Patent Publication Number: US-2017361061-A1

Title: Infection resistant surfaces for devices

Description:
CROSS-REFERENCE TO RELATED APPLICATION 
     This application claims priority to Provisional Application No. 62/351,027, filed Jun. 16, 2016, which is herein incorporated by reference in its entirety. 
    
    
     TECHNICAL FIELD 
     The present disclosure relates to inhibiting and preventing microorganism infections associated with devices. More specifically, the disclosure relates to infection resistant surfaces for medical devices and methods for manufacturing these surfaces. 
     BACKGROUND 
     Some devices, including some medical devices, are implanted or inserted into humans for treating diseases or conditions. Devices such as these include catheters, pulse generators, electronic leads, and diagnostic devices. Often, the devices have one or more surfaces or surface features that provide a safe haven for microorganisms, such as bacteria. The microorganisms attach themselves to the surface of the medical device and colonize the device. When the device is inserted or implanted into the body of the patient, it introduces the microorganisms into the body. This can lead to serious and costly complications including infections, bacteremia, and endocarditis, and result in removal of any implanted device. 
     Medical personal and patients would welcome advances in medical devices that inhibit the adhesion and growth of microorganisms on the medical devices. 
     SUMMARY 
     In an Example 1, a medical device including a surface that has been roughened to provide a roughened surface that inhibits the adhesion of microorganisms on the roughened surface. 
     In an Example 2, the medical device of Example 1, wherein the roughened surface is one of highly hydrophobic and highly hydrophilic. 
     In an Example 3, the medical device of any of Examples 1 and 2, wherein the roughened surface includes depressions, such that material has been removed from the surface to provide the depressions in the roughened surface. 
     In an Example 4, the medical device of any of Examples 1-3, wherein the roughened surface includes material that has been added to the surface to provide the roughened surface. 
     In an Example 5, the medical device of any of Examples 1-4, wherein the surface is at least one of a metal surface and a polymer surface. 
     In an Example 6, the medical device of any of Examples 1-5, wherein the roughened surface includes a layer of parylene that has been textured to provide the roughened surface. 
     In an Example 7, the medical device of any of Examples 1-6, wherein the roughened surface has at least one of a cross-hatch pattern, a striped pattern, and a checkerboard pattern. 
     In an Example 8, the medical device of any of Examples 1-7, wherein the surface has been roughened by at least one of laser patterning, chemical etching, plasma etching, physical vapor deposition coating, sputtering, and atomic layer deposition to provide the roughened surface. 
     In an Example 9, a method of manufacturing a medical device, the method including roughening a surface of the medical device to create a roughened surface that inhibits the adhesion of microorganisms on the roughened surface. 
     In an Example 10, the method of Example 9, wherein roughening the surface of the medical device includes roughening the surface to provide one of a highly hydrophobic surface and a highly hydrophilic surface that inhibits the adhesion of microorganisms on the one of the highly hydrophobic surface and the highly hydrophilic surface. 
     In an Example 11, the method of any of Examples 9 and 10, wherein roughening the surface of the medical device includes at least one of laser patterning, chemical etching, plasma etching, physical vapor deposition coating, sputtering, and atomic layer deposition. 
     In an Example 12, the method of any of Examples 9-11, wherein the surface material of the medical device includes at least one of metal and a polymer. 
     In an Example 13, the method of any of Examples 9-12, wherein the surface material of the medical device includes a parylene coating. 
     In an Example 14, the method of any of Examples 9-13, wherein roughening the surface of the medical device includes texturing a surface of a mold that is used to create the medical device, and molding the medical device in the mold to create the roughened surface. 
     In an Example 15, the method of any of Examples 9-13, wherein roughening the surface of the medical device comprises directly texturing material on the surface of the medical device. 
     In an Example 16, a medical device including a surface that has been roughened to provide a roughened surface that inhibits the adhesion of microorganisms on the roughened surface. 
     In an Example 17, the medical device of Example 16, wherein the roughened surface is one of highly hydrophobic and highly hydrophilic. 
     In an Example 18, the medical device of Example 16, wherein the roughened surface includes depressions, such that material has been removed from the surface to provide the depressions in the roughened surface. 
