Catheter tips and related methods

Abstract

The present invention provides a method of manufacturing a catheter tip by electroplating a conductive material on an insert including a negative version of a dome-like shape, thereby forming a shape of a catheter tip including a dome having a dome-like shape; selectively positioning a plurality of irrigation holes between an outer surface and an inner surface of the catheter tip; removing the insert, thereby leaving the catheter tip and the plurality of irrigation holes; and electropolishing the catheter tip. In other examples, the insert is not removed, but the step of electroplating causes the insert to be encapsulated by the conductive material, thereby forming the catheter tip.

Description

Technical Field

[0001] The present disclosure relates generally to producing tips for use in ablation catheters, and particularly to methods for mass producing tips for use in ablation catheters. Background Art

[0002] Arrhythmias such as atrial fibrillation occur when an area of ​​cardiac tissue abnormally conducts electrical signals to adjacent tissue, disrupting the normal heart cycle and causing an irregular heartbeat.

[0003] Procedures used to treat cardiac arrhythmias involve surgically disrupting the source of the signals that cause the arrhythmia, as well as disrupting the conduction pathways for such signals. By selectively ablating cardiac tissue through the application of energy via a catheter, it is sometimes possible to prevent or alter the propagation of unwanted electrical signals from one part of the heart to another. Ablation methods destroy unwanted electrical pathways by creating non-conductive lesions.

[0004] Currently, radio frequency (RF) ablation catheter tips must each be individually machined to form irrigation holes and / or to form a housing. This is time-consuming and labor-intensive, which increases overall costs but also reduces repeatable and scalable manufacturing.

[0005] The solution of the present disclosure addresses these and other problems in the art. Summary of the invention

[0006] Thus, the inventors of the present disclosure have recognized a need to manufacture multiple catheter tips at once using one or more removable inserts or molds that can be plated to form catheter tips including domes. Depending on the size, many inserts can be processed at once.

[0007] In some examples, a method for manufacturing a catheter tip is disclosed. The method includes: electroplating a conductive material on an insert including a negative version of a dome-like shape to form a shape of a catheter tip including a dome having a dome-like shape; selectively positioning a plurality of irrigation holes between an outer surface and an inner surface of the catheter tip; removing the insert to leave the catheter tip and the plurality of irrigation holes; and electropolishing the catheter tip.

[0008] In some examples, the catheter tip is a generally tubular member with a dome-shaped cap.

[0009] In some examples, the insert is a generally tubular member having an inner lumen.

[0010] In some examples, the insert includes plastic.

[0011] In some examples, the plastic includes acrylonitrile butadiene styrene (ABS).

[0012] In some examples, the plastic includes polycarbonate.

[0013] In some examples, the conductive material includes gold.

[0014] In some examples, the conductive material includes palladium.

[0015] In some examples, the conductive material includes platinum.

[0016] In some examples, the method includes forming the insert by molding a plastic material from a mold having a size and shape of the catheter tip.

[0017] In some examples, the step of selectively positioning the plurality of irrigation holes comprises the steps of: selecting an irrigation hole diameter; selecting a catheter tip wall thickness; determining lateral and vertical growth rates of the material; and determining a size of a negative of the insert irrigation hole based on the irrigation hole diameter, wall thickness, and lateral and vertical growth rates of the material.

[0018] In some examples, the lateral and vertical growth rates of the material are 1:1, and the step of determining the size of the negative of the insert irrigation hole includes adding the irrigation hole diameter to the catheter tip wall thickness.

[0019] In some examples, the steps of selectively positioning a plurality of flushing holes are performed simultaneously.

[0020] In some examples, the step of electroplating the conductive material on the insert includes axially aligning the pin with the longitudinal axis of the insert and retaining the insert by the pin during electroplating.

[0021] In some examples, the step of selectively positioning the plurality of irrigation holes includes forming an irrigation hole pattern on the catheter tip from a secondary non-plateable material.

[0022] In some examples, the secondary non-plateable material is nylon.

[0023] In some examples, the secondary non-plateable material is polypropylene.

[0024] In some examples, the secondary non-plateable material is polyester.

