Abstract
An insertion device that allows gaining access to the left ventricle of the heart, via the tissue forming the wall of the right ventricle and via the ventricular septum, which includes a tubular shaft with a lumen extending there through, the shaft comprising distal, proximal and central sections, whereby the distal and proximal sections are disc-shaped extended thus forming each a double disc and whereby the central section links the distally placed double disc with the proximally placed double disc and whereby pressure valves are fixed inside the shaft preferably on its distal and proximal end.
Claims
1. Insertion unit comprising: a tubular shaft with a lumen extending there through; said shaft includes distal, proximal and central sections, whereby the distal and proximal sections are disc-shaped extended thus forming each a double disc whereby the central section links the distally placed double disc, with the proximally placed double disc; and whereby a pressure valve is fixed inside the shaft on its distal and proximal end.
2. Insertion unit according to claim 1, consisting of braided wires of memory material, preferably nitinol.
3. Insertion unit according to claim 1, consisting in part or in total of Silicon, Polyurethane, PTFE, Polyester, biocompatible fibers, Nitinol, Titanium or Stainless Steel.
4. Insertion unit according to claim 1, whereby the inner and/or outer central section of shaft is covered by a biocompatible synthetic material.
5. Insertion unit according to claim 1, whereby the central section is coil shaped.
6. Insertion unit according to claim 1, whereby the tubular shaft is longitudinally extended thus forming an extended shaft, the thus extended shaft comprising a further double disc, with pressure valve at its proximal end.
7. Device for stimulation and/or defibrillation consisting of an insertion unit according to claim 1 and of at least one stimulation electrode connected to a pacemaker, each electrode consisting of a lead provided with a pole at its distal end whereby the insertion unit is conductive and is connected to an ICD to form one of the defibrillation electrodes or to form an indifferent pole and whereby the lead of the stimulation electrode runs inside the shaft of the insertion unit.
8. Device for the cardiac valve replacement, consisting of an insertion unit according to claim 1 and a catheter or trocar, whereby the catheter or trocar runs inside the shaft of the insertion unit, whereby a cardiac valve prosthesis is insertable via that catheter or trocar.
9. Device for improving the cardiac output, consisting of an insertion unit according to claim 1 and a heart pump, whereby the heart pump is insertable through the shaft of the insertion unit, said heart pump being driven by a motor to which the propeller shaft is connected said shaft running inside the shaft.
10. Device for the ventricle reduction, consisting of an insertion unit according to claim 1, whereby the number of distally placed discs, is reduced to one disc having fixation hooks and whereby the central section is elastic.
11. Device suitable as port catheter consisting of an insertion unit according to claim 1, whereby the proximally placed disc of the double disc, is connected to a port chamber by a port catheter.
12. Device for taking blood from the left ventricle and for supplying the heart muscle tissue with blood via the coronary arteries consisting of an insertion unit according to claim 1 and an artificial blood vessel system whereby the insertion unit is connected to an artificial blood vessel system consisting of a tube, one end of the tube being placed and fixed within the shaft of the insertion unit and the other end can be placed around the heart and whereby the tube has one or more small branches being connectable to a coronary artery and thus serving as bypass and/or whereby the tube has cannula-like branches.
13. Device for bypass control comprising a device according to claim 11, whereby one or more sensors, are placed around the small branches, said sensors being connected to an electrical impedance measurement device.
14. Device for taking blood from the left ventricle and for the simultaneous stimulation and defibrillation, consisting of a device according to claim 11, whereby the tube is wrapped in part with a metallic coil said coil being connected to an ICD thus serving as defibrillation electrode.
15. Device for the support of the cardiac output, consisting of an insertion unit according to claim 1, and an artificial blood vessel system whereby the insertion unit is connected to an artificial blood vessel system consisting of a tube, one end of the tube being placed and fixed within the shaft of the insertion unit and the other end is configured to be disposed in the aorta and whereby a pump is placed into the tube.
