Heart Implantation of a Medical Device

The Seeker is looking for new approaches to implant a medical device into the heart. This is a Theoretical Challenge that requires only a written proposal.

Detailed Description & Requirements

Percutaneous intervention has become a mainstream medical procedure in diagnostics and treatment of heart and coronary diseases. Among different tools of percutaneous intervention, one of the most promising is using of so-called leadless devices (LD), an approach allowing small pieces of medical equipment to be introduced into the bloodstream – usually through femoral vein -- and then to be delivered to a pre-determined location, for example, heart for diagnostic or treatment purpose.

Two major obstacles need to be overcome to achieve successful functioning of a LD. First, the LD has to be delivered to its precise destination. Second, the LD has to be fixed at the pre-determine place in such a way that it functions properly. It may need to be moved after initial testing if it does not function properly.

Especially challenging is LD implantation into the heart. Factors complicating the delivery and fixation of LD in the heart include its distance from the usual place of LD entry and its difficult (highly trabecular) internal "geometry", resulting in the need to make the curve through the heart valve to reach the heart apex. Due to these complications, LD fixation to any area other than the apex has been so far complicated and inconsistent. Besides, if the device dislodges, it may block the heart valve creating a dangerous extraction scenario.

The Seeker is looking for novel approaches to implant LD anywhere in the right ventricle the heart (i.e. apex, septum), which would be free of the above complications.

For the purpose of this Challenge, the LD the Seeker has in mind is a cylindrical object of 25 mm long and 7 mm in diameter having a rigid primarily metal surface, which will be coated with an insulating medical grade polymer.

Eventually, the LD must reach the right ventricle of the heart. For the body entry point, femoral or jugular vein are usually considered first. However, the Seeker is quite flexible on this point and will accept any reasonable vascular (venous) route capable of accommodating a 24 Fr catheter delivery system. It is crucially important that once the LD reached the heart right ventricle, it must attach to the ventricular wall. However, this attachment should be reversible in the sense that the LD must be able to detach from the heart wall and reattach in another location (once or twice for the lifetime of the device).

Naturally, the proposed approach for LD heart implantation must be completely safe for the heart, blood vessels or any other organs of the body. It also should not confer undue discomfort on a patient. For this reason, approaches involving thoracic or abdominal punctures of the skin will not be accepted.

The proposed implantation procedure should meet the following Solution Requirements:

1. The proposed implantation procedure should deliver a leadless device from outside the body to the right ventricle of the heart and attach it to the ventricular wall;
2. The proposed implantation procedure should be operational with a leadless device of cylindrical shape (25 mm long and 7 mm in diameter) and a rigid primarily metal surface;
3. The proposed implantation procedure should ensure that once attached, the device should be able to detach device from heart wall and reattach in another location;
4. The proposed implantation procedure should be compatible with a 24 Fr catheter delivery system;
5. The proposed implantation procedure should ensure that navigating and attaching/reattaching the device will not damage – not obstruct functioning in any way – the heart, blood vessels or any distal organs.
6. Ideally, the proposed approach will use only commercially available reagents and equipment. Using custom-made and expensive equipment (over $10,000) is strongly discouraged.

The Solvers are expected to provide a detailed description of the proposed procedure including schematics of the design, fundamentals of operation, and possible limitations. Special attention must be paid to the way the leadless device is attached to (detach from) the ventricular wall. Any literature/patent precedents justifying the feasibility of the proposed procedure will be highly valuable. Ideally, sufficient details will be given to the Seeker to build a prototype of the delivery system.

Project Criteria

The Seeker is looking for new approaches to implant a medical device into the heart for the purpose of diagnostics and treatment. The Solvers are expected to provide a detailed description of the proposed procedure including schematics of the design, fundamentals of operation, and possible limitations. Special attention must be paid to the way the leadless device is attached to (detach from) the ventricular wall.

This is a Theoretical Challenge that requires only a written proposal to be submitted. The Challenge award will be contingent upon theoretical evaluation of the proposal by the Seeker.

The Seeker is not looking for a literature review. The proposed solutions should provide the Seeker with "freedom to practice", i.e. there should be no patents or patent applications, which would prevent the use of the proposed solution in commercial applications. The Seeker will be willing to consider a licensing agreement.