[0025] In some examples, the method includes setting an outer diameter of the insert to an inner diameter of the catheter tip.

[0026] In some examples, the method includes thickening a lower edge of the catheter tip with a secondary non-plateable material to prevent a rounded edge from forming adjacent a base of the catheter tip.

[0027] In some examples, the method includes the step of positioning a secondary non-plateable material at a lower edge of a base adjacent to the catheter tip.

[0028] In some examples, the step includes a height of approximately 0.002", thereby thickening the lower edge and preventing the formation of a rounded edge.

[0029] In some examples, the method includes compensating a hole diameter of one or more holes in the hole pattern by a wall thickness.

[0030] In some examples, the step of selectively positioning the plurality of irrigation holes includes oversizing the operative catheter tip diameter by a wall thickness of the catheter tip.

[0031] In some examples, the step of selectively positioning the plurality of irrigation holes includes setting a manufactured diameter of the irrigation holes by an operative catheter tip diameter plus a wall thickness of the catheter tip.

[0032] In some examples, the method includes maintaining a 1:1 ratio of lateral and vertical growth of the conductive material after the step of selectively positioning the plurality of flushing holes and the step of removing the insert.

[0033] In some examples, the method includes overmolding a secondary non-plateable material onto the insert.

[0034] In some examples, the holes of the hole pattern are configured to be filled with the secondary material.

[0035] In some examples, the step of removing the insert includes melting the insert, thereby leaving behind the catheter tip.

[0036] In some examples, the step of removing the insert includes dissolving the insert in an acid, thereby leaving behind the catheter tip.

[0037] In some examples, electropolishing the dome includes removing surface roughness and / or burrs.

[0038] In some examples, a method of manufacturing a plurality of catheter tips is disclosed. The method comprises simultaneously performing the method of any preceding claim to manufacture the plurality of catheter tips.

[0039] In some examples, the catheter tip is manufactured by any of the methods disclosed herein.

[0040] In some examples, a method of manufacturing a plurality of catheter tips is disclosed. The method includes electroplating a conductive material on a plurality of inserts including a negative version of a dome-like shape, thereby forming a plurality of domes including a dome-like shape; selectively positioning a plurality of irrigation holes between an outer surface and an inner surface of each respective dome; removing each respective insert, thereby leaving a respective dome; and electropolishing the domes of the plurality of catheter tips.

[0041] In some examples, the insert is a generally tubular member having an inner lumen.

[0042] In some examples, each respective insert comprises plastic.

[0043] In some examples, the plastic includes acrylonitrile butadiene styrene (ABS).

[0044] In some examples, the plastic includes polycarbonate.

[0045] In some examples, the conductive material includes gold.

[0046] In some examples, the conductive material includes palladium.

[0047] In some examples, the conductive material includes platinum.

[0048] In some examples, the method includes forming each respective insert by molding a plastic material from a mold having a size and shape of each respective catheter tip.

[0049] In some examples, the step of selectively positioning the plurality of irrigation holes comprises the steps of: selecting an irrigation hole diameter; selecting a catheter tip wall thickness; determining lateral and vertical growth rates of the material; and determining a size of a negative of the insert irrigation hole based on the irrigation hole diameter, wall thickness, and lateral and vertical growth rates of the material.

[0050] In some examples, the lateral and vertical growth rates of the material are 1:1, and the step of determining the size of the negative of the insert irrigation hole includes adding the irrigation hole diameter to the catheter tip wall thickness.

[0051] In some examples, the steps of selectively positioning a plurality of flushing holes are performed simultaneously.

[0052] In some examples, the step of electroplating the conductive material on the plurality of inserts includes axially aligning a pin with a longitudinal axis of each respective insert and retaining the respective insert by the pin during electroplating.

[0053] In some examples, the step of selectively positioning the plurality of irrigation holes includes forming an irrigation hole pattern on each respective catheter tip from a secondary non-plateable material.

[0054] In some examples, the secondary non-plateable material is nylon.

[0055] In some examples, the secondary non-plateable material is polypropylene.

[0056] In some examples, the secondary non-plateable material is polyester.

[0057] In some examples, the method includes setting an outer diameter of each respective insert to an inner diameter of the respective catheter tip.

