for expansion and contraction in different directions compared to other actuators of the implant.

[0265] According to some exemplary embodiments, the plurality of actuators include a shape memory alloy, such as Nitinol, which is configured to change shape when heated.

[0266] According to some exemplary embodiments, such as as Figure 2A and 2B shown, the implant 202 includes a plurality of actuators, such as actuators 204, 206, 208, 210, and 212. In some embodiments, at least some of the plurality of actuators are arranged and aligned along a similar axis, such as actuators 204, 206, 208, and 210. In some embodiments, at least some of the plurality of actuators, such as actuator 212, are oriented in a different direction relative to other actuators of the implant. In some embodiments, the plurality of actuators are connected to a material layer, such as a base layer 216 or a tissue engagement layer 218. In some embodiments, the material layer is flexible, such as allowing the implant to be configured in accordance with body tissue shape and / or anatomy. In some embodiments, such as as Figure 2A and 2BAs shown, the implant 202 is implanted beneath the fatty or muscular layer 220, which is beneath the skin 222. Alternatively, the implant is implanted directly under the skin. In some embodiments, the basal layer 216 of the implant contacts body tissue 217, such as bone tissue.

[0267] According to some exemplary embodiments, energy 224 transmitted from an energy source 226 located outside the body towards the implant 202 selectively powers one or more actuators within the implant, such as Figure 2A shown. In some embodiments, energy 224 selectively powers actuators 206, 208, 210, and 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, and 212.

[0268] According to some exemplary embodiments, such as Figure 2B shown, selectively powering, such as selectively heating multiple actuators, causes actuators 206, 208, 210, and 212 to expand within the implant, thereby pushing against surrounding tissue in contact with the implant, such as fatty and / or muscular tissue 220 and / or skin tissue 220, such that the outer surface of the body is reshaped, such as changing the curvature of the outer skin surface above the implant or above the powered actuators.

[0269] Now refer to Figure 2C and 2D , which depict tissue shaping using an implant including at least one three-dimensional actuator according to some exemplary embodiments of the present invention.

[0270] According to some exemplary embodiments, the implant 250 includes one or more three-dimensional actuators shaped as 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.

[0271] According to some exemplary embodiments, the springs 252, 254, and 256 are connected to a body engagement portion 258, such as a soft body engagement portion. In some embodiments, such as Figure 2C shown, the implant 250 is implanted beneath the skin 262 and optionally beneath fatty and / or muscular tissue 260. In some embodiments, the implant 250 is oriented such that the springs contact body tissue 264 (such as bone), and the body engagement portion 258 contacts the skin 262, muscle, and / or fatty tissue 260.

[0272] According to some exemplary embodiments, for example, transferring energy 268 (from an energy source 270) to a spring causes the spring to expand. In some embodiments, the energy source 270 includes a magnetic field source, such as an alternating magnetic field. In some embodiments, the energy 268 includes a magnetic field. In some embodiments, the spring includes a conductive material that is heated when exposed to the magnetic field. In some embodiments, the inductive heating causes the spring to relax and moves the heated spring to an expanded state, such as as Figure 2D shown.

[0273] According to some exemplary embodiments, selective exposure of one or more springs (such as spring 258) to energy 268 causes spring 258 to expand. In some embodiments, the expansion of the selected one or more springs is a relative expansion compared to the expansion of other springs of the implant.

[0274] According to some exemplary embodiments, relative expansion of one or more springs of an implant compared to other springs is achieved by using springs having different characteristics compared to other springs. For example, one or more of the plurality of springs may be formed to have at least one of the following: different cross-sectional thicknesses, different radii, and / or different numbers of turns of the helix, etc. Thus, by applying the same energy 268 to the springs, their respective different characteristics provide different expansions relative to other springs. In some embodiments, different expansions of different springs can be facilitated by locally transferring different amounts of energy to each of the plurality of springs.

[0275] According to some exemplary embodiments, such as as Figure 2D shown, expansion of one or more springs pushes the body engagement portion 258 against at least one of the skin 262, fat, and / or muscle layer of the body, resulting in a change in tissue shape, such as a change in the curvature of the outer surface of the tissue.

[0276] In some embodiments, expansion of one or more springs between rigid body tissue and, for example, soft body tissue (such as skin, fat, and muscle tissue) causes the soft tissue to be pushed outwardly away from the rigid body tissue.

[0277] Exemplary implant

[0278] According to some exemplary embodiments, an implant is used for shaping the shape of tissue, such as facial tissue or any other tissue of the body. In some embodiments, tissue shaping includes changing the external curvature or external contour of the tissue. Alternatively or additionally, the implant is used to fill the volume of missing tissue within the body, the volume of the missing tissue within the body being formed by at least one of: body trauma, removal of tumorous tissue, and removal of inflamed tissue. In some embodiments, the removal of tissue can cause a change in the body contour due to the skin surface collapsing into the formed void. In some embodiments, the implant is used to fill the formed void and, by pressing outward against the skin, reshape the outer surface of the body distally to the filled void. Optionally, the implant is used to restore the shape of the outer surface of the body to the shape of the outer surface of the body before the void was formed.

[0279] Now refer to Figure 3A and 3B , which depict an implant according to some exemplary embodiments of the present invention.

[0280] According to some exemplary embodiments, as shown, for example, in Figure 3A , the implant 302 includes at least one actuator or two or more actuators, such as actuators 304, 306, 308, and 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 plurality of actuators is configured to expand or compress along a selected axis, such as along the long axis 305 of an actuator. In some embodiments, each actuator or at least some of the actuators of the implant expands or compresses more along a particular axis (such as the long axis 305) compared to expansion or compression along a different axis (such as the short axis 307) of the actuator.

[0281] According to some exemplary embodiments, at least some or all of the actuators are three-dimensional actuators. In some embodiments, at least some or all of the actuators include a spring or are shaped like a spring. In some embodiments, the actuator (such as a spring) is formed of a shape memory material (SMM), including shape memory alloy (SMA) and / or shape memory polymer (SMP), as described by Huang et al. (2010). In some embodiments, the actuator (such as a spring) is configured to recover its original shape from a significant and seemingly plastic deformation when a specific stimulus is applied.

[0282] According to some exemplary embodiments, when the actuator is exposed to a stimulus (such as in the form of energy), the actuator optionally expands to its original shape. Alternatively, when the actuator is exposed to a stimulus, such as in the form of energy, the actuator collapses.

[0283] According to some exemplary embodiments, at least some or all of the actuators 304, 306, 308, and 310 are formed of a shape memory alloy (such as a copper-aluminum-nickel alloy, a nickel-titanium (NiTi) alloy (nitinol)). In some embodiments, when the actuators formed of a shape memory alloy are heated, they expand and optionally acquire their original shape. Alternatively or additionally, at least some or all of the actuators 304, 306, 308, and 310 are formed of a different shape memory material (such as a shape memory polymer).

[0284] According to some exemplary embodiments, each of the plurality of actuators is located within a separate isolation sleeve configured to isolate the actuator (such as a spring) from the surrounding environment. In some embodiments, the isolation sleeve is configured to thermally isolate the actuator from the surrounding environment, such as from the tissue surrounding the implant after the implant is implanted in the body.

[0285] According to some exemplary embodiments, the implant 302 includes a tissue engagement portion 312 configured to contact the tissue of the body, such as the soft tissue of the body. In some embodiments, the soft tissue of the body includes at least one of skin, muscle, and adipose tissue. In some embodiments, the tissue engagement portion 312 includes a pad or cushion. In some embodiments, the tissue engagement portion 312 is soft and / or flexible, such as to conform to the shape of the body's soft tissue. Optionally, the tissue engagement portion 312 is filled with a fluid or viscous material, such as a gel.

[0286] According to some exemplary embodiments, the tissue engagement portion 312, such as a first tissue engagement portion, includes at least one first surface 314 and at least one second surface 316, the at least one first surface 314 being configured to contact body tissue, such as the soft tissue of the body. Optionally, the at least one second surface is opposite the at least one first surface 314. In some embodiments, the actuator is connected to the at least one second surface 316. In some embodiments, such as when one or more actuators expand, a force is applied to the at least one second surface to push at least one surface 314 against the tissue. In some embodiments, the applied force changes the shape of the tissue engagement portion 312, such as changing the shape or curvature of at least one surface 314 at a level relative to the force applied to at least one second surface 318. Optionally, locally applying a force on the at least one second surface 316 causes local deformation of the shape of a region of the tissue engagement portion 312 that is aligned with the direction of the applied force.

[0287] 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 actuator is connected to at least one second surface 316 of the tissue engagement portion 312 by the first end 318 of each actuator.

[0288] According to some exemplary embodiments, the plurality of actuators includes an inflatable chamber, such as a balloon. In some embodiments, inflation of the inflatable chamber causes the chamber to expand and apply a force to the surface 316, causing the tissue engagement portion 312 to bend upward.

[0289] According to some exemplary embodiments, the implant 302 includes a separate base 322 for each actuator, the base 322 being connected to at least one second end 320 of each actuator. In some embodiments, the base 322 is configured to allow stable contact between the actuator and body tissue (e.g., rigid tissue of the body). In some embodiments, the rigid tissue of the body includes bone tissue. In some embodiments, the base 322 is configured to anchor the actuator to the rigid body tissue, such as through an opening in the base and / or one or more of the actuators, the opening being adapted to receive a nail or screw. Alternatively or additionally, a cover (e.g., the tissue engagement portion 312) extends into the bone tissue and is fixed to the bone tissue using a nail or screw that passes through the cover and into the bone. Alternatively, an implant (e.g., at least one of the base, actuator, or cover) is attached to the bone tissue using an adhesive (e.g., glue).

[0290] According to some exemplary embodiments, the base 322 is harder than the tissue engagement portion 312. In some embodiments, the actuator is connected to the tissue to anchor the implant 302 in the body.

[0291] According to some exemplary embodiments, the plurality of actuators are spaced apart from each other, e.g., allowing tissue to grow inwardly into the implant in the region located between adjacent actuators.

[0292] According to some exemplary embodiments, for example as Figure 3B shown, the implant 330 includes a hollow body 332 having at least one actuator or a plurality of actuators, such as actuators 304, 306, 308, and 310 located within the body 322. In some embodiments, the actuators are located between the tissue engagement portion 312 and a shared base 334, the shared base 334 being configured to contact rigid tissue of the body, such as bone. In some embodiments, the base 334 is configured to anchor the implant 330 to the body, e.g., to rigid tissue of the human body.

[0293] According to some exemplary embodiments, the hollow body 332 is a closed hollow body configured to isolate the actuator from surrounding tissue when the implant 330 is implanted in the body. Alternatively, the hollow body 332 is at least partially perforated, such as the base 334 being perforated, to allow tissue ingrowth into the implant.

[0294] According to some exemplary embodiments, at least one or all of the actuators are substantially perpendicular to the tissue engagement portion. Alternatively, at least one or all of the actuators are positioned at an angle selected from the range of 30 degrees to 90 degrees (e.g., at an angle selected from the range of 40 degrees to 90 degrees, at an angle within the range of 40 degrees to 50 degrees, or any intermediate, smaller, or larger angle) relative to the tissue engagement portion 312.

[0295] Now refer to Figure 3C , which depicts an implant according to some exemplary embodiments of the present invention, the implant having a tissue engagement portion connected to two or more inflatable chambers.

[0296] According to some exemplary embodiments, an implant, such as implant 350, includes a tissue engagement portion 312 and two or more inflatable actuators, such as actuators 352, 354, 356, and 358, which are connected to a surface 316 opposite the skin contact surface 314, such as as Figure 3A shown. In some embodiments, at least one or all of the inflatable actuators include one or more inflatable chambers configured to inflate by introducing fluid into the inflatable chambers and, optionally, deflate, such as when fluid is removed from the inflatable chambers.

[0297] According to some exemplary embodiments, fluid is introduced into the inflatable actuators via a fluid flow path (such as channel 360). In some embodiments, the channel interconnects all or at least one of the inflatable actuators to at least one opening 362, optionally the at least one opening 362 includes a valve, such as a duckbill valve. In some embodiments, at least one opening 362 is located in the tissue engagement portion, such as in the tissue contact surface of the tissue engagement portion, such as to allow easy access to the channel 360 from outside the body. In some embodiments, a needle penetrating the opening 362 is used to introduce and / or remove fluid (such as gas or liquid) from the inflatable actuators. Optionally, each inflatable actuator is connected to a separate channel and a separate opening, such as to allow selective introduction or removal of fluid from each inflatable actuator.

[0298] According to some exemplary embodiments, the implant includes only three-dimensional actuators, such as springs, or only inflatable actuators. Alternatively, the implant includes a combination of three-dimensional actuators and inflatable actuators.

