A miniaturized catheter 2-D array for real-time, 3-D intracardiac echocardiography

The design, fabrication, and characterization of a 112 channel, 5 MHz, two-dimensional (2-D) array transducer constructed on a six layer flexible polyimide interconnect circuit is described. The transducer was mounted in a 7 Fr (2.33 mm outside diameter) catheter for use in real-time intracardiac volumetric imaging. Two transducers were constructed: one with a single silver epoxy matching layer and the other without a matching layer. The center frequency and -6 dB fractional bandwidth of the transducer with a matching layer were 4.9 MHz and 31%, respectively. The 50 omega pitch-catch insertion loss was 80 dB, and the typical interelement crosstalk was -30 dB. The final element yield was greater than 97% for both transducers. The transducers were used to acquire real-time, 3-D images in an in vivo sheep model. We present in vivo images of cardiac anatomy obtained from within the coronary sinus, including the left and right atria, aorta, coronary arteries, and pulmonary veins. We also present images showing the manipulation of a separate electrophysiological catheter into the coronary sinus.     

Tunneled-cuffed catheter implanted into the accessory hemiazygos vein because of occlusion of the left innominate vein

Hemodialyzed patients are at risk of multiple catheterizations. Nephrologists performing such procedures need to be familiar with congenital and acquired vascular abnormalities. We describe a successful insertion and use of a cuffed-tunneled catheter in a patient with unusual anatomy of the central venous system. Computed tomography angiography revealed thrombosis of the right subclavian vein and bilateral occlusion of innominate veins. The left internal jugular and subclavian veins joined to form a large vessel that drained through the accessory hemiazygos and azygos veins into the superior vena cava. The catheter was implanted through the left internal jugular vein into the accessory hemiazygos vein. The presented case demonstrates that the catheter can be implanted into distended collateral, especially when no other location is possible.     

Optimizing the beam pattern of a forward-viewing ring-annular ultrasound array for intravascular imaging

Intravascular ultrasound (IVUS) imaging systems using circumferential arrays mounted on cardiac catheter tips fire beams orthogonal to the principal axis of the catheter. The system produces high resolution cross-sectional images but must be guided by conventional angioscopy. A real-time forward-viewing array, integrated into the same catheter, could greatly reduce radiation exposure by decreasing angiographic guidance. Unfortunately, the mounting requirement of a catheter guide wire prohibits a full-disk imaging aperture. Given only an annulus of array elements, prior theoretical investigations have only considered a circular ring of point transceivers and focusing strategies using all elements in the highly dense array, both impractical assumptions. In this paper, we consider a practical array geometry and signal processing architecture for a forward-viewing IVUS system. Our specific design uses a total of 210 transceiver firings with synthetic reconstruction for a given 3-D image frame. Simulation results demonstrate this design can achieve side-lobes under -40 dB for on-axis situations and under -30 dB for steering to the edge of a 60/spl deg/ cone.     

Catheter tip malposition after percutaneous placement of tunneled hemodialysis catheters

The percutaneous catheterization of central veins is increasingly used in nephrological practice as a temporary or permanent vascular access. The aim of our study was to present and to analyze episodes of catheter tip malposition during percutaneous tunneled hemodialysis catheter insertion in the large, unselected group of patients. All patients who underwent the procedure of catheter insertion in our department during year 2012 were analyzed retrospectively. One hundred four tunneled hemodialysis catheters were inserted in 101 patients. In 58 patients, the catheter was inserted at the initiation of hemodialysis therapy as the first access and in 46 the catheter was placed because of the failure of the existing one. In 68 patients, the catheter was inserted into the right internal jugular vein and in 20 patients into the left internal jugular vein (LIJV). Subclavian veins were used in five cases and femoral veins in 11 cases. Malposition of the catheter tips occurred in six patients. In all cases, the LIJV was cannulated. In two cases, the catheter tip malposition was in the right innominate vein and in four cases in the azygos vein. Our data demonstrate that with the blind insertion of tunneled hemodialysis catheters, the risk of catheter tip malposition is significantly higher with the left side insertion. As catheter insertion through the LIJV holds very high (30%) risk of the tip malposition, it should always be performed under the fluoroscopic control.     