[0058] In some examples, the method includes thickening a lower edge of each respective conduit tip with a secondary non-plateable material to prevent a rounded edge from forming adjacent a base of the respective conduit tip.

[0059] In some examples, the method includes the step of positioning a secondary non-plateable material at a lower edge of a base adjacent to a respective conduit tip.

[0060] In some examples, the step includes a height of approximately 0.002", thereby thickening the lower edge and preventing the formation of a rounded edge.

[0061] In some examples, the method includes compensating a hole diameter of one or more holes in the hole pattern by a wall thickness.

[0062] In some examples, the step of selectively positioning the plurality of irrigation holes includes oversizing the operative catheter tip diameter by a wall thickness of each respective catheter tip.

[0063] In some examples, the step of selectively positioning the plurality of irrigation holes includes setting a manufactured diameter of the irrigation holes by the operative catheter tip diameter plus a wall thickness of each respective catheter tip.

[0064] In some examples, the method includes maintaining a 1:1 ratio of lateral and vertical growth of the conductive material of each respective catheter tip after the step of selectively positioning the plurality of irrigation holes and the step of removing the insert.

[0065] In some examples, the method includes overmolding a secondary non-plateable material onto each respective insert.

[0066] In some examples, the holes of the hole pattern are configured to be filled with the secondary material.

[0067] In some examples, the step of removing each respective plated insert includes melting the respective insert, thereby leaving behind the respective conduit tip.

[0068] In some examples, the step of removing each respective electroplated insert includes dissolving the respective insert in an acid, thereby leaving behind the respective catheter tip.

[0069] In some examples, electropolishing the plurality of catheter tips includes removing surface roughness and / or burrs.

[0070] In some examples, a catheter tip is disclosed that is made by a method comprising the steps of: electroplating a conductive material on an insert having a negative version of a dome-like shape to form a catheter tip including a dome; selectively positioning a plurality of flushing holes between an outer surface and an inner surface of the dome; removing the insert to leave a catheter tip; and electropolishing the catheter tip.

[0071] In some examples, a plurality of catheter ends are disclosed, the plurality of catheter ends being made by a method comprising the steps of: electroplating a conductive material onto a plurality of inserts comprising a negative version of a dome-like shape, thereby forming a plurality of catheter ends each having a dome-like shape; selectively positioning a plurality of flushing holes between an outer surface and an inner surface of each respective catheter end; removing each respective insert, thereby leaving a respective catheter end; and electropolishing each of the plurality of catheter ends.

[0072] The present invention will be more fully understood from the following detailed description of the embodiments of the present disclosure taken in conjunction with the accompanying drawings. BRIEF DESCRIPTION OF THE DRAWINGS

[0073] The above aspects and additional aspects of the present disclosure will be further discussed with reference to the following description and in conjunction with the accompanying drawings, in which like numbers indicate similar structural elements and features in various figures. The accompanying drawings are not necessarily drawn to scale, but emphasis is placed on illustrating the principles of the present disclosure. The accompanying drawings depict one or more specific implementations of the present invention by way of example only and not by way of limitation.

[0074] Figure 1 is a schematic diagram of a system for ablating tissue of a subject according to some embodiments of the present disclosure.

[0075] Figure 2 is a schematic diagram of a step in a method of making an exemplary catheter tip of the present disclosure.

[0076] Figure 3 is a schematic diagram of a step in a method of making an exemplary catheter tip of the present disclosure.

[0077] Figure 4 is an illustration of a flow chart showing an exemplary method according to aspects of the present disclosure.

[0078] Figure 5 is an illustration of a flow chart showing an exemplary method according to aspects of the invention.

[0079] Figure 6 is an illustration of a flow chart showing an exemplary method according to aspects of the invention.

[0080] Figure 7 is an illustration of a flow chart showing an exemplary method according to aspects of the present disclosure.

[0081] Figure 8 is an illustration of a flow chart showing an exemplary method according to aspects of the invention. DETAILED DESCRIPTION

[0082] The term "electroplating" in this disclosure is intended to refer to the act of coating an object with a metal (eg, chromium, silver, gold, platinum, palladium, etc.) by electrolytic deposition.