[0299] According to some exemplary embodiments, the implant is oriented such that the tissue engagement portion contacts tissue beneath the skin and the actuator contacts rigid tissue (e.g., bone) directly or indirectly. Alternatively, the implant is oriented such that the tissue engagement portion contacts bone while at least one or two or more actuators connected to the tissue engagement portion push tissue beneath the skin.

[0300] Exemplarily, the implant is fitted to the target implantation site

[0301] According to some exemplary embodiments, prior to implanting an adjustable implant, an implant with specific characteristics needs to be installed at a specific implantation site, optionally taking into account the location of the implantation site, the shape and / or dimensions of the implantation site, and / or the target shape of the soft tissue after implantation and recovery. In some embodiments, to conform the implant to a specific implantation site, an expert can select an implant from a variety of preformed implants. Alternatively, the expert can modify an existing preformed implant. Alternatively, the expert can form a new implant to match the implantation site and / or the future target shape of the tissue.

[0302] Now refer to Figure 3D , which depicts a process for fitting an implant according to some exemplary embodiments of the present invention based on at least one of the following: the dimensions and / or shape of the implantation site, the target shape of the body tissue after implantation, and / or the ability of the implant to be adjusted during recovery to achieve the target tissue shape.

[0303] According to some exemplary embodiments, the target implantation site is identified at block 370. In some embodiments, the target implantation site is a site on the head, limb, torso, and / or back, or a site at any other location in the subject's body. In some embodiments, the target implantation site is identified during or after a surgical procedure (e.g., a tumor or mass resection procedure).

[0304] 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 the dimensions, shape, volume, composition, and / or proximity to different tissues of the surrounding tissue. In some embodiments, the different tissues include at least one of nerve tissue, blood vessels, bone tissue, and / or skin tissue.

[0305] According to some exemplary embodiments, the desired tissue shape after implantation is optionally determined at block 374. In some embodiments, the desired tissue shape after recovery from the implantation procedure is determined at block 374. In some embodiments, the desired tissue shape includes the external body curvature at the implantation site and / or tissue volume.

[0306] According to some exemplary embodiments, one or more parameters of an adjustable implant are determined at block 376. In some embodiments, the one or more parameters are determined based on one or more parameters of the implantation site and / or based on a desired shape after treatment. In some embodiments, the one or more implant parameters include at least one of the following: shape, size, volume, expansion ability, type of material forming the implant, degree of implant porosity, type of actuator, actuator shape, actuator helical shape type, distribution of the actuator within the implant, and / or number of actuators.

[0307] According to some exemplary embodiments, at block 378, an existing implant, such as an implant that has been preformed, is selected. In some embodiments, the existing implant is selected from at least two existing implants, each existing implant 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 an off-the-shelf product.

[0308] 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 determined implant parameters determined at block 376. In some embodiments, the existing implant is modified, for example, by cutting the implant according to a specific shape.

[0309] According to some exemplary embodiments, alternatively, a new implant is assembled at block 382. In some embodiments, the implant is assembled according to the implant parameters determined at block 376. In some embodiments, the implant is assembled in the operating room, such as before or during the implantation surgery. Alternatively, the implant is assembled outside the operating room before the implantation surgery.

[0310] According to some exemplary embodiments, after the implant has the target parameters or characteristics, the implant is implanted into the implantation site, such as described at block 102. Optionally, one or more actuators are powered, such as selectively powered before implantation. In some embodiments, before implantation, the one or more actuators are powered by heating the actuators, such as by injecting a hot liquid into the implant and / or by exposing the one or more actuators to energy.

[0311] Exemplary Facial and Body Remodeling

[0312] According to some exemplary embodiments, an implant is used for aesthetically shaping the skin and treating defects, such as those caused by physical trauma and birth defects. In some embodiments, the implant is implanted beneath the skin and optionally beneath at least one additional tissue layer of the body, such as a muscle and adipose tissue layer. In some embodiments, the implant is configured to be implanted in one or more regions of the body, such as 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 body region, such as the implanted body region.

[0313] According to some exemplary embodiments, the implant is controllably and / or selectively expandable to push on the skin in a selected region, such as to shape the skin surface and / or skin contour into a desired shape. Additionally or alternatively, the implant is used to fill voids or lumens within the body caused by trauma, surgical procedures, or birth defects.

[0314] Now refer to Figure 4 , which depicts a process for facial shaping (such as facial remodeling) according to some exemplary embodiments of the present invention.

[0315] 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 the portion of the face to be remodeled, such as the chin, forehead, cheeks.

[0316] According to some exemplary embodiments, the target facial shape is determined at block 404. In some embodiments, determining the target shape includes determining the shape selected for the remodeled portion of the face after the facial remodeling surgery has healed.

[0317] According to some exemplary embodiments, an implant is selected at block 406. In some embodiments, the implant is selected based on the determined target facial shape and / or based on the current shape of the portion of the face selected for remodeling. In some embodiments, an implant having the desired shape, size, and / or function is selected at block 406.

[0318] According to some exemplary embodiments, optionally, the implant is modified at block 408. In some embodiments, at block 408, at least one of the following is optionally modified: the shape, structure, and / or composition of the implant to match the current shape of the facial portion selected for reshaping and / or according to the determined target facial shape, at least one of the following is optionally modified: the shape, structure, and / or composition of the implant. In some embodiments, the implant is a modular implant and can be optionally modified at block 408, for example, by removing or adding actuators to the implant.

[0319] According to some exemplary embodiments, at block 410, the implant is implanted into the facial tissue. In some embodiments, the implant includes only two or more actuators connected to each other implanted into the body. Optionally, each of the two or more actuators includes a separate tissue engagement portion configured to push the skin. Alternatively, as Figures 3A to 3C shown, the actuators are connected to at least one tissue engagement portion, such as a single shared engagement portion.

[0320] According to some exemplary embodiments, during the implantation of the implant at block 410, the implant and / or the plurality of actuators or at least one actuator are connected, such as anchored to the bone tissue. Optionally, anchoring the implant or at least one actuator to the bone tissue fixes the position of the implant in the body and optionally prevents the implant from migrating from the implantation site.

[0321] According to some exemplary embodiments, after the implant is implanted, the skin is closed at block 412. In some embodiments, the skin is closed while covering the implant.

[0322] According to some exemplary embodiments, at block 414, one or more actuators of the implant are powered. In some embodiments, powering the at least one actuator causes the actuator to expand and optionally push the skin surface. In some embodiments, when the patient is still in surgery, one or more actuators are powered and optionally before closing the skin at block 412. In some embodiments, when the patient is still undergoing the implantation surgery, one or more actuators are selectively powered after the skin is closed. Alternatively, after the healing period after the implantation surgery, for example, after a healing period of at least 12 hours, at least 24 hours, at least 48 hours, at least 72 hours, after a period of at least 1 week, after a period of at least 2 or 3 weeks, after a period of at least 1 month, or after any intermediate, shorter or longer period, one or more actuators are selectively powered.

[0323] According to some exemplary embodiments, selectively energizing one or more actuators at block 414 includes heating the actuators using at least one of the following: inductive heating, ultrasound through the skin towards the implant, radio frequency (RF), and by injecting warm fluid into the implant. Alternatively, when the actuator includes at least one inflatable chamber, selectively energizing the actuator includes inflating the at least one inflatable chamber, for example, by introducing fluid into the at least one inflatable chamber.

[0324] According to some exemplary embodiments, at block 416, after selectively energizing and optionally after a healing period, the tissue shape is determined. In some embodiments, at block 416, the relationship between the tissue shape after selective energizing and optionally after the healing period and a target shape (e.g., a target facial shape) is determined. Optionally, at block 416, the tissue shape after selective energizing and optionally after the healing period is compared with the target facial shape. In some embodiments, if the tissue shape is the target shape, the facial reshaping process ends.

[0325] According to some exemplary embodiments, if the tissue shape is not the target shape, the implant shape is modified at block 418. In some embodiments, the shape of the implant is modified by energizing at least one actuator, and optionally energizing an actuator different from the actuator energized at block 414. Alternatively or additionally, the shape of the implant is changed by applying a force to the implant, for example, by pressing on the implant. In some embodiments, a force is applied to the implant during or after selectively energizing one or more actuators.

[0326] According to some exemplary embodiments, when the actuator includes at least one inflatable chamber, the implant shape is modified, for example, by deflating at least one inflation chamber and / or inflating at least one inflatable chamber.

[0327] Exemplary helical springs and implant

[0328] According to some exemplary embodiments, the implant includes one or more three-dimensional actuators, such as a plurality of three-dimensional actuators. In some embodiments, the actuator includes a spring that can move between a contracted state (e.g., a collapsed state) and an expanded state when exposed to energy. In some embodiments, the energy heats the springs and allows them to move to a relaxed, exposed state. In some embodiments, each spring is formed of a shape memory alloy, such as nitinol. In some embodiments, heating the springs causes the spring shape to return to a pre-deformed expanded shape.

[0329] Now refer to Figures 5A to 5D, which depicts an actuator of an implant according to some exemplary embodiments of the present invention, wherein the actuator is in the shape of a helical spring.

[0330] According to some exemplary embodiments, for example, as Figures 5A to 5C shown, the three-dimensional actuator includes at least one spring, such as the helical spring 502. In some embodiments, the helical spring 502 includes a base 504 and a movable part 506 integrated with the base. In some embodiments, the movable part 506 moves between a collapsed state (such as Figure 5A shown) and an expanded state (such as Figure 5B shown). In some embodiments, the expansion of the movable part is an axial expansion along an axis substantially perpendicular to the base 504.

[0331] According to some exemplary embodiments, the helical spring 502 (such as the movable part 506) has a double-helix structure. In some embodiments, the double-helix structure is formed by winding two metal components, such as wires or strips around the long axis of the helical spring from opposite directions until they are connected, for example, at the apex of the helical spring. In some embodiments, the metal components are joined using welding or soldering. In some embodiments, the helical spring 502, optionally formed of a shape memory alloy, expands into a pre-deformed expanded shape when heated to a temperature level between 37°C and 65°C (for example, when heated to a temperature level between 37°C and 45°C, when heated to a temperature level between 40°C and 60°C, or any temperature level with an intermediate, smaller, or larger temperature range).

[0332] According to some exemplary embodiments, the helical spring, such as the helical spring 502, is formed by cutting a nickel-titanium (Niti) plate / sheet, for example, by laser cutting, with a desired flat coil pattern. Then, in some embodiments, the flat-shaped coil is formed into a pre-deformed shape using a mold and heat-treated at about 500°C to form the final shape and then obtain shape memory. In some embodiments, additional options for manufacturing are by laser cutting of a nickel-titanium (NiTi) tube and / or 3D printing of NiTi.

[0333] According to some exemplary embodiments, for example, Figure 5D the helical springs shown can be assembled together to form an array of multiple helical springs. In some embodiments, the helical springs are connected to each other, for example, by at least one fastener to form an array. Alternatively, the helical springs are attached to each other and connected to a shared base. Alternatively or additionally, the helical springs are attached to each other and connected to a shared tissue engagement portion configured to contact soft tissues of the body, such as skin, fat, and muscle tissues.

[0334] According to some exemplary embodiments, such as Figure 5D shown, a single three-dimensional actuator, such as a helical spring actuator, is in contact with two or more, such as two, three, four, five, six or any greater number of three-dimensional actuators. In some embodiments, actuator 502 is in contact with actuators 508, 510, 512, and 514. In some embodiments, the geometric polygon shape of base 504 allows contact with multiple actuators on the polygon sides, such as forming an array of multiple actuators. In some embodiments, such as Figure 5D shown, the shape of base 504 of the actuator is hexagonal, allowing a single actuator to contact up to six actuators, such as through the sides of the hexagonal base.

[0335] Now refer to Figure 5E and 5F , which depict an implant according to some exemplary embodiments of the present invention, the implant including a plurality of helical actuators connected to an implant base and a tissue engagement portion.

[0336] According to some exemplary embodiments, such as Figure 5E shown, a polygon helical actuator array (such as actuators 516, 518, 520, and 522) is connected to implant base 524. In some embodiments, each base of the plurality of actuators is connected to the implant base. In some embodiments, such as Figure 5F shown, implant 530 includes implant base 524 and tissue engagement portion 532 connected to a movable portion (such as the movable portion 506 of each actuator). In some embodiments, tissue engagement portion 532 is a soft tissue engagement portion, optionally filled with a fluid, such as a viscous fluid, or a gel, such as silicone. In some embodiments, tissue engagement portion 532 is connected to the vertex of the actuator movable portion. In some embodiments, the shape of tissue engagement portion 532 is a cap structure located on top of the actuator.

[0337] Now refer to Figures 6A to 6D , which depicts a three-dimensional actuator according to some exemplary embodiments of the present invention, such as an actuator spring having a rectangular base.

