APPARATUS, CONTROL DEVICE, KIT FOR SUPPORTING THE HEART ACTION, INSERTION SYSTEM, AND METHOD
20210402171 · 2021-12-30
Inventors
Cpc classification
A61M60/861
HUMAN NECESSITIES
A61M60/489
HUMAN NECESSITIES
A61M60/468
HUMAN NECESSITIES
A61M60/289
HUMAN NECESSITIES
A61M60/865
HUMAN NECESSITIES
A61M60/196
HUMAN NECESSITIES
A61M60/187
HUMAN NECESSITIES
A61M60/47
HUMAN NECESSITIES
International classification
A61M60/861
HUMAN NECESSITIES
A61M60/196
HUMAN NECESSITIES
A61M60/289
HUMAN NECESSITIES
A61M60/468
HUMAN NECESSITIES
A61M60/47
HUMAN NECESSITIES
Abstract
The present invention relates to an apparatus (500) for supporting the heart action, preferably by displacing the heart base (110) and/or the aortic root (201), comprising at least a first anchor (501) and a pulling device or guiding device (502, 503, 732, 732a, 732b) for moving the first anchor (501), wherein the first anchor (501) is provided and designed for implantation in or on the heart base (110), the heart skeleton (120), the aortic root (201) and/or a structure in local proximity to the aortic root (210), and/or comprising at least one lifting drive (502, 503). The present invention further relates to a control device (901), an insertion system, a kit and a method for supporting the heart action.
Claims
1. An apparatus for supporting the heart action, comprising at least a first anchor and a pulling device or guiding device for displacing the first anchor, wherein the first anchor is provided and configured for implantation in or on the heart base, the heart skeleton, the aortic root and/or a structure in local proximity to the aortic root, and/or said apparatus encompassing at least one lifting drive.
2. The apparatus according to claim 1, wherein the pulling device or guiding device is, or comprises a linear guiding device.
3. The apparatus according to claim 2, wherein the first anchor comprises a V- or U-shaped section and the first anchor is connected, with or by at least one linear guide sleeve, to at least one end of the first anchor, wherein the linear guide sleeve is designed to guide the linear guiding device.
4. The apparatus according to claim 2, wherein the linear guiding device comprises a piston.
5. The apparatus according to claim 2, wherein the linear guiding device is movable mechanically, hydraulically, pneumatically, electrically or magnetically.
6. The apparatus according to claim 3, wherein a tension or pulling spring in the linear guide sleeve is arranged between the linear guiding device and the first anchor.
7. The apparatus according to claim 3, wherein the connection between the first anchor and the linear guiding sleeve is, or comprises a plug connection, a clamp connection, a bayonet lock or another connection.
8. The apparatus according to claim 1, wherein the pulling device or guiding device comprises an elongated, flexible and tensile element.
9. The apparatus according to claim 1, wherein the apparatus comprises a second anchor for implantation in or on the heart apex, a ligament, a rib, a sternum and/or a structure with local proximity to the heart apex.
10. The apparatus according to claim 1, wherein the apparatus comprises a metal, a plastic and/or a composite material.
11. A control device comprising a mechanical, hydraulic, pneumatic, electric or magnetic drive system for driving a pulling or guiding device of the apparatus according to claim 1.
12. An insertion system comprising: an apparatus having a guiding device for displacing a first anchor; and at least one of an insertion catheter, a guiding catheter, a guidewire and at least one delivery or supply catheter.
13. A kit comprising: the apparatus according to claim 1, a control device comprising a mechanical, hydraulic, pneumatic, electric or magnetic drive system for driving a pulling or guiding device, and/or an insertion system having at least one of an insertion catheter, a guiding catheter, a guidewire and at least one delivery or supply catheter.
14. A method for supporting the heart action, said method comprising: providing the apparatus according to claim 1; implanting the first anchor in or on the heart base, the heart skeleton, the aortic root and/or a structure in local proximity to the aortic root; implanting the pulling or guidance device for moving the first anchor; and connecting the first anchor and the pulling or guiding device.
15. The method according to claim 14, further comprising: implanting the second anchor in or on the heart apex, a ligament, a rib, a sternum and/or a structure in local proximity to the heart apex; and connecting the first anchor and the second anchor.
16. The method according to claim 14, further comprising: providing a control device comprising a mechanical, hydraulic, pneumatic, electric or magnetic drive system for driving the pulling or guiding device of the apparatus according to claim 1; moving the pulling or guiding device using the control unit to support the heart action.
17. The apparatus of claim 3, wherein the first anchor is connected with or by at least two linear guide brushes to the at least one end of the first anchor.
18. The apparatus according to claim 8, wherein the elongated, flexible and tensile element is a rope or a belt.
19. The method of claim 14, further comprising an insertion system—having at least one of an insertion catheter, a guiding catheter, a guidewire and at least one delivery or supply catheter, wherein the insertion system is used during the implanting of the first anchor, the implanting of the pulling or guidance device for moving the first anchor, and the connecting of the first anchor and the pulling or guiding device.
