Development of a Hemostatic Urinary Catheter for Transurethral Prostatic Surgical Applications

Abstract

Objective: To investigate a novel transurethral hemostatic catheter device with an integrated chitosan endoluminal hemostatic dressing (CEHD). Development and implementation of this technology may help address bleeding following surgery such as transurethral resection of prostate (TURP). Bleeding remains the most common complication following TURP, leading to increased morbidity and hospitalization.

Methods: Investigation of hemostasis, delivery, safety and efficacy of the CEHD device is conducted using Female Yorkshire swine (N = 23). Hemostatic efficacy of the CEHD (N = 12) is investigated against a control of gauze (N = 12) in a splenic injury model (3 swine). The delivery, safety, and efficacy of the CEHD device (N = 10) are investigated against Foley-catheter control (N = 10) for 7 days using a swine bladder-neck-injury model.

Results: In the splenic injury study, 9/12 CEHD dressings successfully achieved hemostasis within 150 seconds (mean 83 seconds) vs success of 6/12 (mean 150 seconds) for gauze (P = .04). In the 7-day study, the CEHD was successfully deployed in 10/10 animals and all dressings were tolerated without histologic or clinical adverse effect. Hemostasis of the CEHD device was found to be noninferior to control catheters. Noninferiority is attributed to low bleeding rates in the swine bladder neck injury model.

Conclusion: This investigation successfully demonstrated the feasibility of transurethral deployment of the CEHD in vivo. Routine use of safe and slowly dissolvable CEHDs could reduce the rate of complications and hospitalizations associated with bleeding and blood loss in TURP procedures. Further investigation is warranted.

Figure 1.

Top photos: The CEHD prototype consisting of (a) 2.5” diameter, 0.005” thick dressing folded with catechol-modified chitosan adhesive surface exposed and (b, c) secured around a 14 Fr catheter to encompass the proximal balloon and the base of the distal balloon. (d) The final CEHD device is protected by a tearable polypropylene sheath and ready for transurethral deployment. Bottom illustration: CEHD device schematic depicting proposed dual balloon deployment of CEHD in human prostatic surgery (top row) and in the swine model (bottom row).

Figure 2.

Bleed rate (%) of control and treatment animals over time in the 7 day study. No Significant Difference between groups was found using multiple linear regression (Mean ± SEM, P = .399).

Figure 3.

(A) Top panels under cystoscopic view: Left: Cool hook blade (arrow) creates bladder neck bleeding injury; Middle: CEHD device inserts in bladder cavity, the CEHD is still encased in cover sheath (arrow); Right: Delivery balloon is inflated (star) to press the CEHD (arrow) to wall of bladder neck. Bottom panels: Left: Delivery balloon is deflated (star) and the CEHD adheres to bladder wall and injury site (arrows) under cystoscopic view; Middle: Bladder ultrasound image shows the distal balloon (arrow) inflated in bladder cavity (star) and the CEHD is visible on the uninflated proximal delivery balloon (arrowhead); Right: Bladder ultrasound image shows the inflated distal balloon (arrow) is pulled down to bladder neck to position CEHD delivery. Bladder cavity marked with star. (B) Histologic examination revealed that healing processes in bladder neck injury are identical in both CEHD and control groups which demonstrated robust wound healing and complete recovery of transitional urothelium at day 7 postoperatively (white stars). Occasional traces of hemorrhaging (hollow star, middle) and lymphocyte aggregation (black star, right) are visible in the submucosa.