Objects, and method and apparatus for making and using the same

Abstract

Exemplary methods can be used to modify a base part, form battery devices, or form devices with surface modification. Exemplary methods can form at least one junction in a base part, and devices can have at least one material junction therein. Exemplary devices, systems, and methods can deliver a drug to body tissue. Exemplary devices and methods can transmit a signal to, or receive the signal from, cardiovascular anatomy and / or a nervous system. Exemplary devices can interface with body tissue and methods can fixate a device to body tissue. Exemplary methods can use a microneedle device. Exemplary biopsy systems and methods can use a biopsy device, the biopsy device including a first tube and a second tube nested in the first tube. Exemplary devices, systems, and methods can cauterize target tissue within body tissue, ablate the target tissue, map electrical activity in the target tissue, or a combination thereof.

Description

OBJECTS, AND METHOD AND APPARATUS FOR MAKING AND USING THESAMECROSS-REFERENCE TO RELATED APPLICATIONS

[0001] This application claims priority to United States provisional patent application, Serial No. 63 / 563,139, filed on March 8, 2024, and United States provisional patent application, Serial No. 63 / 667,354, filed on July 3, 2024. Priority to the provisional patent applications is expressly claimed, and the disclosures of the provisional patent applications are hereby incorporated herein by reference in its entirety and for all purposes.TECHNICAL FIELD

[0002] The disclosed embodiments relate generally to objects fabrication, and more particularly, but not exclusively, to objects and method and apparatus for making and using the same.BACKGROUND

[0003] High precision functional devices or structures, and methods of making the same in an efficient and inexpensive manner, are highly desired in modern society. For example, small- scale medical devices and implants have become commonplace in modern medicine. Innovative microscale devices are needed for improvement in capability, user experience, and new applications. Such devices can often be challenging to make in large scale to be commercially viable.

[0004] Digital fabrication, also known as additive manufacturing (AM), solid freeform fabrication (SFF), three-dimensional printing (or 3-D printing, or 3DP), direct digital manufacturing (DDM), or solid imaging, has increasingly become a widely adopted method of prototyping both visually demonstrative and functional parts. In some instances, this has become a cost-effective means for production manufacturing as well. A wide variety of means for producing components based on digital models exist, and all have reduced the time and cost required for a complete design cycle, which has improved the pace of innovation in many industries.

[0005] Existing techniques for SFF all have limitations in one or more aspects among resolution, precision, manufacturing efficiency, and flexibility in material properties. Such limitations pose restrictions on the structures that can be made via SFF. For example, some innovative microscale medical devices cannot be made with SFF in a cost-effective manner, or cannot be made with SFF at all. The challenges in SFF as described above often exist in many other manufacturing techniques.

[0006] In view of the foregoing, there is a need for methods and apparatus for fabrication with high resolution, high precision and high manufacturing efficiency that overcome disadvantages of existing methods and apparatus. There is also a need for novel small-scale devices for a plurality of applications.SUMMARY

[0007] In accordance with a first aspect disclosed herein, there is set forth a method for modifying a base part, the base part being a three-dimensional object including at least one first function body, at least one second function body, and at least one connecting body that connects the first and second function bodies, the method including: exposing, the second function body, the connecting body, or a combination thereof, to a chemical solution; and etching the connecting body to disconnect the first function body from the second function body, to modify electrical conductivity of at least a portion of the connecting body, or a combination thereof.

[0008] In some embodiments of the disclosed method, the etching the connecting body includes electrochemically etching the connecting body, and the chemical solution includes an electrolyte.

[0009] In some embodiments of the disclosed method, the exposing includes submerging at least a portion of the second function body in the chemical solution, the chemical solution flows into the connecting body via the second function body such that the chemical solution etches the connecting body without etching the first function body.

[0010] In some embodiments of the disclosed method, the exposing includes submerging at least the portion of the second function body, and none of the connecting body, in the chemical solution.

[0011] In some embodiments of the disclosed method, the base part defines one or more channels in the connecting body such that the chemical solution wicks in the channels via a capillary action.

[0012] In some embodiments of the disclosed method, the channels extend into the second function body such that the chemical solution wicks into the channels from the second function body.

[0013] In some embodiments of the disclosed method, the channels terminate at a boundary region that is in the connecting body and adjacent to the first function body such that the chemical solution does not flow into the first function body.

[0014] In some embodiments of the disclosed method, the exposing includes further submerging at least a portion of the connecting body in the chemical solution.

[0015] In some embodiments of the disclosed method, the connecting body includes one or more struts each having a characteristic width of less than 100 microns, less than 50 microns, less than 20 microns, less than 10 microns, or a combination thereof.

[0016] In some embodiments of the disclosed method, the connecting body has a micro-lattice structure including one or more sub-struts each having a characteristic width of less than 100 microns, less than 50 microns, less than 20 microns, less than 10 microns, or a combination thereof.

[0017] In some embodiments of the disclosed method, the etching the connecting body includes removing at least a portion of the connecting body such that the first function body disconnects from the second function body.

[0018] In some embodiments of the disclosed method, the etching the connecting body includes modifying the electrical conductivity of at least a portion of the connecting body.

[0019] In some embodiments of the disclosed method, the modifying includes converting at least the portion the connecting body from conductive to insulative.

[0020] In some embodiments of the disclosed method, the base part is made of a metal alloy including at least first and second metal elements.

[0021] In some embodiments of the disclosed method, the etching includes at least partially removing the first metal element from the connecting body.

[0022] In some embodiments of the disclosed method, the method further includes oxidizing the second metal element in the connecting body to form a ceramic material.

[0023] In some embodiments of the disclosed method, the oxidizing includes oxidizing the second metal element in the connecting body via passive oxidation.

[0024] In some embodiments of the disclosed method, the oxidizing includes converting the connecting body entirely to the ceramic material.

[0025] In some embodiments of the disclosed method, the method further includes breaking the connecting body such that the first function body is disconnected from the second function body.

[0026] In some embodiments of the disclosed method, the metal alloy includes stainless steel, and the first and second metal elements include iron and chromium, respectively.

[0027] In some embodiments of the disclosed method, the exposing includes submerging at least a portion of the connecting body in the chemical solution.

[0028] In some embodiments of the disclosed method, the connecting body has a micro-lattice structure including one or more sub-struts each having a characteristic width of less than 100 microns, less than 50 microns, less than 20 microns, less than 10 microns, or a combination thereof.

[0029] In some embodiments of the disclosed method, the base part defines one or more channels in the connecting body, the first function body, the second function body, or a combination thereof, such that the chemical solution wicks in the channels, and such that a selected region of the connecting body, of the first function body, of the second function body, or a combination thereof, is modified.

[0030] In some embodiments of the disclosed method, the etching includes modifying the electrical conductivity of a surface region of the first function body, a surface region of the second function body, or a combination thereof.

[0031] In some embodiments of the disclosed method, the first function body and the second function body each includes a microneedle.

[0032] In some embodiments of the disclosed method, the microneedle has a length less than 3 millimeters (mm), less than 1 mm, or less than 0.5 mm, and has a cross-sectional base diameter that is less than 0.5 mm, less than 0.3 mm, or less than 0.2 mm.

[0033] In some embodiments of the disclosed method: the at least one first function body, the at least one second function body, and the at least one connecting body includes a plurality of first function bodies, a plurality of second function bodies, and a plurality of connecting bodies, respectively; the first function bodies and the second function bodies form an array of microneedles; and at least one of the connecting bodies connects one of the first function bodies with one of the second function bodies.

[0034] In some embodiments of the disclosed method, the method further includes electrochemically modifying the first function body by using the second function body as an electrochemical machining tool.

[0035] In some embodiments of the disclosed method, the electrochemically modifying includes smoothing the first function body based upon a shape of the second function body.

[0036] In some embodiments of the disclosed method, the electrochemically modifying includes sharpening the first function body based upon a shape of the second function body.

[0037] In some embodiments of the disclosed method, the method further includes, after the electrochemically modifying, breaking the connecting body such that the first function body is disconnected from the second function body.

[0038] In some embodiments of the disclosed method, the method further includes, after the electrochemically modifying, electrochemically etching the connecting body such that the first function body is disconnected from the second function body.

[0039] In some embodiments of the disclosed method, the base part defines one or more channels in the connecting body such that, during the electrochemically etching after the electrochemically modifying, the chemical solution wicks in the channels via a capillary action and etches the connecting body without etching the first function body.

[0040] In some embodiments of the disclosed method, the method further includes electrochemically modifying the first function body to form a first electrode for a battery device.

[0041] In some embodiments of the disclosed method, the electrochemically modifying the first function body includes electrochemically plating the first function body with a first electrode coating.

[0042] In some embodiments of the disclosed method, the base part is made of an alloy including at least first and second elements, and the electrochemically modifying the first function body includes electrochemically etching the first function body to remove the second element from the first function body.

[0043] In some embodiments of the disclosed method, the electrochemically modifying the first function body includes submerging at least a portion of the first function body in a first el ectrode-proces sing el ectroly te .

[0044] In some embodiments of the disclosed method, the electrochemically modifying the first function body includes entirely submerging the base part in the first electrode-processing electrolyte.

[0045] In some embodiments of the disclosed method, the method further includes electrochemically modifying the second function body to form a second electrode for the battery device, a composition of the second electrode being different from a composition of the first electrode.

[0046] In some embodiments of the disclosed method, a polarity of the second electrode is opposite to the polarity of the first electrode.

[0047] In some embodiments of the disclosed method, the electrochemically modifying the second function body includes electrochemically plating the second function body with a second electrode coating.

[0048] In some embodiments of the disclosed method, the base part is made of an alloy including at least first and second elements, and the electrochemically modifying the second function body includes electrochemically etching the second function body to remove the first element from the second function body.

[0049] In some embodiments of the disclosed method, the first and second function bodies respectively include first and second lattices that are interwoven and non-intersecting.

[0050] In some embodiments of the disclosed method, the connecting body includes a grid structure including a plurality of intersected bars.

[0051] In some embodiments of the disclosed method, the method further includes, before the exposing, forming the base part via three-dimensional printing (3-D printing).

[0052] In some embodiments of the disclosed method, the base part is monolithic before the exposing.

[0053] In accordance with another aspect disclosed herein, there is set forth a battery device, including: a first electrode; a second electrode, a composition of the second electrode being different from a composition of the first electrode; and a support that is insulative and connects the first and second function bodies, the support sharing at least one chemical element with the first electrode, the second electrode, or a combination thereof.

[0054] In some embodiments of the disclosed battery device, a polarity of the second electrode is opposite to the polarity of the first electrode.

[0055] In some embodiments of the disclosed battery device, the first electrode includes a first electrode body and a first coating thereon, the first electrode body includes at least one metal element that is in the support in an oxidized form and includes at least one metal element that is not in the support.

[0056] In some embodiments of the disclosed battery device, the second electrode includes a second electrode body and a second coating thereon, the first and second electrode bodies have the same composition, and a composition of the first coating is different from a composition of the second coating.

[0057] In some embodiments of the disclosed battery device, the first and second function bodies respectively include first and second lattices that are interwoven and non-intersecting.

[0058] In some embodiments of the disclosed battery device, the connecting body includes a grid structure including a plurality of intersected bars.

[0059] In accordance with yet another aspect disclosed herein, there is set forth a method for modifying a base part, including: submerging the base part in an electrolyte, the base part made of a first material; and modifying a surface region of the base part such that the surface region is converted into a second material different from the first material, wherein: the surface region has a thickness ranging from 1 micron to 100 microns;the second material does not include a first element that is in the first material, and includes an oxide of a second element that is in the first material; or a combination thereof.

[0060] In some embodiments of the disclosed method, the modifying includes modifying an electrical conductivity of the surface region.

[0061] In some embodiments of the disclosed method, the base part is conductive before the submerging, and the modifying includes converting the surface region from conductive to insulative.

[0062] In some embodiments of the disclosed method, the first material includes a metal alloy including at least the first and second elements each being metallic.

[0063] In some embodiments of the disclosed method, the modifying includes electrochemically etching the surface region by at least partially removing the first element from the surface region.

[0064] In some embodiments of the disclosed method, the modifying further includes oxidizing the second element in the surface region to form a ceramic material.

[0065] In some embodiments of the disclosed method, the oxidizing includes oxidizing the second element in the surface region via passive oxidation.

[0066] In some embodiments of the disclosed method, the metal alloy includes stainless steel, and the first and second elements include iron and chromium, respectively.

[0067] In some embodiments of the disclosed method, the base part includes at least one helical coil.

[0068] In some embodiments of the disclosed method, the base part includes one or more struts connecting each two adjacent winding of the base part.

[0069] In some embodiments of the disclosed method, the modifying further includes converting the struts from conductive to insulative concurrently with the modifying the electrical conductivity of the surface region.

[0070] In some embodiments of the disclosed method, the struts each have a thickness that is less than or equal to two times of a thickness of the surface region.

[0071] In accordance with yet another aspect disclosed herein, there is set forth a device with surface modification, including:an internal region that is conductive; and a surface region that is insulative and coats the internal region, wherein: the surface region has a thickness ranging from 1 micron to 100 microns; the internal region is made of a metal alloy including at least first and second metal elements, the first metal element being not in the surface region, the surface region including an oxide of the second metal element; or a combination thereof.

[0072] In some embodiments of the disclosed device, the device has a shape of at least one helical coil.

[0073] In some embodiments of the disclosed device, the device includes one or more struts connecting each two adjacent winding of the helical coil, the struts having a composition that is the same as the composition of the surface region.

[0074] In some embodiments of the disclosed device, the internal region includes a stainless steel, and the surface region includes chromium oxide.

[0075] In accordance with yet another aspect disclosed herein, there is set forth a method for forming at least one junction in a base part, the base part including at least one first section, at least one second section, and at least one connecting section each connecting a pair of adjacent first and second sections, the first and second sections each defining first and second edge regions, respectively, the method including: modifying the first section by exposing the first edge region to a first chemical reaction medium.

[0076] In some embodiments of the disclosed method, the base part includes a blend of at least first and second elements.

[0077] In some embodiments of the disclosed method, the modifying the first section includes removing the second element from the first section by etching.

[0078] In some embodiments of the disclosed method, the method further includes: exposing the first edge region to a first plating electrolyte; at least partially re-filling voids in the first section generated by the etching by plating via the first plating electrolyte.

[0079] In some embodiments of the disclosed method, the re-filling includes plating the first section with the first element.

[0080] In some embodiments of the disclosed method, the base part includes the blend of: nickel and copper; copper and cobalt; silver and bismuth; or a combination thereof.

[0081] In some embodiments of the disclosed method, the method further includes changing, before the modifying, an orientation of the base part relative to ground.

[0082] In some embodiments of the disclosed method, the exposing the first edge region includes orienting the first and second edge regions proximal to and distal from ground, respectively.

[0083] In some embodiments of the disclosed method, the changing includes inverting the base part relative to ground.

[0084] In some embodiments of the disclosed method, the at least one first section includes a plurality of the first sections, and the at least one second section includes a plurality of the second sections.

[0085] In some embodiments of the disclosed method, the exposing the first edge region includes exposing the first edge regions of all the first sections without exposing any portion of the second sections to the first chemical reaction medium.

[0086] In some embodiments of the disclosed method, the first and second sections respectively form two rows, the two rows being offset such that the first and second sections alternate in a zig-zag arrangement, the first edge regions and the second edge regions forming two opposite edge regions of the base part.

[0087] In some embodiments of the disclosed method: the first edge region is smaller than the first section and the base part defines one or more channels extending from the first edge regions into the first section without extending into the second section, such that the first chemical reaction medium wicks into the first section.

[0088] In some embodiments of the disclosed method, the method further includes modifying the second section by exposing the second edge region to a second chemical reaction medium.

[0089] In some embodiments of the disclosed method, the modifying the second section includes removing the first element from the second section by etching.

[0090] In some embodiments of the disclosed method, the method further includes: exposing the second edge region to a second plating electrolyte; at least partially re-filling voids in the second section generated by the etching by plating via the second plating electrolyte.

[0091] In some embodiments of the disclosed method, the re-filling includes plating the second section with the second element.

[0092] In some embodiments of the disclosed method, the exposing the second edge region includes exposing the second edge region without exposing the first section to the second chemical reaction medium.

[0093] In some embodiments of the disclosed method, the second edge region is smaller than the second section and the base part defines one or more channels extending from the second edge region into the second section without extending into the first section such that the second chemical reaction medium wicks into the second section.

[0094] In accordance with yet another aspect disclosed herein, there is set forth a device having at least one material junction therein, including: at least one first section; at least one second section; and at least one connecting section each connecting a pair of adjacent first and second sections, the connecting section including a blend of at least first and second elements, the first section including the first element and not the second element, the second section including the second element and not the first element.

[0095] In some embodiments of the disclosed device, the first and second sections each defining first and second edge regions, respectively, the first and second edge regions defining opposite edge regions of the device.

[0096] In some embodiments of the disclosed device, the at least one first section includes a plurality of the first sections, and the at least one second section includes a plurality of the second sections.

[0097] In some embodiments of the disclosed device, the first and second sections respectively form two rows, the two rows being offset such that the first and second sections alternate in a zig-zag arrangement.

[0098] In some embodiments of the disclosed device: the first edge region is smaller than the first section and the device defines one or more channels extending from the first edge regions into the first section without extending into the second section; the second edge region is smaller than the second section and the device defines one or more channels extending from the second edge regions into the second section without extending into the first section; or a combination thereof.

[0099] In some embodiments of the disclosed device, the first and second sections form the material junction therebetween that is adapted for thermoelectric effect.

[0100] In some embodiments of the disclosed device, the at least one first section includes a plurality of the first sections, and the at least one second section includes a plurality of the second sections and the first and second sections form a plurality of material junctions in series to form a thermopile.

[0101] In some embodiments of the disclosed device, the connecting section includes the blend of: nickel and copper; copper and cobalt; silver and bismuth; or a combination thereof.

[0102] In accordance with yet another aspect disclosed herein, there is set forth a device for delivering a drug to body tissue, including: at least one spike including: a first end region configured to enter the body tissue; and a second end region opposite to the first end region and configured to receive the drug, the spike defining a main lumen therein that extends between the first and second endregions, the spike having a length less than 10 mm, less than 5 mm, less than 3 mm, less than 1 mm, or less than 0.5 mm.

[0103] In some embodiments of the disclosed device, the spike has a cross-sectional base diameter less than 0.5 mm, less than 0.3 mm, or less than 0.2 mm.

[0104] In some embodiments of the disclosed device, the main lumen extends along a primary axis of the spike.

[0105] In some embodiments of the disclosed device, the device further includes at least one thread wrapping helically around the spike.

[0106] In some embodiments of the disclosed device, the spike further defines at least one side lumens therein each in communication with the main lumen.

[0107] In some embodiments of the disclosed device, the side lumen terminates at an edge region of a tooth of the thread, at a surface of the spike between two adjacent teeth of the thread, or a combination thereof.

[0108] In some embodiments of the disclosed device, the device further includes at least one barb projecting from the spike.

[0109] In some embodiments of the disclosed device, the spike further defines at least one side lumen therein each in communication with the main lumen.

[0110] In some embodiments of the disclosed device, the side lumen extends along an axis of the barb and terminates at an edge region of the barb, terminates at a surface of the spike between two adjacent barbs, or a combination thereof.[0U1] In some embodiments of the disclosed device, the barb projects radially from the spike and at least partially projects against a direction of the spike.

[0112] In some embodiments of the disclosed device, the method further includes a base piece, wherein the spike includes an array of spikes each coupled with the base piece at the second end region.

[0113] In accordance with yet another aspect disclosed herein, there is set forth a system for delivering a drug to body tissue, including: the device for delivering a drug to body tissue;a tube having a first terminal region and a second terminal region opposite to the first terminal region, the first terminal region being connected to the second end region of the spike and in communication with the main lumen; and a port connected to the second terminal region of the tube and configured to be embedded below skin.

[0114] In accordance with yet another aspect disclosed herein, there is set forth a method for delivering a chemotherapy drug to body tissue using a device, the device including at least one spike each including: a first end region configured to enter the body tissue; and a second end region opposite to the first end region and configured to receive the drug, the spike defining a main lumen therein that extends between the first and second end regions, the method including: advancing at least the first end region into the body tissue; and supplying the chemotherapy drug into the body tissue via the device, the spike having a length less than 10 mm, less than 5 mm, less than 3 mm, less than 1 mm, or less than 0.5 mm.

[0115] In accordance with yet another aspect disclosed herein, there is set forth a method for delivering a chemotherapy drug to tumor tissue using a device, the device including at least one spike each including: a first end region configured to enter the tumor tissue; and a second end region opposite to the first end region and configured to receive the drug, the spike defining a main lumen therein that extends between the first and second end regions, the method including: advancing at least the first end region into the tumor tissue; and supplying the chemotherapy drug into the tumor tissue via the device.

[0116] In accordance with yet another aspect disclosed herein, there is set forth a device for transmitting a signal to, or receiving the signal from, cardiovascular anatomy and / or a nervous system, including: at least one electrode each including: a first end region configured to enter body tissue; anda second end region opposite to the first end region and configured to electrically connect with a system for electrical signal transmission associated with the body tissue, the electrode having a length ranging from 50 micrometers to 100 micrometers, less than 10 mm, less than 5 mm, less than 3 mm, less than 1 mm, less than 0.5 mm, or a combination thereof.

[0117] In some embodiments of the disclosed device, the electrode has a cross-sectional base diameter that is less than 0.5 mm, less than 0.3 mm, or less than 0.2 mm, or a combination thereof.

[0118] In some embodiments of the disclosed device, the device further includes at least one thread wrapping helically around the electrode.

[0119] In some embodiments of the disclosed device, the thread is saw-toothed.

[0120] In some embodiments of the disclosed device, the device further includes at least one barb projecting from the electrode.

