US20030195577A1 - Steerable catheter and method for locating coronary sinus - Google Patents
Steerable catheter and method for locating coronary sinus Download PDFInfo
- Publication number
- US20030195577A1 US20030195577A1 US10/446,266 US44626603A US2003195577A1 US 20030195577 A1 US20030195577 A1 US 20030195577A1 US 44626603 A US44626603 A US 44626603A US 2003195577 A1 US2003195577 A1 US 2003195577A1
- Authority
- US
- United States
- Prior art keywords
- catheter
- cannula
- distal end
- coronary sinus
- blood
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Abandoned
Links
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/14539—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring pH
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B5/00—Measuring for diagnostic purposes; Identification of persons
- A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
- A61B5/1455—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters
- A61B5/1459—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue using optical sensors, e.g. spectral photometrical oximeters invasive, e.g. introduced into the body by a catheter
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/056—Transvascular endocardial electrode systems
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00292—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery mounted on or guided by flexible, e.g. catheter-like, means
- A61B2017/003—Steerable
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
- A61N1/00—Electrotherapy; Circuits therefor
- A61N1/02—Details
- A61N1/04—Electrodes
- A61N1/05—Electrodes for implantation or insertion into the body, e.g. heart electrode
- A61N1/056—Transvascular endocardial electrode systems
- A61N2001/0585—Coronary sinus electrodes
Definitions
- This invention relates generally to medical devices and methods for locating the coronary sinus of a heart and preferably placing an electrical lead for use with an implantable pulse generator.
- Implantable electrical pulse generators are commonly used to treat such disorders.
- Modern implantable pulse generators include an hermetically sealed housing containing control electronics and a battery, and have standard connectors to which implantable electrical leads can be connected.
- Such leads include insulated conductors and one or more exposed electrodes near the distal end of the lead for electrically connecting the pulse generator to one or more chambers of the heart.
- Sensing electrodes sense the electrical activity of the heart so that electrical markers of the electrocardiogram such as the P-wave or R-wave can be detected.
- Stimulating electrodes conduct pulses of electrical energy from the pulse generator to excitable cardiac tissue. Often both types of electrodes are employed, with the nature and timing of the stimulation pulses being related to the sensed electrical activity. Selected placement of the leads and electrodes permits delivery of therapeutic electrical pulses appropriate to the disorder to be treated.
- Lead systems for use with modern implantable pulse generators can include single lead systems and multiple lead systems, with single or dual chamber sensing or therapy. Some systems provide four-chamber sensing and therapy. Examples of such systems can be found in Dual Chamber Cardiac Pacing from a Single Electrode, U.S. Pat. No. 5,265,601; Bi-atrial and/or Bi-ventricular Sequential Cardiac Pacing Systems, U.S. Pat. No. 5,902,324; Bi-ventricular Pacing Method, U.S. Pat. No. 6,223,079; and Multiple Channel Sequential Cardiac Pacing Method, U.S. Pat. No. 6,122,545, all incorporated by reference.
- leads and electrodes can be applied directly to the epicardium via thoracotomy, it is generally preferred to insert the leads endovascularly into a chamber of the heart, when possible.
- the lead In most single lead systems, the lead is passed through the superior vena cava, right atrium and tricuspid valve, and into the right ventricle. The electrode is fixed within the right ventricle usually at the apex position.
- one lead In many multiple lead systems and some single lead systems, one lead is passed through the superior vena cava, right atrium and coronary sinus, generally with the aid of fluoroscopy, and fixed within the great vein or a deep coronary vein to locate the electrode in proximity to the left atrium or left ventricle.
- Implantable pulse generators may be particularly useful for treating congestive heart failure (“CHF”) manifested by conduction defects or other cardiomyopathies.
- CHF congestive heart failure
- the electrical conduction system of the heart sends signals to the chambers of the heart that cause them to contract in a precise pattern to pump blood throughout the circulatory system.
- the electrical conduction system is often impaired and fails to coordinate the contractions of the heart's chambers.
- the left and right ventricles no longer contract in the usual synchronized manner. This can reduce cardiac output, leading to symptoms such as shortness of breath, fatigue, and swelling of the feet and ankles.
- bi-ventricular pacing also known as cardiac re-synchronization.
- cardiac re-synchronization By sensing and pacing the left and right ventricles separately, the desired timing of the contractions of the ventricles can be obtained. This will result in an increase in cardiac output.
- Bi-ventricular pacing involves placement of right and left ventricular pacing leads.
- the procedure for placing a pacing lead within a right ventricle is well known and has been effectively practiced for decades.
- a lead passing through the left atrium and mitral valve into the left ventricle could interfere with complete closure of the valve, thereby impairing the performance of the left ventricle in pumping oxygenated blood throughout the body.
- pacing leads may be a site of clot formation. Such clots, if dislodged, may cause serious problems in the arterial circulation system, e.g., stroke.
- Pacing of the left ventricle can be achieved by placing a lead into a branch of the coronary sinus that overlies the left ventricle. As noted above, placing a left ventricular pacing lead into the coronary sinus can be extremely difficult even when performed by the most experienced electrophysiologists.
- Preformed catheters have been used to permit access to the coronary sinus via the superior vena cava and right atrium.
- the use of such preformed catheters is complicated in patients with CHF and dilated cardiomyopathy because the location of the coronary sinus is quite variable.
- cannulation of the coronary sinus was attempted by experienced and expert electrophysiologists who cannulate the coronary sinus daily for arrhythmia testing. Despite their experience and expertise, the coronary sinus was successfully accessed only 85 percent of the time.
- bi-ventricular pacing is to become a widely used treatment for congestive heart failure, then reliable and easy access to the coronary sinus must be provided. There are insufficient numbers of experienced electrophysiologists to accommodate the demand for this therapy.
- the present invention permits cardiologists and others without daily experience accessing the coronary sinus to do so reliably. Other medical procedures that require endovascular access to the coronary sinus likewise will be facilitated by the present invention. An example of such a procedure is electrophysiologic testing when the coronary sinus is difficult to locate or cannulate.
- the present invention relates to the medical procedure of accessing the orifice of the coronary sinus for the purpose of placing a medical device adjacent to or through the orifice.
- a medical device is a permanent left ventricular pacing lead.
- Other medical devices include temporary sensing or pacing catheters for electrophysiologic testing.
- the present invention involves locating the orifice of the coronary sinus by sensing characteristics of blood emerging from the coronary sinus into the right atrium.
- One characteristic that is especially correlated with blood from the coronary sinus is oxygen content.
- the percent oxygen saturation in the coronary sinus is among the lowest in the human body.
- Other characteristics correlated with blood from the coronary sinus are lower pH and higher CO 2 concentration.
- the medical device can be introduced into the coronary sinus or used to establish a pathway for guiding another device into the coronary sinus.
- One such medical device is a left ventricular pacing lead.
- the present invention also permits determination of oxygen saturations in other vascular structures. This may be particularly important in patients with congenital heart disease as well as in patients in whom specific organ venous and arterial oxygen saturations are needed to guide medical therapy.
- a steerable oximetric catheter includes an elongate cannula having a proximal end and a distal end.
- a blood oxygen sensor is connected to the cannula and is disposed to sense percent oxygen saturation of blood at the distal end of the cannula.
- the blood oxygen sensor generates a signal indicative of percent oxygen saturation.
- An oximetry display is responsive to the signal and is capable of displaying sensed percent oxygen saturation in a form understandable by an operator.
- a steering mechanism is operably connected to the cannula and selectively operable by an operator to deflect the distal end of the cannula toward a region of relatively low percent oxygen saturation.
- a pacing lead can be inserted through the cannula to be fixed proximate to the coronary sinus or inserted into and fixed into the great vein or a coronary vein extending from the coronary sinus.
- the steerable catheter then can be removed.
- a hollow sheath can be advanced over the steerable catheter and held at the coronary sinus.
- the steerable catheter then can be removed and the pacing lead can be inserted through the hollow sheath to have its distal end fixed in the coronary sinus or a coronary vein extending from it.
- the hollow sheath then can be removed.
- the present invention also includes a kit comprising a steerable oximetric catheter and a sheath used to locate the pacing lead.
- FIG. 1 is a partially cut-away view of a human heart in which a prior art pacing lead is implanted.
- the lead extends through the superior vena cava, right atrium, coronary sinus and a left coronary vein;
- FIG. 2 is a plan view of an embodiment of a steerable, oximetric catheter of the present invention
- FIG. 3 is an enlarged view of a portion of the embodiment of FIG. 2, shown cut-away;
- FIG. 4 is an enlarged cross-sectional view of the embodiment of FIG. 2;
- FIG. 5 is a plan view of another embodiment of a steerable, oximetric catheter of the present invention.
