Intraprostatic Sustained-Release Injection for Localized BPH Treatment
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Solution Overview
Problem
Existing treatments for benign prostatic hyperplasia (BPH) are invasive, require frequent dosing, and often cause significant side effects, failing to provide sustained efficacy and localized drug delivery without affecting nearby tissues.
Innovation Solution
A needle syringe delivers a sustained release formulation (SRF) in low unit volumes to the prostate, utilizing a K-injectate Rating (KIR) to ensure minimal uncontrolled drug diffusion, sustained release, and low unit volume delivery, accessible via transrectal or transperineal routes with imaging guidance.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If oral medications are prescribed for BPH treatment, then lower urinary tract symptoms can be managed, but patient compliance is compromised due to daily dosing requirements and long onset time
Solution Approach 1:
The treatment is segmented into localized intraprostatic injections rather than systemic oral administration. The needle syringe delivers drug composition directly to specific prostate regions, converting a continuous daily dosing regimen into a single or limited-number injection procedure, thereby dramatically improving patient compliance while maintaining treatment efficacy
Solution Approach 2:
A sustained-release formulation acts as an intermediary between the administered drug and the prostate tissue. The formulation includes polymers or lipids that encapsulate the active ingredient, enabling controlled local release over time and eliminating the need for repeated patient dosing actions
2Reliability
If invasive surgical procedures are performed for BPH, then significant symptom relief is achieved, but patient morbidity and recovery time increase
Solution Approach 1:
The treatment applies local quality by delivering drug composition directly to the prostate tissue through needle injection, rather than through invasive surgical incisions. This localized approach achieves therapeutic effect at the target site while avoiding the widespread tissue trauma and morbidity associated with open or laparoscopic surgery
Solution Approach 2:
The invention replaces mechanical surgical removal or ablation of prostate tissue with a pharmacological approach. Instead of physically cutting, scraping, or burning tissue through surgical instruments, the treatment uses chemically active compositions delivered via fine needle injection, substituting mechanical destruction with controlled drug-mediated tissue modification
3Reliability
If high doses of medication are administered systemically, then treatment efficacy is improved, but side effects such as erectile dysfunction and ejaculation changes increase
Solution Approach 1:
The treatment achieves high local drug concentration at the prostate site through direct injection, eliminating the need for high systemic doses. The drug composition is deposited directly into the prostate tissue where it is needed, creating a localized high-concentration environment that produces therapeutic effect without exposing the rest of the body to high drug levels that cause side effects
Solution Approach 2:
The sustained-release formulation serves as an intermediary that confines the active drug to the prostate tissue. The polymer or lipid matrix acts as a local reservoir, releasing the drug gradually at the injection site and preventing systemic circulation of high drug concentrations, thereby blocking the pathway to systemic side effects while maintaining local efficacy
4Ease of operation
If conventional needle injection is used for prostate treatment, then drug delivery is simple, but uncontrolled drug diffusion to nearby tissues occurs
Solution Approach 1:
The sustained-release formulation acts as a spatial intermediary that confines the drug to the injection site. The polymer or lipid matrix creates a physical barrier that limits drug diffusion, allowing simple needle injection technique while achieving precise local drug deposition. The formulation itself becomes the containment structure that prevents uncontrolled spread to adjacent tissues
Solution Approach 2:
The sustained-release formulation functions as a flexible microscopic shell or matrix that encapsulates the drug at the injection site. This flexible polymer or lipid structure contains the drug locally and releases it in a controlled manner, providing precision drug delivery without requiring complex injection techniques or specialized delivery devices
Data Source
AI summary
Minimally invasive treatment methods for benign prostatic hyperplasia (BPH) tissue. A system includes a sustained release formulation comprising a cytostatic or cytotoxic drug, and an applicator or delivery system for local delivery of a composition comprising or consisting essentially of the sustained release formulation to the prostate. The applicator containing the composition is characterized by a KIR value of between 40 and 400 Centipoise per unit area.