Catheter assembly having a microtextured surface and method of manufacture - Patent Application 20070122997

Abstract

A catheter assembly and a method for manufacturing the same are described. The catheter assembly includes a catheter body having a proximal end, a distal end, and a lumen formed by an inner wall of the catheter body extending along a longitudinal axis between the proximal and distal ends. The catheter body further includes an outer surface extending between the proximal and distal ends, the outer surface having a first portion and a second portion. The device includes the second portion of the outer surface having a microtextured surface configured to spread droplets of the liquid tissue adhesive onto the second portion of the outer surface by capillary action to form a thin film and / or microdroplets of the liquid tissue adhesive, thereby achieving faster curing and adhesion between the catheter and the skin.

Description

[Technical Field]

[0001] Aspects of the present disclosure relate to catheter assemblies having a micro-textured surface and methods of manufacturing the same, and specific embodiments relate to intravenous catheter assemblies having a micro-textured surface that facilitates fixation to a patient's skin and methods of manufacturing such intravenous catheter assemblies.

[0002] This application claims priority under 35 U.S.C. §119(e) to U.S. Provisional Application No. 63 / 450,540, filed March 7, 2023, the disclosure of which is incorporated herein by reference in its entirety. [Background technology]

[0003] Generally, vascular access devices are used to provide fluid communication with a patient's vascular system. For example, catheters are used to infuse fluids (e.g., saline, medications, and / or total parenteral nutrition) into a patient, withdraw fluids (e.g., blood) from a patient, and / or monitor various parameters of a patient's vascular system.

[0004] Intravenous (IV) catheter assemblies are one of many types of vascular access devices. Over-the-needle peripheral IV catheters are a common IV catheter configuration. As the name suggests, over-the-needle catheters are attached to an introducer needle with a sharp distal tip. The introducer needle, typically a venipuncture needle, is coupled to a needle assembly. The needle assembly guides the needle and facilitates its engagement with the catheter. At least the inner surface of the distal portion of the catheter securely engages the outer surface of the needle to prevent catheter dislodgement, thereby facilitating insertion of the catheter into a blood vessel. The catheter and introducer needle are often assembled so that the sharp distal tip of the introducer needle protrudes beyond the distal tip of the catheter. Furthermore, the catheter and needle are often assembled so that the bevel of the needle faces upward, away from the patient's skin, during insertion. The catheter and introducer needle are typically inserted through the patient's skin into a blood vessel at a shallow angle.

[0005] After catheter insertion, an intravenous catheter assembly is secured to the patient to prevent premature and / or unintentional removal. In some cases, a clinician uses finger pressure to hold the inserted catheter assembly in place while preparing and applying an adhesive strip to the catheter assembly. Because this task typically requires the clinician's two hands, the clinician typically must prepare the adhesive strip and place it in a temporary position while attempting to secure the catheter assembly before inserting the catheter assembly into the patient. This temporary placement can increase the opportunity for infectious agents to come into contact with the catheter assembly after the adhesive strip is in place. In other examples, a first clinician inserts the catheter into a patient while a second clinician prepares and applies an adhesive strip to secure the inserted catheter assembly, reducing the risk of infection but significantly increasing the resources and effort required to place the catheter. Thus, the process of securing an inserted catheter assembly to a patient is time-consuming, cumbersome, and, in some cases, potentially adding undue risk of infection.