[0338] According to some exemplary embodiments, such as Figures 6A to 6C shown, a three-dimensional actuator (such as spring actuator 602) includes a rectangular base 604 and a movable portion 606. In some embodiments, movable portion 606 is integrated with base 604. In some embodiments, compared to the rectangular (e.g., square) base of actuator 602, spring actuator 602 is similar to spring actuator 502 having a hexagonal base.

[0339] According to some exemplary embodiments, for example as Figure 6D shown, the rectangular base 604 allows up to 4 actuators to be attached to a single actuator, for example via the sides of the actuator rectangular base, to form an actuator array. In some embodiments, for example as Figure 6C shown, the actuator base 604 includes one or more openings, such as opening 608, for mechanically connecting the base 604 to a tissue junction, such as a soft tissue junction of an implant, or to body tissue, such as bone tissue.

[0340] Exemplary actuator array

[0341] According to some exemplary embodiments, a plurality of actuators of an implant are arranged in an array, for example to increase the contact area with the soft tissue junction of the implant, or to allow, for example, effective anchoring of the implant to bone tissue. In some embodiments, the position of each or at least some of the actuators in the array (such as screw actuators) is fixed relative to other actuators in the array (such as adjacent actuators). Alternatively, each or at least some of the plurality of actuators is movable relative to other actuators in the array, such as laterally movable. In some embodiments, when exposed to energy (such as energy that heats the actuator to a temperature above a specific temperature level), the actuator moves laterally within the array. In some embodiments, the actuators are connected to each other by connectors that allow one or more actuators to be removed from the array, for example to allow the shape and / or size of the array or implant to be adjusted to a specific in-vivo implantation site.

[0342] Now refer to Figure 7A and 7B , which depict an array of actuators (such as screw actuators) connected to each other according to some exemplary embodiments of the present invention.

[0343] According to some exemplary embodiments, the implant 702 includes a plurality of actuators, such as screw actuators 704, 706, and 708 configured in an array. In some embodiments, the screw actuators 704, 706, and 708 are connected to a base or tissue junction 710, optionally made of a soft material (such as silicon). In some embodiments, at least some of the screw actuators of the array, such as actuators 708, 712, and 714, are connected to each other, for example, by a helix or the helix that forms each screw actuator. Optionally, two or more screw actuators are formed by at least one shared winding of the material used to form the helical shape of each actuator. Optionally, the screw actuators 708, 712, and 714 are arranged in a row in the array, such as a linear row, arranged one after another in sequence.

[0344] According to some exemplary embodiments, energy is delivered to the actuator, optionally causing heating of the actuator, allowing relative lateral movement of actuators connected to each other within a row of actuators. Alternatively, the delivered energy allows a group of actuators connected to each other to move laterally relative to different groups of actuators in the same array or the same implant. In some embodiments, the lateral movement of the actuator deforms, such as stretching the substrate or tissue engagement portion 710. Optionally, selectively heating and / or deforming individual helical actuators in a group of actuators directly connected to each other heats and / or deforms other helical actuators in the array.

[0345] Now refer to Figures 7C to 7E , which depicts additional actuator arrays connected to each other according to some exemplary embodiments of the present invention, such as helical actuators.

[0346] According to some exemplary embodiments, actuators (such as helical actuators) are interconnected to form a two-dimensional (2D) array of actuators, such as as Figure 7C , 7D and shown in 7E. In some embodiments, the actuators 720, 722, and 724 are interconnected by at least one connector 726, such as by a wire or strip of material. In some embodiments, the at least one connector 726 is formed of a thermally insulating and / or electrically insulating material. Alternatively, at least one connector 726 is formed of a thermally conductive and / or electrically conductive material, such as metal. In some embodiments, the actuators are interconnected via the base of each actuator using at least one connector 726.

[0347] Now refer to Figure 7F , which depicts an actuator array interconnected by deformable connectors according to some exemplary embodiments of the present invention.

[0348] According to some exemplary embodiments, at least two actuators, such as actuators 720, 722, and 724, are interconnected via at least one deformable connector (such as connector 742). In some embodiments, at least one deformable connector 742 is configured to move between a collapsed state and an expanded state, such as when heated. In some embodiments, the at least one deformable connector 742 is formed of a shape memory material, such as a shape memory alloy or a shape memory polymer. In some embodiments, the shape memory alloy includes nitinol. In some embodiments, the deformation of the connector 742 connecting two actuators in the array changes the distance between the two actuators, thereby deforming the array. In some embodiments, the deformation of the connector causes the actuators to move relative to each other in the lateral direction.

[0349] According to some exemplary embodiments, two or more helical solid figure actuators are directly interconnected, for example, through the base of the actuator or through the spring or helical portion of the actuator. Alternatively, each actuator includes at least two extensions extending from the actuator, which are configured to allow two actuators to be connected to each other. In some embodiments, a single actuator includes two or more extensions, such as 2, 3, 4, 5, 6, or any greater number of extensions, which are configured to allow the actuator to be connected to other actuators of the array.

[0350] A potential advantage of actuators interconnected by extensions to form an array may be that by disconnecting the actuator from the array at the extension, optionally by cutting, it allows the array to be easily shaped to fit the desired shape or size with minimal or no damage to the actuator itself. In some embodiments, this may allow for modular implants or modular actuator arrays that can be easily modified when needed.

[0351] Now refer to Figures 7G to 7J , which depicts an array of interconnected helical actuators according to some exemplary embodiments of the present invention.

[0352] According to some exemplary embodiments, for example, as Figure 7G shown, an array 760 (e.g., a grid) of actuators includes two or more actuators, such as actuators 762 and 764, which are interconnected to each other by 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 the actuator with at least one different actuator. In some embodiments, the actuators are interconnected by connecting the extension of a first actuator to the extension of a second actuator, such as connecting to each other. Optionally, the entire array is formed as a single unit, where all actuators and extensions are formed of the same material (e.g., a deformable material, optionally a shape memory alloy), such as as Figure 7I and 7J shown. According to some exemplary embodiments, actuator 770 includes at least one extension (e.g., extension 772) extending outward from the base 774 of the actuator. Optionally, each actuator includes at least 3 extensions. In some embodiments, the extensions are evenly distributed on the circumference of the actuator or the actuator base. Alternatively, the extensions are not evenly distributed on the circumference of the actuator. In some embodiments, the number of extensions of all actuators in the array is similar or different. In some embodiments, one actuator is formed with at least one extension. Alternatively, after forming the actuator and optionally when forming the array, at least one extension is connected to at least one actuator.

[0353] According to some exemplary embodiments, the at least one extension is planar. In some embodiments, at least one extension interconnecting two actuators has at least one narrow-width portion relative to the width of other portions of the extension along the extension length. Optionally, the at least one narrow-width portion represents a break point of the extension to allow separation between the two actuators, e.g., by cutting the extension at the narrowed portion of the extension. A potential advantage of having a narrowed portion can be to allow easy disconnection of at least one extension and thus easy disconnection of the connection between the two actuators. Optionally, the extension is formed of the same material as the actuator as a single integrated unit, e.g., as Figures 7I to 7J shown.

[0354] According to some exemplary embodiments, e.g., as Figure 7H shown, the array 776 includes two or more actuators interconnected by at least one twisted extension 782. In some embodiments, the at least one twisted extension is formed of a deformable material configured to deform when exposed to energy. In some embodiments, the material includes a shape memory alloy. In some embodiments, the deformation of the extension allows the actuators to move laterally relative to each other in the array. Alternatively or additionally, the deformation of the extension allows lateral elasticity of the array at the actuator plane.

[0355] According to some exemplary embodiments, at least one twisted extension forms and / or represents a break region between adjacent actuators in the array.

[0356] According to some exemplary embodiments, e.g., as Figure 7I shown, the actuator array 784 includes a plurality of actuators that are connected to each other via the base of each actuator, optionally formed by precision cutting (e.g., laser cutting). In some embodiments, the plurality of actuators are connected to each other like tiles. In some embodiments, at least some or each actuator includes a polygonal base that can be attached to other adjacent actuator bases through at least one side of the polygonal base. In some embodiments, the shape of the base is triangular, quadrilateral, rectangular, hexagonal, or optionally any polygon that can be tiled. A potential advantage of having a polygonal shape can be to allow a larger surface area when in contact with a surface (e.g., a polymer or silicon surface to which the actuator is attached) to optionally prevent surface collapse when the actuator expands in the opposite direction.

[0357] According to some exemplary embodiments, e.g., as Figure 7I shown, the actuator 786 includes a hexagonal base 788 that is shaped and sized to be connected to at least one actuator, e.g., actuator 790, through one side of the base. In some embodiments, the actuator 786 is configured to be connected to up to 6 actuators via the sides of the hexagonal base.

[0358] According to some exemplary embodiments, each actuator, such as actuator 786, includes a base 788 and at least three helically extending portions, each helically extending portion having a first end connected or integrated with the base 788 and a second end remote from the base 788. In some embodiments, the helically extending portions are optionally twisted into a helix shape between the first end and the second end to form a spring-like structure of the actuator. In some embodiments, the spring-like structure is configured to extend in a direction substantially perpendicular to the base and away from the base when the actuator or the helically extending portions are deformed. Optionally, the helically extending portions extend in response to energy applied to the actuator, and the energy optionally heats the helically extending portions.

[0359] According to some exemplary embodiments, such as Figure 7J shown, the array 792 includes two or more actuators, such as actuators 794 and 796, connected to each other by the helically extending portions of each actuator (such as the helically extending portion 798 of actuator 794 and the helically extending portion 799 of actuator 796). In some embodiments, the actuator includes at least two or at least three helically extending portions twisted together to form a spring-like extensible portion of the actuator, such as described above with respect to actuator 786.

[0360] Exemplary implant shaping

[0361] According to some exemplary embodiments, at least a portion of an existing implant can be adjusted to have a desired shape and / or size according to the shape and / or size of a target implantation site in a subject's body. A potential advantage of an implant that can be shaped prior to implantation can be that it allows a small number of implants to be used for a greater number of implantation sites, thereby optionally reducing manufacturing costs while allowing for a maximum degree of customization and ease of use. Another advantage of an implant that can be shaped prior to implantation can be that it allows the implant to be installed into newly formed voids in the body, such as voids newly formed due to trauma or tumor resection having non-conventional shapes, sizes, and / or volumes.

[0362] Now refer to Figure 7K and 7L , which depict implants that can be shaped according to some exemplary embodiments of the present invention, such as cut to form a desired shape, area, volume, and / or size.

[0363] According to some exemplary embodiments, the implant includes a plurality of actuators, such as three-dimensional actuators, connected to a surface, such as connected to a base. In some embodiments, such as Figure 7KAs shown, the implant 719 includes a plurality (e.g., two or more) of actuators 721 and 723 connected to a surface 725. In some embodiments, the base of each actuator is connected to the shared surface 725. Alternatively, the apex of the spring portion of the actuator, e.g., the apex of the extendable portion of the actuator, is connected to the surface 725. In some embodiments, the surface is the surface of a sheet, and the surface is the surface opposite the tissue contact surface of the sheet.

[0364] According to some exemplary embodiments, the base is formed of a polymeric material, which may optionally be elastic. In some embodiments, the base connected to one or more actuators is thin, e.g., having a maximum thickness in the range between 0.01 mm and 10 mm, e.g., a thickness between 0.01 mm and 5 mm, a thickness between 0.5 mm and 3 mm, between 1 mm and 10 mm, or intermediate, smaller or larger values. In some embodiments, the base is bendable, e.g., flexible. Optionally, the base is elastic. In some embodiments, the base is formed of a material that allows cutting. Optionally, the base includes one or more cutting lines and / or cutting regions, where the base has a narrower thickness and / or the base includes a plurality of openings to allow easy separation between the plurality of portions of the base.

[0365] According to some exemplary embodiments, the actuators are evenly distributed on the surface 725, equidistant from each other. Alternatively or additionally, the distance between at least some of the actuators varies. In some embodiments, the sheet extends beyond one or more of the actuators. In some embodiments, e.g., as Figure 7K shown, the actuators 721 and 723 are directly connected to the surface 725, e.g., a surface of a sheet. Alternatively, e.g., as Figure 7L shown, the actuator (e.g., actuator 727) is connected to the surface (e.g., surface 725) via one or more extensions 729 and 731 extending from each or at least some of the actuators. In some embodiments, the actuators are connected to each other by one or more extensions, as Figure 7G and 7H shown, and are connected to the surface by the extensions. Alternatively, as Figure 7K and 7L shown, the actuators are spaced apart and separated from each other.

[0366] According to some exemplary embodiments, e.g., as Figure 7K and 7L shown, the implant is shaped by cutting along a line 733 between the surface and the plurality of actuators, e.g., shaping the implant according to a desired shape, size, and / or profile.

[0367] According to some exemplary embodiments, the surface of the implant to which the actuator is connected is formed of a material that is easily cuttable, such as using scissors, a blade, a knife, or any cutting edge.