- FIG. 6 is an enlarged plan view of a portion of the embodiment of FIG. 5;
- FIG. 7 is a cut-away view of a human heart, showing placement of the steerable oximetric catheters of FIGS. 2 - 6 ;
- FIG. 8 is a cross-sectional view of the catheter of FIGS. 5 and 6;
- FIG. 9 is a cross-sectional view of an alternative embodiment of a steerable, oximetric catheter
- FIG. 10 is a cross-sectional view of yet another alternative embodiment of a steerable, oximetric catheter.
- FIG. 11 is a plan view of a kit for performing the placement of an endovascular lead.
- FIG. 1 shows a human heart H, partially cut away, in which an electrical pacing lead L is implanted.
- lead L has been placed endovascularly through the superior vena cava SVC and right atrium RA, and through the orifice of the coronary sinus OCS into the coronary sinus CS and into a left ventricular venous branch thereof.
- Pacing lead L includes at least one electrically insulated conductor extending lengthwise therethrough and at least one electrode E.
- Connector C at the proximal end of lead L is electrically connected via the insulated conductor to electrode E.
- a pulse generator P usually implanted in a subcutaneous pocket in the chest wall of the patient, is connected to lead L via connector C.
- an electrical pulse can be delivered from pulse generator P via lead L and electrode E to stimulate contraction of the left ventricle.
- This lead arrangement is particularly suitable for pacing, cardioversion, or defibrillation of the left ventricle.
- this lead arrangement can be used for sensing electrical activity in the vicinity of the left atrium or left ventricle, or for stimulating the left atrium.
- this lead arrangement can be used to effect bi-ventricular pacing for the treatment of congestive heart failure, as well as other medical conditions.
- a lead or other elongate medical device such as a catheter or cannula through the superior vena cava and right atrium into the orifice of the coronary sinus can be quite difficult, even with the use of fluoroscopy to monitor the location of the distal end of the medical device.
- the angles that the cannula must traverse are difficult to negotiate, even if the location of the orifice of the coronary sinus is generally known.
- the orifice of the coronary sinus can be more difficult to locate.
- FIGS. 2, 3 and 4 show one embodiment of a steerable oximetric catheter 10 that can be used to practice the present invention.
- Catheter 10 includes a steerable cannula 20 , including a blood-contacting sheath 21 that is fabricated from biocompatible polymers with low thrombogenicity. Radiopaque markers 22 may be placed along the length of the cannula 20 for fluoroscopic detection.
- a steering mechanism including a steerable guide 24 , and a blood characteristic sensor such as a fiber optic oxygen sensor assembly 28 .
- the steerable guide 24 and fiber optic oxygen sensor assembly 28 preferably run the entire length of cannula 20 to the distal end 32 and also extend from the proximal end 26 of cannula 20 .
- the fiber optic oxygen sensor assembly 28 could be replaced by another sensor appropriate to other blood characteristics that are correlated with the blood of the coronary sinus, such as pH or CO 2 content.
- Steerable guide 24 preferably includes an outer tube 25 and an internal wire 27 that runs from the distal end 32 to steering control module 30 .
- Finger grips 34 and thumb grip 36 of control module 30 are reciprocably movable relative to each other along the axis of steerable guide 24 .
- Thumb grip 36 is affixed to the outer tube 25 of guide 24 and finger grips 34 are affixed to the proximal end of the internal wire 27 .
- the distal end of the internal wire 27 is affixed to the distal end of the outer tube 25 of steerable guide 24 in an axially offset manner as is known in the art.
- the outer tube 25 can be eliminated and the internal wire 27 instead affixed directly to the sheath 21 of cannula 20 , in which case the thumb grip 36 could be affixed to sheath 21 with finger grips 34 being affixed to wire 27 .
- the internal wire 27 is placed in tension, thereby deflecting the distal end of steering guide 24 , and hence sheath 21 and cannula 20 , to one side.
- the distal end of catheter 10 can be steered anywhere within a 360 degree range.
- Other steering mechanisms as known in the art can also be used.
- the preferred blood characteristic sensor uses fiber optics to sense oxygen content, but alternatively, pH or CO 2 sensors can be used.
- the preferred fiber optic assembly 28 includes a pair of optical fibers 29 and 31 encased in a tube 33 . These fibers run the entire length of assembly 28 and are connected at their proximal end to a photodetector optical module 38 . The distal ends of the optical fibers are exposed at the distal end of assembly 28 , and hence at the distal end 32 of cannula 20 .
- the tube 33 can be eliminated and the optical fibers 29 and 31 can be carried inside sheath 21 , or the steering guide 25 , or on the outside of the cannula 20 .
- Optical module 38 includes a light source in optical communication with the proximal end of one of the optical fibers 29 , 31 , and a photodetector in optical communication with the proximal end of the other of the optical fibers 29 , 31 .
- Light from the light source travels the length of the one optical fiber and exits at the distal end thereof, thereby illuminating the blood in the vicinity of the distal end 32 of the catheter 10 .
- Light is reflected from the blood into the exposed distal end of the other optical fiber and is carried the length of that optical fiber to the photodetector in optical module 38 .
- the color of the blood is a function of the percentage of oxygen saturation of the blood. Consequently, the color of the light absorbed by the blood, and hence the color of the light reflected back to the optical module 38 , is also a function of oxygen content of the blood.
- the photodetector in optical module 38 is differentially responsive to different wavelengths of light, and generates an electrical signal indicative of the wavelength of the reflected light received via the optical fiber.
- the generated signal can be conveyed via suitable conductors 39 to a processor and display module 41 that can process the signal and display the percentage oxygen saturation in a form that is directly readable by a human, such as a digital display.
- the signal could be conveyed to a computing device for further manipulation prior to being displayed in human-readable form.
- a computing device for further manipulation prior to being displayed in human-readable form.
- One example of such a system is Optical Oximeter Apparatus and Method, U.S. Pat. No. 3,847,483, incorporated by reference.
- Steerable oximetric catheter 10 which combines an oxygen sensing optical fiber assembly 28 with a wire-steerable guide 24 in a common cannula 20 , is useful for locating the coronary sinus in accordance with the method of the present invention.
- the oxygen content of blood in the coronary sinus is known to be among the lowest in the human body. This phenomenon is exploited by the steerable oximetric catheter 10 to facilitate locating the coronary sinus.
- the operator can know whether the distal end of the catheter is either on or deviating from a path approaching the coronary sinus.
- the operator knows that the distal end of the catheter is getting closer to the coronary sinus. If the oxygen saturation begins to rise as the catheter is advanced, then the operator knows that the catheter is off course and he can correct the course using the steerability feature of the catheter. In effect, the operator is seeking to detect the low oxygen blood that exits from the coronary sinus into the right atrium. With an iterative procedure, the operator can make use of the percentage oxygen saturation being sensed in real time to guide and adjust his steering of the catheter to find the coronary sinus.
- FIGS. 5 and 6 show an alternative embodiment of a steerable oximetric catheter 110 that is substantially similar to the embodiment of FIGS. 2, 3 and 4 , except that the steering control module 130 is somewhat different.
- Components that correspond in structure and function to the components described above with respect to the embodiment of FIG. 1 are indicated by similar reference numbers in the 100 series having the last two digits in common. The description above may be referred to for an understanding of the corresponding components of the embodiment of FIGS. 5 and 6.
- Steering control module 130 rather than having members that reciprocate axially relative to one another, has grip members that rotate relative to one another.
- Grip portion 140 which loosely corresponds to finger grip portion 34 , is held in the operator's hand, while steering member 142 is gripped and rotated relative to grip portion 140 .
- Steering member 142 is connected to the internal steering wire, whereas grip portion 140 is connected to the outer cannula of the steering guide 124 .
- Rotation of member 142 relative to portion 140 places the steering wire in tension, effecting deflection of the distal end 132 of cannula 120 .
- a locking lever 144 locks the steering member 142 in a selected position to maintain a selected deflection of the distal end 132 of cannula 120 .
- Steering control module 130 is shown enlarged in FIG. 6 for clarity.
- a hollow, flexible, peel-away sheath 43 can be placed over the cannula 20 of catheter 10 , for example, and slid to a position near proximal end 26 .
- Cannula 20 with the peel-away sheath in place, can be introduced endovascularly under fluoroscopy through the superior vena cava 50 and into the right atrium 52 .
- the coronary sinus 54 is located and the distal end of cannula 20 is steered into coronary sinus 54 .
- the hollow, flexible peel-away sheath 43 can be slid distally over the cannula 20 toward distal end 32 , guided into the coronary sinus 54 , and held there.
- the steerable catheter 10 then can be withdrawn and removed, leaving the sheath 43 in place.