[0006] Another method of securing a catheter assembly to a patient involves using a liquid tissue adhesive to adhere the catheter hub to the patient's skin by dispensing a drop of the liquid tissue adhesive onto the catheter hub and applying the catheter hub to the patient's skin. However, the liquid tissue adhesive is dispensed in large drops that require a relatively long time to harden and adhere to the patient's skin, securing the catheter assembly to the patient. This results in the clinician having to wait a long time to ensure that fixation has been achieved. This also creates discomfort and resistance to this fixation mode for the clinician. Summary of the Invention [Problem to be solved by the invention]

[0007] Therefore, there remains an unresolved problem of providing a catheter assembly that reduces cure time with sufficient adhesive strength, thereby reducing the overall time spent securing the catheter assembly to the patient's skin. [Means for solving the problem]

[0008] Aspects of the present disclosure relate to a catheter adapter assembly including a catheter body having a proximal end, a distal end, and a lumen formed by an inner wall of the catheter body extending along a longitudinal axis between the proximal and distal ends. The catheter body further includes an outer surface extending between the proximal and distal ends, the outer surface including a first portion and a second portion. The second portion of the outer surface includes a microtextured surface configured to spread droplets of liquid tissue adhesive across the second portion of the outer surface by capillary action to form a thin film and / or form microdroplets of the liquid tissue adhesive.

[0009] Another aspect of the present disclosure relates to a method of manufacturing a catheter adapter assembly. In one embodiment, the method includes providing a catheter body having a proximal end, a distal end, and a lumen, the lumen being defined by an inner wall of the catheter body extending along a longitudinal axis between the proximal end and the distal end, the catheter body further having an outer surface extending between the proximal end and the distal end, the outer surface further having a first portion and a second portion, and forming a microtextured surface on the second portion of the outer surface, the microtextured surface configured to spread droplets of liquid tissue adhesive onto the second portion of the outer surface by capillary action to form a thin film and / or microdroplets of liquid tissue adhesive. [Brief explanation of the drawings]

[0010] [Figure 1A] FIG. 1 is a side view of a catheter adapter assembly according to an embodiment of the present disclosure. [Figure 1B] FIG. 1B is a bottom view of the catheter adapter assembly shown in FIG. 1A. [Figure 1C] FIG. 1B is a bottom perspective view of the catheter adapter assembly shown in FIG. 1A. [Figure 2] FIG. 16 is a bottom perspective view of a catheter adapter assembly including wings. [Figure 3] FIG. 3 is a bottom view of the catheter adapter assembly shown in FIG. 2. [Figure 4A] FIG. 1C is a side view of the catheter adapter assembly shown in FIGS. 1A-C with liquid tissue adhesive applied. [Figure 4B] 1A-1C is a side view of the catheter adapter assembly shown in FIGS. 1A-1C with the liquid tissue adhesive applied, illustrating the distribution of the liquid tissue adhesive on a rough surface. [Figure 5A] FIG. 10 is a side view of a catheter adapter assembly with a liquid tissue adhesive applied and a foam insert. [Figure 5B] FIG. 5B is a side view of the catheter adapter assembly shown in FIG. 5A with liquid tissue adhesive applied, illustrating the dispersal of the liquid tissue adhesive onto the foam insert. [Figure 6A] FIG. 1 is a side view of a micro-post. [Figure 6B] FIG. 1 is a top view of a roughened surface including recesses. [Figure 7] FIG. 10 is a flowchart diagram of a method of forming a catheter adapter assembly according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0011] Before describing several example embodiments of the present disclosure, it is to be understood that the present disclosure is not limited to the details of construction or process steps set forth in the following description. The present disclosure is capable of other embodiments and of being practiced or carried out in various ways.

[0012] In this disclosure, the convention is followed that the distal end of the device is the end closest to the patient and the proximal end of the device is the end away from the patient and closest to the practitioner or clinician.

[0013] As used herein, the term "dimension" shall include the length, diameter, or width of a geometric shape or part of a geometric shape described herein. The term "cross-sectional diameter" shall include the measurement of the longest or greatest distance between two points on the edge of the cross section of an object or part having a circular or non-circular cross section.

[0014] The two points can be located on the inner or outer surface of the cross-sectional edge of the object. The cross-sectional diameter at two points located on the inner surface of the cross-sectional edge of the object is called the "inner cross-sectional diameter," and the cross-sectional diameter at two points located on the outer surface of the cross-sectional edge of the object is called the "outer cross-sectional diameter." It should be noted that the "cross-sectional diameter" of an object with a circular cross-section can also be called the "cross-sectional dimension" or "diameter" of the object. The terms "cross-sectional dimension," "cross-sectional diameter," and "diameter" can be used interchangeably for objects with circular cross-sections.