[0121] In some embodiments of the disclosed device, the device further includes at least one protrusion on a side surface of the electrode.

[0122] In some embodiments of the disclosed device, the protrusion defines first and second edges raised beyond the side surface of the electrode, the first and second edges being proximal to, and distal from, the first end region of the electrode respectively.

[0123] In some embodiments of the disclosed device, a slope of the second edge relative to the side surface of the electrode is equal to, or greater than, the slope of the first edge.

[0124] In some embodiments of the disclosed device, the device further includes a base piece, wherein the electrode includes an array of electrodes each coupled with the base piece at the second end region.

[0125] In some embodiments of the disclosed device, the base piece includes a plate having a solid pattern, a lattice pattern, or a combination thereof.

[0126] In some embodiments of the disclosed device, the plate with the lattice pattern includes at least one section connecting two adjacent electrodes, the section being straight, curved, zigzagged, or a combination thereof.

[0127] In some embodiments of the disclosed device, the base piece is configured to flex to conform with the body tissue.

[0128] In some embodiments of the disclosed device, the base piece is at least partially made of a shape-memory material.

[0129] In some embodiments of the disclosed device, the base piece is at least partially made of nitinol.

[0130] In some embodiments of the disclosed device, the electrode is at least partially made of a shape-memory material.

[0131] In accordance with yet another aspect disclosed herein, there is set forth a method for transmitting a signal to, or receiving the signal from, cardiovascular anatomy and / or a nervous system using a device, the device including at least one electrode each including: a first end region configured to enter body tissue; and a second end region opposite to the first end region and configured to electrically connect with a system for electrical signal transmission associated with the body tissue, the method including: advancing at least the first end region into the body tissue; and receiving the signal from, or sending the signal to, the body tissue via the electrode, the electrode having a length ranging from 50 micrometers to 100 micrometers, less than 10 mm, less than 5 mm, less than 3 mm, less than 1 mm, less than 0.5 mm, or a combination thereof.

[0132] In accordance with yet another aspect disclosed herein, there is set forth a device for interfacing with body tissue via flexural fixation, including: a substrate; and at least two function units each including: a first end region configured to enter body tissue; and a second end region opposite to the first end region and connected to the substrate, the function units being aligned in parallel when the substrate is in a stressed state, and non-parallel when the substrate is in a relaxed state.

[0133] In some embodiments of the disclosed device, when the substrate is in the relaxed state, the function units angle away from each other, toward each other, or a combination thereof.

[0134] In some embodiments of the disclosed device, the substrate is at least partially made of a material having super-elasticity, a shape-memory material, or a combination thereof.

[0135] In some embodiments of the disclosed device, the substrate is at least partially made of ni tinol.

[0136] In some embodiments of the disclosed device, at least one of the function units includes one or more micro-retention features.

[0137] In some embodiments of the disclosed device, the function units include a spike for drug delivery, an electrode for physiological signal transmission, or a combination thereof.

[0138] In some embodiments of the disclosed device, the function units are arranged on the substrate in a line, a circle, or a combination thereof.

[0139] In some embodiments of the disclosed device, the function units each have a length less than 3 mm, less than 1 mm, or less than 0.5 mm.

[0140] In some embodiments of the disclosed device, the function units each have a cross- sectional base diameter that is less than 0.5 mm, less than 0.3 mm, or less than 0.2 mm.

[0141] In accordance with yet another aspect disclosed herein, there is set forth a method for fixating a device to body tissue, including: deforming the device into a stressed state, the device including: a substrate and at least two function units each including: a first end region configured to enter body tissue; and a second end region opposite to the first end region and connected to the substrate, the function units being aligned in parallel when the device is in the stressed state; inserting the function units into body tissue; and releasing the device into a relaxed state, the function units being non-parallel.

[0142] In some embodiments of the disclosed method, the deforming includes deforming the substrate into the stressed state.

[0143] In some embodiments of the disclosed method, the releasing includes releasing the substrate into the relaxed state.

[0144] In some embodiments of the disclosed method, the releasing includes conforming the substrate with the body tissue.

[0145] In some embodiments of the disclosed method, when the substrate is in the relaxed state, the function units angle away from each other, toward each other, or a combination thereof.

[0146] In accordance with yet another aspect disclosed herein, there is set forth a device for interfacing with body tissue, including: a base piece defining a center of rotation thereon; and one or more rotary needles distributed on the base plate and about the center, each of the needles including: a tip region; and a base region opposite to the tip region and connected to the base piece, the needle tilting from the base piece at a tilting angle.

[0147] In some embodiments of the disclosed device: a distance between the center and a projection of the tip region on the plate defines a tip distance; and a distance between the center and the projection of the base region on the plate defines a base distance.

[0148] In some embodiments of the disclosed device, the tip distance is greater than, less than, or equal to, the base distance.

[0149] In some embodiments of the disclosed device, the rotary needles include an array of rotary needles distributed about the center.

[0150] In some embodiments of the disclosed device, the rotary needles have uniform tip distances, and uniform base distances.

[0151] In some embodiments of the disclosed device, the rotary needles are straight, curved, or a combination thereof.

[0152] In some embodiments of the disclosed device, the rotary needles are curved and a projection of each needle on the base piece defines an arc.

[0153] In some embodiments of the disclosed device, any point on the arc is equal distance from the center.

[0154] In some embodiments of the disclosed device, at least one of the rotary needles includes one or more micro-retention features.

[0155] In some embodiments of the disclosed device, the device includes one or more locking structures connected to the base piece, the locking structures and the needles being on a same surface of the base piece.

[0156] In some embodiments of the disclosed device, the locking structures each includes a protrusion projecting from the surface of the base piece.

[0157] In some embodiments of the disclosed device, the protrusions are shorter or smaller than the rotary needles.

[0158] In some embodiments of the disclosed device, the protrusions are configured to engage with the body tissue in a direction opposite to a direction of the rotary needles engaging with the body tissue.

[0159] In some embodiments of the disclosed device, the protrusions point in a direction opposite to a direction of the rotary needles.

[0160] In some embodiments of the disclosed device, the locking structures include an array of locking structures distributed about the center.

[0161] In some embodiments of the disclosed device, the rotary needles are conductive and the base piece electrically isolates the rotary needles.

[0162] In some embodiments of the disclosed device, the base piece includes: an inner section; an outer section surrounding the inner section; and one or more connecting sections each connecting the outer section with the inner section.

[0163] In some embodiments of the disclosed device, the device further includes at least one locking structure on the inner section, wherein the rotary needles are connected to the outer section.

[0164] In some embodiments of the disclosed device, the locking structure includes a needle pointing perpendicularly from the base piece.

[0165] In some embodiments of the disclosed device, the locking structure, the rotary needles, and the outer and inner sections, are conductive, and the connecting sections electrically insulate the outer section from the inner section.

[0166] In accordance with yet another aspect disclosed herein, there is set forth a method for using a microneedle device, the device including: a base piece defining a center of rotation thereon; andone or more rotary needles distributed on the base plate and about the center, each of the needles including a tip region and a base region opposite to the tip region and connected to the base piece, the needle tilting from the base piece at a tilting angle, the method including: orienting a device relative to body tissue, such that the rotary needle and the base piece are proximal to and distal from the body tissue, respectively; and advancing the rotary needle into the body tissue by rotating the base piece about the center of rotation.

[0167] In accordance with yet another aspect disclosed herein, there is set forth a biopsy system, including: a biopsy device including: a first tube; and a second tube nested in the first tube and configured to translate along an axis defined in the first tube, each of the first and second tubes respectively defining a lead edge region; and a vacuum source in communication with the first and second tubes and configured to apply vacuum to the first tube, the second tube, or a combination thereof.

[0168] In some embodiments of the disclosed system, the second tube is configured to rotate axially within the first tube.

[0169] In some embodiments of the disclosed system, the lead edge region of the second tube defines a sharp cutting feature.

[0170] In some embodiments of the disclosed system, the biopsy device further includes an endoscope located in space between the first and second tubes.

[0171] In some embodiments of the disclosed system, an outer diameter of the first tube is no greater than 6 mm.

[0172] In accordance with yet another aspect disclosed herein, there is set forth a method for using a biopsy device, the biopsy device including a first tube and a second tube nested in the first tube, the method including: applying a vacuum in the first tube such that a lead edge region of the first tube is fixed on body tissue;advancing a lead edge region of the second tube into the body tissue; obtaining, by the second tube, a sample from the body issue; and retracting the second tube with the sample from the body issue.

[0173] In some embodiments of the disclosed method, the lead edge region of the second tube defines a sharp cutting feature and the advancing includes cutting the second tube into the body tissue.

[0174] In some embodiments of the disclosed method, the obtaining includes applying a vacuum in the second tube.

[0175] In some embodiments of the disclosed method, the obtaining includes rotating the second tube axially relative to the body tissue.

[0176] In some embodiments of the disclosed method, the method further includes releasing, after the retracting, the vacuum in the first tube.

[0177] In some embodiments of the disclosed method, the method further includes capturing, before the obtaining, at least an image of the body tissue via an endoscope located in space between the first and second tubes.

[0178] In accordance with yet another aspect disclosed herein, there is set forth a device for cauterizing target tissue within body tissue, ablating the target tissue, mapping electrical activity in the target tissue, or a combination thereof, including: a support structure; and one or more function units each including: a first end region configured to enter the body tissue; and a second end region opposite to the first end region, the function unit being connected to the support structure at the second end region.

[0179] In some embodiments of the disclosed device, each of the function units has a shape of a needle.

[0180] In some embodiments of the disclosed device, at least one of the function units defines at least one fluid pathway therein.

[0181] In some embodiments of the disclosed device, the support structure has an elongated shape defining a direction of extension.

[0182] In some embodiments of the disclosed device, the support structure includes a catheter device.

[0183] In some embodiments of the disclosed device, the support structure includes an articulation mechanism to set the functional units at a selected angle relative to the direction of extension of the support structure, the angle ranging from 0 to 90 degrees.

[0184] In some embodiments of the disclosed device, the function units are on an end surface of the support structure and aligned with the direction of extension of the support structure.

[0185] In some embodiments of the disclosed device, the function units are on an end region of the support structure and point at an angle with a direction of extension of the support structure, the angle being greater than 0 degree and smaller than 90 degrees.

[0186] In some embodiments of the disclosed device, the function units are on a lateral surface of the support structure and point perpendicularly to a direction of extension of the support structure.

[0187] In some embodiments of the disclosed device, the support structure includes jaws of a laparoscopic device, the function units being located on two opposing surfaces of the jaws.

[0188] In accordance with yet another aspect disclosed herein, there is set forth a system for cauterizing the target tissue, ablating the target tissue, mapping the electrical activity in the target tissue, or a combination thereof, including: the device for cauterizing target tissue within body tissue, ablating the target tissue, mapping electrical activity in the target tissue, or a combination thereof; and a control system coupled with the support structure and configured to, via the support structure: supply energy to the function units such that the function units cauterize or ablate the target tissue; supply a fluid to the function units such that the function units ablate the target tissue; receive, from the function units, an electrical signal associated with the target tissue; or a combination thereof.

[0189] In some embodiments of the disclosed system, the energy being thermal, electromagnetic, ultrasound, laser, microwave, or a combination thereof.

[0190] In some embodiments of the disclosed system, the fluid including a coolant, and the function units are configured to freeze the target tissue via the coolant.

[0191] In accordance with yet another aspect disclosed herein, there is set forth a method for cauterizing target tissue within body tissue, ablating the target tissue, mapping electrical activity in the target tissue, or a combination thereof, by using a device, the device including: a support structure; and one or more function units each including: a first end region configured to enter the body tissue; and a second end region opposite to the first end region, the function unit being connected to the support structure at the second end region, the method including: inserting the function units into the body tissue toward the target tissue; and performing an operation on the target tissue, the performing including: supplying, via the support structure, energy to the function units such that the function units cauterize the target tissue; supplying, via the support structure, a fluid to the function units such that the function units ablate the target tissue; receiving, from the function units and via the support structure, an electrical signal associated with the target tissue; or a combination thereof.

[0192] In some embodiments of the disclosed method, the method further includes setting the functional units at a selected angle relative to a direction of extension of the support structure, the angle ranging from 0 to 90 degrees.

[0193] In some embodiments of the disclosed method, the setting is at any time relative to the inserting or performing.

[0194] In some embodiments of the disclosed method, the energy being thermal, electromagnetic, ultrasound, laser, microwave, or a combination thereof.

[0195] In some embodiments of the disclosed method, the fluid including a coolant, and the function units are configured to ablate the target tissue via cryoablation.

[0196] In some embodiments of the disclosed method, the method further includes forming the base part and / or device via 3-D printing.

[0197] In some embodiments of the disclosed method, the base part and / or device has a size adapted for medical implantation.

[0198] In some embodiments of the disclosed method, the base part is monolithic before a secondary process.

[0199] Further features of the subject invention will become more readily apparent from the following detailed description of the invention taken in conjunction with the accompanying drawings.BRIEF DESCRIPTION OF THE DRAWINGS

[0200] Figs. 1- 19 are exemplary diagrams illustrating 3D structures and methods for modifying the same in accordance with various embodiments.

[0201] Figs. 20-26 are exemplary diagrams illustrating a 3D structure including workpiece and tool and methods for making and modifying the same in accordance with various embodiments.

[0202] Figs. 27-39 are exemplary diagrams illustrating targeted drug delivery devices and methods for making the same in accordance with various embodiments.

[0203] Figs. 40-48 and 108-110 are exemplary diagrams illustrating atraumatic electrodes for cardiac electrophysiology devices or neuromodulation, and methods for making the same in accordance with various embodiments.

[0204] Figs. 49A-52B are exemplary diagrams illustrating devices for flexural fixation and methods for using the same in accordance with various embodiments.

[0205] Figs. 53-59 are exemplary diagrams illustrating biopsy devices and methods for using the same in accordance with various embodiments.

[0206] Figs. 60-72 are exemplary diagrams illustrating devices for cautery and / or ablation in accordance with various embodiments.

[0207] Figs. 73-76 and 111 are exemplary diagrams illustrating devices with surface modification and methods for making the same in accordance with various embodiments.

[0208] Figs. 77-83 are exemplary diagrams illustrating battery devices and methods for making the same in accordance with various embodiments.

[0209] Figs. 84-91 are exemplary diagrams illustrating thermopile devices and methods for making the same in accordance with various embodiments.

[0210] Figs. 92A-107 are exemplary diagrams illustrating rotary needle arrays and methods for making the same in accordance with various embodiments.

[0211] Fig. 112 is an exemplary diagram illustrating a system for targeted drug delivery devices in accordance with various embodiments.

[0212] Fig. 113 is an exemplary diagram illustrating an embodiment of a control system for making or using the devices, or implementing the methods, of Figs. 1-112.

[0213] It should be noted that the figures are not drawn to scale and that elements of similar structures or functions are generally represented by like reference numerals for illustrative purposes throughout the figures. It also should be noted that the figures are only intended to facilitate the description of the preferred embodiments. The figures do not illustrate every aspect of the described embodiments and do not limit the scope of the present disclosure.DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0214] Since currently-available methods and apparatus are incapable of fabrication with high resolution, or high precision, at high manufacturing efficiency, a fabrication method that optimizes performance in various aspects of fabrication can prove desirable and provide a basis for a wide range of manufacturing applications, such as manufacturing of microscale medical devices, biological sensors and biological research equipment. In various embodiments, such fabrication method can include a secondary process that can be applied to an object made via a selected technique, which can be SFF or any other techniques, without limitation.

[0215] Modifying a 3D structure

[0216] Turning to Fig. 1, an exemplary base part 100 is shown as including first and second function bodies 110, 120 and at least one connecting body 140 that connects the first and second function bodies 110, 120. The first and second function bodies 110, 120 can each include a body that can implement one or more selected functions. In some embodiments, the second function body 120 can include a stand and / or platform for supporting the connecting body 140 and thefirst function body 110 when the base part 100 is positioned on a surface. In some embodiments, the first function body 110 can include an object of selected resolution in size and / or shape that can be the purpose of the manufacture. For example, the first function body 110 can include a device configured for interfacing with an object or living tissue for measurement, signal transmission, and / or substance delivery. An exemplary device can include a needle, jaw, blade, surgical device, and / or electrode.

[0217] In accordance with various embodiments, the base part 100 can be formed in any suitable manner. In various embodiments, the base part 100 can be made with 3D printing. Post-processing can be performed on one or more selected portions of the base part 100. Stated somewhat differently, the base part 100 can be selectively post-processed and is not necessarily post-processed entirely and / or uniformly. In various embodiments, the post-processing can include electrochemical etching and / or wet chemical etching. In various embodiments throughout the present disclosure, even if the base part 100 is modified via an electrochemical etching process using an electrolyte, such modification may be achieved by a suitable etching process using a suitable chemical solution (or a suitable salt solution), and is not necessarily limited to electrochemical etching.

[0218] In various embodiments, the post-processing can remove, and / or modify chemical composition of, selected portions of the base part 100, such that the first function body 110 can be usable for a certain application. In one embodiment, the post-processing can selectively remove at least a portion of the connecting body 140 such that the first function body 110 can be removed from the base part 100. For example, the first function body 110 can be the end product of a manufacturing process and the second function bodies 120 can be a support structure attached with the first function body 110 such that the first function body 110 can be more easily transported and / or handled during various stages of manufacturing. In another embodiment, the post-processing can selectively change the chemical composition of at least a portion of the connecting body 140 so the electrical and / or mechanical property of the connecting body 140 can change.

[0219] Turning to Fig. 2, the base part 100 is shown as including a plurality of connecting bodies 140 for connecting the first and second function bodies 110, 120. Although connecting bodies 140 are shown as having the same size and being arranged in parallel for illustratedpurposes only, the base part 100 can include any number of uniform and / or different connecting bodies 140 arranged in any suitable manner, without limitation.

[0220] Turning to Fig. 3, an exemplary flow chart of an embodiment of a method 200 of making a three-dimensional (3D) object is shown. In various embodiments, the 3D object can include the base part 100, or any other structure resulting from the method 200. The base part 100 can be formed at 202. In various embodiments, the base part 100 can be formed using 3D printing. However, the base part 100 can be formed using any other suitable methods, without limitation. A selected portion of the base part 100 can be electrochemically etched at 204. In various embodiments, at least a part of the connecting body 140 can be etched. If the base part 100 is electrochemically etched in a non-selective manner, the base part 100 is entirely submerged in an electrolyte 580 (shown in Fig. 5). The resulting base part 100 cannot maintain any sharp edges, thus compromising quality of the base part 100 if sharp edges are desired. By selectively electrochemically etching the base part 100 in accordance with the disclosed method, the base part 100 can be etched while maintaining sharp geometry. The high quality of the base part 100 can advantageously be achieved.

[0221] Although Figs. 1 and 2 show the base part 100 as including one first function body 110 and one second function body 120 for illustrative purposes only, the base part 100 can include any suitable number of uniform and / or different first function bodies 110, and any suitable number of uniform and / or different second function bodies 120, and connected to any suitable number of uniform and / or different connecting bodies 140, without limitation.

[0222] Turning to Fig. 4, a diagram of an exemplary system 400 for making the base part 100 is shown. In various embodiments, the system 400 can be configured for 3D printing. The system 400 is shown as including a build platform 480. The system 400 can include a build material unit 420 and a selective processing unit 440. The build material unit 420 is configured to dispose a build material 460 on the build platform 480. An exemplary build material 460 can include a mixture and / or blend of a powder and a carrier fluid. An exemplary carrier fluid (320) can include a resin, photocurable resin, photosensitive material, and / or photocurable material. The blend can be in the form of a slurry.

[0223] The selective processing unit 440 is configured to selectively process the build material 460 such that a portion of the build material 460 can form the base part 100. Selectiveprocessing can include applying at least one process that modifies only a selected portion of the build material 460 such that one or more characteristics of the selected portion can be different from the characteristics of the rest of the build material 460. In one embodiment, the selective processing unit 440 can modify a photosensitive material by irradiating the selected portion. In one embodiment, the selective processing unit 440 can modify a photosensitive material by irradiating all areas except the selected portion.

[0224] In one embodiment, the selective processing unit 440 can modify an ability of the selected portion to be cured, solidified, sintered, or a combination thereof. In one example, the selective processing unit 440 can modify the selected portion of the build material 460 such that the selected portion can be cured (or sintered) while the unmodified portion of the build material 460 cannot be cured (or sintered). Upon the modifying, the selected portion can form the base part 100 after any other optional and / or suitable post-processing. In another example, the selective processing unit 440 can modify the selected portion of the build material 460 such that the selected portion cannot be cured (or sintered) while the unmodified portion of the build material 460 can be cured (or sintered). Upon the modifying, the rest of the build material 460, excluding the selected portion, can form the base part 100 after any other optional and / or suitable post-processing. The selective processing unit 440, and / or any other suitable equipment, can apply additional post-processing steps as needed to achieve or complete the curing (and / or sintering).

[0225] In another embodiment, the selective processing unit 440 can modify a state of matter of the selected portion. For example, the selective processing unit 440 can cure and / or solidify at least the selected portion of the build material 460 in accordance with a shape of the base part 100. An exemplary selective processing unit 440 can include a projection module. In some embodiments, after the build material 460 is deposited, the projection module can be used to at least partially cure at least a portion of the deposited layer, to define one layer of the base part 100 (or of an array of the base parts 100). This layer image may be obtained by calculated the intersection of a horizontal plane and a three-dimensional digital representation of the base part 100.

[0226] Turning to Fig. 5, an exemplary diagram for electrochemically etching the base part 100 is shown. The base part 100 is shown as being partially immersed in an electrolyte (orelectrolytic fluid, or electrolyte solution) 580. The base part 100 can be connected to an electric current source and function as one electrode. Another electrode (not shown) is also immersed in the electrolyte 580. In various embodiments, the base part 100 can include a metal and can be connected to a pole of the electric current source and function as an anode. The other electrode is connected to a negative pole of the electric current source and function as a cathode.

