Automatic and real-time tissue sensing for autonomous intestinal anastomosis using hybrid MLP-DC-CNN classifier-based optical coherence tomography.

Anastomosis is a common and critical part of reconstructive procedures within gastrointestinal, urologic, and gynecologic surgery. The use of autonomous surgical robots such as the smart tissue autonomous robot (STAR) system demonstrates an improved efficiency and consistency of the laparoscopic small bowel anastomosis over the current da Vinci surgical system. However, the STAR workflow requires auxiliary manual monitoring during the suturing procedure to avoid missed or wrong stitches. To eliminate this monitoring task from the operators, we integrated an optical coherence tomography (OCT) fiber sensor with the suture tool and developed an automatic tissue classification algorithm for detecting missed or wrong stitches in real time. The classification results were updated and sent to the control loop of STAR robot in real time. The suture tool was guided to approach the object by a dual-camera system. If the tissue inside the tool jaw was inconsistent with the desired suture pattern, a warning message would be generated. The proposed hybrid multilayer perceptron dual-channel convolutional neural network (MLP-DC-CNN) classification platform can automatically classify eight different abdominal tissue types that require different suture strategies for anastomosis. In MLP, numerous handcrafted features (∼1955) were utilized including optical properties and morphological features of one-dimensional (1D) OCT A-line signals. In DC-CNN, intensity-based features and depth-resolved tissues' attenuation coefficients were fully exploited. A decision fusion technique was applied to leverage the information collected from both classifiers to further increase the accuracy. The algorithm was evaluated on 69,773 testing A-line data. The results showed that our model can classify the 1D OCT signals of small bowels in real time with an accuracy of 90.06%, a precision of 88.34%, and a sensitivity of 87.29%, respectively. The refresh rate of the displayed A-line signals was set as 300 Hz, the maximum sensing depth of the fiber was 3.6 mm, and the running time of the image processing algorithm was ∼1.56 s for 1,024 A-lines. The proposed fully automated tissue sensing model outperformed the single classifier of CNN, MLP, or SVM with optimized architectures, showing the complementarity of different feature sets and network architectures in classifying intestinal OCT A-line signals. It can potentially reduce the manual involvement of robotic laparoscopic surgery, which is a crucial step towards a fully autonomous STAR system.

Autonomous System for Tumor Resection (ASTR) - Dual-Arm Robotic Midline Partial Glossectomy.

Head and neck cancers are the seventh most common cancers worldwide, with squamous cell carcinoma being the most prevalent histologic subtype. Surgical resection is a primary treatment modality for many patients with head and neck squamous cell carcinoma, and accurately identifying tumor boundaries and ensuring sufficient resection margins are critical for optimizing oncologic outcomes. This study presents an innovative autonomous system for tumor resection (ASTR) and conducts a feasibility study by performing supervised autonomous midline partial glossectomy for pseudotumor with millimeter accuracy. The proposed ASTR system consists of a dual-camera vision system, an electrosurgical instrument, a newly developed vacuum grasping instrument, two 6-DOF manipulators, and a novel autonomous control system. The letter introduces an ontology-based research framework for creating and implementing a complex autonomous surgical workflow, using the glossectomy as a case study. Porcine tongue tissues are used in this study, and marked using color inks and near-infrared fluorescent (NIRF) markers to indicate the pseudotumor. ASTR actively monitors the NIRF markers and gathers spatial and color data from the samples, enabling planning and execution of robot trajectories in accordance with the proposed glossectomy workflow. The system successfully performs six consecutive supervised autonomous pseudotumor resections on porcine specimens. The average surface and depth resection errors measure 0.73±0.60 mm and 1.89±0.54 mm, respectively, with no positive tumor margins detected in any of the six resections. The resection accuracy is demonstrated to be on par with manual pseudotumor glossectomy performed by an experienced otolaryngologist.

Common-path optical coherence tomography guided vertical pneumodissection for DALK.