- a ventricular pacing lead can be advanced through the sheath 43 into the coronary sinus and placed into one of the coronary veins 56 associated with the left ventricle 58 .
- the sheath 43 then can be withdrawn and peeled away from the lead.
- the cannula 220 can be hollow defining a lumen 262 along its length as shown in cross section in FIG. 8. After the coronary sinus is located, the pacing lead is introduced through the lumen 262 and into one of the coronary veins 56 .
- This system has the advantage of eliminating the use of the sheath, but does require that the cannula be large enough to carry the pacing lead.
- the cannula 320 can be hollow defining a lumen 362 along its length, similarly to the cannula 220 of FIG. 8, but not including an embedded steering mechanism, as shown in FIG. 9.
- a steering mechanism such as the steerable guide 24 of FIGS. 2, 3 and 4 could be inserted within the lumen 362 and used to steer the cannula 320 .
- the steering mechanism could be withdrawn from lumen 362 , leaving lumen 362 open.
- the pacing lead could then be introduced through open lumen 362 and into the coronary sinus and great vein.
- the cannula 420 can include a steering mechanism 427 , optical fibers 429 and 431 , and a pacing lead 464 embedded or otherwise disposed therein, as shown in FIG. 10.
- the cannula 420 and lead 464 can be advanced as a unit into the coronary sinus and great vein.
- the proximal end of the cannula 420 can be cut off, or otherwise separated from the bulky steering controls and optical module.
- the pacing lead 464 including cannula 420 , steering wire 427 and optical fibers 429 and 431 can be left permanently implanted as a unit.
- a guidewire could be used to guide a hollow lead into the coronary sinus, with the lead riding over the guidewire instead of riding inside a sheath.
- the patient is placed upon a fluoroscopy table in a cardiac catheterization laboratory or in an operating room.
- a typical pacemaker incision below the clavicle the subclavian vein or cephalic vein is accessed and cannulated with a hollow, flexible tube.
- the steerable, oximetric catheter 10 is placed through the hollow, flexible tube and into the superior vena cava, then advanced into the right atrium.
- the distal end of the oximetric assembly 28 is then connected to the optical module 38 , which is connected to its associated processor and display 41 .
- a right atrial baseline oxygen saturation is obtained.
- Fluoroscopic evaluation of the end 32 of catheter 10 will permit the operator to estimate the approximate region in which the coronary sinus is located.
- the steerable, oximetric catheter 10 may then be advanced under fluoroscopy while percentage oxygen saturation is monitored. Any changes in oxygen saturation are noted. As the catheter 10 nears the coronary sinus orifice, the sensed oxygen saturation will drop. Using the steerable feature of the catheter, the site of the lowest oxygen saturation can be sought. The operator can continue to advance the steerable, oximetric catheter 10 under fluoroscopy and oximetric guidance into and through the coronary sinus orifice and into the coronary sinus. By monitoring the percentage oxygen saturation as the catheter is advanced, the operator may place the catheter 10 into the coronary sinus despite difficult angulations related to unusual physiology of the patient. Such difficulties could not be so easily overcome with fluoroscopic guidance alone.
- a steerable, oximetric catheter was successfully placed into the coronary sinus of a pig. Conventional general endotracheal anesthesia was employed. The pig was placed in the decubitus position with the left side down. A right internal jugular cutdown was performed to access the central venous system.
- a prototype steerable oximetric catheter was created by attaching an Edwards central venous line with oximetry capability to a Blazer II model steerable catheter from EP Technologies. An in-vitro calibration of the oximetry probe was performed successfully. The prototype catheter was then introduced through the jugular vein into the superior vena cava and right atrium.
- the prototype catheter Under fluoroscopy, the prototype catheter was placed into the coronary sinus using oximetric guidance. When the prototype catheter was placed in the coronary sinus, the percentage oxygen saturation dropped from the sixty percent range to the mid-thirty percent range. After verifying placement, the prototype was withdrawn into the right atrium. Again, under fluoroscopy, the prototype catheter was steered into the coronary sinus under oximetric guidance. Following successful coronary sinus cannulation, the prototype catheter was withdrawn and the pig euthenized.
- the present invention in one embodiment includes a kit for performing the placement of a pacing lead.
- the kit includes a steerable oximetric catheter 310 and a sheath 270 in a sterile container 272 .
- the kit can also include one or more of the following: catheter, sheath, syringe, large needle, dilator or a floppy wire, e.g., having a diameter of about 0.018 inches.
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Physics & Mathematics (AREA)
- Heart & Thoracic Surgery (AREA)
- General Health & Medical Sciences (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Medical Informatics (AREA)
- Surgery (AREA)
- Molecular Biology (AREA)
- Pathology (AREA)
- Biophysics (AREA)
- Optics & Photonics (AREA)
- Spectroscopy & Molecular Physics (AREA)
- Cardiology (AREA)
- Vascular Medicine (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Radiology & Medical Imaging (AREA)
- Electrotherapy Devices (AREA)
- Measurement Of The Respiration, Hearing Ability, Form, And Blood Characteristics Of Living Organisms (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
A steerable catheter includes an elongate cannula having a proximal end and a distal end. A blood characteristic sensor, such as an oxygen sensor, is connected to the cannula and disposed to sense percent oxygen saturation of blood at the distal end of the cannula. The blood oxygen sensor generates a signal indicative of percent oxygen saturation. An oximetry display is responsive to the signal and capable of displaying sensed percent oxygen saturation in a form understandable by an operator. A steering mechanism is operably connected to the cannula and is selectively operable by an operator to deflect the distal end of the cannula. A method of locating the coronary sinus of a heart involves endovascularly introducing a catheter into the right atrium, sensing percent oxygen saturation at the distal end of the catheter, and steering the catheter toward a region of lowest percent oxygen saturation.
Description
- This application is a divisional of co-pending U.S. Ser. No. 10/044,587 filed on Oct. 23, 2001.
- This invention relates generally to medical devices and methods for locating the coronary sinus of a heart and preferably placing an electrical lead for use with an implantable pulse generator.
- Many cardiac disorders, such as bradycardia, tachycardia and ventricular fibrillation, for example, involve abnormalities of cardiac rhythm or rate. Implantable electrical pulse generators are commonly used to treat such disorders. Modern implantable pulse generators include an hermetically sealed housing containing control electronics and a battery, and have standard connectors to which implantable electrical leads can be connected. Such leads include insulated conductors and one or more exposed electrodes near the distal end of the lead for electrically connecting the pulse generator to one or more chambers of the heart. Sensing electrodes sense the electrical activity of the heart so that electrical markers of the electrocardiogram such as the P-wave or R-wave can be detected. Stimulating electrodes conduct pulses of electrical energy from the pulse generator to excitable cardiac tissue. Often both types of electrodes are employed, with the nature and timing of the stimulation pulses being related to the sensed electrical activity. Selected placement of the leads and electrodes permits delivery of therapeutic electrical pulses appropriate to the disorder to be treated.
- Lead systems for use with modern implantable pulse generators can include single lead systems and multiple lead systems, with single or dual chamber sensing or therapy. Some systems provide four-chamber sensing and therapy. Examples of such systems can be found in Dual Chamber Cardiac Pacing from a Single Electrode, U.S. Pat. No. 5,265,601; Bi-atrial and/or Bi-ventricular Sequential Cardiac Pacing Systems, U.S. Pat. No. 5,902,324; Bi-ventricular Pacing Method, U.S. Pat. No. 6,223,079; and Multiple Channel Sequential Cardiac Pacing Method, U.S. Pat. No. 6,122,545, all incorporated by reference.
- Although leads and electrodes can be applied directly to the epicardium via thoracotomy, it is generally preferred to insert the leads endovascularly into a chamber of the heart, when possible. In most single lead systems, the lead is passed through the superior vena cava, right atrium and tricuspid valve, and into the right ventricle. The electrode is fixed within the right ventricle usually at the apex position. In many multiple lead systems and some single lead systems, one lead is passed through the superior vena cava, right atrium and coronary sinus, generally with the aid of fluoroscopy, and fixed within the great vein or a deep coronary vein to locate the electrode in proximity to the left atrium or left ventricle.
- Determining the location of the coronary sinus and placing a lead therein can be difficult. The lead must traverse an angle to enter the orifice of the coronary sinus in the wall of the right atrium. The difficulty of locating the coronary sinus and placing a lead therein is especially great in patients with congestive heart failure and dilated cardiomyopathy. In such patients, the heart is enlarged and the location of the coronary sinus can vary significantly from the location in a heart with normal anatomy. Nevertheless, the ongoing need to place endovascular cardiac leads in patients with an unusually disposed coronary sinus is expected to increase. This is because of the emerging use of implantable pulse generators to treat congestive heart failure.