     In an Example 19, the medical device of Example 16, wherein the roughened surface includes material that has been added to the surface to provide the roughened surface. 
     In an Example 20, the medical device of Example 16, wherein the surface is at least one of a metal surface and a polymer surface. 
     In an Example 21, the medical device of Example 16, wherein the roughened surface includes a layer of parylene that has been textured to provide the roughened surface. 
     In an Example 22, the medical device of Example 16, wherein the roughened surface has at least one of a cross-hatch pattern, a striped pattern, and a checkerboard pattern. 
     In an Example 23, the medical device of Example 16, wherein the surface has been roughened by at least one of laser patterning, chemical etching, plasma etching, physical vapor deposition coating, sputtering, and atomic layer deposition to provide the roughened surface. 
     In an Example 24, a method of manufacturing a medical device, the method including roughening a surface of the medical device to create a roughened surface that inhibits the adhesion of microorganisms on the roughened surface. 
     In an Example 25, the method of Example 24, wherein roughening the surface of the medical device includes texturing a surface of a mold that is used to create the medical device, and molding the medical device in the mold to create the roughened surface. 
     In an Example 26, the method of Example 25, wherein the mold includes at least one of epoxy and silicone. 
     In an Example 27, the method of Example 24, wherein roughening the surface of the medical device comprises directly texturing a surface material of the medical device. 
     In an Example 28, the method of Example 27, wherein the surface material of the medical device includes at least one of metal and a polymer. 
     In an Example 29, the method of Example 27, wherein the surface material of the medical device includes a parylene coating that is directly textured to create the roughened surface. 
     In an Example 30, the method of Example 24, wherein roughening the surface of the medical device includes at least one of laser patterning, chemical etching, plasma etching, physical vapor deposition coating, sputtering, and atomic layer deposition. 
     In an Example 31, a method of manufacturing a medical device, the method including roughening a surface of the medical device to provide one of a highly hydrophobic surface and a highly hydrophilic surface that inhibits the adhesion of microorganisms on the one of the highly hydrophobic surface and the highly hydrophilic surface. 
     In an Example 32, the method of Example 31, wherein the highly hydrophobic surface provides a first water contact angle of greater than 110 degrees and the highly hydrophilic surface provides a second water contact angle of less than 10 degrees. 
     In an Example 33, the method of Example 31, wherein roughening the surface of the medical device includes texturing a mold surface of a mold that is used to produce the medical device, and molding the medical device in the mold. 
     In an Example 34, the method of Example 31, wherein roughening the surface of the medical device comprises directly texturing material on the surface of the medical device. 
     In an Example 35, the method of Example 31, wherein roughening the surface of the medical device includes texturing by at least one of laser etching a pattern into one of a mold and surface material of the medical device, chemical etching a pattern into one of the mold and the surface material of the medical device, plasma etching a pattern into one of the mold and the surface material of the medical device, physical vapor deposition of a pattern onto one of the mold and the surface material of the medical device, sputtering a pattern onto one of the mold and the surface material of the medical device, and atomic layer deposition of a pattern onto one of the mold and the surface material of the medical device. 
     While multiple embodiments are disclosed, still other embodiments of the present disclosure will become apparent to those skilled in the art from the following drawings and detailed description, which show and describe illustrative embodiments of the disclosure. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a diagram illustrating a pulse generator and an electrical lead, according to embodiments of the disclosure. 
         FIG. 2  is a diagram illustrating an infection resistant roughened surface, according to embodiments of the disclosure. 
         FIG. 3  is a diagram illustrating another infection resistant roughened surface, according to embodiments of the disclosure. 
         FIG. 4  is a diagram illustrating another infection resistant roughened surface, according to embodiments of the disclosure. 
         FIG. 5  is a diagram illustrating another infection resistant roughened surface, according to embodiments of the disclosure. 
         FIG. 6A  is a diagram illustrating a highly hydrophobic roughened surface, according to embodiments of the disclosure. 
         FIG. 6B  is a diagram illustrating a cross-section of the highly hydrophobic roughened surface, according to embodiments of the disclosure. 