We reported a design and evaluation of an optical coherence tomography (OCT) sensor-integrated 27 gauge vertically inserted razor edge cannula (VIREC) for pneumatic dissection of Descemet's membrane (DM) from the stromal layer. The VIREC was inserted vertically at the apex of the cornea to the desired depth near DM. The study was performed using ex vivo bovine corneas (N = 5) and rabbit corneas (N = 5). A clean penumodissection of a stromal layer was successfully performed using VIREC without any stomal blanching on bovine eyes. The "big bubble" was generated in all five tests without perforation. Only micro bubbles were observed on rabbit eyes. The results proved that VIREC can be an effective surgical option for "big bubble" DALK.

Artificial intelligence meets medical robotics.

Artificial intelligence (AI) applications in medical robots are bringing a new era to medicine. Advanced medical robots can perform diagnostic and surgical procedures, aid rehabilitation, and provide symbiotic prosthetics to replace limbs. The technology used in these devices, including computer vision, medical image analysis, haptics, navigation, precise manipulation, and machine learning (ML) , could allow autonomous robots to carry out diagnostic imaging, remote surgery, surgical subtasks, or even entire surgical procedures. Moreover, AI in rehabilitation devices and advanced prosthetics can provide individualized support, as well as improved functionality and mobility (see the figure). The combination of extraordinary advances in robotics, medicine, materials science, and computing could bring safer, more efficient, and more widely available patient care in the future. -Gemma K. Alderton.

Percutaneous epicardial pacing in infants using direct visualization: A feasibility animal study.

BACKGROUND: Pacemaker implantation in infants and small children is limited to epicardial lead placement via open chest surgery. We propose a minimally invasive solution using a novel percutaneous access kit. OBJECTIVE: To evaluate the acute safety and feasibility of a novel percutaneous pericardial access tool kit to implant pacemaker leads on the epicardium under direct visualization. METHODS: A custom sheath with optical fiber lining the inside wall was built to provide intrathoracic illumination. A Veress needle inside the illumination sheath was inserted through a skin nick just to the left of the xiphoid process and angled toward the thorax. A needle containing a fiberscope within the lumen was inserted through the sheath and used to access the pericardium under direct visualization. A custom dilator and peel-away sheath with pre-tunneled fiberscope was passed over a guidewire into the pericardial space via modified Seldinger technique. A side-biting multipolar pacemaker lead was inserted through the sheath and affixed against the epicardium. RESULTS: Six piglets (weight 3.7-4.0 kg) had successful lead implantation. The pericardial space could be visualized and entered in all animals. Median time from skin nick to sheath access of the pericardium was 9.5 (interquartile range [IQR] 8-11) min. Median total procedure time was 16 (IQR 14-19) min. Median R wave sensing was 5.4 (IQR 4.0-7.3) mV. Median capture threshold was 2.1 (IQR 1.7-2.4) V at 0.4 ms and 1.3 (IQR 1.2-2.0) V at 1.0 ms. There were no complications. CONCLUSION: Percutaneous epicardial lead implantation under direct visualization was successful in six piglets of neonatal size and weight with clinically acceptable acute pacing parameters.

A novel videoscope and tool kit for percutaneous pericardial access under direct visualization.

BACKGROUND: Pericardial access is necessary for the application of epicardial cardiac therapies including ablation catheters, pacing and defibrillation leads, and left atrial appendage closure systems. Pericardial access under fluoroscopic guidance is difficult in patients without pericardial effusions and may result in coronary artery damage, ventricular injury, or perforation with potentially life-threatening pericardial bleeding in up to 10% of cases. There is a clinical need for a pericardial access technique to safely deliver epicardial cardiac therapies. METHODS: In this paper, we describe the design and evaluation of a novel videoscope and tool kit to percutaneously access the pericardial space under direct visualization. Imaging is performed by a micro-CMOS camera with an automatic gain adjustment software to prevent image saturation. Imaging quality is quantified using known optical targets, while tool performance is evaluated in pediatric insufflation and pericardial access simulators. Device safety and efficacy is demonstrated by infant porcine preclinical studies (N = 6). RESULTS: The videoscope has a resolution of 400 × 400 pixels, imaging rate of 30 frames per second, and fits within the lumen of a 14G needle. The tool can resolve features smaller than 39.4 µm, achieves a magnification of 24x, and has a maximum of 3.5% distortion within the field of view. Successful pericardial access was achieved in pediatric simulators and acute in vivo animal studies. During in vivo testing, it took the electrophysiologist an average of 66.83 ± 32.86 s to insert the pericardial access tool into the thoracic space and visualize the heart. After visualizing the heart, it took an average of 136.67 ± 80.63 s to access the pericardial space under direct visualization. The total time to pericardial access measured from needle insertion was 6.7 × quicker than pericardial access using alternative direct visualization techniques. There was no incidence of ventricular perforation. CONCLUSIONS: Percutaneous pericardial access under direct visualization is a promising technique to access the pericardial space without complications in simulated and in vivo animal models.