- Implantable pulse generators may be particularly useful for treating congestive heart failure (“CHF”) manifested by conduction defects or other cardiomyopathies. In a healthy person, the electrical conduction system of the heart sends signals to the chambers of the heart that cause them to contract in a precise pattern to pump blood throughout the circulatory system. In people with congestive heart failure, however, the electrical conduction system is often impaired and fails to coordinate the contractions of the heart's chambers. In many patients with CHF, the left and right ventricles no longer contract in the usual synchronized manner. This can reduce cardiac output, leading to symptoms such as shortness of breath, fatigue, and swelling of the feet and ankles.
- A promising therapy for treating congestive heart failure through the use of implantable pulse generators is bi-ventricular pacing, also known as cardiac re-synchronization. By sensing and pacing the left and right ventricles separately, the desired timing of the contractions of the ventricles can be obtained. This will result in an increase in cardiac output.
- Bi-ventricular pacing involves placement of right and left ventricular pacing leads. The procedure for placing a pacing lead within a right ventricle is well known and has been effectively practiced for decades. In contrast, it is not desirable to place a pacing lead within the left ventricle. A lead passing through the left atrium and mitral valve into the left ventricle could interfere with complete closure of the valve, thereby impairing the performance of the left ventricle in pumping oxygenated blood throughout the body. Also, pacing leads may be a site of clot formation. Such clots, if dislodged, may cause serious problems in the arterial circulation system, e.g., stroke. Pacing of the left ventricle can be achieved by placing a lead into a branch of the coronary sinus that overlies the left ventricle. As noted above, placing a left ventricular pacing lead into the coronary sinus can be extremely difficult even when performed by the most experienced electrophysiologists.
- Preformed catheters have been used to permit access to the coronary sinus via the superior vena cava and right atrium. The use of such preformed catheters is complicated in patients with CHF and dilated cardiomyopathy because the location of the coronary sinus is quite variable. In recent clinical trials of bi-ventricular pacing, cannulation of the coronary sinus was attempted by experienced and expert electrophysiologists who cannulate the coronary sinus daily for arrhythmia testing. Despite their experience and expertise, the coronary sinus was successfully accessed only 85 percent of the time.
- If bi-ventricular pacing is to become a widely used treatment for congestive heart failure, then reliable and easy access to the coronary sinus must be provided. There are insufficient numbers of experienced electrophysiologists to accommodate the demand for this therapy. The present invention permits cardiologists and others without daily experience accessing the coronary sinus to do so reliably. Other medical procedures that require endovascular access to the coronary sinus likewise will be facilitated by the present invention. An example of such a procedure is electrophysiologic testing when the coronary sinus is difficult to locate or cannulate.
- The present invention relates to the medical procedure of accessing the orifice of the coronary sinus for the purpose of placing a medical device adjacent to or through the orifice. One such medical device is a permanent left ventricular pacing lead. Other medical devices include temporary sensing or pacing catheters for electrophysiologic testing.
- According to one aspect, the present invention involves locating the orifice of the coronary sinus by sensing characteristics of blood emerging from the coronary sinus into the right atrium. One characteristic that is especially correlated with blood from the coronary sinus is oxygen content. The percent oxygen saturation in the coronary sinus is among the lowest in the human body. Other characteristics correlated with blood from the coronary sinus are lower pH and higher CO2 concentration. By sensing the oxygen concentration, pH, CO2 or other characteristic at the distal end of a medical device placed within the right atrium, and by steering the distal end of the medical device toward a region of lower oxygen concentration, lower pH or higher CO2 concentration, for example, the location of the orifice of the coronary sinus can be determined. Once the orifice of the coronary sinus is located, the medical device can be introduced into the coronary sinus or used to establish a pathway for guiding another device into the coronary sinus. One such medical device is a left ventricular pacing lead.
- The present invention also permits determination of oxygen saturations in other vascular structures. This may be particularly important in patients with congenital heart disease as well as in patients in whom specific organ venous and arterial oxygen saturations are needed to guide medical therapy.
- According to another aspect of the invention, a steerable oximetric catheter includes an elongate cannula having a proximal end and a distal end. A blood oxygen sensor is connected to the cannula and is disposed to sense percent oxygen saturation of blood at the distal end of the cannula. The blood oxygen sensor generates a signal indicative of percent oxygen saturation. An oximetry display is responsive to the signal and is capable of displaying sensed percent oxygen saturation in a form understandable by an operator. A steering mechanism is operably connected to the cannula and selectively operable by an operator to deflect the distal end of the cannula toward a region of relatively low percent oxygen saturation.
- Once the coronary sinus is located, a pacing lead can be inserted through the cannula to be fixed proximate to the coronary sinus or inserted into and fixed into the great vein or a coronary vein extending from the coronary sinus. The steerable catheter then can be removed. Alternatively, once the coronary sinus is located, a hollow sheath can be advanced over the steerable catheter and held at the coronary sinus. The steerable catheter then can be removed and the pacing lead can be inserted through the hollow sheath to have its distal end fixed in the coronary sinus or a coronary vein extending from it. The hollow sheath then can be removed.
- The present invention also includes a kit comprising a steerable oximetric catheter and a sheath used to locate the pacing lead.
- Further aspects and advantages of the present invention are apparent from the following description of preferred embodiments and methods, made with reference to the drawings.
- In the drawings,
- FIG. 1 is a partially cut-away view of a human heart in which a prior art pacing lead is implanted. The lead extends through the superior vena cava, right atrium, coronary sinus and a left coronary vein;
- FIG. 2 is a plan view of an embodiment of a steerable, oximetric catheter of the present invention;
- FIG. 3 is an enlarged view of a portion of the embodiment of FIG. 2, shown cut-away;
- FIG. 4 is an enlarged cross-sectional view of the embodiment of FIG. 2;
- FIG. 5 is a plan view of another embodiment of a steerable, oximetric catheter of the present invention;
- FIG. 6 is an enlarged plan view of a portion of the embodiment of FIG. 5;
- FIG. 7 is a cut-away view of a human heart, showing placement of the steerable oximetric catheters of FIGS.2-6;
- FIG. 8 is a cross-sectional view of the catheter of FIGS. 5 and 6;
- FIG. 9 is a cross-sectional view of an alternative embodiment of a steerable, oximetric catheter;
- FIG. 10 is a cross-sectional view of yet another alternative embodiment of a steerable, oximetric catheter; and
- FIG. 11 is a plan view of a kit for performing the placement of an endovascular lead.
- FIG. 1 shows a human heart H, partially cut away, in which an electrical pacing lead L is implanted. In accordance with the prior art, lead L has been placed endovascularly through the superior vena cava SVC and right atrium RA, and through the orifice of the coronary sinus OCS into the coronary sinus CS and into a left ventricular venous branch thereof. Pacing lead L includes at least one electrically insulated conductor extending lengthwise therethrough and at least one electrode E. Connector C at the proximal end of lead L is electrically connected via the insulated conductor to electrode E. A pulse generator P, usually implanted in a subcutaneous pocket in the chest wall of the patient, is connected to lead L via connector C. Because the left ventricular branches of the coronary sinus overly and are in physical proximity to the left ventricle LV, an electrical pulse can be delivered from pulse generator P via lead L and electrode E to stimulate contraction of the left ventricle. This lead arrangement is particularly suitable for pacing, cardioversion, or defibrillation of the left ventricle. Alternatively, with appropriate electrode placement, this lead arrangement can be used for sensing electrical activity in the vicinity of the left atrium or left ventricle, or for stimulating the left atrium. In combination with a second lead (not shown) disposed in the right ventricle RV, this lead arrangement can be used to effect bi-ventricular pacing for the treatment of congestive heart failure, as well as other medical conditions.
- Placing a lead or other elongate medical device such as a catheter or cannula through the superior vena cava and right atrium into the orifice of the coronary sinus can be quite difficult, even with the use of fluoroscopy to monitor the location of the distal end of the medical device. The angles that the cannula must traverse are difficult to negotiate, even if the location of the orifice of the coronary sinus is generally known. In patients with distorted cardiac anatomy, such as that associated with congestive heart failure, the orifice of the coronary sinus can be more difficult to locate. An improved device and method for facilitating locating the coronary sinus is provided by the present invention, preferred embodiments of which are described below.