Multifunctional catheters combining intracardiac ultrasound imaging and electrophysiology sensing

A family of 3 multifunctional intracardiac imaging and electrophysiology (EP) mapping catheters has been in development to help guide diagnostic and therapeutic intracardiac EP procedures. The catheter tip on the first device includes a 7.5 MHz, 64-element, side-looking phased array for high resolution sector scanning. The second device is a forward-looking catheter with a 24-element 14 MHz phased array. Both of these catheters operate on a commercial imaging system with standard software. Multiple EP mapping sensors were mounted as ring electrodes near the arrays for electrocardiographic synchronization of ultrasound images and used for unique integration with EP mapping technologies. To help establish the catheters' ability for integration with EP interventional procedures, tests were performed in vivo in a porcine animal model to demonstrate both useful intracardiac echocardiographic (ICE) visualization and simultaneous 3-D positional information using integrated electroanatomical mapping techniques. The catheters also performed well in high frame rate imaging, color flow imaging, and strain rate imaging of atrial and ventricular structures. The companion paper of this work discusses the catheter design of the side-looking catheter with special attention to acoustic lens design. The third device in development is a 10 MHz forward-looking ring array that is to be mounted at the distal tip of a 9F catheter to permit use of the available catheter lumen for adjunctive therapy tools.     

Integrated catheter for 3-D intracardiac echocardiography and ultrasound ablation

A catheter device with integrated ultrasound imaging array and ultrasound ablation transducer is introduced. This device has been designed for use in interventional cardiac procedures in which the cardiac anatomy is first imaged using real-time three-dimensional (3-D) ultrasound, then ablated to treat arrhythmias. The imaging array includes 112 elements operating at 5.4 MHz arranged in a 2-D matrix. Individual elements have a bandwidth of 21% and an insertion loss of 80 dB. The array has an azimuth resolution of 12 degrees and an elevation resolution of 8.7 degrees. The ablation transducer is a concentric piezoelectric transducer PZT-4 ring (outside diameter (O.D.), 4.5 mm, inside diameter (I.D.), 3.1 mm) operating at 10 MHz that surrounds the imaging array. It can produce a spatial-peak, temporal-average intensity up to 16 W/cm2. The entire device fits into a 9 Fr lumen with a 14 Fr tip to accommodate the ablation ring. With this device we have imaged, in realtime 3-D, a variety of targets including wire phantoms, fixed sheep hearts, and fresh bovine tissue. The ablation ring has been used to heat tissue-mimicking rubber 14 degrees C, as well as create lesions in fresh bovine tissue.     

Successful Long-Term Central Venous Access

Daily home hemodialysis (DHHD) requires simple, vascular access to minimize patients' discomfort but also to guarantee tolerance and long-term efficiency. The arteriovenous fistula is not ideal for DHHD because of the double puncture required every day; in addition, the rate of dysfunction is probably greater because of the more frequent use. Central venous catheters may be a good alternative to the arteriovenous fistula as long-term vascular access for DHHD. In this study we report our experience with the internal jugular vein two-catheter access for long-term dialysis and evaluate its possible use for DHHD. Since 1988, Tesio's twin catheters have been positioned in 908 patients with exhausted peripheral vascular bed. In all patients hemodialysis could be performed a few minutes after the surgical procedure. The survival rate of catheters, in a selected group of 46 patients, at 1, 2, and 5 years was, respectively, 92%, 87%, and 82%. The mean blood flow was 282±29 mL/min at 1 month, 286±36 mL/min at 1 year, and 274±37 mL/min at 5 years. Venous pressure in the inlet side was 102±31 mm Hg at 1 month, 126±36 mm Hg at 1 year, and 132±58 mm Hg at 5 years. Catheter clotting was treated either with thrombolytic agents or with catheter (one or both) replacement. Sepsis was treated with systemic antibiotic therapy or catheter removal. Data support the potential role of the internal jugular vein two-catheter system for DHHD.     

Can a left internal jugular catheter be used in the hemodialysis of a patient with persistent left superior vena cava?

A patient with a persistent left superior vena cava (PLSVC) was incidentally diagnosed after positioning of a dual lumen catheter for hemodialysis into the left internal jugular vein. Although PLSVC is a relatively rare condition, it is the most common congenital anomaly of thoracic venous circulation. It represents the persistence of the left horn of the embryonic sinus venosus, which normally involutes during embryogenesis to become the coronary sinus. The existence of a PLSVC can cause a significant diagnostic dilemma during catheterization of the left internal jugular vein, pertaining to the positioning of the catheter. It may also be associated with significant clinical implications such as systemic embolization, provocation of arrhythmia, and thrombosis of the vessel. The safety of such catheterization has not been adequately evaluated due to the rarity of this condition. We believe that a diagnostic workup including blood gas analysis, echocardiography, and computed tomography is necessary to confirm a right atrial drainage and a patent innominate vein as prerequisites to maintain the catheter in position.     

Maintenance of blood flow rate on dialysis with self‐centering CentrosFLO catheter: A multicenter prospective study

Introduction Chronic central venous catheters (CVC) for dialysis lose patency and deliver lower blood flow over time, often due to fibrous sheathing that covers the lumen tips. The CentrosFLO central venous catheter has a shape that directs the arterial and venous tips away from the walls of the vena cava and right atrium, making sheathing of the tips less likely. Methods A prospective, multicenter, single arm, non‐controlled, observational study was conducted at eight sites in the United States. All consenting dialysis patients receiving CentrosFLO catheters through the right or left internal jugular veins were accepted in the study, as long as the catheter was expected to be used for 45 days and was not an over‐the‐wire replacement for a previous CVC. Data were automatically collected on initial and average dialysis blood flow rate and initial arterial and venous pressures, for up to 26 weeks of dialysis therapy. Findings 75 patients were enrolled. Kaplan‐Meier analysis indicated that 87% of patients maintained blood flow rate over 300 mL/min throughout 26 weeks of follow‐up. There was no decline in average dialysis blood flow rate and no significant change in hydraulic resistance of the arterial or venous lumens of the catheters during the study. Discussion The CentrosFLO catheter demonstrates long term patency with good flow rates on dialysis, which, by comparison with previous studies, shows a clinically significant improvement in blood flow rate vs. other catheters. Stable hydraulic resistance of the catheter lumens showed no evidence of tip encroachment by fibrous sheaths.     

Effect of extrusion process melt temperature on polyurethane catheter surfaces

Determination of optimum process melt temperature of medical-grade polyurethane (PU) is an indispensable challenge witnessed during the catheter manufacturing process. This resin does not contain a uniform crystal structure but exists in an amorphous state. The lower shore hardness PU material, used in catheter manufacture, has just a “melt temperature range” instead of a definite melt temperature. This temperature plays a significant role in shaping the catheter surfaces, which directly interact with human tissues and cause health-care-associated issues. The objective of this work is to evaluate the effects of variations in the melt temperature during the extrusion process of medical catheters on their outer surfaces. Medical PU, Pellethane, was used for this study and 12 Fr (4.0?mm) catheters were manufactured with optimal validated parameters, excluding melt temperature. The manufactured catheters were examined under Optical Microscopy and Atomic Force Microscopy (AFM) for surface topography studies. Wettability studies were carried out using a Goniometer for evaluating the water contact angles. The effects of melt temperature on the surface roughness (R_a) and wettability of the catheter surfaces were analyzed through analysis of variance (ANOVA). The conclusion was that the process melt temperature variations have a significant effect on catheter R_a and its wettability characteristics.     

Femoral arteriovenous fistula 3 months after removal of catheter for hemodialysis

A 56‐year‐old Asian woman was admitted to hospital for the consideration of hemodialysis (HD). A right femoral dialysis catheter was inserted for HD. Three months after removal of catheter, she was admitted because of right inguinal swelling. A thrill and bruit were felt and heard at the inguinal area. Color Doppler detected a fistula between right superficial femoral artery and right common femoral vein and subsequently confirmed by contrast enhanced computed tomography scan and 3‐dimensional reconstruction with computed tomography. At surgery, a 4‐mm–diameter fistula was found between the right superficial femoral artery and right common femoral vein. A primary closure of both defects in the artery and vein was then carried out. A follow‐up digital vascular study 3 months after surgical repair was normal. In conclusion, nephrologist should have a heightened awareness to the potential of this complication and should at least document a normal exam following the removal of femoral catheters.     

3-D ultrasound guidance of surgical robotics using catheter transducers: feasibility study

The goal of this study was to test the feasibility of using a real-time 3-D (RT3D) ultrasound scanner with matrix array catheter probes to guide a surgical robot. We tested the accuracy of using 3-D catheter transducers with the 3-D measurement software of the scanner to direct automatically a robot arm that touched two needle tips together within a water tank and inside a vascular graft. RMS measurement error ranged from 2.4 to 3.4 mm for two catheter designs.     

Right atrial thrombus due to internal jugular vein catheter

Right atrial thrombus is rare complication of hemodialysis central venous catheter. Literature survey revealed 49 documentations of right atrial thrombus due to a central venous catheter. We report a 58-year-old type 2 diabetic, hypertensive, end-stage renal disease patient, who 2 months after initiation of hemodialysis through a right internal jugular vein catheter, developed clinical features suggestive of pulmonary thromboembolism. An echocardiography revealed presence of a serpentine thrombus in right atrium. The internal jugular vein catheter was removed and unfractionated heparin was initiated. At the end of 6 weeks he was symptom free. We compared conservative treatment with surgery for RAT. Conservative management with central venous catheter removal and anticoagulation therapy is not inferior to the surgery.     

A rare cause of abdominal pain: Catheter in the middle hepatic vein

Hemodialysis catheters are vital for chronic renal failure patients. Permanent tunneled dialysis catheters may be inserted through the jugular, subclavian, and femoral veins. In this paper, we aimed to present the computed tomography findings of a chronic renal failure patient who had referred our clinic with abdominal pain and dyspnea symptoms. This patient had a formerly inserted hemodialysis catheter for chronic renal failure and her catheter was found to be extending towards the middle hepatic vein with the tip leaning onto the parenchyma. Hemodialysis catheters can provide instant vascular access and can also be used for the consecutive procedures. Permanent hemodialysis catheters are ideal for long‐term use when placing an arteriovenous fistula is contraindicated or is no longer possible under conditions like advanced heart failure, peripheral artery disease or short life expectancy. The internal jugular, subclavian, the femoral veins, and the inferior vena cava can be used for catheter insertion. The tip of the catheters inserted in the neck or the thorax must extend to the vena cava superior. Catheter malposition may both lead to fatal outcomes and ineffective dialysis. It is important to obtain chest X‐rays after the procedure, particularly to detect catheter malposition.     

Efficacy of Tissue Plasminogen Activator for Thrombolysis in Central Venous Dialysis Catheters

Background:  Low blood flow is a frequent complication of central‐vein (CV) dialysis catheters. Since thrombotic occlusion accounts for many cases of reduced blood flow, it is common practice to administer empiric thrombolytic therapy in an attempt to restore catheter patency and improve function.
Methods:  We prepared tissue plasminogen activator (tPA) from 50 mg lyophilized powder, which was diluted (1 mg/mL) in sterile water for injection. A volume of 1 mL was frozen in 3 cc polystyrene syringes at −20 °C and thawed at room temperature when needed. tPA was then administered into the arterial and venous ports of the central venous catheter in a volume equal to the manufacturer's stated luminal volume and was allowed to dwell for 30 minutes.
Results:  tPA was administered 62 times in 25 patients with 30 catheters (11 Tesio, 17 PermCath, 2 Shiley) for treatment of low blood flow (pump speed < 250 mL/min). Complete restoration of patency was achieved in 23 episodes (mean blood flow pre‐tPA 130 mL/min; post‐tPA 320 mL/min); partial restoration of patency was achieved in 20 episodes (mean blood flow pre‐tPA 69 mL/min; post‐tPA 233 mL/min). tPA was just as likely to be effective in patients with complete catheter occlusion (i.e., no blood flow) as it was when some initial blood flow was present. Nineteen episodes failed to respond to tPA. These episodes occurred in 13 catheters, 12 of which ultimately underwent radiologic evaluation; an extraluminal cause for low blood flow was found in all 12 catheters (6 malpositioned, 6 fibrin sheaths).
Conclusions:  tPA at a dose of 1 mg/mL is effective for restoring patency in CV dialysis catheters. Failure to respond to tPA strongly suggests an extraluminal cause of catheter malfunction.     

An easy way to remove a stuck hemodialysis catheter

The replacement of tunneled hemodialysis catheters (CVCs) is a common procedure. In some cases, the CVC cannot be removed from the central vein because of tight adhesions to the surrounding fibrin sheath. A tight fibrin sheath leads to firm adherence between the catheter and the central veins or right atrial wall. Such stuck catheters cannot be removed from the central vein using standard methods. We present here a case demonstrating the successful removal of such a stuck CVC using the reverse Seldinger method.     

Feasibility of noncontact intracardiac ultrasound ablation and imaging catheter for treatment of atrial fibrillation

Atrial fibrillation (AF) affects 1% of the population and results in a cost of 2.8 billion dollars from hospitalizations alone. Treatments that electrically isolate portions of the atria are clinically effective in curing AF. However, such minimally invasive catheter treatments face difficulties in mechanically positioning the catheter tip and visualizing the anatomy of the region. We propose a noncontact, intracardiac transducer that can ablate tissue and provide rudimentary imaging to guide therapy. Our design consists of a high-power, 20 mm by 2 mm, 128-element, transducer array placed on the side of 7-French catheter. The transducer will be used in imaging mode to locate the atrial wall; then, by focusing at that location, a lesion can be formed. Imaging of previously formed lesions could potentially guide placement of subsequent lesions. Successive rotations of the catheter will potentially enable a contiguous circular lesion to be created around the pulmonary vein. The challenge of intracardiac-sized transducers is achieving high intensities (300-5000 W/cm2) needed to raise the temperature of the tissue above 43 degrees C. In this paper, we demonstrate the feasibility of an intracardiac-sized transducer for treatment of atrial fibrillation. In simulations and proof-of-concept experiments, we show a 37 degrees C temperature rise in the lesion location and demonstrate the possibility of lesion imaging.     

颈内静脉穿刺置管术术前彩色多普勒超声定位和术后超声监测的研究

目的:评估彩色多普勒超声监测颈内静脉置管术的临床价值。方法:应用彩色多普勒超声实时监测120例患者的置管过程,对临床"盲穿"不成功的25例患者及"盲穿"后出现并发症的30例患者进行超声检查分析。结果:120例经实时超声监测的患者均取得成功,没有出现严重的并发症;临床盲穿不成功的原因有误穿颈总动脉、颈内静脉瓣膜过长、误穿颈外静脉、穿入颈内静脉或锁骨下静脉的对侧壁致使导丝不能下移;"盲穿"后出现的并发症主要为血肿、导管堵塞、胸锁乳突肌肿胀、静脉血栓形成、胸腔积血、误穿动脉、假性动脉瘤形成、导管周围纤维鞘膜形成等。结论:超声定位有助于顺利完成颈内静脉穿刺置管,并且对颈内静脉穿刺的各种并发症能够作出准确的诊断。     

Hemothorax caused by replacement of hemodialysis catheter: A case report

Central venous catheters (CVC) are widely used in clinics to gain vascular access, but the risk and prevalence of catheter‐related complications remains a serious issue. We report a long‐term dialysis catheter accidentally inserted into the mediastinum via the right jugular vein in a hemodialysis patient. We also review complications associated with vascular catheterization and propose immediate therapeutic interventions for such cases.     

Cuffed-catheter-related Lemierre syndrome

Sepsis is a common problem in patients who have cuffed catheters for hemodialysis. Line sepsis, however, has not often been associated with septic thrombophlebitis as seen in Lemierre syndrome. Thrombophlebitis of a central vein associated with catheter placement is extremely rare and when encountered is known to affect the femoral or the subclavian vein. Thrombophlebitis of the internal jugular vein after hemodialysis catheter placement has not been reported. We present the case of a woman with line sepsis who developed Lemierre syndrome, a serious complication of which the medical community should be aware. Lemierre syndrome requires a high index of suspicion for diagnosis and can have a fatal outcome if not treated with appropriate antibiotics.