Source: http://www.google.com/patents/US20020077554?ie=ISO-8859-1&dq=5,832,511
Timestamp: 2014-09-16 15:41:39
Document Index: 689473846

Matched Legal Cases: ['art 400', 'art 400', 'art 400', 'art 400', 'art 400', 'art 400', 'art 400', 'art 400']

Patent US20020077554 - Intracardiac pressure monitoring method - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign in<nobr>Advanced Patent Search</nobr>PatentsA method for telemetrically measuring a parameter in a patient's heart comprises the steps of imaging the heart and identifying an implantation site in the heart. An opening is created in the tissue at the implantation site. A sensor comprising a housing, a membrane at one end of the housing wherein...http://www.google.com/patents/US20020077554?utm_source=gb-gplus-sharePatent US20020077554 - Intracardiac pressure monitoring methodAdvanced Patent SearchPublication numberUS20020077554 A1Publication typeApplicationApplication numberUS 09/739,062Publication dateJun 20, 2002Filing dateDec 18, 2000Priority dateDec 18, 2000Also published asCA2365207A1, DE60117355D1, DE60117355T2, EP1216655A1, EP1216655B1, US6652464Publication number09739062, 739062, US 2002/0077554 A1, US 2002/077554 A1, US 20020077554 A1, US 20020077554A1, US 2002077554 A1, US 2002077554A1, US-A1-20020077554, US-A1-2002077554, US2002/0077554A1, US2002/077554A1, US20020077554 A1, US20020077554A1, US2002077554 A1, US2002077554A1InventorsYitzhack Schwartz, Assaf Govari, Shlomo Ben-Haim, Joel Zilberstein, Louis CapezzutoOriginal AssigneeYitzhack Schwartz, Assaf Govari, Shlomo Ben-Haim, Joel Zilberstein, Capezzuto Louis J.Export CitationBiBTeX, EndNote, RefManReferenced by (9), Classifications (21), Legal Events (3) External Links: USPTO, USPTO Assignment, EspacenetIntracardiac pressure monitoring methodUS 20020077554 A1Abstract A method for telemetrically measuring a parameter in a patient's heart comprises the steps of imaging the heart and identifying an implantation site in the heart. An opening is created in the tissue at the implantation site. A sensor comprising a housing, a membrane at one end of the housing wherein the membrane is deformable in response to the parameter, and a microchip positioned within the housing and operatively communicating with the membrane for transmitting a signal indicative of the parameter is provided. The sensor is placed in the opening and the parameter is telemetrically measured from outside of the patient's body based on the transmitted signal by the sensor. The sensor is also telemetrically powered from outside of the patient's body. A signal charging and reading device is placed outside of the patient's body for telemetric powering and signal reading with respect to the sensor. In an alternative embodiment, the sensor has a tapered distal end and a tissue piercing tip for direct implantation into tissue. Alternative embodiments of this sensor include helical threads on the tapered distal end for threading the sensor into tissue and a plurality of tissue barbs for direct and firm anchoring of the sensor in tissue. Images(12) Claims(28)
P=(KD 3 /A 2)X 2 [0065] where P is the pressure value, D is the thickness of the membrane, A is the membrane radius, X is the deflection from the equilibrium and K is a constant. [0066] The LCD display 172 is operatively connected to the processing unit 170 for displaying the measured parameter (hemodynamic blood pressure in the example above) converted from the digital signal in real time. [0067] By utilizing the signal reading and charging device 140 at the exterior of the patient's body, continuous parameter readings (for determining aspects of the parameter such as magnitude) are obtainable for both the mean and active or individual values of the sampled parameter. [0068] When measuring characteristics of a body fluid such as blood, the signal reading and charging device 140 maintains an active reading volume around the sensor 50, ranging anywhere from 5-25 cm, and preferably, an active reading volume ranging approximately 10-15 cm. Moreover, with the telemetric medical system 30, through the sensor 50, and the signal reading and charging device 140, it is possible to sample multiple readings per second. Preferably, approximately 10-20 readings per second are possible with the present invention. [0069] Other attributes associated with the present invention when utilized as a pressure monitor in a chamber of the heart include monitoring a pressure range of +/−30 mmHg; an accuracy (at 5 mSec. integration) of +/−1 mmHg with a repeatability (at 5 mSec. integration) of +/−1 mmHg. It is important to note that the pressure boundaries can be changed easily by changing the size and dimensions, such as width, of the membrane without any change to the electronics. This is important for allowing the present invention to be adapted for various applications while using the same design. [0070] The control unit 154 is also operatively connected to a sine-wave driver 158 for generating a sinusoidal wave signal of approximately 4 to 6 MHz. The sinusoidal wave signal is generated by the sine-wave driver 158 through capacitor 160 to the reader/charger antenna coil 162 for transmission or sending to the antenna coil 68 of the sensor 50 in order to power or charge the sensor 50 as described above. Medical Procedures [0071] As mentioned above, the telemetric medical system 30 according to the present invention is useful for nearly any type of medical diagnostic procedure where it is desireable to implant the sensor 50 at a portion of the body, particularly tissue or organ of interest. The telemetric medical system 30 according to the present invention allows for remote monitoring and diagnosis of a condition of the tissue or organ by being able to rapidly sample various parameters or variables of any physical condition within the patient's body at the site of interest. Since the telemetric medical system 30 is wireless, these types of procedures are conducted in a completely non-invasive manner with minimal trauma to the patient. [0072] One particular example for the telemetric medical system 30 according to the present invention, its components and their method of use, is in the field of congestive heart failure (CHF). CHF is defined as a condition in which a heart 400 (FIG. 10) fails to pump enough blood to the body's other organs. This can result from narrowed arteries that supply blood to the heart muscle (due to coronary artery disease), past heart attack, or myocardial infarction, with scar tissue that interferes with the heart muscle's normal work, high blood pressure, heart valve disease due to past rheumatic fever (in valves such as semilunar valve, tricuspid valve 417 or mitral valve 418) or other causes, primary disease of the heart muscle itself, called cardiomyopathy, defects in the heart present at birth such as congenital heart disease, infection of the heart valves and/or heart muscle itself (endocarditis and/or myocarditis). [0073] The ailing heart 400 keeps functioning but not as efficiently as it should. People with CHF cannot exert themselves because they become short of breath and tired. As blood flowing out of the heart 400 slows, blood returning to the heart 400 through the veins backs up, causing congestion in the tissues. Often swelling (edema) results, most commonly in the legs and ankles, but possibly in other parts of the body as well. Sometimes fluid collects in the lungs and interferes with breathing, causing shortness of breath, especially when a person is lying down. Heart failure also affects the ability of the kidneys to dispose of sodium and water. The retained water increases the edema. [0074] CHF is the most common heart disease in the United States and it is estimated that over 5 million patients suffer from it. One of the more predictive hemodynamic parameters being measured in patients with CHF is blood pressure in the left atrium 410, e.g. left atrial (LA) pressure. To date, this parameter is measured by employing invasive right heart catheterization with a special balloon catheter such as the Swan-Gantz catheter. [0075] Accordingly, in moderating for effects of CHF, it is desireable to measure the blood pressure in a particular chamber (either right atrium 415, right ventricle 419, left atrium 410 or left ventricle 420) in the heart 400 utilizing the telemetric medical system 30 according to the present invention. [0076] Accordingly, in conducting one preferred method according the present invention, blood pressure can be directly monitored in the left atrium 410 of the heart 400. Accordingly, it is desireable to implant the sensor 50 at fossa ovalis 407 within the septum 405. [0077] With respect to the specific anatomy of the septum 405, in approximately 15% of the normal population, the fossa ovalis 407 has a pre-existing hole or opening that either remains open or patent and is normally covered by a small flap of tissue. In approximately 85% of the normal population, the fossa ovalis 407 is completely occluded, e.g. there is