         FIG. 7A  is a diagram illustrating a highly hydrophilic roughened surface, according to embodiments of the disclosure. 
         FIG. 7B  is a diagram illustrating a cross-section of the highly hydrophilic roughened surface including the plateaus and the vertical troughs, according to embodiments of the disclosure. 
         FIG. 8A  is a diagram illustrating a control coupon having a control surface that has not been patterned or textured to provide a roughened surface to inhibit the adhesion or growth of microorganisms. 
         FIG. 8B  is a diagram illustrating colonies of bacteria cells that were grown via the procedure described above. 
         FIG. 9A  is a diagram illustrating a textured coupon having a surface including a textured surface area, according to embodiments of the disclosure. 
         FIG. 9B  is a diagram illustrating the resulting pattern of cell colonies on the growth plate. 
         FIG. 10  is a diagram illustrating a method of manufacturing a device having an infection resistant surface, according to embodiments of the disclosure. 
         FIG. 11  is a diagram illustrating another method of manufacturing a device having an infection resistant surface, according to embodiments of the disclosure. 
     
    
    
     While the disclosure is amenable to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. The intention, however, is not to limit the disclosure to the particular embodiments described. On the contrary, the disclosure is intended to cover all modifications, equivalents, and alternatives falling within the scope of the disclosure as defined by the appended claims. 
     DETAILED DESCRIPTION 
       FIG. 1  is a diagram illustrating a pulse generator  20  and an electrical lead  22 , according to embodiments of the disclosure. The pulse generator  20  includes at least one surface, including front surface  24 , that is an infection resistant surface, and the lead  22  includes at least one surface, including lead surface  26 , which is an infection resistant surface. Each of the infection resistant surfaces (of front surface  24  and lead surface  26 ) inhibits the adhesion and growth of microorganisms on the associated device, which reduces the chance of serious and costly complications such as infections, bacteremia, endocarditis, and removal of an implanted device. 
     The pulse generator  20  and the lead  22  are medical devices configured to be implanted into a human being. The pulse generator  20  can be made with a metal or a plastic/polymer, such that the front surface  24  can be a metal surface or a plastic/polymer surface. Also, the lead  22  can be made out of or with a plastic/polymer, such that the lead surface  26  is a plastic/polymer surface. In some embodiments, surfaces of the pulse generator  20  and/or the lead  22 , such as the front surface  24  and the lead surface  26 , include a parylene coating that acts as a biocompatible dielectric/insulator. In some embodiments, surfaces of the pulse generator  20  and/or the lead  22 , such as the front surface  24  and the lead surface  26 , include a polymer coating, such as a polyimide coating. In some embodiments, surfaces of the pulse generator  20  and/or the lead  22 , such as the front surface  24  and the lead surface  26 , include a metal substrate with a parylene coating and/or a polymer coating, such as a polyimide coating. 
     The pulse generator  20  and the lead  22  can be implanted for a short period of time, such as weeks or months, or for a long period of time, such as decades. The pulse generator  22  is electrically coupled to the lead  22  to provide electrical pulses at the tip  28  of the electrical lead  22  to the patient, such as to the patient&#39;s heart. In some embodiments, the pulse generator  20  is or includes a pacemaker device. 
     The pulse generator  20  and the lead  22  are only examples of devices that can include one or more of the infection resistant surfaces described in this disclosure. In other examples, other devices can include one or more of the infection resistant surfaces described in this disclosure, such that the infection resistant surfaces are not limited to being applied to the pulse generator  20  and/or the lead  22 , or even to medical devices. Instead, the infection resistant surfaces can be put on a surface of a device that comes into contact with a human being. In some embodiments, medical devices that include one or more infection resistant surfaces include catheters, cannulas, and diagnostic devices, which may be temporarily inserted into a human and withdrawn or implanted into a patient for a short or long period of time. 