[0368] Exemplary implant with spring actuators

[0369] Now refer to Figures 8A to 8D , which depicts an implant including an array of multiple spring actuators according to some exemplary embodiments of the present invention.

[0370] According to some exemplary embodiments, the implant 802 includes an array of multiple actuators, such as helical actuators 804, 806, and 808, which are connected to a first tissue engagement portion 810, such as a soft tissue engagement portion. In some embodiments, each actuator is individually connected to a second tissue engagement portion, such as a rigid tissue engagement portion. In some embodiments, the soft tissue engagement portion is an engagement portion between implants, such as between one or more implant actuators and the soft tissue of the body (such as muscle, ligament, tendon, connective tissue, adipose tissue, skin tissue). In some embodiments, the hard tissue engagement portion is an engagement portion between an implant (such as one or more implant actuators) and the hard tissue of the body (such as bone tissue).

[0371] According to some exemplary embodiments, the soft tissue engagement portion 810 includes a soft engagement portion, such as an inflated or inflatable engagement portion, a cushion. In some embodiments, the soft tissue engagement portion 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 engagement portion 810 is configured to prevent damage to the soft tissue of the body when one or more actuators of the implant push the soft tissue engagement portion against the soft tissue of the body (such as lifting the skin surface).

[0372] According to some exemplary embodiments, the actuators 804, 806, and 808 of the implant move between a collapsed state (such as as Figure 8A shown) and an expanded state (such as Figure 8B shown). In some embodiments, when the actuator is in a compressed state, the implant 802 is introduced into the body, such as a thin implant that can be inserted into the body through a thin and / or small incision. In some embodiments, when one or more actuators are energized, the energized actuators expand to the expanded state.

[0373] According to some exemplary embodiments, such as as Figure 8C and 8D shown, the implant 802 is implanted between the bone tissue 814 and the soft tissue 816, such as the soft tissue under the skin tissue. In some embodiments, the tissue engagement portion 812 is used to connect (such as anchor) the implant 802 to the hard tissue (such as the bone tissue 814).

[0374] According to some exemplary embodiments, for example as Figure 8C shown, the implant 802 is implanted in the body in a compressed state (e.g., when one or more or all of the implant actuators are compressed). In some embodiments, for example as Figure 8D shown, after activation, for example, selectively activating at least one actuator or a group of actuators of the implant 802, the activated actuator expands and increases the distance between the bone tissue 814 and the soft tissue 816. In some embodiments, activation of the actuator causes the soft tissue 816 to lift relative to the bone 814.

[0375] According to some exemplary embodiments, selective activation of at least one actuator is performed by selectively delivering energy to the at least one actuator. In some embodiments, the selective delivery of energy causes heating of 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 preformed to expand to a certain extent and / or expand when heated to a predetermined temperature. In some embodiments, the degree of expansion of at least one actuator of the implant is different from that of another actuator of the same implant.

[0376] According to some exemplary embodiments, for example as Figure 8E shown, at least one tissue engagement portion of the actuator (e.g., the tissue engagement portion 812) includes at least one opening shaped and sized to receive a nail or screw 811, e.g., allowing the actuator and / or the implant to be fixed to body tissue (e.g., bone tissue).

[0377] According to some exemplary embodiments, for example as Figure 9A and 9B shown, the actuator is coated with a thermal insulation coating, e.g., a silicon coating. In some embodiments, the actuator 902 (e.g., a helical actuator) includes a helix 904 coated with a bellow 906 (e.g., a conical bellow). In some embodiments, the bellow 906 thermally isolates the helix (optionally formed of a metal or a shape memory alloy) from the body tissue and / or adjacent actuators of the implant. In some embodiments, for example as Figure 9B shown, the end 908 of the actuator body 904 is coated or connected (optionally filled with fluid) with a soft pad or cushion. In some embodiments, the end 908 is the apex of the actuator helix 904, e.g., a narrow portion.

[0378] In some embodiments, for example as Figures 9C to 9G shown, the implant (e.g., the tissue engagement portion 910 of the implant) includes an undercut, e.g., an undercut opening 912. In some embodiments, for example as Figure 9E and 9FAs shown, the shape and dimensions of the undercut are designed to accommodate the base 909 of the body 904, such as the wide end. In some embodiments, the shape and dimensions of the undercut are designed to at least partially surround the base 909, such as to prevent the body 904 from being released from the implant, such as from the tissue engagement portion 910 of the implant. Optionally, the tissue engagement portion 910 is a soft tissue engagement portion. Optionally, the tissue engagement portion 910 is formed of a thermally insulating material, such as to thermally insulate an actuator (which may optionally be made of metal) from the tissue. One potential advantage of thermally insulating the tissue engagement portion can be to prevent tissue damage, such as burns or tissue coagulation, when the actuator is heated.

[0379] Now refer to Figures 10A to 10C , which depicts an implant having a single actuator according to some exemplary embodiments of the present invention.

[0380] According to some exemplary embodiments, the implant 1002 includes an actuator 1004 that is (optionally within an undercut of the tissue engagement portion) connected to a tissue engagement portion 1006 (such as a soft tissue engagement portion). In some embodiments, for example, as Figure 10B shown, the tissue engagement portion 1008 is a rectangular tissue engagement portion, optionally shaped as a square. In some embodiments, the rectangular tissue engagement portion 1008 has rounded corners, such as to prevent damage to the tissue contacting the tissue engagement portion 1008. Alternatively, for example, as Figure 10C shown, the tissue engagement portion 1010 is circular.

[0381] Now refer to Figures 11A to 11D , which depicts an array of implants having multiple actuators according to some exemplary embodiments of the present invention.

[0382] According to some exemplary embodiments, for example, as Figure 11A and 11B shown, the implant 1102 includes a rectangular tissue engagement portion 1104, such as a square tissue engagement portion, and a plurality of actuators (such as actuators 1106, 1108, 1110, and 1112) arranged in an actuator array. In some embodiments, the actuators are arranged in an even number in each row or each column of the array.

[0383] According to some exemplary embodiments, for example, as Figure 11C and 11D shown, the implant 1120 includes a circular or triangular tissue engagement portion 1122.

[0384] Now refer to Figure 12A and 12B, which depicts a multi-unit implant formed from a plurality of monomer units or poly units implants according to some exemplary embodiments of the present invention.

[0385] According to some exemplary embodiments, the multi-unit implant 1202 includes two monomer unit implants, such as implants 1204 and 1206, which are connected to each other by connectors 1208 and 1210. In some embodiments, the connectors (such as connectors 1208 and 1210) at least partially fill the gap between the two units 1204 and 1206. In some embodiments, connectors 1208 and 1210 are formed of a soft material (such as a soft polymer), a hard material (such as a hard polymer), and / or a metallic material. In some embodiments, the multi-unit implant is modular and may include any number of monomer unit implants connected to each other by connectors. In some embodiments, the connectors are configured to be reversibly assembled to the monomer unit implants, for example, allowing for easy disassembly to form multi-unit implants of various shapes and sizes. In some embodiments, the connectors are configured to allow the generation of modular implants, such as modular multi-unit implants.

[0386] According to some exemplary embodiments, such as Figure 12B shown, the connectors are configured to connect, for example, reversibly connect to each other. For example, allowing for the modular formation of multi-unit implants. In some embodiments, by interconnecting connector 1208 and connector 1214, implant units 1202 and 1205 are connected to each other to form a four-unit implant. In some embodiments, connecting a plurality of monomer actuator units to form a multi-unit implant allows, for example, adapting the implant to the shape of the implantation site. In some embodiments, the monomer units have a circular, rectangular, hexagonal, or any geometric shape.

[0387] Exemplary implant with non-collapsing edge portion

[0388] According to some exemplary embodiments, the implant includes one or more actuators covered by a cover body, and the cover body is optionally used as a tissue engagement portion, which is configured to contact the tissue. In some embodiments, the cover body includes at least a portion located at the edge of the implant, and at least a portion of the implant edge remains non-collapsing when the implant actuator collapses. In some embodiments, when the actuator of the implant expands, the middle portion of the cover body is stretched by the actuator. In some embodiments, the stretching of the middle portion of the cover body aligns the middle portion of the cover body with the non-collapsing position of the edge to form a uniform and smooth outer surface of the implant, such as at the implant edge.

[0389] Now refer to Figure 12C and 12D, depicts an implant having a non-collapsing edge portion when the implant actuator is in a collapsed state (12C) and when the implant actuator is in an expanded state (12D).

[0390] According to some exemplary embodiments, the implant 1220 includes at least one actuator, such as actuators 1222 and 1224. In some embodiments, the implant 1220 further includes a cover 1226, which is optionally formed of a soft and / or compressible and / or flexible material (such as silicon). In some embodiments, the cover includes at least one intermediate portion 1228 and at least one edge portion 1230. In some embodiments, the intermediate portion 1228 is located above the actuator and optionally contacts one end of the actuator. In some embodiments, the edge portion 1230 is located at the edge of the implant 1220. In some embodiments, the intermediate portion 1228 is thicker than the edge portion 1230 of the cover. Optionally, the edge portion is located in the circumference of the implant 1220. In some embodiments, the intermediate portion is connected to the edge portion via a hinge portion 1232 of the cover 1226.

[0391] According to some exemplary embodiments, the edge portion 1230 includes one or more openings, the shape and size of which are adapted to receive screws 1234 or nails for fixing the edge of the implant 1220 to tissue, such as bone tissue. Optionally, the cover edge portion 1230 is tapered.

[0392] According to some exemplary embodiments, the edge portion 1230 of the cover 1226 is non-collapsing, for example, when the actuators 1222 and 1224 are in a collapsed state and the intermediate portion 1228 collapses, the edge portion 1230 remains in a non-collapsing state. In some embodiments, for example, when the actuator expands to an expanded state, the actuator pushes the intermediate portion 1226, aligning the intermediate portion 1228 relative to the edge portion 1230 to form a uniform and smooth tissue contact surface of the cover 1226. In some embodiments, the expansion of one or more actuators lifts the tissue 1240 (such as soft tissue) in contact with the cover, while keeping the implant 1220 fixed to the bone with a uniform and smooth surface and the bone tissue 1236 in contact with the edge.

[0393] According to some exemplary embodiments, the cover 1226 includes a plurality of holes, the shape and size of which allow fluid and / or tissue to penetrate into the implant, such as into the voids between the plurality of actuators and / or the voids between the cover 1226 and the bone 1236.

[0394] According to some exemplary embodiments, such as Figure 12E and 12FAs shown, the implant includes a filler 1244 located between the cover body 1226 and the bone tissue 1236. In some embodiments, the filler is flexible and optionally an elastic filler configured to expand when the actuator expands, filling the void formed within the implant. In some embodiments, in an implant including a filler, the cover body is sealed to prevent fluid and / or tissue from entering the implant. Alternatively, the cover body includes a plurality of holes that allow fluid and / or tissue to enter the implant and the filler 1244. In some embodiments, the filler 1244 includes a material shaped like a sponge. Optionally, the filler 1244 is formed of a shape memory material, such as a shape memory polymer or a shape memory material, such as nitinol.

[0395] Exemplary waveform spring actuator

[0396] Now refer to Figures 13A to 13B , which depicts a waveform spring actuator according to some exemplary embodiments of the present invention.

[0397] According to some exemplary embodiments, the implant includes one or more waveform spring actuators, such as waveform spring actuator 1302. In some embodiments, the waveform spring actuator 1302 is formed of a shape memory alloy, such as nitinol (NiTi) or copper-aluminum-nickel alloy. In some embodiments, a spring actuator formed of a shape memory alloy (such as waveform spring actuator 1302) is configured to move between a compressed state (such as a martensite state, optionally when cooled) and an expanded state (such as an austenite state, optionally when heated).

[0398] According to some exemplary embodiments, the spring actuator is configured to move to the martensite state when the shape memory alloy is cooled to a temperature below a predetermined value (such as cooled to below 38 °C, below 37 °C, below 35 °C, or any intermediate, smaller, or larger temperature level), such as the compressed state shown in Figure 13A . In some embodiments, when the spring actuator is cooled and forced to remain in the compressed state, for example, by applying an external force to the actuator, the spring actuator moves to the martensite state. Alternatively, the spring actuator has two shape memory states, and cooling the spring is sufficient to move between the first memory state and the second memory state without actively compressing the actuator.

[0399] According to some exemplary embodiments, the spring actuator is configured to obtain the austenite state when the shape memory alloy is heated to a temperature above a predetermined value (such as heated to above 40 °C, above 38 °C, above 37 °C, above 35 °C temperature level, or any intermediate, smaller, or larger temperature level), such as shown in Figure 13BThe expanded state shown. In some embodiments, when the transformation from the martensitic phase to the austenitic phase is complete, the actuator (such as a spring actuator) obtains a fully expanded state, i.e., Af (austenite finish). To achieve this Af state, the transformation temperature value needs to be higher (e.g., 50 to 60 °C) compared to As (austenite start temperature of 35 to 38 °C). The phase change temperature value is predetermined according to the desired transformation temperature.

