US20050113632A1 - Implantable heart assist devices and methods - Google Patents
Implantable heart assist devices and methods Download PDFInfo
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- US20050113632A1 US20050113632A1 US10/958,184 US95818404A US2005113632A1 US 20050113632 A1 US20050113632 A1 US 20050113632A1 US 95818404 A US95818404 A US 95818404A US 2005113632 A1 US2005113632 A1 US 2005113632A1
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2478—Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands
- A61F2/2481—Devices outside the heart wall, e.g. bags, strips or bands
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/10—Location thereof with respect to the patient's body
- A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
- A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
- A61M60/187—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart mechanically acting upon the inside of the patient's native heart, e.g. contractile structures placed inside the heart
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/10—Location thereof with respect to the patient's body
- A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
- A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
- A61M60/191—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart mechanically acting upon the outside of the patient's native heart, e.g. compressive structures placed around the heart
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/20—Type thereof
- A61M60/289—Devices for mechanical circulatory actuation assisting the residual heart function by means mechanically acting upon the patient's native heart or blood vessel structure, e.g. direct cardiac compression [DCC] devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/40—Details relating to driving
- A61M60/465—Details relating to driving for devices for mechanical circulatory actuation
- A61M60/468—Details relating to driving for devices for mechanical circulatory actuation the force acting on the actuation means being hydraulic or pneumatic
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/40—Details relating to driving
- A61M60/465—Details relating to driving for devices for mechanical circulatory actuation
- A61M60/47—Details relating to driving for devices for mechanical circulatory actuation the force acting on the actuation means being mechanical, e.g. mechanically driven members clamping a blood vessel
- A61M60/481—Details relating to driving for devices for mechanical circulatory actuation the force acting on the actuation means being mechanical, e.g. mechanically driven members clamping a blood vessel generated by a solenoid
-
- 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
- A61B2017/00238—Type of minimally invasive operation
- A61B2017/00243—Type of minimally invasive operation cardiac
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2478—Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands
- A61F2/2487—Devices within the heart chamber, e.g. splints
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
- A61M60/80—Constructional details other than related to driving
- A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
- A61M60/89—Valves
- A61M60/894—Passive valves, i.e. valves actuated by the blood
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- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Heart & Thoracic Surgery (AREA)
- Engineering & Computer Science (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Biomedical Technology (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Anesthesiology (AREA)
- Hematology (AREA)
- Mechanical Engineering (AREA)
- Vascular Medicine (AREA)
- Surgery (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Medical Informatics (AREA)
- Molecular Biology (AREA)
- Prostheses (AREA)
- External Artificial Organs (AREA)
Abstract
Heart support and assist devices for supporting and assisting the pumping action of the heart. Various embodiments include mesh support devices, devices using straps, spiral-shaped devices, catheter-based devices and related methods.
Description
- This application is a divisional of application Ser. No. 09/677,981 filed Oct. 3, 2000 (now pending), the disclosure of which is fully incorporated herein by reference.
- The present invention generally relates to devices used to physically support the heart and, alternatively, also actively assist the pumping action of the heart.
- The treatment of heart failure over the long term is a difficult problem. At the same time, weak cardiac muscle function is becoming an increasing problem. Patients are surviving longer and more patients are surviving myocardial infarcts leading to a large pool of patients who are inadequately served by current medical practice. Drug treatment to increase the strength of mycardial contraction has been unsuccessful over the long term. Recently, biventricular pacing (rather than the usual univentricular pacing) has been tried and this offers some promise in selected patients but is unlikely to solve the problem.
- Devices will therefore remain the mainstay of treatment for terminal heart failure. Conventional methods have been unable to inject adequate energy into the cardiovascular system. Past attempts with the Jarvic heart or other replacement systems have met with problems such as failure due to thromboembolism. The patient is typically connected to a bulky internal or external controller and power supply for the heart replacement system. The inside of the artificial heart exposes a large artificial surface area to the flow of blood and clots develop as a result. These clots eventually break off and lodge in the brain leading to strokes or resulting in ischemic injury to other body organs. It has also been postulated that long-term exposure of blood to large artificial surfaces sets up a chronic inflammatory reaction which may predispose the patient to infection.
- Currently, there are two major areas of development. A simplified system involves cannulation of the left ventricle or atrium with a tube-like structure and pumping of blood from this source into the aorta. A blood propeller system is located within the tubing of this system. A drive system powers the pump. The drive system can be located outside the patient, or can be implanted within the patient. If implanted, energy may be transmitted by induction coils from outside the body to the device. This device requires considerable residual cardiac function to operate. The heart must beat adequately to perform some function and usually only the left ventricle is supported by the device. Thus, right ventricular function must be adequate for survival.