[0015] Embodiments of the present disclosure relate to surface modification of a catheter hub and / or wings. In some embodiments, the surface modification includes providing a microtextured surface to the catheter hub and / or wings. In other embodiments, the surface modification of the catheter hub includes integrating foam into the surface of the catheter hub and / or wings. The surface modification according to one or more embodiments promotes capillary action to form a tissue adhesive film and / or microdroplets, speeding up curing and reducing the physician's wait time for the adhesive to reach the required bond strength.

[0016] In one or more embodiments, the catheter hub and / or wings are micro-textured or roughened on the portion of the hub surface and / or wings that contacts the patient's skin during catheter placement prior to intravenous insertion. Adhesive can be applied directly to the catheter hub and / or wings near the surface-modified catheter body, which can be micro-patterned on the hub and / or wing body, or on foam integrated into the hub and / or wing surface. Macrodroplets of adhesive penetrate through the micropattern formed on the hub and / or wings, or through roughened surfaces such as micropores in the foam, and the liquid tissue adhesive spreads rapidly (by capillary action), forming a thin film and / or microdroplets of liquid tissue adhesive at the interface of the hub and / or wings that contacts the patient's skin. In one or more embodiments, the larger surface area provided by the micro-patterned catheter hub and / or wings, or catheter hub and / or wings with integrated foam, allows the catheter assembly to adhere (and cure) to the patient's skin more quickly.

[0017] Intravenous (IV) catheter tissue adhesives secure the catheter to the insertion site and the hub to the skin, reducing catheter migration, displacement, and dislodgement. In embodiments of the catheter assemblies described herein, droplets of liquid tissue adhesive are placed at the insertion site and around the catheter hub and / or wings.

[0018] According to one or more embodiments, capillary action is the process by which a liquid flows through a narrow space without the aid of, or in some embodiments against, an external force such as gravity. In some embodiments, capillary action is the spontaneous rise of a liquid through a narrow tube, fiber, or micro-post against gravity due to adhesive, cohesive, and surface tension forces, resulting in the liquid rising within the narrow tube, fiber, or micro-post. According to one or more embodiments, "capillary action" is the phenomenon in which a liquid flows through a narrow space, is attracted to the inner surface of a capillary, and moves longitudinally and / or upward against gravity. For example, this can be observed as the rising of a liquid through a narrow tube when wicking between the bristles of a paintbrush, or as the permeation of a liquid through a porous material such as a sponge. In some embodiments, capillary action is caused by intermolecular forces between the liquid and the surrounding solid surface. When the diameter of a tube or the spacing between adjacent surfaces, such as fibers or small diameter microposts, is small enough, the liquid moves and forms a thin film due to a combination of surface tension caused by cohesive forces within the liquid and adhesive forces between the liquid and the solid surface.

[0019] In one or more embodiments, the tissue adhesive comprises a liquid containing at least one liquid monomer, such as a cyanoacrylate or a mixture of cyanoacrylates. In some embodiments, the tissue adhesive comprises 2-octyl cyanoacrylate, 2-butyl cyanoacrylate, or a mixture thereof. Non-limiting examples of tissue adhesives include Dermabond® (Ethicon US, LLC), SecurePort IV® (Adhezion Biomedical, LLC, Wyomissing, PA, USA), and Histoacryl® (B Braun, Sheffield, UK). In some embodiments, the tissue adhesive is a liquid monomer or mixture of liquid monomers that undergoes an exothermic reaction upon exposure to atmospheric moisture (cyanoacrylates undergo anionic polymerization in the presence of a weak base, such as water), thereby polymerizing and forming a bond between the catheter and the patient's skin. In one or more embodiments, the tissue adhesive has a low viscosity (e.g., less than 200 cps at room temperature) to promote capillary action, forming a thin film of tissue adhesive on the microtextured surface, thereby providing good adhesion of the catheter assembly to the patient's skin.

