Intracellular Treatment Device with Local Electroporation Control
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Solution Overview
Problem
Current methods for delivering intracellular therapies are hindered by the inability to achieve reliable and consistent application due to variability in technique, operator skill, and patient physiologic differences, leading to issues such as immune responses, off-target effects, and high costs.
Innovation Solution
An in vivo electroporation device with a housing comprising electrode needles, a retractable insulating sheath, and a penetration limiting means, allowing for precise delivery of therapeutic substances directly to target tissues via percutaneous access, using electrical pulses to enhance uptake.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If systemic injection is used to deliver therapeutic agents, then therapeutic effect can be achieved, but immune responses and off-target effects increase
Solution Approach 1:
The device applies electroporation locally at the target tissue site through electrode needles inserted directly into the tissue. This creates a localized treatment zone where therapeutic agents are delivered systemically but activated only at the target site, reducing systemic immune responses and off-target effects while maintaining therapeutic efficacy.
Solution Approach 2:
The device uses electrical pulses as an intermediary to enhance cellular uptake of therapeutic agents. The electroporation effect created by the electrical pulses temporarily increases cell membrane permeability at the target site, facilitating localized delivery and reducing the need for high systemic doses that cause adverse immune responses.
2Reliability
If high doses are delivered systemically to overcome the endothelial barrier, then therapeutic effect is achieved, but risks of inflammation and insertional mutagenesis increase
Solution Approach 1:
The device creates a localized electroporation field at the target tissue site, enabling therapeutic agents to be delivered systemically but activated only where needed. This localized approach reduces the overall dose required and minimizes systemic inflammation and insertional mutagenesis risks while maintaining effective treatment at the target site.
3Reliability
If percutaneous access is used to directly access target tissue, then delivery consistency is improved, but penetration depth control becomes critical
Solution Approach 1:
The device incorporates a penetration limiting means that is pre-configured to control the maximum insertion depth of the electrode needles before the procedure begins. This preliminary depth control mechanism ensures consistent delivery across patients without requiring complex real-time adjustment during the procedure, maintaining reliability while managing device complexity.
Solution Approach 2:
The device allows adjustment of the penetration limiting means to modify the maximum insertion depth parameter according to patient-specific anatomy and treatment requirements. This parameter adjustment capability enables consistent and reliable delivery across varying patient anatomies while maintaining manageable device complexity through a single controllable parameter.
4Adaptability or versatility
If variable technique and operator skill are used, then flexibility is maintained, but application consistency deteriorates
Solution Approach 1:
The device incorporates an insulating sheath that automatically limits the treatment field to a predetermined size and shape, reducing the need for operator skill in controlling the extent of treatment. The device self-regulates the treatment parameters through its design features, maintaining application consistency while allowing operator flexibility in positioning and patient-specific adjustments.
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
Facilitates higher transfection rates and lower therapeutic doses by overcoming the endothelial barrier and minimizing adverse reactions, while ensuring consistent and targeted delivery across varying patient anatomies.
Implementation Method 1
activating an electrical energy source in electrical communication with each of the at least one electrode needle, thereby providing a pulse of electrical energy to the at least one electrode causing poration of the target tissue's cells for their uptake of the therapeutic substance
Data Source
AI summary
The present disclosure relates to an intracellular device for delivering therapeutics. The device may be an in vivo electroporation device which may include at least one electrode needle adapted to produce an electric field and a plurality of infusion ports on at least one axially extending line along the length of the needle configured to deliver a therapeutic substance. The device may include a retractable insulating sheath configured to limit a treatment field of the device, and a penetration limiting means configured to limit the depth of insertion of the electrode needle. The device may include an injection needle configured to deliver a therapeutic substance and at least two electrode needles adapted to produce an electric field, which may cause poration of the target tissue's cells for uptake of the therapeutic substance.