[0227] The first function body 110 is shown as being not immersed in the electrolyte 580. Only a portion of the second function body 120 is shown as being partially immersed in the electrolyte 580. The base part 100 can have a structure such that the electrolyte 580 can permeate (or wick) into the connecting body 140 only up to a selected boundary region 130. Stated somewhat differently, the boundary region 130 can define a limit of permeation of the electrolyte 580. The direction of permeation of the electrolyte 580 is illustratively shown as an arrow 102. Thus, the electrolyte 580 can etch the second function body 120 and / or the connecting body 140 without etching the first function body 110. The etching can electrochemically remove the connecting body 140 from the first function body 110 and the shape of the first function body 110 is not changed during the etching. Advantageously, when the first function body 110 has sharp edges, the quality of the first function body 110 can be maintained.

[0228] Although Fig. 5 shows only a bottom portion of the second function body 120 as being immersed in the electrolyte 580 for illustrated purposes only, any portion of the second function body 120 and / or the connecting body 140 can be immersed in the electrolyte 580 in any suitable manner to achieve the effect as set forth above, without limitation.

[0229] Turning to Fig. 6, the base part 100 is shown as defining one or more channels 160 extending from the electrolyte 580 and up to the boundary region 130. Stated somewhat differently, the channels 160 can start at a region (not shown) in the connecting body 140 and / or the second function body 120 that contacts the electrolyte 580. The channels 160 can each have a selected size, dimension and / or shape such that the electrolyte 580 can travel into the channels 160 up to the boundary region 130 via a capillary action. Accordingly, the electrolyte 580 does not reach the first function body 110, so the first function body 110 is not electrochemically etched.

[0230] In some embodiments, the connecting body 140 can include a strut with a characteristic width. In various embodiments, the characteristic width can include an effective width (or thickness) that the electrolyte 580 needs to penetrate to fully complete the etching. Additionally and / or alternatively, the connecting body 140 can have a micro-lattice structure (illustrated in Figs. 16-19) that contains sub-struts having a cross-sectional thickness that can define the characteristic width. An exemplary characteristic width can be less than 100 micrometers (or microns), less than 50 microns, less than 20 microns, and / or less than 10 microns. The characteristic width can be at least partially based upon the purpose of etching. In some embodiments, the micro lattice structure can be needed for selective etching of one or more alloying components of the base part (for example, in Figs. 16-19). In some embodiments, the entirety of the struts can be etched away (for example, in Figs. 7-9).

[0231] Although Fig. 6 shows two channels 160 that are parallel and straight for illustrated purposes only, the base part 100 can define any number of uniform and / or different two channels 160 arranged in any suitable manner, without limitation.

[0232] Turning to Fig. 7, a detail drawing of an exemplary base part 100 is shown. The base part 100 is shown as including an array of connecting bodies 140. The first function body 110 is shown as having a cone shape with a base 112 that has an edge region 114 that has a circular and / or oval shape.

[0233] Turning to Fig. 8, a cross-sectional view of the base part 100 is shown. The second function body 120 is shown as defining a plurality of channels 122 in communication with the connecting bodies 140, respectively. The base part 100 is shown as defining two channels 160 in each connecting body 140 that extend into a portion of the depth of the channel 122 and terminates at the boundary region 130. Thus, when the base part 100 is positioned in the electrolyte 580 (shown in Fig. 5), the electrolyte 580 can enter the channel 122, and wick up to the boundary region 130 via the channels 160. The first function body 110 is thus not etched and can maintain the quality of the cone shape. For example, sharpness of the edge region 114 can be maintained. Fig. 9 shows a perspective view of the cross-sectioned base part 100 to show further details of the channels 160.

[0234] Turning to Fig. 10, a schematic diagram of the base part 100 made by the method 200 (shown in Fig. 3) is shown. The base part 100 can be electrochemically etched such thatchemical composition of the selected portion of the base part 100 can be modified. The connecting body 140 and the second function body 120 are shown as being modified chemically for illustrative purposes only. Any selected portion(s) of the base part 100 can be modified, without limitation.

[0235] In some embodiments, the base part 100 can be made of an alloy. An exemplary alloy can include a metal alloy. The alloy can include first and second elements. The electrochemical etching can remove the first element from the portion of the base part 100. Additionally and / or alternatively, the second element of the portion can optionally be oxidized (and / or modified via another chemical reaction) and form a new material, such as a ceramic material. For example, the alloy can include a stainless steel, the first and second elements can include iron and chrome (or chromium), respectively. The iron can be removed via etching. The chrome without the iron can be oxidized naturally in air and form the chrome oxide. By properly controlling process parameters and / or timing of the etching, the iron can be removed and / or oxidized, and the chrome can be oxidized, such that the alloy can be converted to ceramic and be insulative.

[0236] In various embodiments, etching (or corrosion) process as set forth above can be achieved with a range of electrolytes and voltage and / or current conditions. Conversion of an alloy to ceramic can require selective galvanic removal of one material, which requires the material being removed to have a lower half reaction potential than the other element(s) in the alloy. The involves applying a voltage that is higher than the half reaction potential of the material being removed, but lower than the half reaction potential of the other element(s).

[0237] In some embodiments, the base part 100 can be made of the metal alloy using 3D printing and optional sintering. Thus, upon the electrochemical etching, a portion of the base part 100 can be made of the metal alloy and another portion of the base part 100 can be made of the oxide. For example, upon the electrochemical etch, both stainless steel and chrome oxide can be integrated in the base part 100. Thus, by using the post-processing as set forth above, a homogenous, and / or monolithic, object made using 3D printing, or any other methods, can be modified into a single object with two different types of materials (for example, having a portion made of a metal and another portion made of a ceramic).

[0238] Thus, objects can advantageously be modified in a simple manner to achieve a wide variety of structures and chemical compositions. In one embodiment, by converting at least partof the connecting body 140 into a ceramic material, the connecting body 140 can advantageously become more brittle and break more easily with the first function body 110. Additionally and / or alternatively, the connecting body 140 can be electrically insulating while connected to the first function body 110 that can be electrically conducting, thus the base part 100 can have a desired structure for certain applications in electrical signal transmission.

[0239] Turning to Fig. 11, an extended etch section 180 is shown as being formed on a portion of the first function body 110, the portion being proximal to the connecting body 140. The extended etch section 180 can include any portion of the first function body 110 formed as the result of the etching. In some embodiments, the extended etch section 180 of the first function body 110 can include a surface region of the first function body 110, the surface region being proximal to the connecting body 140. In some embodiments, the electrolyte 580 (shown in Fig, 14) can travel to the first function body 110. For example, the channel 160 (shown in Fig, 6) can extend to a portion of the first function body 110. The electrochemical etching can form the extended etch section 180 made of the ceramic. The extended etch section 180 can advantageously protect, and / or electrically insulate, a part of the first function body 110.

[0240] Turning to Fig. 12, the first and second function bodies 110, 120 and the connecting body 140 are shown in an alternative arrangement. As shown, the second function body is not necessarily used for supporting the first function body 110 or the connecting body 140. In various embodiments, the first and second function bodies 110, 120 can be similarly supported and / or connected by the connecting body 140. In various embodiments, a portion of, or all of, the connecting body 140 can be etched. For example, the connecting body 140 can be converted from the alloy to the ceramic.

[0241] Turning to Fig. 13, the extended etch section 180 is shown as being formed at a portion of the first and / or second function bodies 110, 120 that is proximal to the connecting body 140. In some embodiments, the extended etch section 180 can include at least a part of the surface regions of the first and second function bodies 110, 120, the surface regions being proximal to the connecting body 140.

[0242] Turning to Fig. 14, an exemplary diagram for electrochemically etching the base part 100 of Fig. 13 is shown. The connecting body 140 is shown as being partially immersed in the electrolyte 580. Only a portion of the connecting body 140 is shown as being immersed in theelectrolyte 580. The base part 100 can have a structure such that the electrolyte 580 can permeate (or wick) into the connecting body 140 only up to the selected boundary region 130. Thus, the electrolyte 580 can modify at least a part of the connecting body 140 without entirely modifying the first and second function bodies 110, 120. In some embodiments, the etching can convert at least part of the connecting body 140 into an electric insulator such that the connecting body 140 can electrically isolate the first and second function bodies 110, 120. The portion of the first and second function bodies 110, 120 distal to the connecting body 140 can be electrically conductive.

[0243] Although Fig. 14 shows only a bottom portion of the connecting body 140 as being immersed in the electrolyte 580 for illustrated purposes only, any portion of the connecting body 140 and / or the first and second function bodies 110, 120 can be immersed in the electrolyte 580 in any suitable manner to achieve the effect as set forth above, without limitation.

[0244] Turning to Fig. 15, an exemplary diagram of the base part 100 is shown. The base part 100 is shown as including a plurality of first and second function bodies 110, 120 and a plurality of connecting bodies 140. Each connecting body 140 is shown as connecting two neighboring first and second function bodies 110, 120. In various embodiments, each of the first and second function bodies 110, 120 can include a needle and / or microneedle. Stated somewhat differently, the base part 100 can include a microneedle array. Exemplary needles can be used as electrodes for cardiac electrophysiology devices, neuromodulation, and / or neurostimulation. In some embodiments, the first and second function bodies 110, 120 can be identical or similar.

[0245] One or more of the selected connecting bodies 140 can be electrically insulating. For example, the connecting bodies 140 can optionally define some channels 160 (shown in Fig. 6) to adjust the extent of etching of the connecting bodies 140. A group of the first and second function bodies 110, 120 connected by conductive connecting bodies 140, thus collectively forming an electrode, can be predetermined. Advantageously, the magnitude of current delivered by the base part 100 for medical treatment can be tailored and / or customized via a simple manufacturing process.

[0246] Turning to Fig. 16, a detail drawing of an exemplary base part 100 is shown. The base part 100 is shown as including a microneedle array. The connecting bodies 140 are shown as having a lattice structure defining an array of square and / or rectangular voids. Fig. 17 shows thebase part 100 including the extended etch section 180. In various embodiments, the extended etch section 180 can include a cover and / or surface region of each of the first and second function bodies 110, 120 proximal to the connecting bodies 140. In some embodiments, a strut width of the lattice (or the strut-width of the sub-struts) can double the target etch depth. Accordingly, even if some etching is done on the first and second function bodies 110, 120 (for example, in the shape of a needle), there can still be a conductive core to the needle but the lattice structure can be fully converted to ceramic. The base part 100 shown in Figs. 16 and 17 can be used as an electrode array that can be implantable. For example, the base part 100 can be used for spinal implant, neural implant, and / or cardiac implant.

[0247] Turning to Figs. 18 and 19, detail drawings of an exemplary base part 100 are shown. Figs. 18 and 19 are similar to Figs. 16 and 17, respectively, except that the first and second function bodies 110, 120 shown in Figs. 18 and 19 each define the channel 160. In various embodiments, the channel 160 can be used for drug delivery. In one embodiment, the channel 160 can be used for controlling flow of the electrolyte 580 (shown in Fig. 5) and / or other processing fluids. In some embodiments, the channels 160 can control what portion of the first and second function bodies 110, 120 receive and / or form the extended etch section 180 (for example, a ceramic skin), or which portion remain electrically conductive (or electrically active). The base part 100 shown in Figs. 18 and 19 can be used for drug delivery system which can be implantable. For example, the base part 100 can be used for detecting electrical signals and / or administering therapeutics at the site of detection.

[0248] 3D structure including workpiece and tool

[0249] Turning to Fig. 20, an exemplary diagram of the base part 100 is shown. In various embodiments, the connecting bodies 140 can be electrically insulative and the first and second function bodies 110, 120 can be electrically conductive. Thus, the first and second function bodies 110, 120 can be used as a workpiece and an electrochemical machining tool, respectively. When the first and second function bodies 110, 120 are immersed in an electrolyte (not shown) and each electrically biased as an anode and a cathode, respectively, geometry of the first function body 110 can be modified via electrochemical machining (or electrochemical etching).

[0250] Turning to Fig. 21, the first function body 110 is shown as being etched based upon geometry of the second function body 120. In various embodiments, surface regions and / orfeatures of the first function body 110 can be smoothed and / or sharpened. Such smoothing and / or sharpening can be in accordance with tolerances that exceed a level of precision that is native to the 3D printing process. Optionally, the first and second function bodies 110, 120 can be separated after the electrochemical machining. In some embodiments, the connecting bodies 140 can include a ceramic that is brittle so the separation can be easy.

[0251] Accordingly, the workpiece and an electrochemical machining tool can be made all at once. That is, the workpiece and an electrochemical machining tool can be integrated in the same base part 100 and be formed concurrently as one printed object. Accordingly, the workpiece can be fixed relative to the electrochemical machining tool with high precision.

[0252] Without the method as set forth above, the workpiece and an electrochemical machining tool would be made separately. To electrochemically machine each workpiece, an operator would need to remove a previously-machined workpiece away from the electrochemical machining tool, reset the position of the electrochemical machining tool to align with a new workpiece. Such a process can be time-consuming and can result in a loss of alignment precision. This is particularly challenging in micro-manufacturing, where alignment tolerances may be less than 10 microns. In contrast, the method as set forth above can simultaneously achieve formation of the workpiece and the electrochemical machining tool, tool-setting, and tool fixturing.

[0253] In various embodiments, the method can be used for forming sharp edge(s) and / or sharp tip(s) on the first function body 110. For example, the 3D printing can achieve a resolution of 5 microns or 2 microns. An exemplary sharp edge made by 3D printing can have an edge radius no smaller than 1 micron. However, a cutting instrument (for example, in medical devices) would preferably have a razor-sharp edge with an edge radius no greater than 0.5 micron. Such edge sharpness can be achieved by electrochemical machining but such machining process, without the disclosed method, would be only a one-off process for each first function body 110 and thus would not be cost-effective or practical for large scale production.

[0254] In contrast, by using the disclosed method, a large-scale batch process can be used. For example, a large number (for example, hundreds) of base parts 100 can be made in an array (not shown). The first function bodies 110 of the base parts 100 can be electromechanicallymachined in parallel. No human operators need to touch the base parts 100 during the process. Advantageously, a much more automated, scalable, and hands-off process can be achieved.

[0255] Turning to Fig. 22, a detail drawing of an exemplary base part 100 according to Fig. 20 is shown. The first function bodies 110 is shown as defining a flat surface proximal to the second function body 120 prior to the electrochemical machining. The second function body 120 is shown as defining a sharp tip proximal to the first function bodies 110,

[0256] Turning to Fig. 23, a detail drawing of an exemplary base part 100 after the electrochemical machining is shown. The first function bodies 110 is shown as being etched based upon geometry of the second function body 120.

[0257] Figs. 24 and 25 show cross-sectional views of the base part 100 of Figs. 22 and 23, respectively. The second function body 120 is shown as defining a plurality of channels 122 in communication with the connecting bodies 140, respectively. The base part 100 is shown as defining two channels 160 in each connecting body 140 that extend into a portion of the depth of the channel 122 and terminates at the boundary region 130. Thus, during the production of the base part 100 when the base part 100 is positioned in the electrolyte 580 (shown in Fig. 5), the electrolyte 580 can enter the channel 122, and wick up to the boundary region 130 via the channels 160. The etching can transform the connecting bodies 140 into an electric insulator (for example, a ceramic). The first function body 110 is thus not etched and can remain electrically conducting. Similarly, at least a portion of the second function body 120 can be not etched and remain electrically conducting. Thus, the electrochemical machining can be performed on first function body 110 by using the second function body 120 as a tool.

[0258] Turning to Fig. 26, an exemplary diagram of the base part 100 is shown, with one or more connecting bodies 140 each defining ajoint region 104. The joint region 104 can be proximal to the first function body 110 and can be a contact point region between the first function body 110 and the connecting body 140. In various embodiments, after the electrochemical machining of the first function body 110, the base part 100 can be at least partially immersed in an electrolyte 580 (shown in Fig. 5). The electrolyte can reach, and etch away, the joint region 104 without etching the first function body 110. The first function body 110 can thus be removed from the base part 100.

[0259] For example, the joint region 104 can include, and / or equal to, the boundary region 130 (shown in Fig. 5 or Fig. 14). The channels 160 (shown in Fig. 6) can wick the electrolyte 580 to the joint region 104.

[0260] In Figs. 25 and 26, for illustrative purposes only, the channels 122 are defined in the second function body 120, such that the second function body 120 can be at least partially immersed in the electrolyte 580 for converting the connecting body 140 into an electrically insulating material. However, the channels 122 are optional, and can be defined in the first function body 110, without limitation.

[0261] Targeted drug delivery device

[0262] Turning to Fig. 27, a device 600 for delivering a drug to biological tissue is shown in an environment 500. When in use, the device 600 can be at least partially embedded in body tissue 520. Exemplary body tissue 520 can include tumor tissue (or malignant tissue). The device 600 can deliver medicine (or drug), such as chemotherapy medication, into the body tissue 520 in a direct and targeted manner. Advantageously, side effects for a patient from the chemotherapy can be reduced, in comparison with the existing chemotherapy process where the medication is systematically delivering to the entire human body.

[0263] The device 600 is shown as including a first end region 610 and a second end region 620 opposite to the first end region 610. The first end region 610 can be configured to enter the body tissue 520 and be secured or anchored in place. In various embodiments, the first end region 610 can define at least one sharp point. However, the first end region 610 can have any shape, size, and / or dimension to enable entry into the body tissue 520, without limitation.

[0264] The second end region 620 can be connected, via a tube (not shown) for example, with a port 540 that supplies the medicine. The device 600 is shown as defining a main lumen 640 therein that extends between the first and second end regions 610, 620. The main lumen 640 can terminate at one or more suitable locations at a surface, of the first end region 610, that is embedded in the body tissue 520. The medicine from the port 540 can flow through the main lumen 640, exit at the first end region 610, and reach the body tissue 520.

[0265] The device 600 can be a part of a system 544 (shown in Fig. 1 12) for delivering a chemotherapy drug to the body tissue 520. The body tissue 520 can include tumor tissue. The system 544 is shown as further including a tube 543 having a first terminal region 541 and asecond terminal region 542 opposite to the first terminal region 541. The first terminal region 541 is shown as being connected to the second end region 620 of the spike 660 and in communication with the main lumen 640. The system 544 is shown as further including the port 540 connected to the second terminal region 542 of the tube 543 and configured to be embedded, for example, below (or right beneath) skin 521 to allow access to the system 544 by a human or machine operator. Advantageously, device 600 can be implanted and / or embedded in the tumor and drug from the port 540 can be injected directly into the tumor.

[0266] Turning to Fig. 28, the device 600 is shown as including a spike 660 defining a primary sharp point 662. An exemplary spike 660 can have a cone shape. In some embodiments, the spike 660 can form a part of, or all of, the first end region 610. In some embodiments, the spike 660 can form the first end region 610 and a part of, or all of, the second end region 620.

[0267] Turning to Fig. 29, the spike 660 is shown as defining a primary axis 664. The position of the primary axis 664 can be determined in any suitable manner. An exemplary primary axis 664 can pass through the primary sharp point 662, and / or the center of mass of the spike 660.The main lumen 640 can extend along the primary axis 664.

[0268] In some embodiments, the spike 660 can be symmetrical about the primary axis 664 such that the primary axis 664 can be the central axis of the spike 660. The main lumen 640 can extend along the central axis and terminate at the primary sharp point 662.

[0269] Turning to Fig. 30, the device 600 is shown as including the spike 660 and at least one thread 680 winding helically around the spike 660. The thread 680 can wrap around the spike 660 for a selected number of revolutions. Stated somewhat differently, the device 600 can be shaped as a screw that enters the body tissue 520 (shown in Fig. 27) via rotating or turning. Advantageously, the thread 680 can securely fix the device 600 to the body tissue 520. The thread can have any suitable shape. Exemplary thread 680 can have a smooth edge.Additionally and / or alternatively, the thread 680 can have sawtooth-shaped edge to facilitate retention with the body tissue 520.

[0270] Turning to Fig. 31, in a cross-sectional view, the device 600 is shown as defining one or more side (or secondary) lumens 642 each communicating with, and branching from, the main lumen 640. Each of the side lumens 642 can terminate at a selected location that is on the device 600 and embedded in the body tissue 520 (shown in Fig. 27). The medicine can flow from themain lumen 640 into the side lumens 642 and reach the body tissue 520. In some embodiments, at least one side lumen 642 can terminate at an edge region 682 of a tooth 684 of the thread 680. In some embodiments, as shown in Fig. 31, one or more side lumen 642 can terminate at the surface of the spike 660 between two adjacent teeth 684 of the thread 680. Fig. 32 shows a detail drawing of the device 600 with the side lumen 642 each terminating between two adjacent teeth 684 of the thread 680.

[0271] Turning to Fig. 33, the device 600 is shown as including the spike 660 and one or more barbs 610 projecting from the spike 660. In some embodiments, the barbs 610 can be arranged in any manner, such as in rows, columns, clusters, and / or randomly. One or more of, and / or all of the barbs 610 can project radially from the spike 660 and at least partially project against the direction of the primary sharp point 662. Stated somewhat differently, the device 600 can be barbed such that retraction of the spike 660 from the body tissue 520 (shown in Fig. 27) can be difficult. Advantageously, the barbs 610 can ensure retention of the device 600 and prevent dislodging of the device 600 from the body tissue 520.

[0272] Turning to Fig. 34, the device 600 is shown as including three groups of barbs 610. In various embodiments, the device 600 can include one or more groups of barbs 610. Each group of barbs 610 can be connected to a selected location on the spike 660.