- FIGS. 2, 3 and4 show one embodiment of a steerable
oximetric catheter 10 that can be used to practice the present invention.Catheter 10 includes asteerable cannula 20, including a blood-contactingsheath 21 that is fabricated from biocompatible polymers with low thrombogenicity.Radiopaque markers 22 may be placed along the length of thecannula 20 for fluoroscopic detection. Preferably encased within thesheath 21 ofcannula 20 is a steering mechanism including asteerable guide 24, and a blood characteristic sensor such as a fiber opticoxygen sensor assembly 28. Thesteerable guide 24 and fiber opticoxygen sensor assembly 28 preferably run the entire length ofcannula 20 to thedistal end 32 and also extend from theproximal end 26 ofcannula 20. The fiber opticoxygen sensor assembly 28 could be replaced by another sensor appropriate to other blood characteristics that are correlated with the blood of the coronary sinus, such as pH or CO2 content. -
Steerable guide 24 preferably includes anouter tube 25 and aninternal wire 27 that runs from thedistal end 32 tosteering control module 30. Finger grips 34 andthumb grip 36 ofcontrol module 30 are reciprocably movable relative to each other along the axis ofsteerable guide 24.Thumb grip 36 is affixed to theouter tube 25 ofguide 24 and finger grips 34 are affixed to the proximal end of theinternal wire 27. The distal end of theinternal wire 27 is affixed to the distal end of theouter tube 25 ofsteerable guide 24 in an axially offset manner as is known in the art. Alternatively, theouter tube 25 can be eliminated and theinternal wire 27 instead affixed directly to thesheath 21 ofcannula 20, in which case thethumb grip 36 could be affixed tosheath 21 with finger grips 34 being affixed towire 27. By pulling finger grips 34 towardthumb grip 36, theinternal wire 27 is placed in tension, thereby deflecting the distal end of steeringguide 24, and hencesheath 21 andcannula 20, to one side. Through a combination of deflecting the distal end ofcannula 20 viagrips entire catheter 10 about its longitudinal axis, likewise viagrips catheter 10 can be steered anywhere within a 360 degree range. Other steering mechanisms as known in the art can also be used. - The preferred blood characteristic sensor uses fiber optics to sense oxygen content, but alternatively, pH or CO2 sensors can be used. The preferred
fiber optic assembly 28 includes a pair ofoptical fibers tube 33. These fibers run the entire length ofassembly 28 and are connected at their proximal end to a photodetectoroptical module 38. The distal ends of the optical fibers are exposed at the distal end ofassembly 28, and hence at thedistal end 32 ofcannula 20. Alternatively, thetube 33 can be eliminated and theoptical fibers sheath 21, or thesteering guide 25, or on the outside of thecannula 20.Optical module 38 includes a light source in optical communication with the proximal end of one of theoptical fibers optical fibers distal end 32 of thecatheter 10. Light is reflected from the blood into the exposed distal end of the other optical fiber and is carried the length of that optical fiber to the photodetector inoptical module 38. - According to a well known phenomenon, the color of the blood is a function of the percentage of oxygen saturation of the blood. Consequently, the color of the light absorbed by the blood, and hence the color of the light reflected back to the
optical module 38, is also a function of oxygen content of the blood. The photodetector inoptical module 38 is differentially responsive to different wavelengths of light, and generates an electrical signal indicative of the wavelength of the reflected light received via the optical fiber. The generated signal can be conveyed viasuitable conductors 39 to a processor anddisplay module 41 that can process the signal and display the percentage oxygen saturation in a form that is directly readable by a human, such as a digital display. Alternatively, the signal could be conveyed to a computing device for further manipulation prior to being displayed in human-readable form. One example of such a system is Optical Oximeter Apparatus and Method, U.S. Pat. No. 3,847,483, incorporated by reference. -
Steerable oximetric catheter 10, which combines an oxygen sensingoptical fiber assembly 28 with a wire-steerable guide 24 in acommon cannula 20, is useful for locating the coronary sinus in accordance with the method of the present invention. The oxygen content of blood in the coronary sinus is known to be among the lowest in the human body. This phenomenon is exploited by the steerableoximetric catheter 10 to facilitate locating the coronary sinus. By monitoring the oxygen content or other characteristic of the blood in the vicinity of the distal end ofcatheter 10 in real time ascatheter 10 is advanced through the right atrium, the operator can know whether the distal end of the catheter is either on or deviating from a path approaching the coronary sinus. If the sensed percentage of oxygen saturation continues to drop ascatheter 10 is advanced, then the operator knows that the distal end of the catheter is getting closer to the coronary sinus. If the oxygen saturation begins to rise as the catheter is advanced, then the operator knows that the catheter is off course and he can correct the course using the steerability feature of the catheter. In effect, the operator is seeking to detect the low oxygen blood that exits from the coronary sinus into the right atrium. With an iterative procedure, the operator can make use of the percentage oxygen saturation being sensed in real time to guide and adjust his steering of the catheter to find the coronary sinus. - FIGS. 5 and 6 show an alternative embodiment of a steerable oximetric catheter110 that is substantially similar to the embodiment of FIGS. 2, 3 and 4, except that the
steering control module 130 is somewhat different. Components that correspond in structure and function to the components described above with respect to the embodiment of FIG. 1 are indicated by similar reference numbers in the 100 series having the last two digits in common. The description above may be referred to for an understanding of the corresponding components of the embodiment of FIGS. 5 and 6.Steering control module 130, rather than having members that reciprocate axially relative to one another, has grip members that rotate relative to one another.Grip portion 140, which loosely corresponds to fingergrip portion 34, is held in the operator's hand, while steeringmember 142 is gripped and rotated relative to gripportion 140.Steering member 142 is connected to the internal steering wire, whereasgrip portion 140 is connected to the outer cannula of thesteering guide 124. Rotation ofmember 142 relative toportion 140 places the steering wire in tension, effecting deflection of thedistal end 132 ofcannula 120. A lockinglever 144 locks the steeringmember 142 in a selected position to maintain a selected deflection of thedistal end 132 ofcannula 120.Steering control module 130 is shown enlarged in FIG. 6 for clarity. - With the above description of preferred embodiments of steerable oximetric catheters in mind, the preferred procedures for practicing the inventive method for locating the coronary sinus will be described with reference to FIG. 7. In brief summary, a hollow, flexible, peel-away sheath43 can be placed over the
cannula 20 ofcatheter 10, for example, and slid to a position nearproximal end 26.Cannula 20, with the peel-away sheath in place, can be introduced endovascularly under fluoroscopy through thesuperior vena cava 50 and into theright atrium 52. Using the steering mechanism in concert with the oximetry sensor ofcatheter 10, thecoronary sinus 54 is located and the distal end ofcannula 20 is steered intocoronary sinus 54. Once thesteerable catheter 10 is in thecoronary sinus 54, the hollow, flexible peel-away sheath 43 can be slid distally over thecannula 20 towarddistal end 32, guided into thecoronary sinus 54, and held there. Thesteerable catheter 10 then can be withdrawn and removed, leaving the sheath 43 in place. Subsequently, a ventricular pacing lead can be advanced through the sheath 43 into the coronary sinus and placed into one of thecoronary veins 56 associated with theleft ventricle 58. The sheath 43 then can be withdrawn and peeled away from the lead. - Instead of using a sheath, the
cannula 220 can be hollow defining alumen 262 along its length as shown in cross section in FIG. 8. After the coronary sinus is located, the pacing lead is introduced through thelumen 262 and into one of thecoronary veins 56. This system has the advantage of eliminating the use of the sheath, but does require that the cannula be large enough to carry the pacing lead. - Alternatively, the
cannula 320 can be hollow defining alumen 362 along its length, similarly to thecannula 220 of FIG. 8, but not including an embedded steering mechanism, as shown in FIG. 9. In use, a steering mechanism such as thesteerable guide 24 of FIGS. 2, 3 and 4 could be inserted within thelumen 362 and used to steer thecannula 320. After the coronary sinus is located, the steering mechanism could be withdrawn fromlumen 362, leavinglumen 362 open. The pacing lead could then be introduced throughopen lumen 362 and into the coronary sinus and great vein. - In yet another alternative arrangement, the
cannula 420 can include asteering mechanism 427,optical fibers pacing lead 464 embedded or otherwise disposed therein, as shown in FIG. 10. After the coronary sinus is located, thecannula 420 and lead 464 can be advanced as a unit into the coronary sinus and great vein. The proximal end of thecannula 420 can be cut off, or otherwise separated from the bulky steering controls and optical module. Thepacing lead 464, includingcannula 420, steeringwire 427 andoptical fibers - In lieu of a sheath, a guidewire could be used to guide a hollow lead into the coronary sinus, with the lead riding over the guidewire instead of riding inside a sheath.