[0083] As used herein, the term "non-electroplatable material" may mean any material that is not easily or cannot be electroplated. Such materials may include nylon, polypropylene, polyester, non-compound plastics, One or a combination of commercially available materials, etc. (they are thermoplastic polymer resins).

[0084] As used herein, the term "about" or "approximately" for any numerical value or range indicates a suitable dimensional tolerance that allows a collection of parts or elements to achieve its intended purpose as described herein. More specifically, "about" or "approximately" may refer to a range of ±20% of the value of the recited value, for example, "about 90%" may refer to a range of values ​​from 71% to 99%.

[0085] Medical devices such as some types of catheters include, for example, electrodes for conducting electrical signals to or from patient tissue. The embodiments of the present disclosure described below provide a method for producing a catheter tip for use with an electrode having low impedance at low frequencies. In principle, such electrodes may be produced by coating (e.g., welding or gluing) discrete locations of a catheter with a conductive (e.g., metal) layer. These metal layers reduce the impedance of the electrode at low frequencies, but such coating processes are inefficient for high volume manufacturing (HVM). The disclosed technology enables the use of a very large-scale integration (VLSI) process that can achieve high productivity in HVM to produce the catheter tip. The disclosed technology helps increase the functionality of the catheter tip by producing the catheter tip with HVM without compromising production costs. In addition, the use of VLSI processes on the catheter tip reduces the production cost of the distal end.

[0086] Figure 1 is a schematic illustration of a catheterization system 20 according to an embodiment of the present disclosure. System 20 includes a probe, in this example a cardiac catheter 22, and a console 24. Catheter 22 may be used for any suitable therapeutic and / or diagnostic purposes, such as sensing signals from a heart (not shown) of a patient 28.

[0087] The console 24 may include a processor 34 (typically a general purpose computer) having suitable front-end and interface circuitry for receiving signals from the catheter 22 and for controlling other components of the system 20 described herein. The console 24 may include drive circuitry 42 that drives a magnetic field generator 36 that is placed at a known location external to the body of a patient 28 lying on an operating table 29 (e.g., beneath the patient's torso).

[0088] In some embodiments, console 24 includes memory 50 and display 46 configured to display data, such as an image 44 of at least a portion of a heart of patient 28. In some embodiments, image 44 may be acquired using a computed tomography (CT) system, a magnetic resonance imaging (MRI) scanner, or using any other suitable anatomical imaging system. A physician 30, such as an interventional cardiologist, inserts catheter 22 through the vascular system of patient 28 lying on operating table 29. Catheter 22 includes a distal assembly 40, which is shown in inset 26. Physician 30 moves assembly 40 near a target location in the heart by manipulating catheter 22 using manipulator 32 near the proximal end of catheter 22. The proximal end of catheter 22 is connected to interface circuitry in processor 34.

[0089] Reference is now made to illustration 26 with a distal assembly 40, which may include a flexible printed circuit board (PCB) sheet 60 disposed around an inner member 69. In some embodiments, assembly 40 further includes a dome 66. Sheet 60 and / or dome 66 may be perforated to form one or more irrigation holes 64 configured to allow irrigation fluid to flow out of the insertion tube when irrigating tissue of the heart, such as during an ablation procedure.

[0090] Once completed, assembly 40 may include one or more electrodes 62 and / or one or more ring electrodes 63 configured to conduct electrical signals to or from tissue of the heart. During a medical procedure such as cardiac mapping, electrodes 62 and / or ring electrodes 63 are brought into contact with tissue of the heart to sense electrical signals generated thereby. Assembly 40 may be used to ablate tissue of the heart.

[0091] In some embodiments, processor 34 typically comprises a general purpose processor that is programmed in software to perform the functions described herein. The software may be downloaded to a computer in electronic form over a network, for example, or it may alternatively or additionally be disposed and / or stored on a non-transitory tangible medium such as a magnetic memory, an optical memory, or an electronic memory.

[0092] Figure 1 The configuration of the assembly 40 shown in the figure is merely an exemplary configuration selected for conceptual clarity. In alternative embodiments, any other suitable configuration may also be used. For example, the size and shape of the assembly 40 and the number and position of the electrodes 62 and / or ring electrodes 63 may be implemented using any suitable components and layout suitable for performing a suitable medical procedure on the tissue of any organ of the patient 28.