[0400] In some embodiments, a plurality of spring actuators, such as wave spring actuators, are arranged in an array within the implant.

[0401] The potential advantages of using wave spring actuators can be that they allow for an increase in height, force, and can form different diameter sizes.

[0402] In some embodiments, the compression force exerted by a single wave spring formed of NiTi in the austenitic state is selected from the range of 700 to 1100 grams (gr), and the compression force exerted by a single wave spring formed of NiTi in the martensitic state is selected from the range of 300 to 600 grams (gr).

[0403] In some embodiments, the actuator shape and / or size are designed according to the expansion force required to lift the tissue. In some embodiments, the force / strength of the actuator depends on the geometry of the element: the width of the material and / or the length of the element structure.

[0404] In some embodiments, adding more actuators to the implant proportionally increases the force distributed to the tissue. Optionally, the compression force is proportional to the overall area of the implant and depends on the number of actuators supporting the implant.

[0405] Exemplary closed implant

[0406] According to some exemplary embodiments, the implant includes a closed body having a base and a soft tissue engagement portion. The base is configured to connect the implant body to hard tissue (e.g., connect to bone), and the soft tissue engagement portion is configured to allow contact between the implant body and soft tissue. In some embodiments, the implant includes one or more actuators enclosed within the body. In some embodiments, the closed body is configured to isolate the actuator and / or the lumen of the implant from body tissue after implantation. In some embodiments, the body of the implant is an expandable body configured to move between a collapsed state and an expanded state. In some embodiments, the body is configured to expand after the actuator is heated, optionally expand in the axial direction, e.g., according to the alignment of the actuator.

[0407] Now refer to Figures 14A to 14E , which depicts a closed expandable implant according to some exemplary embodiments of the present invention.

[0408] According to some exemplary embodiments, an implant (e.g., implant 1402) includes an expandable body 1404 having a lumen 1406. In some embodiments, implant 1402 includes a base 1408 that is configured to attach implant 1402 to hard tissue, such as bone. In some embodiments, the base is formed of a rigid material. Alternatively, base 1408 is formed of a flexible material. In some embodiments, body 1404 includes a tissue engagement portion 1410, such as a soft tissue engagement portion. In some embodiments, tissue engagement portion 1410 includes a layer of soft material that optionally includes a fluid, such as a liquid, air, gas, or gel. Optionally, the tissue engagement portion layer is thicker, such as thicker than base 1408.

[0409] According to some exemplary embodiments, implant 1402 includes a plurality of actuators, such as actuators 1410 and 1412, which are optionally arranged in an array and located within lumen 1406 of implant 1402. In some embodiments, such as Figure 14B and 14C shown, the actuators are positioned and aligned between base 1408 and the inner surface of tissue engagement portion 1410. In some embodiments, a first end of each actuator is connected to base 1408 and a second end of each actuator is connected to the inner surface of tissue engagement portion 1410.

[0410] According to some exemplary embodiments, the actuators (e.g., actuators 1408, 1410, and 1412) are expandable actuators, including, for example, Figures 13A to 13B the waveform spring actuator shown. In some embodiments, the actuators are configured to move between a collapsed state (e.g., as Figure 14D and 14E shown) and an expanded state (e.g., Figure 14B and 14C shown). In some embodiments, when one or more actuators expand, body 1404 of the implant expands, such as Figure 14B and 14C shown. In some embodiments, when the body of the implant expands, tissue engagement portion 1410 pushes against soft tissue and changes the curvature and shape of the outer surface of the skin, such as Figure 2D and 8C shown.

[0411] According to some exemplary embodiments, the shape of body 1404 is a bellows-like structure having a plurality of folded portions, such as allowing body 1404 to collapse and expand.

[0412] Exemplary Flexible Implant

[0413] According to some exemplary embodiments, the implant is flexible, e.g., allowing the implant to contact and / or anchor to tissue, such as rigid tissue having a non-planar (e.g., curved shape). In some embodiments, the rigid tissue (e.g., bone tissue having a non-planar shape) is found in the head. In some embodiments, the implant is soft enough to be placed in contact and optionally anchored to the skull.

[0414] 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 includes a flexible tissue engagement portion and / or a flexible array of a plurality of actuators. Now refer Figures 15A to 15F to, which depicts a flexible implant according to some exemplary embodiments of the present invention.

[0415] According to some exemplary embodiments, implant 1502 is flexible, e.g., bendable in one or more directions. In some embodiments, implant 1502 includes tissue engagement portion 1512 and a plurality of actuators, such as actuators 1504, 1506, and 1508 connected to the tissue engagement portion. In some embodiments, e.g., as Figure 15A shown, each actuator includes a first end 1503 connected to tissue engagement portion 1512 and a second end 1505 located distal to the tissue engagement portion 1512.

[0416] According to some exemplary embodiments, each actuator includes a spring 1510, e.g., formed of a shape memory alloy, which is configured to move between a compressed state and an extended state, optionally when heated.

[0417] According to some exemplary embodiments, the actuators are distributed on the surface of tissue engagement portion 1512 to have a uniform or non-uniform distance between a plurality of adjacent actuators. In some embodiments, the plurality of actuators are spaced apart on the tissue engagement portion surface. In some embodiments, each actuator includes a cover 1514, e.g., a spring cover, which isolates the spring of the actuator from adjacent actuators and / or tissue surrounding the implant. In some embodiments, cover 1514 is flexible and optionally includes a corrugated structure cover. In some embodiments, the cover is configured to stretch as the actuator expands, e.g., when the spring in the actuator expands. In some embodiments, the corrugated structure cover is formed of a sheet (e.g., a coated fabric) in a folded accordion-like structure. In some embodiments, the shape of the corrugated structure cover is designed to fold and unfold with the movement of the actuator (e.g., the actuator spring). In some embodiments, the corrugated structure covering material is made of a polymer layer (silicone, polyurethane).

[0418] According to some exemplary embodiments, each corrugated structure cover 1514 is optionally perforated, for example, after implantation (e.g., after actuator activation is complete), to allow tissue ingrowth into the actuator. Alternatively, the corrugated structure cover is impermeable to tissue. In some embodiments, the space between multiple actuators of the implant allows tissue ingrowth between the multiple actuators. In some embodiments, the corrugated structure is made of a biodegradable material, allowing tissue growth for several months after implantation.

[0419] According to some exemplary embodiments, the tissue engagement portion 1512 is soft and / or flexible. In some embodiments, the tissue engagement portion 1512 includes one or more layers of soft and / or flexible material. Optionally, as Figures 15D to 15F shown, the tissue engagement portion 1512 is overlaid or covered by the cover of the actuator, e.g., the tissue engagement portion 1512 is covered or the cover of the tissue engagement portion 1512 is integrated with the corrugated structure cover.

[0420] According to some exemplary embodiments, as Figures 15D to 15G shown, the flexible implant (e.g., implant 1530) is configured to bend about the long axis 1533 of the implant and / or about the short axis 1535 of the implant. In some embodiments, as Figure 15E shown, the bending of the implant 1530 changes the distance between the second ends 1505 of each actuator that are not connected to the user engagement portion (e.g., tissue engagement portion 1532). In some embodiments, the flexible implant 1530 bends when one or more actuators are in a compressed state, as Figure 15D shown, and / or when more than one actuator is in an extended state, as Figure 15E and 15F shown.

[0421] According to some exemplary embodiments, as Figure 15G shown, the flexibility of the implant 1530 allows the actuators to conform to the curved surface of the bone 1540 while keeping the tissue engagement portion 1532 in contact with the soft tissue of the body.

[0422] According to some exemplary embodiments, as Figure 16 shown, the implant 1530 is attached to the mandible. In some embodiments, the second ends 1505 of one or more actuators of the implant 1530 are connected to the mandible, for example, using an adhesive, a screw, or a nail.

[0423] According to some exemplary embodiments, the tissue engagement portion (e.g., Figure 3A and 3BThe tissue junction (312) therein includes one or more perforations that allow tissue to grow inward through the tissue junction into one or more actuators. In some embodiments, the location of the perforations allows energy to be transmitted through the tissue junction to the actuators. In some embodiments, the perforations are configured to provide openings for transmitting other energy sources (such as lasers), which can be used to selectively (e.g., through focused light transmission) or uniformly (e.g., through collimated or wider beam light transmission) induce heating in the actuators.

[0424] Exemplary mesh implant

[0425] According to some exemplary embodiments, the implant includes a body formed of a mesh material and one or more actuators located within the body. Alternatively or optionally, each of the distal and proximal ends of the actuator is connected to at least one layer of mesh material. In some embodiments, positioning the actuator between at least two opposing mesh material layers allows, for example, tissue to grow inward into the implant and optionally into the actuator.

[0426] Now refer to Figures 17A to 17D , which depicts an implant having an actuator connected to two mesh layers, with one mesh layer on each side of the actuator, according to some exemplary embodiments of the present invention.

[0427] According to some exemplary embodiments, the implant 1702 includes at least one actuator (such as spring actuators 1704 and 1706), and at least two layers of mesh material (such as at least one first mesh layer 1708 and at least one second mesh layer 1710). In some embodiments, the first end of the actuator is connected to at least one first mesh layer 1708 of the implant, and the second end of each actuator is connected to at least one second mesh layer 1710 of the implant.

[0428] According to some exemplary embodiments, the implant is located between two tissue layers, between a first tissue layer 1712 (such as a soft tissue layer) and a second tissue layer 1714 (such as a bone layer). In some embodiments, the mesh layer 1710 is, for example, anchored to the bone layer 1714, and the mesh layer 1708 is in contact with the soft tissue layer 1712. Optionally, for example, as Figure 17A shown, when multiple actuators or at least some of the actuators are in a collapsed state, the implant is located between two layers of the body.

[0429] According to some exemplary embodiments, for example, as Figure 17CAs shown, when powered, one or more actuators (e.g., actuator 1704) expand and push the mesh layer 1708, and tissue (e.g., soft tissue 1712, which contacts or abuts against the mesh layer 1708) away from the bone tissue 1714. In some embodiments, after the healing period following implantation surgery, body tissue migrates through the mesh pores into the implant. In some embodiments, if the actuator is not coated with a tissue-penetration-preventing coating, body tissue optionally enters the actuator before the activation procedure begins. Alternatively, if the actuator is coated, body tissue penetrates into the implant and between the actuators, thereby improving and fixing the support of the actuators and improving the biological healing response of the implant, as Figure 17D shown.

[0430] In some embodiments, the mesh material includes at least one of the following: fabric, perforated polymer / or other biomaterial, metal mesh, and / or metallic reticulum. In some embodiments, the mesh material allows, for example, the force applied by an actuator (e.g., a spring actuator) to be distributed or dispersed over the tissue. Additionally or alternatively, the mesh material allows, for example, tissue growth or biological fluid to cross through the implant from one side to the other. Optionally, one or more or all of the actuators are coated or encapsulated. Alternatively, one or more or all of the actuators remain uncoated.

[0431] Exemplary implant with isolated actuators

[0432] 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, one or more isolation layers surround one or more actuators. In some embodiments, one or more isolation layers include a plurality of pleats, such as circumferential pleats around each actuator, for example allowing free expansion without interference from the isolation layer. In some embodiments, isolating the actuators of the implant allows, for example, tissue to penetrate between adjacent actuators and prevents tissue from penetrating the actuator body. Optionally, tissue penetration into the actuator body, such as into the spring body, may interfere with the axial movement of the spring, such as expansion and collapse.

[0433] Now refer to Figures 18A to 18D , which depicts an implant with isolated actuators according to some exemplary embodiments of the present invention.

[0434] According to some exemplary embodiments, the implant includes two or more spaced-apart actuators located within a hollow corrugated structure, such as corrugated structures 1806 and 1808. In some embodiments, the hollow corrugated structures are interconnected, such as to form at least one cover or coating that isolates the actuators from the surrounding environment. In some embodiments, the corrugated structure includes silicon or is formed at least in part of silicon. In some embodiments, the corrugated structures surrounding the actuators are interconnected by a sleeve, such as a silicone rubber corrugated structure sleeve. In some embodiments, the corrugated structure is formed of a material configured to prevent cells and / or tissue from passing through the corrugated structure, such as into the actuator. In some embodiments, the corrugated structure is formed of a non-perforated material or a perforated material having a plurality of holes that are too narrow in size to permit penetration units. In some embodiments, the holes have a maximum width value between 30 μm (micrometers) and 5 micrometers (e.g., between 30 micrometers and 10 micrometers, between 15 micrometers and 3 micrometers, or any intermediate, smaller, or larger value range). In some embodiments, the holes have a maximum width value within a range between 0.1 mm and 1 mm (e.g., between 0.1 mm and 0.4 mm, between 0.6 mm and 0.9 mm, or any intermediate, smaller, or larger value range). In some embodiments, the corrugated structure is formed of a material that prevents outward or inward growth of tissue on the corrugated structure.