     Each infection resistant surface, such as front surface  24  and lead surface  26 , is a roughened surface that creates an anti-favorable surface for microorganism adhesion (attachment) and growth. The roughened surface can have a random pattern or a predefined pattern with non-fouling properties. In one embodiment, an infection resistant surface is a surface of a device that has been roughened to provide a roughened surface that inhibits the adhesion of microorganisms on the roughened surface. In one embodiment, an infection resistant surface is a surface of a device that has been made one of highly hydrophobic or highly hydrophilic to inhibit the adhesion and growth of microorganisms on the device. In other embodiments, an infection resistant surface can be a highly polished surface, which is, however, difficult to maintain in a highly polished state. 
     The roughened surface can be created using a number of different methods. For example, an infection resistant roughened surface can be created by laser patterning, chemical etching, plasma etching, physical vapor deposition (PVD), sputter coating, atomic layer deposition (ALD), and media roughening. In some embodiments, a surface of a device is roughened by removing material, such as metal, plastic/polymer, and/or parylene, from the surface of the device. In some embodiments, the plastic/polymer removed is a polyimide. In some embodiments, a surface of a device is roughened by adding material, such as metal, plastic/polymer, and/or parylene, to the surface of the device. In some embodiments, the plastic/polymer added is a polyimide. In some embodiments, a surface of a device is roughened by texturing or patterning the surface of a mold in which the device is molded or formed, where the molded device includes the negative of the pattern created in the mold, where molding may be well suited for manufacturing lead insulation tubes, strain reliefs, suture sleeves, and epoxy headers. In some embodiments, the mold includes at least one of epoxy and silicone. 
       FIG. 2  is a diagram illustrating an infection resistant roughened surface  40 , according to embodiments of the disclosure. The roughened surface  40  includes ribs  42  separated by troughs  44  in a vertical stripe pattern that extends from the top of  FIG. 2  to the bottom of  FIG. 2 . The ribs  42  are separated from one another by the troughs  44  a distance D 1 . In some embodiments, the distance D 1  is in a range of from 2 to 4 micrometers. In some embodiments, the depth of the troughs  44 , from the peak or top of the ribs  42  to the bottom of the troughs  44 , is in a range of from 2 to 4 micrometers. In other embodiments, the roughened surface  40  includes the ribs  42  in a stripe pattern that extends in another direction, such as horizontally from one side (the left side) to the opposing side (the right side) or diagonally across the roughened surface  40 . 
     The roughened surface  40  is manufactured from a surface of a device, which can be or include one or more of a metal, a plastic/polymer, and a parylene covered surface. In some embodiments, the plastic/polymer is a polyimide. In one embodiment, the surface of the device is patterned and textured by laser etching the surface of the device to remove material from the surface and produce the roughened surface  40 . In one embodiment, the surface of the device is patterned and textured by chemically etching the surface of the device to remove material from the surface and produce the roughened surface  40 . In one embodiment, the surface of the device is patterned and textured by plasma etching the surface of the device to remove material from the surface and produce the roughened surface  40 . In other embodiments, the surface of the device is patterned and textured by adding material to the surface, such as by ALD, to produce the roughened surface  40 . 
     The roughened surface  40  can be used on devices, such as medical devices including the pulse generator  20  and the electrical lead  22 . The roughened surface  40  inhibits the adhesion and growth of microorganisms on the associated device, which reduces the chance of serious and costly complications such as infections, bacteremia, endocarditis, and removal of an implanted device. 
       FIG. 3  is a diagram illustrating another infection resistant roughened surface  60 , according to embodiments of the disclosure. The roughened surface  60  includes diagonally crisscrossed primary troughs  62  that define diamond shaped islands  64 , referred to herein as a cross-hatch pattern or a diamond-hatch pattern. In some embodiments, the roughened surface  60  has a pattern that is similar to a cross-hatch pattern or diamond-hatch pattern. In some embodiments, the pattern of the roughened surface  60  is a super-hydrophilic design having a water contact angle of less than 10 degrees. 