- The second and more complex pump is a totally implantable heart. The patient's heart is entirely removed or both ventricles are cannulated and artificial left and right ventricles are attached by a surgeon. The patient has a large surface exposed to the flow of blood as the blood comes in contact with the artificial ventricles, the connection tubes and the valves. Blood clotting, hemolysis and degradation of blood become problems in this situation.
- For an entire generation, attempts have been made to create a heart assist device which leaves the native heart in place and squeezes the native heart. The blood is thus exposed only to the patient's natural tissue. Clotting on natural tissue is extremely rare. Pneumatically and electrically driven devices have been evaluated, but these devices have not reached clinical application. These devices have wrapped around the entire heart and squeezed both the left and right ventricles. Unfortunately, this does not mimic the way the heart contracts.
- U.S. Pat. No. 4,925,443 illustrates a heart assist device including a tension band which is surgically placed within an interventricular muscle wall in order to compensate for weakness of the interventricular muscle wall or septum. An operating mechanism then opens and closes a pair of pressure plates to compress the left ventricle. The drawback to this device, however, is that the interventricular wall or septum experiences significant trauma due to the surgical implantation of the band within the wall or septum itself. Especially in cases in which the interventricular wall is already weakened, such trauma could severely damage the heart.
- Another proposed device is disclosed in U.S. Pat. No. 5,119,804. With this device, the heart is placed within a cup having a vacuum source connected to hold the cup in position around the heart and having a pulsed pressure system to alternately apply relatively high positive and negative pressures to provide systolic and diastolic effects on the heart. This system, however, squeezes the entire heart muscle at one time and will tend to cause weaker portions of the heart to bulge outward while stronger portions of the heart muscle retain a normal shape. Therefore, the contraction applied to the heart muscle is not a natural one, but one that is dictated by the particular heart problems of the patient.
- Another ventricular assist device is disclosed in U.S. Pat. No. 4,685,446. This device utilizes an inflatable balloon secured to the end of a catheter and inserted into the left ventricle. The balloon is inflated during left ventricular systole and then deflated in a repeating manner. Unfortunately, this device will also tend to cause weakened portions of the heart muscle to bulge around the left ventricle rather than causing the intended function of expelling blood from the ventricle. Thus, the ejection fraction of blood can be deficient with this device as well.
- Despite the intuitively attractive nature of heart assist devices, no device has ever been clinically proven. Attention to some physiologic details will make the difference. The left ventricle is a thick-walled structure which propels blood into the systemic circulation at high pressure. The left ventricle is shaped as a truncated cone. During systole (contraction) this cone shortens along its length and narrows around its circumference. By this narrowing and shortening action, the internal volume of the left ventricular cavity decreases and blood is expelled. In a healthy heart, 60% to 70% of the blood volume (that is, the ejection fraction) is expelled on each beat. As the heart fails, the cavity enlarges, the heart wall thins and progressively smaller fractions of blood are expelled on each beat. In other words, the heart shortens and narrows much less during each beat.
- The right ventricle has been described as a bellows pump. It wraps around and attaches to the circumference of the outside of the left ventricular wall. The outside wall of the right ventricle is considerably thinner than the wall of the left ventricle and also contracts against a lower pressure. The energy consumption of the right ventricle is therefore much lower than that of the left ventricle. The right ventricle expels blood when the muscle shortens and reduces the diameter of the crescent shaped cavity which is located between the outside wall the interventricular wall or septum shared with the left ventricle.
- It is not surprising that merely squeezing the left and right ventricles with a device wrapped around both ventricles has not been successful. With previous devices, the left ventricle does not shorten from base to apex. There is also limited short axis shortening because the device does not squeeze the left ventricle in isolation, but with the right ventricle. To be effective the left ventricle requires more controlled compression. Generally, blood must be expelled from the ventricle in a more controlled and complete manner.
- The present invention is generally directed toward heart support and assist devices including fully passive restraints, combinations of passive and active devices and fully active devices for assisting with heart contractions. Passive restraints generally include an external support member, which may be a strap, web or mesh, sheathing or other member configured to extend around the outside of the heart coupled with an internal support member extending within at least one of the ventricles and against one side of the interventricular septum. This type of passive restraining system can assist the heart muscle by supporting those portions of the muscle necessary to produce efficient contractions either naturally or with another active assist device. This support is provided in a manner that minimizes trauma to the heart muscle. Additional internal tensile members, such as cables, may be connected to the external tensile member or members longitudinally and/or transversely through one or both ventricles. These cables will assist with long axis and short axis shortening of the heart muscle during each contraction.