[0435] According to some exemplary embodiments, such as Figures 18B to 18D shown, the implant 1803 includes a tissue contact layer 1810, such as a soft tissue contact layer. In some embodiments, the tissue contact layer 1810 is the tissue engagement portion of the implant and is optionally formed of silicon and / or rubber. In some embodiments, such as Figure 18B shown, the implant is implanted between two tissue layers, such as between bone tissue 1812 and softer tissue 1814. In some embodiments, in the collapsed state, the corrugated structure having a plurality of circumferential folding portions is folded. In some embodiments, after the actuator is energized, the actuator 1802 expands within the corrugated structure 1806. In some embodiments, the expansion of the actuator 1802 unfolds the lower portion 1806, such as straightening the circumferential corrugated structure folds.

[0436] According to some exemplary embodiments, such as Figure 18D shown, the corrugated structure defines a void between the plurality of isolated actuators that permits tissue to penetrate into the implant, such as into the implant body, between adjacent isolated actuators.

[0437] According to some exemplary embodiments, the corrugated structure is configured to thermally insulate the plurality of actuators from the surrounding environment, e.g., to prevent heat loss from the actuators to the surrounding environment after the actuators are energized. Additionally or alternatively, the corrugated structure is configured to reduce the air volume and / or reduce the vacuum pressure on the spring actuators.

[0438] According to some exemplary embodiments, such as Figures 19A to 19C shown, the spring actuators of the implant (e.g., spring actuators 1902 and 1904) are located within the hollow corrugated structures 1906 and 1908, respectively. In some embodiments, the hollow corrugated structures are configured to reduce the folded volume and are optionally formed of silicone or different polymers.

[0439] According to some exemplary embodiments, the hollow corrugated structures 1906 and 1908 and / or the spring actuators 1902 and 1904 are connected to a junction, such as a cover 1910. In some embodiments, the cover is optionally formed of a thermally insulating material, which is configured to reduce heat transfer to the surrounding tissue and / or reduce heat loss of the spring actuators heated after the spring actuators are energized. Optionally, the hollow corrugated structures 1906 and 1908 are integrated with the cover 1910. Optionally, the cover 1910 has a foldable shape.

[0440] According to some exemplary embodiments, such as Figures 20A to 20C shown, the junction (e.g., cover 2002) includes at least one socket 2004. In some embodiments, the at least one socket 2004 is located in a surface of the cover that is opposite to the tissue contact surface of the cover 2002. In some embodiments, the at least one socket is configured to receive at least one of the hollow corrugated structure and the spring actuator within the corrugated structure.

[0441] 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, e.g., to maintain a thin cross-section of the implant, which does not interfere with the insertion of the implant into the body through a thin incision and / or interfere with the implantation of the implant at the implantation site.

[0442] Exemplary expansion actuator

[0443] Now refer to Figures 21A to 21G , which depicts an implant having at least one thin expandable actuator according to some exemplary embodiments.

[0444] According to some exemplary embodiments, an implant (e.g., implant 2102) includes at least one thin expandable actuator 2104 shaped as a thin plate or thin grid. In some embodiments, the thin expandable actuator 2104 is formed of a shape memory alloy, such as Nitinol. In some embodiments, the thin expandable actuator is located between a base 2106 and a cover 2107 of the implant 2102, optionally surrounding the thin expandable actuator. In some embodiments, the cover is a tissue contacting junction and is optionally soft.

[0445] According to some exemplary embodiments, the thin expandable actuator includes a plurality of expandable segments, such as bridge structures 2108, 2110, and 2112. In some embodiments, the bridge structures are configured to move between a collapsed state and an expanded state when energized (e.g., heated). In some embodiments, in the collapsed state, for example as Figure 21C shown, the bridge structures are compressed and the actuator is flat, optionally planar. In some embodiments, when the bridge structures are in a compressed state, the implant 2102 has a thin cross-section, which optionally allows the implant to be inserted into the body through a thin or narrow incision.

[0446] In some embodiments, the thickness of the implant 2102 in the collapsed state is in the range of 0.5 millimeters to 3 millimeters (e.g., in the range of 0.5 millimeters to 1 millimeter, 0.5 millimeters to 2 millimeters, 1 millimeter to 2 millimeters, 1 millimeter to 3 millimeters, or any intermediate, smaller or larger values or ranges of values).

[0447] According to some exemplary embodiments, for example as Figures 21C to 21E shown, when heated, the bridge structures expand. In some embodiments, the amount of expansion of the bridge structures depends on the temperature of the thin expandable actuator 2104 and / or the temperature of each bridge structure. In some embodiments, for example when the bridge structures are thermally connected and / or have similar properties, the bridge structures expand uniformly. Alternatively, at least one bridge structure is preformed to expand to a different extent than one or more other bridge structures in the implant, which can result in non-uniform expansion of the implant 2102. Alternatively, at least one bridge structure is thermally insulated from other bridge structures and can be heated to a different temperature than the other bridge structures, resulting in non-uniform expansion of the implant 2102.

[0448] According to some exemplary embodiments, for example as Figure 21F shown, the bridge structures are encapsulated within the implant 2102, such as by the cover 2107.

[0449] According to some exemplary embodiments, for example as Figure 21G shown, the bridge structures 2108 and 2110 are formed by laser cutting and can optionally be formed in any shape and / or size.

[0450] Exemplary inflatable implant

[0451] Now refer to Figures 22A to 22E , which depicts an inflatable actuator in accordance with some exemplary embodiments of the present invention.

[0452] According to some exemplary embodiments, the implant includes one or more inflatable actuators, such as inflatable actuator 2202. In some embodiments, inflatable actuator 2202 includes at least one inflatable chamber 2204, which is located between a base 2206 (e.g., a first tissue contact junction) and a second tissue contact junction 2208. In some embodiments, base 2206 is optionally planar and configured to contact body tissue, such as bone. In some embodiments, junction 2208 includes a compressible and optionally soft junction, such as a cushion, which is configured to be pushed against soft tissue of the body when the implant expands.

[0453] According to some exemplary embodiments, implant 2202 includes at least one channel, such as channel 2210 connected to chamber 2204, and configured to allow fluid to flow between chamber 2204 and at least one fluid source. Optionally, the channel (e.g., channel 2212) passes through junction 2208. Optionally, at least one channel (e.g., channels 2210 and 2212) includes at least one valve (e.g., a one-way valve) to control fluid flow through the channel.

[0454] According to some exemplary embodiments, such as as Figure 22B shown, the expansion of chamber 2204, such as by introducing fluid into chamber 2204 via a channel, causes implant 2202 to expand.

[0455] According to some exemplary embodiments, such as as Figure 22C shown, the implant (e.g., implant 2214) includes a series of inflatable actuators, such as actuators 2216, 2218, and 2220. In some embodiments, the series of actuators are fluidly connected by at least one channel. In some embodiments, the at least one channel includes at least one valve for controlling the flow of liquid to and / or from a single chamber of at least one inflatable actuator of the implant, or the flow from all chambers of a plurality of inflatable actuators of the implant. Optionally, each inflatable actuator includes a fluid separation channel leading to at least one inflatable chamber of the actuator, such as allowing separate inflation of at least one inflation chamber.

[0456] According to some exemplary embodiments, such as as Figure 22DAs shown, one or more tissue contacting junctions 2208 of the implant have a circular and / or curved outer surface facing the tissue, such as a circular and / or curved tissue contacting surface. In some embodiments, such as as Figure 22D shown, the junction 2208 is dome-shaped. Alternatively, such as as Figure 22E shown, the junction 2208 of the implant 2232 has a rectangular shape. Optionally, such as as Figure 22E shown, the junction 2208 has a flat tissue contacting or outer surface. Optionally, such as as Figure 22E shown, the junction 2208 has a planar tissue contacting or outer surface.

[0457] Exemplary modular implant

[0458] According to some exemplary embodiments, the implant includes two or more, such as a plurality of monomeric actuators connected to each other. In some embodiments, the connection of the plurality of monomeric actuators allows, for example, the generation of a modular implant having a predetermined size and / or shape. Additionally, or alternatively, the connection of the plurality of monomeric actuators allows the formation of an implant that matches a selected implantation site in the body.

[0459] Now refer to Figures 23A to 23E , which depicts a modular implant according to some exemplary embodiments of the present invention.

[0460] According to some exemplary embodiments, the implant (such as a modular implant) includes two or more monomeric unit expandable actuators, such as actuator 2302. In some embodiments, such as as Figure 23B shown, the actuator 2302 includes at least one expandable portion, such as an expandable chamber 2304, which is configured to move between a compressed state and an expanded state when energized or inflated. In some embodiments, the chamber is connected to a base 2306. Optionally, the base 2306 is shaped like a flat plate. Optionally, the base has a customized 3D shape to fit / replace / accommodate a specific anatomical bone shape. Optionally, the base 2306 is rigid.

[0461] According to some exemplary embodiments, the base 2306 includes one or more openings or pores, such as opening 2308, which is configured to allow the base 230 to connect to bone tissue. Additionally, the base includes one or more openings or pores, which are configured to allow the base of at least one first actuator unit to be connected to the base of at least one second actuator unit. In some embodiments, at least one first actuator unit is connected to at least one second actuator unit via a hub structure. In some embodiments, at least one first actuator unit is movably connected to at least one second actuator unit, such as to allow the first actuator unit to move relative to the second actuator unit.

[0462] According to some exemplary embodiments, such as Figure 23C shown, an implant (e.g., a modular implant) includes an array 2310 of a plurality of actuator units that can be assembled or disassembled from the array. In some embodiments, such as Figure 23D shown, the array is located 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.

[0463] Alternatively, the implant includes an array of a plurality of monomeric actuator units that are connected to a single tissue engagement portion, or two or more tissue engagement portions, each tissue engagement portion covering two or more actuators.

[0464] According to some exemplary embodiments, such as Figure 23E shown, an array of actuator units that can be moved relative to adjacent actuators in the array is flexible, e.g., bendable, e.g., to accommodate the curvature of the tissue in the implantation site in the body. In some embodiments, such as Figure 23E shown, the flexible array bends to accommodate the curvature of the cranial tissue, e.g., in the mandibular region of the head, the temporal region of the head, or the cheek region of the head.

[0465] Exemplary actuator arrays

[0466] According to some exemplary embodiments, such as previously in Figure 23C and 23D described, the implant includes an array of a plurality of actuators. In some embodiments, the plurality of actuators in the array are assembled with each other. Alternatively, the plurality of actuators of the array are connected to a base layer. Now refer to Figure 24A and 24B , which depict an actuator array connected to a base according to some exemplary embodiments of the present invention.

[0467] According to some exemplary embodiments, such as Figure 24A shown, the implant 24A includes an array of a plurality 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) includes one or more openings or fasteners (e.g., screws 2414) that are configured to fasten the base 2412 to body tissue, e.g., bone tissue. In some embodiments, such as Figure 24BAs shown, the implant 2440 includes a plurality of actuators, such as actuators 2442 and 2444, which are arranged in an array, such as a compact array. In some embodiments, the actuators 2442 and 2444 in the array are in contact with each other and optionally have a polygonal shape that allows for a compact arrangement of the actuators, with the compact arrangement of the actuators being in contact with each other through the sides of the polygonal shape.

[0468] According to some exemplary embodiments, such as Figure 24C As shown, the base 2450 of the implant 2440 includes one or more fluid flow paths, such as channels 2452. In some embodiments, the implant 2440 includes at least one valve 2454 located on the channel 2452, which is configured to control the 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.

[0469] According to some exemplary embodiments, each actuator, such as actuators 2442 and 2444, is configured to be assembled onto the base 2450. Optionally, the actuator is configured to be irreversibly assembled onto the base 2450. Alternatively, the actuator is configured to be reversibly assembled onto the base 2450.

[0470] According to some exemplary embodiments, such as Figure 24D As shown, the actuator 2442 includes at least one inflatable unit 2460 connected to the actuator base 2462. In some embodiments, the actuator base is rigid and optionally includes one or more fasteners 2464, which are configured to fasten the actuator 2442 to the implant base 2450. In some embodiments, each actuator includes a piercing element, such as a needle 2466, that is fluidly connected to the unit 2460. In some embodiments, as shown in FIG. 24, for example, the actuator 2442 is fastened using the fastener 2464 and the needle tip is inserted into the channel 2452 to form a flow path between the channel 2452 and the inflatable unit 2460. In some embodiments, such as Figure 24D As shown, the inflatable units of the implant are inflated through the channels 2452 in the implant base, with each actuator being fluidly connected to the channels.

[0471] Alternatively or additionally, such as Figure 24E As shown, each unit of the actuator includes at least one valve 2480, such as allowing each unit to be inflated separately from other units of the implant actuator.