     Each island  64  in the roughened surface  60  includes ribs  66  separated by secondary troughs  68  in a vertically striped pattern. The ribs  66  and secondary troughs  68  extend from the top of the island  64  to the bottom of the island  64  across the island  64 , such that the ribs  66  and secondary troughs  68  increase in length, reach a maximum length, and decrease in length from one side of the island  64  to the other side of the island  64 . The ribs  66  are separated from one another by the secondary troughs  68  a distance D 2 . In some embodiments, the distance D 2  is in a range of from 2 to 8 micrometers. In some embodiments, the depth of the secondary troughs  68 , from the peak or top of the ribs  66  to the bottom of the troughs  68 , is in a range of from 3 to 5 micrometers. In some embodiments, the depth of the primary troughs  62 , from the peak or top of the ribs  66  to the bottom of the primary troughs  62 , is in a range of from 3 to 8 micrometers. In other embodiments, the roughened surface  60  includes the ribs  66  and secondary troughs  68  in a stripe pattern that extends in another direction, such as horizontally from one side (the left side) to the opposing side (the right side) or diagonally across each of the islands  64 . 
     The roughened surface  60  is manufactured from a surface of a device, which can be or include one or more of a metal, a plastic/polymer, and a parylene covered surface. In some embodiments, the plastic/polymer is a polyimide. In one embodiment, the surface of the device is patterned and textured by laser etching the surface of the device to remove material from the surface and produce the roughened surface  60 . In one embodiment, the surface of the device is patterned and textured by chemically etching the surface of the device to remove material from the surface and produce the roughened surface  60 . In one embodiment, the surface of the device is patterned and textured by plasma etching the surface of the device to remove material from the surface and produce the roughened surface  60 . In other embodiments, the surface of the device is patterned and textured by adding material to the surface, such as by ALD, to produce the roughened surface  60 . 
     The roughened surface  60  can be used on devices, such as medical devices including the pulse generator  20  and the electrical lead  22 . The roughened surface  60  inhibits the adhesion and growth of microorganisms on the associated device, which reduces the chance of serious and costly complications such as infections, bacteremia, endocarditis, and removal of an implanted device. 
       FIG. 4  is a diagram illustrating another infection resistant roughened surface  80 , according to embodiments of the disclosure. The roughened surface  80  includes bumps or nodules  82  in a random pattern across the roughened surface  80 . The nodules  82  have peaks and define valleys situated between the nodules  82 . In some embodiments, the depth of the valleys, from the top of the peaks to the troughs of the valleys, is in a range of from 2 to 4 micrometers. 
     The roughened surface  80  is manufactured from a surface of a device, which can be or include one or more of a metal, a plastic/polymer, and a parylene covered surface. In some embodiments, the plastic/polymer is a polyimide. In one embodiment, the surface of the device is textured by adding material to the surface, such as by PVD and/or sputter coating, to produce the roughened surface  80 . In other embodiments, the surface of the device can be pseudo-randomly patterned and textured by removing material from the surface, such as by laser etching, chemical etching, and plasma etching, to produce the roughened surface  80 . In other embodiments, the surface of the device can be pseudo-randomly patterned and textured by adding material to the surface, such as by ALD, to produce the roughened surface  80 . 
     The roughened surface  80  can be used on devices, such as medical devices including the pulse generator  20  and the electrical lead  22 . The roughened surface  80  inhibits the adhesion and growth of microorganisms on the associated device, which reduces the chance of serious and costly complications such as infections, bacteremia, endocarditis, and removal of an implanted device. 
       FIG. 5  is a diagram illustrating another infection resistant roughened surface  100 , according to embodiments of the disclosure. This roughened surface  100  includes nodules  102  in a random pattern across the roughened surface  100 . The nodules  102  define random valleys  104  between nodules  102  and groups of nodules  102 . In some embodiments, the depth of the random valleys  104 , from the top of the nodules  102  to the troughs of the valleys  104 , is in a range of from 2 to 4 micrometers. 
     The roughened surface  100  is manufactured from a surface of a device, which can be or include one or more of a metal, a plastic/polymer, and a parylene covered surface. In some embodiments, the plastic/polymer is a polyimide. In one embodiment, the surface of the device is textured by adding material to the surface, such as by PVD and/or sputter coating, to produce the roughened surface  100 . In other embodiments, the surface of the device can be pseudo-randomly patterned and textured by removing material from the surface, such as by laser etching, chemical etching, and plasma etching, to produce the roughened surface  100 . In other embodiments, the surface of the device can be pseudo-randomly patterned and textured by adding material to the surface, such as by ALD, to produce the roughened surface  100 . 