Design and Functionality of a Multilumen Thoracic Access Port for Pericardial Access Under Direct Visualization.

Small vasculature, venous obstruction, or congenital anomalies can preclude transvenous access to the heart, often resulting in open chest surgery to implant cardiac therapy leads for pacing, defibrillation, or cardiac resynchronization. A minimally invasive approach under direct visualization could reduce tissue damage, minimize pain, shorten recovery time, and obviate the need for fluoroscopy. Therefore, PeriPath was designed as a single-use, low-cost pericardial access tool based on clinical requirements. Its mechanical design aids in safe placement of conductive leads to the pericardium using a modified Seldinger technique. The crossed working channels provide an optimal view of the surgical field under direct visualization. Finite element analysis (FEA) confirms that the device is likely not to fail under clinical working conditions. Mechanical testing demonstrates that the tensile strength of its components is sufficient for use, with minimal risk of fracture. The PeriPath procedure is also compatible with common lead implantation tools and can be readily adopted by interventional cardiologists and electrophysiologists, allowing for widespread implementation. Prior animal work and a physician preliminary validation study suggest that PeriPath functions effectively for minimally invasive lead implantation procedures.

Muscle usage and workload assessment of cardiac ablation procedure with the use of a novel catheter torque tool in a pediatric simulator.

BACKGROUND: Cardiac ablation catheters are small in diameter and pose ergonomic challenges that can affect catheter stability. Significant finger dexterity and strength are necessary to maneuver them safely. We evaluated a novel torque tool to reduce muscle activation when manipulating catheters and improve perceived workload of ablation tasks. The objective was to evaluate measurable success, user perception of workload, and muscle usage when completing a simulated ablation task with and without the use of a catheter torque tool. METHODS: Cardiology attendings and fellows were fitted with surface electromyographic (EMG) sensors on 6 key muscle groups in the left hand and forearm. A standard ablation catheter was inserted into a pediatric cardiac ablation simulator and subjects navigated the catheter tip to 6 specific electrophysiologic targets, including a 1-min simulated radiofrequency ablation lesion. Time to complete the task, number of attempts required to complete the lesion, and EMG activity normalized to percentage of maximum voluntary contraction were collected throughout the task. The task was completed 4 times, twice with and twice without the torque tool, in semi-randomized order. A NASA Task Load Index survey was completed by the participant at the conclusion of each task. RESULTS: Time to complete the task and number of attempts to create a lesion were not altered by the tool. Subjectively, participants reported a significant decrease in physical demand, effort, and frustration, and a significant increase in performance. Muscle activation was decreased in 4 of 6 muscle groups. CONCLUSION: The catheter torque tool may improve the perceived workload of cardiac ablation procedures and reduce muscle fatigue caused by manipulating catheters. This may result in improved catheter stability and increased procedural safety.

An infant phantom for pediatric pericardial access and electrophysiology training.