[0472] Exemplary actuator assembly

[0473] According to some exemplary embodiments, the implant is modular and can be assembled as required, such as Figure 3Das described in block 382. In some embodiments, the desired number of actuators are placed at selected locations by using the positioning base of the actuator (e.g., Figures 5A to 5D the helical, spring-like actuators shown in FIGS. 6A through 6D and FIGS. 7A through 7J) to assemble the implant. In some embodiments, the substrate is a layer of material, such as a sheet.

[0474] Now refer to Figures 25A to 25C , which depicts the positioning of actuators using the positioning base of a plurality of actuators according to some exemplary embodiments of the present invention.

[0475] According to some exemplary embodiments, the actuator assembly 2502 includes a positioning base (e.g., layer 2504) having at least one (e.g., at least two) predetermined positioning locations distributed in the layer 2504. In some embodiments, each positioning location is configured to connect at least one actuator to the layer 2504 directly or indirectly, e.g., via an adapter. In some embodiments, as shown, for example, in Figure 25A , each positioning location includes an extension 2506 extending from the layer 2504, such as a pin. In some embodiments, the actuator adapter (e.g., adapter 2508) is configured to connect to the extension 2508. In addition, the adapter is configured to connect to the actuator, such as a helical spring-like actuator. In some embodiments, each adapter includes a first opening 2510 shaped and sized to receive the extension 2506 and a second opening 2512 shaped and sized to receive the actuator 2514. Alternatively, the actuator is directly connected to the extension, e.g., through an opening in the actuator.

[0476] According to some exemplary embodiments, as shown, for example, in Figure 25B , the base 2516 includes an opening 2518 at each positioning location. In some embodiments, the opening is configured to receive a portion of the adapter, such as the pin 2522. In some embodiments, each adapter, as shown, for example, in Figure 25A , is configured to optionally connect to the actuator 2514 through an opening in the adapter.

[0477] According to some exemplary embodiments, as shown, for example, in Figure 25A and 25B , each actuator is positioned at a desired location on the base using an adapter that is connected to the base using, for example, a snap-fit mechanism and is positioned at a specific predetermined location in the base. Optionally, each actuator is reversibly or irreversibly connected to the adapter, e.g., using a snap-fit or interference lock. Optionally, each adapter is reversibly or irreversibly connected to the base, e.g., using a snap-fit mechanism or interference lock. Optionally, the actuator is directly reversibly or irreversibly connected to the base, e.g., using a snap-fit or interference lock mechanism.

[0478] A potential advantage of using an adapter to connect an actuator to a base can be that it allows a standard actuator to be connected to the base, or an actuator with different base sizes and extendable part heights to be connected, which actuators can extend at different temperatures.

[0479] According to some exemplary embodiments, such as Figure 25C shown, a base 2524 having a plurality of predetermined actuator connection positions allows an actuator to be positioned at a specific location and in a specific distribution on the base 2524, either through an adapter 2528 or directly, to form a customized component 2530.

[0480] According to some exemplary embodiments, the base is flexible, e.g., bendable, and includes a plurality of connection regions, each configured to connect at least one actuator to the base. In some embodiments, the base is formed of at least one of the following: polymeric materials, silicon or derivatives, plastics, and / or metals. A potential advantage of forming the base from a material different from that of the actuator (e.g., from a polymeric material) can be to allow the base to be easily cut without damaging the actuator. In some embodiments, such as Figure 25D shown, the base 2540 includes a plurality of spaced-apart openings, such as openings 2542 and 2544. In some embodiments, the shape and size of the openings 2542 and 2544 allow an actuator 2548 to be optionally connected to the base 2540 via an adapter 2550. In some embodiments, the actuator 2548 or the actuator adapter 2550 is configured to be connected to the base 2540 by a snap connection, optionally using at least one snap-fit connector. Optionally, the actuator includes a portion configured to be connected to the base by a snap connection.

[0481] According to some exemplary embodiments, the base 2540 includes at least two types of openings, one type for connecting an adapter or an actuator to the base in a first orientation direction, e.g., for connecting an actuator base directly or indirectly to the base 2540, and another type of opening (e.g., opening 2546) for connecting an adapter or an actuator in a second direction (optionally an opposite orientation direction).

[0482] According to some exemplary embodiments, such as Figure 25E shown, connecting the actuator in an orientation direction opposite to that of the base allows a head-to-tail arrangement, where the base 2554 of at least one first actuator 2556 is adjacent to the top 2558 of the extendable part of at least one second actuator 2580. A potential advantage of arranging the actuators in a head-to-tail direction can be to effectively utilize the space of the base to allow as many actuators as possible to be connected to a single shared base.

[0483] Now refer to Figures 26A to 26E, which depicts an implant assembly according to some exemplary embodiments of the present invention.

[0484] According to some exemplary embodiments, the implant assembly includes a positioning base for a plurality of actuators, such as base 2602. In some embodiments, base 2602 is a grid including one or more actuator connectors (such as connectors 2604 and 2606), and each actuator connector is configured to connect to an actuator (such as a three-dimensional figure, a helical actuator 2608). In some embodiments, each actuator is reversibly or irreversibly connected to base 2602, for example, via connectors 2604 and / or 2606. In some embodiments, base 2602 includes one or more tissue fixators for connecting base 2602 to body tissue, such as rigid body tissue, optionally including bone tissue. In some embodiments, one or more tissue fixators include a plurality of openings 2610, and the shape and size of openings 2610 are designed to accommodate screws for connecting the base to the tissue.

[0485] According to some exemplary embodiments, the shape of base 2602 is a grid, in which actuator connectors 2604 and 2606 are connected to each other by at least one bridge-like structure 2603. In some embodiments, the shape of base 2602 can be modified by cutting or disconnecting the bridge-like structure.

[0486] According to some exemplary embodiments, the assembly includes an array of a plurality of cap-like structures, such as array 2612 includes at least one or more cap-like structures, such as cap-like structures 2614 and 2616. In some embodiments, the cap-like structures are spaced apart from each other. In some embodiments, the distance between the centers of adjacent cap-like structures is similar to the distance between the centers of adjacent actuator connectors.

[0487] According to some exemplary embodiments, the concave side (such as the dome) of each cap-like structure is configured to connect to an actuator, and the opposite convex side of the cap-like structure is optionally configured to be placed in contact with soft tissue. In some embodiments, adjacent cap-like structures in the cap-like structure array are interconnected with each other by one or more interconnecting bridge-like structures or interconnecting portions 2618. In some embodiments, the cap-like structure array includes one or more connectors for connecting the cap-like structure array to the actuator array. Optionally, the one or more connectors include openings 2620, and when the cap-like structure array 2612 is connected to the actuator base 2602, openings 2620 are aligned with openings 2610. In some embodiments, for example, as Figure 26E shown, openings 2610 and 2620 allow screw 2622 to be inserted through the implant 2630 into the rigid tissue of the body, such as bone 2632.

[0488] Figure 26D The implant assembly 2630 is depicted from a bottom view.

[0489] Now refer to Figures 27A to 27C which depicts an implant assembly according to some exemplary embodiments of the present invention, wherein the actuator is clamped between a base layer and a cover layer, and wherein the actuator is interlocked with the base layer and the cover layer.

[0490] According to some exemplary embodiments, the implant assembly 2702 includes an actuator base 2704 and one or more actuators or actuator housings 2710 and 2712, and the actuator base 2703 includes one or more actuator connection locations 2706 and 2708. In some embodiments, the actuator housing includes an actuator connected to an adapter, and the actuator is optionally irreversible.

[0491] According to some exemplary embodiments, the implant assembly 2702 includes a cover 2714. In some embodiments, the actuator (e.g., an actuator housing or an adapter) is connected between the base 2704 and the cover 2714. In some embodiments, for example, as Figures 27A to 27C shown, the cover layer 2714 is connected to the actuator via an intermediate connection layer 2716. In some embodiments, the actuators 2710 and 2712 and the cover 2714 are interlocked with the intermediate connection layer 2716 on opposite sides, optionally using an interlocking mechanism, such as one or more snap-fit connectors. Optionally, the actuator or actuator housing is interlocked with the base 2704 via an interlocking mechanism (e.g., an interlocking connector 2722, such as a snap-fit connector).

[0492] Exemplary implant with an internal actuator array

[0493] Now refer to Figures 28A to 28D which depicts an implant with an internal actuator array according to some exemplary embodiments of the present invention.

[0494] According to some exemplary embodiments, the implant 2802 includes a chamber 2804 having a wall structure that surrounds and defines an inner cavity. In some embodiments, the chamber 2804 includes at least one opening 2806 leading to the inner cavity. In some embodiments, the chamber is formed of an elastic material, and at least one tissue contact surface of the chamber is soft and / or smooth. In some embodiments, the chamber 2804 is formed as a single unit. Alternatively, the chamber is assembled from two or more separate units connected to each other.

[0495] According to some exemplary embodiments, for example, as Figure 28B shown, the implant 2802 includes an internal actuator array 2808. In some embodiments, for example, as Figure 28CAs shown, the actuator array 2808 includes a base 2814 and at least one actuator or a plurality of actuators (e.g., actuators 2812 and 2810) connected to the base 2814 (e.g., using at least one adapter, at least one locking structure, using an adhesive and / or fasteners).

[0496] According to some exemplary embodiments, the actuator array 2808 is formed by positioning one or more actuators (e.g., actuators 2810 and 2812) at predetermined actuator positioning locations in 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 positioning location, such as Figure 28A the groove 2813 shown in the perspective view of the implant. In some embodiments, the shape and size of the groove 2813 are designed to accommodate at least a portion of the actuator, such as the base of the actuator. 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, or triangular, or any geometric shape that matches the actuator portion configured to be located within the groove 2813.

[0497] According to some exemplary embodiments, in the implant, one or more of the grooves are empty. In some embodiments, the grooves are spaced apart and have a minimum distance between them of between 0.1 millimeters and 10 millimeters, such as a minimum distance between 0.1 millimeters and 1 millimeter, between 0.5 millimeters and 3 millimeters, between 0.5 millimeters and 5 millimeters, or any intermediate, smaller, or larger distance or range of distance values.

[0498] According to some exemplary embodiments, such as Figure 28C shown, for example, the implant 2802 is assembled by inserting the actuator array 2808 into the inner cavity of the chamber via at least one opening 2806. In some embodiments, after insertion, the actuator array is connected to the chamber using an adhesive or one or more pins or staples that pass at least partially through the chamber 2804 and the array 2808, such as to the inner surface of the chamber wall.

[0499] According to some exemplary embodiments, such as Figure 28D shown, the chamber 2804 has a tapered edge 2816 that at least partially surrounds the chamber 2804. In some embodiments, the chamber 2804 includes an inner cavity 2818 surrounded by a wall structure 2820.

[0500] According to some exemplary embodiments, such as Figure 28EAs shown, the implant (e.g., implant 2802) includes one or more holes or openings in the chamber, such as opening 2822. In some embodiments, the opening is configured to allow cells to penetrate into the lumen of the implant, such as lumen 2818, during the healing process. In some embodiments, for example, as Figure 28E shown, implant 2802 is used as a temporal implant in a temporal skull surgery. In some embodiments, the implant is placed in the temporal region of the skull 2824 and is used to form a volume between the skull and the skin. Alternatively, the implant is implanted in the mandibular region, cheek region, chin region of the face, or any other region of the face or head.

[0501] For example, as Figure 28B shown, one potential advantage of forming an implant from a closed flexible compartment and having an actuator array within the lumen of the compartment can be a more integrated design where the actuators are kept within the chamber and do not come into direct contact with tissue, which will optionally result in longer tissue growth around the implant and a longer implant adjustment period postoperatively. Another advantage, if desired, can be allowing the actuators to be easily removed from the body as a single unit with the implant.

[0502] It is expected that during the term of the patent derived from this application, a variety of related actuators will be developed; the scope of protection of the term "actuator (actuator or actuators)" is intended to pre - cover all such new technologies.

[0503] In this document, when referring to a quantity or a numerical value, the word "about" means "within ± 10%".

[0504] The terms "comprises, comprising, includes, including", "has, having" and their conjugates mean "including but not limited to".

[0505] "Consisting of" is intended to mean "including and limited to".

[0506] "Consisting essentially of" means that the composition, method or structure may include additional ingredients, steps and / or parts only when the additional ingredients, steps and / or parts do not substantially change the basic and novel characteristics of the claimed composition, method or structure.

[0507] As used herein, the singular forms "a, an" and "the" include plural referents unless the context clearly dictates otherwise. For example, the term "compound" or "at least one compound" may include multiple compounds, including mixtures thereof.

[0508] In this application, the embodiments of the present invention can be represented with reference to a range format. It should be understood that the description of the range format is only for convenience and brevity and should not be construed as a rigid limitation on the scope of the present invention. Therefore, the description of a range should be regarded as having specifically disclosed all possible sub-ranges and individual values within that range. For example, the description of a range such as from 1 to 6 should be regarded as specifically disclosing sub-ranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6, etc., and individual numbers within that range, such as 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.

