Tissue-Piercing Prostatic Implant for Capsule Anchoring
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Solution Overview
Problem
Current treatments for Benign Prostatic Hyperplasia (BPH) are only partially effective and burdened with significant side effects, necessitating the development of new devices and methods to relieve pressure on the prostatic urethra by compressing the prostate gland.
Innovation Solution
A prostatic implant with a distal anchor portion and a urethral endpiece, anchored to the prostate capsule and urethral side, respectively, using a blunt distal piercing portion and a flexible tail portion to compress the prostate tissue, eliminating the need for a separate piercing needle and reducing the risk of damage to bony structures.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If a separate piercing needle is used to anchor the distal anchor portion to the prostatic capsule, then the anchoring function is achieved, but the complexity of the device increases and the risk of damage to bony structures increases
Solution Approach 1:
The piercing needle and distal anchor portion are merged into a single integrated component. The distal anchor portion itself is configured with a piercing tip that can directly penetrate the prostatic capsule, eliminating the need for a separate piercing needle. This integration reduces device complexity while maintaining anchoring reliability through the unified design.
Solution Approach 2:
The distal anchor portion is designed to perform multiple functions: it serves as both the piercing instrument and the anchoring element. By making the anchor portion itself capable of piercing the capsule and then anchoring to it, the device achieves multi-functionality, reducing the number of separate components needed while ensuring reliable anchoring.
2Reliability
If the distal anchor portion is advanced far beyond the prostatic capsule to ensure proper anchoring, then anchoring security is improved, but the risk of contacting and damaging bony structures increases
Solution Approach 1:
The distal anchor portion features a localized piercing tip with concentrated hardness and sharpness at the distal end, while the rest of the anchor portion has different properties suitable for anchoring. This local quality differentiation allows the tip to penetrate the capsule effectively without requiring excessive advancement that would risk contacting bony structures further distally.
Solution Approach 2:
The piercing tip is pre-configured with sufficient hardness and sharpness to penetrate the prostatic capsule at the intended anchoring site. This preliminary preparation of the piercing surface allows the anchor to be advanced only the necessary distance to reach the capsule, preventing over-advancement that could lead to contact with bony structures.
3Strength
If the distal anchor portion is made larger to improve anchoring capability, then anchoring strength is improved, but the size of the implant increases which may complicate delivery
Solution Approach 1:
The distal anchor portion concentrates anchoring strength at the local interface with the prostatic capsule through a specialized geometry and material properties at the piercing tip and anchoring surface. This localized quality enhancement provides strong anchoring without requiring a large overall implant size, allowing the rest of the implant to remain compact for easy delivery.
Data Source
AI summary
A prostatic implant configured to compress an enlarged prostate gland includes a distal anchor portion and a proximal end portion connected by a middle portion. The distal anchor portion includes a distal piercing portion and a proximal tail portion. The distal piercing portion includes a sharp distal tip configured to penetrate a lobe of the prostate gland, including the firm prostatic capsule. A tubular push member coupled with the prostatic implant advances the implant distally, led by the distal piercing portion, until the proximal tail portion is positioned outside the prostatic capsule, at which point the tubular push member is retracted proximally, unsheathing the distal anchor portion of the implant. The proximal tail portion is biased such that, upon exiting the tubular push member, the tail portion extends away from a longitudinal axis of the tubular push member, across the outer surface of the capsule.