16. Device for detecting and inspecting structural defects in the inner heart tissue consisting of an insertion unit according to claim 1, and an endoscope having a shaft and a tip with a video chip and a light fiber at the tip whereby the endoscope tip is surrounded by a transparent balloon and whereby the shaft runs through the insertion unit.
17. Device for repairing cardiac valves consisting of an insertion unit according to claim 1, and a device for pushing anchors comprising a feed catheter and an anchor pusher whereby the feed catheter runs through the shaft.
Description
[0081] Many aspects of the invention can be better understood with reference to the following figures showing the insertion unit in detail and number devices using the insertion device.
[0082] The reference numbers represent:
TABLE-US-00001 A Aorta CV Coronary vein LV left ventricle RV right ventricle RF radio frequency ICD (Implantable Cardiac Defibrillator) (1,2), (3,4), (53, 54) double discs 5 tubular shaft 6, 7, 55 pressure valves 8 lumen 9 pressure sensor 10 catheter (trocar) 11 metal frame of the artificial valve 12 balloon 13 heart pump 14, 15 stimulation electrodes, pace sense electrodes (lead and pole) 16, 17 electrode lead 18, 19 impedance measuring electrodes 20, 21, 22, 23 defibrillation electrodes 24, 25, 26, 27, 28, 31 electrical connection line 30 pump motor 31 propeller shaft 32 electrical impedance measurement unit 33 pump control unit 34 pacemaker 40 port chamber 41 port catheter 50 central section of the tubular shaft 51 extended tubular shaft 52 surgical threads 60 fixing hook 61, 62 spring 63 sleeve 70 abdomen (abdominal wall, chest wall) 80 artificial blood vessel, tube member 81 small vessel branch, 82 cannula-like branches 83 tube member branch 90 electrode pole 91 control electrode (sensor) 92, 93 pair of electrodes, pair of sensors 100 hose pump 110 endoscope 111 endoscope-balloon 112 endoscope shaft 113 endo scope tip 120 new tissue material 121 anchor pusher 122 feed catheter for anchor pusher 130 dilation catheter 131 elongated expanding elements
BRIEF DESCRIPTION OF THE DRAWINGS
[0083] FIG. 1 shows the insertion unit according to the invention.
[0084] In FIG. 1a all the discs (1),(2),(3),(4) are formed by braiding two discs braids that lie on top of each other. In FIGS. 1b and 1c one of the discs (disc 1) is formed by braiding only one disc braid.
[0085] FIG. 1a shows the insertion unit consisting of a tubular shaft (5) braided of nitinol wire. The shaft has a lumen (8) extending through the whole shaft in axial direction. The central section (50) links the distally placed double discs (1), (2) with the proximal placed double discs (3), (4). Pressure valves (6) rep. (7) is fixed inside the shaft on its distal and proximal end.
[0086] FIG. 1b shows a longitudinally extended tubular shaft (51).
[0087] In FIG. 1c surgical threads (52) are woven into the braiding proximally. The threads can be tied with a knot together and serve as additional fixing of the proximal double disc and as sealing of the heart-wall tissue.
[0088] FIG. 1d shows an insertion unit where the central section (50) of the tubular shaft (5) has another design than the distal and proximal sections. The central section (50) of the tubular shaft is coil shaped, said coil (61) serving as spring. Said coil is covered with a silicone tube. The extended section is also coil shaped (62).
[0089] The proximal wire ends of the braided double discs (1) (2) resp. (3), (4) are fixed by a sleeve (63) that has an opening too, so that lumen (8) is continuous.
[0090] The following figures show the insertion unit implanted in the heart.
[0091] FIG. 2 shows the insertion unit implanted in the heart chambers. The braided double discs (1), (2) are implanted in the ventricular septum. The braided double discs (3), (4) are implanted in the tissue forming the heart wall of the right ventricle. Double disc (1), (2) is linked to double disc (3), (4) by the central section (50) of the shaft (5). Valve (6) prevents the blood flow from the left to the right ventricle. Valve (7) prevents bleeding through the puncture of the right ventricle. A pressure sensor (9) can be fixed inside the shaft at its distal end for measuring the left ventricular pressure. The pressure sensor can either transfer the data according to the RFID principle, or can transfer the data to a measurement unit. If required, the data can be saved.
