COIL CATHETER METHOD OF MANUFACTURE

Abstract

A catheter device and manufacturing process for manufacturing the catheter device, wherein the catheter device has a halo-shaped coiled portion extending away from a perpendicular stem portion through a swan neck portion. Eyelets on the halo coil portion, and swan neck portion facilitate flow out of the bladder through the catheter device vertical to the catheter, rather than perpendicularly as is the case with existing catheters. The catheter device is formed by using a straight catheter tube, heating and cooling it within a formed mold to have the halo coil and swan neck, such that it can be straightened using a pusher and stylet, inserted into the body while straightened, and thereafter return to its coiled shape when the stylet is removed.

Claims

1. A method of manufacturing a catheter, the method comprising: placing a catheter tube into a mold base, wherein the mold base comprises a forming block having a first form and a second form; positioning a first portion of the catheter tube within the forming block; capping the mold base with a mold cap; heating the mold base with a heating element; cooling the mold base with a chiller, wherein: the chiller is connected to a temperature gauge; and cooling the mold base comprises cooling the mold base as a function of the temperature gauge; deactivating the chiller as a function of the temperature gauge; removing the mold cap from the mold base; and removing a thermoset catheter tube from the mold base, wherein the thermoset catheter tube comprises a proximal end and a distal end; and the proximal end comprises a coil having a first portion and a second portion.

2. The method of claim 1, wherein: the first form comprises a swan neck form; and the second form comprises a halo form.

3. The method of claim 1, wherein: the mold base further comprises a stem receiver; and placing the catheter tube into the mold base comprises placing a second portion of the catheter tube into the stem receiver.

4. The method of claim 1, wherein the distal end comprises a tubular portion.

5. The method of claim 4, wherein the second portion is disposed in a horizontal plane that is at an angle with the tubular portion.

6. The method of claim 5, wherein the angle comprises a right angle.

7. The method of claim 4, wherein the tubular portion comprises a star-shaped exterior, thereby allowing liquid to travel around rather than through the catheter.

8. The method of claim 1, wherein the proximal end further comprises a tapered end.

9. The method of claim 1, wherein the thermoset catheter tube comprises at least an eyelet, wherein the at least an eyelet is disposed in a direction perpendicular to a direction of flow and configured to facilitate and enhance flow through the catheter.

10. The method of claim 1, wherein the thermoset catheter tube is configured to move between a coiled state and an uncoiled state.

11. The method of claim 1, wherein: the first portion comprises swan neck portion; and the second portion comprises a halo portion.

12. The method of claim 1, wherein: the heating element is connected to the temperature gauge; and heating the mold base comprises heating the mold base as a function of the temperature gauge.

13. The method of claim 12, wherein: the temperature gauge is configured to identify at least a first temperature threshold; and heating the mold base comprises deactivating the heating element as a function of an indicated temperature outside of the at least a first temperature threshold.

14. The method of claim 1, wherein the temperature gauge is configured to identify at least a second temperature threshold.

15. The method of claim 14, wherein deactivating the chiller comprises deactivating the chiller as a function of an indicated temperature outside of the at least a second temperature threshold.

16. The method of claim 14, wherein at least a second temperature threshold includes 5 degrees Celsius.

17. The method of claim 1, wherein the temperature gauge comprises a temperature alarm configured to track a heating or chilling process.

18. The method of claim 1, further comprising: placing a tubing support protector into the catheter tube prior to placing the catheter tube into the mold base.

19. The method of claim 1, further comprising: forming a stabilizing elbow using the first portion and the second portion, wherein the stabilizing elbow terminates into a straight stem at the distal end of the thermoset catheter tube.

20. The method of claim 1, further comprising: providing a portion configured to place a suture external to a lumen of the thermoset catheter tube and external to a pusher, thereby being configured to prevent obstruction and tethering of the catheter and to allow for bridging a sphincter, positioning the catheter, and removing the catheter.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0031] For the purpose of illustrating the invention, the drawings show aspects of one or more embodiments of the invention. The drawings constitute a part of this specification and include exemplary embodiments of the present invention illustrating various objects and features thereof. However, it should be understood that the present invention is not limited to the precise arrangements and instrumentalities shown in the drawings, wherein:

[0032] FIG. 1 is a diagrammatic representation of a preferred embodiment of the present invention shown in a typical environment;

[0033] FIG. 2 is a front elevational view of a preferred embodiment of the present invention shown in a straightened orientation;

[0034] FIG. 3 is a top plan view of the embodiment shown in FIG. 2;

[0035] FIG. 4 is a bottom plan view of the embodiment shown in FIG. 2;

