COIL CATHETER, METHOD OF USE, AND 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 catheter system for a halo-style catheter capable of transforming a catheter from a first, straight orientation to a second, coiled orientation, the catheter system comprising: the catheter having a catheter body including a proximal end and a distal end; said proximal end of said catheter body comprising a single coil terminating into a swan neck element and a right-angle bend, wherein said swan neck element and said right-angle element are configured to form a stabilizing elbow, and wherein said proximal end terminates into a tapered tip; said stabilizing elbow configured to allow for dynamic movement and further configured to provide a memory force to allow for snap back in proximity with a sphincter; said stabilizing elbow terminating into a straight stem culminating in said distal end of said catheter body, said straight stem configured to stent a prostatic urethra and to be placed above said sphincter without penetrating said sphincter during use; said single coil being perpendicular to said straight portion; a single first eyelet located along a horizontal plane of said single coil; a single second eyelet located along said stabilizing elbow; and whereas the catheter body functions as a prosthetic urethral stent while inserted in said body with said distal end located above said sphincter.

2. The system of claim 1, further comprising: a suture-to-tube portion configured to allow for bridging said sphincter, positioning the catheter body, and removing the catheter body.

3. The system of claim 2, wherein said suture-to-tube portion comprises an extra-luminal suture threaded through a pair of receivers passing through said catheter body about said distal end of said catheter body.

4. The system of claim 1, further comprising: said catheter body comprising a suture-to-tube portion configured to place a suture external to a lumen of said catheter body and external to a pusher, thereby being configured to prevent obstruction and tethering of said catheter body and to allow for bridging said sphincter, positioning the catheter body, and removing the catheter body.

5. The system of claim 4, further comprising: a snap cap configured to keep said suture from migrating and further configured to provide visual validation of placement of said catheter body; and said snap cap comprising a magnet.

6. The system of claim 1, further comprising: a pusher including a stylet having a guidewire, said pusher having a diameter smaller than a diameter of said catheter; said guidewire configured to guide said catheter into place within said bladder while said stylet is inserted at least partially into said catheter; and wherein said guidewire and said stylet are configured to be withdrawn from said catheter upon insertion into said bladder, thereby transforming said catheter from a first, straight orientation into a second, coiled orientation via said memory force.

7. The system of claim 6, wherein a diameter of said pusher is less than a diameter of said catheter body.

8. The system of claim 1, wherein said catheter body is comprised of Carbothane.

9. The system of claim 1, further comprising: said catheter body configured to be manufactured from a first straight tube orientation using a mold base comprising a forming block having a swan neck form portion and a halo coil form portion; said mold base configured to receive a mold cap secured to said mold base, said mold base and said mold cap configured to be heated by a heating element and subsequently configured to be chilled with a chiller; and whereby said mold base, said heating element, and said chiller are configured to provide said memory force to said stabilizing elbow.

10. A catheter system for a halo-style catheter capable of transforming a catheter from a first, straight orientation to a second, coiled orientation, the catheter system comprising: the catheter having a catheter body including a proximal end and a distal end; said proximal end of said catheter body comprising a single coil terminating into a swan neck element and a right-angle bend, wherein said swan neck element and said right-angle element are configured to form a stabilizing elbow, and wherein said proximal end terminates into a tapered tip; said stabilizing elbow configured to allow for dynamic movement and further configured to provide a memory force to allow for snap back in proximity with a sphincter; said stabilizing elbow terminating into a straight stem culminating in said distal end of said catheter body, said straight stem configured to stent a prostatic urethra and to be placed above said sphincter without penetrating said sphincter during use; said single coil being perpendicular to said straight portion; a single first eyelet located along a horizontal plane of said single coil; a single second eyelet located along said stabilizing elbow; a suture-to-tube portion configured to allow for bridging said sphincter, positioning the catheter body, and removing the catheter body, wherein said suture-to-tube portion comprises an extra-luminal suture threaded through a pair of receivers passing through said catheter body about said distal end of said catheter body; a pusher including a stylet having a guidewire, said pusher having a diameter smaller than a diameter of said catheter; said guidewire configured to guide said catheter into place within said bladder while said stylet is inserted at least partially into said catheter; wherein said guidewire and said stylet are configured to be withdrawn from said catheter upon insertion into said bladder, thereby transforming said catheter from a first, straight orientation into a second, coiled orientation via said memory force; and whereas the catheter body functions as a prosthetic urethral stent while inserted in said body with said distal end located above said sphincter.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0030] The drawings constitute a part of this specification and include exemplary embodiments of the present invention illustrating various objects and features thereof.

[0031] FIG. 1 is a diagrammatic representation of a preferred embodiment of the present inventions shown in a typical environment.

[0032] FIG. 2 is a front elevational view of a preferred embodiment of the present invention shown in a straightened orientation.

[0033] FIG. 3 is a top plan view thereof.

[0034] FIG. 4 is a bottom plan view thereof.

[0035] FIG. 5 is a top plan view of a preferred embodiment of the present invention in a coiled orientation.

