Cardiac Surgeon with 30 Years of Experience Invents Minimally Invasive Cardioplegia Infusion Device, Secures National Patent and Advances Toward Market Commercialization

Cardiac surgery under cardiopulmonary bypass is the mainstream procedure in the field of cardiac surgery. With technological advancements and improvements, surgical models such as “minimally invasive, small-incision, robot-assisted, and totally endoscopic” cardiac surgeries have emerged and are being rapidly popularized and widely adopted.

“Throughout this process, improvements and refinements to supporting instruments and equipment were implemented in tandem. The minimally invasive cardioplegia delivery device I invented represents an advancement in the administration of cardioplegic solution,” said Liu Luqi, Director of the Department of Cardiac Surgery at the First Affiliated Hospital of Shandong First Medical University (Shandong Provincial Qianfoshan Hospital), in an interview with VCBeat (WeChat ID: vcbeat).

He pointed out that,Newly Invented “Minimally Invasive Cardioplegia Infusion Device””Suitable for every case of cardiopulmonary bypass cardiac surgery, it is characterized by optimizing the application of the "cardioplegia infusion line" during cardiac surgery. It integrates the functions of the original two sets of tubing into one, reducing excess lines that interfere with the exposure of the minimally invasive surgical field, thereby improving the convenience and safety of the procedure.

Liu Luqi stated that the minimally invasive cardioplegia delivery device has obtained a national patent and is expected to be promoted for clinical use.

The prevalence of cardiovascular disease in China is on a continuous rise, with data indicating that one in every five adults suffers from the condition.

According to the "Report on Cardiovascular Diseases in China 2018,"China has 290 million prevalent cases of cardiovascular disease., including 13 million cases of stroke, 11 million cases of coronary heart disease, 5 million cases of cor pulmonale, 4.5 million cases of heart failure, 2.5 million cases of rheumatic heart disease, 2 million cases of congenital heart disease, and 245 million cases of hypertension.

“Against this backdrop of big data, the clinical volume of cardiac surgeries has grown rapidly. With the swift advancement of minimally invasive procedures, the proportion of minimally invasive therapies in cardiac surgery has reached 10%–20%,” introduced Liu Luqi.

Driven by a compassionate healer’s spirit, Liu Luqi, who has performed over a thousand cardiac surgeries, has been contemplating how to leverage his clinical experience to creatively optimize surgical techniques or design instruments used in operations.

(Figure: The First Affiliated Hospital of Shandong First Medical University “Shandong Provincial Qianfoshan Hospital”)”Director of Cardiac Surgery, Liu Luqi）

“Continuous accumulation and constant reflection led to the development of the minimally invasive cardioplegia delivery device,” said Liu Luqi.

In the second half of 2014, Liu Luqi led his team in initiating research on a minimally invasive cardioplegia infusion device. By the end of the year, a preliminary model of the device had been successfully developed and validated in human trials.

How Is a Minimally Invasive Cardioplegia Delivery System Constructed, and How Is It Operated?In response to reporters’ questions, Liu Luqi provided the following answers.

Minimally Invasive Cardioplegia Delivery Device, Also Known as an Integrated Perfusion Device for Cardiac SurgeryThe device consists of a perfusion lumen, a suture lumen, a metal trocar stylet, and a suture tensioner. It features an elongated integrated design that combines the perfusion and suturing lumens into a single unit, providing both perfusion and fixation functions. This design reduces the number of tubes entering and exiting the surgical field during the procedure, thereby facilitating surgical operations, particularly in minimally invasive procedures with small incisions.

During the procedure, the perfusion lumen is used for cardioplegia infusion. A metal stylet is inserted through this lumen during use to provide support and facilitate puncture. Upon successful puncture, the stylet is withdrawn; at this point, one end of the flexible plastic tube has penetrated the aortic wall, while the other end is connected to the cardioplegia extension tubing, thereby achieving fluid perfusion.