no hole in the septum 405. [0078] (1) Transcatheter Approach [0079] In accordance with the method according to the present invention, a transcatheter approach has been found to be particularly useful for the patient population already having the pre-existing hole at the fossa ovalis 407. Accordingly, in performing this method according to the present invention, first, a transesophageal ultrasonic probe (not shown) is inserted into the patient's mouth and placed in the esophagus. In most cases, the transesophageal ultrasonic probe is positioned approximately 30-35 cm from the mouth, i.e. in most cases positioned just above the patient's stomach. [0080] Under transesophageal ultrasonic guidance, a wire (not shown) is inserted into the right atrium 415 through an appropriate vessel such as the inferior vena cava 408 wherein the wire is guided through the fossa ovalis 407 by gently lifting the tissue flap away from the patent opening at the fossa ovalis 407. Once the wire is inserted through the fossa ovalis 407, the wire is guided to one of the pulmonary veins 416 for placement of the distal end of the wire in order to properly position and anchor the wire in the opening of the pulmonary vein 416. Accordingly, the pulmonary vein 416 has been proven to be a very reliable and steady anchoring point for the wire. [0081] Once the wire is properly positioned in the fossa ovalis 407 and anchored in the pulmonary vein 416, a catheter sheath (�over-the-wire� type�not shown) is guided over the wire through the right atrium 415 and the fossa ovalis 407 and positioned within the left atrium 410, for instance, very close to the opening of the pulmonary vein 416. [0082] Once the catheter sheath has been properly positioned, the wire is removed from the patient's heart 400 and the sensor 50 is delivered through the catheter sheath by one of the many standard catheter-based delivery devices (not shown). Accordingly, the sensor 50 can be delivered to the fossa ovalis 407 by any of the typical catheter-based delivery devices normally associated with implantable pacemakers, electrodes, atrial septal defect (ASD) occlusion devices, etc. Accordingly, the sensor 50 is deliverable with typical delivery devices such as the Amplatzer� Delivery System, manufactured by AGA Medical Corporation of Golden Valley, Minn. [0083] After placement of the catheter sheath, the sensor 50 is deployed from the catheter sheath within the fossa ovalis 407 as best illustrated in FIG. 11. Upon deployment, the sensor 50 utilizes the anchoring legs 64 for anchoring the sensor 50 to the septum 405 and occluding the opening at the fossa ovalis 407. [0084] (2) Anterograde Approach [0085] The sensor 50 is placed in the fossa ovalis 407 for those patients not having a pre-existing opening in the fossa ovalis 407 through means of an anterograde approach. Once again, a transesophageal ultrasonic probe is positioned in the patient's esophagus as described above. Under transesophageal ultrasonic imaging guidance, an opening is made in the septum 405 at the fossa ovalis 407 in order to place and accommodate the sensor 50. Thus, the opening is made with a standard needle catheter (not shown) such as the BRK� Series Transseptal Needle manufactured by St. Jude Medical, Inc. of St. Paul, Minn. Accordingly, under transesophageal ultrasonic guidance, the needle catheter is initially placed in the right atrium 415 and positioned at the fossa ovalis 407. At this point, the tip of the needle of the needle catheter penetrates the fossa ovalis 407 and the catheter is inserted through the fossa ovalis 407 into the left atrium 410 through the newly created opening in the fossa ovalis 407 by the needle catheter. Once the opening in the fossa ovalis 407 is created, the sensor 50 is introduced with the delivery device, such as the delivery device described above, and placed in the fossa ovalis opening as shown in FIG. 11. Upon deployment of the anchoring legs 64, the opening in the fossa ovalis 407 is occluded around the sensor housing 52 and the sensor 50 fixed to the septum 405 in a secure fashion. [0086] It is important to note that transesophageal ultrasonic imaging is utilized for both the transcatheter and the anterograde approach as described above in accordance with each method step of the present invention. Since either method according to the present invention can be utilized with the transesophageal ultrasonic guidance, other imaging modalities such as flouroscopy can be eliminated. As such, the methods