[0509] Unless the context clearly indicates otherwise, any numerical range indicated in this specification (e.g., "10 - 15", "10 to 15", or any pair of numbers represented in such forms) shall be understood to include all numerical values within that range (including integers and decimals) as well as the endpoint values of that range itself. The phrases "ranging / ranges between" a first indicated number and a second indicated number and "ranging / ranges from" a first indicated number "to" a second indicated number (or other words having a range meaning) are used interchangeably herein and mean including the first and second indicated numbers and all integers and fractions therebetween.

[0510] Unless otherwise specified, the numbers used herein and any numerical ranges based thereon are approximations within the reasonable measurement accuracy and rounding errors understood by those skilled in the art.

[0511] It should be understood that, for clarity, certain features of the present invention described in the context of separate embodiments may also be provided in combination in a single embodiment. Conversely, for brevity, the various features of the present invention described in the context of a single embodiment may also be provided separately or in any suitable sub-combination, or appropriately in any other described embodiment of the present invention. Certain features described in the context of various embodiments should not be regarded as essential features of those embodiments unless the embodiment cannot operate without these elements.

[0512] Although the present invention has been described in connection with specific embodiments thereof, it is apparent that many alternatives, modifications, and variations will be apparent to those skilled in the art. Therefore, the aim of the present invention is to embrace all such alternatives, modifications, and variations that fall within the spirit and broad scope of the appended claims.

[0513] It is the applicant's intention that all publications, patents, and patent applications mentioned in this specification are hereby incorporated by reference in their entirety into the specification as if each individual publication, patent, or patent application was specifically and individually indicated at the time of reference and it was to be incorporated herein by reference. Further, the 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. In the event that section headings are used, they should not be construed as necessarily limiting. Additionally, any priority documents of this application are hereby incorporated by reference in their entirety into this application.

Claims

1. A method for tissue shaping, characterized in that The method includes the following steps: Provide an implant, the implant including at least one actuator configured to expand when exposed to an external energy; Implant the implant at an implant site between at least one first tissue and at least one second tissue of the body within a patient's body; Selectively energize the at least one actuator; In response to the selective energization, shape the at least one first tissue and / or the at least one second tissue according to the expansion of the at least one actuator that is energized.

2. The method according to claim 1, characterized in that, The selectively energizing step includes remotely selectively energizing the at least one actuator from a remote location external to the body.

3. The method according to any one of claims 1 or 2, characterized in that The selectively energizing step includes selectively heating the at least one actuator to a temperature level at which the at least one actuator expands.

4. The method according to claim 3, characterized in that, The selectively heating step includes exposing the at least one actuator to an electromagnetic field generated external to the body.

5. The method according to claim 3, characterized in that, The selectively heating step includes exposing the at least one actuator to at least one of the following: ultrasonic energy, radio frequency energy, laser, infrared, or a thermally insulating liquid.

6. The method according to any one of the preceding claims, characterized in that, The selectively energizing step is performed before or during the implanting step.

7. The method according to any one of the preceding claims, characterized in that, The method includes allowing the implant site to heal before the selectively energizing step.

8. The method according to any one of the preceding claims, characterized in that, The method includes repeating the selectively energizing step and the shaping step if the shaped tissue does not obtain a target shape.

9. The method according to any one of the preceding claims, characterized in that The providing step includes providing the implant with at least one tissue engagement portion, and the at least one actuator is connected to the at least one tissue engagement portion, and the implanting step includes bringing the at least one actuator into contact with the at least one second tissue and bringing the at least one tissue engagement portion into contact with the at least one first tissue.

10. The method according to any one of the preceding claims, characterized in that, The implanting step includes plastically or elastically bending the implant to conform the implant to a surface of the at least one first tissue or a surface of the at least one second tissue.

11. The method according to any one of the preceding claims, characterized in that, The method includes modifying the shape and / or size of the provided implant before and / or during the implanting step to conform to the implant site.

12. The method according to claim 11, characterized in that, The modifying step includes changing the number of actuators of the implant.

13. The method according to any one of the preceding claims, characterized in that The at least one first tissue includes soft tissue, and the at least one second tissue includes bone tissue, and the shaping step includes shaping the soft tissue according to the expansion of the at least one actuator that is energized.

14. The method according to any one of claims 1 to 12, characterized in that, The at least one first tissue includes a first soft tissue, and the at least one second tissue includes a second soft tissue, wherein the shaping step includes shaping the first soft tissue according to the expansion of the at least one actuator that is energized.

15. The method according to any one of the preceding claims, characterized in that, The at least one actuator includes a plurality of actuators, and the selectively energizing step includes selectively energizing at least one of the plurality of actuators.

16. A body implant configured to be implanted in an implantation site within a body, characterized in that, The body implant includes: The positioning base of at least one actuator, the positioning base of the at least one actuator including a plurality of spaced-apart actuator connection regions, each actuator connection region being configured to connect at least one actuator to the positioning base; A plurality of actuators, connected to the positioning base of the at least one actuator, wherein at least one of the plurality of actuators is configured to expand and / or contract when exposed to energy.

17. The body implant according to claim 16, wherein, The plurality of actuators includes a plurality of perforated actuators.

18. The body implant according to claim 16 or 17, characterized in that, The positioning base of the at least one actuator is configured to bend.

19. The body implant according to any one of claims 16 to 18, characterized in that, The positioning base of the actuator includes at least one opening in each of the plurality of spaced-apart actuator connection regions, the at least one opening being configured to connect at least one of the plurality of actuators to the positioning base of the actuator by a snap connection.

20. The body implant according to any one of claims 16 to 19, characterized in that, At least some of the plurality of actuators are connected to each other by one or more connectors.

21. The body implant according to any one of claims 16 to 20, characterized in that, The plurality of actuators are configured to move laterally relative to each other when heated by the energy.

22. The body implant according to any one of claims 16 to 21, characterized in that, Each of the plurality of actuators includes a shape memory material configured to expand when heated by the energy.

23. The body implant according to claim 22, characterized in that, At least one of the plurality of actuators is configured to expand in a direction substantially perpendicular to the positioning base of the plurality of actuators when heated.

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

25. The body implant according to any one of claims 22 to 24, characterized in that, Each of the plurality of actuators includes a spring formed of the shape memory material, the spring being configured to expand when heated by the energy.

26. The body implant according to claim 25, characterized in that, The shape of the spring is helical or helicoid.

27. The body implant according to any one of claims 25 or 26, characterized in that, Each actuator includes a base connected to the spring, and wherein the bases of two or more actuators are connected together to form an array of the plurality of actuators connected to the positioning base of the actuator.

28. The body implant according to any one of claims 16 to 27, characterized in that, The positioning base of the actuator includes a tissue engagement portion having at least one of a soft portion and / or a bendable portion configured to contact body tissue.

29. The body implant according to claim 28, characterized in that, The tissue engagement portion includes at least one first surface configured to contact soft body tissue and at least one second surface configured to connect to the plurality of actuators, wherein the at least one first surface is soft and / or bendable.

30. The body implant according to claim 29, wherein, The at least one tissue engagement portion and / or the at least first surface includes at least one inflatable chamber.

31. The body implant according to claim 29, characterized in that, The at least one tissue engagement portion includes at least one chamber filled with fluid or gel.

32. The body implant according to any one of claims 16 to 31, characterized in that, Each of the plurality of actuators includes a separate actuator cover that isolates each actuator from the other actuators of the plurality of actuators.

33. The body implant according to any one of claims 16 to 32, characterized in that, The body implant includes a flexible cover connected to the positioning base of the plurality of actuators, wherein the plurality of actuators are located within an inner cavity between the flexible cover and the base.

34. The body implant according to any one of claims 16 to 33, characterized in that, The positioning base of the at least one actuator and the plurality of actuators form an array of the plurality of actuators, and the body implant includes a flexible closure cover that defines a lumen and has an outer surface and an inner surface, the outer surface being configured to contact body tissue, and wherein the actuator array is positioned within the lumen and connected to the inner surface of the flexible cover.

35. The body implant according to any one of claims 33 or 34, characterized in that, The flexible cover includes one or more perforations, the shape and size of the one or more perforations allowing tissue ingrowth into the implant and / or fluid injection into the lumen.

36. The body implant according to any one of claims 16 to 35, characterized in that, Each of the plurality of actuators includes a first end connected to the positioning base of the at least one actuator and an opposite second end, and the implant includes a plurality of tissue contact pads, each tissue contact pad being connected to the opposite second end of the actuator, and the plurality of tissue contact pads being configured to contact bone tissue or soft tissue.

37. The body implant according to any one of claims 16 to 36, characterized in that, The body implant is configured to move between a collapsed state and an expanded state when the at least one actuator expands, and the thickness of the body implant in the collapsed state is in the range of 1 millimeter to 4 millimeters.

38. A body implant, characterized in that, The body implant includes: An array of a plurality of perforated actuators, wherein each actuator is configured to expand when heated; A cover having a tissue-contacting outer surface, wherein the cover surrounds the array of the plurality of perforated actuators.

39. The body implant according to claim 38, wherein, The array of the plurality of perforated actuators is formed of a shape memory alloy that is configured to expand when the shape memory alloy expands and apply a force on an inner surface of the cover.

40. The body implant according to any one of claims 38 or 39, characterized in that, The plurality of perforated actuators are interconnected in the array.

41. The body implant according to any one of claims 38 to 40, characterized in that, The array and the plurality of perforated actuators are formed as a single unit.

42. The body implant according to claim 41, characterized in that, The array and the plurality of perforated actuators are formed as a single unit by a shape memory alloy.

43. The body implant according to any one of claims 38 to 42, characterized in that, The cover forms a pouch that surrounds the array of the plurality of perforated actuators.

44. The body implant according to any one of claims 38 to 43, characterized in that, One of the plurality of perforated actuators includes a plurality of openings that pass through a body of the perforated actuator.

45. The body implant according to claim 44, characterized in that, The shape of the perforated actuator is an extensible spring.

46. An inflatable actuator unit, characterized in that, The inflatable actuator unit includes: At least one flexible tissue engagement portion configured to contact tissue; At least one base; At least one inflatable unit connected between the at least one base and the at least one flexible tissue engagement portion; At least one inflation port in the at least one inflatable unit, wherein the at least one inflatable unit is 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 allow movement of the inflatable actuator unit relative to an adjacent inflatable actuator unit.

47. The inflatable actuator unit according to claim 46, wherein, The at least one connector includes at least one of the following: a joint, a hub portion, and / or a rotary connector.

48. The inflatable actuator unit according to claim 46 or 47, characterized in that, The upper limit of the maximum size of the inflatable actuator unit is 20 millimeters.

49. A body implant, characterized in that, The body implant includes: An array of a plurality of inflatable actuator units connected to each other as claimed in claim 44, 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.

50. A body implant, characterized in that, The body implant comprises: An array of a plurality of actuators formed of a shape memory alloy, the plurality of actuators being interconnected by a plurality of shape memory alloy bridge structures; Wherein at least one of the plurality of actuators is configured to expand and contract and to move laterally relative to other actuators in the array when heated.

51. A multi-unit body implant, characterized in that, The multi-unit body implant comprises: A plurality of single-unit implants connected to each other, wherein each single-unit implant comprises: At least one tissue engagement portion configured to contact a body tissue; At least one expandable actuator connected to the at least one tissue engagement portion; At least one connector configured to connect each single-unit implant to at least one different single-unit implant among the plurality of single-unit implants, wherein the maximum size limit of each single unit is 20 millimeters.

52. The implant according to claim 51, wherein, The at least one expandable actuator includes at least one inflatable chamber, and the at least one expandable actuator is configured to expand when the inflatable chamber is inflated.

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

54. The implant according to any one of claims 51 to 53, characterized in that, Each single-unit implant includes a base, the base being connected to the at least one expandable actuator relative to the at least one tissue engagement portion, the base including one or more openings, the shape and size of the one or more openings allowing a screw or a nail to pass through the base and into the tissue to connect the single-unit implant to the tissue.

55. A body implant, characterized in that, The body implant comprises: At least one implant cover having a tissue contact surface and at least one opposite surface, wherein the at least one implant cover includes at least one intermediate portion, at least one edge portion, and at least one hinge portion between the at least one intermediate portion and the at least one edge portion, the at least one edge portion being configured to connect the body implant to tissue; At least one expandable actuator in contact with the at least another opposite surface of the at least one intermediate portion, wherein the expandable actuator is configured to move from a collapsed state to an expanded state; Wherein when the at least one expandable actuator expands, the at least one expandable actuator uses the hinge portion to push the at least one intermediate portion relative to the at least one edge portion to obtain a continuous tissue contact surface of the at least one implant cover.

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