     The roughened surface  100  can be used on devices, such as medical devices including the pulse generator  20  and the electrical lead  22 . The roughened surface  100  inhibits the adhesion and growth of microorganisms on the associated device, which reduces the chance of serious and costly complications such as infections, bacteremia, endocarditis, and removal of an implanted device. 
       FIG. 6A  is a diagram illustrating a highly hydrophobic roughened surface  120 , according to embodiments of the disclosure. The highly hydrophobic roughened surface  120  includes ribs  122  separated by troughs  124  in a vertical stripe pattern that extends from the top of  FIG. 6A  to the bottom of  FIG. 6A . In other embodiments, the roughened surface  120  can include the ribs  122  and troughs  124  in a stripe pattern that extends in another direction, such as horizontally from one side, such as the left side, to the opposing side, the right side, or diagonally across the roughened surface  120 . 
       FIG. 6B  is a diagram illustrating a cross-section of the highly hydrophobic roughened surface  120 , according to embodiments of the disclosure. Each of the ribs  122  has a width W 1  and each of the troughs  124  has a width W 2 . Also, each of the troughs has a depth D 3 , as measured from the peak or top of the ribs  122  to the bottom of the troughs  124 . The ribs  122  are separated from one another by the troughs  124  a distance D 4 , as taken from the midline of adjacent ribs  122 . The highly hydrophobic roughened surface  120  has a water contact angle in a range of from 110 to 150 degrees. In some embodiments, the width W 1  of each of the ribs  122  is in a range of from 25 to 75 micrometers. In some embodiments, the width W 2  of each of the troughs  124  is in a range of from 25 to 75 micrometers. In some embodiments, the depth D 3  of each of the troughs  124  is in a range of from 10 to 30 micrometers. In some embodiments, the distance D 4  between adjacent ribs  122  is in a range of from 75 to 125 micrometers. 
     The roughened surface  120  is manufactured from a surface of a device, which can be or include one or more of a metal, a plastic/polymer, and a parylene covered surface. In some embodiments, the plastic/polymer is a polyimide. In one embodiment, the surface of the device is patterned and textured by laser etching the surface of the device to remove material from the surface and produce the roughened surface  120 . In one embodiment, the surface of the device is patterned and textured by chemically etching the surface of the device to remove material from the surface and produce the roughened surface  120 . In one embodiment, the surface of the device is patterned and textured by plasma etching the surface of the device to remove material from the surface and produce the roughened surface  120 . In other embodiments, the surface of the device is patterned and textured by adding material to the surface, such as by ALD, to produce the roughened surface  120 . 
     The highly hydrophobic roughened surface  120  can be used on devices, such as medical devices including the pulse generator  20  and the electrical lead  22 . The roughened surface  120  inhibits the adhesion and growth of microorganisms on the associated device, which reduces the chance of serious and costly complications such as infections, bacteremia, endocarditis, and removal of an implanted device. 
       FIG. 7A  is a diagram illustrating a highly hydrophilic roughened surface  140 , according to embodiments of the disclosure. The highly hydrophilic roughened surface  140  includes plateaus  142  separated by horizontal troughs  144   a  and vertical troughs  144   b , to produce a checkerboard pattern. 
       FIG. 7B  is a diagram illustrating a cross-section of the highly hydrophilic roughened surface  140  including the plateaus  142  and the vertical troughs  144   b , according to embodiments of the disclosure. Each of the plateaus  142  has a length L (as shown in  FIG. 7A ) and a width W 3 , and each of the troughs  144   b  has a width W 4 . Also, each of the troughs  144   b  has a depth D 5 , as measured from the peak or top of the plateaus  142  to the bottom of the troughs  144   b . The plateaus  142  are separated from one another by the troughs  144   b  a distance D 6 , as taken from the middle of adjacent plateaus  142 . The highly hydrophilic roughened surface  140  has a water contact angle in a range of from 0 to 10 degrees. In some embodiments, the length L of each of the plateaus  142  is in a range of from 20 to 60 micrometers and the width W 3  of each of the plateaus  142  is in a range of from 20 to 60 micrometers. In some embodiments, the width W 4  of each of the troughs  144   b  is in a range of from 20 to 60 micrometers. In some embodiments, the depth D 5  of each of the troughs  144   b  is in a range of from 10 to 30 micrometers. In some embodiments, the distance D 6  between adjacent plateaus  142  is in a range of from 40 to 80 micrometers. 