[0273] Turning to Fig. 35, in a cross-sectional view, the device 600 is shown as defining the side lumens 642 each communicating with and branching from the main lumen 640. In some embodiments, at least one side lumen 642 can extend along an axis of one of the barbs 610, and terminate at an edge region 614 of the barb 610. In some embodiments, as shown in Fig. 34, one or more side lumen 642 can terminate at the surface of the spike 660 between two adjacent barbs 610 (and / or two adjacent groups of barbs 610). Fig. 36 shows a detail drawing of the device 600 with the side lumen 642 each terminating between two adjacent groups of barbs 610.

[0274] Figs. 37-39 illustrate alternative embodiments of the device 600. The device 600 is shown as including two groups of barbs 610. In a cross-sectional view shown in Fig. 38, the device 600 defines the main lumen 640 without the side lumens 642. The main lumen 640 is shown as terminating at the primary sharp point 662.

[0275] In some embodiments, the device 600 can have a length less than 3 millimeters (mm), less than 1 mm, and / or less than 0.5 mm. The device 600 can have a cross-sectional basediameter, that is less than 0.5 mm, less than 0.3 mm, and / or less than 0.2 mm. The cross- sectional base diameter can be defined in a cross-sectional plane perpendicular to the length of the second end region 620 and at the widest part of the second end region 620.

[0276] The device 600 can provide significant advantages over existing techniques. Conventionally, in chemotherapy, medication is systematically delivered, that is, delivered into the blood that circulates in the entire body. Such delivery results in massive side effects. Further, certain tumors (for example, pancreatic cancer) cannot easily receive chemotherapy medication in a vascular manner and may benefit from an alternate approach. A further advantage of this approach is that direct mechanical delivery of a therapeutic is largely independent of the specific chemistry of the therapeutic being delivered, which enables a wide range of treatments.

[0277] Atraumatic electrode for cardiac electrophysiology devices and / or neuromodulation

[0278] Turning to Fig. 40, a device 700 for physiological signal transmission is shown in the environment 500. When in use, the device 700 can be at least partially embedded in the body tissue 520. In some embodiments, the body tissue 520 can include cardiac tissue. Exemplary device 700 can be used as electrode(s) for cardiac electrophysiological (EP) devices including, for example, implantable defibrillators and / or pacemakers. In some embodiments, the body tissue 520 can include spinal cord, brain tissue, muscles. Exemplary device 700 can be used as electrode(s) for a neuromodulator and / or neurological signal measurement equipment.

[0279] The device 700 is shown as including at least one electrode 740. The electrode 740 can include a first end region 710 and a second end region 720 opposite to the first end region 710. The first end region 710 can be configured to enter the body tissue 520 and be secured or anchored in place. In various embodiments, the first end region 710 can define at least one sharp point. However, the first end region 710 can have any shape, size, and / or dimension to enable entry into the body tissue 520, without limitation. The second end region 720 can be connected, via a wire (not shown) for example, with an external system 560 that receives electric signals from, and / or sends the electric signals to, the body tissue 520.

[0280] In various embodiments, the device 700, and / or each electrode 740, can have a shape such as to be fixed with the body tissue 520. In various embodiments, an exemplary electrode740, and / or the first end region 710 of the electrode 740, can have an external shape similar to the device 600 (shown in Figs. 28-39). Stated somewhat differently, the electrode 740 can include a spike (similar to the shape shown in Figs. 28-29), a spike with at least one thread (similar to the shape shown in Figs. 30-32), and / or a barbed spike (similar to the shape shown in Figs. 33-39). When the electrode 740 includes the barbed spike, the barbs can be shaped, arranged, distributed, and / or oriented in any suitable manner to minimize scar tissue incurred by insertion and / or retraction of the electrode 740. For example, if the barbs point perpendicular to the direction of insertion, the barbs may cut the body tissue 520, but the barbs can be aligned to point partially against the direction of insertion and / or be in line with spread of the body tissue 520.

[0281] Additionally and / or alternatively, the device 700, and / or each electrode 740, can have a size that is sufficiently small so as to reduce and / or minimize scar tissue formed on the body tissue 520 arising from installation of the device 700. An exemplary electrode 740, and / or the first end region 710 of the electrode 740, can have a length ranging from 50 micrometers to 100 micrometers. In some embodiments, the electrode 740 can have a length less than 3 mm, less than 1 mm, and / or less than 0.5 mm. The electrode 740 can have a cross-sectional base diameter that is less than 0.5 mm, less than 0.3 mm, and / or less than 0.2 mm. The cross-sectional base diameter can be defined in a cross-sectional plane perpendicular to the length and at the widest part of the second end region 720,

[0282] Turning to Fig. 41, the device 700 is shown as including a base piece 760 and a plurality of the electrodes 740 each having the second end region 720 being connected with the base piece 760. The base piece 760 can have any suitable size, shape, dimension and / or pattern, without limitation. The plurality of the electrodes 740 can increase an effective electrical contact area between the device 700 and the body tissue 520. Advantageously, electrical current transmitted via the device 700 can be increased.

[0283] Turning to Fig. 42, the device 700 is shown as being similar to the device 700 of Fig. 41 but each electrode 740 can be barbed. Although Figs. 41 and 42 show four electrodes 740 as being identical and arranged parallel for illustrative purposes only, the device 700 can include any suitable number of uniform and / or different electrodes 740 arranged in any suitable manner, without limitation.

[0284] Fig. 108 shows the device 700 as being similar to the device 700 of Fig. 40 but each electrode 740 can include one or more bumps (or protrusions) 742 surrounding the side surface of the electrode 740. Each bump 742 can define first and second edges 742A, 742B raised beyond the side surface of the electrode 740. The first and second edges 742A, 742B can be proximal to, and distal from, the first end region 710 of the electrode 740, respectively. Stated somewhat differently, the first and second edges 742A, 742B can respectively define slopes at least partially toward, and face at least partially against, the first end region 710. Accordingly, when the first end region 710 is inserted in the body tissue 520 (shown in Fig. 40), the first edges 742A does not inhibit the penetration. Upon penetration, the second edge 742B can prevent the electrode 740 from backing out from the body tissue 520. The bump 742 can have a symmetrical shape. Stated somewhat differently, the first and second edges 742A, 742B can have define the same slope relative to the side surface of the electrode 740.

[0285] Figs. 109 and 110 show the bump 742 as having an asymmetrical shape. The second edge 742B is shown as having a greater slope than the first edge 742A. Stated somewhat differently, the second edge 742B rises more sharply, than the first edge 742A, from the side surface of the electrode 740. Advantageously, the bump 742 can more easily be inserted in the body tissue 520 (shown in Fig. 40), but can more strongly inhibit any dislodging movement of the electrode 740.

[0286] Turning to Fig. 43, the device 700 is shown as including at least one base piece 760 connected with the plurality of electrodes 740. Each of the electrodes 740 can be connected to the base piece 760 at the second end region 720 (shown in Fig. 40). Thus, the electric contact area between the device 700 and the body tissue 520 can be increased, in comparison with a single electrode 740. A greater electric signal can thus be sent and / or received with the device 700. In various embodiments, the base piece 760 can be compatible with the electrodes 740 of selected shapes. For example, when the electrode 740 is a spike with at least one thread, the device 700 may include a single electrode 740 not connected to a base piece 760. The threaded electrode 740 may need to rotate individually and making multiple electrodes 740 rotate individually on one base piece 760 can be possible but may increase mechanical complexity of the device 700.

[0287] Fig. 43 shows the base piece 760 as having a solid (or full) pattern, as an example. Stated somewhat differently, the base piece 760 is shown as having no opening and / or voids.

[0288] Turning to Fig. 44, the base piece 760 is shown as having a lattice pattern. Stated somewhat differently, the base piece 760 can have one or more openings and / or voids and shaped similar to a screen. The lattice pattern can be of any regular and / or irregular shape and size, without limitation. In the example shown, the base piece 760 can include one or more sections 762. Each two adjacent electrodes 740 can be connected with a section 762. The sections 762 can have any uniform and / or different shape, size, and / or dimension. An exemplary section 762 can be straight, curved, and / or zig-zag (shown in Figs. 47 and 48).

[0289] In some embodiments, the body tissue 520 can include cardiac tissue. Because the cardiac tissue is a type of muscle tissue that flex constantly, it is desirable for the device 700 to flex with the cardiac tissue while exerting minimal strain on the cardiac tissue. In some embodiments, a non-straight section 762 can be more flexible than a straight section 762, and thus can more easily flex to conform with the body tissue 520 during expansion and / or contraction of the body tissue 520. Advantageously, stress and / or scarring of the body tissue 520 due to the fixation with the device 700, and stress within the device 700, can be reduced.

[0290] Additionally and / or alternatively, for the base piece 760 of any pattern, the device 700 can be at least partially made of a shape-memory material. For example, the electrodes 740 and / or the base piece 760, can be at least partially made of the shape-memory material. The shape-memory material can maximize flexibility and / or fatigue life of the device 700. An exemplary shape-memory material can include nitinol. In one embodiment, the nitinol can include an alloy composed of equimolar proportions of nickel and titanium.

[0291] The device 700 can provide significant advantages over existing techniques. For example, a conventional EP device is an electrode having a shape similar to a corkscrew and is screwed in the cardiac tissue. The corkscrew shape has a length of about 5 to 6 mm, and a cross- sectional diameter of 0.5 mm, and is embedded almost entirely through a wall of a ventricle. Such an installation can result in a significant amount of scar tissue in the cardiac tissue. The scar tissue might improve fixation of the electrode but decreases conductivity at an interface of the cardiac tissue and the electrode, and thus degrades the electrical contact over time. Thus, scar tissue is overall undesired. To minimize the scar tissue, the size of the electrode can bereduced, so that inflammatory response of the body tissue 520 can be reduced and / or prevented. Being significantly smaller than conventional electrodes, the electrode 740 as set forth above can advantageously be much less traumatic to body tissue 520.

[0292] Additionally and / or alternatively, the device 700 can be advantageous in improving retention in the body tissue 520. For example, one of two existing types of neuromodulation devices is in the form of wires that are inserted in a spinal column via a needle. Although such an approach is not very invasive, the device is of only a small surface area and can be insufficient to deliver signal or measure accurately, depending on the specific application. The other type is an array of electrical pads embedded in a polymer substrate. The device can be put directly on the spinal cord. That device is more invasive but may have a better electrical property. For both types, fixation with body tissue is challenging. The electrodes tend to move over time. Moving and / or dislodging of the electrodes, or any scar tissue created, all compromise function of the electrodes. In many cases, the electrodes get dislodged over time (for example, within only a few months) or have certain mechanical failure, and stop working entirely.

[0293] In contrast to existing electrodes, the electrode 740 can be microscale retention pieces that are small so as to promote minimal inflammatory response but have much better retention. The electrode 740 can stay exactly at a correct location and send signals appropriately for a much longer time.

[0294] Turning to Fig. 45, a detail drawing of an exemplary device 700 is shown. The device 700 is shown as including a plurality of electrodes 740 that are barbed. The base piece 760 is shown as having a rectangular shape including a plurality of straight sections 762 that define rectangular voids.

[0295] Turning to Fig. 46, a detail drawing of another exemplary device 700 is shown. The device 700 is shown as being similar to the device 700 in Fig. 45, but each electrode 740 in Fig. 46 defines an opening 780 at the first end region 710. The opening 780 can be the opening of an internal lumen (not shown) for drug delivery, for example. Such a lumen can be similar to the lumen 640 (shown in Figs. 29, 31, 32, 35 and 38). Thus, the device 700 can be used for delivering medication in a manner similar to the device 600 (shown in Figs. 27-39).

[0296] Turning to Figs. 47 and 48, detail drawings of exemplary devices 700 are shown. The devices 700 are shown as being similar to the devices 700 in Figs. 45 and 46, respectively, but the base plates 760 in Figs. 47 and 48 are shown as having a circular shape including a plurality of zig-zag shaped sections 762 that define the circular shape and radial lines. Accordingly, the devices 700 can have great flexibility. Fig. 48 shows only some the electrodes 740 defining the opening 780. Thus, each of the electrodes 740 are not necessarily the same and can be configured respectively for implementing respective functions.

[0297] Device for flexural fixation

[0298] Turning to Figs. 49A and 49B, a device 800 for interfacing with the body tissue 520 (shown in Figs. 27 and 40) based upon flexural fixation is shown. Stated somewhat differently, the device 800 can be secured and / or fixed to the body tissue 520 via a capability of flexing. The device 800 is shown as including a plurality of function units 840 and a substrate 860. The function unit 840 can include a first end region 810 and a second end region 820 opposite to the first end region 810. Each function unit 840 can be connected to the substrate 860 via the second end region 820. The function units 840 can be uniform and / or different and configured for interfacing with the body tissue 520 to implement uniform and / or different medical functions.

[0299] The function unit 840 can include any component to be attached to, inserted in, and / or embedded in the body tissue 520 for medical treatment or procedures. In some embodiments, the function unit 840 can include the device 600 (shown in Figs. 27-39). Accordingly, the device 800 can be used for targeted delivery of medicine. Additionally and / or alternatively, the function unit 840 can include the electrode 740 (shown in Figs. 40-48). and the substrate 860 can include the base piece 760 (shown in Figs. 41-48). Accordingly, the device 800 can be used for as electrode(s) for cardiac electrophysiological (EP) devices and / or as electrode(s) for a neuromodulator.

[0300] Figs. 49A and 49B show the substrate 860, and the device 800, as being in stressed and relaxed states, respectively. In the relaxed state, the substrate 860 can be under no strain and can maintain the shape naturally without any external strain and / or force. In the stressed state, a strain is applied on the substrate 860 such that the substrate 860 deviates from the shape of the relaxed state. In various embodiments, when the substrate 860 is in the stressed state, thefunction units 840 can be aligned in parallel. When the substrate 860 is in the relaxed state, at least two of the function unit 840 can be angled with, and / or non-parallel to, each other.

[0301] In various embodiments, the substrate 860 in the stressed state can be easily inserted into the body tissue 520. After completing insertion of the function unit 840, application of the strain can be stopped, and the substrate 860 can be in the relaxed state. Thus, dislodging of the function units 840 from the body tissue 520 can be difficult, and thus can be prevented. Because the substrate 860 is in the relaxed state, retention of the function units 840 in the body tissue 520 can be maintained for a long time. Advantageously, with a simple structure as set forth above, the device 800 can be easily installed onto the body tissue 520 while retention upon installation can be ensured.

[0302] The function units 840 can optionally have micro-retention features for improving fixation of the function units 840 within the body tissue 520. In various embodiments, the function units 840 can have the shape, size and / or structure as the device 600 and / or the electrode 740. For example, each of the function units 840 can include a spike, a threaded spike, and / or a barbed spike. Additionally and / or alternatively, the function units 840 can be small so as to minimize scar tissue formation. In some embodiments, the function unit 840 can have a length less than 3 mm, less than 1 mm, and / or less than 0.5 mm. The function unit 840 can have a cross-sectional base diameter that is less than 0.5 mm, less than 0.3 mm, and / or less than 0.2 mm. The cross-sectional base diameter can be defined in a cross-sectional plane perpendicular to the length and intersecting with the substrate 860. Additionally and / or alternatively, the function units 840 and / or the substrate 860 can be at least partially made of the shape-memory material.

[0303] Figs. 49A and 49B show the substrate 860 as being bent and flat in the stressed and relaxed states, respectively. In the relaxed state, the two function units 840 can be angled inward. Stated somewhat differently, the two function units 840 can be point toward each other. Figs. 49A and 49B are for illustrative purposes only. Whether the substrate 860 is bent or flat, and / or the extent of bending, at any state can be determined based upon the specific application, and / or the specific body tissue 520 that the substrate 860 need to conform to, without limitation.

[0304] Turning to Fig. 50, an exemplary flow chart of an embodiment of a method 880 of fixating the device 800 to the body tissue 520 (shown in Figs. 27 and 40) is shown. The device800 can be deformed, at 882, into the stressed state. The device 800 can be deformed into a shape, and held in the shape in the stressed state. The function units 840 can be inserted, at 884, into the body tissue 520. The device 800 can be released, at 886, into the relaxed state. In the relaxed state, the function units 840 can be angled with each other within the body tissue 520. The releasing can be upon and / or after the inserting. In various embodiments, the device 800 can be produced in a relaxed state before the deforming at 882.

[0305] The use of the device 800 can be implemented in various manners. In one embodiment, the device 800 can be deformed when cold but returns to a “remembered” shape when heated. Thus, the device 800 can be embedded in living tissue while being cold, reach body temperature and turn to the remembered body temperature shape. In various embodiments, the device 800 can exhibit super elasticity, and thus can be ideal for high deformation applications regardless of temperature. The device 800 can be heat-set to a target final shape, but can be deformed from that shape and held in the deformed position by multiple methods, including an insertion tool. For example, for the exemplary device 800 in Figs. 49A-49B and 51A-52B, shape-memory materials may be advantageous but are not necessary, depending on the required deformation.

[0306] Figs. 51 A and 5 IB show the substrate 860 as being bent and flat in the stressed and relaxed states, respectively. In the relaxed state, the two function units 840 can be angled outward. Stated somewhat differently, the two function units 840 can be point away from each other.

[0307] Figs. 52A and 52B show the substrate 860 as being flat and bent in the stressed and relaxed states, respectively. In the relaxed state, the two function units 840 can be angled inward. Stated somewhat differently, the two function units 840 can be point toward each other. In another example (not show), the substrate 860 can be flat and bent in the stressed and relaxed states, respectively. In the relaxed state, the two function units 840 can be angled outward.

[0308] The device 800 can provide significant advantages over existing techniques. For example, conventional devices used for chemotherapy delivery, EP, and / or neuromodulation can all face challenges of retention capabilities. The device 800 achieves great retention via an integral piece of a simple structure with few moving parts, making the overall system simple, low cost, and miniaturized.

[0309] Biopsy device

[0310] Turning to Fig. 53, a schematic diagram of a device 900 for performing a biopsy is shown in the environment 500. The biopsy device 900 is shown as including a first tube and a second tube 920 nested in the first tube 910. The first tube 910 includes a lead edge region 912 and an optional trail edge region 914 opposite to the lead edge region 912. The second tube 910 includes a lead edge region 922 and an optional trail edge region 924 opposite to the lead edge region 922. In various embodiments, during the biopsy, the lead edge regions 912, 922 can be proximal to the body tissue 520, and the trail edge regions 914, 924 can be distal from the body tissue 520. In various embodiments, the lead edge region 922 can be sharp and configured to cut the body tissue 520.

[0311] In various embodiments, the second tube 920 can be configured to translate along an axis 916 defined by the first tube 910. The axis 916 can be parallel to the first tube 910. In some embodiments, the axis 916 can be a central axis of the first tube 910. Additionally and / or alternatively, the second tube 920 can be configured to rotate axially within the first tube 910. Stated somewhat differently, the second tube 920 can define an axis 926 and rotate about the axis 926. For example, the axis 926 can be parallel to the second tube 920.

[0312] Turning to Fig. 54, the lead edge region 912 is shown as being fixated on the body tissue 520. In various embodiments, the lead edge region 912 can be fixed on the body tissue 520 via a vacuum applied within the first tube 910. The fixation with the body tissue 520 can allow the second tube 920 to perform the biopsy.

[0313] Turning to Fig. 55, the device 900 is shown as being connected to a control system 940 for controlling the first and second tubes 910, 920. In various embodiments, the trail edge regions 914, 924 can be connected with the control system 940 in any suitable manner. The control system 940 can include any suitable machine and / or computer that operates automatically and / or under human operation. The control system 940 can apply vacuum, and / or control movement of the device 900 or of the first and second tubes 910, 920. In various embodiments, the control system 940 can apply the vacuum in the first tube 910. Stated somewhat differently, the device 900 can include the control system 940, or the device 900 and the control system 940 can combine to form a biopsy system. In various embodiments, the controlling of the device 900 can be mechanical and does not require software. In various embodiments, the control system 940 can include a vacuum source which may be selectively applied to the first tube 910 (or theouter tube). Additionally and / or alternatively, the control system 940 can include mechanical means for translating and / or rotating the second tube 920 (or the inner tube). Stated somewhat differently, the control system 940 can include suitable components that mechanically controls translating and / or rotating of the second tube 920.

[0314] Turning to Fig. 56, the second tube 920 is shown as being advanced into the body tissue 520. Stated somewhat differently, the lead edge region 922 can enter the body tissue 520. In various embodiments, the advancing of the second tube 920 can be implemented by an operator and / or by the control system 940 (shown in Fig. 55).

[0315] Turning to Fig. 57, the second tube 920 is shown as having cut a sample 522 from the body tissue 520. The second tube 920, along with the sample 522, can be retracted from the body tissue 520 and back into the first tube 910. In various embodiments, a vacuum can be applied in the second tube 920 for extraction and / or retention of the sample 522. For example, the vacuum can be applied by the control system 940 (shown in Fig. 55). In various embodiments, the retraction of the second tube 920 can be implemented by the operator and / or by the control system 940. In various embodiments, when a vacuum is applied in the second tube 920, the sample 522 can tear away on retraction. Even without vacuum, the friction between the sample 522 and the wall of the second tube 920 may be enough to cause the sample 522 to tear away. Optionally, twisting the sample 522 relative to the body tissue 520 can facilitate separation of the sample 522 from the body tissue 520. Upon the retraction of the second tube 920, the device 900 can be removed from the body tissue 520. For example, the vacuum applied in the first tube 910 can be released.

[0316] Turning to Fig. 58, an exemplary flow chart of an embodiment of a method 980 for performing a biopsy is shown. The method 980 can be implemented using the device 900. Vacuum can be applied, at 982, in the first tube 910 such that the lead edge region 912 can be fixed on the body tissue 520. The lead edge region 922 can be advanced, at 984, into the body tissue 520. The second tube 920 can cut, at 986, a sample 522 from the body tissue 520. The second tube 920 with the sample 522 can be retracted, at 988, from the body tissue 520. As set forth above, the cutting at 986 and the retracting at 988 can be separate actions and / or concurrent actions. Stated somewhat differently, the lead edge region 922, along with the sample 522, can be retracted, at 988, back into the first tube 910.