20. The method of claim 15, wherein the insertion system is used during the connecting of the first anchor and the second anchor.
Description
[0144] In the following, the apparatus according to the invention is described on the basis of preferred embodiments thereof with reference to the attached drawings. However, the invention is not limited to these embodiments. In the drawings:
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[0155] In
[0156] The mitral valve 111 and tricuspid valve 112 close at the end of the diastole and ensure that when the ventricles 101 and 103 contract, the blood does not flow back into the atria 102 and 104 but is pumped forward and, on the right side, into the lungs and, on the left side, into the body's circuit. The aortic valve 113 and the pulmonary valve 114 close at the end of systole and ensure that, after the contraction of the two ventricles 101 and 103, the blood does not flow back into the ventricles 101 and 103, but rather that the diastolic blood pressure is maintained in the pulmonary artery and lungs on the right side and that the diastolic pressure is maintained in the aorta and the body's circuit on the left side.
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[0161] As the heart contracts, the pericardium 300 may follow the reduction in heart circumference 210 during the systole. Since the closed pericardium is stretched between the relatively immobile sternum 303 and the mediastinum 306 via the sterno-pericardial ligament 301, the heart apex 105 cannot move away from the sternum 303 in the direction of the heart base 110. For this reason, contraction of the heart and shortening of the longitudinal axis 220 of the heart results in traction on the heart base 110 and the elastic aortic root 201, which is thus stretched in the systole and the heart base 101 with the aortic root 201 is pulled toward the heart apex 105.
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[0166] After the systole
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[0168] In several embodiments, the length of the apparatus 500 according to the present invention is preferably between 70 mm and 120 mm in the diastole, particularly preferably between 72 mm and 116 mm, and preferably between 60 mm and 115 mm in the systole, particularly preferably between 62 mm and 114 mm. The change in length of the apparatus 500 from diastole to systole is preferably a minimum of 0 mm and a maximum of 21 mm, particularly preferably a minimum of 10 mm and a maximum of 15 mm.
[0169] The first anchor 501 comprises two ends 513 and 514. A first end 513 is optionally arranged in the implanted state at the lower end of the right atrium 104 in the immediate vicinity of the base of the septal leaflet of the tricuspid valve 112. A second end 514 of the first anchor 501 is optionally arranged in the implanted state at the lower end of the left atrium 102 in the immediate vicinity of the base of the anterior leaflet of the mitral valve 111. The first anchor 501 optionally penetrates the atrial septum 124 at the lower end of the atrial septum 124 and, as shown in
[0170] The first anchor 501 is connected at its first end 513 (When referring to an end herein, this may optionally be understood as an end region. These two terms may optionally be interchanged.) in the right atrium 104 to the first end 511 of the guiding device 502. The first end 511 of the guiding device 502 penetrates the septal leaflet of the tricuspid valve 112 directly at the base of the valve leaflet. The guiding device 502 is located in the right ventricle 103, directly adjacent to the interventricular septum 125 and penetrates the heart apex 105 with its second end 512a. The second end 512a of the guiding device 502 is optionally connected to a rib 305 (see
[0171] The first anchor 501 is connected at its second end 514 in the left atrium 102 to the first end 511b of the second guiding device 503. For simplicity, the second guiding device 503 will also be referred to as guiding device hereinafter. The first end 511b of the guiding device 503 has penetrated the anterior leaflet of the mitral valve 111 directly at the base of the valve leaflet. The second guiding device 503 is located in the left ventricle 101, directly next to the interventricular septum 125 and penetrates with its second end 512b into the heart apex 105, preferably all the way through it. The second end 512b of the second guiding device 503 is optionally connected to a rib 305; alternatively, the second end 512b can be anchored directly in the heart apex 105 or on the sterno-pericardial ligament 301.
[0172] In several embodiments, the apparatus 500 according to the present invention may be implanted entirely surgically via open heart surgery. Alternatively, in several embodiments, the apparatus 500 according to the present invention may be implanted via a combination procedure using a catheter and surgical intervention. Alternatively, in several embodiments, the apparatus 500 according to the present invention may also be introduced completely by a catheter.
[0173] The complete surgical implantation is preferably carried out via a conventional heart operation.
[0174] Alternatively, in several embodiments, the implantation may be performed by performing or carrying out a combination procedure in which a catheter is used to introduce the first anchor 501 into the atrial septum via the vena cava and the right atrium 104. The chest is surgically opened over the heart apex 105, and the first two ends 511a and 511b of the guiding devices 502 and 503 are inserted over the apex 105 into the beating heart along the interventricular septum 125. In this case, the guiding devices 502 and 503 perforate the tricuspid valve 112 and mitral valve 111 from the ventricular side. The two first ends 511a, 511b of the guiding devices 502, 503 are then connected to the corresponding end 513 or 514, respectively, of the first anchor 501 under fluoroscopy at the beating heart. The second ends 512a, 512b of the guide devices 502, 503 are then openly surgically connected to a rib. Alternatively, the second ends 512a, 512b may be anchored directly in the heart apex 105 or the sterno-pericardial ligament 301.