[0093] Go to Figure 2, a schematic diagram of a step in an exemplary method of manufacturing an exemplary catheter end of the present disclosure, such as the manufacture of some or all of component 40, is shown. In some examples, the solutions of the present disclosure use electroplating to metalize components, including plastics such as polycarbonate and ABS. The systems and methods of the present disclosure use removable inserts and / or molds that can be electroplated to form a catheter end including a dome. Once electroplated, the insert can be removed (e.g., by melting the insert, by dissolving the insert in an acid, etc.) to leave the electroplated shell that has now formed the catheter end. The electroplated catheter end can then be electropolished to remove surface roughness and / or burrs. The solutions of the present disclosure include using and / or manufacturing multiple inserts that can be processed simultaneously (e.g., see 100-1000 inserts plated simultaneously).

[0094] Specifically, Figure 2 An exemplary mold 200 is depicted that can form the insert 100. For example, the insert 100 can be formed by molding a plastic material from the mold 200, which can be the size and shape of the component 40 as shown. The mold 200 can be substantially cylindrical, with the middle section 165 corresponding to the outer surface of the middle section 155 of the insert 100. The mold 200 can also include a dome area 176 corresponding to the dome 166 of the insert 100, and a base section 168 corresponding to the base 158 of the insert 100, and a plurality of flushing hole areas 164 for corresponding holes 64 of the component 40.

[0095] To locate the hole region 164 in some examples, the flushing hole diameter and the desired catheter tip wall thickness may be selected. The lateral and vertical growth rates of the material may also be determined and the size of the insert flushing hole negative may be determined based on the flushing hole diameter, wall thickness, and lateral and vertical growth rates of the material. For example, the size of the hole region 164 may be set to approximately 0.0065 inches to compensate for the lateral growth of the approximately 0.0035 inch thick plating material.

[0096] In determining the size of the negative of the flushing holes of the insert, the flushing hole diameter of the hole area 164 can be added to the wall thickness of the catheter end. In addition, the lateral and vertical growth rates of the material can be predetermined at a ratio of about 1:1, but other larger or smaller ratios are contemplated as needed or required. The hole area 164 can also be positioned, sized, or otherwise formed at the same time. The hole area 164 can be positioned by forming a flushing hole pattern from a secondary non-platable material on one or more areas of the insert 100 (e.g., the dome cover 166).

[0097] The hole area 164 can also be formed by a predetermined hole of the insert 100. In some examples, the hole diameter of one or more hole areas 164 in the irrigation hole pattern can be compensated by the wall thickness of the insert 100. The hole area 164 in this example can be positioned by the wall thickness of the finished component 40 plus the size of the operative catheter tip diameter. The hole area 164 can also be positioned by setting the manufacturing diameter of the hole 64 by the operative catheter tip diameter plus the wall thickness of the finished component 40.

[0098] The hole regions 164 of any hole pattern according to the present disclosure may also be configured to be filled with a secondary non-electroplatable material. It should be understood that the hole regions 164 and / or the holes 64 themselves associated with the component 40 may also be formed after the insert 100 has been plated and removed (e.g., by drilling). In some examples, the secondary non-electroplatable material may be overmolded onto the insert 100.

[0099] Once molded, the insert 100 may be correspondingly shaped to have a generally tubular feature with an inner cavity and may include at least one plastic, such as acrylonitrile butadiene styrene (ABS) and polycarbonate. The shapes of the insert 100 depicted are merely exemplary, and other shapes and designs may be envisioned as needed or required. The insert 100 may be formed in the mold 200 by a variety of techniques, including injection molding, open molding, resin transfer molding (e.g., castable resins), mass molding, compression molding, additive manufacturing, etc. The insert 100 may be a negative of the dome-like shape having a dome section 166. The outer diameter D of the insert 100 may be set or otherwise based on the desired diameter of the finished component 40. For example, the diameter D may be .091 inches to simulate the inner diameter of the component 40.