An ear-shaped protrusion is located on the proximal segment of the infusion lumen tubing, positioned opposite and perpendicular to the tube axis. It is used for purse-string suture fixation to secure the cannula to the vessel wall, thereby achieving hemostasis.

The portion of the device that penetrates the vascular wall and enters the lumen is approximately 0.7 cm in length. In addition to the end hole, there are two micro-holes on its side wall to facilitate air evacuation and fluid infusion into the vascular lumen postoperatively. The distal end of this lumen is connected to an infusion extension tube via a spiral connector after the metal stylet is withdrawn.

The suture channel is designed for the insertion of the ends of purse-string sutures. This channel runs parallel to and is integrated with the aforementioned irrigation lumen, forming a unified elongated tubular structure. The length of the integrated body varies by model, typically ranging from 10 to 15 cm. The proximal end opens on the side opposite the "ear-shaped" protrusion, while the distal end becomes free-floating after exiting the integrated body.

After completion of the purse-string suture on the heart and blood vessels, the two free ends of the suture are threaded through the aforementioned free lumen using a wire guide made of metal wire with micro-hooks at the distal end. The suture is passed through the lumen and pulled out beyond the distal end of the lumen to facilitate cross-clamping and fixation.

“Existing cardioplegia delivery instruments feature separate, unconnected devices for perfusion/fixation and hemostasis, which are introduced into the surgical field through incisions separately during use, thereby interfering with surgical manipulation and visual exposure. The minimally invasive cardioplegia delivery device can directly address this pain point.”Liu Luqi told VCBeat.

He pointed out that,Minimally Invasive Cardiac Surgery: Due to the small incision and deep surgical field, instruments and devices such as cannulas inserted through this incision should adhere to the principle of maximal simplification and minimal necessity.

Minimally Invasive Cardioplegia Infusion Device Integrates Infusion, Fixation, and Hemostatic Instruments: Rational Operation Simplifies the Device and Reduces Tubing in the Surgical Field, Providing Better Exposure for Rapidly Developing and Widely Applied Minimally Invasive Cardiac Surgery While Maintaining All Functions of Traditional Cardioplegia Infusion Systems

"Furthermore,Its core competitive advantage lies in the fact that there is currently no standardized device on the clinical market suitable for minimally invasive aortic root perfusion; the emergence of this device effectively fills this gap.”said Liu Luqi.

Liu Luqi told VCBeat that, as the minimally invasive cardioplegia delivery device can be used in every case of cardiopulmonary bypass cardiac surgery, including those performed via minimally invasive or conventional incisions, its clinical benefits are highly significant, creating a certain level of market demand.

“I have discussed this device with colleagues at Shanghai Zhongshan Hospital who perform minimally invasive cardiac surgery; they highly endorsed it and are eager to see it brought to market,” said Liu Luqi.At the end of 2014, the device received national patent certification.

“We drafted the design blueprints and handled the cutting and fabrication for the first set of materials in-house. Initially, we considered engaging manufacturers; although there was interest during negotiations, all efforts ultimately came to nothing,” said Liu Luqi. Since 2014, he has been seeking opportunities for commercial market promotion, but the results have been less than satisfactory.

“I even considered using 3D printing, but the manufacturer said it couldn’t be done due to the special material of the tubing,” said Liu Luqi.

Why Is Promotion Difficult? Liu Luqi Attributes It to the Following Reasons: First, traditional infusion devices have extensive market coverage; second, the cost of changing molds is prohibitively high for manufacturers.

“Traditional perfusion devices use two sets of tubing to access the ascending aorta, which are then operated separately; this approach can also achieve cardiac arrest by delivering cardioplegia. The newer perfusion device, however, is simpler and more convenient, while ensuring absolute safety for patients.”Liu Luqi said.

In his view, although this invention of his was only a minor improvement, even such small enhancements can reduce some unnecessary risks for patients undergoing major procedures like cardiac surgery.

“The presence of a minimally invasive cardioplegia delivery device holds clinical value,” Liu Luqi told VCBeat.Next, he hopes to secure corporate support to facilitate the market promotion of this patent.