according to the present invention can be conducted in an outpatient clinic or doctor's office as a bedside procedure. By eliminating the need for a flouroscope, the method according to the present invention also eliminates the need for conducting the procedure in a catheter lab which only adds additional time and cost to the procedure and additional time and inconvenience to the patient. [0087] After the sensor 50 has been implanted in the patient's septum 405, the patient is provided with standard treatment to prevent excessive coagulation or endothelialization. For instance, it is common practice to prescribe aspirin and/or an anticoagulant such as Heparin for a period of time such as six months. [0088] With either of the methods described above, the sensor 50 is fixed to the septum 405 in order to provide real time pressure monitoring in the left atrium 410. Since the sensor 50 is a wireless transponder and a battery low power receiver, the sensor 50 does not impede the natural function of the heart 400 and is truly minimally invasive. [0089] By utilizing the signal reading and charging device 140 at the exterior of the patient's body, continuous pressure readings are obtainable for both the mean and pulsating values of pressure in the left atrium 410 provided by the sensor 50. [0090] With the telemetric system 30, the signal reading and charging device 140 maintains an active reading volume around the sensor 50 ranging anywhere from 5-25 cm, and preferably, an active reading volume ranging approximately 10-15 cm. Moreover, with the sensor 50, and the signal reading and charging device 140, it is possible to sample multiple readings per second. Preferably, approximately 10-20 readings per second are possible with the present invention. [0091] Other attributes associated with the present invention when utilized as a pressure monitor in a chamber of the heart include monitoring a pressure range of plus/minus 30 mmHg; and accuracy (at five Mmsec. integration) of plus/minus 1 mmHg and a repeatability (at 5 msec. integration) of plus/minus 1 mmHg. [0092] Although preferred embodiments are described hereinabove with reference to a medical system, devices, components and methods of use, it will be understood that the principles of the present invention may be used in other types of objects as well. The preferred embodiments are cited by way of example, and the full scope of the invention is limited only by the claims. Referenced byCiting PatentFiling datePublication dateApplicantTitleUS6746404 *Jun 8, 2001Jun 8, 2004Biosense, Inc.Method for anchoring a medical device between tissueUS6783499 *Jun 8, 2001Aug 31, 2004Biosense, Inc.Anchoring mechanism for implantable telemetric medical sensorUS7314451 *Aug 3, 2005Jan 1, 2008Earlysense Ltd.Techniques for prediction and monitoring of clinical episodesUS7344505Oct 15, 2002Mar 18, 2008Transoma Medical, Inc.Barriers and methods for pressure measurement cathetersUS8538535Aug 5, 2010Sep 17, 2013Rainbow Medical Ltd.Enhancing perfusion by contractionUS8626290Aug 16, 2011Jan 7, 2014Enopace Biomedical Ltd.Acute myocardial infarction treatment by electrical stimulation of the thoracic aortaUS8626299Dec 1, 2010Jan 7, 2014Enopace Biomedical Ltd.Thoracic aorta and vagus nerve stimulationUS8649863Dec 20, 2010Feb 11, 2014Rainbow Medical Ltd.Pacemaker with no productionUS20100168565 *Dec 20, 2007Jul 1, 2010Sense A/SSystem for measuring blood pressure in an artery* Cited by examinerClassifications U.S. Classification600/486, 600/561, 600/488International ClassificationA61B5/0215, A61B8/12, H04Q9/00, A61B5/07, A61B5/00, A61B5/021, A61B5/02Cooperative ClassificationY10S128/903, A61B5/0215, A61B5/0031, A61B5/076, A61B2560/0219, A61B5/6882, A61B2562/046, A61B2562/0233European ClassificationA61B5/68D3D, A61B5/00B9, A61B5/07DLegal EventsDateCodeEventDescriptionApr 27, 2011FPAYFee paymentYear of fee payment: 8Apr 27, 2007FPAYFee paymentYear of fee payment: 4Apr 25, 2001ASAssignmentOwner name: BIOSENSE, INC., NEW JERSEYFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:GOVARI, ASSAF;BEN-HAIM, SHLOMO;ZILBERSTEIN, JOEL;AND OTHERS;REEL/FRAME:011787/0785;SIGNING DATES FROM 20010405 TO 20010423Owner name: BIOSENSE, INC. ONE JOHNSON AND JOHNSON PLAZANEW BRFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:GOVARI, ASSAF /AR;REEL/FRAME:011787/0785;SIGNING DATES FROM 20010405 TO 20010423RotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About Google Patents - Send FeedbackData provided by IFI CLAIMS Patent Services©2012 Google