[0092] FIG. 3 and FIG. 4 show a device for the cardiac valve replacement and/or the dilation of the replaced valves. A catheter (trocar) (10) is inserted through shaft (5) of the inventive insertion unit and guided to the left ventricle. Cardiac valve prosthesis comprising a metal frame (11) positioned on a balloon (12) is pushed through said catheter and guided to the aortic valve to be replaced. FIG. 4 shows the possible replacement of the mitral valve.
[0093] FIG. 5 shows a device supporting the cardiac blood flow output consisting of the inventive insertion unit and heart pump (13) being inserted through the shaft (5) of the insertion unit and guided via the left ventricle to the ascending aorta. The device pumps blood from the left ventricle into the ascending aorta. The heart pump (13) is driven by a motor (30) to which the propeller shaft is connected, said propeller shaft (31) running inside the insertion unit (5).
[0094] FIG. 6 shows a biventricular stimulation device. Depending of the number and the position of the pacing leads, one can use it as a one chamber pacing system or a biventricular stimulation system. The stimulation electrodes (screw tip) (14) from the left ventricle and (15) from the right ventricle are connected to the pacemaker (34). The electrical connection line (24) leads to the proximally placed disc (4) of the insertion unit. The insertion unit is braided of nitinol wires and the whole insertion unit with the discs 1,2,3,4, thus serves as the indifferent pole (20).
[0095] FIG. 7 shows the inventive insertion unit with a DDD stimulation device. The position of one screw tip lead (14a) is within the right atrium, the other electrode (15a) is fixed within the right ventricle.
[0096] The following FIGS. 8, 9, 10 and 15 show a stimulation/defibrillation device.
[0097] FIG. 8 shows a device for stimulation and defibrillation. In FIG. 8 an occluder implanted in the atrial septum, is connected to the ICD via electrical connection line (25). The occluder serves as defibrillation electrode (21). The electrical connection line (24) leads to the ICD. The insertion unit is braided of nitinol wires and the whole unit with the discs 1,2,3,4, thus serves as the second defibrillation electrode (20). The shock is given between the defibrillation electrodes (20) and (21). The stimulation and sensing electrodes (14) and (15) each consisting of a lead provided with a pole at its distal end are also connected to the ICD.
[0098] The field strength distribution is marked. One can see a homogenous electrical field over the right and over the left ventricle which may reduce the necessary defibrillation shock energy.
[0099] FIG. 9a also shows another possible device for stimulation and defibrillation for patients which have already an implanted artificial valve.
[0100] In FIG. 9a the metal frame (11) of the artificial valve is connected to the ICD via electrical connection line (26). The valve prosthesis thus forms one of the defibrillation electrodes (22). The shock is applied between the defibrillation electrodes (20) (disc (1), (2), (3), (4) of the insertion unit and the metal frame (11) forming the electrode (22). The stimulation electrodes (14) and (15) are connected to the ICD as described above.
[0101] If desired, a coil-shaped pole (23) may also serve as second defibrillation electrode. The coil is placed below the cardiac apex and is connected to the ICD. The shock is applied between the valve prosthesis (22) and the coil (23) or between the valve prosthesis (22) and the coil and parallel to the insertion unit (20).
[0102] The field strength distribution is marked. One can see a homogenous electrical field over the right and over the left ventricle.
[0103] FIG. 9b also shows another possible device for stimulation and defibrillation of the heart. One of the defibrillation poles is a flexible coil (23), which is placed on left side of the heart. The shock is given between insertion unit serving as the defibrillation electrode (20) and (23). The ICD is implanted within the abdomen. The battery of the ICD can be exchanged without disconnecting the electrical circuitry from the electrodes. Thus the special program for pacing and defibrillation of those patients can be saved and continued to use without any new programming. A further advantage is that the capacity of the battery can be enlarged and the exchange of the battery can be done by any surgeon without any special experience in ICDs.