- Combinations of passive and active devices may include, for example, external support members, in the form of straps, sheaths, wraps, mesh elements or webs, etc., combined with a blood pump connected for fluid communication directly with the left ventricle, right ventricle or both. Alternatively, a fluid inflatable bladder may be placed between the external tensile member and the outside surface of the heart to provide compression to one or both of the ventricles to assist in pumping blood through the heart. Finally, an active contraction device may integrate an external tensile member system with a powered actuator device to provide cyclical compression of the heart muscle through a pulling action on the tensile member or members.
- In another aspect, the invention is directed to a heart assist device generally including a plurality of flexible tensile members adapted to be wrapped circumferentially about the heart of a patient. At least one tensile member is configured to extend around the left ventricle and a second tensile member is configured to extend around the right ventricle. A support member is configured to be received within the right ventricle against the interventricular septum and coupled to at least one of the first and second tensile members. This support member may be a portion of at least one of the tensile members or may be a separate member connected to at least one of the tensile members. At least one powered actuator may be operatively connected with the first and second tensile members and operates to pull the tensile members respectively against the left and right ventricles to expel blood therefrom.
- More preferably, the heart assist device includes a plurality of tensile members configured to extend around the left ventricle and a plurality of tensile members configured to extend around the right ventricle. Each tensile member is secured at least indirectly to the support member. The support member is preferably a plate covered with a biocompatible material for inhibiting blood clotting. The actuator pulls the tensile members extending around the left ventricle against the outside surfaces of the heart and pulls the support member or plate against the interventricular septum in an opposing direction. The tensile members extending around the right ventricle are pulled against the left ventricle in an independent fashion.
- One preferred embodiment of the invention may include a plurality of pulley members coupled with the tensile members and operating to allow a single powered actuator, such as an electric or pneumatic actuator, to pull multiple tensile members. Alternatively, multiple powered actuators may be used to independently pull the various tensile members. The tensile members, pulleys and other actuating structure may be contained in a suitable jacket or sheath positioned around the heart.
- In accordance with another aspect of the invention, at least one internal tensile member is provided and configured to be connected lengthwise within the left ventricle between the mitral valve of the heart and the apex of the left ventricle. The internal tensile member inhibits lengthening of the ventricle when the powered actuator or actuators pull the tensile members to compress the left and right ventricles. As further options, transverse, internal tensile members may be connected within the left ventricle between the outside wall thereof and the interventricular septum to control widthwise expansion. Also, one or more internal tensile members may be utilized in the right ventricle for similar purposes.
- As additional aspects of the invention, the tensile members may be contained in sleeves to prevent cutting of the heart by the tensile members during use. Also, a plurality of coronary obstruction preventing members may be used between the tensile members and the coronary arteries on the outside of the heart for preventing the coronary arteries from being compressed and obstructed by the tensile members.
- The present invention also generally contemplates methods for assisting the pumping action of the heart. In a preferred embodiment, the method includes inserting an anchor member within the right ventricle and against the interventricular septum; encircling the outside of the right and left ventricles with respective tensile members; coupling the tensile members with the anchor member; and compressing the right and left ventricles by pulling the tensile members against the outside of the heart. Other methods will be apparent to those of ordinary skill based on a full review of this disclosure.
- In various aspects of the invention, a basic device for assisting a heart may comprise a plurality of flexible, external tensile members adapted to be wrapped circumferentially around the heart of a patient. Preferably, this includes at least a first external tensile member configured to extend around the left ventricle and a second external tensile member configured to extend around the right ventricle. In accordance with the invention, an internal support member is configured to be received within at least one of the left and right ventricles and against the interventricular septum. This support member is coupled either directly or indirectly to at least one of the first and second external tensile members. The internal support member may comprise a portion of one or more of the external tensile members or may be a separate member, such as a plate, coupled with the external tensile members. The external tensile members are preferably flat straps or other similar structures that will not harm the outside of the patient's heart, and may be formed from any biocompatible material. In various embodiments, the support members may be implanted either partially or completely through one or more catheters.
- In another embodiment of the invention, at least one of the first and second external tensile members may be configured generally in a spiral shape to facilitate the application of compression to the heart. In this embodiment, for example, one or more coils of the spiral may extend into one of the ventricles of the heart and bear against one side of the interventricular septum to form a support member as described above. An actuator is used to draw the spiral-shaped external tensile member into a tighter, coiled shape to actively compress or passively support one or both ventricles of the heart.