[0100] Once one or more inserts 100 are formed, such as Figure 3 As shown, conductive material may be plated along the inner surface of insert 100 to form a plated housing for use with component 40, and any corresponding selectively located apertures 64. In some examples, multiple housings for corresponding multiple components 40 and apertures 64 may be formed simultaneously. Figure 3 The insert 100 in FIG. 4 includes a dome cover 166 having a dome support 168, each dome cover corresponding to a similar feature of the component 40 once plated. The insert 100 also includes one or more hole areas 164 that are selectively positioned between the inner and outer surfaces of the insert 100 by the mold 200, including on or around the dome cover 166 and the intermediate section 155. Although not shown, the hole areas 164 can also be positioned on or around the base 158, which can be located at the proximal end of the insert 100. It should be understood that the insert 100 can include an internal cavity for ultimately directing irrigation to the interior of the cavity of the component 40.

[0101] In some examples, the method of electroplating the inner surface of the insert 100 with the conductive material can include vapor deposition or some other chemical deposition process that deposits a thin layer of the conductive material on the inner surface of the insert 100. The conductive material can completely cover or plate the inner wall of the insert 100, and one or more computing systems can control the entire process of electroplating and / or removal of the insert 100. In some examples, the conductive material can also be electroplated on the insert 100 by axially aligning the pin 78 with the longitudinal axis 125 of the insert 100 and holding the insert 100 by the pin 78 during electroplating.

[0102] In some examples, as shown, the lower edge of the insert 100 on or adjacent to the base 158 can be thickened. The lower edge can be thickened with a secondary non-platable material to prevent a rounded edge from forming therearound. Step 153 can be used to thicken the lower edge, whereby step 153 can have a height of approximately .002 inches or any other height as desired or required.

[0103] After the insert 100 has been plated with the conductive material, the insert 100 may be removed, leaving behind the conduit ends and corresponding domes 66 and holes 64 of the assembly 40. The insert 100 may be removed from the conductive plated material by applying heat (e.g., melting) to the insert 100, leaving behind the dome cap 66, the middle section 55, the base 58, and other corresponding areas of the assembly 40. It is also contemplated that the insert 100 may be removed by dissolving the insert 100 in an acid, leaving behind the assembly 40. Once the insert 100 is removed, the assembly 40 may be electropolished. In some examples, electropolishing the assembly 40 may include removing surface roughness and / or burrs from the plated material previously formed with the insert 100. In some examples, the assembly 40 and any of its components manufactured using one or more of the steps disclosed herein may be finished to include a fingerprint, such as a unique mark, identifier, etc. Such marks and / or identifiers may include, but are not limited to, surface roughness, a unique edge of a part, certain sharpness, etc.

[0104] Figure 4 is a flow chart illustrating an exemplary method 400 of manufacturing a catheter tip according to one example of the present disclosure. Step 410 of method 400 may include electroplating a conductive material on an insert including a negative version of a dome-like shape, thereby forming a shape of a catheter tip including a dome having a dome-like shape. Step 420 of method 400 may include selectively positioning a plurality of irrigation holes between an outer surface and an inner surface of the catheter tip. Step 430 of method 400 may include removing the insert, thereby leaving the catheter tip and the plurality of irrigation holes. Step 440 of method 400 may include electropolishing the catheter tip.

[0105] The method 400 may include additional steps as will be known and appreciated by one of ordinary skill in the art. For example, the method 400 may include forming the insert by molding a plastic material from a mold having the size and shape of the catheter tip. The exemplary method 400 may be performed by the exemplary system as disclosed herein, variations thereof, or alternatives thereof as will be known and appreciated by one of ordinary skill in the art.

[0106] Figure 5 is a flow chart illustrating an exemplary method 500 of manufacturing a plurality of catheter tips according to an example of the present disclosure. Step 510 of method 500 may include electroplating a conductive material on a plurality of inserts comprising a negative version of a dome-like shape, thereby forming a plurality of catheter tips comprising a dome-like shape. Step 520 of method 500 may include selectively positioning a plurality of irrigation holes between an outer surface and an inner surface of each respective catheter tip. Step 530 of method 500 may include removing each respective insert, thereby leaving a respective catheter tip comprising a dome-like shape. Step 540 of method 500 may include electropolishing each catheter tip of the plurality of catheter tips.