Background: Cardiac procedures in infants and children require a high level of skill and dexterity owing to small stature and anatomy. Lower incidence of procedure volume in this population results in fewer clinical opportunities for learning. Simulators have grown in popularity for education and training, though most existing simulators are often cost-prohibitive or model adult anatomy. Objective: Develop a low-cost simulator for practicing the skills to perform percutaneous pericardial access and cardiac ablation procedures in pediatric patients. Methods: We describe 2 simulators for practicing cardiac procedures in pediatric patients, with a total cost of less than $500. Both simulators are housed within an infant-size doll. The first simulator is composed of an infant-size heart and a skin-like covering to practice percutaneous pericardial access to the heart. Participants obtained sheath access to the heart under direct visualization. The second simulator houses a child-size heart with 7 touch-activated targets to practice manipulating a catheter through a small heart. This can be performed under direct visualization and with 3-dimensional mapping via CARTO. Participants manipulated a catheter to map the heart by touching the 6 positive targets, avoiding the negative target. Results: Physicians-in-training improved their time to complete the task between the first and second attempts. Physicians experienced with the tools took less time to complete the task than physicians-in-training. Conclusion: This inexpensive simulator is anatomically realistic and can be used to practice manipulating procedure tools and develop competency for pediatric cardiac procedures.

Deep point cloud landmark localization for fringe projection profilometry.

Point clouds have been widely used due to their information being richer than images. Fringe projection profilometry (FPP) is one of the camera-based point cloud acquisition techniques that is being developed as a vision system for robotic surgery. For semi-autonomous robotic suturing, fluorescent fiducials were previously used on a target tissue as suture landmarks. This not only increases system complexity but also imposes safety concerns. To address these problems, we propose a numerical landmark localization algorithm based on a convolutional neural network (CNN) and a conditional random field (CRF). A CNN is applied to regress landmark heatmaps from the four-channel image data generated by the FPP. A CRF leveraging both local and global shape constraints is developed to better tune the landmark coordinates, reject extra landmarks, and recover missing landmarks. The robustness of the proposed method is demonstrated through ex vivo porcine intestine landmark localization experiments.

Surgical pericardial adhesions do not preclude minimally invasive epicardial pacemaker lead placement in an infant porcine model.

BACKGROUND: Pericardial adhesions in infants and small children following cardiac surgery can impede access to the epicardium. We previously described minimally invasive epicardial lead placement under direct visualization in an infant porcine model using a single subxiphoid incision. The objective of this study was to assess the acute feasibility of this approach in the presence of postoperative pericardial adhesions. METHODS: Adhesion group piglets underwent left thoracotomy with pericardiotomy followed by a recovery period to develop pericardial adhesions. Control group piglets did not undergo surgery. Both groups underwent minimally invasive epicardial lead placement using a 2-channel access port (PeriPath) inserted through a 1 cm subxiphoid incision. Under direct thoracoscopic visualization, pericardial access was obtained with a 7-French sheath, and a pacing lead was affixed against the ventricular epicardium. Sensed R-wave amplitudes, lead impedances and capture thresholds were measured. RESULTS: Eight piglets underwent successful pericardiectomy and developed adhesions after a median recovery time of 45 days. Epicardial lead placement was successful in adhesion (9.5 ± 2.7 kg, n = 8) and control (5.6 ± 1.5 kg, n = 7) piglets. There were no acute complications. There were no significant differences in capture thresholds or sensing between groups. Procedure times in the adhesion group were longer than in controls, and while lead impedances were significantly higher in the adhesion group, all were within normal range. CONCLUSIONS: Pericardial adhesions do not preclude minimally invasive placement of epicardial leads in an infant porcine model. This minimally invasive approach could potentially be applied to pediatric patients with prior cardiac surgery.

Role of surgeon intuition and computer-aided design in Fontan optimization: A computational fluid dynamics simulation study.

