Implantable Prostatic Tissue Retractors With Adjustable Balloons
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Solution Overview
Problem
Current treatments for benign prostatic hyperplasia (BPH), such as medications and surgical procedures, suffer from significant complications, side effects, and inefficiencies, while existing minimally-invasive devices face issues like implant migration, tissue ingrowth, and lack of adjustability for tissue retraction.
Innovation Solution
Development of an implantable device with a shaft and multiple balloons or locking tabs that can be expanded to retract prostatic tissue, allowing for adjustable and durable relief of lower urinary tract symptoms, with features like MR safety and ease of removal.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If surgical options like TURP or ablation are used to remove prostate tissue, then LUTS relief is achieved, but the procedure requires lengthy surgery, general anesthesia, several weeks of recovery, and can cause morbidities such as prolonged heavy bleeding, pain, and permanent sexual side effects
Solution Approach 1:
The device extracts only the problematic function (tissue removal) and replaces it with a minimally-invasive mechanical displacement approach. The implantable device displaces impinging prostate tissue to open the urethra without requiring actual tissue removal, thereby achieving LUTS relief while avoiding surgical morbidities
Solution Approach 2:
The implantable device acts as an intermediary mechanical structure positioned within the prostate gland. It provides a physical barrier that displaces tissue and opens the urethra, serving as a mediator between the prostate tissue and urethra without requiring aggressive surgical intervention
2Ease of operation
If minimally-invasive devices are used to mechanically displace prostate tissue, then implantation is easier and recovery is faster, but devices face problems like implant migration, excessive tissue ingrowth, and lack of adjustability for tissue retraction
Solution Approach 1:
The device is segmented into multiple expandable balloons positioned at different locations within the prostate. This segmentation allows independent control of each balloon to achieve precise tissue displacement while distributing mechanical forces to prevent migration and excessive tissue ingrowth
Solution Approach 2:
The device incorporates expandable balloons that can be dynamically adjusted in size and inflation pressure. This dynamic capability allows the device to adapt to different patient anatomies, achieve desired tissue retraction degrees, and maintain stable positioning by adjusting expansion forces to prevent migration
3Device complexity
If a single commercially available minimally-invasive device is used, then implantation is simplified, but the device lacks removability post-deployment and cannot achieve desired degrees of tissue retraction for specific patient needs
Solution Approach 1:
The device employs dynamically controllable expandable balloons that can be inflated to varying degrees to achieve different tissue retraction levels. The balloons can be selectively inflated or deflated through catheters, allowing adjustment of tissue displacement to meet specific patient needs while maintaining a relatively simple overall device structure
Solution Approach 2:
The device allows changing key parameters such as balloon inflation pressure and volume to achieve different tissue retraction degrees. The system can also change the operational state from implanted to removed by deflating balloons and withdrawing the device, providing both adaptability and removability without significantly increasing structural complexity
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
Provides rapid, effective, and durable relief from BPH-related symptoms without side effects, offering adjustable retraction and ease of implantation, suitable for both developed and emerging economies.
Implementation Method 1
a proximal balloon fixedly attached to the shaft, the proximal balloon positioned closer to the proximal end than the distal end; a distal balloon fixedly attached to the shaft, the distal balloon positioned closer to the distal end than the proximal end; and an intermediate balloon (140) fixedly attached to the shaft
Data Source
Figure 1A~1B
Figure 1C~1D
Figure 2A~2C
AI summary
Implantable devices for retracting prostatic tissue of a patient are provided. In some embodiments, an implantable device may include a main body and a suture extending through at least a portion of the main body. The main body may be configured to extend through prostatic tissue of the patient such that a distal end portion of the main body resides at least partially outside of a prostatic capsule of the patient, and the distal end portion may be configured to deform from an undeformed configuration to a deformed configuration. The suture may include a first end and a second end extending from a proximal end of the main body, and the suture may be configured to cause the distal end portion to deform from the undeformed configuration to the deformed configuration when the first end and the second end are pulled proximally relative to the main body.