- To place the steerable
oximetric catheter 10 into the coronary sinus, the patient is placed upon a fluoroscopy table in a cardiac catheterization laboratory or in an operating room. Through a typical pacemaker incision below the clavicle, the subclavian vein or cephalic vein is accessed and cannulated with a hollow, flexible tube. The steerable,oximetric catheter 10 is placed through the hollow, flexible tube and into the superior vena cava, then advanced into the right atrium. The distal end of theoximetric assembly 28 is then connected to theoptical module 38, which is connected to its associated processor anddisplay 41. A right atrial baseline oxygen saturation is obtained. - Fluoroscopic evaluation of the
end 32 ofcatheter 10 will permit the operator to estimate the approximate region in which the coronary sinus is located. The steerable,oximetric catheter 10 may then be advanced under fluoroscopy while percentage oxygen saturation is monitored. Any changes in oxygen saturation are noted. As thecatheter 10 nears the coronary sinus orifice, the sensed oxygen saturation will drop. Using the steerable feature of the catheter, the site of the lowest oxygen saturation can be sought. The operator can continue to advance the steerable,oximetric catheter 10 under fluoroscopy and oximetric guidance into and through the coronary sinus orifice and into the coronary sinus. By monitoring the percentage oxygen saturation as the catheter is advanced, the operator may place thecatheter 10 into the coronary sinus despite difficult angulations related to unusual physiology of the patient. Such difficulties could not be so easily overcome with fluoroscopic guidance alone. - The utility of the catheter and method of the present invention was demonstrated in an experiment involving an adult swine. A steerable, oximetric catheter was successfully placed into the coronary sinus of a pig. Conventional general endotracheal anesthesia was employed. The pig was placed in the decubitus position with the left side down. A right internal jugular cutdown was performed to access the central venous system. A prototype steerable oximetric catheter was created by attaching an Edwards central venous line with oximetry capability to a Blazer II model steerable catheter from EP Technologies. An in-vitro calibration of the oximetry probe was performed successfully. The prototype catheter was then introduced through the jugular vein into the superior vena cava and right atrium. Under fluoroscopy, the prototype catheter was placed into the coronary sinus using oximetric guidance. When the prototype catheter was placed in the coronary sinus, the percentage oxygen saturation dropped from the sixty percent range to the mid-thirty percent range. After verifying placement, the prototype was withdrawn into the right atrium. Again, under fluoroscopy, the prototype catheter was steered into the coronary sinus under oximetric guidance. Following successful coronary sinus cannulation, the prototype catheter was withdrawn and the pig euthenized.
- The present invention in one embodiment includes a kit for performing the placement of a pacing lead. As shown in FIG. 11, the kit includes a steerable
oximetric catheter 310 and asheath 270 in asterile container 272. The kit can also include one or more of the following: catheter, sheath, syringe, large needle, dilator or a floppy wire, e.g., having a diameter of about 0.018 inches. - Although the present invention has been described in detail in terms of preferred embodiments, no limitation on the scope of the invention is intended.
Claims (19)
1. A method of placing a pacing lead proximate to or through a coronary sinus of a heart, comprising the steps of:
introducing a catheter having a distal end into the right atrium of the heart; and
steering the catheter while concurrently monitoring at the distal end of the catheter a characteristic of blood indicative of blood in the coronary sinus to introduce the distal end of the catheter into the coronary sinus; and
introducing a pacing lead into the coronary sinus.
2. The method of claim 1 wherein the characteristic is oxygen concentration.
3. The method of claim 1 wherein the characteristic is pH.
4. The method of claim 1 wherein the pacing lead is fixed to the heart proximate to the coronary sinus.
5. The method of claim 1 wherein the catheter is introduced through the coronary sinus and into the great vein.
6. The method of claim 1 wherein the pacing lead is fixed in the great vein.
7. The method of claim 5 wherein the pacing lead is fixed in a coronary vein extending from the great vein.
8. The method of claim 1 wherein a hollow sheath is advanced over the catheter after the distal end of the catheter is introduced into the coronary sinus, the catheter is then removed and the pacing lead is introduced through the hollow sheath.
9. The method of claim 1 , wherein the catheter includes a hollow cannula and the pacing lead is introduced through the hollow cannula.
10. The method of claim 1 , wherein the catheter includes a hollow cannula and a steering guide disposed therein, the steering guide being withdrawn from the hollow cannula and replaced by a pacing lead after the distal end of the catheter is introduced into the coronary sinus.
11. A steerable oximetric catheter comprising:
an elongate cannula having a proximal end and a distal end; a blood oxygen sensor connected to the cannula and disposed to sense oxygen content of blood at the distal end of the cannula; and
a steering mechanism operably connected to the cannula and selectively operable by an operator to steer the distal end of the cannula.
12. The catheter of claim 11 , wherein the blood oxygen sensor includes at least one pair of optical fibers extending from the distal end to the proximal end of the elongate cannula.
13. The catheter of claim 12 , wherein the pair of optical fibers have distal ends optically exposed at the distal end of the elongate cannula.
14. The catheter of claim 11 , wherein the steering mechanism includes a wire extending from the distal end to the proximal end of the elongate cannula.
15. The catheter of claim 14 , wherein the wire is affixed to the elongate cannula proximate the distal end thereof.
16. The catheter of claim 15 , wherein the steering mechanism includes a steering control module affixed to the wire and manipulable by an operator.
17. The catheter of claim 11 wherein the cannula defines a passageway along its length.
18. A kit for placing a pacing lead in a patient comprising:
a) a steerable catheter having a blood characteristic sensor;
b) a sheath adapted to fit over the catheter; and
c) a container for holding the catheter and sheath in a sterile condition.
19. The kit of claim 18 , wherein the blood characteristic sensor is an oxygen sensor.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/446,266 US20030195577A1 (en) | 2001-10-23 | 2003-05-23 | Steerable catheter and method for locating coronary sinus |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US10/044,587 US6591144B2 (en) | 2001-10-23 | 2001-10-23 | Steerable catheter and method for locating coronary sinus |
US10/446,266 US20030195577A1 (en) | 2001-10-23 | 2003-05-23 | Steerable catheter and method for locating coronary sinus |
Related Parent Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US10/044,587 Division US6591144B2 (en) | 2001-10-23 | 2001-10-23 | Steerable catheter and method for locating coronary sinus |
Publications (1)
Publication Number | Publication Date |
---|---|
US20030195577A1 true US20030195577A1 (en) | 2003-10-16 |
Family
ID=21933183
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US10/044,587 Expired - Lifetime US6591144B2 (en) | 2001-10-23 | 2001-10-23 | Steerable catheter and method for locating coronary sinus |
US10/446,266 Abandoned US20030195577A1 (en) | 2001-10-23 | 2003-05-23 | Steerable catheter and method for locating coronary sinus |
Family Applications Before (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
US10/044,587 Expired - Lifetime US6591144B2 (en) | 2001-10-23 | 2001-10-23 | Steerable catheter and method for locating coronary sinus |
Country Status (6)
Country | Link |
---|---|
US (2) | US6591144B2 (en) |
EP (1) | EP1455889B1 (en) |