OBJECTIVE: Customized Fontan designs, generated by computer-aided design (CAD) and optimized by computational fluid dynamics simulations, can lead to novel, patient-specific Fontan conduits unconstrained by off-the-shelf grafts. The relative contributions of both surgical expertise and CAD to Fontan optimization have not been addressed. In this study, we assessed hemodynamic performance of Fontans designed by both surgeon's unconstrained modeling (SUM) and by CAD. METHODS: Ten cardiac magnetic resonance imaging datasets were used to create 3-dimensional (3D) models of Fontans. Baseline computational fluid dynamics simulations assessed Fontan indexed power loss (iPL), hepatic flow distribution, and percentage of conduit surface area with abnormally low wall shear stress for venous flow (<1 dyne/cm2). Fontans not meeting thresholds were redesigned using 2 methods: SUM (ie, original venous anatomy without the Fontan was 3D printed and sent to surgeon for Fontan redesign with clay modeling) and CAD (ie, the same 3D geometry was sent to engineers for iterative Fontan redesign guided by computational fluid dynamics). Both groups were blinded to each other's results. RESULTS: Eight Fontans were redesigned by SUM and CAD methods. Both SUM and CAD redesigns met iPL thresholds. SUM had lower iPL, whereas CAD demonstrated balanced hepatic flow distribution and lower wall shear stress percentage. Wall shear stress percentage shared an inverse relationship with iPL, preventing oversized Fontan designs. CONCLUSIONS: Customized Fontan conduits with low iPL can be created by either a surgeon or CAD. CAD can also improve hepatic flow distribution and prevent oversized Fontan designs. Future studies should investigate workflows that combine SUM and CAD to optimize Fontan conduits.

Chronic performance of subxiphoid minimally invasive pericardial Model 20066 pacemaker lead insertion in an infant animal model.

PURPOSE: To describe chronic performance of subxiphoid minimally invasive pacemaker lead insertion in a piglet model. METHODS: Minimally invasive pacemaker lead implantation was performed through a 10-mm incision under direct visualization using the PeriPath port. Epicardial access was obtained and the commercially available Medtronic Model 20066 pacemaker lead was inserted into the pericardial space and epicardial fixation was performed using the side-action helix. The lead was connected to a pacemaker generator in a para-rectus pocket. Animals underwent a 12-14-week observation period and lead impedances, R-wave amplitudes, and ventricular capture thresholds were tested biweekly. After the survival period, animals were euthanized and gross and histopathology were performed. RESULTS: Subxiphoid minimally invasive pacemaker lead placement was performed in 8 animals (median 4.9 kg) with 100% acute success. Median procedure time was 65 min (IQR 60.5-77). At implant, median lead impedance was 650 Ω (IQR 244-984), R-wave amplitude 11.1 mV (IQR 8-12.3), and ventricular capture threshold 1.5 V @ 0.4 ms (IQR 1-2.6). Over a median survival period of 13 weeks, there was a median lead impedance change of + 262 Ω (IQR 5.3-618.3), R-wave change of - 4.5 mV (IQR - 7.1-- 2.7) and capture threshold change (1.0 ms) of + 1.5 V (IQR 0-3.3). At autopsy, epicardial fixation sites showed fibrovascular proliferation and minimal chronic inflammation. CONCLUSIONS: Subxiphoid pericardial pacemaker placement is safe and effective in a piglet model. Further study and development of leads designed for pericardial placement are warranted.

Percutaneous epicardial placement of a prototype miniature pacemaker under direct visualization: An infant porcine chronic survival study.

INTRODUCTION: Pacemaker implantation in infants typically consists of surgical epicardial lead placement with an abdominal generator. Here, we describe the chronic performance of our minimally invasive prototype miniature pacemaker implanted under direct visualization in an immature porcine model. METHODS: Twelve piglets underwent miniature pacemaker implantation. A self-anchoring two-channel access port was inserted into a 1 cm incision in the subxiphoid space, and a thoracoscope was inserted into the main channel to visualize the thoracic cavity under insufflation. The pacemaker leadlet was inserted through a sheath via secondary channel and affixed against the epicardium using a helical side-biting electrode. The miniature pacemaker was tucked into the incision, which was sutured closed. Ventricular sensing, leadlet impedance, and capture thresholds were measured biweekly. A limited necropsy was performed after euthanasia. RESULTS: Nine piglets were followed for a median of 78 (IQR 52-82) days and gained 6.6 ± 3.2 kg. Three animals were censored from the analysis due to complications unrelated to the procedure. Capture thresholds rose above maximal output after a median of 67 (IQR 40-69) days. At termination, there was a significant decrease in R-wave amplitude (P = .03) and rise in capture thresholds at 0.4 ms (P = .01) and 1.0 ms pulse widths (P = .02). There was no significant change in leadlet impedance (P = .74). There were no wound infections. CONCLUSIONS: There were no infections following minimally invasive implantation of our prototype miniature pacemaker. Improvements to epicardial fixation are necessary to address diminished leadlet efficacy over time.

