COIL CATHETER METHOD OF MANUFACTURE

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.

FIELD OF THE INVENTION

The present invention relates generally to a coil catheter, method for use thereof, and method of manufacture thereof. More specifically, the present invention relates to a catheter having a retention coil member for repositioning, validation of placement, and removal, method of use, and method of manufacture thereof.

BACKGROUND

Urinary retention in males generally implies that urine is produced normally but is retained within the bladder due to primary detrusor dysfunction or an obstruction at or distal to the bladder neck. Prostatic obstruction may cause an increased resistance for the passage of urine with subsequent increased pressure on the bladder musculature resulting in two successive phases: 1) compensation, where bladder emptying may still take place, and 2) decompensation, characterized by increasing amounts of residual urine and ultimately urine retention. Bladder outlet obstruction producing urinary retention may result from, including but not limited to, benign prostatic hypertrophy, prostate cancer, or any acute enlargement of the prostate including but not limited to acute prostatitis, post focal procedures on the prostate, radiation, cryotherapy, or instrumentation. Urinary retention occurs primarily in males, with benign prostatic hypertrophy being the most common cause in men over the age of 50 years. It has been estimated that one in four men in the United States will have been treated for symptomatic benign prostatic hypertrophy by the time they reach 80 years of age.

The prior art contains several examples, including devices which are disclosed in U.S. Pat. No. 7,044,980, incorporated herein by reference. Relevant, but distinguishable, prior art also includes U.S. Pat. No. 4,738,667 which teaches a halo-style catheter which presents additional issues that would need to be solved. For example, existing concepts and systems require external draining and a sheath requiring a bulbous end which was designed, at the time, to avoid stiff guidewires. New guidewires for catheter placement have reduced this stiffness, and are superior to such sheathes as taught in the prior art. What is desirable is a tapered end with a guidewire for ease of placement.

Material choices in existing systems can also be problematic. For example, Dacron (a cloth-like material) is taught by the prior art for use in coating a catheter. This material can become highly lithogenic when exposed to urine, so it would be ideal to use an alternative material or method. Another issue taught in the prior art is a sheath which becomes a permanent part of the system required to straighten the catheter for insertion and is further used to uncoil and retract the catheter from the bladder. It would be desirable not to require a permanently placed sheath to remove additional obstacles during the operation of a catheter.

It is also taught through prior systems to transverse the external sphincter of the bladder. This results in incontinence, even though the bladder may be draining through the catheter, because the sphincter is required to be kept open due to the presence of existing catheters. It is desirable to shorten the upper arm of such a catheter such that it sits above the urinary sphincter rather than retaining that sphincter in an open orientation.

Management for urinary retention related to prostate obstruction involves bladder drainage generally accomplished by placement of a transurethral, suprapubic catheter or intermittent self-catheterization. This creates a passageway between the bladder and the exterior of the body that allows a flow of urine to the outside.

Heretofore there has not been available a system or method for a catheter with the advantages and features of the present invention.

SUMMARY OF THE DISCLOSURE

The invention involves facilitating drainage and, more specifically, but not by way of limitation, facilitating fluid drainage from the bladder and through the urethra of a patient experiencing either acute or chronic urinary obstruction.

The retaining member for the device is a coil device which has a straight non-coiled iteration for placement. Once placed into the bladder, a stylet may be removed, which allows for a coiled default state to be achieved. A pusher segment may be connected during placement and may be utilized for a period of time to collect urine and then removed, allowing the device to have only a thread (which may be constructed using monofilament suture-type material) connected externally. A coiled tubular portion abutted to the pusher segment may allow for passage and collection of urine. Upon disconnection from the pusher segment, the coil catheter may allow for the passage of urine without an external tubular structure or external collection device. The converted iteration may be from a long external catheter to a short coil device without a tubular extension through the sphincter or distal urethra.