[0107] The method 500 may include additional steps as will be known and appreciated by one of ordinary skill in the art. For example, the method 500 may include forming each respective insert by molding a plastic material from a mold having the size and shape of each respective catheter tip. The exemplary method 500 may be performed by the exemplary system as disclosed herein, variations thereof, or alternatives thereof as will be known and appreciated by one of ordinary skill in the art.

[0108] Figure 6 6 is a flow chart illustrating an exemplary method 600 of manufacturing a catheter tip according to one example of the present disclosure. Step 610 of method 600 may include electroplating a conductive material on an insert that is a negative of a dome-like shape, thereby forming the shape of the catheter tip into a dome having a dome-like shape. The step of electroplating causes the insert to be encapsulated by the conductive material, thereby forming the catheter tip. Step 620 of method 600 may include selectively positioning a plurality of irrigation holes between an outer surface and an inner surface of the catheter tip. Step 630 of method 600 may include electropolishing the catheter tip.

[0109] Figure 7is a flow chart illustrating an exemplary method 700 of manufacturing a plurality of catheter tips according to one example of the present disclosure. Step 710 of method 700 may include electroplating a conductive material on a plurality of inserts including a negative version of a dome-like shape, thereby forming a plurality of catheter tips having a dome-like shape. The step of electroplating causes the inserts to be encapsulated by the conductive material, thereby forming the catheter tips. Step 720 of method 700 may include selectively positioning a plurality of irrigation holes between an outer surface and an inner surface of the catheter tip. Step 730 of method 700 may include electropolishing the catheter tip.

[0110] Figure 8 is a flow chart illustrating an exemplary method 800 of manufacturing a plurality of catheter tips according to one example of the present disclosure. Step 810 of method 800 may include simultaneously performing any of the previously described methods for manufacturing a plurality of catheter tips.

[0111] In some examples, the insert can be formed by applying a negative mask coating formed of photoresist to a negative molded part at the location of each flushing hole, the size of the flushing hole being set according to the flushing hole target and wall thickness to account for lateral growth. In some examples, a .003-inch hole in a .005-inch thick dome can include a .013-inch photoresist dot. The mask area of ​​this example can prohibit surface plating on the mask area and allow annular growth from the surrounding delicious surface. By controlling the thickness of the plate and / or maintaining a plate height: width ratio of approximately 1:1, the resulting hole size can reach the target. In this regard, the negative photoresist process can work by coating the negative molded part in a photocrosslinking layer (e.g., SU-8 epoxy polymer) or a photopolymerizable (e.g., methyl methacrylate) material, and then exposing the hole pattern location to an appropriate curing process (e.g., electron beam or ultraviolet light). In some examples, a photoresist developer can then be applied to remove the undeveloped layer, leaving only the resist layer in the pattern and the desired size. In some examples, the electrode material may not grow from this surface, so the flushing hole can remain open. This example is particularly advantageous because it can leave an insert shape (e.g., circular) on the inside of the formed electrode, with the same diameter and thickness as the photoresist deposit used to form the flushing hole, which can occur when the electrode metal grows on the edge of the photoresist coating.

[0112] The descriptions contained herein are examples of embodiments of the present disclosure and are not intended to limit the scope of the present disclosure in any way. As described herein, the present disclosure contemplates many variations and modifications, including any of the methods, steps, catheter tips, and solutions for manufacturing multiple catheter tips simultaneously discussed herein. These modifications will be apparent to one of ordinary skill in the art to which the present disclosure relates, and are intended to be within the scope of the following claims.

Claims

1. A method for manufacturing a catheter tip, comprising the following steps: forming an insert comprising a negative of a dome-like shape and having a dome, a tubular feature with a lumen, and a base; Plating a conductive material along an inner surface of the insert to completely cover or plate an inner wall of the insert to form a shape of the conduit tip including a dome having a dome-like shape; thickening a lower edge of the insert on or adjacent the base with a secondary non-plateable material to prevent a rounded edge from forming about the lower edge; selectively positioning a plurality of irrigation holes between the outer surface and the inner surface of the catheter tip; removing the insert, thereby leaving behind the catheter tip and the plurality of irrigation holes; as well as The catheter tip is electropolished.