- In another embodiment of the invention, the first and second external tensile members are configured as first and second halves of a cup. The cup is configured to envelop the patient's heart and comprises first and second shells with at least a first bladder configured for disposition between one of the shells and an outside surface of the heart. As with the other embodiments, one or more support members extend between opposite sides of the cup and within one or both ventricles of the heart to bear against the interventricular septum. A pump is provided for selectively inflating and deflating the bladder to apply compression to at least one of the left and right ventricles. In the preferred embodiment, a bladder is connected within each of the shells associated with the cup for compressing both of the ventricles. The support member or members are connected at a position generally between the first and second halves of the cup such as by being retained in place by the same connectors used to affix each half of the cup together. The cup may be formed in one, two or more pieces and, again, is formed from any suitable biocompatible material or materials as with all of the implantable components of each embodiment.
- Various objectives, features and advantages of the invention will become more readily apparent to those of ordinary skill in the art upon review of the following detailed description taken in conjunction with the the accompanying drawings.
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FIG. 1 is a perspective view showing one embodiment of the invention in an illustrative manner coupled to a patient's heart; -
FIG. 2 is a partially fragmented perspective view showing the heart assist device ofFIG. 1 coupled to the patient's heart; -
FIG. 3 is a cross sectional view taken generally along line 3-3 ofFIG. 2 ; -
FIG. 3A is a cross sectional view similar toFIG. 3 , but illustrating optional inflatable bladders for providing a pump assist to the heart; -
FIG. 4 is perspective view illustrating an embodiment with a single powered actuator for operating the heart assist device through the use of pulleys; -
FIG. 5 is a perspective view similar toFIG. 4 , but showing independent powered actuators; -
FIG. 6 is a perspective view of another alternative assist device comprising a spiral-shaped external tensile member; -
FIG. 7 is an exploded perspective view illustrating another alternative heart assist device comprised of a split cup and inflatable bladder system; -
FIG. 8 is a perspective view of another alternative heart assist device used to directly pump blood into one or more heart chambers; -
FIG. 9 is a fragmented perspective view of the heart with another embodiment of a passive heart support device implanted around the left ventricle; -
FIG. 10 is a perspective view of a passive heart support device similar toFIG. 9 but having alternative internal support members; -
FIG. 11 is a transverse, cross sectional view of a heart with another alternative passive support device; -
FIG. 12 is a cross sectional view showing an initial step of implanting a catheter-implanted heart support device; -
FIG. 12A is a fragmented perspective view showing one embodiment of a catheter-implanted heart support device; -
FIG. 13A is a schematic, cross sectional view of the heart during a later step of implanting the catheter-implanted support device; -
FIG. 13B is a cross sectional view similar toFIG. 13A , but illustrating the fully implanted, catheter-implanted passive support device; -
FIG. 14A is a transverse, cross sectional view of a heart schematically illustrating another catheter-based implantation method of a passive support device; -
FIG. 14B is a cross sectional view similar toFIG. 14A , but illustrating a later point in the implantation procedure; -
FIG. 14C is a cross sectional view similar toFIGS. 14A and 14B , but illustrating the fully implanted support device; -
FIG. 15 is a partially sectioned, perspective view of a heart with another alternative passive support device affixed around the left ventricle; -
FIG. 16 is a schematic, perspective view showing the heart in cross section and another alternative passive support device; and -
FIG. 17 is a schematic, cross sectional view of the heart shown inFIG. 16 with the device fully implanted around the left ventricle. -
FIG. 1 illustrates a heart assistdevice 10 constructed in accordance with the invention and schematically illustrated implanted within apatient 12 in surrounding relation to the patient'sheart 14. Apower supply 16, such as an electric or pneumatic power supply, is operatively connected to heart assistdevice 10 for reasons to be discussed below. As generally shown inFIG. 2 ,heart 14 has four chambers. Theright atrium 18 receives blood flowing through veins in the patient's body. Theright ventricle 20 pumps the blood to the lungs of the patient through thepulmonary artery 22. Theleft atrium 24 receives oxygenated blood flowing back from the patient's lungs through the pulmonary vein and theleft ventricle 28 pumps this blood out through theaorta 30 to the patient's body. The right andleft ventricles device 10 will be used to increase the pumping action or expulsion of blood from the right andleft ventricles interventricular septum 32 separates the right andleft ventricles - As further shown in