[0317] In various embodiments, the device 900 can be sufficiently small, the method 980 and / or the device 900 can perform certain biopsies that cannot be done by conventional methods. In some embodiments, the outer diameter of the first tube 910 can be no greater than 6 mm. Thus, the method 980 and / or the device 900 can allow for a transurethral approach to biopsy potential malignancies in a bladder and / or a kidney.

[0318] Turning to Fig. 59, the device 900 is shown as including an endoscope 960. In various embodiments, the endoscope 960 can be located in space between the first and second tubes 910, 920. The endoscope 960 can be configured to visualize the body tissue 520 before and after the biopsy. Optionally, the endoscope 960 can be connected with the control system 940 and / or any other suitable computer system in a wired and / or wireless manner. Advantageously, the operator and / or the computer system can obtain real-time images of the body tissue 520 and thus can perform the biopsy accurately and efficiently.

[0319] Although Fig. 59 shows the endoscope 960 as being located in the first tube 910 for illustrative purposes only, the endoscope 960 and the device 900 can be coupled in any other manner, without limitation. In one embodiment, the device 900 can be mounted on the end of the endoscope 960. The endoscope 960 can be a part of the device 900 or a separate component not included as a part of the device 900. Although Figs. 53 and 55 show the device 900 as including the trail edge regions 914, 924 for illustrative purposes only, the trail edge regions 914, 924 is not necessarily defined by the device 900, and is not necessarily defined by the device 900 in the manner as shown. Stated somewhat differently, the device 900 can interface with other systems and / or devices in any manner and not necessarily via the trail edge regions 914, 924.

[0320] The device 900 can be used as a micro core biopsy device suitable for biopsies at a wide range of depths in human or animal body, with good control and minimizing pain of the human or animal. The device 900 can be especially suitable for transurethral procedures on the bladder and the kidney. The device 900 can provide significant advantages over existing techniques at least for the following reasons. For example, one type of conventional biopsy technique is claw (or plier) biopsy, where a claw-shaped device with sharp edges grabs body tissue and tear some of the body tissue off. For biopsy at microscale (for a device with a size smaller than 1 mm), it is hard to obtain a sample of good quality. For example, for transurethral procedures, the entire device should have a diameter under 6 mm, and typically a biopsy deviceis only 1-2 mm in diameter. The quality or size of the sample is often not good, and cellular structure might not be preserved to a degree sufficient for laboratory analysis. Sometimes, multiple samples need to be obtained to make sure that the samples can produce reliable results in the laboratory.

[0321] An alternative conventional method is a core biopsy device that samples using a punching approach. The device has a sharp blade in the front and a large spring at the back. The spring winds up and force the blade into the tissue quickly. Because the tissue naturally deflects from the blade during a cut, the blade must puncture fast before the tissue deflects. Such a devices may improve the quality of sample compared with the claw device. However, such devices can only reach a limited depth in human or animal body, and incurs pain. For example, to reach great depth at microscale, the device can only be delivered by a catheter. The catheter is long and flexible and thus cannot transfer the rapid linear spring force or motion as required by the punching approach.

[0322] The device 900 can be advantageous over both conventional techniques as set forth above. With vacuum applied to secure the body tissue 520 with the first tube 910, the second tube 920 can gently cut the body tissue 520. The resulting sample 522 (shown in Fig. 57) can be clean, cylindrical and with cell structures intact and suitable for histology, even when the sample 522 is very small (for example, with a diameter less than 1 mm). The second tube 920 can be activated slowly without having to use the spring or punching mechanism. Accordingly, the biopsy can incur less pain to the patient. Additionally and / or alternatively, the device 900 can be used with a long and articulated device, such as a catheter. The catheter can deliver the device 900 in transurethral procedures and / or other natural orifice approaches where traditional spring- loaded mechanism is not feasible.

[0323] The device 900 can be made using any suitable methods, without limitation. In various embodiments, at least the lead edge region 922 can be made by 3D printing. Selected 3D printing methods can achieve the cutting geometry of the lead edge region 922 with high precision and low cost. In some embodiments, at least the portion of the second tube 920 that enters the body tissue 520 can be rigid. The remaining portion of the device 900 can be flexible. Stated somewhat differently, when a length of the lead edge region 922 defines a depth of a cut in the body tissue 520, at least the lead edge region 922 can be rigid.

[0324] Device for Cautery and / or ablation

[0325] Turning to Fig. 60, a schematic diagram of a device 300 for cauterization is shown. The device 300 is shown as including one or more function units 340. In various embodiments, the function unit 340 can have an elongated shape. The function unit 340 can include a first end region 310 and a second end region 320 opposite to the first end region 310. The first end region 310 can be configured to enter the body tissue 520 (shown in Fig. 61 A). In various embodiments, the first end region 310 can define at least one sharp point to ease insertion.Stated somewhat differently, the function unit 340 can be in the shape of a needle. The device 300 is shown as further including a support structure 360. The function unit 340 can be connected to the support structure 360 at the second end region 320.

[0326] In various embodiments, the support structure 360 can be connected, via a cable, wire and / or tube (not shown) with a control system (not shown). The control system can supply a selected type of energy and / or signal to the function units 340 via the support structure 360.

[0327] In one embodiment, the control system can include a power generator configured to supply an electric current to each of the function unit 340 along a direction 380. The function unit 340 can be electrically conductive. Accordingly, the device 300 can be used for cautery (for example, electrocautery) and / or electricity-based ablation. In some embodiments, the current can be supplied to the function unit 340 and there can be a second grounding electrode external to the body (for example, the second grounding electrode including a large pad adhered to the patient’s back). In some embodiments, the device 300 can include a bipolar cautery system and can include two electrodes at the site of cautery. In one example, the device 300 can include two sets of function units 340 (or two sets of electrically isolated needles), each set being one of the electrodes. In another example, the device 300 can include a set of function units 340 (for example, needles), all electrically being isolated from one another, where the current can be applied between any pair of needles or sets of needles. Additionally, ultrasonic energy can be used for cautery, and thus the device 300 does not require additional hardware.

[0328] In another embodiment, the control system can include a heat and / or power generator configured to supply heat to the function unit 340. The function unit 340 can be thermally conductive. Accordingly, the device 300 can be used for cautery and / or ablation.

[0329] In yet another embodiment, the control system can include a heat and / or power generator configured to supply cooling fluid to the function unit 340, and to circulate the cooling fluid. Stated somewhat differently, the function unit 340 can include a cry oprobe that is hollow and can be thermally conductive. In some embodiments, at least one function unit 340 can define a fluid pathway, or internal channel, therein for delivering working fluid (for example, cooling liquid such as liquid nitrogen) to the body tissue 520. In some embodiments, the function unit 340 can be solid internally or define the fluid pathway, and the support structure 360 can define one or more internal channels for delivering the working fluid. Accordingly, the device 300 can be used for cryoablation. In various embodiments, the base 360 can have flow paths for a coolant to apply a very low temperature to the body tissue 520 and freeze target tissue 524 (as shown in Figs. 61 A and 6 IB) until the cells die. The function units 340 (for example, needles) can act as a mechanism for amplifying thermal conductivity into the tissue. For cautery via any type of thermal mechanism, the benefit of using the function units 340 is that thermal penetration can be deeper for a given energy dose, while limiting lateral energy spread 528 (as illustrated in Figs. 61A and 61B) or lateral thermal spread.

[0330] In yet another embodiment, the control system can include a power generator configured to supply a selected type of energy to the function unit 340 in the form of electromagnetic waves. Exemplary energy can be based on ultrasound, laser, microwave, and / or the like. Accordingly, the device 300 can be used for ablation.

[0331] In various embodiments, ablation can include destruction of tissue to form a lesion, and such function can be implemented by cautery, cryoablation, radio frequency ablation, and / or other types of ablation. Cautery can include burning tissue, and such burning can be for the purpose of destroying tissue to form a lesion or can be for the purpose of vessel sealing. Thus, depending on specific application, an exemplary device 300 can implement cautery only, ablation only, or both cautery and ablation.

[0332] Turning to Fig. 61A, the device 300 is shown as being used in the environment 500. The function units 340 are shown as being inserted in the body tissue 520, with the first end regions 310 proximal to target tissue 524 that is an interior part of the body tissue 520.

[0333] In one embodiment, the device 300 can cauterize at least a part of the target tissue 524 using a suitable type of energy transmitted from the function unit 340, to form a lesion. Forexample, the body tissue 520 can include heart tissue. The target tissue 524 can include tissue that is, but should not be, conductive, resulting in atrial fibrillation. Additionally and / or alternatively, the target tissue 524 can be an area of precancerous tissue. The cautery or the ablation can use small burns or freezes to cause some scarring on the target tissue 524 to make the target tissue 524 non- conductive, so as to break up the electrical signals that cause irregular heartbeats.

[0334] Additionally and / or alternatively, the function units 340 can be used for mapping electrical activity in the heart before ablation. Because the function units 340 can be electrically conductive, an electric current path with enhanced conduction can be formed between the function units 340 and the body tissue 520, so the electrical activity can be mapped with greater sensitivity, accuracy and efficiency. In various embodiments, the function units 340 can include needles, bumps, and / or other forms of microscale texture that can enhance electrical conductivity without traumatizing tissue.

[0335] In another embodiment, the target tissue 524 can include at least a portion of a blood vessel. The device 300 can bum the target tissue 524 to close or seal off the blood vessels from the organ. The device 300 can thus be used for hemostasis in a surgery (for example, a surgery for removing a body organ).

[0336] Figs. 61A and 61B illustrate significant advantages of the device 300 via a comparison. As shown in Fig. 61 A, the function units 340 can transfer energy directly to the target tissue 524 and thus can burn or freeze the target tissue 524 very fast. Stated somewhat differently, an energy transmission depth (or burn depth) 526 can be very small or zero, resulting in an energy transmission time (or bum time) that is short. The energy transmission depth 526 can include a distance extending between the function unit 340 and the target tissue 524. The energy transmission time can include a length of time required to remove and / or close off the target tissue 524 by the device 300. Stated somewhat differently, the function units 340 can be more energy-conductive than the body tissue 520, so the function units 340 can provide additional penetration of thermal effect (or effects incurred by other types of energy) into the body tissue 520.

[0337] Concurrently with burning or freezing of the target tissue 524, the device 300 can incur lateral energy spread (or lateral burn) 528 in the body tissue 520. The lateral energy spread 528can include bum (or effects incurred by other types of energy) that extends and / or spreads from the function units 340 in a plane perpendicular to direction of the energy transmission depth 526. Fig. 61 A shows the lateral burn 528 in the form of arrows for illustrative purposes. Because the energy transmission time is short, the lateral energy spread 528 can be reduced, energy transmission efficiency (or burning efficiency) can advantageously be improved. For example, when the target tissue 524 includes a portion of a blood vessel, the lateral energy spread 528 can be spread less along the remainder of the blood vessel.

[0338] For illustrative purposes only, the target tissue 524 is shown as not touching or overlapping with the function units 340. In one embodiment, the target tissue 524 can directly contact or overlap with the function units 340. In another embodiment, there can be a distance between the target tissue 524 and the function units 340. Even though the function units 340 does not necessarily reach far to directly contact the target tissue 524, the function units 340 can penetrate deeper for a given energy dose, while limiting the lateral energy spread 528.

[0339] In contrast, Fig. 61B shows the device 300 as being replaced by an electrode 510 burning at a surface of the body tissue 520 and has a flat interface with the body tissue 520. The electrode 510 is a conventional cautery device. The electrode 510 has to keep burning until the burns gets to the energy transmission depth 526. Compared with Fig. 61 A, the electrode 510 requires a greater energy transmission depth 526, thus resulting in a greater energy transmission time and greater lateral energy spread 528. For illustrative purposes only, the relative extent of the lateral energy spread 528 in Figs. 61 A and 61B is compared via the lengths of the corresponding arrows (not necessarily to scale). Accordingly, by using the device 300, a variety of medical procedures can achieve improved results. Exemplary medical procedures can include, for example, vessel ligation, cardiac ablation, precancerous tissue ablation.

[0340] Turning to Figs. 62-64, the support structure 360 is shown as including a catheter device. For example, the catheter device can be used in cardiac procedures. The support structure 360 is shown as having an elongated shape, and the function units 340 are shown as being located on an end region of the support structure 360 and aligned with a direction of the extension of the support structure 360. Stated somewhat differently, the function units 340 can be on an end surface 362 of the support structure 360.

[0341] Turning to Figs. 65 and 66, the device 300 as shown is similar to the device 300 of Figs. 62-64, except that the function units 340 are shown as being at an angle with the direction of the extension of the support structure 360. The angle can be any suitable value greater than 0 degree and less than 90 degrees. An exemplary angle can be 30, 45, or 60 degrees. The angle can be determined by the specific purpose of medical procedure.

[0342] Turning to Figs. 67-69, the device 300 as shown is similar to the device 300 of Figs. 62-66, except that the function units 340 are shown as being perpendicular with the direction of the extension of the support structure 360. Stated somewhat differently, the function units 340 can be on a lateral surface 364 of the support structure 360. In various embodiments, the support structure 360 can contain an articulation mechanism (not shown) to allow the functional units 340 to achieve multiple angles as illustrated various embodiments shown in Figs. 62-69.

[0343] Turning to Figs. 70-72, the support structure 360 is shown as including jaws that can be used for a certain surgery. Stated somewhat differently, the device 300 can include a laparoscopic device. The function units 340 are shown as being located in the jaws.

[0344] Device with surface modification

[0345] Turning to Fig. 73, an exemplary base part 150 is shown as including an internal region 152 and a surface region 154. The surface region 154 can cover at least part of the internal region 152. In various embodiments, the surface region 154 can cover the internal region 152 entirely. In various embodiments, the internal region 152 and the surface region 154 can be made of first and second materials, respectively. The second material and be different from the first material. The base part 150 can have any suitable shapes. In various embodiments, the base part 150 is shaped in a manner such that the internal region 152 can form a pathway (or structure) 151 that is continuous and made of the first material.

[0346] In various embodiments, the first and second materials can be conductive and insulative, respectively. For example, the first and second materials can be metallic and ceramic, respectively. Stated somewhat differently, the first and second materials can include a metal and include a ceramic, respectively. Exemplary first and second materials can include a stainless steel and include chromium oxide (Cr2Ch), respectively. Accordingly, the pathway 151 can be conductive and insulated from an external environment, and thus can implement specific electrical functions for a wide range of applications.

[0347] In some embodiments, the base part 150 can have a shape of at least one helical coil. The exemplary base parts 150 are shown in Figs. 75-76. Accordingly, the pathway 151 can similarly have a shape of the helical coil. Thus, the base part 150 can be configured to transmit power and / or signal via induction.

[0348] In some embodiments, the base part 150 can have a small size. For example, the base part 150 having the shape of the helical coil can have a coil outer diameter smaller than 10mm, smaller than 5mm, or smaller than 1mm. The helical coil can have a wire diameter smaller than 1mm, or smaller than 0.5mm, or smaller than 0.2mm. Such size and shape may be difficult to achieve by conventional methods in a commercially viable manner. Thus, the base part 150 can be a part of a medical implant device, and can be configured to transmit power and / or signal, via induction, from and / or to the medical implant device.

[0349] In various embodiments, the base part 150 can have a depth of material conversion, or a thickness of the surface region 154, greater than 1 micron but less than 100 microns.Additionally and / or alternatively, the ceramic material of the surface region 154 can include an oxide of one of the elements in the original alloy of the internal region 152. Even though existing techniques may create an oxide layer at a surface, such oxide can only have a thickness on the order of nanometers. In contrast, the method set forth above can creates a layer with a thickness of multiple microns in a controllable manner. Advantageously, the exemplary layer can be used for the purpose of electrically insulating the core material with a thick and mechanically robust layer.

[0350] Turning to Fig. 74, an exemplary flow chart of an embodiment of a method 250 for making the base part 150 is shown. The base part 150 can be formed, at 252, with a first material. In various embodiments, the base part 150 can be made using 3D printing. The surface region 154 of the base part 150 can be electrochemically modified, at 254, such that the surface region 154 can convert to the second material. In various embodiments, the base part 150 can be entirely submerged in an electrolyte and be electrochemically treated. For example, the electrochemical treatment can etch away one or more of the metal components from the surface region 154, and oxidize the remaining metal component in the surface region 154.

[0351] Although the base part 150 can be made using any suitable methods, without limitation, the method 250 can be advantageous compared with conventional methods for the followingreasons. The base part 150 of a complex shape can be made in an easy manner using 3D printing. For example, the base part 150 can include a plurality of helical coils arranged in multiple layers. Stated somewhat differently, an exemplary base part 150 can include a helical coil enclosed by another helical coil that can be further enclosed by a third helical coil. Although coil structures may conventionally be made using a mandrel-based winding process, such a process would be very difficult and expensive, and thus not commercially viable, for a structure that is complex and / or microscale. The method 250 provides a way to make complex radiofrequency components as integrated pieces without a need of manual assembly process.

[0352] Turning to Fig. 75, the base part 150 is shown as having a helical shape that includes a plurality of windings 156. The windings 156 can be uniform and / or different. The base part 150 can be used as an inductor to power implant devices and / or batteries. Because the base part 150 can include the surface region 154 (shown in Fig. 73) as a shell (or skin) that can be insulative, the base part 150 can be within a biological body and remain functional.

[0353] Turning to Fig. 76, the base part 150 is shown as including one or more struts 158 that connect at least two adjacent windings 156. In various embodiments, the base part 150 can include the struts 158 for connecting each two adjacent windings 156. Advantageously, the base part 150 can be mechanically more stable. The struts 158 can be 3D printed, or made with any other methods, as a part of the base part 150 using the first material. The base part 150 can have any other shapes, without limitation. Fig. 111 shows details drawings of the base part 150 with a planar coil shape. During the electrochemical treatment, a penetration depth of the electrolyte can be such that, the electrolyte can fully penetrate the struts 158 and fully convert the struts 158 into the second material, but the electrolyte can convert only the surface region 154 of other portion(s) (for example, of the helix coil) of the base part 150. In various embodiments, the struts 158 can each have a suitable size. For example, the strut 158 prior to the conversion can have a width (or thickness, or diameter) that is less than or equal to two times of a surface modification depth of the electrochemical treatment. Stated somewhat differently, the strut 158, after the conversion, can have the width that is less than or equal to two times of the thickness of the surface region 154 formed in the based part 150.

[0354] Battery device

[0355] Turning to Fig. 77, an exemplary base part 170 is shown as including a support 174, and first and second electrode bodies 171A, 172A connected to the support 174. The base part170 can be used for making a battery device. The first and second electrode bodies 171 A, 172A can be used for forming opposite electrodes of the battery device. In various embodiments, the base part 170 can be made with a first material. The first material can be electrically conductive. Stated somewhat differently, the first and second electrode bodies 171A, 172A can each form a conductive pathway (or structure). The support 174 and first and second electrode bodies 171 A, 172A can have any suitable shapes.

[0356] In various embodiments, the support 174 can be at least partially converted into a second material such that the support 174 can electrically isolating the first electrode body 171A from the second electrode body 172A. Accordingly, the first and second electrode bodies 171 A and 172A can be biased separately in any subsequent electrochemical reactions, and thus result in different respective electrical properties. In some embodiments, the support 174 can be entirely converted into a second material.

[0357] In various embodiments, the support 174 can be converted into the second material via electrochemical etch. For example, the first and second materials can be metallic and ceramic, respectively. Stated somewhat differently, the first and second materials can include a metal and include a ceramic, respectively. Exemplary first and second materials can include a stainless steel and include chromium oxide (Cr2Ch), respectively. Accordingly, the electrode bodies171 A, 17 IB and the ceramic support 174 can share at least one metal component.

[0358] Turning to Fig. 78, an exemplary battery structure 176 made using the base part 170 is shown. The battery structure 176 is shown as including the base part 170, and first and second electrode coatings 171B, 172B formed on the first and second electrode bodies 171A, 172A, respectively. The first electrode body 171 A and the first electrode coating 17 IB can be a first electrode structure 171 of the battery structure 176. The second electrode body 172A and the second electrode coating 172B can be a second electrode structure 172 of the battery structure 176. The first electrode coating 17 IB is different from the second electrode coating 172B such that the first and second electrode structures 171, 172 can be the two opposite electrode structures of the battery structure 176. For example, the first and second electrode coatings 17 IB, 172B can include anode and cathode materials, respectively, such that the first and secondelectrodes 171, 172 can be the anode and cathode structures of the battery structure 176. In another example, the first and second electrode coatings 17 IB, 172B can include cathode and anode materials, respectively, such that the first and second electrodes 171, 172 can be the cathode and anode structures of the battery structure 176. Although the first and second electrodes 171, 172 can function as electrodes of opposite polarity in a battery for illustrative purposes only, a composition (or chemical composition) of the first electrodes 171 can be different from the composition of the second electrodes 171, 172 in any suitable manner, and do not necessarily result in the first and second electrodes 171, 172 having opposite polarity. Stated somewhat differently, the base part 170 can be modified to be any suitable device that has dissimilar electrodes and is not necessarily modified into the battery structure 176. In some embodiments, the first and second electrodes 171, 172 can be configured to have a relative difference therebetween such that the first and second electrodes 171, 172 can be used as two electrodes of opposite polarity suitable for being used in a battery.

[0359] Turning to Fig. 79, an exemplary flow chart of an embodiment of the method 270 for making the battery structure 176 is shown. The base part 170 can be formed, at 272, with a conductive material. The base part 170 can include the support 174, and the first and second electrode bodies 171A, 171B on the support 174. The base part 170 can be made using any suitable methods. In various embodiments, the base part 170 can be formed using 3D printing.