2. The method of claim 1, wherein the catheter tip is a tubular member having a dome-shaped cover.

3. The method of claim 1, the insert comprising plastic comprising acrylonitrile butadiene styrene (ABS).

4. The method of claim 1, the insert comprising plastic comprising polycarbonate. The method of claim 1 , wherein the conductive material comprises at least one of gold, palladium, and platinum.

6. The method of claim 1, wherein the step of selectively positioning the plurality of flushing holes comprises the steps of: Select flushing hole diameter; Select the catheter tip wall thickness; determining lateral and vertical growth rates of the conductive material; as well as The dimensions of the negative insert flushing hole are determined based on the flushing hole diameter, the wall thickness, and the lateral and vertical growth rates of the conductive material.

7. The method of claim 6, wherein the lateral and vertical growth rates of the conductive material are 1:1; and the step of determining the size of the negative of the insert irrigation hole comprises adding the irrigation hole diameter to the conduit tip wall thickness.

8. The method of claim 1, wherein the step of selectively positioning the plurality of irrigation holes is performed simultaneously.

9. The method according to claim 1, wherein the step of electroplating the conductive material comprises: axially aligning a pin with a longitudinal axis of the insert; as well as The insert is held by the pins during electroplating.

10. The method of claim 1, the step of selectively positioning the plurality of irrigation holes comprising forming an irrigation hole pattern on the catheter tip from a secondary non-plateable material.

11. The method according to claim 10, further comprising: The step of thickening the lower edge of the insert on or adjacent the base with the secondary non-plateable material to prevent the rounded edge from forming about the lower edge includes a height of 0.002 inches.

12. The method according to claim 10, further comprising: The hole diameter of one or more holes in the hole pattern is compensated by the wall thickness.

13. The method according to claim 12, further comprising: After the steps of selectively positioning the plurality of flushing holes and removing the insert, a 1:1 ratio of lateral and vertical growth of the conductive material is maintained.

14. A method of manufacturing a plurality of catheter tips, forming an insert comprising a negative of a dome-like shape and having a dome, a tubular feature with a lumen, and a base; Plating a conductive material along the inner surfaces of the plurality of inserts to completely cover or plate the inner walls of the plurality of inserts to form a plurality of conduit tips including a dome-like shape; thickening a lower edge of the base or adjacent to the base of each of the plurality of inserts with a secondary non-plateable material to prevent formation of a rounded edge about the lower edge; selectively positioning a plurality of irrigation holes between the outer surface and the inner surface of each respective catheter tip; removing each respective insert, thereby leaving a respective catheter tip including the dome-like shape; as well as A catheter tip of the plurality of catheter tips is electropolished.

15. The method of claim 14, wherein the step of selectively positioning the plurality of flushing holes comprises the steps of: Select flushing hole diameter; Select the catheter tip wall thickness; determining lateral and vertical growth rates of the conductive material; as well as The dimensions of the negative insert flushing hole are determined based on the flushing hole diameter, the wall thickness, and the lateral and vertical growth rates of the conductive material.

16. The method of claim 15, wherein the lateral and vertical growth rates of the conductive material are 1:1; and the step of determining the size of the negative of the insert irrigation hole comprises adding the irrigation hole diameter to the conduit tip wall thickness.

17. A method of manufacturing a plurality of catheter tips, forming an insert comprising a negative of a dome-like shape and having a dome, a tubular feature with a lumen, and a base; Plating a conductive material along the inner surfaces of the plurality of inserts to completely cover or plate the inner walls of the plurality of inserts to form a plurality of conduit tips including a dome-like shape; thickening a lower edge of the base or adjacent to the base of each of the plurality of inserts with a secondary non-plateable material to prevent formation of a rounded edge about the lower edge; selectively positioning a plurality of irrigation holes between the outer surface and the inner surface of each respective catheter tip; as well as A catheter tip of the plurality of catheter tips is electropolished.

18. A plurality of catheter tips made by the method of claim 17.

Images