FIGS. 2 and 3 ,device 10 preferably comprises a plurality of flexibletensile members 40 a through 40 f. In this embodiment, a flexibletensile member 40 a is adapted to be wrapped circumferentially around leftventricle 28, as is another flexibletensile member 40 b. A tensile member 40 c may interconnecttensile members tensile members right ventricle 20. Each of these tensile members is effectively connected to the other to form an integrated unit by connection to an internalsupport anchor member 42. In this embodiment,support member 42 comprises a plate surgically inserted intoright ventricle 20 and bearing againstinterventricular septum 32.Plate 42 may comprise a plate of rigid or semi-rigid polymeric material or metallic material covered in a biocompatible material adapted to resist blood clotting. Onceplate 42 is implanted through a suitable incision intoright ventricle 20, flexibletensile members FIG. 2 . Alternatively, one of the pairs of tensile members may be secured to plate 42, while the other pair is secured to the first pair. - As shown in
FIG. 2 ,tensile members 40 a through 40 f may, comprise flexible cables contained within a sheath or sleeve of biocompatible material. Internal flexibletensile members device 10 is used to assist with the pumping action as described further below. Twotensile members annulus 52 ofmitral valve 54 and the apex 56 ofleft ventricle 28. Abutton 58 may be used at the apex for securement purposes and may bear against the intersections oftensile members 40 c, 40 f. Transverse internaltensile members FIG. 3 between the outer wall ofleft ventricle 28 and theinterventricular septum 32.Tensile members tensile members left ventricle 28, such as by being secured to an annuloplasty ring or to a replacement mitral valve. -
FIG. 3A illustrates an alternative passive/active heart assistdevice 10′ taking the form of a modified version ofdevice 10 shown inFIGS. 2 and 3 .Device 10′ includes various elements having like reference numerals inFIG. 3 , but adds aninflatable bladder 47 which may be positioned between flexibletensile member 40 a and the outside wall ofleft ventricle 28.Bladder 47 is connected through asuitable conduit 49 to a fluid pump which may direct air or other fluid intobladder 47 in a cyclical manner. Inflation and subsequent deflation ofbladder 47 will contract leftventricle 28 against the support provided byinternal support member 42 to expel blood and subsequent deflation will allowleft ventricle 28 to expand and refill with blood. Alternatively, aninternal bladder 53 may be provided and cyclically inflated and deflated, as shown, to expel blood fromleft ventricle 28 and allow subsequent refilling of the ventricle with blood.Bladder 53 would likewise be supplied with air or other appropriate fluid through a catheter from a suitable pump device (not shown). - As further shown in
FIG. 4 , a series ofpulley members 60 may be used with asingle actuator 62, such as an electric solenoid or pneumatic actuator having areciprocating element 62 a attached to a series of cables ortensile members 63 extending throughpulley members 60.Actuator 62 may be contained in asuitable pouch 64 or other containment structure and springs 66, 68 may be used to control the amount of compression applied by cables ortensile members 63. As reciprocatingmember 62 moves inwardly in the direction of the arrow inFIG. 4 , cables ortensile members 63 will move under tension and cause simultaneous compression of the right and left ventricles. -
FIG. 5 illustrates an embodiment similar toFIG. 4 , but usingmultiple actuators heart 14.Actuator 70 applies transverse compression to an upper portion ofheart 14, whileactuator 72 applies transverse compression to a lower portion ofheart 14.Actuator 74 applies compression in a lengthwise direction. As with the other embodiments, suitable flexible tensile members, such as cables extending over or within straps, are provided to apply the compression upon operation ofactuators -
FIG. 6 illustrates another alternative heart support and assistdevice 80 formed by a generally spiral shapedtensile member 82 extending aroundheart 14.Tensile member 82 preferably comprises an outerhollow member 84 and an innermovable cable 86 connected at one end to asuitable actuator 88 affixed to ajacket 90 and at an opposite end being rigidly affixed by aconnector 92 tojacket 90. An upper end ofjacket 90 may be suitably connected toheart 14, as throughstitching 94. As shown inFIG. 6 , two coils of the spiraltensile member 82 extend intoright ventricle 20 and bear againstinterventricular septum 32 before exitingheart 14 and again extending around the outside ofjacket 90. The remaining upper and lower sets of coils extend around the outside ofjacket 90. This configuration is intended to compress both the right andleft ventricles heart 14, while focusing onleft ventricle 28, which is the ventricle with which most heart patients experience problems.Actuator 88 may be a conventional linear electric actuator that cyclically pulls oncable 86 in concert with the patient's own natural heart rhythm or as activated by a conventional pacing device which sets the patient's heart rhythm. It will also be appreciated that this type of generally spiral-shaped support device may be used in a passive manner without an active pump assist function. The spiral shape can be used for adjusting the tightness oftensile member 82 against the heart for achieving the proper amount of support. -
FIG. 7 illustrates another alternative heart assist device 100 comprised of a cup having twohalves heart 14. Eachhalf innerinflatable bladder combination - One or more
internal support members halves heart 14.Support members heart 14 and bear against the interventricular septum (not shown), as with the support members used in other embodiments of the invention. This provides support for the interventricular septum during compression of the heart without a significant amount of trauma to the heart muscle.Support members -
