EP-4736928-A2 - COIL CATHETER AND METHOD OF MANUFACTURE

Abstract

A catheter system comprising a catheter body having a stem portion and a coil having a halo portion, a swan neck element and a right-angle element. Said halo portion is along a plane perpendicular to the direction of the stem portion and connected to the stem portion via the swan neck element and the right-angle element. Said swan neck is configured to allow for dynamic movement and further configured to relax to allow for snap back in proximity with a sphincter.

Inventors

• HAMMOND, GAINES, JR.

Assignees

• Blue Halo Biomedical, LLC

Dates

Publication Date

20260506

Application Date

20210907

Claims (7)

1. A catheter system (2) comprising: a catheter body having a stem portion (8); a coil having a halo portion (6), a swan neck element (7) and a right-angle element; said halo portion (6) being along a plane perpendicular to the direction of the stem portion (8) and connected to the stem portion (8) via the swan neck element (7) and the right-angle element; and said swan neck (7) configured to allow for dynamic movement and further configured to relax to allow for snap back in proximity with a sphincter.
2. The system of claim 1, further comprising: a long-segmented catheter portion configured to be converted to a short catheter iteration after collecting fluid.
3. 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.
4. The system of claim 1, further comprising: at least one eyelet (22) along a horizontal plane of said catheter body along said coil, said at least one eyelet (22) configured to facilitate and enhance flow through the catheter; and whereby said at least one eyelet (22) further are configured to reduce biofilm production about said catheter body.
5. The system of claim 1, further comprising: a stylet (32), a guide wire channel (24), and a pusher (26) coupled together for placement with said a tethering suture.
6. The system of claim 5, further comprising: a snap cap (12) configured to keep said suture from migrating and further configured to provide visual validation of placement of said catheter body; and said snap cap (12) comprising a magnet.
7. The system of claim 1, further comprising: said catheter body configured to be transformed from a first, straight orientation into a second, coiled orientation comprising said coil having said swan neck element (7) and said right-angle element.

Description

CROSS-REFERENCE TO RELATED APPLICATION This application claims priority in U.S. Provisional Patent Application No. 62/896,724 Filed September 6, 2019, which is incorporated herein by reference. BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates generally to a coil catheter, method for use thereof, and method of manufacture thereof, and more specifically to a catheter having a retention coil member for repositioning, validation of placement, and removal, method of use, and method of manufacture thereof. 2. Description of the Related Art 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 causes 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 still takes 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 limiting, 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 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. The Blue Halo Coil device references prior devices are disclosed in U.S. Patent No. 7,044,980. Heretofore there has not been available a system or method for a catheter with the advantages and features of the present invention. BRIEF SUMMARY OF THE INVENTION The invention involves facilitating drainage and, more specifically, but not by way of limitation, to facilitating fluid drainage from the bladder and through the urethra of a patient experiencing either acute or chronic urinary obstruction. The retention member for the device is a coil device which has a straight non coiled iteration for placement. Once placed into the bladder a stylet is removed which allows for the coiled default state to be achieved. The pusher segment is connected during placement and can be utilized for a period of time to collect urine and then removed allowing the device to have only a thread (Monofilament Suture type material) connected externally. The coil tubular portion abutted to the pusher allows for passage and collection of urine. With the disconnection of the pusher segment, the coil catheter allows for the passage of urine without an external tubular structure and external collection device. The converted iteration is from long external catheter to short coil device without the tubular extension thru 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 the bladder or body cavity by an attached thread traversing thru the urethra to the exterior. The coil catheter comprises a body member and a coil retaining member. The body member includes a distal terminating end, a proximal end portion, and a lumen extending within the body member to allow fluid drainage through the body member a well as around the tubular segment. Eyelets are placed in the device at but not limited to at the swan neck section and at the proximal coil tip. A guide wire opening at the tip allows 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 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. The body member is 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 extends from the proximal end portion of the body member. The coil retaining member is straightened into a first state to allow passage of the catheter into the urethra, and the