[0175] In the fully catheter-based implantation, the guiding device 502 is inserted into the heart via the right atrium 104 and the septal leaflet of the tricuspid valve 112 is perforated with the second end 512a of the guiding device 502. The guiding device 502 is advanced into the heart apex 105 and is anchored there. Alternatively, the heart apex 105 can be perforated with the second end 512a of the guiding device 502 and then anchored in the sterno-pericardial ligament 301 or on the rib 305.
[0176] The second guiding device 503 is introduced into the heart via the right atrium 104 and advanced into the left atrium 102 via a perforation in the atrial septum 124. The anterior mitral valve leaflet 111 is perforated with the second end 512b of the guiding device 503. The second end 512b of the guiding device 503 is advanced into the heart apex 105 and anchored there. Alternatively, the heart apex 105 may be perforated with the second end 512a of the guiding device 502 and then anchored in the sterno-pericardial ligament 301 or on the rib 305.
[0177] The first anchor 501 is inserted into the heart via the right atrium 104, and the second end 514 is inserted into the left atrium 102 via a perforation in the interatrial septum 124. Under fluoroscopy, a closure system (not shown) is connected between the first end 514 of the connector 501 to the first end 511b of the guiding device 503 and between the second end 513 of the first anchor 501 to the first end 511a of the guiding device 502.
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[0180] The guiding devices 502 and 503 are stretched, the long axis of the heart 220 is longest in the heart cycle, the heart base 110 is farthest from the heart apex 105, and the aortic root 201 is correspondingly short.
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[0182] On the way back from systole in
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[0184] In
[0185] In
[0186] By pulling on the ropes 732a, 732b, the cylinders 701a, 701b are pulled over the respective pistons 702a, 702b and the respective first end 710a, 710b of the cylinders 701a, 701b moves to the first ends 720a, 720b of the pistons 702a, 702b. This results in a shortening of the guiding devices 502 and 503 and the connecting piece 501 is pulled towards the heart apex 105.
[0187] In
[0188] In addition to the apparatuses 500 described, other active shortening mechanisms are also conceivable and encompassed by the invention, such as shortening by magnetic force, by a transplanted muscle, a bioengineered muscle, or an artificial muscle, each of which may be used to generate force.
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[0190] In addition to the described second anchor 800 on the rib, other designs and anchor shapes are conceivable (e.g. also merely the use of a surgical thread), which are also encompassed by the present invention.
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LIST OF REFERENCE NUMERALS
[0192] 100 heart [0193] 101 left ventricle, [0194] 102 left atrium [0195] 103 right ventricle, [0196] 104 right atrium [0197] 105 heart apex [0198] 110 heart base [0199] 111 mitral valve [0200] 112 tricuspid valve [0201] 113 Aortic valve [0202] 114 pulmonary valve [0203] 120 heart skeleton [0204] 121 left fibrous trigone [0205] 122 right fibrous trigone [0206] 123 heart muscle [0207] 124 interatrial septum [0208] 125 interventricular septum, ventricle septum [0209] 130 aortic valve ring [0210] 131 mitral valve ring [0211] 132 tricuspid valve ring [0212] 201 aortic root [0213] 210 circumference of the ventricles in the diastole, orthogonal diameter [0214] 220 longitudinal axis of the ventricles [0215] 300 pericardium, heart sac [0216] 301 sterno-pericardial ligament [0217] 302 diaphragm, midriff [0218] 303 sternum [0219] 304 xiphoid process [0220] 305 rib [0221] 306 mediastinum, mediastinal area [0222] 401 blood flow or influx [0223] 500 apparatus for supporting heart action [0224] 501 first anchor; bracket; connecting piece between the two guiding devices [0225] 502 guiding device; lifting drive [0226] 503 guiding device; second guiding device; [0227] 511a,b first end of the guiding device [0228] 512a,b second end of the guiding device [0229] 513 first end of connecting piece 501 in the right atrium [0230] 514 second end of the connecting piece 501 in the lift atrium [0231] 701a,b cylinder; linear guiding sleeve [0232] 702a,b piston; linear guiding device [0233] 710a,b first end of the cylinder [0234] 711a,b second end of the cylinder [0235] 720a,b first end of the piston [0236] 721a,b second end of the piston [0237] 731a,b spring [0238] 732 pulling device; rope [0239] 732a,b pulling device; rope [0240] 735 first anchor; connecting piece between the atria [0241] 800 second anchor; optionally arranged on the rib [0242] 801 abutment on the outer side of the rib [0243] 802 abutment on the inner side of the rib [0244] 803 connection of the abutment on the outer side of the rib with the abutment on the inner side of the rib [0245] 804 ball joint [0246] 900 energy source [0247] 901 control unit [0248] 902 connection of control unit with guiding device