In general, and in one aspect, the invention relates to a catheter system, which embodies the ability to control a coil tip catheter within a bladder or body cavity by an attached thread traversing through a urethra to the exterior. The coil catheter may include a body member and a coil retaining member. The body member may include a distal terminating end, a proximal end portion, and a lumen extending within the body member to allow fluid drainage through the body member as well as around the tubular segment. Eyelets may be placed in the device at but not limited to a swan neck portion and/or a proximal coil tip. A guide wire opening at the tip may allow for use of a guide wire to facilitate delivery of the device due to urethral or prostate anatomical challenges.

The directional terms proximal and distal may require a point of reference. In this application, the point of reference in determining a direction is 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.

The body member may be sized for placement substantially within the bladder and bladder neck, prostate urethra, with the distal terminating end located proximal to an external urethral sphincter to allow normal operation of the external sphincter. The coil retaining member may extend from the proximal end portion of the body member. The coil retaining member may be straightened into a first state to allow passage of the catheter into the urethra. The coil retaining member may be coiled into a second state when located in a bladder to hold the body member in place substantially within the urethra by removing a straightening stylet. The pusher segment may abut the distal tubular segment such that the device does not migrate as the straightening stylet is removed.

Embodiments of this aspect may include the following features. The coil catheter system may include a coil catheter, a connecting segment, a monofilament suture, and a pusher tubular device. The coil catheter may include a body member and a proximal coil retaining member. The coil catheter may include a swan neck portion, which is the transition from the tubular segment, and the coil may angle proximally then curve distally into a horizontal portion of the coil. The right angle and swan neck configuration may allow for retaining of the device as well as a tolerance to traction prior to removal. The length of the tubular segment, swan neck portion, and coil catheter may be changed to facilitate a variety of anatomical and gender-specific challenges. Multiple coils and a short tubular segment may be appropriate for females with short urethra which may allow for catheterization from inside the bladder outward and be controlled externally with a control suture. In patients with a dysfunctional sphincter, the device may require bridging the sphincter to empty the bladder then snapping back proximal to the sphincter to allow for continence. The invention described herein may be implemented as a dynamic catheterization device which has a passive state in the prostate fossa in men and bladder for females. For spinal cord patients, the invention described herein may be disposed by default at a location proximal to the urinary sphincter with dynamic positioning for bladder emptying while bridging the sphincter. Upon bladder drainage, the suture, without gently pulling, may revert back to a position proximal to the sphincter which allows for continence.

The coil may replace a balloon as a retaining member. The coil may include a tapered tip with a guide wire channel, with eyelets placed at various locations without limitation on the coil segment. The eyelet placed in the swan neck portion may be perpendicular to the direction of flow. The bladder mucosa trauma may be minimized due to such placement of the eyelets. The curve of the coil may be fashioned to have a swan neck portion which extends from the horizontal plane of the coil device, wherein the horizontal plane may be at a right angle to the tubular (e.g., stem) portion. The swan neck portion may allow for traction on the device prior to uncoiling of the horizontal member. While an inadvertent removal of an inflated balloon-type catheter may result in urethral mucosal injury, catheter mucosal injury may be minimized if inadvertent removal of the coil occurs, since the diameter of the device upon removal is the same as the diameter upon insertion.

The coil retaining member of the coil catheter may be a tube constructed with coil-shape memory. The coil retaining member may also be rounded at the ends of the tubing to provide user comfort during insertion of the catheter into the patient's urethra. A guide wire channel may allow for a guide wire to be utilized with difficult placement due to false passages in the urethra or other anatomical challenges.

The process for creating the swan neck, vertical, and dynamic portion of the device with a horizontal coil is a unique process encompassing features defined in the utility patent identified as Manufacturing Process for integration of retaining member with vertical component coupled with the horizontal coil. The vectors of pull may impact the device in two separate phases of uncoiling, and they may be coupled with a resistance against pull out which is initially absorbed by the vertical swan neck component.