[0104] FIG. 10 shows a port device. The insertion unit according to the invention is connected with a port catheter (41) and thus creates a unit that allows gaining access to the left and right ventricle and to the abdominal cavity, if required. The subcutaneously implanted hollow chamber with silicone membrane (port chamber) (40) is connected with the insertion unit by a port catheter (41). The port chamber can be filled up through a membrane by means of an injection through the abdomen. A direct access to the ventricles is thus achieved by which medicine, contrast agents, blood thinners, stem cells etc. can be applied or blood samples can be withdrawn.
[0105] FIG. 11 shows a device for reducing the ventricle size in case of a pathological ventricle enlargement. The inventive insertion unit is modified by reducing the number of distally placed discs. There is only one distally placed disc (1) having fixation hooks (60) so that an unit is created that can be fixed in the heart muscle tissue resp. in the ventricular septum. The central section (50) is formed as a spring (61)
[0106] FIG. 12 shows the insertion unit implanted in the heart chambers, as shown in FIG. 2 for the access to the abdomen, right ventricle and left ventricle of the heart at any time. However, the tubular shaft (5) is longitudinally extended to form an extended shaft (51). Shaft (51) is guided through the chest wall (70) resp. through the abdominal wall. The extended shaft (51) comprises double disc (53), (54) with pressure valve (55) sealing the chest wall. Double disc (53), (54) is equivalent to double disc (1), (2) resp. (3), (4).
[0107] FIG. 13 shows a device for taking blood from the left ventricle and for supplying the heart muscle tissue with blood via the coronary arteries.
[0108] The insertion unit implanted in the heart chambers as shown in FIG. 2 is combined with an artificial blood vessel (80) being a tube. One end of the tube is placed and fixed within the shaft (5) of the insertion unit. Thus the artificial blood vessel (80) has direct access to the left ventricle (LV). The artificial vessel (80) is placed over the heart and fixed on the heart tissue above the ventricles. The artificial vessel has several small branches (81) serving as bypasses.
[0109] FIG. 14 also shows a device in which the insertion unit according to the invention is combined with an artificial blood vessel (80) (83) being a tube. Contrary to the device described in FIG. 13, the artificial blood vessel is arranged in a circle around the heart. The tubular body of the artificial blood vessel has small branches (81) serving as bypasses. Furthermore, cannula-like branches (82) are arranged along the circular vessel that extend up into the myocardium like an injection needle and supply the myocardium with more blood in order to initiate some new arteries.
[0110] FIG. 15 shows a device for taking blood from the left ventricle, said device can simultaneously be used for the stimulation and defibrillation of the heart.
[0111] In addition to the device shown in FIG. 13 the tubular body of the artificial blood vessel (80) is wrapped in part with a metallic coil (90) to form an electrical defibrillation pole. The coil (90) is connected to an ICD via one of the electrical connection lines (28). If desired, the defibrillation shock is given between coil (90) and the insertion unit (20) The insertion unit is connected to the ICD via the electrical connection line (24) that leads to the proximally placed disc (4). The whole insertion unit (the discs 1,2,3,4) thus serves as second defibrillation electrode or as indifferent pole. Said second defibrillation electrode is equivalent to the defibrillation electrode described in FIGS. 8 and 9.
[0112] Further electrical connection lines (28) lead from the measurement device (32) to the small branches (81) and to the electrodes (91) placed around the branches (81). By measuring individually the electrical impedance between each of the electrodes (91) the blood flow in each bypass can be controlled. The detailed positioning of the control electrodes (sensors) is shown in FIG. 16.