     The roughened surface  140  is manufactured from a surface of a device, which can be or include one or more of a metal, a plastic/polymer, and a parylene covered surface. In some embodiments, the plastic/polymer is a polyimide. In one embodiment, the surface of the device is patterned and textured by laser etching the surface of the device to remove material from the surface and produce the roughened surface  140 . In one embodiment, the surface of the device is patterned and textured by chemically etching the surface of the device to remove material from the surface and produce the roughened surface  140 . In one embodiment, the surface of the device is patterned and textured by plasma etching the surface of the device to remove material from the surface and produce the roughened surface  140 . In other embodiments, the surface of the device is patterned and textured by adding material to the surface, such as by ALD, to produce the roughened surface  140 . 
     The highly hydrophilic roughened surface  140  can be used on devices, such as medical devices including the pulse generator  20  and the electrical lead  22 . The roughened surface  140  inhibits the adhesion and growth of microorganisms on the associated device, which reduces the chance of serious and costly complications such as infections, bacteremia, endocarditis, and removal of an implanted device. 
       FIG. 8A  is a diagram illustrating a control coupon  160  having a control surface  162  that has not been patterned or textured to provide a roughened surface to inhibit the adhesion or growth of microorganisms. The control coupon  160  was used in testing to provide a non-textured control sample. In some embodiments, the control coupon  160  includes or is made out of titanium. 
     In embodiments, the control coupon  160  was incubated for a period of time, such as 2 or more hours, with liquid cultures of bacteria, such as  E. Coli  and/or  S. Aureus . After the incubation period, the control coupon  160  was washed to remove loosely attached cells and then stamped face down onto a growth plate  164 . The cells transferred to the growth plate  164  were grown out for a growth time and at a growth temperature, such as overnight at 37 degrees Celsius or for 72 hours at 25 degrees Celsius, to provide quantifiable colonies of cells. 
       FIG. 8B  is a diagram illustrating colonies of bacteria cells  166  that were grown via the procedure described above. As illustrated, the control coupon  160  with the non-textured control surface  162  produced or resulted in a number of bacteria colonies  166 . 
       FIG. 9A  is a diagram illustrating a textured coupon  180  having a surface  182  including a textured surface area  184 , according to embodiments of the disclosure. The textured surface area  184  has been textured to provide a roughened surface that inhibits the adhesion and growth of microorganisms. The textured surface area  184  is a substantially square or rectangular region including a roughened surface as described in this disclosure. In some embodiments, the textured coupon  180  includes or is made out of titanium. 
     In embodiments, the textured coupon  180  was incubated and cells were grown as described above for the control coupon  160 . The textured coupon  180  was incubated for a period of time, such as 2 or more hours, with liquid cultures of bacteria, such as  E. Coli  and/or  S. Aureus . After the incubation period, the textured coupon  180  was washed to remove loosely attached cells and then stamped face down onto a growth plate  186 . The cells transferred to the growth plate  186  were grown out for a growth time and at a growth temperature, such as overnight at 37 degrees Celsius or for 72 hours at 25 degrees Celsius, to provide quantifiable colonies of cells. 
       FIG. 9B  is a diagram illustrating the resulting pattern of cell colonies on the growth plate  186 . As illustrated, few or no cell colonies were grown in an area  188  corresponding to the textured surface area  184  of the textured coupon  180 . However, the surrounding area  190 , which corresponds to non-textured portions of the textured coupon  180 , includes a number of cell colonies produced as a result of the above process. 
       FIG. 10  is a diagram illustrating a method of manufacturing a device having an infection resistant surface, according to embodiments of the disclosure. The device has a surface that is made into the infection resistant surface. In some embodiments, the device is a medical device, such as the pulse generator  20  or the electrical lead  22  (shown in  FIG. 1 ). In some embodiments, the surface of the device is similar to the front surface  24  of the pulse generator  20  and/or the lead surface of the electrical lead  22 . 
