Multifunctional, electrophysiological diagnostic catheter for treatments in electrocardiology

Abstract

The multifunctional, electrophysiological diagnostic catheter for electrocardiologic treatments includes a distal end, diagnostic rings, a balloon, a main channel, a manipulation handgrip, functional connection and internal channels. There is an internally-located open central channel, wherein inlet/outlet of an internal channel is located in the distal ring. There is a pumping channel for pumping up and pumping out of the occlusion-stabilizing balloon located after the diagnostic rings. There is a division of a central channel into two branches in the region of the catheter proximal end.

Claims

1. A multifunctional electrophysiological diagnostic catheter for electrocardiology, the catheter comprising: a main tube 2 being flexible in a deployed configuration and having a distal end and a proximal end; a control system 2.3 connected to said distal end so as to bend said distal end; a plurality of diagnostic rings 3 on said main tube, wherein at least one diagnostic ring is a distal diagnostic ring 1 at said distal end of said main tube; a manipulation handgrip 5 on said main tube adjacent said proximal end; a balloon 4 within said main tube between said diagnostic rings and said manipulation handgrip, wherein said balloon is placed after said plurality of said diagnostic rings from said distal end of said main tube, said distal end of said main tube and said plurality of diagnostic rings being in a bent position independent from said balloon, when said balloon is in an inflated configuration, wherein said main tube is comprised of: a central channel B being centered within said main tube and having a central proximal opening at said proximal end and a central distal opening at said distal end, said distal diagnostic ring being positioned at said distal opening; a plurality of electrical wires 8.1 around said central channel; and a pumping channel A being in fluid connection with said balloon, being aligned with said electrical wires, said electrical wires and said pumping channel forming a circle around said central channel, and having a pumping proximal opening at said proximal end and a pumping distal opening connected to said balloon; a first channel 2.1 being connected to said pumping proximal opening and being in fluid connection with said pumping channel; and a second channel 2.2 being in fluid connection with said central channel and connected to said central proximal opening of said central channel, wherein said second channel is in fluid connection with said distal opening at said distal end of said main tube through said central proximal opening, and wherein said distal diagnostic ring is comprised of a central recess 1.1, said distal opening being connected to said central recess, said central recess having smooth round edges 1.2.

2. The multifunctional catheter, according to claim 1, further comprising: a microdevice 6.2 in fluid connection with said central channel through said second channel connected to said central proximal opening at said proximal end.

3. The multifunctional catheter, according to claim 1, further comprising: a pump 6.5 and a compartment 6.6 containing a liquid, said compartment being in fluid connection with said central channel through said second channel connected to said central proximal opening at said proximal end.

4. The multifunctional catheter, according to claim 1, further comprising: a blood pressure measurement device 6.2 in fluid connection with said central channel through said second channel connected to said central proximal opening at said proximal end.

5. The multifunctional catheter, according to claim 1, wherein said balloon has a modifiable diameter and a shape ranging from spherical to ellipsoidal.

6. The multifunctional catheter, according to claim 5, wherein said modified diameter is set by at least one of a group consisting of air and saline filling said balloon.

7. The multifunctional catheter, according to claim 1, further comprising: a system for electroanatomic mapping in communication with said diagnostic rings.

8. The multifunctional catheter, according to claim 1, wherein said manipulation handgrip comprises: a distal handgrip opening 5.1 receiving said main tube; and a proximal handgrip opening 5.2, said first channel extending through said proximal handgrip opening, said second channel extending through said proximal handgrip opening, and said electrical wires 8.1 extending through said proximal handgrip opening.

9. The multifunctional catheter, according to claim 1, further comprising: a tee 6.1 dividing said second channel into a first tee branch 6.3 and a second tee branch 6.4; a diaphragm 6.7 in fluid connection with said first tee branch; a valve 6.8 connected to said second tee branch; and a connection for a pump 6.5 in fluid connection with said second tee branch.

10. The multifunctional catheter, according to claim 1, further comprising: a balloon pump 7.1 and a balloon compartment 7.2 containing a liquid, said balloon compartment being in fluid connection with said pumping channel through said first channel.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The multifunctional catheter according to the invention was described in more details in exemplary embodiments and on the drawing.

(2) FIG. 1 shows a side elevation view of a main channel, a covering distal ring, diagnostic rings and a balloon.

(3) FIG. 2 shows a cross-sectional view of the main channel of the multifunctional catheter.

(4) FIG. 3 shows a side elevation view of the multifunctional diagnostic catheter with the manipulation handgrip and functional connections.

DETAILED DESCRIPTION OF THE DRAWINGS

(5) The multifunctional catheter comprises manipulation handgrip 5, main channel or main tube 2, distal ring 1, occluding-stimulation balloon 4, diagnostic rings 3, and three connections: liquid connection 6 for contrast administration or blood sampling from coronary sinus or introduction of microdevices 6.2; pumping connection 7 for pumping up and pumping out of balloon with a pump 7.1 and compartment 7.2 of saline or air; and electric connection 8 for electrical wires 8.1 connecting diagnostic rings 3 and distal ring 1 with electrophysiological system.

(6) The multifunctional catheter comprises two channels. Channel B is centrally located flow channel for liquids, which opens through the distal diagnostic ring 1 at an atraumatic ending of the catheter, as shown in FIG. 1. Pumping channel A is a channel used for filling and draining of occlusion-stabilizing balloon 4 through pumping connection 7 for liquid or gas pumping/draining from balloon. Balloon 4 is an expandable balloon made of elastic material.

(7) Channel A and channel B are surrounded by electric wires connecting diagnostic rings 3 and distal ring 1 with manipulation handgrip 5 and transmitting electrophysiological parameters of electrophysiological system.

(8) Additionally, in main channel 2, there are wires placed controlling distal end of catheter.