[0036] FIG. 5 is a top plan view of a preferred embodiment of the present invention in a coiled orientation;

[0037] FIG. 6 is a front elevational view of the embodiment shown in FIG. 5;

[0038] FIG. 7 is a three-dimensional isometric view of the embodiment shown in FIG. 5;

[0039] FIG. 8 is a front elevational view of a preferred embodiment of the present invention in combination with a typical pusher device;

[0040] FIG. 8A is a detailed view of a portion thereof taken about the circle 8A in FIG. 8;

[0041] FIG. 9 is a diagrammatic representation of an embodiment of the present inventions shown in a typical environment;

[0042] FIG. 9A is a detailed view of a portion thereof taken about the circle 9A in FIG. 9;

[0043] FIG. 10 is a diagrammatic representation of an embodiment of the present invention shown without an external container;

[0044] FIG. 10A is a detailed view of a portion thereof taken about the circle 10A in FIG. 10;

[0045] FIG. 10B is a detailed view of a portion thereof taken about the circle 10B in FIG. 10;

[0046] FIG. 11 is a three-dimensional view showing the preferred embodiment of the present invention in combination with a pusher;

[0047] FIG. 11A is a detailed view of a portion thereof taken about the circle 11A in FIG. 11;

[0048] FIG. 12 is a three-dimensional view showing a first manufacturing step for manufacturing a preferred embodiment of the present invention;

[0049] FIG. 13 is a three-dimensional isometric view showing a second manufacturing step thereof;

[0050] FIG. 14 is a three-dimensional isometric view showing a third manufacturing step thereof;

[0051] FIG. 15 is a three-dimensional isometric view showing a fourth manufacturing step thereof;

[0052] FIG. 16 is a three-dimensional isometric view showing a fifth manufacturing step thereof;

[0053] FIG. 17 is a three-dimensional isometric view showing a sixth manufacturing step thereof;

[0054] FIG. 18 is a three-dimensional isometric view showing a seventh manufacturing step thereof;

[0055] FIG. 19 is a flow chart diagramming a method of using a preferred embodiment of the present invention; and

[0056] FIG. 20 is a flow chart diagramming a method of manufacturing a preferred embodiment of the present invention.

[0057] The drawings are not necessarily to scale and may be illustrated by phantom lines, diagrammatic representations and fragmentary views. In certain instances, details that are not necessary for an understanding of the embodiments or that render other details difficult to perceive may have been omitted.

DETAILED DESCRIPTION

I. Introduction and Environment

[0058] As required, detailed aspects of the present invention are disclosed herein. However, it is to be understood that the disclosed aspects are merely exemplary of the invention, which may be embodied in various forms. Therefore, specific structural and functional details disclosed herein are not to be interpreted as limiting, but merely as a basis for the claims and as a representative basis for teaching one skilled in the art how to variously employ the present invention in virtually any appropriately detailed structure.

[0059] Certain terminology will be used in the following description for convenience in reference only and will not be limiting. For example, up, down, front, back, right and left refer to the invention as orientated in the view being referred to. The words, inwardly and outwardly refer to directions toward and away from, respectively, the geometric center of the aspect being described and designated parts thereof. Forwardly and rearwardly are generally in reference to the direction of travel, if appropriate. Said terminology may include the words specifically mentioned, derivatives thereof and words of similar meaning.

[0060] The directional terms proximal and distal may require a point of reference. In this application, the point of reference in determining direction may be from the perspective of a patient. Therefore, the term proximal may refer to a direction that points into a patient's body, whereas distal may refer to a direction that points away from the patient's body.

II. Preferred Embodiment Catheter System 2

[0061] As shown in a typical environment in FIG. 1, the present invention is a catheter system 2 which features a coiled catheter 4 having a halo portion 6 connected to a stem portion 8 via a swan neck portion 7, such that the halo portion 6 is disposed along a plane perpendicular to the direction of the stem portion 8. Halo portion 6 may be located within a bladder 16 once properly placed and may serve to provide optimal flow out of catheter 4 through stem portion 8. FIG. 1 shows a thread 10 connected to a snap cap 12 located outside of the body to prevent the thread 10 from being drawn up into the body, and instead the thread 10 would be stopped at the glans 15 of a penis 13 (as shown). This may function similarly in a female patient. Thread 10 may be formed from a monofilament suture-type material in a preferred embodiment. Snap cap 12 may include a magnet or be made of a magnetic material.

[0062] Stem portion 8 of catheter 4 may pass through a prostate gland 14 and the end of the stem portion 8 may be located in proximity to an external sphincter 18. This system may facilitate flow from bladder 16 through catheter 4, via eyelets 22, which may be located at swan neck portion 7 and/or at a proximal coil tip 23 of halo portion 6, and out through the urethra 20 (see FIG. 2). It is important that stem portion 8 functions as a short straight arm that un-obstructs the prostatic urethra and sits above the urinary sphincter 18. In other words, the device does not retain the urinary sphincter in an open orientation. This configuration may allow for volitional voiding of a bladder by a patient, facilitated by catheter 4, without incontinence.

[0063] As shown in FIG. 1, when catheter 4 is inserted into the bladder, halo portion 6 may coil, forming swan neck portion 7 which terminates into a right-angle bend; these elements may together form a stabilizing elbow which ensures that catheter 4 remains properly in place within a bladder for optimal drainage through the catheter 4.

[0064] FIGS. 2-4 show how the catheter 4 may be inserted into a body in a straight orientation for easy placement. A guidewire hole 24 may be located at proximal coil tip 23 of halo portion 6 and at a base 25 of stem portion 8 for use with a pusher 26 and a stylet, as is typical and as is shown in more detail in FIG. 8. As shown in FIG. 2, proximal coil tip 23 may be tapered for easy insertion.

[0065] FIGS. 5-7 show how catheter 4 may adopt a coiled configuration once inserted into its proper environment in bladder 16, with halo portion 6 and stem portion 8 connected through swan neck portion 7. Catheter 4 may default to this form due to a manufacturing process discussed below. Once the guidewire of stylet and pusher 26 is removed (see FIG. 8) or at least withdrawn slightly, catheter 4 may automatically coil into the form shown.

[0066] FIGS. 8 and 8A show catheter 4 in its straight orientation in combination with a pusher 26 having an outer tube 28 and a stylet 30. Thread 10 and snap cap 12 may extend through pusher 26 and connect to the end of catheter 4 near its base 25 or may be located externally to the pusher 26 and threaded through receivers 27 of stem portion 8 of the catheter 4, as shown in more detail in FIG. 11. FIGS. 8 and 11 also show how pusher 26 may have a smaller diameter than that of catheter 4, further easing insertion of the catheter.

[0067] FIG. 9 shows catheter 4 and pusher 26 in the typical environment shown in FIG. 1, where the catheter 4 is fully inserted and coiled in position. Flow 17 is indicated via the arrows through catheter 4 by way of eyelets 22, vertically downward rather than perpendicular to catheter 4 as is the case with prior art catheters. The detailed view of FIG. 9A shows how thread 10 may be retained through receivers 27 in stem portion 8 to secure the thread 10 to catheter 4 for removal. Thread 10 is shown to be external to pusher 26, which abuts base 25 of catheter 4, with stylet 30 contacting the base 25 of the stem portion 8 thereof.

[0068] FIG. 10 shows the insertion of catheter 4 using pusher 26 in a sectional view so as to better show the internal components thereof. FIGS. 10A and 10B show additional detail about their respective circles in FIG. 10, such as FIG. 10B showing how stylet 30 of pusher 26 may be implemented using a functional guidewire that can be placed up and into catheter 4 itself to help position the catheter 4 within a bladder. Catheter 4 may be straightened by internally placed stylet 30 with guidewire. Catheter 4 as shown may be placed over guidewire for safe insertion into the bladder, after which the guidewire and stylet 30 may be removed, leaving only the coiled and unencumbered catheter 4 in a bladder, as shown in FIG. 1.

[0069] FIG. 11 and FIG. 11A show in more detail the extra-luminal suture thread 10 which does not obstruct the lumen of catheter 4. Similar to the positioning of stem portion 8 above sphincter 18, this configuration is intended to prevent incontinence and may be used to safely remove catheter 4 at a later date. No sheath may be required for such procedure.

III. System 52 for Manufacture of Catheter System 2

[0070] FIGS. 12-18 show a manufacturing system 52 for manufacturing coil catheter 4. As shown, coil catheter 4 may be formed from an originally straight catheter tube by placing it into a mold base 34. A flexible yet solid tubing support may be inserted into the catheter tube prior to molding to prevent kinks during the forming process. Mold base 34 may include receiver slots 38 for screws 48 to receive a mold cap 46, as shown in FIG. 14. Mold base 34 may also have a forming block with a first form, such as a swan neck form 44, and a second form, such as a halo form 40. Stem portion 8 may be inserted into a stem receiver 42 and swan neck portion 7 may be placed into swan neck form 44, and halo portion 6 may be curled around in halo form 40. Mold cap 46 may then be secured to mold base 34 via screws 48.

[0071] FIG. 15 shows a heating controller 50 with a temperature gauge 54 and a timer 56. Mold base 34 may be heated to an appropriate temperature to thermoset coil catheter 4. This process may take approximately 15-19 minutes to reach the proper temperature, at which mold base 34 may be held for a period of time, such as 15 minutes. FIG. 16 shows a chiller 58 with a temperature gauge 60 and a timer 62. Chiller 58 may set a temperature of 5.00 degrees Celsius and cool a heated coil catheter 4 down to thermoset its shape. A temperature alarm may be included to properly track chilling. Once temperature gauge 60 indicates a temperature less than 80 degrees Fahrenheit, typically after 15-19 minutes, chiller 58 may be turned off.

[0072] Mold cap 46 may be removed, as shown in FIG. 17, and a thermoset coil catheter 4 may be removed from mold base 34, as shown in FIG. 18. After this step, coil catheter 4 may be placed on a rack for further cooling and should be covered to reduce contamination risks.

IV. Method 102 of Using Catheter System 2

[0073] FIG. 19 shows the steps taken in practicing a method 102 of using coil catheter system 2 as described above. Method 102 starts at step 104, where catheter 4 is obtained at step 106. A pusher 26 is obtained and used with catheter 4 at step 108, and the catheter 4 is straightened as shown in FIG. 8 at step 110. This allows the catheter 4 to be inserted into a body at step 112 using pusher 26. A check of whether the catheter is in place at step 114 may require pusher 26 to be extended at 116 to ensure proper placement of the catheter. Once in place at step 114, the bladder may drain through eyelet 22 into the catheter 4, out through pusher 26, through receiver 27, and into an external container (not shown) at step 118. A determination is made at step 120 regarding whether to remove the tube and external container. If not, they may remain in place. If so, then the tube and container may be removed at step 122.

[0074] A check is then made at step 124 and a determination may be made regarding whether flow is optimal with pusher 26 in place. If not, pusher 26 may remain in place. If so, pusher 26 may be removed at step 126 so that flow may be entirely facilitated using catheter 4 in the body. The process may then end at step 128 until such a time that pusher 26 is to be removed.

V. Method 152 of Manufacturing System 52 for Manufacture of Catheter System 2

[0075] FIG. 20 shows the steps taken in practicing a method 152 of manufacturing coil catheter 4, as described above using manufacturing system 52. Method 152 starts at 154, where a straight catheter tube may be obtained at step 156. This catheter tube should be cut to size, approximately 8.5 long, and may be outfitted with a tubing support protector to reduce the risk of tubing kinks during the forming process at step 158.

[0076] The catheter and protector may then be inserted into mold base 34 at step 160, using swan neck form 44 and halo form 40 of the mold base 34. Mold base may be capped at step 162 and heated at step 164, as described above. A check using temperature gauge 54 may be made at step 166 to determine if a proper temperature has been reached. If not, heating may continue. If so, this proper temperature may be maintained at step 168 for 15 minutes, after which chiller 58 may be activated at step 170 to cool the mold base 34.

[0077] A check may be made to determine if the mold has reached a temperature threshold, e.g., a cooled temperature below 80 degrees Fahrenheit, at step 172. If not, chilling may continue. If so, then chiller 58 may be deactivated at step 174, mold cap 46 may be opened at step 176, and a formed catheter 4 may be removed at step 178, ending the process at step 180.

[0078] The catheter may be manufactured using Carbothane, a registered trademark owned by Lubrizol Advanced Materials, Inc. of Cleveland, OH for a family of medical-grade polycarbonate-based aliphatic and aromatic polyurethanes, or other materials which may provide long, safe use and biocompatibility.

[0079] The foregoing has been a detailed description of illustrative embodiments of the invention. It is to be understood that while certain embodiments and/or aspects of the invention have been shown and described, the invention is not limited thereto and encompasses various other embodiments and aspects. Various modifications and additions can be made without departing from the spirit and scope of this invention. Features of each of the various embodiments described above may be combined with features of other described embodiments as appropriate in order to provide a multiplicity of feature combinations in associated new embodiments. Furthermore, while the foregoing describes a number of separate embodiments, what has been described herein is merely illustrative of the application of the principles of the present invention. Additionally, although particular methods herein may be illustrated and/or described as being performed in a specific order, the ordering is highly variable within ordinary skill to achieve methods, systems, and software according to the present disclosure. Accordingly, this description is meant to be taken only by way of example, and not to otherwise limit the scope of this invention.

[0080] Exemplary embodiments have been disclosed above and illustrated in the accompanying drawings. It will be understood by those skilled in the art that various changes, omissions and additions may be made to that which is specifically disclosed herein without departing from the spirit and scope of the present invention.