[0020] 1A-1C, one embodiment of a catheter adapter assembly 100 is shown, comprising a catheter body 102. The catheter body 102 comprises a proximal end 104, a distal end 106, and a lumen 108 formed by an inner wall of the catheter body extending along a longitudinal axis of the catheter body 102 between the proximal end 104 and the distal end 106. The catheter body 102 further comprises an outer surface extending between the proximal and distal ends, the outer surface comprising a first portion 110 and a second portion 112. The outer surface second portion 112 includes a microtextured surface configured to spread droplets 120 of liquid tissue adhesive onto the outer surface second portion 112 by capillary action to form a thin film and / or microdroplets of the liquid tissue adhesive.

[0021] 2 and 3, an alternative embodiment of a catheter adapter assembly 100 is shown, the catheter adapter assembly 100 including wings 130 having a second microtextured surface 132 thereon. The microtextured surface is configured to spread droplets of liquid tissue adhesive across the wings 130 by capillary action to form a thin film and / or microdroplets of the liquid tissue adhesive. The thin film of liquid tissue adhesive formed on the second microtextured surface 132 of the wings 130 enhances adhesion by increasing the curing rate when adhering the catheter assembly to a patient's skin compared to a wing surface not having a microtextured surface. In some embodiments, the catheter adapter assembly 100 includes a microtextured surface only on the second portion 112 of the catheter body 102. In some embodiments, the catheter adapter assembly 100 includes a microtextured surface only on the wings 130 of the catheter adapter assembly 100. In other embodiments, the catheter adapter assembly 100 includes a microtextured surface on both the second portion 112 and the wings 130 of the catheter body 102. In other embodiments, the microtextured pattern may be present on both the first surface (110) and the second surface (112) of the catheter body 102. A thin film of liquid tissue adhesive 122 formed on one or both of the microtextured surfaces is configured to be applied to the patient's skin 124 when the catheter body is applied to the patient's skin 124.

[0022] According to one or more embodiments, "microtexture" refers to a surface that promotes capillary action of droplets of liquid tissue adhesive, allowing the liquid tissue adhesive to spread as a thin film and / or microdroplets, thereby allowing a catheter adapter assembly having a microtextured surface to adhere to a patient's skin due to faster curing of the liquid tissue adhesive compared to a catheter adapter assembly having a smooth surface that contacts the patient's skin. In some embodiments, the liquid tissue adhesive includes at least one liquid monomer having a viscosity of less than 200 cps. In some embodiments, the liquid monomer includes at least one cyanoacrylate. In some embodiments, the microtextured surface comprises an injection-molded micropatterned polymer (plastic) surface. In some embodiments, the injection-molded micropatterned polymer surface includes a plurality of spaced struts that promote capillary action upon contact with the liquid tissue adhesive. In other embodiments, the microtextured surface is formed with a micromachined and / or laser-patterned mold insert via injection molding. In some embodiments, the microtextured surface is formed with a laser-patterned mold insert.

[0023] In one or more embodiments, the micropatterned surface takes the form of a grid pattern, a rectangular array, a regular polygonal array, a spiral, and combinations thereof. The micropatterned surface is designed to promote capillary action of liquids. For example, the width d, number, and spacing s of individual components (e.g., microposts, holes, etc.) are selected and arranged to adhere the catheter adapter to the patient's skin with a desired level of securement. In at least one embodiment, the micropattern is present on the skin-contacting surface of the catheter adapter assembly. In at least one embodiment, the individual elements of the micropatterned surface can be uniform, or the micropatterned surface can have a random arrangement of microposts, holes, and / or other individual elements to form the micropattern.

[0024] In another embodiment, as shown in FIGS. 5A and 5B, the catheter adapter assembly 100 includes a microtextured surface, the microtextured surface including a foam insert 113 integrated with a second portion of the exterior surface of the catheter body 102. As shown in FIGS. 5A and 5B, a large droplet 120 of liquid tissue adhesive dispensed by a clinician spreads into smaller microdroplets 121, forming a thin film 122 on the patient's skin 124. According to one or more embodiments, a "droplet" or "large droplet" refers to a volume equivalent to 10, 15, or 20 drops of liquid tissue adhesive per ml, whereby each droplet ranges from 0.05 ml to 0.1 ml. In one or more embodiments, a "microdroplet" refers to a volume equivalent to 60 drops of liquid tissue adhesive per ml, where each microdroplet has a volume of 0.0167 ml or less. In some embodiments, the microdroplets range from 15% to 35% of the volume of a macrodroplet. The thin film and / or microdroplets allow the liquid tissue adhesive to set faster due to capillary or wicking action of the liquid tissue adhesive within the pores of the foam compared to a smooth catheter body surface without microtexture and using only droplets larger than the microdroplets. The foam insert 113 has a plurality of pores that promote capillary action upon contact with the liquid tissue adhesive. In some embodiments, the foam insert 113 is laser welded to the second portion 112 of the exterior surface of the catheter body. In other embodiments, the foam insert is snap-fit ​​to the second portion 112 of the exterior surface of the catheter body.

[0025] 6A and 6B, as described above, the microtextured surface 112 in some embodiments comprises microposts 115 having a height H and a width W. The height of the microposts 115 is greater than the width W of the microposts 115 to promote capillary action between the surfaces of the posts. In some embodiments, the posts have an aspect ratio defined by the ratio of the height H to the width W, where the aspect ratio is greater than 0.5, greater than 1, greater than 2, greater than 3, greater than 4, greater than 5, greater than 6, greater than 7, greater than 8, greater than 9, greater than 10, and less than 100. In some embodiments, the width of the microposts 115 may be such that the width at the top of the microposts 115 is greater than the width at the bottom of the microposts 115, resulting in undercuts 117 near the top of the microposts 114, or vice versa, where the width at the top of the microposts 115 is smaller than the width at the bottom.

[0026] Referring to FIG. 6B, second portion 112, which has a microtextured surface, includes a plurality of recesses 119, which can take the form of dimples, microwells, openings, or other features that promote capillary action of the liquid tissue adhesive upon contact with the microtextured surface.

[0027] In some embodiments, the height and width of the microstruts range from 50 μm to 500 μm. Suitable heights and widths include 50 μm, 100 μm, 150 μm, 200 μm, 250 μm, 300 μm, 350 μm, 400 μm, 450 μm, and 500 μm. In other embodiments, a micropatterned elastomeric surface, such as a polymeric material, having microstruts of different heights and widths (e.g., micropillars ranging from 2.5 to 80 μm in width and height and width from 2.5 to 25 μm) is fabricated on the surface of a catheter adapter assembly by injection molding using a metal, ceramic, or silicone mold. In one or more embodiments, the spacing between individual elements, such as microstruts, ranges from 50 μm to 500 μm, with the spacing, height, and width selected to promote capillary action when a liquid, such as a liquid tissue adhesive, is deposited on the microtextured surface. Microtextured surfaces with aspect ratios greater than 0.5 promote higher adhesive forces than flat surfaces without microtexture. The adhesive force of liquid tissue adhesives increases with decreasing micropost width and increasing aspect ratio of the patterned features.

[0028] Another aspect of the present disclosure relates to a method of manufacturing a catheter adapter assembly. In one or more embodiments, the method 200 includes, at step 210, providing a catheter body having a proximal end, a distal end, and a lumen formed by an inner wall of the catheter body extending along a longitudinal axis between the proximal and distal ends. The catheter body further includes an outer surface extending between the proximal and distal ends, the outer surface including a first portion and a second portion, and such catheter adapters are shown and described herein.

[0029] The method further includes forming a microtextured surface on a second portion of the exterior surface at step 220, the microtextured surface configured to spread droplets of liquid tissue adhesive across the second portion of the exterior surface by capillary action to form a thin film and / or microdroplets of the liquid tissue adhesive. Some embodiments of method 200 utilize a catheter body comprising any material used in the manufacture of catheter assemblies, for example, a polymeric material such as polypropylene. At step 230, method 200 further includes injection molding a polymeric material to form a microtextured surface comprising a micropatterned polymeric surface. In some embodiments, injection molding the micropatterned polymeric surface includes injection molding the polymeric material onto a laser-patterned mold insert surface. In other embodiments, the micropatterned polymeric surface formed on the laser-patterned mold comprises a plurality of spaced struts that promote capillary action upon contact with the liquid tissue adhesive.

[0030] In other embodiments, injection molding the micropatterned polymeric surface comprises injection molding the polymeric material in a micromilled mold, hi some embodiments, the micropatterned polymeric surface formed on the micromilled mold comprises a plurality of spaced apart struts that promote capillary action upon contact with the liquid tissue adhesive.

[0031] In another embodiment of the method, the catheter body comprises a polymeric material, and the method 200 further includes, at step 240, integrating a foam insert into the second portion of the exterior surface of the catheter body. In some embodiments, the foam insert comprises a plurality of pores that promote capillary action upon contact with the liquid tissue adhesive. The foam insert can be integrated into the second portion of the exterior surface of the catheter body by laser welding. Alternatively, the method includes snap-fitting the foam insert into the second portion of the exterior surface of the catheter body.

[0032] Applying a liquid tissue adhesive to the microtextured surface of a catheter assembly allows the adhesive to spread more quickly across the surface of the catheter adapter assembly that contacts the patient's skin. Capillary action on the microtextured surface results in faster curing and improved adhesive strength of the catheter adapter assembly compared to a smooth surface. Advantageously, forming a microtextured surface can be easily integrated into existing catheter adapter assembly manufacturing processes by any of several methods. In some embodiments, a mold for injection molding the catheter adapter assembly can be modified to form the desired microtextured surface. Alternatively, a foam insert or attachment can be applied to the catheter adapter assembly after it is formed. The microtextured surface may include one or more of microposts, recesses, dimples, pores, and / or microchannels, which promote wicking and capillary action of the liquid adhesive, thereby improving retention and faster curing of the liquid tissue adhesive compared to a smooth surface.

[0033] Throughout this specification, the references to "one embodiment," "a particular embodiment," "one or more embodiments," or "one embodiment" mean that a particular feature, structure, material, or characteristic described in connection with that embodiment is included in at least one embodiment of the present disclosure. Thus, the appearances of "one or more embodiments," "a particular embodiment," "in one embodiment," or "in one embodiment" in various places throughout this specification are not necessarily referring to the same embodiment of the present disclosure. Furthermore, particular features, structures, materials, or characteristics may be combined in one or more embodiments, as appropriate.

[0034] Although the disclosure herein has been described with reference to particular embodiments, it should be understood that these embodiments are merely illustrative of the principles and applications of the disclosure. It will be apparent to those skilled in the art that various modifications and variations can be made in the disclosed method and apparatus without departing from the spirit and scope of the disclosure. Therefore, it is intended that the disclosure cover such modifications, variations, and variations as come within the scope of the appended claims and their equivalents.

Claims

1. 1. A catheter adapter assembly comprising a catheter body, the catheter body having a proximal end, a distal end, and a lumen formed by an inner wall of the catheter body extending along a longitudinal axis between the proximal end and the distal end; the catheter body includes an exterior surface extending between the proximal end and the distal end, the exterior surface further including a first portion and a second portion; the second portion of the outer surface includes a microtextured surface configured to spread droplets of the liquid tissue adhesive across the second portion of the outer surface by capillary action to form a thin film and / or microdroplets of the liquid tissue adhesive.