Minimally invasive percutaneous epicardial placement of a prototype miniature pacemaker with a leadlet under direct visualization: A feasibility study in an infant porcine model.

BACKGROUND: Pacemaker implantation in infants is limited to epicardial lead placement and an abdominal generator pocket. We propose a minimally invasive solution using a prototype miniature pacemaker with a steroid-eluting leadlet that can affix against the epicardium under thoracoscopy. OBJECTIVE: The purpose of this study was to evaluate the safety and feasibility of acute implantation of a prototype miniature pacemaker in an infant porcine model. METHODS: A self-anchoring 2-channel access port was inserted into a 1-cm incision left of the subxiphoid space. A rigid thoracoscope with variable viewing angle was inserted through the main channel to visualize the heart under insufflation. An 18-G needle through the second channel accessed the pericardial space, which was secured with a 7-F sheath. The leadlet was affixed against the epicardium using a distal helical side-biting electrode. The sheath, thoracoscope, and port were removed, and the pacemaker was tucked into the incision. Ventricular sensing, lead impedances, and capture thresholds were measured. RESULTS: Twelve piglets (weight 4.8 ± 1.9 kg) had successful device implantation. The median time from incision to leadlet fixation was 21 minutes (interquartile range [IQR] 18-31 minutes). The median lead impedance was 510 Ω (IQR 495-620 Ω). The median R-wave amplitude was 5.7 mV (IQR 4.2-7.0 mV). The median capture threshold was 1.63 V (IQR 1.32-2.97 V) at 0.4 ms pulse width and 1.50 V (IQR 1.16-2.38 V) at 1.0 ms pulse width. There were no complications. CONCLUSION: Minimally invasive epicardial placement of a prototype miniature pacemaker under thoracoscopy was safe and avoided open chest surgery and creation of an abdominal generator pocket.

Landmark-Guided Deformable Image Registration for Supervised Autonomous Robotic Tumor Resection.

Oral squamous cell carcinoma (OSCC) is the most common cancer in the head and neck region, and is associated with high morbidity and mortality rates. Surgical resection is usually the primary treatment strategy for OSCC, and maintaining effective tumor resection margins is paramount to surgical outcomes. In practice, wide tumor excisions impair post-surgical organ function, while narrow resection margins are associated with tumor recurrence. Identification and tracking of these resection margins remain a challenge because they migrate and shrink from preoperative chemo or radiation therapies, and deform intra-operatively. This paper reports a novel near-infrared (NIR) fluorescent marking and landmark-based deformable image registration (DIR) method to precisely predict deformed margins. The accuracy of DIR predicted resection margins on porcine cadaver tongues is compared with rigid image registration and surgeon's manual prediction. Furthermore, our tracking and registration technique is integrated into a robotic system, and tested using ex vivo porcine cadaver tongues to demonstrate the feasibility of supervised autonomous tumor bed resections.

Semi-Autonomous Laparoscopic Robotic Electro-surgery with a Novel 3D Endoscope.

This paper reports a robotic laparoscopic surgery system performing electro-surgery on porcine cadaver kidney, and evaluates its accuracy in an open loop control scheme to conduct targeting and cutting tasks guided by a novel 3D endoscope. We describe the design and integration of the novel laparoscopic imaging system that is capable of reconstructing the surgical field using structured light. A targeting task is first performed to determine the average positioning error of the system as guided by the laparoscopic camera. The imaging system is then used to reconstruct the surface of a porcine cadaver kidney, and generate a cutting trajectory with consistent depth. The paper concludes by using the robotic system in open loop control to cut this trajectory using a multi degree of freedom electro-surgical tool. It is demonstrated that for a cutting depth of 3 mm, the robotic surgical system follows the trajectory with an average depth of 2.44 mm and standard deviation of 0.34 mm. The average positional accuracy of the system was 2.74±0.99 mm.