Respective connectors halves connectors 118 extend throughholes support members connectors 120 ofhalf 104 to connect device 100 firmly againstheart 14. Additional connectors or other means may be used to ensure that device 100 remains in position aroundheart 14. Once in position,bladders heart 14 while the opposite side of one or each of the ventricles is supported bymembers pump 124 may be connected tobladders bladders -
FIG. 8 illustrates another alternative heart assistdevice 130 comprised of aflexible strap system 132 configured for disposition around a patient'sheart 14 and connected with a suitableinternal support member 134 for bearing against one side of the interventricular septum within one of the heart's ventricles, as previously discussed. In this embodiment, at least onepump 136 is directly connected through a suitable conduit, such as acatheter 138, to one of the ventricles ofheart 14. For example, pump 136 may be connected to the left ventricle ofheart 14 for directly pumping blood into the left ventricle to assist with the movement of blood throughheart 14. Likewise, anotherpump 140 may be directly connected to the right ventricle ofheart 14 through anotherconduit 142 for assisting with blood flow through the right ventricle.Pumps -
FIG. 9 illustrates a passiveheart support device 150 shown implanted on aheart 14 and, specifically, aroundleft ventricle 28.Support device 150 includes a flexible mesh orweb material 152 serving as an external support member aroundleft ventricle 28 and a plurality ofinternal support members right ventricle 20 and againstinterventricular septum 32.Internal support members web element 152 in numerous ways, such as by stitching or other quicker connection means. At least one end ofinternal support members web element 152 for extension throughright ventricle 20 during implantation and then adjusted for tightness onheart 14 and secured to mesh orweb element 152 preferably at an opposite side of the heart. If necessary, anexternal sheath 160, which may be elastic in nature, may receiveheart 14 after attachingdevice 150, as a further securement means.Sheath 160 may include anopen end 162 and aclosed end 164. -
FIG. 10 illustrates analternative device 150′, which is similar todevice 150, and includes a mesh orweb element 152 for supporting an external portion of the heart. A plurality ofinternal support members mesh element 152.Device 150′, for example, may be introduced into a patient's chest through a relatively small port hole and, using catheter-based devices,internal support elements FIG. 9 . -
FIG. 11 illustrates another alternativepassive support device 170 comprising anexternal support portion 172, which may again be another flexible mesh orweb element 172 andinternal support member support member 176 extends only partially along theinterventricular septum 32 andinternal support member 174 extends throughseptum 32 and connects withexternal support member 172 at one end andinternal support member 176 at an opposite end.Support members Additional support members internal support member 174. -
FIGS. 12, 12A and 13A-B illustrate a partially catheter-based implantation device and method. Specifically, acatheter 190 having a sharpenedportion 192 is introduced from avein 194, for example, originating in the groin of the patient.Catheter 190 entersright atrium 18 and pierces throughwall 18 a intoright ventricle 20. Aheart support device 200 may comprise a cable which, for example, may include a sheath (not shown) and which acts as both an external and internal support members forheart 14.Catheter 190 may be used to introduce opposite ends ofsupport device 200 through opposite walls ofright ventricle 20, as shown inFIG. 13A . Piercingmember 192 may, for example, extend to fully pierce through the wall of the heart, ordevice 200 itself may pierce through the wall ofheart 14.Device 200 includes two looped ends 202, 204 with at least one of these ends being collapsible in the form of a tightening noose. In the embodiment shown, this isend 204. Atool 210 may be introduced through a small port hole in the patient's chest and includes ahook member 212.Tool 210 extends throughloop 204 and hook 212 may be used to grasp loopedend 202 to pull it through loopedend 204. Loopedend 204 is then tightened as shown inFIG. 13B so that an internal portion 200 a ofdevice 200 lies againstseptum 32 withinright ventricle 20 and another portion 200 b ofdevice 200 lies on the external surface ofheart 14 adjacentleft ventricle 28. -
FIGS. 14A and 14B illustrate another alternative embodiment of the invention in the form of a completely catheter-based fixation method using first and secondflexible gripper members Gripper members support member 230.Support member 230 includes respective ends 230 a, 230 b retained between jaws 220 a and 222 a. As with the previous embodiment,gripper members right ventricle 20, pierced through theheart wall 14 aadjacent septum 32 and directed around the outside ofleft ventricle 28.Support member 230 includes ratchet-type connector ends 230 a, 230 b which may be connected together as shown inFIG. 14B withend 230 b being inserted intoend 230 a and retained by the teeth onend 230 b. Jaws 220 a, 222 a release ends 230 a, 230 b and then are used to grip theopposite end ends device 230 aroundleft ventricle 28. It will be appreciated that other forms of the device, as well as other forms of the connecting and locking elements may be used as well. Also, other portions of the heart may be supported and this type of catheter-based insertion method and device may be used in conjunction with other supporting and/or assisting devices. -
FIG. 15 illustrates another alternativeheart support device 240 comprised of threeflexible support members left ventricle 28.Portions right ventricle 20 and connect with asupport plate 248 lying againstseptum 32. -
FIGS. 16 and 17 illustrate another alternative passiveheart support device 250 comprising a substantially rigid annular member having two ends (not shown) affixed to one another by aconnector 252. Two inwardly projectingportions portions Support member 250 is rigid enough to provide such support in a manner that prevents undesirable, outward bulging of the heart muscle. As apparent fromFIG. 16 ,device 250 may also be configured to extend only around the outside surface of the heart. - While the present invention has been illustrated by a description of preferred embodiments and while these embodiments have been described in some detail, it is not the intention of the Applicants to restrict or in any way limit the scope of the appended claims to such detail. Additional advantages and modifications will readily appear to those skilled in the art. The various features and concepts of the invention may be used alone or in numerous combinations within each embodiment or between the embodiments depending on the needs and preferences of the user. This has been a description of the present invention, along with the preferred methods of practicing the present invention as currently known. However, the invention itself should only be defined by the appended claims, wherein we claim:
Claims (39)
1. A system for supporting a heart having a left and right ventricles separated by an interventricular septum, the system comprising:
at least one catheter,
at least one flexible support member configured to be carried within said catheter and having first and second connecting ends, said flexible support member capable of being introduced through said catheter into one of said ventricles, around an external portion of the other of said ventricles and secured using at least one of said connecting ends such that a portion of the flexible support member supports the interventricular septum within said one ventricle and another portion of the flexible support member supports the external portion of the other ventricle.
2. The system of claim 1 , wherein said connecting ends are configured to be connected to each other.
3. The system of claim 2 , wherein at least one of said connecting ends includes a locking element for engaging the other connecting end and locking the first and second connecting ends together.
4. The system of claim 1 , wherein one of said connecting ends is configured to receive the other connecting end in an adjustable manner to allow adjustable pressure to be applied around the other ventricle.
5. The system of claim 1 , wherein said connecting ends each comprise loops.
6. The system of claim 1 , further comprising two of said catheters, each catheter including a gripping element for gripping a respective connecting end.
7. A device for supporting a heart, said device comprising a rigid annular band configured to have at least a portion bear against an external surface of the heart, said portion including an inward projection for supplying selective inward pressure against a selected area of the external surface of the heart.
8. The device of claim 7 , further comprising a plurality of said inward projections disposed at spaced apart locations of said rigid annular band.
9. The device of claim 7 , wherein said rigid annular band is configured to lie entirely outside the heart against the external surface.
10. (canceled).
11. (canceled).
12. (canceled).
13. (canceled).
14. (canceled).
15. (canceled).
16. (canceled).
17. (canceled).
18. (canceled).
19. (canceled).
20. (canceled).
21. (canceled).
22. (canceled).
23. (canceled).
24. (canceled).
25. (canceled).
26. (canceled).
27. (canceled).
28. (canceled).
29. A method of supporting a heart having a plurality of walls, the method comprising:
introducing at least one catheter into the heart,
introducing a heart support member through the catheter and into the heart, and
securing the heart support member adjacent at least one of the walls of the heart to restrict movement of the one wall during a heartbeat.
30. The method of claim 29 , wherein the heart includes left and right ventricles separated by an interventricular septum, and said catheter is introduced into the right ventricle.
31. The method of claim 30 , further comprising:
securing the heart support member adjacent the interventricular septum within the right ventricle.
32. The method of claim 30 , further comprising:
supporting an outer surface of the left ventricle using the heart support member.
33. A method of supporting a heart having a plurality of walls, the method comprising:
securing a support member adjacent a weakened area of at least one of the walls, and
applying discreet pressure to a selected area of the weakened area using an inwardly projecting portion of the support member.
34. The method of claim 33 , wherein the weakened area is an area containing a papillary muscle of the heart.
35. The method of claim 33 , wherein the support member further comprises an annular band of rigid material, and the method further comprises:
securing a first portion of the band adjacent an external wall of the heart, and
securing a second portion of the band adjacent an internal wall of the heart.
36. The method of claim 35 , wherein the heart includes left and right ventricles separated by an interventricular septum and wherein:
the first portion of the band is secured adjacent the interventricular septum of the heart, and
the second portion of the band is secured adjacent an external wall of at least one of the right and left ventricles.