2. 10. The catheter adapter assembly of claim 1, wherein the catheter adapter assembly comprises wings, the wings comprising a second microtextured surface.

3. 3. The catheter adapter assembly of claim 2, wherein the liquid tissue adhesive includes at least one liquid monomer having a viscosity of less than 200 cps.

4. The catheter adapter assembly of claim 3 , wherein the liquid monomer comprises at least one cyanoacrylate.

5. The catheter adapter assembly of claim 1 , wherein the microtextured surface comprises an injection-molded micropatterned polymer surface.

6. 6. The catheter adapter assembly of claim 5, wherein the injection-molded micropatterned polymer surface comprises a plurality of spaced struts that promote capillary action upon contact with the liquid tissue adhesive.

7. 6. The catheter adapter assembly of claim 5, wherein the microtextured surface is formed from a micromachined mold insert.

8. 6. The catheter adapter assembly of claim 5, wherein the microtextured surface is formed from a laser-patterned mold insert.

9. 9. The catheter adapter assembly of claim 8, wherein the injection-molded micropatterned polymer surface comprises a plurality of spaced struts that promote capillary action upon contact with the liquid tissue adhesive.

10. 10. The catheter adapter assembly of claim 1, wherein the microtextured surface comprises a foam insert integrated with the second portion of the exterior surface of the catheter body.

11. 11. The catheter adapter assembly of claim 10, wherein the foam insert comprises a plurality of pores that promote capillary action upon contact with the liquid tissue adhesive.

12. 12. The catheter adapter assembly of claim 11, wherein the foam insert is laser welded to the second portion of the exterior surface of the catheter body.

13. 12. The catheter adapter assembly of claim 11, wherein the foam insert is snap-inserted onto the second portion of the exterior surface of the catheter body.

14. 1. A method of manufacturing a catheter adapter assembly, comprising: providing a catheter body having a proximal end, a distal end, and a lumen, the lumen being defined by an inner wall of the catheter body extending along a longitudinal axis between the proximal end and the distal end, the catheter body further having an outer surface extending between the proximal end and the distal end, the outer surface further having a first portion and a second portion; forming a microtextured surface on the second portion of the exterior surface, the microtextured surface configured to spread droplets of the liquid tissue adhesive onto the second portion of the exterior surface by capillary action to form a thin film and / or microdroplets of liquid tissue adhesive; A method for providing the above.

15. 15. The method of claim 14, wherein the catheter body comprises a polymeric material, the method further comprising injection molding the polymeric material to form a microtextured surface, including a micropatterned polymeric surface.

16. 16. The method of claim 15, wherein injection molding the micropatterned polymeric surface comprises injection molding the polymeric material onto a laser-patterned mold insert surface.

17. 17. The method of claim 16, wherein the micropatterned polymeric surface comprises a plurality of spaced posts that promote capillary action when contacted with a liquid tissue adhesive.

18. 16. The method of claim 15, wherein injection molding the micropatterned polymeric surface comprises injection molding the polymeric material in a micromilled mold.

19. 20. The method of claim 18, wherein the micropatterned polymeric surface comprises a plurality of spaced posts that promote capillary action upon contact with the liquid tissue adhesive.

20. 15. The method of claim 14, wherein the catheter body comprises a polymeric material, the method comprising integrating a foam insert into the second portion of the exterior surface of the catheter body.

21. 21. The method of claim 20, wherein the foam insert comprises a plurality of pores that promote capillary action upon contact with the liquid tissue adhesive.

22. 22. The method of claim 21, wherein the method includes laser welding the foam insert to the second portion of the exterior surface of the catheter body.

23. 22. The method of claim 21, wherein the method includes snap-fitting the foam insert onto the second portion of the exterior surface of the catheter body.

Images