[0360] The support 174 can be electrochemically modified, at 274, to be insulative. In various embodiments, the support 174 can be at least partially, and / or entirely exposed to an electrolyte in any suitable manner and be electrochemically treated. In some embodiments, the support 174 can be at least partially, and / or entirely submerged in an electrolyte and be electrochemically treated. The support 174 can be at least partially electrochemically modified to electrically insulate between the first and second electrode bodies 171A, 171B. For example, the electrochemical treatment can etch away one or more of the metal components from the support 174, and oxidize the remaining metal component in the support 174. Additionally and / or alternatively, the support 174 can be placed on an absorbent material (for example, paper towel, sponge) that is soaked and / or saturated with the electrolyte. Optionally, the support 174 can define channels (not shown) therein for the electrolyte to travel therein via a capillary action, to increase the contact area with the electrolyte and facilitate the electrochemical reaction.

[0361] The first electrode body 171A can be at least partially electrochemically plated, at 276, with the first coating 171B. In various embodiments, the first electrode body 171A can be at least partially, and / or entirely, soaked in an electrolyte for plating the first coating 171B. In some embodiments, the first and second electrode bodies 171A, 171B can be entirely soaked in the electrolyte. In some embodiments, the base part 170 can be entirely soaked in the electrolyte. Only the first electrode body 171 A needs to be electrically biased during the plating. Partial coating the first and / or second electrode bodies 171 A, 17 IB can result in a working battery, but the more coated area can result in a greater capacity of the battery.

[0362] The second electrode body 172A can (optionally) be at least partially electrochemically plated, at 278, with the second coating 172B. In various embodiments, the second electrode body 172A can be at least partially, and / or entirely, soaked in an electrolyte for plating the second coating 172B. Soaking of the second electrode body 172 A can be in a manner similar to the process of plating first electrode body 171 A. Only the second electrode body 172A needs to be electrically biased during the plating. Although the first and / or second electrode bodies 171 A, 17 IB are shown as being plated to form coatings for illustrative purposes only, the first and / or second electrode bodies 171A, 171B can be modified in any uniform and / or different manner, without limitation. For example, the first and / or second electrode bodies 171 A, 171B can be etched to have different remaining elements, respectively, so to form the cathode and anode structures. In another example, the first electrode body 171A can be etched, and the second electrode bodies 171A, 171B can be plated. In yet another example, the first electrode body 171A can be plated, and the second electrode bodies 171A, 171B can be etched. Any suitable process that leads to dissimilar surface layer for the first and second electrode bodies 171 A, 17 IB can be used. Electrolytes for making the first and second electrodes 171, 172, when plating and / or etching is used, can include first and second electrode-processing electrolytes (not shown), respectively. Further, for any embodiments disclosed throughout the present disclosure, when ‘first’ and ‘second’ are designed to any components, units, or the like, the ‘first’ and ‘second’ can be used for ease of reference only, and does not necessarily limit the sequence, or characteristics, of the related to the components, units, or the like. For example, a process for a first component can be performed before, concurrently with, and / or after a process for the secondcomponent. In some embodiments, either a process of the first component or a process of the second component can be optional.

[0363] Turning to Figs. 80 and 81, angled side view and angled top view of the base part 170 are shown. The first and second electrode bodies 171 A, 172A (or the first and second electrodes 171, 172) are shown as each having a lattice structure. The lattice structures of the first and second electrode bodies 171 A, 172A can be interwoven and non-intersecting (or noncontacting). The lattice structures can have a great surface exposure area. Advantageously, charge storage capacity of the battery structure 176 (shown in Fig. 78) can be increased.

[0364] Fig. 82 shows a top view of the base part 170. The lattices of the first and second electrode bodies 171 A, 172A can each have a characteristic strut thickness. The characteristic strut thicknesses of the first and second electrode bodies 171 A, 172A can be uniform and / or different. The characteristic stmt thicknesses can be selected such that the lattice structures can be mechanically stable and sufficient room is available for plating the first and second electrode coatings 171B, 172B (shown in Fig. 78).

[0365] Turning to Fig. 83, a bottom view of the base part 170 of Figs. 80 and 81 is shown.The support 174 is shown as having a planar shape of a grid structure. The support 174 can have any suitable shape and / or pattern, such as a plate / sheet shape with a solid pattern. But the support 174 have the grid structure can advantageously be electrochemically treated at a greater speed. Figs. 80-83 can also be used for showing the battery structure 176 because the base part 17 and the battery structure 176 are similar in shape.

[0366] The support 174 is shown as including a plurality of bars 178 that intersected and / or woven to form the grid structure. The bars 178 can each have a selected characteristic stmt thickness based upon a penetration depth of the electrochemical conversion process, such that the support 174 can be converted to be insulative. The support 174 can have a grid pattern and / or size that is uniform with, and / or different from the lattices of the first and second electrode bodies 171A, 172A. The characteristic stmt thickness of the support 174 can be uniform with, and / or different from, the characteristic stmt thickness of the first and second electrode bodies 171 A, 172A.

[0367] The battery stmcture 176 and the method 270 can be advantageous compared with conventional methods for at least the following reasons. The base part 170 of a complex shapecan be made in an easy manner using 3D printing. Further, even if a conventional method is incorporated with 3D printing, a battery can be expensive and difficult to make because the battery needs to incorporate at least two different types of materials into one object. A conventional method can only make such an object use a multi -material printer, and the manufacturing process slow and expensive. To make two interwoven but non-intersecting lattices, the printing process can be difficult, if at all possible, for the multi -material printer, and the process is not commercially viable. With the method 270, a woven or lattice structure in the battery structure 176 can be achieved without having to use multi-material printing. The battery structure 176 can be electrochemically treated in largescale batches with a high throughput. Thus, the battery structure 176 with the interwoven lattice structure can be mechanically stable, and made in a less expensive and more effective manner.

[0368] Additionally and / or alternatively, the first and second electrode bodies 171 A, 172A can be of any suitable size. In various embodiments, the first and second electrode bodies 171 A, 172A can have the lattice structures with a small characteristic strut thickness, so the battery structure 176 can advantageously have maximized surface area. Even if any conventional method can achieve the lattice structure with small strut thickness (for example, at micron scale), the method would not be cost effective and thus not practical for large batches or large devices needed for commercial applications. In contrast, the method 270 can print lattices with small scale thicknesses but can electrochemically treat the base part 170 at a large scale and in a cost- effective manner.

[0369] Conventionally, once production equipment is set up, the size and shape of a battery cell to be made is fixed. The size of the battery cannot be customized. Battery packs of varying capacity can only be achieved by using fewer or more battery cells. In contrast, the method 270 can achieve the battery structure 176 with any arbitrary size and / or shape to suit a wide variety of applications including, for example, medical implant, hearing aid, or electronic devices. The battery structure 176 can be any shape such as square, circular, or the like. The battery structure 176 can be scaled and / or customized for any application without high cost.

[0370] Thermopile device (or material junction)

[0371] Turning to Fig. 84, an exemplary base part 190 is shown as including first and second sections 191, 192. The first and second sections 191, 192 can be directly and / or indirectlyconnected. For example, the first section 191 can be in direct contact with the second section 192. Additionally and / or alternatively, the base part 190 can include a connecting section 194 (shown in Fig. 87) between the first and second sections 191, 192.

[0372] In various embodiments, the base part 190 can be monolithic. The base part 190 can be made using any suitable methods. In various embodiments, the base part 190 can be formed using 3D printing, or any other methods, without limitation. In various embodiments, the base part 170 can be made of an alloy. In various embodiments, an alloy can include a solid composite material that contains at least two different chemical elements. An exemplary alloy can include at least one metal element mixed with another metal element and / or non-metal element. Another exemplary alloy can include a plurality of metal elements. For example, the alloy can include a NiCu blend, a blend of silver and bismuth, and / or a CuCo blend.

[0373] The base part 190 is shown as defining a first edge region 191 A. The first edge region 191 A can include a region that can be in contact with a chemical reaction medium such that the first section 191 can be modified while the rest (including at least the second section 192) of the base part 190 is not exposed to the chemical reaction medium (for example, liquid phrase and / or gas phase). Stated somewhat differently, the first edge region 191 A can be a boundary portion of the base part 190 that can be the only portion of the base part 190 immersed in a chemical reaction medium. In various embodiments, the first edge region can include all, or a portion of the first section 191. The first edge region 191 A does not include any portion of the second section 192.

[0374] In various embodiments throughout the present disclosure, any modification (or etching) of a portion of a base part using a chemical reaction medium (or chemical solution), submerging (or soaking, or immersing) of the entire portion is not always necessarily required. The modification can be implemented via exposing relevant surface(s) to a chemical solution in any suitable manner. For example, the base part can be in contact with a wet paper towel (or any suitable porous substance) and allow fluid to wick into tubes (or internal channels) via capillary action. Such a process can be independent on orientation, and multiple fluids can be exposed selectively to multiple portions, bodies, and / or surfaces simultaneously. Stated somewhat differently, etching of selected portions of base part 190 can be implemented regardless of how the base part 190 is oriented.

[0375] Turning to Fig. 85, the first section 191 is shown as being modified. The modification can include changing a composition of the alloy in the first section 191. In various embodiments, a first element set can be removed from the alloy. The first element set can include at least one element. The removal of the first element set can be via any suitable methods. Exemplary methods can include electrochemical etch and / or chemical etch. In various embodiments, only the first edge region 191 A, and not the rest of the base part 190, can be soaked in a first chemical reaction medium (now shown). The first chemical reaction medium can include an electrolyte and / or etchant (or etch agent). The electrochemical reaction and / or etching reaction can be implemented accordingly. In various embodiments, the reaction can extend and / or spread in a manner such that the first section 191 can be modified entirely. Thus, a junction of dissimilar materials can be formed between the first and second sections 191, 192. The first and second sections 191, 192 each can include a single element and / or a subset of the elements of the alloy.

[0376] Optionally, the second section 192 is shown as being modified. The modification can include changing a composition of the alloy in the second section 192. The modification of the second section 192 can be different from the modification of the first section 191. In various embodiments, a second element set can be removed from the alloy. The second element set can include at least one element. The second element set can be different from the first element set.

[0377] The base part 190 is shown as defining a second edge region 192A. The second edge region 192A can include a region that can be in contact with a chemical reaction medium such that the second section 192 can be modified while the rest (at least the first section 191) of the base part 190 is not exposed to the chemical reaction medium. Stated somewhat differently, the second edge region 192A can be a boundary portion of the base part 190 that can be the only portion of the base part 190 immersed in a chemical reaction medium. In various embodiments, the second edge region 192A can include all, or a portion of the second section 192. The second edge region 192 A does not include any portion of the first section 191.

[0378] The removal of the second element set can be via any suitable methods. Exemplary methods can include electrochemical etch and / or chemical etch. In various embodiments, only the second edge region 192A, and not the rest of the base part 190, can be soaked in a second chemical reaction medium (not shown). The second chemical reaction medium can include anelectrolyte and / or etchant. The electrochemical reaction and / or etching reaction can be implemented accordingly. In various embodiments, the reaction can extend and / or spread in a manner such that the second section 192 can be modified entirely.

[0379] Turning to Fig. 86, an exemplary flow chart of an embodiment of a method 290 of making a junction of dissimilar materials. The method 290 can be used for selective etching to create multi -material junctions, regardless of any production method of the base part 190. The base part 190 can be formed, at 292, with an alloy. The base structure 190 can include the first and second sections 191, 192. The base part 190 can define the first edge region 191A. The first section 191 can be modified, at 294, by soaking the first edge region 191A in a first chemical reaction medium. For example, when the first chemical reaction medium is a liquid solution, the base part 190 can be oriented such that the first edge region 191 A can face groundward, so the first edge region 191 A can be the only portion of the base structure 190 that enters the liquid solution.

[0380] Optionally, an orientation of the base part 190 can be changed, at 296. In various embodiments, changing of the orientation can include altering how the base part 190 is positioned. Optionally, the second section 192 can be modified, at 298, by soaking the second edge region 192A in a second chemical reaction medium. For example, when the second chemical reaction medium is a liquid solution, changing of the orientation at 296 can include rotating by a selected angle, and / or inverting (or rotating by 180 degrees, moving up-side-down) of the base part 190 such that the second edge region 192 A can face groundward, so the second edge region 192 A can be the only portion of the base structure 190 that enters the liquid solution.

[0381] The base part 190 made using the method 290 as set forth above can be used for any applications that requires making junctions between dissimilar materials. In various embodiments, the first and second sections 191, 192 can be modified to be different metal materials such that the base part 190 can have thermoelectric properties. For example, the base part 190 can be a thermal couple upon modification. Additionally and / or alternatively, the base part 190 can include a plurality of first sections 191 (shown in Fig. 88) and a plurality of second sections 192 (shown in Fig. 88), and thus can be modified to form an array of the junctions. The base part 190 can thus be used as a thermopile and / or thermal couple. In a non-limiting example, the base part 190 can be made of the alloy including an NiCu blend. The first and secondsections 191, 192 can be etched and be respectively modified to include Ni only, and Cu only. In another example, the base part 190 can be made of the alloy including an CuCo blend. The first and second sections 191, 192 can be etched and be respectively modified to include Cu only, and Co only. Additionally and / or alternatively, the base part 190 can be made of the alloy including a blend of silver and bismuth.

[0382] Optionally, when the modification at 294 includes etching, the first section 191 can be processed, after 294, for refilling voids that are generated in the first section 191 by the etching. In various embodiments, the first section 191 can be electrochemically plated with a material that is the same and / or similar to the material of the first section 191 remaining from the modification at 294. Accordingly, mechanical stability, and electrical and / or thermal conductivity, of the first section 191 can be improved. The first section 191 can be exposed to an electrolyte (for example, a first plating electrolyte) for electrochemical plating by soaking the first edge region 191 A in the electrolyte. Similarly, the second section 192 can be processed, after 298, for refilling voids generated in the first section 192 by any etching at 298. For example, the second edge region 192 A can be soaked in a second plating electrolyte.

[0383] Turning to Fig. 87, the base part 190 is shown as including the optional connecting section 194. The connecting section 194 can be a transition section. In some embodiments, the connecting section 194 can be partially in the first or second edge region 191 A, 192A. Stated somewhat differently, a portion of the connecting section 194 can be in the first edge region 191 A and be modified. Another portion of the connecting section 194 can be in the second edge region 192A and be modified. Stated somewhat differently, portions of the connecting section 194 can be converted to become part of the first and / or second sections 191, 192.Advantageously, the first and second sections 191, 192 can expand into the connecting section 194 after the modification, locate more proximally and thus form a more abrupt junction.

[0384] Turning to Fig. 88, the base part 190 is shown as including a plurality of first sections 191 and a plurality of second sections 192. The base part 190 is shown as including a plurality of connecting sections 194 each located between two adjacent first and second sections 191, 192. The first edge region 191 A is shown as including at least a portion of each of the first sections 191, and optionally a portion of each of the connecting sections 194. The second edge region192A is shown as including at least a portion of each of the second sections 192, and optionally another portion of each of the connecting sections 194.

[0385] The first and second sections 191, 192 can have any uniform and / or different suitable sizes, shapes and / or arrangement, without limitation. In the example as shown, the first and second sections 191, 192 respectively forms two rows aligned in a staggered manner. Stated somewhat differently, the first and second sections 191, 192 can be positioned alternately.Center points of the first and second sections 191, 192 can respectively define lines 191B, 192B. In the example shown in Fig. 89, the lines 19 IB, 192B are offset in a direction perpendicular to the lines 191B, 192B by a distance such that the first and second edge regions 191 A, 192A can be defined in the base part 190. Stated somewhat differently, the first and second sections 191, 192 respectively form two rows that are offset such that the first and second sections alternate in a zig-zag arrangement, the first edge regions 191 A and the second edge regions 192A forming two opposite edge regions (or overall edge regions) 191C, 192C of the base part 190, respectively. In various embodiments, only one of the edge regions 191C, 192C can be, or needs to be, submerged in a fluid in the method 290 (shown in Fig. 86).

[0386] Turning to Fig. 89, the base part 190 is shown as defining one or more channels 196. The channel 196 can extend from the first edge region 191 A into the first section 191 such that the chemical reaction medium can travel from the first edge region 191 A into a selected depth of the first section 191 such that the first section 191 can entirely be exposed to the chemical reaction medium and be modified. In some embodiments, the chemical reaction medium can be a liquid solution and can be driven though the channel 196 via the capillary action.Advantageously, the first section 191 can be entirely modified even if the first edge regions 191A is defined to only include a portion of the first section 191 due to any geometric restrictions based on specific applications. Similarly, the channel 196 can extend from the second edge regions 192A into the second section 192 such that the second section 192 can be entirely modified even if the second edge regions 192A is defined to only include a portion of the second section 192 due to any geometric restrictions based on specific applications.

[0387] Turning to Figs. 90 and 91, angled and top views of an embodiment of the base part 190 of Fig. 88 is shown. The base part 190 is shown as defining the channel 196 in the first andsecond sections 191, 192. In various embodiments, each channel 196 can extend partially, and / or entirely, through the first and second sections 191, 192.

[0388] The structures and methods can provide significant advantages over existing techniques. For example, a conventional way to make an array of junctions, such as a thermopile, requires winding wires of different materials together in a large array via a complex, expensive and tedious process. Such a process can be expensive. In certain applications, the array needs to be at microscale. For example, the thermopile is used as a thermoelectric generator (TEG) integrated into a wearable biosensor, or other implant devices, that uses body heat to generate electricity. Using the conventional method can be tedious and very expensive, and thus impractical for making a large quantity of products. In contrast, according to the method as set forth, the base part 190 can be made as a monolithic piece. The monolithic piece can be 3D printed to form any complex shape as needed, and modified in a high volume process. The process can be simple and low lost, making commercialization possible.

[0389] Rotary needle array

[0390] Turning to Fig. 92A, a top view of a device 730 for fixation to body tissue 520 (shown in Fig. 93) is shown. The device 730 is shown as including a base piece 736 defining a center of rotation 738, and one or more rotary needles (or needles) 734 distributed about the center of rotation 738. Each rotary needle 734 defines a tip region 731 and a base region 732 opposite to the tip region 731 and connected to the base piece 736. A distance between the center of rotation 738 and a projection of the tip region 731 on the base piece 736 defines a tip distance 731 A. A distance between the center of rotation 738 and a projection of the base region 732 on the base piece 736 defines a base distance 732A. For a given rotary needle 734, the tip distance 731 A can be greater than, smaller than, or equal to the base distance 732A. Although the device 730 is shown as including two rotary needles 734 for illustrative purposes only, the device 730 can include one rotary needle 734, or any other suitable number of uniform and / or different rotary needles 734 arranged in any suitable manner, without limitation. For practical applications, the device 730 can include greater than two rotary needles 734, or include preferably three rotary needles 734. Although the base piece 736 is shown as having a solid pattern for illustrative purposes, the base piece 736 can have any suitable patterns and / or texture, without limitation.

[0391] Turning to Fig. 92B, a cross-sectional view of the device 730 is shown. The base piece 736 is shown as having a needle-facing surface 736C connecting to the rotary needle 734. The needle-facing surface 736C can be planar but the base piece 736 can have any suitable surface morphology, without limitation. The rotary needle 734 is shown as slanting from the base piece 736 at a tilting angle 733. The tilting angle 733 can be any value between 0 and 90 degrees, without limitation. An exemplary tilting angle 733 that can be useful for many applications can range from 20 degrees to 70 degrees.

[0392] Turning to Fig. 93, the device 730 is shown as being used in the environment 500. To fixating the device 730 to the body tissue 520, the device 730 can approach the body tissue 520 with the needle-facing surface 736C facing toward the body tissue 520. The device 730 can advance the tip region 731 into the body tissue 520 and, at the same time, rotate the base piece 736 about the center of rotation 738. Stated somewhat differently, the base piece 736 can move toward the body tissue 520, while rotating about an axis 738A that passes the center of rotation 738 and perpendicular to the base piece 736. Thus, the rotary needle 734 can penetrate the body tissue 520 in a helical motion. The motion can be both rotational and longitudinal. The rotation can be clockwise and / or counterclockwise, depending on the orientation of the rotary needles 734.

[0393] In various embodiments, friction between the device 730 and the body tissue 520 can prevent the rotary needle 734 from backing out from the body tissue 520. Although the rotary needle 734 is shown as have a smooth surface for illustrative purposes only, the rotary needle 734 can have a suitable surface roughness. The rotary needle 734 can have various surface features and / or shapes on the rotary needle 734 and / or on the base piece 736. For example, bumps and / or barbs can be formed on the rotary needle 734. The bumps can include protrusion that is smooth to avoid harming the body tissue 520. Exemplary bumps can be similar to the bump 742 shown in Figs. 108-110. Additionally and / or alternatively, the needle-facing surface 736C to contact the body tissue 520 can be roughened.

[0394] In various embodiments, fixation of the device 730 can be achieved mechanically and be reliable such that the base piece 736 can be only optionally adhesive. An exemplary base piece 736 is not adhesive. Adhesive material is often compromised by moisture, can be painfulto remove and would be especially undesirable for frequent or daily use (for example, when used with a glucose monitor). Advantageously the device 730 can achieve pain-free removal.

[0395] In various embodiments, the rotary needle 734 can be small such that a patient does not feel penetration of the rotary needle 734. An exemplary rotary needle 734 can have a length of a few hundred microns. The base piece 736 can have any size. An exemplary base piece 736 can be no greater than a dime (or no great than 25 mm in diameter)

[0396] In some embodiments, the rotary needles 734 can be conductive. Accordingly, the device 730 can be used as electrodes for cardiac electrophysiology devices and / or neuromodulation, bioactive electrical sensors, and / or wearable sensor. In some embodiments, the device 730 can be used for chemotherapy delivery.