AT (1) | ATE511876T1 (en) |
AU (1) | AU2002360287A1 (en) |
CA (1) | CA2464649A1 (en) |
WO (1) | WO2003035139A2 (en) |
Cited By (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20050113719A1 (en) * | 2003-09-26 | 2005-05-26 | Vahid Saadat | Left atrial access apparatus and methods |
US20080077190A1 (en) * | 2006-09-21 | 2008-03-27 | Cardiac Pacemakers, Inc. | Implantable Medical Device Header With Optical Interface |
US20090156921A1 (en) * | 2007-12-18 | 2009-06-18 | Huisun Wang | Cardiac ablation catheter with oxygen saturation sensor |
US20090156916A1 (en) * | 2007-12-18 | 2009-06-18 | Huisun Wang | Catheter systems with blood measurement device and methods |
WO2017123764A1 (en) * | 2016-01-12 | 2017-07-20 | Bloodworks, Llc | Peripheral fiberoptic intravascular blood metric probe modular device and method |
Families Citing this family (28)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20050165324A1 (en) * | 2004-01-26 | 2005-07-28 | Rogier Receveur | System and method for using sensors to identify an anatomical position |
WO2005094938A2 (en) * | 2004-03-24 | 2005-10-13 | Windcrest Llc | Method for use of vascular guidewire |
US7615032B2 (en) * | 2004-03-24 | 2009-11-10 | Windcrest Llc | Vascular guidewire control apparatus |
US8070693B2 (en) | 2004-09-30 | 2011-12-06 | Cook Medical Technologies Llc | Articulating steerable wire guide |
US8147481B2 (en) * | 2005-03-24 | 2012-04-03 | The Cleveland Clinic Foundation | Vascular guidewire control apparatus |
US7962208B2 (en) | 2005-04-25 | 2011-06-14 | Cardiac Pacemakers, Inc. | Method and apparatus for pacing during revascularization |
JP4972639B2 (en) * | 2005-05-06 | 2012-07-11 | バソノバ・インコーポレイテッド | Method and apparatus for guiding and positioning an intravascular device |
US20090118612A1 (en) * | 2005-05-06 | 2009-05-07 | Sorin Grunwald | Apparatus and Method for Vascular Access |
US7885710B2 (en) | 2005-12-23 | 2011-02-08 | Cardiac Pacemakers, Inc. | Method and apparatus for tissue protection against ischemia using remote conditioning |
WO2007130392A2 (en) * | 2006-05-04 | 2007-11-15 | The Cleveland Clinic Foundation | Intrajugular catheter |
US8715205B2 (en) | 2006-08-25 | 2014-05-06 | Cook Medical Tecnologies Llc | Loop tip wire guide |
US20080071315A1 (en) * | 2006-08-31 | 2008-03-20 | Tamara Colette Baynham | Integrated catheter and pulse generator systems and methods |
US8068920B2 (en) * | 2006-10-03 | 2011-11-29 | Vincent A Gaudiani | Transcoronary sinus pacing system, LV summit pacing, early mitral closure pacing, and methods therefor |
EP2170162B1 (en) | 2007-06-26 | 2017-08-23 | Vasonova, Inc. | Apparatus for endovascular device guiding and positioning using physiological parameters |
US9037235B2 (en) | 2008-06-19 | 2015-05-19 | Cardiac Pacemakers, Inc. | Pacing catheter with expandable distal end |
US9409012B2 (en) | 2008-06-19 | 2016-08-09 | Cardiac Pacemakers, Inc. | Pacemaker integrated with vascular intervention catheter |
US8170661B2 (en) | 2008-07-01 | 2012-05-01 | Cardiac Pacemakers, Inc. | Pacing system controller integrated into indeflator |
US8983567B1 (en) | 2009-08-01 | 2015-03-17 | Nuvasive, Inc. | Systems and methods for vessel avoidance during spine surgery |
US8369932B2 (en) * | 2010-01-29 | 2013-02-05 | Medtronic Ablation Frontiers Llc | Optical methods of identifying the location of a medical device within a patient's body in order to locate the fossa ovalis for trans-septal procedures |
WO2011156688A2 (en) | 2010-06-10 | 2011-12-15 | Windcrest Llc | Guidewire control device |
EP2637568B1 (en) | 2010-11-08 | 2017-04-12 | Vasonova, Inc. | Endovascular navigation system |
US9446189B2 (en) * | 2011-02-11 | 2016-09-20 | Lifecell Corporation | Tissue transfer systems |
JP6185048B2 (en) | 2012-05-07 | 2017-08-23 | バソノバ・インコーポレイテッドVasonova, Inc. | System and method for detection of superior vena cava area and vena cava atrial junction |
US10028682B2 (en) | 2012-10-12 | 2018-07-24 | University Of Virginia Patent Foundation | Oxidation measurement system and related method thereof |
CN105842444A (en) * | 2015-11-22 | 2016-08-10 | 李静 | Kit for specific detection on endometrial cancer |
US11648397B1 (en) | 2018-10-12 | 2023-05-16 | Vincent Gaudiani | Transcoronary sinus pacing of posteroseptal left ventricular base |
US11577075B1 (en) | 2018-10-12 | 2023-02-14 | Vincent A. Gaudiani | Transcoronary sinus pacing of his bundle |
US11278313B2 (en) * | 2020-02-24 | 2022-03-22 | AerWave Medical, Inc. | Transeptal puncture procedure |
Citations (30)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3847483A (en) * | 1972-02-01 | 1974-11-12 | R Shaw | Optical oximeter apparatus and method |
US4114604A (en) * | 1976-10-18 | 1978-09-19 | Shaw Robert F | Catheter oximeter apparatus and method |
US4697593A (en) * | 1984-06-26 | 1987-10-06 | Evans John M | Method and apparatus for measuring blood oxygen levels |
US4796636A (en) * | 1987-09-10 | 1989-01-10 | Nippon Colin Co., Ltd. | Noninvasive reflectance oximeter |
US5168864A (en) * | 1991-09-26 | 1992-12-08 | Clarus Medical Systems, Inc. | Deflectable endoscope |
US5199428A (en) * | 1991-03-22 | 1993-04-06 | Medtronic, Inc. | Implantable electrical nerve stimulator/pacemaker with ischemia for decreasing cardiac workload |
US5265601A (en) * | 1992-05-01 | 1993-11-30 | Medtronic, Inc. | Dual chamber cardiac pacing from a single electrode |
US5275151A (en) * | 1991-12-11 | 1994-01-04 | Clarus Medical Systems, Inc. | Handle for deflectable catheter |
US5277181A (en) * | 1991-12-12 | 1994-01-11 | Vivascan Corporation | Noninvasive measurement of hematocrit and hemoglobin content by differential optical analysis |
US5531686A (en) * | 1990-02-02 | 1996-07-02 | Ep Technologies, Inc. | Catheter steering mechanism |
US5569911A (en) * | 1993-07-19 | 1996-10-29 | General Electric Company | Fiber optic system for remote fluorescent sensing using excitation and return fibers |
US5597377A (en) * | 1994-05-06 | 1997-01-28 | Trustees Of Boston University | Coronary sinus reperfusion catheter |
US5843132A (en) * | 1996-10-07 | 1998-12-01 | Ilvento; Joseph P. | Self-contained, self-powered temporary intravenous pacing catheter assembly |
US5891088A (en) * | 1990-02-02 | 1999-04-06 | Ep Technologies, Inc. | Catheter steering assembly providing asymmetric left and right curve configurations |
US5902324A (en) * | 1998-04-28 | 1999-05-11 | Medtronic, Inc. | Bi-atrial and/or bi-ventricular sequential cardiac pacing systems |
US5906590A (en) * | 1995-05-22 | 1999-05-25 | Ep Technologies, Inc. | Bidirectional steerable catheter with deflectable distal tip |
US6031603A (en) * | 1995-06-09 | 2000-02-29 | Cybro Medical, Ltd. | Sensor, method and device for optical blood oximetry |
US6033376A (en) * | 1998-09-30 | 2000-03-07 | Allergan Sales, Inc. | Wound shaper sleeve |
US6070100A (en) * | 1997-12-15 | 2000-05-30 | Medtronic Inc. | Pacing system for optimizing cardiac output and determining heart condition |
US6122552A (en) * | 1999-03-03 | 2000-09-19 | Cardiac Pacemakers, Inc. | Insertion apparatus for left ventricular access lead |
US6122545A (en) * | 1998-04-28 | 2000-09-19 | Medtronic, Inc. | Multiple channel sequential cardiac pacing method |
US6178356B1 (en) * | 1998-02-20 | 2001-01-23 | Cardiac Pacemakers, Inc. | Coronary venous lead having fixation mechanism |
US6264627B1 (en) * | 1998-03-11 | 2001-07-24 | Jan Liska | Catheter to be inserted into a blood vessel, and a method for detection of substances and metabolic changes in a heart |
US6266563B1 (en) * | 1997-03-14 | 2001-07-24 | Uab Research Foundation | Method and apparatus for treating cardiac arrhythmia |
US6270476B1 (en) * | 1999-04-23 | 2001-08-07 | Cryocath Technologies, Inc. | Catheter |
US6363288B1 (en) * | 1999-08-20 | 2002-03-26 | Pacesetter, Inc. | CS lead with single site sensing and dual site pacing |
US6370427B1 (en) * | 1998-07-23 | 2002-04-09 | Intermedics, Inc. | Method and apparatus for dual chamber bi-ventricular pacing and defibrillation |
US6591114B1 (en) * | 2000-02-24 | 2003-07-08 | Qualicom Systems, Inc. | Fixed cellular communications system |
US6650923B1 (en) * | 2000-04-13 | 2003-11-18 | Ev3 Sunnyvale, Inc. | Method for accessing the left atrium of the heart by locating the fossa ovalis |