     The method, at  200 , includes the step of roughening the surface of the device to create a roughened surface that inhibits the adhesion and growth of microorganisms on the roughened surface. Where, inhibiting the adhesion and growth of microorganisms on the roughened surface reduces the chance of serious and costly complications such as infections, bacteremia, endocarditis, and removal of an implanted device. 
     The surface can be roughened using one or more of the methods or procedures described above. 
     In some embodiments, roughening the surface of the device includes directly texturing the surface material of the device. In some embodiments, the surface material of the device includes at least one of metal and a polymer. In some embodiments, the polymer is a polyimide. In some embodiments, the surface material of the device includes a parylene coating that is directly textured to create the roughened surface. 
     In some embodiments, roughening the surface of the device includes texturing a surface of a mold that is used to create the device and molding the device in the mold to create the roughened surface. In some embodiments, the mold includes at least one of epoxy and silicone. 
     In some embodiments, roughening the surface of the device includes at least one of laser etching a pattern into a mold or the surface material of the device, chemically etching a pattern into one of the mold or the surface material of the device, plasma etching a pattern into one of the mold or the surface material of the device, PVD coating a pattern onto one of the mold or the surface material of the device; sputtering or sputter coating a pattern onto one of the mold or the surface material of the device, and ALD of a pattern onto one of the mold or the surface material of the device. 
       FIG. 11  is a diagram illustrating another method of manufacturing a device having an infection resistant surface, according to embodiments of the disclosure. The device has a surface that is made into the infection resistant surface. In some embodiments, the device is a medical device, such as the pulse generator  20  or the electrical lead  22  (shown in  FIG. 1 ). In some embodiments, the surface of the device is similar to the front surface  24  of the pulse generator  20  and/or the lead surface of the electrical lead  22 . 
     The method, at  220 , includes the step of roughening a surface of the device to provide one of a highly hydrophobic surface and a highly hydrophilic surface that inhibits the adhesion of microorganisms on the one of the highly hydrophobic surface and the highly hydrophilic surface. Where, inhibiting the adhesion and growth of microorganisms reduces the chance of serious and costly complications such as infections, bacteremia, endocarditis, and removal of an implanted device. In some embodiments, the highly hydrophobic surface provides a water contact angle in a range of from 110 to 150 degrees. In some embodiments, the highly hydrophilic surface provides a water contact angle in a range of from 0 to 10 degrees. In some embodiments, the highly hydrophobic surface provides a water contact angle of greater than 110 degrees. In some embodiments, the highly hydrophilic surface provides a water contact angle of less than 10 degrees. 
     As described above for the previous method, the surface can be roughened using one or more of the methods or procedures described above. 
     In some embodiments, roughening the surface of the device includes directly texturing the surface material of the device. In some embodiments, the surface material of the device includes at least one of metal and a polymer. In some embodiments, the polymer is a polyimide. In some embodiments, the surface material of the device includes a parylene coating that is directly textured to create the roughened surface. 
     In some embodiments, roughening the surface of the device includes texturing a surface of a mold that is used to create the device and molding the device in the mold to create the roughened surface. In some embodiments, the mold includes at least one of epoxy and silicone. 
     In some embodiments, roughening the surface of the device includes at least one of laser etching a pattern into a mold or the surface material of the device, chemically etching a pattern into one of the mold or the surface material of the device, plasma etching a pattern into one of the mold or the surface material of the device, PVD coating of a pattern onto one of the mold or the surface material of the device; sputtering or sputter coating a pattern onto one of the mold or the surface material of the device, and ALD of a pattern onto one of the mold or the surface material of the device. 
     Various modifications and additions can be made to the exemplary embodiments discussed without departing from the scope of the disclosure. For example, while the embodiments described above refer to particular features, the scope of this disclosure also includes embodiments having different combinations of features and embodiments that do not include all of the described features. Accordingly, the scope of the disclosure is intended to embrace all such alternatives, modifications, and variations as fall within the scope of the claims, together with all equivalents thereof.