[0113] The screw electrode (15), which is monitoring the ECG is connected to an ICD. In case of ventricular fibrillation the shock process starts. Analogue to the device shown in FIG. 8 a further screw electrode can be fixed in the left ventricle. FIG. 15 also shows the field strength distribution during the defibrillation. The positioning of the defibrillation electrodes results an optimal field strength distribution so that less shock energy is required.
[0114] FIG. 16 shows a device for the bypass control. In addition to the device shown in FIG. 15, the positioning of the control electrodes/sensors is shown in detail. The control electrodes (91) consist of two electrodes (92, 93) spaced circularly around the artificial blood vessel and being in contact with an electrical impedance measurement unit (32). The electrodes (92), (93) are suitable to monitor the blood flow in the bridged coronary artery (CA, bypass).
[0115] FIG. 17 shows a device for the support of the cardiac output. The inventive insertion unit is connected to an artificial blood vessel system consisting of a tube (80), one end of the tube being placed and fixed within the shaft of the insertion unit and the other end is configured to be disposed in the aorta (A). A blood pump (hose pump) (100) is placed into the tube (80). The hose pump sucks blood from the left ventricle and transports it into the aorta. The connection from the pump (100) to the control unit (33) is lead through the chest wall.
[0116] FIG. 18 shows a device for detecting and inspecting changes in the inner heart tissue. Catheter type endoscopes having a shaft (112) and a tip (113) with a video chip and a light fiber at the tip within a transparent balloon (111) can be inserted through the shaft of the inventive insertion unit and guided to the inner part of the heart. By inflating the transparent balloon with CO2 gas or saline solution and pushing it to the desired area, the endoscope can inspect visually structural defects in the interior parts of the heart and vessels.
[0117] FIG. 19 shows a closing device using enlarged braided occlusion discs (1), (2) being equivalent to the braided discs (1), (2) as described in FIG. 2 as clamping means for closing ventricular septal defects (VSD) or rupture. The occlusion discs (1), (2) are covered with special tissue growing material (120).
[0118] FIG. 20 shows a device for improving the mitral cardiac valve geometry by reducing the valve area.
[0119] A catheter (122) is inserted through the shaft of the inventive insertion unit. A device for pushing anchors (121) like T-bars with attached surgical sutures are pushed through said catheter and guided to the cardiac valve and knot together. A device for pushing suitable anchors is described in WO2007079952 corresponding to US20090012557.
[0120] FIG. 21 shows a device for calculating and monitoring the cardiac output.
[0121] A first impedance measuring electrode (18) resp. (19) is inserted through the shaft of the insertion unit and fixed in the tissue of the left ventricle resp. the right ventricle. The electrode (18) in the left ventricle is one pole; the electrode (19) in the right ventricle is the other pole. Both poles are connected to an impedance measuring device (32) thus forming an impedance measurement circuit. The cardiac synchronous impedance change which is temporally concordant with the stroke volume is determined.
[0122] An apparatus and a method for determining an approximate value for the stroke volume and the cardiac output of a person's heart is described in U.S. Pat. No. 6,511,438.
[0123] FIG. 22 shows a device for the cardiac valve replacement and/or the dilation of the replaced valves.
[0124] FIG. 22a shows the device implanted in the heart. Similar to the device shown in FIGS. 3 and 4 a catheter (trocar) (10) is inserted through shaft (5) of the inventive insertion unit and guided to the left ventricle. Cardiac valve prosthesis mounted on metal frame (11) said frame being positioned on a dilatation catheter (133) is pushed through said trocar (10) and guided to the aortic valve to be replaced. The dilation catheter (133) comprises elongated expanding formed metal elements (131), preferably made from Nitinol or stainless steel.
[0125] FIG. 22b shows the basket designed dilatation catheter in folded and unfolded position. The basket is expanded by using a handle actuation (133) by turning the handle. The turn mechanism enables precise adjusting of the diameter of the basket, which is especially important for post dilatation purposes, reducing any leakage problems. The advantage compared to the balloon catheter is, that during the procedure the blood can continue to flow.