[0036] FIG. 6 is a front elevational view thereof.

[0037] FIG. 7 is a three-dimensional isometric view thereof.

[0038] FIG. 8 is a front elevational view of a preferred embodiment of the present invention in combination with a typical pusher device.

[0039] FIG. 8A is a detailed view of a portion thereof taken a bout the circle 8A in FIG. 8.

[0040] FIG. 9 is a diagrammatic representation thereof shown in a typical environment with an external container.

[0041] FIG. 9A is a detailed view of a portion thereof taken about the circle 9A in FIG. 9.

[0042] FIG. 10 is a diagrammatic representation thereof shown without an external container.

[0043] FIG. 10A. is a detailed view of a portion thereof taken about the circle 10A in FIG. 10.

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

[0045] FIG. 11 is a three-dimensional view showing the preferred embodiment of the present invention in combination with a pusher.

[0046] FIG. 11A is a detailed view of a portion thereof taken about the circle 11A in FIG. 11.

[0047] FIG. 12 is a three-dimensional view showing a manufacturing step for manufacturing a preferred embodiment of the present invention.

[0048] FIG. 13 is a three-dimensional isometric view showing a second manufacturing step thereof.

[0049] FIG. 14 is a three-dimensional isometric view showing a third manufacturing step thereof.

[0050] FIG. 15 is a three-dimensional isometric view showing a fourth manufacturing step thereof.

[0051] FIG. 16 is a three-dimensional isometric view showing a fifth manufacturing step thereof.

[0052] FIG. 17 is a three-dimensional isometric view showing a sixth manufacturing step thereof.

[0053] FIG. 18 is a three-dimensional isometric view showing a seventh manufacturing step thereof.

[0054] FIG. 19 is a flow chart diagramming the method of using a preferred embodiment of the present invention.

[0055] FIG. 20 is a flow chart diagramming the method of manufacturing a preferred embodiment of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

I. Introduction and Environment

[0056] 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.

[0057] 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 will include the words specifically mentioned, derivatives thereof and words of similar meaning.

[0058] The directional terms proximal and distal require a point of reference. In this application, the point of reference in determining direction is from the perspective of the patient. Therefore, the term proximal will always refer to a direction that points into the patient's body, whereas distal will always refer to a direction that points out of the patient's body.

II. Preferred Embodiment Catheter System 2

[0059] 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 bend 7 such that the halo portion is along a plane perpendicular to the direction of the stem portion. The halo portion 6 is located within the bladder 16 once properly placed, and serves to provide optimal flow out of the catheter 4 through the stem 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 would be stopped at the glans 15 of the penis 13 (as shown). This would function similarly in a female patient. The thread would be formed from a monofilament suture-type material in a preferred embodiment. The snap cap 12 may include a magnet or be made of magnetic material.

[0060] The catheter 4 stem 8 passes through the prostate gland 14 and the end of the stem is located in proximity with the external sphincter 18. This system facilitates flow from the bladder 16 through the catheter 4 via eyelets 22, located at least at the swan neck section 7 and at the proximal coil tip 23 of the coil portion 6, and out through the urethra 20 (see FIG. 2). It is important that the stem 8 functions as a short straight arm that un-obstructs the prostatic urethra and sits above the urinary sphincter 18. It does not retain the urinary sphincter in an open orientation ever. This allows for volitional voiding of the bladder by the patient, facilitated by the internal catheter 4, without incontinence.

[0061] As shown in FIG. 1, when the catheter 4 is inserted into the bladder, the coil portion 6 coils, forming the swan neck portion which terminates into a right-angle bend which together form a stabilizing elbow which ensures the catheter remains properly in place within the bladder for optimal drainage through the catheter.

[0062] FIGS. 2-4 show how the catheter 4 would be inserted into the body in a straight orientation for easy placement. A guidewire hole 24 is located at the tip 23 of the coil portion 6 and at the base 25 of the stem portion 8 for use with a pusher 26 and stylet 30 as is typical. As shown in FIG. 2, the tip 23 is tapered for easy insertion.

[0063] FIG. 5-7 show how the catheter 4 forms into a coiled catheter with a halo portion 6 and swan neck 7 connecting to the stem portion 8 once inserted into its proper environment in the bladder 16. The catheter 4 defaults to this form due to a manufacturing process discussed below. Once the guidewire of the stylet 30 and pusher 26 elements is removed or at least withdrawn slightly, the catheter 4 will automatically coil into the form shown.

[0064] FIGS. 8 and 8A show the catheter 4 in its straight orientation in combination with a pusher 26 having an outer tube 28 and a stylet 30. The thread 10 and snap cap 12 extend through the pusher 26 and connect to the end of the catheter 4 near its base 25, shown in more detail in FIG. 11. These figures also show how the pusher 26 has a smaller diameter than that of the catheter 4, further easing insertion of the catheter.

[0065] FIG. 9 shows the catheter 4 and pusher 26 in the typical environment shown in FIG. 1 where the catheter is fully inserted and coiled in position. Flow 17 is indicated via the arrows through the catheter 4 by way of eyelets 22, vertically downward rather than perpendicular to the catheter as is the case with prior art catheters. The detailed view of FIG. 9A shows how the thread 10 is retained through receivers 27 in the catheter stem portion 8 to secure the thread to the catheter 4 for removal. The thread is shown external to the pusher 26, which abuts the base 25 of the catheter 4 with the stylet 30 making contact with the base of the stem portion 8 thereof.

[0066] FIG. 10 shows the insertion of the catheter 4 using the 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 the stylet 30 of the pusher is a functional guidewire that can be placed up and into the catheter itself to help position it within the bladder. The catheter 4 is straightened by the internally placed stylet 30 with guidewire. The catheter as shown is placed over the guidewire for safe insertion into the bladder, after which the guidewire and stylet are removed leaving only the coiled and unencumbered catheter 4 in the bladder as shown in FIG. 1.

[0067] FIG. 11 and FIG. 11A show in more detail the extra-luminal suture thread 10 which does not obstruct the lumen of the catheter 4. Like the positioning of the stem 8 about the sphincter 18, this is intended to prevent incontinence and is used to safely remove the catheter at a later date. No sheath is required for such procedure.

III. System 52 for Manufacture of Catheter System 2

[0068] FIGS. 12-18 show a manufacturing system 52 for manufacturing the coil catheter 4. As shown, the coil catheter 4 is 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 tubing prior to molding to prevent kinks during the forming process. The mold base 34 has receiver slots 38 for screws 48 to receive the mold cap 46 as shown in FIG. 14. The mold base 34 also has a forming block with a swan neck form 44 and halo form 40. The stem 8 is inserted into the stem receiver 42 and the swan neck 7 portion is placed into the swan neck form 44, and the halo portion 6 is curled around in the halo form 40. The mold cap 46 is then secured to the mold base 34 via the screws 48.

[0069] FIG. 15 shows a heating controller 50 with a temperature gauge 54 and timer 56. The mold is heated to an appropriate level to thermoset the coil catheter 4. This process can take approximately 15-19 minutes to reach the proper temperature, at which point the mold 34 is held at that temperature for 15 minutes. FIG. 16 shows a chiller 58 with a temperature gauge 60 and timer 62. The chiller 58 sets a temperature of 5.00 degrees Celsius and cools the heated coil catheter 4 down to thermoset its shape. A temperature alarm may be included to properly track chilling. Once the temperature gauge 60 indicates a temperature less than 80 degrees Fahrenheit, typically after 15-19 minutes, the chiller 58 is turned off.

[0070] The mold cap 46 is removed as shown in FIG. 17 and the thermoset coil catheter 4 is removed from the mold base 34 as shown in FIG. 18. After this step, the coil catheter 4 can be placed on a rack for further cooling and should be covered to reduce contamination risks.

IV. Method 102 of Using Catheter System 2

[0071] FIG. 19 shows the steps taken in practicing a method 102 of using the coil catheter 4 system 2 as described above. The process starts at 104, where the catheter 4 is obtained at 106. A pusher 36 is obtained and used with the catheter at 108, and the catheter 4 is straightened as shown in FIG. 8 at 110. This allows the catheter 4 to be inserted into the body at 112 using the pusher 36. A check of whether the catheter is in place at 114 may require the pusher 36 to be extended at 116 to ensure proper placement of the catheter. Once in place at 114, the bladder will drain through the catheter 4 eyelet 22 into the catheter 4, out through the pusher 36, through a connected tube 27 and into an external container 29 at 118. A determination is made at 120 whether to remove the tube and external container. If not, they remain in place. If so, then the tube and container are removed at 122.

[0072] A check is then made at 124 and a determination made whether flow is optimal with the pusher 36 in place. If not, the pusher will remain. If so, the pusher can be removed at 126 so that flow is entirely facilitated using the catheter 4 in the body. The process then ends at 128 until such a time that the catheter is to be removed.

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

[0073] FIG. 20 shows the steps taken in practicing a method 152 of manufacturing the coil catheter 4 as described above using the manufacturing system 52. The process starts at 154, where a straight catheter tube is obtained at 156. This catheter tube should be cut to size, approximately 8.5″ long, and may be outfitted with a tubing support to reduce the risk of tubing kinks during the forming process at 158.

[0074] The catheter and protector are then inserted into the mold at 160, using the swan neck form 44 and the halo form 40 of the mold base 34. The mold is capped at 162 and heated at 164 as described above. A check using the temperature gauge 54 is made at 166 to determine if the proper temperature has been reached. If not, heating continues. If so, temperature is maintained at 168 for 15 minutes, after which the chiller is activated at 170 to cool the mold.

[0075] A check to determine if the mold has reached its cooled temperature below 80 degrees Fahrenheit at 172. If not, chilling continues. If so, then the chiller is deactivated at 174, the mold is opened at 176, and the formed catheter 4 is removed at 178, ending the process at 180.

[0076] The catheter may be manufactured of Carbothane or other materials which provide long safety use and biocompatibility.

[0077] 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.