(9) Proximal end of main channel 2, while connecting with manipulation handgrip 5 at the distal handgrip opening 5.1, divides into two channels (a first channel 2.1 and a second channel 2.2) and a cluster of electric wires. There are emerging branches or channels coming out from a proximal hand grip opening 5.2 of the manipulation handgrip 5 to liquid connection 6 of central channel B, pumping connection 7 for filling and draining of the occlusion-stabilizing balloon, and the electric connection 8.

(10) Liquid connection 6 ends with tee 6.1 from which a first tee branch 6.3 is an extension of the central channel and creates a proximal end of the central channel and is equipped with a diaphragm 6.7 enabling introduction of microdevices 6.2, such as a blood pressure measurement device, without liquid leakage. A second tee branch 6.4 is equipped with a valve 6.8 and an ending for a pump 6.5 and compartment 6.6, such as a syringe.

(11) Pumping connection 7 is equipped with a valve and an ending for a syringe, which is used for balloon pumping up and pumping out 4.

(12) Electric connection 8 creates electric socket, which is connected with an electrophysiological system through a connector.

(13) The inlet/outlet of central channel B is located in a distal ring of the catheter and is shaped atraumatically, what means that the edges are smooth and curved as shown in FIG. 2. Besides, there is a gap placed below external walls. Sharp edges could break the blood vessels continually and increase perforation risks.

(14) The multifunctional diagnostic catheter comprises diagnostic rings 3 present in an amount of 4 to 20 (default 10) for analysis of electric parameters of heart and vessels evenly distributed on length of 6 to 14 cm. These rings are located in the vicinity of distal and of catheter. In a preferred embodiment, diagnostic rings are used as rings visible under X-ray or in system of non-fluoroscopic navigation and mapping.

(15) On the distal end of the catheter, there is also occlusion-stabilizing balloon 4 present, which is placed after diagnostic rings 3 and which enables selective blockage of blood flow in an intubated vessel.

(16) In a vicinity of the main channel of the proximal end, there is a manipulation handgrip present, where channel division occurs. Division of catheter channels and electric wires enables interchangeable usage of a liquid dosing device in case of drug administration, contrast agent, or suction device in case of blood sampling. Channel division enables easy separation of main channel component functions and its redirection to connections going out of the proximal part of handgrip. The multifunctional catheter is made of elastic material enabling its easy bending, and the distal end is equipped with a control system localized in the catheter handgrip and connected with a proper ties.

(17) The catheter is finally positioned using X-rays, analysis of electric potentials or using a non-fluoroscopic three dimensional electroanatomical system. Subsequently, occlusion-stabilizing balloon 4 is pumped up in order to stabilize catheter position in vessel in a proximal end of a coronary sinus. To the central channel B, a blood sample is taken, sucked using a low-pressure suction device (syringe), and, after passage through a distributor and disconnection of the suction device, and is poured into the test-tube. In a case when there is a need to administer a drug, contrast or other medical agent to a specific heart region or vessels, liquid connection 6 is connected to the pumping device (syringe) and through a distributor and next through the central channel B, a medical agent is administered. Between activities described above, there is a need for central channel B to be flushed using saline solution.

(18) Through central channel B, there is a possibility of microdevice introduction e.g. MicroCosinus electrode for ultrasonography, to the heart regions, which can be used for blood vessels diagnostics with a small diameter.

(19) In a preferred embodiment it is possible to measure blood pressure in a chosen region of heart or vessels based on connection to the liquid connection 6.

(20) A catheter with occlusion-stabilizing balloon 4 in a drained state is introduced to the patient's peripheral vein vessels (femoral vein, subclavian vein) and is further passed through main vessels to right cardiac cavities. A control system 2.3 enables bending of the catheter distal end, which permits localization of coronary sinus outflow. Navigation and localization of the catheter position can be performed based on catheter translucency in X-rays or based on analysis of potentials and electrophysiological parameters by a three-dimensional system and non-fluoroscopic navigation (without X-rays). A catheter, thanks to diagnostic rings 3, enables continuous registration of potentials and construction of virtual electroanatomical map giving an image of examined vessels and cardiac cavities. When an operator reaches his goal, so when he gets to his desirable location, occlusion-stabilizing balloon 4 is pumped up and can become an electrode-stabilizing system in a coronary sinus (reducing risk of the electrode falling out during patient's heart stoppage or breathing movement). Additionally stable electrode localization enables stable and precise building of cardiac cavities contours and use of intracardial electrode as a marker/reference point for other points in created virtual map of heart. Additionally, a balloon can, in a precise manner, prevent blood from mixing from a coronary sinus with blood coming from the right vestibule, which enables reliable and selective blood sampling from the catheter end.

(21) Blood is sampled using a syringe connected to the liquid connection 6 protected by a valve. Gap in liquid connection 6 for substance administration or blood sampling can be also used for drug administration, pressure measurement. Gap on the proximal end of central channel B is ended with a gate (diaphragm), through first tee branch 6.3 which enables introduction of microdevices with an additional diagnostic-therapeutic functions e.g. MicroCosinus electrode with a diameter below 2 mm for electrophysiological diagnostics of vessel with a very small diameter. Pressure measurement can be registered using liquid connection 6 or using microdevice for pressure measurement introduced through gap on proximal end of central channel.

(22) Diagnostic rings 3 distributed in distance 6 to 14 cm from distal ring 1 of catheter enable registration of electrophysiological parameters (shape and amplitude of mono- and bipolar electric potential, impedance), selective stimulation using external stimulator or non-fluoroscopic navigation using three-dimensional system.

(23) Occlusion-stabilizing balloon 4 is filled using saline solution and performs stabilizing and blocking functions for flow in coronary sinus.