Cryoprotective Composition for Prostate Cryosurgery Nerve Protection

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Solution Overview

Problem

Current cryotherapy procedures for prostate cancer often result in significant side effects such as erectile dysfunction due to injury to the neurovascular bundle, with complications occurring in 80-90% of whole gland treatments and 40% of focal treatments, as existing methods lack precision in protecting adjacent tissues from cold temperatures.

Innovation Solution

A surgical kit and method using a cryoprotective composition comprising a biodegradable fluid agent and a non-toxic cryoprotectant agent, such as hyaluronic acid, Dimethyl sulfoxide (DMSO), and trehalose, which is applied to create a protective barrier around the prostate and neurovascular bundle during cryosurgery, preventing nerve damage and maintaining tissue viability.

Engineering Contradictions & Design Principles

VSEngineering Contradiction Analysis

1Reliability

If cryotherapy is applied to treat prostate cancer, then cancer treatment efficacy is improved, but nerve damage and erectile dysfunction occur due to cold temperature exposure to the neurovascular bundle

Engineering Contradiction:
Improvecancer treatment efficacyVSAvoidnerve damage
Core Design Contradiction:
ReliabilityVSObject-affected harmful factors

Solution Approach 1:

A cryoprotective composition acts as an intermediary substance applied to the neurovascular bundle before cryotherapy. This composition creates a protective barrier that mediates between the cold temperature field and the nerve tissue, preventing direct thermal damage while allowing the cryotherapy to effectively treat the prostate cancer.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The cryoprotective composition is applied to the neurovascular bundle in advance of the cryotherapy procedure. This preliminary protective measure ensures that when the cold temperature is subsequently applied for cancer treatment, the nerves are already protected and will not suffer damage from the thermal exposure.

Inventive Principle:
Principle #10Preliminary action

2Object-affected harmful factors

If focal cryotherapy is used to minimize injury to adjacent structures, then quality of life is improved, but precision in positioning and temperature control is reduced

Engineering Contradiction:
Improveinjury to adjacent structuresVSAvoidpositioning precision
Core Design Contradiction:
Object-affected harmful factorsVSMeasurement precision

Solution Approach 1:

The cryoprotective composition serves as a protective intermediary that can be applied more broadly to adjacent structures without causing harm. This eliminates the need for extremely precise positioning, as the composition provides a margin of safety that protects nerves and other tissues even if the cryotherapy field is not perfectly localized.

Inventive Principle:
Principle #24Intermediary (Mediator)

Solution Approach 2:

The cryoprotective composition provides beforehand cushioning or protection to the neurovascular bundle and adjacent structures. This pre-established protective layer acts as a buffer that tolerates less precise positioning and temperature control during the cryotherapy procedure, reducing the risk of injury to surrounding tissues.

Inventive Principle:
Principle #11Beforehand cushioning (Prior cushioning)

3Object-affected harmful factors

If active heating is applied to counteract tissue freezing, then nerve protection is improved, but reliability of the procedure is reduced due to lack of precision in temperature control

Engineering Contradiction:
Improvenerve protectionVSAvoidprocedure reliability
Core Design Contradiction:
Object-affected harmful factorsVSReliability

Solution Approach 1:

The cryoprotective composition acts as a chemical intermediary that provides passive protection rather than requiring active thermal management. Instead of needing to precisely control heating temperatures to protect nerves, the composition itself provides the protective function, eliminating the reliability issues associated with imprecise temperature control in active heating systems.

Inventive Principle:
Principle #24Intermediary (Mediator)

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

The composition effectively reduces nerve damage and maintains tissue viability, allowing for safer and more effective cryosurgical procedures with reduced risk of complications like erectile dysfunction and cancer recurrence, while allowing for precise control and protection of surrounding tissues.

Implementation Method 1

cryoprotectant agents (CPAs) of low toxicity and sufficient viscosity to remain within body spaces

Methodology Applied
Scientific EffectCryoprotection: Freezing

Implementation Method 2

non-toxic cryoprotectant agent, such as hyaluronic acid, Dimethyl sulfoxide (DMSO), and trehalose, which is applied to create a protective barrier

Methodology Applied
Scientific EffectFreeze point depression: Freezing

Implementation Method 3

sufficient viscosity to remain within body spaces, for example surrounding organs and nerve structures, for sufficient duration

Methodology Applied
Scientific EffectViscosity: Viscometer

Implementation Method 4

applied to create a protective barrier around the prostate and neurovascular bundle during cryosurgery, preventing nerve damage and maintaining tissue viability

Methodology Applied
Scientific EffectThermal insulation: Thermal Insulation

Data Source

PatentEP4248946A1Cryoprotective compositions, surgical kits, and methods for protection of a surgical site during cryosurgery
Publication Date: 2023.09.27 EVEREST MEDICAL INNOVATION GMBH
  • EP4248946A1 patent drawingFigure 1A
  • EP4248946A1 patent drawingFigure 1B
  • EP4248946A1 patent drawingFigure 2A

AI summary

A surgical kit for providing a cryoprotective composition configured to be applied during cryotreatment of a patient includes: a first container containing a predetermined amount or volume of a biodegradable and/or bioerodible fluid agent; and a second container containing a predetermined amount or volume of a non-toxic cryoprotectant agent. The predetermined amount or volume of the biodegradable and/or bioerodible fluid agent and the predetermined amount or volume of a non-toxic cryoprotectant agent are configured to be mixed together to form the cryoprotective composition in which a therapeutically effective amount of the cryoprotective composition deposited in a body space of the patient in proximity to the cryotreatment remains within at least a portion of the body space for a duration of the cryotreatment and at least a portion of a body tissue proximate to the body space is viable after the cryotreatment.