Prior to and during insertion of the coil catheter into the patient's urethra, the coil retaining member may be in a straightened first state. The coil retaining member may return to substantially the second coil state once inside the patient's bladder and thereby may act as an anchor to keep the body member of the catheter substantially within the prostatic urethra.

In one embodiment, the body member may include one or more side openings to allow fluid to drain from the urethra. The lumen of the body member and length of the tube may be designed to be equivalent to a variety of tubular dimensions. One embodiment may include a tubular portion which is constructed to have a star shaped exterior which may allow urine to travel predominantly around rather than through the device.

In one embodiment, the suture may be long enough to extend from the body member to the outside of the patient's body. The suture may be constructed with monofilament nylon or other equivalent materials. The coil catheter may be removed easily from the patient's body by pulling downward on the suture. The end of the suture may be connected to a structure (e.g., snap cap, ball, ring, coil, or the like) that extends out of the body entirely. The purpose of the snap cap is to facilitate location of the suture's end and eventual removal of the coil catheter by simply pulling on the located suture, providing a gentle traction on the suture. In patients with diminished manual dexterity, a magnet may be placed on the snap cap and on the end of the stylet device. Such magnet may allow for engaging the snap cap with gentle traction and may be placed on the device to engage the device into the bladder in females or traverse the sphincter in male patients with sphincter resistance.

The device may utilize additional materials which may add qualities such as without limitation lubrication, hydrophilic coating, radiographic enhancing material, among others. The material for the device may include without limitation Carbothane™ and may be constructed with various inner diameters (ID), outer diameters (OD), stiffness, or the like. The pusher, stylet, and/or suture material may not be limited in size or characteristics.

In another embodiment, the invention relates to a coil catheter system for draining fluid from a patient's body cavity including without limitation bladder, stomach, colon, ileal loop, colostomy, and/or abdominal peritoneal cavity, among others.

In general, in still another aspect, the invention may allow for a variety of devices within the body cavity to be controlled and/or manipulated externally with a tethering suture. This may allow for episodic movement from a passive state of the device to an active state, which may change the fluid dynamics to favor voiding or continence. To void, the user may pull on the suture, causing the distal end of the coil to move into the bladder neck and through the sphincter valve, allowing the bladder to drain.

In another device iteration, the device may be fashioned to have an inverted umbrella membrane, which may occlude the bladder neck, allowing continence to be achieved.

Another iteration may include the capability of the coil being imbedded with various medications which may allow for a unique drug delivery into body cavities such as without limitation the bladder, stomach, colon, ileal loop, colostomy, and/or abdominal cavity, among others. The tethered control may also allow for manipulation of the device in the cavity. The device may be configured with monitoring devices allowing for wireless transmission of images or data.

In another embodiment, the catheter may be used for cervical dilation to induce labor.

In yet another embodiment, the catheter may be used for widening the nasal passages to treat sleep disorders (e.g., sleep apnea).

The coil catheter may allow the bladder to fill and contract in synchronous sphincter relaxation without prostate urethral resistance. This feature may allow for defining the functional capacity of both the bladder and the urinary sphincter. In patients with chronic overdistension due to prostate obstruction, the device may act as a bladder rehabilitation device as well as a bladder neck, and/or provide prostate fossa dilation. With acute urinary or chronic retention, the improvement in bladder muscular contraction in a volitional manner may obviate the need for a variety of interventional procedures, which may focus on only the reduction in prostate resistance but may not have the capacity to enhance the vesicular (bladder) pressure; an enhanced vesicular pressure, when coupled with a reduction in the prostate resistance, may increase the flow rate of fluids in patients. More efficient voiding, with reduced residual urine in the bladder, coupled with a competent urinary sphincter and elimination of the need for an external collection device, may result in a collage of clinical improvements.

The coiled shape has been utilized in a variety of medical devices to resist removing of a straight tubular device. The unique feature of the current vertical and horizontal design includes the horizontal portion disposed distally with respect to the apex of the device. Proximal refers to an inward direction toward the patient, whereas distal refers to an outward direction away from the patient. Prior coiled shapes may include an extension proximal to the tubular device. With tension on these designs, uncoiling may begin with any tension on the distal tubular portion. The current design may protect the uncoiling of the horizontal component from the initial tension. The swan neck portion may allow for lengthening of the vertical tubular component and, upon lifting the tension, the vertical tubular portion may “snap back” to its original configuration due to a horizontal stabilizing effect. The distance for the extension and snap back may allow for a variety of medical applications with an innate resistance against inappropriate migration, which is common in “pig tail curl” or “J” shaped tips. The application defines the unique manufacturing process to construct the vertical—swan neck—horizontal-shaped device.

DETAILED DESCRIPTION

I. Introduction and Environment

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.

As shown in a typical environment inFIG.1, the present invention is a catheter system2which features a coiled catheter4having a halo portion6connected to a stem portion8via a swan neck portion7, such that the halo portion6is disposed along a plane perpendicular to the direction of the stem portion8. Halo portion6may be located within a bladder16once properly placed and may serve to provide optimal flow out of catheter4through stem portion8.FIG.1shows a thread10connected to a snap cap12located outside of the body to prevent the thread10from being drawn up into the body, and instead the thread10would be stopped at the glans15of a penis13(as shown). This may function similarly in a female patient. Thread10may be formed from a monofilament suture-type material in a preferred embodiment. Snap cap12may include a magnet or be made of a magnetic material.

Stem portion8of catheter4may pass through a prostate gland14and the end of the stem portion8may be located in proximity to an external sphincter18. This system may facilitate flow from bladder16through catheter4, via eyelets22, which may be located at swan neck portion7and/or at a proximal coil tip23of halo portion6, and out through the urethra20(seeFIG.2). It is important that stem portion8functions as a short straight arm that un-obstructs the prostatic urethra and sits above the urinary sphincter18. 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 catheter4, without incontinence.

As shown inFIG.1, when catheter4is inserted into the bladder, halo portion6may coil, forming swan neck portion7which terminates into a right-angle bend; these elements may together form a stabilizing elbow which ensures that catheter4remains properly in place within a bladder for optimal drainage through the catheter4.

FIGS.2-4show how the catheter4may be inserted into a body in a straight orientation for easy placement. A guidewire hole24may be located at proximal coil tip23of halo portion6and at a base25of stem portion8for use with a pusher26and a stylet, as is typical and as is shown in more detail inFIG.8. As shown inFIG.2, proximal coil tip23may be tapered for easy insertion.

FIGS.5-7show how catheter4may adopt a coiled configuration once inserted into its proper environment in bladder16, with halo portion6and stem portion8connected through swan neck portion7. Catheter4may default to this form due to a manufacturing process discussed below. Once the guidewire of stylet and pusher26is removed (seeFIG.8) or at least withdrawn slightly, catheter4may automatically coil into the form shown.

FIGS.8and8Ashow catheter4in its straight orientation in combination with a pusher26having an outer tube28and a stylet30. Thread10and snap cap12may extend through pusher26and connect to the end of catheter4near its base25or may be located externally to the pusher26and threaded through receivers27of stem portion8of the catheter4, as shown in more detail inFIG.11.FIGS.8and11also show how pusher26may have a smaller diameter than that of catheter4, further easing insertion of the catheter.

FIG.9shows catheter4and pusher26in the typical environment shown inFIG.1, where the catheter4is fully inserted and coiled in position. Flow17is indicated via the arrows through catheter4by way of eyelets22, vertically downward rather than perpendicular to catheter4as is the case with prior art catheters. The detailed view ofFIG.9Ashows how thread10may be retained through receivers27in stem portion8to secure the thread10to catheter4for removal. Thread10is shown to be external to pusher26, which abuts base25of catheter4, with stylet30contacting the base25of the stem portion8thereof.

FIG.10shows the insertion of catheter4using pusher26in a sectional view so as to better show the internal components thereof.FIGS.10A and10Bshow additional detail about their respective circles inFIG.10, such asFIG.10Bshowing how stylet30of pusher26may be implemented using a functional guidewire that can be placed up and into catheter4itself to help position the catheter4within a bladder. Catheter4may be straightened by internally placed stylet30with guidewire. Catheter4as shown may be placed over guidewire for safe insertion into the bladder, after which the guidewire and stylet30may be removed, leaving only the coiled and unencumbered catheter4in a bladder, as shown inFIG.1.

FIG.11andFIG.11Ashow in more detail the extra-luminal suture thread10which does not obstruct the lumen of catheter4. Similar to the positioning of stem portion8above sphincter18, this configuration is intended to prevent incontinence and may be used to safely remove catheter4at a later date. No sheath may be required for such procedure.

FIGS.12-18show a manufacturing system52for manufacturing coil catheter4. As shown, coil catheter4may be formed from an originally straight catheter tube by placing it into a mold base34. A flexible yet solid tubing support may be inserted into the catheter tube prior to molding to prevent kinks during the forming process. Mold base34may include receiver slots38for screws48to receive a mold cap46, as shown inFIG.14. Mold base34may also have a forming block with a first form, such as a swan neck form44, and a second form, such as a halo form40. Stem portion8may be inserted into a stem receiver42and swan neck portion7may be placed into swan neck form44, and halo portion6may be curled around in halo form40. Mold cap46may then be secured to mold base34via screws48.

FIG.15shows a heating controller50with a temperature gauge54and a timer56. Mold base34may be heated to an appropriate temperature to thermoset coil catheter4. This process may take approximately 15-19 minutes to reach the proper temperature, at which mold base34may be held for a period of time, such as 15 minutes.FIG.16shows a chiller58with a temperature gauge60and a timer62. Chiller58may set a temperature of 5.00 degrees Celsius and cool a heated coil catheter4down to thermoset its shape. A temperature alarm may be included to properly track chilling. Once temperature gauge60indicates a temperature less than 80 degrees Fahrenheit, typically after 15-19 minutes, chiller58may be turned off.

Mold cap46may be removed, as shown inFIG.17, and a thermoset coil catheter4may be removed from mold base34, as shown inFIG.18. After this step, coil catheter4may be placed on a rack for further cooling and should be covered to reduce contamination risks.

FIG.19shows the steps taken in practicing a method102of using coil catheter system2as described above. Method102starts at step104, where catheter4is obtained at step106. A pusher26is obtained and used with catheter4at step108, and the catheter4is straightened as shown inFIG.8at step110. This allows the catheter4to be inserted into a body at step112using pusher26. A check of whether the catheter is in place at step114may require pusher26to be extended at116to ensure proper placement of the catheter. Once in place at step114, the bladder may drain through eyelet22into the catheter4, out through pusher26, through receiver27, and into an external container (not shown) at step118. A determination is made at step120regarding 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 step122.

A check is then made at step124and a determination may be made regarding whether flow is optimal with pusher26in place. If not, pusher26may remain in place. If so, pusher26may be removed at step126so that flow may be entirely facilitated using catheter4in the body. The process may then end at step128until such a time that pusher26is to be removed.

FIG.20shows the steps taken in practicing a method152of manufacturing coil catheter4, as described above using manufacturing system52. Method152starts at154, where a straight catheter tube may be obtained at step156. 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 step158.

The catheter and protector may then be inserted into mold base34at step160, using swan neck form44and halo form40of the mold base34. Mold base may be capped at step162and heated at step164, as described above. A check using temperature gauge54may be made at step166to determine if a proper temperature has been reached. If not, heating may continue. If so, this proper temperature may be maintained at step168for 15 minutes, after which chiller58may be activated at step170to cool the mold base34.

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 step172. If not, chilling may continue. If so, then chiller58may be deactivated at step174, mold cap46may be opened at step176, and a formed catheter4may be removed at step178, ending the process at step180.

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.