A Confidence-Based Shared Control Strategy for the Smart Tissue Autonomous Robot (STAR).

Autonomous robotic assisted surgery (RAS) systems aim to reduce human errors and improve patient outcomes leveraging robotic accuracy and repeatability during surgical procedures. However, full automation of RAS in complex surgical environments is still not feasible and collaboration with the surgeon is required for safe and effective use. In this work, we utilize our Smart Tissue Autonomous Robot (STAR) to develop and evaluate a shared control strategy for the collaboration of the robot with a human operator in surgical scenarios. We consider 2D pattern cutting tasks with partial blood occlusion of the cutting pattern using a robotic electrocautery tool. For this surgical task and RAS system, we i) develop a confidence-based shared control strategy, ii) assess the pattern tracking performances of manual and autonomous controls and identify the confidence models for human and robot as well as a confidence-based control allocation function, and iii) experimentally evaluate the accuracy of our proposed shared control strategy. In our experiments on porcine fat samples, by combining the best elements of autonomous robot controller with complementary skills of a human operator, our proposed control strategy improved the cutting accuracy by 6.4%, while reducing the operator work time to 44 % compared to a pure manual control.

An Implantable Micro-Caged Device for Direct Local Delivery of Agents.

Local and controlled delivery of therapeutic agents directly into focally afflicted tissues is the ideal for the treatment of diseases that require direct interventions. However, current options are obtrusive, difficult to implement, and limited in their scope of utilization; the optimal solution requires a method that may be optimized for available therapies and is designed for exact delivery. To address these needs, we propose the Biocage, a customizable implantable local drug delivery platform. The device is a needle-sized porous container capable of encasing therapeutic molecules and matrices of interest to be eluted into the region of interest over time. The Biocage was fabricated using the Nanoscribe Photonic Professional GT 3D laser lithography system, a two-photon polymerization (2PP) 3D printer capable of micron-level precision on a millimeter scale. We demonstrate the build consistency and features of the fabricated device; its ability to release molecules; and a method for its accurate, stable delivery in mouse brain tissue. The Biocage provides a powerful tool for customizable and precise delivery of therapeutic agents into target tissues.

Single-incision percutaneous pericardial ICD lead placement in a piglet model.

INTRODUCTION: Our group has demonstrated the feasibility of percutaneous pericardial ICD lead placement in a piglet model utilizing direct visualization from a lateral thoracoscopic approach. Development of a novel delivery tool that incorporates visualization allows for the procedure to be performed with a 1 cm subxiphoid incision. METHODS AND RESULTS: A 1 cm incision is made in the subxiphoid area and a novel self-anchoring delivery tool is inserted. A rigid thoracoscope and needle are inserted into two crossed working channels of the tool. After needle visualization, pericardial needle access, followed by sheath access is obtained. A modified side-biting ICD lead is inserted and fixated to the ventricular epicardial surface. The lead is connected to an ICD generator and lead testing followed by defibrillation threshold testing (DFT) is performed. Single-incision ICD lead placement was performed in 6 piglets without acute complications. Median time from subxiphoid incision to DFT testing was 64 minutes; median time from thoracoscope insertion to lead fixation was 16.5 minutes (range 9-30). All had adequate ventricular sensing and pacing at implant and underwent successful defibrillation (range 3-5 J). Survival period ranged from 1 to 16 weeks. Two piglets had survival periods of 12 and 16 weeks with mean weight gain of 7 kg; both had successful repeat DFT at 10 J. All survival animals had stable lead impedances and R-wave amplitudes throughout the survival period. CONCLUSION: Percutaneous pericardial placement of an ICD lead using our novel access tool can be safely performed through a 1 cm incision without complications.