US6969379B1 (en) * | 1998-08-27 | 2005-11-29 | A-Med Systems, Inc. | Intravascular cannulation apparatus and methods of use |
Family Cites Families (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6033378A (en) | 1990-02-02 | 2000-03-07 | Ep Technologies, Inc. | Catheter steering mechanism |
-
2001
- 2001-10-23 US US10/044,587 patent/US6591144B2/en not_active Expired - Lifetime
-
2002
- 2002-10-18 CA CA002464649A patent/CA2464649A1/en not_active Abandoned
- 2002-10-18 EP EP02795535A patent/EP1455889B1/en not_active Expired - Lifetime
- 2002-10-18 AT AT02795535T patent/ATE511876T1/en not_active IP Right Cessation
- 2002-10-18 WO PCT/US2002/033521 patent/WO2003035139A2/en not_active Application Discontinuation
- 2002-10-18 AU AU2002360287A patent/AU2002360287A1/en not_active Abandoned
-
2003
- 2003-05-23 US US10/446,266 patent/US20030195577A1/en not_active Abandoned
Patent Citations (31)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3847483A (en) * | 1972-02-01 | 1974-11-12 | R Shaw | Optical oximeter apparatus and method |
US4114604A (en) * | 1976-10-18 | 1978-09-19 | Shaw Robert F | Catheter oximeter apparatus and method |
US4697593A (en) * | 1984-06-26 | 1987-10-06 | Evans John M | Method and apparatus for measuring blood oxygen levels |
US4796636A (en) * | 1987-09-10 | 1989-01-10 | Nippon Colin Co., Ltd. | Noninvasive reflectance oximeter |
US5531686A (en) * | 1990-02-02 | 1996-07-02 | Ep Technologies, Inc. | Catheter steering mechanism |
US5891088A (en) * | 1990-02-02 | 1999-04-06 | Ep Technologies, Inc. | Catheter steering assembly providing asymmetric left and right curve configurations |
US5199428A (en) * | 1991-03-22 | 1993-04-06 | Medtronic, Inc. | Implantable electrical nerve stimulator/pacemaker with ischemia for decreasing cardiac workload |
US5168864A (en) * | 1991-09-26 | 1992-12-08 | Clarus Medical Systems, Inc. | Deflectable endoscope |
US5275151A (en) * | 1991-12-11 | 1994-01-04 | Clarus Medical Systems, Inc. | Handle for deflectable catheter |
US5277181A (en) * | 1991-12-12 | 1994-01-11 | Vivascan Corporation | Noninvasive measurement of hematocrit and hemoglobin content by differential optical analysis |
US5265601A (en) * | 1992-05-01 | 1993-11-30 | Medtronic, Inc. | Dual chamber cardiac pacing from a single electrode |
US5569911A (en) * | 1993-07-19 | 1996-10-29 | General Electric Company | Fiber optic system for remote fluorescent sensing using excitation and return fibers |
US5597377A (en) * | 1994-05-06 | 1997-01-28 | Trustees Of Boston University | Coronary sinus reperfusion catheter |
US5906590A (en) * | 1995-05-22 | 1999-05-25 | Ep Technologies, Inc. | Bidirectional steerable catheter with deflectable distal tip |
US6031603A (en) * | 1995-06-09 | 2000-02-29 | Cybro Medical, Ltd. | Sensor, method and device for optical blood oximetry |
US5843132A (en) * | 1996-10-07 | 1998-12-01 | Ilvento; Joseph P. | Self-contained, self-powered temporary intravenous pacing catheter assembly |
US6266563B1 (en) * | 1997-03-14 | 2001-07-24 | Uab Research Foundation | Method and apparatus for treating cardiac arrhythmia |
US6223079B1 (en) * | 1997-12-15 | 2001-04-24 | Medtronic, Inc | Bi-ventricular pacing method |
US6070100A (en) * | 1997-12-15 | 2000-05-30 | Medtronic Inc. | Pacing system for optimizing cardiac output and determining heart condition |
US6178356B1 (en) * | 1998-02-20 | 2001-01-23 | Cardiac Pacemakers, Inc. | Coronary venous lead having fixation mechanism |
US6264627B1 (en) * | 1998-03-11 | 2001-07-24 | Jan Liska | Catheter to be inserted into a blood vessel, and a method for detection of substances and metabolic changes in a heart |
US6122545A (en) * | 1998-04-28 | 2000-09-19 | Medtronic, Inc. | Multiple channel sequential cardiac pacing method |
US5902324A (en) * | 1998-04-28 | 1999-05-11 | Medtronic, Inc. | Bi-atrial and/or bi-ventricular sequential cardiac pacing systems |
US6370427B1 (en) * | 1998-07-23 | 2002-04-09 | Intermedics, Inc. | Method and apparatus for dual chamber bi-ventricular pacing and defibrillation |
US6969379B1 (en) * | 1998-08-27 | 2005-11-29 | A-Med Systems, Inc. | Intravascular cannulation apparatus and methods of use |
US6033376A (en) * | 1998-09-30 | 2000-03-07 | Allergan Sales, Inc. | Wound shaper sleeve |
US6122552A (en) * | 1999-03-03 | 2000-09-19 | Cardiac Pacemakers, Inc. | Insertion apparatus for left ventricular access lead |
US6270476B1 (en) * | 1999-04-23 | 2001-08-07 | Cryocath Technologies, Inc. | Catheter |
US6363288B1 (en) * | 1999-08-20 | 2002-03-26 | Pacesetter, Inc. | CS lead with single site sensing and dual site pacing |
US6591114B1 (en) * | 2000-02-24 | 2003-07-08 | Qualicom Systems, Inc. | Fixed cellular communications system |
US6650923B1 (en) * | 2000-04-13 | 2003-11-18 | Ev3 Sunnyvale, Inc. | Method for accessing the left atrium of the heart by locating the fossa ovalis |
Cited By (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US20050113719A1 (en) * | 2003-09-26 | 2005-05-26 | Vahid Saadat | Left atrial access apparatus and methods |
US20080200821A1 (en) * | 2003-09-26 | 2008-08-21 | Hansen Medical, Inc. | Left atrial access apparatus and methods |
US7753853B2 (en) | 2003-09-26 | 2010-07-13 | Hansen Medical, Inc. | Left atrial access apparatus and methods |
US20080077190A1 (en) * | 2006-09-21 | 2008-03-27 | Cardiac Pacemakers, Inc. | Implantable Medical Device Header With Optical Interface |
US8290592B2 (en) | 2006-09-21 | 2012-10-16 | Cardiac Pacemakers, Inc. | Implantable medical device header with optical interface |
US20090156921A1 (en) * | 2007-12-18 | 2009-06-18 | Huisun Wang | Cardiac ablation catheter with oxygen saturation sensor |
US20090156916A1 (en) * | 2007-12-18 | 2009-06-18 | Huisun Wang | Catheter systems with blood measurement device and methods |
WO2017123764A1 (en) * | 2016-01-12 | 2017-07-20 | Bloodworks, Llc | Peripheral fiberoptic intravascular blood metric probe modular device and method |
Also Published As
Publication number | Publication date |
---|---|
WO2003035139A3 (en) | 2004-03-11 |
AU2002360287A1 (en) | 2003-05-06 |
US6591144B2 (en) | 2003-07-08 |
EP1455889B1 (en) | 2011-06-08 |
EP1455889A2 (en) | 2004-09-15 |
EP1455889A4 (en) | 2006-05-17 |
ATE511876T1 (en) | 2011-06-15 |
US20030078645A1 (en) | 2003-04-24 |
CA2464649A1 (en) | 2003-05-01 |
WO2003035139A2 (en) | 2003-05-01 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US6591144B2 (en) | Steerable catheter and method for locating coronary sinus | |
EP2291212B1 (en) | Delivery catheter including side port and electrodes | |
US10369356B2 (en) | Transcoronary sinus pacing system, LV summit pacing, early mitral closure pacing, and methods therefor | |
Sosa et al. | A new technique to perform epicardial mapping in the electrophysiology laboratory | |
EP0745406B1 (en) | Coronary sinus catheter | |
US5984909A (en) | Coronary sinus catheter | |
US6001085A (en) | Coronary sinus catheter | |
CA2134909C (en) | Guiding introducer for left atrium | |
US5423772A (en) | Coronary sinus catheter | |
US5810730A (en) | Guiding introducer for right atrium | |
US5913887A (en) | Device for the transvenous cardioversion of atrial fibrillation or atrial flutter including three coil electrodes | |
US7967758B2 (en) | Devices and methods for detecting and treating inadequate tissue perfusion | |
US20090069694A1 (en) | Coronary sinus access catheter with forward-imaging means | |
US20070208389A1 (en) | Coronary Sinus Locater Method and Apparatus for Biventricular Pacing | |
EP1455648A2 (en) | Coronary sinus access catheter with forward-imaging | |
CA2160510A1 (en) | Process for the treatment of atrial arrhythmia using a catheter guided by shaped guiding introducers | |
EP0745408A2 (en) | Guiding introducer for nonsurgical mapping and/or treatment of ectopic atrial tachycardia | |
US6647291B1 (en) | Method and apparatus for cardiac defibrillation | |
US4552157A (en) | Open curve, atrial "J" electrode | |
SU1591962A1 (en) | Method of transvenous injection of cardiostimulant electrode | |
Malinowski | The Benefits of Upgrading a Pacemaker from Right-Ventricular to Biventricular Pacing in Congestive Heart Failure: A Case Report | |
JPH08299358A (en) | Guidance introducing apparatus for medical treatment of atrium cordis flutter |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION |