scholarly journals Design of a Catheter-Based Device for Performing Percutaneous Chordal-Cutting Procedures

2009 ◽  
Vol 3 (2) ◽  
Author(s):  
A. H. Slocum ◽  
W. R. Bosworth ◽  
A. Mazumdar ◽  
M. A. Saez ◽  
M. L. Culpepper ◽  
...  

In this paper we detail the rapid design, fabrication and testing of a percutaneous catheterbased device that is envisioned to enable externally controlled manipulation and cutting of specific chordae tendinae within the heart. The importance of this work is that it (a) provides a means that surgeons may use to alleviate problems associated with some forms of mitral valve regurgitation and (b) demonstrates how a deterministic design process may be used to drive design innovation in medical devices while lowering development cost/time/resources. In the United States alone, approximately 500,000 people develop ischemic or functional MR per year. A chordal cutting procedure and device could allow many patients, who would otherwise be unable to survive open-heart surgery, to undergo a potentially life-saving operation at reduced risk. The design process has enabled us to generate a solution to this problem in a relatively short time. A deterministic design process was used to generate several design concepts and then evaluate and compare each concept based on a set of functional requirements. A final concept to be alpha prototyped was then chosen, optimized, and fabricated. The design process made it possible to make rapid progress during the project and to achieve a device design that worked the first time. This approach is important to medical device design as it reduces engineering effort, cost, and the amount of time spent in iterative design cycles. An overview of the design process will be presented and discussed within the context of a specific case study–the rapid design/fabrication of a chordal cutting device. Experimental results will be used to assess: (i) The performance of the catheter in maneuvering into the heart and grasping various structures. (ii) The effectiveness of the catheter's RF ablation tip at cutting chordae inside of a heart. In the first experiment, the catheter was guided to the basal chordae under direct visualization, which showed that the catheter is capable of successfully grasping a chord. During the second experiment, ultrasound was shown to be a viable method of visualizing the catheter within the heart. During this experiment, once contact between the chord and RF ablator tip was confirmed, the chord was successfully ablated. We will also discuss experiments that are currently underway to visualize the catheter utilizing a Trans-Esophageal Echo probe, as well as imaging the mitral valve from the apex of the heart with a laparoscope so that video of the basal chord being grasped and cut can be acquired on a heart whose anatomical structures are intact. A brief synopsis will then be given of how the design process has been used in research and educational collaborations between MIT and local hospitals.

Author(s):  
Toufic Azar ◽  
Sumitra Rajagopalan ◽  
Renzo Cecere ◽  
Joszef Kovecses ◽  
Jorge Angeles

Mitral valve regurgitation [1] (MVR) is a functional heart disease in which the valve does not close completely and causes blood to leak back into the left atrium. This condition increases the workload on the heart, and if left untreated, can lead to irreversible heart damage, cardiac arrhythmia, and congestive heart failure. Annually, in the United States, more than 50 000 patients undergo mitral valve repair. The causes of MR can be either primary, due to an anatomical change of the valve apparatus, or secondary to ischemic heart disease and idiopathic cardiomyopathy. Currently, the intervention requires an open heart surgery with cardiopulmonary bypass. Under such conditions, the patient is subjected to intra and post-operative trauma that can result in a mortality increase and that can prevent high risk individuals from undergoing the repair. A non-invasive percutaneous method would greatly reduce risks associated with a conventional surgery while increasing the potential candidates for repair. Introduced in this paper is a concept for a novel procedure that relies on a robotically-guided compliant catheter, fitted with an anchoring mechanism, intended to reshape the mitral-valve annulus to dimensions suitable for the effective support of the valve leaflets.


2009 ◽  
Vol 3 (2) ◽  
Author(s):  
Alexander H. Slocum ◽  
William R. Bosworth ◽  
Anirban Mazumdar ◽  
Miguel A. Saez ◽  
Martin L. Culpepper ◽  
...  

This paper focuses on the design and implementation of a percutaneous catheter-based device to provide physicians with an externally controlled tool capable of manipulating and cutting specific chordae tendinae within the heart to alleviate problems associated with some forms of mitral valve (MV) regurgitation. In the United States alone, approximately 500,000 people develop ischemic or functional mitral regurgitation per year. Many of these patients do not possess the required level of health necessary to survive open-heart surgery, and the development of a chordal cutting procedure and device is needed to allow these patients to receive treatment. A deterministic design process was used to generate several design concepts and then evaluate and compare each concept based on a set of functional requirements. A final concept to be alpha prototyped was then chosen, further developed, and fabricated. Experiments showed that the design was capable of locating and grabbing a chord and that ultrasound imaging is a viable method for navigating the device inside of the human body. Once contact between the chord and radio-frequency (RF) ablation tip was confirmed, the chord was successfully ablated.


Author(s):  
Alfred Ibrahimi ◽  
Saimir Kuci ◽  
Ervin Bejko ◽  
Stavri Llazo ◽  
Jehona Neziraj ◽  
...  

The occurrence of hyperbilirubinaemia after heart surgery using cardiopulmonary bypass or post-operative heart failure is fairly common. Mechanism of hyperbilirubinemiais still not completely clarified, and there are so few specific therapies available for acute hepatobiliary injury. Post-operative mortality well correlates with increasing total bilirubin values, particularly for bilirubin-associate acute kidney tubular necrosis. The difficulty to reduce mortality is partially a consequence of not completely understood physiopathology. It is obvious that long-lasting CPB plays an important role, in association with hemodilution, hypotension, ischemia-reperfusion, and increasing hematic level of endogenous catecholamine with reduction of hepatic blood flow. Case report. A 68 years old man with severe mitral valve regurgitation and pulmonary hypertension and low EF 30%. Mitral valve replacement and tricuspid anuloplastic was performed. Due to low cardiac output syndrome severe hyperbilirubiemeia was seen (24 mg/dl. and unconjugated fraction 16mg/dl) days after. Phenobarbital (luminal) was started 15 mg/kg daily. Two days later the level decreased until 8 mg/dl with normalization of conjugation/unconjugation ratio.Postoperative hyperbilirubinemia is a multifactorial process caused by both impaired liver function of bilirubin transport. In case of elevated level of unconjugated fraction we suggest to use Luminal as alternative for decreasing unconjugated fraction.


Author(s):  
Zhaoming He ◽  
Suveen Emmadi ◽  
Shamik Bhattacharya

Edge-to-edge repair (ETER) was introduced to correct mitral valve (MV) regurgitation and has demonstrated efficacy in a spectrum of MV diseases [1], especially MV prolapse. This technique changes MV geometric configuration by suturing the anterior and posterior leaflets at central or commissural edges (depending on lesion), and consequently alters MV mechanics. MV prolapse is the most common heart valve abnormality in the United States. It is mainly caused by chordal rupture or elongation in which imbalanced chordal lengths protrude MV anterior and/or posterior leaflets. Chordal repair or leaflet resection are common surgical procedures in an open heart surgery. ETER is also effective in treatment of MV prolapse and preferred because of potential percutaneous application of the similar procedure. However, ETER restore leaflet coaptation from a prolapsed MV and may alter leaflet stress and chordal tension distribution. Our hypothesis is that ETER changes leaflet and chord special configuration of a prolapsed MV and thus chordal tensions as compared with normal and prolapsed MVs. The aim of the current study was to investigate tensions of marginal, strut chordae of anterior leaflet, and of marginal, intermediate chordae of posterior leaflet during systole before and after ETER on the MV with a prolapsed posterior leaflet. Hypothesis is tested by comparison of chordal tension change.


Heart ◽  
1973 ◽  
Vol 35 (1) ◽  
pp. 103-106 ◽  
Author(s):  
S J Wood ◽  
J Thomas ◽  
M V Braimbridge

Author(s):  
S. Ludwig ◽  
D. Kalbacher ◽  
N. Schofer ◽  
A. Schäfer ◽  
B. Koell ◽  
...  

Abstract Aims Transcatheter mitral valve replacement (TMVR) with dedicated devices promises to fill the treatment gap between open-heart surgery and edge-to-edge repair for patients with severe mitral regurgitation (MR). We herein present a single-centre experience of a TMVR series with two transapical devices. Methods and results A total of 11 patients were treated with the Tendyne™ (N = 7) or the Tiara™ TMVR systems (N = 4) from 2016 to 2020 either as compassionate-use procedures or as commercial implants. Clinical and echocardiographic data were collected at baseline, discharge and follow-up and are presented in accordance with the Mitral Valve Academic Research Consortium (MVARC) definitions. The study cohort [age 77 years (73, 84); 27.3% male] presented with primary (N = 4), secondary (N = 5) or mixed (N = 2) MR etiology. Patients were symptomatic (all NYHA III/IV) and at high surgical risk [logEuroSCORE II 8.1% (4.0, 17.4)]. Rates of impaired RV function (72.7%), severe pulmonary hypertension (27.3%), moderate or severe tricuspid regurgitation (63.6%) and prior aortic valve replacement (63.6%) were high. Severe mitral annulus calcification was present in two patients. Technical success was achieved in all patients. In 90.9% (N = 10) MR was completely eliminated (i.e. no or trace MR). Procedural and 30-day mortality were 0.0%. At follow-up NYHA class was I/II in the majority of patients. Overall mortality after 3 and 6 months was 10.0% and 22.2%. Conclusions TMVR was performed successfully in these selected patients with complete elimination of MR in the majority of patients. Short-term mortality was low and most patients experienced persisting functional improvement. Graphic abstract


2019 ◽  
Vol 3 (3) ◽  
Author(s):  
Masahiko Asami ◽  
Thomas Pilgrim ◽  
Stephan Windecker ◽  
Fabien Praz

Abstract Background Concomitant structural degeneration of surgical mitral bioprostheses and paravalvular leak (PVL) is rare but potentially fatal. Data pertaining to simultaneous transcatheter mitral valve implantation (TMVI) and percutaneous PVL closure are limited, and the optimal treatment strategy remains undetermined. We report a case of simultaneous TMVI and double percutaneous PVL closure in a patient with a degenerated bioprosthetic mitral valve and associated medial and lateral PVLs. Case summary A 75-year-old woman who underwent combined aortic (Edwards Perimount Magna 19 mm) and mitral (Edwards Perimount Magna 25 mm) surgical valve replacement 6 years ago was referred for treatment of new-onset orthopnoea and severely reduced exercise capacity. Transoesophageal echocardiography revealed severe mitral stenosis and concomitant moderate to severe mitral regurgitation, originating from two PVLs located medial and lateral from the surgical bioprosthesis. Due to high surgical risk, we performed successful transseptal mitral valve-in-valve (ViV) implantation combined with the closure of two PVLs during the same procedure. Discussion Although surgery should be considered as a first-line treatment in this setting, most patients have extremely high or prohibitive surgical risk inherent to repeat open heart surgery. Mitral ViV implantation appears a reasonable treatment option for patients with failed mitral bioprostheses. Furthermore, a recent study of percutaneous PVL closure showed no significant difference in long-term all-cause mortality compared with redo open-heart surgery. Simultaneous TMVI and percutaneous PVL closure appears feasible in selected high-risk patients.


Author(s):  
Nanxin Wang ◽  
Vijitha Kiridena ◽  
Gianna Gomez-Levi ◽  
Jian Wan ◽  
Steven Sieczka ◽  
...  

Appraising vehicle package design concepts using seating bucks — physical prototypes representing vehicle package, is an integral part of the vehicle package design process. Building such bucks is costly and may impose substantial burden on the vehicle design cycle time. Further, static seating bucks lack the flexibility to accommodate design iterations during the gradual progression of a vehicle program. A “Computer controlled seating buck”, as described in this paper, is a quick and inexpensive alternative to the traditional seating bucks with the desired degree of fidelity. It is particularly useful to perform package and ergonomic studies in the early stages of a vehicle program, long before the data is available to build a traditional seating buck. Such a seating buck has been developed to accommodate Ford vehicle package design needs. This paper presents the functional requirements, the high level conceptual design of how these requirements are realized, and the methods to verify, improve and sustain the dimensional accuracy and capability of the new computer controlled seating buck.


2003 ◽  
Vol 25 (2) ◽  
pp. 131-133 ◽  
Author(s):  
K. Ghosh ◽  
M. Madkaikar ◽  
F. Jijina ◽  
S. Gandhi ◽  
S. Shetty ◽  
...  

2012 ◽  
Vol 8 (6) ◽  
pp. 797-799
Author(s):  
Saina Attaran ◽  
Jon Anderson ◽  
Prakash Punjabi

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