[0397] Turning to Fig. 94, an exemplary flow chart of an embodiment of a method 750 of using the device 730 is shown. The device 730 can be oriented, at 752, such that the rotary needle 734 and the base piece 736 are proximal to and distal from the body tissue 520, respectively. The rotary needle 734 can be advanced, at 754, into the body tissue 520 while the base piece 736 being rotated about the center of rotation 738.

[0398] The device 730 and the method 750 can provide significant advantages over existing techniques. Existing microneedle arrays point straight up from a base, and pushes straight and linearly to the tissue. When such needles press on skin or tissue, the skin or tissue deflects to prevent penetration (especially significantly for large area of soft tissue). Further, pressure is applied over many needles and there is not sufficient pressure over any individual needle tip to cause penetration. Thus, if an array of needles presses on the tissue, the ‘bed of nails’ effect can take place, resulting in tissue deflection without penetration. Therefore, the needles have low efficiency in needle penetration, and the needle does not necessarily get full penetration every time. A sharper needle can exert less force and result in less tissue deflection. Using fewer needles may help to reduce the ‘bed of nails’ effect. However, with a given needle type, given sharpness, and given number of needles as required by a specific application, soft tissue can often lead to the ‘bed of nails’ effect that the needle array needs to overcome. Accordingly, needles at the periphery of the array penetrate more than those at the center of the array. So the total penetration can be inefficient and / or unpredictable or unrepeatable. This is problematic in drug delivery because it can impact dosage repeatability. For solid coated drug delivery needles,it leads to inconsistency in the total amount of surface area of the needles that is embedded in the skin. For hollow needles, it can lead to leaks in the middle of the array where needles failed to penetrate. It’s also problematic in diagnostics, since the penetration efficiency will affect the reliability and / or repeatability of the signal generated by the sensor.

[0399] In contrast, the device 730 uses circular and / or angled configuration of needles and generates rotation actions to create tension in the body tissue 520. With a given needle type, given sharpness, and given number of needles for a certain application (such as drug delivery, sensing), the device 730 can overcome the ‘bed of nails’ effect, and result in better penetration than conventional straight- and linearly-applied needles. The device 730 has a simple structure without any complex moving parts, thus can be more miniaturized and efficiently operated. The initial helical rotation motion can be achieved manually and / or with an application device (not shown) coupled to the device 730.

[0400] For example, when the tip distance 731 A is greater than the base distance 732A (in example shown in Fig. 95A), the tip region 731 contacts the body tissue 520 at an insertion point (not shown), starts rotating, and makes the insertion point slide along the rotary needle 734. The sliding motion can further pull the body tissue 520 toward the center of rotation 738 because the base distance 732A is smaller than the tip distance 731 A. Thus, tension can be created in the body tissue 520. Thus, deformation and / or deflection of the body tissue 520 can be prevented. Because the deformation and / or deflection can prevent needle penetration, the device 730 can result in more efficient and reliable needle penetration. The amount of tissue tension can be tuned by geometry of the device 730.

[0401] For example, when the tip distance 731 A is equal to the base distance 732A (also in example shown in Fig. 95B), there is no net movement of the body tissue 520 between initial contact and full penetration of the rotary needle 734. Stated somewhat differently, a temporary tension can be incurred during rotation but the body tissue 520 can relax after full penetration. Such a configuration can be advantageous when it is undesirable to keep the body tissue 520 in tension overtime.

[0402] Therefore, by controlling the difference between the tip distance 731 A and the base distance 732A, and / or geometry of the rotary needle 734, the device 730 can create a force, such as compression and / or tension, on the body tissue 520 in which the rotary needle 734 isembedded. The force can be controlled, and / or varied, precisely throughout the process of engagement, from the initial contact to full penetration. The tension to create in the body tissue 520 can depend on the specific type of application of the device 730, the number of rotary needles 734, functions of the rotary needles 734, the type of surface area of the body tissue 520, and the type of fixation desired upon penetration. For example, skin can be stretchy so can be compliant to the tension, thus keeping the skin in less tension can be acceptable in some cases. In another example, certain body tissue, tension may need to be kept to ensure the tissue is retained. In another example, an internal cardiac implant device (for example, implantable defibrillator, or pacemaker) may need to keep electrodes on a heart. It may be desirable to create engagement with the heart tissue. But the heart tissue still needs some mobility, so it may be beneficial to create no net tension on the tissue after engagement. In one embodiment, a single rotary needle 734 can switch between tension and compression during engagement (for example, having a zigzag shape).

[0403] Turning to Figs. 95A-95C, alternative embodiments of the device 730 are shown. The device 730 is shown as including a plurality of the rotary needles 734. The rotary needles 734 can be distributed to surround the center of rotation 738. In various embodiments, the tip distances 731 A of the rotary needles 734 can be the same such that the tip regions 731 of the rotary needles 734 can define a tip circle 735 centered at the center of rotation 738 with a radius equal to the tip distance 731 A. Additionally and / or alternatively, the base distances 732A of the rotary needles 734 can be the same such that the base regions 732 of the rotary needles 734 can define a base circle 737 centered at the center of rotation 738 with a radius equal to the tip distance 731 A. Figs. 95A-95C show the radius of the tip circle 735 being greater than, equal to, and small than the radius of the base circle 737, respectively.

[0404] For illustrative purposes, Figs. 95A-95C shows the base piece 736 as having a circular shape and coinciding with the size of the base circle 737. However, the base piece 736 can have any suitable shapes and sizes, without limitation. Further, the base piece 736 is not necessarily in the shape of a sheet. Each of the tip circle 735 and the base circle 737 can be imaginary only. The tip circle 735 can have any suitable sizes. The base circle 735 and can have any suitable sizes permitted by the area of the base piece 736.

[0405] Turning to Fig. 96, the rotary needles 734 are shown as having a curved shape. In the non-limited example, the rotary needles 734 are shown as having a shape of an arc that can be a fraction of a circle 738B centered at the center of rotation 738. The projection of the arc on the base piece 736 can have an angle 733A. The angle 733A can have any suitable value, without limitation. An exemplary angle 733A can be 20, 25, 30, and / or 40 degrees. Stated somewhat differently, the projection of any part of the rotary needle 734 on the base piece 736 can be equal distance from the center of rotation 738. The cross-sectional view of the device 730 can be similar to the view in Fig. 92. Thus, the rotary needle 734 can be a helical shape that engages the body tissue 520 (shown in Fig. 93) in a helical motion and / or at a constant radius. Figs. 99 and 100 show detailed drawings of the device 730 with the rotary needle 734 being helical.

[0406] In some embodiments, the rotary needle 734 that is helical does not necessarily have to have a constant radius from the center of rotation 738. Figs. 101 and 102 show the rotary needle 734 as curving farther away, or distally, from the center of rotation 738. Figs. 103 and 104 show the rotary needle 734 as curving closer, or proximally, to the center of rotation 738.

[0407] Turning to Figs. 97A-97B, the device 730 is shown as including at least one locking structure 739 connected to the base piece 736. In various embodiments, the locking structure 739 can be perpendicular to the base piece 736. For example, the locking structure 739 can be connected to the base piece 736 at the center of rotation 738. The locking structure 739 and the rotary needles 734 can be located at the same side of the base piece 736. When the rotary needles 734 penetrate the body tissue 520 (shown in Fig. 93), the locking structure 739 can penetrate the body tissue 520 simultaneously for more securely locking the device 730 in place. In various embodiments, the locking structure(s) 739 can form a locking rotary array separate from the first array formed by the rotary needles 734. Preferably, the locking structure(s) 739 can be shorter than the rotary needles 734. Additionally and / or alternatively, the locking structure(s) 739 can preferably point in the opposite direction relative to the direction of the rotary needles 734, such that the locking structure(s) 739 can allow tissue engagement with the first array prior to locking. In various embodiments, the locking structures 739 can be protrusions, teeth or bumps smaller than the rotary needles 734, rather than a full needle, to prevent counter rotation and to allow for removal without excessive trauma to the tissue, depending on the application. The locking structure 739 can be used as a ground electrode (asset forth below) in some embodiments, but can be used for locking function without necessarily being an electrode, or grounding electrode, in other embodiments. In one embodiment, the locking structure 739 can include a needle. An exemplary needle can be straight.

[0408] Figs. 105-107 show detail drawings of an exemplary device 730 with the locking structures 739 each including a bump defining first and second edges 739A, 739B raised beyond the base piece 736. Stated somewhat differently, the first and second edges 739A, 739B can respectively define slopes at least partially toward, and face at least partially against, the direction of the rotary needles 734. Accordingly, when the rotary needle 734 is inserted in the body tissue 520 (shown in Fig. 93), the first edges 739A does not inhibit the penetration. Upon penetration, the second edge 739B can prevent the rotary needles 734 from backing out from the body tissue 520. The bump is shown as having an asymmetrical shape. The second edge 739B is shown as having a greater slope than the first edge 739A. Stated somewhat differently, the second edge 739B rises more sharply, than the first edge 739A, from the base piece 736. Advantageously, the locking structures 739 can more easily be inserted in the body tissue 520, but can more strongly inhibit any dislodging movement of the rotary needles 734.

[0409] Turning to Fig. 98, the base piece 736 is shown as including an inner section 736A, an outer section 736B surrounding the inner section 736A, and one or more connecting sections 736C that connects the outer section 736B with the inner section 736A. The inner and outer sections 736A, 736 can be located concentrically about the center of rotation 738. In some embodiments, the device 730 can include the locking structure 739 connected to the inner section 736A. The locking structure 739 and the rotary needles 734 can be conductive. The connecting sections 736C can be insulative.

[0410] For example, the device 730 can be used as a biosensor. The locking structure 739 can be a ground electrode and the rotary needles 734 can be the measurement electrodes for sensing the body tissue 520 (shown in Fig. 93). The ground electrode can be electrically isolated from the other needles. The ground electrode may or may not need to penetrate tissue, and in general would not need to penetrate as deeply as the sensing needles (or the rotary needles 734). Stated somewhat differently, the ground electrode can function as the locking structure 739 in some embodiments, but can be used for grounding without necessarily providing the function of locking structure 739 in other embodiments.

[0411] The device 730 can be made using any suitable methods. In various embodiments, the device 730 can be made of 3D printing and advantageously be made in a simple and precise manner compared with other methods. Stated somewhat differently, the device 730 can be 3D printed as a monolithic piece. To produce the device 730 shown in Fig. 98 and having the connecting sections 736C that are insulative, various methods set forth in the present disclosure (for example, the method 200 in Fig. 3) for modifying a monolithic structure into dissimilar materials can be used.

[0412] Turning to Fig. 113, the control system 940 for operating the devices as set forth throughout the present disclosure, and / or for implementing the methods as set forth throughout the present disclosure, is shown. The control system 940 can include a processor 941. The processor 941 can include one or more microprocessors (for example, single or multi-core processors), application-specific integrated circuits, application-specific instruction-set processors, graphics processing units, physics processing units, digital signal processing units, coprocessors, network processing units, encryption processing units, and the like. The processor 941 can execute specialized instruction for implementing the control system 940 and / or any hardware (for example, electrical, mechanical) equipment in communication with the control system 940.

[0413] In one embodiment, the control system 940 can be configured for controlling the device 900 (shown in Figs. 53-57, and 59). Accordingly, exemplary instruction can include software programs for operating vacuum pump(s), pump motor(s), mechanical movement of tube(s), and coordination therebetween. In another embodiment, the control system 940 can be configured for controlling the device 300 (shown in Figs. 60-72). Accordingly, exemplary instruction can include software programs for supplying energy to the device to cauterize or ablate target tissue, supplying the fluid to the device to ablate target tissue, and / or receive electrical signal from the device. In yet another embodiment, the control system 940 can be configured for controlling post-processing of the devices. Accordingly, exemplary instruction can include software programs for controlling, and / or monitoring, electrochemical etching processes. In yet another embodiment, the control system 940 can be configured for SFF. The instruction can include SFF software program such as G-code to control an SFF system 400 (shown in Fig. 4). Additionally and / or alternatively, the processor 941 can execute specialized instruction for monitoring SFF,electrochemical post-processing, device operation, body tissue reaction, via implementation of any suitable sensors such as cameras.

[0414] The control system 940 can include one or more additional hardware components as desired. Exemplary additional hardware components can include, but are not limited to, a memory 942 (alternatively referred to herein as a non-transitory computer readable medium). Exemplary memory 942 can include, for example, random access memory (RAM), static RAM, dynamic RAM, read-only memory (ROM), programmable ROM, erasable programmable ROM, electrically erasable programmable ROM, flash memory, secure digital (SD) card, and / or the like. Instruction for implementing the control system 940, and / or computerized model of the disclosed devices, can be stored on the memory 942, to be executed by the processor 941.

[0415] Additionally and / or alternatively, the control system 940 can include a communication module 943. The communication module 943 can include any conventional hardware and software that operates to exchange data and / or instruction between the control system 940 and another computer system (not shown), and / or hardware equipment, using any wired and / or wireless communication methods. In one example, the control system 940 can remotely control the operation of the devices (for example, the device 900 or the device 300), for a medical practitioner and / or robot in a first location to remotely perform medical procedure on a patient that is located in the second location. In another example, the control system 940 can receive computer-design data corresponding to the object (800) via the communication module 943. Exemplary communication methods include, for example, radio, Wireless Fidelity (Wi-Fi), cellular, satellite, broadcasting, or a combination thereof.

[0416] Additionally and / or alternatively, the control system 940 can include a display device 944. The display device 944 can include any device that operates to present programming instructions for operating the control system 940, display the 3D computer model of the disclosed devices, and / or present data related to the operation of the devices. For example, the display device 944 can display images from the endoscope 960 (shown in Fig. 59). Additionally and / or alternatively, the control system 940 can include one or more input / output devices 945 (for example, buttons, a keyboard, keypad, trackball), as desired.

[0417] The processor 941, the memory 942, the communication module 943, the display device 944, and / or the input / output device 945, can be configured to communicate, for example, using hardware connectors and buses and / or in a wireless manner.

[0418] The present subject matter can be embodied in other forms without departure from the spirit and essential characteristics thereof. The embodiments described therefore are to be considered in all respects as illustrative and not restrictive. Although the present subject matter has been described in terms of certain preferred embodiments, other embodiments that are apparent to those of ordinary skill in the art are also within the scope of the present subject matter.

Claims

CLAIMSWhat is claimed is:

1. A method for modifying a base part, the base part being a three-dimensional object including at least one first function body, at least one second function body, and at least one connecting body that connects the first and second function bodies, the method comprising: exposing, the second function body, the connecting body, or a combination thereof, to a chemical solution; and etching the connecting body to disconnect the first function body from the second function body, to modify electrical conductivity of at least a portion of the connecting body, or a combination thereof.

2. The method of claim 1, wherein said etching the connecting body includes electrochemically etching the connecting body, and the chemical solution includes an electrolyte.

3. The method of claim 1 or claim 2, wherein said exposing includes submerging at least a portion of the second function body in the chemical solution, the chemical solution flows into the connecting body via the second function body such that the chemical solution etches the connecting body without etching the first function body.

4. The method of claim 3, wherein said exposing includes submerging at least the portion of the second function body, and none of the connecting body, in the chemical solution.

5. The method of claim 3 or claim 4, wherein the base part defines one or more channels in the connecting body such that the chemical solution wicks in the channels via a capillary action.

6. The method of claim 5, wherein the channels extend into the second function body such that the chemical solution wicks into the channels from the second function body.

7. The method of claim 5 or claim 6, wherein the channels terminate at a boundary region that is in the connecting body and adjacent to the first function body such that the chemical solution does not flow into the first function body.

8. The method of any one of claims 3-7, wherein said exposing includes further submerging at least a portion of the connecting body in the chemical solution.

9. The method of any one of claims 1-8, wherein the connecting body includes one or more struts each having a characteristic width of less than 100 microns, less than 50 microns, less than 20 microns, less than 10 microns, or a combination thereof.

10. The method of any one of claims 1-9, wherein the connecting body has a micro-lattice structure including one or more sub-struts each having a characteristic width of less than 100 microns, less than 50 microns, less than 20 microns, less than 10 microns, or a combination thereof.

11. The method of any one of claim 1-10, wherein said etching the connecting body includes removing at least a portion of the connecting body such that the first function body disconnects from the second function body.

12. The method of any one of claims 1-11, wherein said etching the connecting body includes modifying the electrical conductivity of at least a portion of the connecting body.

13. The method of claim 12, wherein said modifying includes converting at least the portion the connecting body from conductive to insulative.

14. The method of claim 13, wherein the base part is made of a metal alloy including at least first and second metal elements.

15. The method of claim 14, wherein said etching includes at least partially removing the first metal element from the connecting body.

16. The method of claim 15, further comprising oxidizing the second metal element in the connecting body to form a ceramic material.

17. The method of claim 16, wherein said oxidizing includes oxidizing the second metal element in the connecting body via passive oxidation.

18. The method of claim 16 or claim 17, wherein said oxidizing includes converting the connecting body entirely to the ceramic material.

19. The method of any one of claims 16-18, further comprising breaking the connecting body such that the first function body is disconnected from the second function body.

20. The method of any one of claims 14-19, wherein the metal alloy includes stainless steel, and the first and second metal elements include iron and chromium, respectively.

21. The method of any one of claims 12-20, wherein said exposing includes submerging at least a portion of the connecting body in the chemical solution.

22. The method of claim 21, wherein the connecting body has a micro-lattice structure including one or more sub-struts each having a characteristic width of less than 100 microns, less than 50 microns, less than 20 microns, less than 10 microns, or a combination thereof.

23. The method of claim 21 or claim 22, wherein the base part defines one or more channels in the connecting body, the first function body, the second function body, or a combination thereof, such that the chemical solution wicks in the channels, and such that a selected region of the connecting body, of the first function body, of the second function body, or a combination thereof, is modified.

24. The method of any one of claims 21-23, wherein said etching includes modifying the electrical conductivity of a surface region of the first function body, a surface region of the second function body, or a combination thereof.

25. The method of any one of claims 13-20, wherein the first function body and the second function body each includes a microneedle.

26. The method of claim 25, wherein the microneedle has a length less than 3 millimeters (mm), less than 1 mm, or less than 0.5 mm, and has a cross-sectional base diameter that is less than 0.5 mm, less than 0.3 mm, or less than 0.2 mm.

27. The method of claim 25 or claim 26, wherein: the at least one first function body, the at least one second function body, and the at least one connecting body includes a plurality of first function bodies, a plurality of second function bodies, and a plurality of connecting bodies, respectively; the first function bodies and the second function bodies form an array of microneedles; and at least one of the connecting bodies connects one of the first function bodies with one of the second function bodies.

28. The method of any one of claims 13-20 and 25-27, further comprising electrochemically modifying the first function body by using the second function body as an electrochemical machining tool.

29. The method of claim 28, wherein said electrochemically modifying includes smoothing the first function body based upon a shape of the second function body.

30. The method of claim 28 or claim 29, wherein said electrochemically modifying includes sharpening the first function body based upon a shape of the second function body.

31. The method of any one of claims 28-30, further comprising, after said electrochemically modifying, breaking the connecting body such that the first function body is disconnected from the second function body.

32. The method of any one of claims 28-31, further comprising, after said electrochemically modifying, electrochemically etching the connecting body such that the first function body is disconnected from the second function body.

33. The method of claim 32, wherein the base part defines one or more channels in the connecting body such that, during said electrochemically etching after said electrochemically modifying, the chemical solution wicks in the channels via a capillary action and etches the connecting body without etching the first function body.

34. The method of any one of claims 13-20 and 25-33, further comprising electrochemically modifying the first function body to form a first electrode for a battery device.

35. The method of claim 34, wherein said electrochemically modifying the first function body includes electrochemically plating the first function body with a first electrode coating.

36. The method of claim 34 or claim 35, wherein said base part is made of an alloy including at least first and second elements, and said electrochemically modifying the first function body includes electrochemically etching the first function body to remove the second element from the first function body.

37. The method of any one of claims 34-36, wherein said electrochemically modifying the first function body includes submerging at least a portion of the first function body in a first electrode-processing electrolyte.

38. The method of claim 37, wherein said electrochemically modifying the first function body includes entirely submerging the base part in the first electrode-processing electrolyte.

39. The method of any one of claims 34-38, further comprising electrochemically modifying the second function body to form a second electrode for the battery device, a composition of the second electrode being different from a composition of the first electrode.

40. The method of claim 39, wherein a polarity of the second electrode is opposite to the polarity of the first electrode.

41. The method of claim 39 or claim 40, wherein said electrochemically modifying the second function body includes electrochemically plating the second function body with a second electrode coating.

42. The method of any one of claims 39-41, wherein the base part is made of an alloy including at least first and second elements, and said electrochemically modifying the second function body includes electrochemically etching the second function body to remove the first element from the second function body.

43. The method of any one of claim 34-42, wherein the first and second function bodies respectively include first and second lattices that are interwoven and non-intersecting.

44. The method of any one of claims 34-43, wherein the connecting body includes a grid structure including a plurality of intersected bars.

45. The method of any one of claims 1-44, further comprising, before said exposing, forming the base part via three-dimensional printing (3-D printing).

46. The method of any one of claims 1-45, wherein the base part is monolithic before said exposing.

47. A battery device, comprising: a first electrode; a second electrode, a composition of the second electrode being different from a composition of the first electrode; and a support that is insulative and connects the first and second function bodies, the support sharing at least one chemical element with the first electrode, the second electrode, or a combination thereof.

48. The battery device of claim 47, wherein a polarity of the second electrode is opposite to the polarity of the first electrode.

49. The battery device of claim 47 or claim 48, wherein the first electrode includes a first electrode body and a first coating thereon, the first electrode body includes at least one metal element that is in the support in an oxidized form and includes at least one metal element that is not in the support.

50. The battery device of claim 49, wherein the second electrode includes a second electrode body and a second coating thereon, the first and second electrode bodies have the same composition, and a composition of the first coating is different from a composition of the second coating.

51. The battery device of any one of claims 47-50, wherein the first and second function bodies respectively include first and second lattices that are interwoven and nonintersecting.

52. The battery device of any one of claims 47-51, wherein the connecting body includes a grid structure including a plurality of intersected bars.

53. A method for modifying a base part, comprising: submerging the base part in an electrolyte, the base part made of a first material; and modifying a surface region of the base part such that the surface region is converted into a second material different from the first material, wherein: the surface region has a thickness ranging from 1 micron to 100 microns; the second material does not include a first element that is in the first material, and includes an oxide of a second element that is in the first material; or a combination thereof.

54. The method of claim 53, wherein said modifying includes modifying an electrical conductivity of the surface region.

55. The method of claim 54, wherein the base part is conductive before said submerging, and said modifying includes converting the surface region from conductive to insulative.

56. The method of claim 55, wherein the first material includes a metal alloy including at least the first and second elements each being metallic.

57. The method of claim 56, wherein said modifying includes electrochemically etching the surface region by at least partially removing the first element from the surface region.

58. The method of claim 57, wherein said modifying further includes oxidizing the second element in the surface region to form a ceramic material.

59. The method of claim 58, wherein said oxidizing includes oxidizing the second element in the surface region via passive oxidation.

60. The method of any one of claims 56-59, wherein the metal alloy includes stainless steel, and the first and second elements include iron and chromium, respectively.

61. The method of any one of claims 55-60, wherein the base part includes at least one helical coil.

62. The method of claim 61, wherein the base part includes one or more struts connecting each two adjacent winding of the base part.

63. The method of claim 62, wherein said modifying further includes converting the struts from conductive to insulative concurrently with the modifying the electrical conductivity of the surface region.

64. The method of claim 63, wherein the struts each have a thickness that is less than or equal to two times of a thickness of the surface region.

65. A device with surface modification, comprising: an internal region that is conductive; and a surface region that is insulative and coats the internal region, wherein: the surface region has a thickness ranging from 1 micron to 100 microns; the internal region is made of a metal alloy including at least first and second metal elements, the first metal element being not in the surface region, the surface region including an oxide of the second metal element; or a combination thereof.

66. The device of claim 65, wherein the device has a shape of at least one helical coil.

67. The device of claim 66, wherein the device includes one or more struts connecting each two adjacent winding of the helical coil, the struts having a composition that is the same as the composition of the surface region.

68. The device of any one of claims 65-67, wherein the internal region includes a stainless steel, and the surface region includes chromium oxide.

69. A method for forming at least one junction in a base part, the base part including at least one first section, at least one second section, and at least one connecting section each connecting a pair of adjacent first and second sections, the first and second sections each defining first and second edge regions, respectively, the method comprising: modifying the first section by exposing the first edge region to a first chemical reaction medium.

70. The method of claim 69, wherein the base part includes a blend of at least first and second elements.

71. The method of claim 70, wherein said modifying the first section includes removing the second element from the first section by etching.

72. The method of claim 71, further comprising: exposing the first edge region to a first plating electrolyte; at least partially re-filling voids in the first section generated by the etching by plating via the first plating electrolyte.

73. The method of claim 72, wherein said re-filling includes plating the first section with the first element.

74. The method of any one of claims 70-73, wherein the base part includes the blend of: nickel and copper; copper and cobalt; silver and bismuth; or a combination thereof.

75. The method of any one of claims 69-74, further comprising changing, before said modifying, an orientation of the base part relative to ground.

76. The method of claim 75, wherein the exposing the first edge region includes orienting the first and second edge regions proximal to and distal from ground, respectively.

77. The method of claim 76, wherein said changing includes inverting the base part relative to ground.

78. The method of any one of claims 69-77, wherein the at least one first section includes a plurality of the first sections, and the at least one second section includes a plurality of the second sections.

79. The method of claim 78, wherein the exposing the first edge region includes exposing the first edge regions of all the first sections without exposing any portion of the second sections to the first chemical reaction medium.

80. The method of claim 78 or claim 79, wherein the first and second sections respectively form two rows, the two rows being offset such that the first and second sections alternate in a zig-zag arrangement, the first edge regions and the second edge regions forming two opposite edge regions of the base part.

81. The method of any one of claims 69-80, wherein: the first edge region is smaller than the first section and the base part defines one or more channels extending from the first edge regions into the first section without extending into the second section, such that the first chemical reaction medium wicks into the first section.

82. The method of any one of claims 70-74, further comprising modifying the second section by exposing the second edge region to a second chemical reaction medium.

83. The method of claim 82, wherein said modifying the second section includes removing the first element from the second section by etching.

84. The method of claim 83, further comprising: exposing the second edge region to a second plating electrolyte; at least partially re-filling voids in the second section generated by the etching by plating via the second plating electrolyte.

85. The method of claim 84, wherein said re-filling includes plating the second section with the second element.

86. The method of any one of claims 82-84, wherein the exposing the second edge region includes exposing the second edge region without exposing the first section to the second chemical reaction medium.

87. The method of any one of claims 82-86, wherein the second edge region is smaller than the second section and the base part defines one or more channels extending from the second edge region into the second section without extending into the first section such that the second chemical reaction medium wicks into the second section.

88. A device having at least one material junction therein, comprising:at least one first section; at least one second section; and at least one connecting section each connecting a pair of adjacent first and second sections, the connecting section including a blend of at least first and second elements, the first section including the first element and not the second element, the second section including the second element and not the first element.

89. The device of claim 88, the first and second sections each defining first and second edge regions, respectively, the first and second edge regions defining opposite edge regions of the device.

90. The device of claim 89, wherein the at least one first section includes a plurality of the first sections, and the at least one second section includes a plurality of the second sections.

91. The device of claim 90, wherein the first and second sections respectively form two rows, the two rows being offset such that the first and second sections alternate in a zig-zag arrangement.

92. The method of any one of claims 89-91, wherein: the first edge region is smaller than the first section and the device defines one or more channels extending from the first edge regions into the first section without extending into the second section; the second edge region is smaller than the second section and the device defines one or more channels extending from the second edge regions into the second section without extending into the first section; or a combination thereof.

93. The device of any one of claims 88-92, wherein the first and second sections form the material junction therebetween that is adapted for thermoelectric effect.

94. The device of claim 93, wherein the at least one first section includes a plurality of the first sections, and the at least one second section includes a plurality of the second sections and the first and second sections form a plurality of material junctions in series to form a thermopile.

95. The device of claim 93 or claim 94, wherein the connecting section includes the blend of:nickel and copper; copper and cobalt; silver and bismuth; or a combination thereof.

96. A device for delivering a drug to body tissue, comprising: at least one spike including: a first end region configured to enter the body tissue; and a second end region opposite to the first end region and configured to receive the drug, the spike defining a main lumen therein that extends between the first and second end regions, said spike having a length less than 10 mm, less than 5 mm, less than 3 mm, less than 1 mm, or less than 0.5 mm.

97. The device of claim 96, wherein said spike has a cross-sectional base diameter less than 0.5 mm, less than 0.3 mm, or less than 0.2 mm.

98. The device of claim 96 or claim 97, wherein the main lumen extends along a primary axis of said spike.

99. The device of any one of claims 96-98, further comprising at least one thread wrapping helically around the spike.

100. The device of claim 99, wherein said spike further defines at least one side lumens therein each in communication with the main lumen.

101. The device of claim 100, wherein the side lumen terminates at an edge region of a tooth of the thread, at a surface of the spike between two adjacent teeth of the thread, or a combination thereof.

102. The device of any one of claims 96-101, further comprising at least one barb projecting from said spike.

103. The device of claim 102, wherein said spike further defines at least one side lumen therein each in communication with the main lumen.

104. The device of claim 103, wherein the side lumen extends along an axis of the barb and terminates at an edge region of the barb, terminates at a surface of said spike between two adjacent barbs, or a combination thereof.

105. The device of claim 102 or claim 103, wherein the barb projects radially from said spike and at least partially projects against a direction of said spike.

106. The device of any one of claims 96-105, further comprising a base piece, wherein said spike includes an array of spikes each coupled with said base piece at the second end region.

107. A system for delivering a drug to body tissue, comprising: the device of any one of claims 96-106; a tube having a first terminal region and a second terminal region opposite to the first terminal region, the first terminal region being connected to the second end region of the spike and in communication with the main lumen; and a port connected to the second terminal region of the tube and configured to be embedded below skin.

108. A method for delivering a chemotherapy drug to body tissue using a device, the device including at least one spike each including: a first end region configured to enter the body tissue; and a second end region opposite to the first end region and configured to receive the drug, the spike defining a main lumen therein that extends between the first and second end regions, the method comprising: advancing at least the first end region into the body tissue; and supplying the chemotherapy drug into the body tissue via the device, said spike having a length less than 10 mm, less than 5 mm, less than 3 mm, less than 1 mm, or less than 0.5 mm.

109. A method for delivering a chemotherapy drug to tumor tissue using a device, the device including at least one spike each including: a first end region configured to enter the tumor tissue; and a second end region opposite to the first end region and configured to receive the drug, the spike defining a main lumen therein that extends between the first and second end regions, the method comprising:advancing at least the first end region into the tumor tissue; and supplying the chemotherapy drug into the tumor tissue via the device.

110. A device for transmitting a signal to, or receiving the signal from, cardiovascular anatomy and / or a nervous system, comprising: at least one electrode each including: a first end region configured to enter body tissue; and a second end region opposite to the first end region and configured to electrically connect with a system for electrical signal transmission associated with the body tissue, said electrode having a length ranging from 50 micrometers to 100 micrometers, less than 10 mm, less than 5 mm, less than 3 mm, less than 1 mm, less than 0.5 mm, or a combination thereof.

111. The device of claim 110, wherein said electrode has a cross-sectional base diameter that is less than 0.5 mm, less than 0.3 mm, or less than 0.2 mm, or a combination thereof.

112. The device of claim 110 or claim 111, further comprising at least one thread wrapping helically around said electrode.

113. The device of claim 112, wherein said thread is saw-toothed.

114. The device of any one of claims 110-113, further comprising at least one barb projecting from said electrode.

115. The device of any one of claims 110-114, further comprising at least one protrusion on a side surface of the electrode.

116. The device of claim 115, wherein the protrusion defines first and second edges raised beyond the side surface of the electrode, the first and second edges being proximal to, and distal from, the first end region of the electrode respectively.

117. The device of claim 116, wherein a slope of the second edge relative to the side surface of the electrode is equal to, or greater than, the slope of the first edge.

118. The device of any one of claims 110-117, further comprising a base piece, wherein said electrode includes an array of electrodes each coupled with said base piece at the second end region.

119. The device of claim 118, wherein said base piece includes a plate having a solid pattern, a lattice pattern, or a combination thereof.

120. The device of claim 119, wherein the plate with the lattice pattern includes at least one section connecting two adjacent electrodes, the section being straight, curved, zig-zagged, or a combination thereof.

121. The device of any one of claims 118-120, wherein said base piece is configured to flex to conform with the body tissue.

122. The device of any one of claims 118-121, wherein said base piece is at least partially made of a shape-memory material.

123. The device of claim 122, wherein said base piece is at least partially made of nitinol.

124. The device of any one of claims 110-122, wherein said electrode is at least partially made of a shape-memory material.

125. A method for transmitting a signal to, or receiving the signal from, cardiovascular anatomy and / or a nervous system using a device, the device including at least one electrode each including: a first end region configured to enter body tissue; and a second end region opposite to the first end region and configured to electrically connect with a system for electrical signal transmission associated with the body tissue, the method comprising: advancing at least the first end region into the body tissue; and receiving the signal from, or sending the signal to, the body tissue via the electrode, the electrode having a length ranging from 50 micrometers to 100 micrometers, less than 10 mm, less than 5 mm, less than 3 mm, less than 1 mm, less than 0.5 mm, or a combination thereof.

126. A device for interfacing with body tissue via flexural fixation, comprising: a substrate; and at least two function units each including: a first end region configured to enter body tissue; and a second end region opposite to the first end region and connected to said substrate, the function units being aligned in parallel when the substrate is in a stressed state, and non-parallel when the substrate is in a relaxed state.

127. The device of claim 126, wherein, when the substrate is in the relaxed state, the function units angle away from each other, toward each other, or a combination thereof.

128. The device of claim 126 or claim 127, wherein said substrate is at least partially made of a material having super-elasticity, a shape-memory material, or a combination thereof.

129. The device of claim 128, wherein said substrate is at least partially made of nitinol.

130. The device of any one of claims 126-129, wherein at least one of the function units includes one or more micro-retention features.

131. The device of any one of claims 126-130, wherein the function units include a spike for drug delivery, an electrode for physiological signal transmission, or a combination thereof.

132. The device of any one of claims 126-131, wherein the function units are arranged on the substrate in a line, a circle, or a combination thereof.

133. The device of any one of claims 126-132, wherein the function units each have a length less than 3 mm, less than 1 mm, or less than 0.5 mm.

134. The device of any one of claims 126-133, wherein the function units each have a cross- sectional base diameter that is less than 0.5 mm, less than 0.3 mm, or less than 0.2 mm.

135. A method for fixating a device to body tissue, comprising: deforming the device into a stressed state, the device including: a substrate and at least two function units each including: a first end region configured to enter body tissue; and a second end region opposite to the first end region and connected to the substrate, the function units being aligned in parallel when the device is in the stressed state; inserting the function units into body tissue; and releasing the device into a relaxed state, the function units being non-parallel.

136. The method of claim 135, wherein said deforming includes deforming the substrate into the stressed state.

137. The method of claim 135 or claim 136, wherein said releasing includes releasing the substrate into the relaxed state.

138. The method of claim 137, wherein said releasing includes conforming the substrate with the body tissue.

139. The method of claim 137 or claim 138, wherein, when the substrate is in the relaxed state, the function units angle away from each other, toward each other, or a combination thereof.

140. A device for interfacing with body tissue, comprising: a base piece defining a center of rotation thereon; and one or more rotary needles distributed on the base plate and about the center, each of the needles including: a tip region; and a base region opposite to the tip region and connected to said base piece, the needle tilting from the base piece at a tilting angle.

141. The device of claim 140, wherein: a distance between the center and a projection of the tip region on the plate defines a tip distance; and a distance between the center and the projection of the base region on the plate defines a base distance.

142. The device of claim 141, wherein the tip distance is greater than, less than, or equal to, the base distance.

143. The device of claim 141 or claim 142, wherein said rotary needles include an array of rotary needles distributed about the center.

144. The device of claim 143, wherein the rotary needles have uniform tip distances, and uniform base distances.

145. The device of any one of claims 140-144, wherein the rotary needles are straight, curved, or a combination thereof.

146. The device of claim 145, wherein the rotary needles are curved and a projection of each needle on the base piece defines an arc.

147. The device of claim 146, wherein any point on the arc is equal distance from the center.

148. The device of any one of claims 140-147, wherein at least one of the rotary needles includes one or more micro-retention features.

149. The device of any one of claims 140-148, further comprising one or more locking structures connected to the base piece, the locking structures and the needles being on a same surface of the base piece.

150. The device of claim 149, wherein the locking structures each includes a protrusion projecting from the surface of the base piece.

151. The device of claim 150, wherein the protrusions are shorter or smaller than the rotary needles.

152. The device of claim 150 or claim 151, wherein the protrusions are configured to engage with the body tissue in a direction opposite to a direction of the rotary needles engaging with the body tissue.

153. The device of claim 152, wherein the protrusions point in a direction opposite to a direction of the rotary needles.

154. The device of any one of claims 149-153, wherein said locking structures include an array of locking structures distributed about the center.

155. The device of any one of claims 140-154, wherein the rotary needles are conductive and the base piece electrically isolates the rotary needles.

156. The device of any one of claims 140-155, wherein said base piece includes: an inner section; an outer section surrounding the inner section; and one or more connecting sections each connecting the outer section with the inner section.

157. The device of claim 156, further comprising at least one locking structure on the inner section, wherein the rotary needles are connected to the outer section.

158. The device of claim 157, wherein the locking structure includes a needle pointing perpendicularly from the base piece.

159. The device of claim 157 or claim 158, wherein the locking structure, the rotary needles, and the outer and inner sections, are conductive, and the connecting sections electrically insulate the outer section from the inner section.

160. A method for using a microneedle device, the device including: a base piece defining a center of rotation thereon; andone or more rotary needles distributed on the base plate and about the center, each of the needles including a tip region and a base region opposite to the tip region and connected to said base piece, the needle tilting from the base piece at a tilting angle, the method comprising: orienting a device relative to body tissue, such that the rotary needle and the base piece are proximal to and distal from the body tissue, respectively; and advancing the rotary needle into the body tissue by rotating the base piece about the center of rotation.

161. A biopsy system, comprising: a biopsy device including: a first tube; and a second tube nested in the first tube and configured to translate along an axis defined in the first tube, each of the first and second tubes respectively defining a lead edge region; and a vacuum source in communication with the first and second tubes and configured to apply vacuum to the first tube, the second tube, or a combination thereof.

162. The system of claim 161, wherein the second tube is configured to rotate axially within the first tube.

163. The system of claim 161 or claim 162, wherein the lead edge region of the second tube defines a sharp cutting feature.

164. The system of any one of claims 161-163, wherein the biopsy device further includes an endoscope located in space between the first and second tubes.

165. The system of any one of claims 161-164, wherein an outer diameter of the first tube is no greater than 6 mm.

166. A method for using a biopsy device, the biopsy device including a first tube and a second tube nested in the first tube, the method comprising: applying a vacuum in the first tube such that a lead edge region of the first tube is fixed on body tissue; advancing a lead edge region of the second tube into the body tissue; obtaining, by the second tube, a sample from the body issue; andretracting the second tube with the sample from the body issue.

167. The method of claim 166, wherein the lead edge region of the second tube defines a sharp cutting feature and said advancing includes cutting the second tube into the body tissue.

168. The method of claim 166 or claim 167, wherein said obtaining includes applying a vacuum in the second tube.

169. The method of any one of claims 166-168, wherein said obtaining includes rotating the second tube axially relative to the body tissue.

170. The method of any one of claims 166-169, further comprising releasing, after said retracting, the vacuum in the first tube.

171. The method of any one of claims 166-170, further comprising capturing, before said obtaining, at least an image of the body tissue via an endoscope located in space between the first and second tubes.

172. A device for cauterizing target tissue within body tissue, ablating the target tissue, mapping electrical activity in the target tissue, or a combination thereof, comprising: a support structure; and one or more function units each including: a first end region configured to enter the body tissue; and a second end region opposite to the first end region, the function unit being connected to the support structure at the second end region.

173. The device of claim 172, wherein each of the function units has a shape of a needle.

174. The device of claim 172 or claim 173, wherein at least one of the function units defines at least one fluid pathway therein.

175. The device of any one of claims 172-174, wherein said support structure has an elongated shape defining a direction of extension.

176. The device of claim 175, wherein said support structure includes a catheter device.

177. The device of claim 175 or claim 176, wherein said support structure includes an articulation mechanism to set the functional units at a selected angle relative to the direction of extension of the support structure, the angle ranging from 0 to 90 degrees.

178. The device of claim 177, wherein the function units are on an end surface of the support structure and aligned with the direction of extension of the support structure.

179. The device of claim 177 or claim 178, wherein the function units are on an end region of the support structure and point at an angle with a direction of extension of the support structure, the angle being greater than 0 degree and smaller than 90 degrees.

180. The device of any one of claims 177-179, wherein the function units are on a lateral surface of the support structure and point perpendicularly to a direction of extension of the support structure.

181. The device of any one of claims 172-180, wherein said support structure includes jaws of a laparoscopic device, the function units being located on two opposing surfaces of the jaws.

182. A system for cauterizing the target tissue, ablating the target tissue, mapping the electrical activity in the target tissue, or a combination thereof, comprising: the device of any one of claims 172-181; and a control system coupled with said support structure and configured to, via said support structure: supply energy to said function units such that said function units cauterize or ablate the target tissue; supply a fluid to said function units such that said function units ablate the target tissue; receive, from said function units, an electrical signal associated with the target tissue; or a combination thereof.

183. The system of claim 182, wherein the energy being thermal, electromagnetic, ultrasound, laser, microwave, or a combination thereof.

184. The system of claim 182 or claim 183, wherein the fluid including a coolant, and said function units are configured to freeze the target tissue via the coolant.

185. A method for cauterizing target tissue within body tissue, ablating the target tissue, mapping electrical activity in the target tissue, or a combination thereof, by using a device, the device including: a support structure; and one or more function units each including:a first end region configured to enter the body tissue; and a second end region opposite to the first end region, the function unit being connected to the support structure at the second end region, the method comprising: inserting the function units into the body tissue toward the target tissue; and performing an operation on the target tissue, said performing including: supplying, via the support structure, energy to the function units such that the function units cauterize the target tissue; supplying, via the support structure, a fluid to the function units such that the function units ablate the target tissue; receiving, from said function units and via the support structure, an electrical signal associated with the target tissue; or a combination thereof.

186. The method of claim 185, further comprising setting the functional units at a selected angle relative to a direction of extension of the support structure, the angle ranging from 0 to 90 degrees.

187. The method of claim 186, wherein said setting is at any time relative to said inserting or performing.

188. The method of any one of claims 185-187, wherein the energy being thermal, electromagnetic, ultrasound, laser, microwave, or a combination thereof.

189. The method of any one of claims 185-188, wherein the fluid including a coolant, and said function units are configured to ablate the target tissue via cryoablation.

190. The method or device of claims 1-189, further comprising forming the base part and / or device via 3-D printing.

191. The method or device of claims 1-189, wherein the base part and / or device has a size adapted for medical implantation.

192. The method or device of claims 1-189, wherein the base part is monolithic before a secondary process.

Images