37. A method of assisting the pumping action of the heart having left and right ventricles separated by an interventricular septum, the method comprising:
inserting a support member within one of the right and left ventricles and against the interventricular septum,
encircling the outside of the other of the right and left ventricles with at least one external member, and
coupling the external member with the support member, and
compressing said one ventricle in a direction toward the interventricular septum.
38. The method of claim 37 , wherein the compressing step is performed by inflating a bladder between the external member and an outside wall of the heart.
39. The method of claim 37 , wherein the compressing step is performed by pulling said external member with a tensile force.
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- 2000-10-03 US US09/677,981 patent/US6808483B1/en not_active Expired - Fee Related
-
2001
- 2001-09-17 WO PCT/US2001/028995 patent/WO2002028450A2/en active Application Filing
- 2001-09-17 EP EP01968916A patent/EP1322229A2/en not_active Withdrawn
- 2001-09-17 AU AU2001289120A patent/AU2001289120A1/en not_active Abandoned
-
2004
- 2004-10-04 US US10/958,184 patent/US20050113632A1/en not_active Abandoned
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Cited By (21)
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US20050234289A1 (en) * | 2003-06-26 | 2005-10-20 | Anstadt Mark P | Therapeutic agent delivery apparatus with direct mechanical ventricular assistance capability |
US20060142634A1 (en) * | 2003-06-26 | 2006-06-29 | Advanced Resuscitation, Llc | Sensor-equipped and algorithm controlled direct mechanical ventricular assist device |
US20060167334A1 (en) * | 2003-06-26 | 2006-07-27 | Anstadt Mark P | Method and apparatus for direct mechanical ventricular actuation with favorable conditioning and minimal heart stress |
US20040267086A1 (en) * | 2003-06-26 | 2004-12-30 | Anstadt Mark P. | Sensor-equipped and algorithm-controlled direct mechanical ventricular assist device |
US20100152523A1 (en) * | 2005-11-28 | 2010-06-17 | Myocardiocare, Inc. | Method and Apparatus for Minimally Invasive Direct Mechanical Ventricular Actuation |
US9925318B2 (en) * | 2008-10-10 | 2018-03-27 | Peter Forsell | Heart help device, system, and method |
US20170021073A1 (en) * | 2008-10-10 | 2017-01-26 | Peter Forsell | Heart help device, system, and method |
US20110196189A1 (en) * | 2010-02-09 | 2011-08-11 | Myocardiocare, Inc. | Extra-cardiac differential ventricular actuation by inertial and baric partitioning |
US10828409B2 (en) | 2011-12-01 | 2020-11-10 | The Trustees Of The University Of Pennsylvania | Non-blood contacting mechanical device that improves heart function after injury |
EP2785393A4 (en) * | 2011-12-01 | 2015-09-02 | Univ Pennsylvania | A non-blood contacting mechanical device that improves heart function after injury |
US11752321B2 (en) | 2011-12-01 | 2023-09-12 | The Trustees Of The University Of Pennsylvania | Non-blood contacting mechanical device that improves heart function after injury |
US11185677B2 (en) | 2017-06-07 | 2021-11-30 | Shifamed Holdings, Llc | Intravascular fluid movement devices, systems, and methods of use |
US11717670B2 (en) | 2017-06-07 | 2023-08-08 | Shifamed Holdings, LLP | Intravascular fluid movement devices, systems, and methods of use |
US11511103B2 (en) | 2017-11-13 | 2022-11-29 | Shifamed Holdings, Llc | Intravascular fluid movement devices, systems, and methods of use |
US10722631B2 (en) | 2018-02-01 | 2020-07-28 | Shifamed Holdings, Llc | Intravascular blood pumps and methods of use and manufacture |
US11229784B2 (en) | 2018-02-01 | 2022-01-25 | Shifamed Holdings, Llc | Intravascular blood pumps and methods of use and manufacture |
US11964145B2 (en) | 2019-07-12 | 2024-04-23 | Shifamed Holdings, Llc | Intravascular blood pumps and methods of manufacture and use |
US11654275B2 (en) | 2019-07-22 | 2023-05-23 | Shifamed Holdings, Llc | Intravascular blood pumps with struts and methods of use and manufacture |
US11724089B2 (en) | 2019-09-25 | 2023-08-15 | Shifamed Holdings, Llc | Intravascular blood pump systems and methods of use and control thereof |
US11383076B2 (en) | 2020-10-01 | 2022-07-12 | Lifebridge Technologies, Llc | Pump regulation based on heart size and function |
US11896812B1 (en) | 2023-01-27 | 2024-02-13 | Lifebridge Technologies Llc | Versatile modular heart pump for non-blood contacting ventricular function augmentation |
Also Published As
Publication number | Publication date |
---|---|
US6808483B1 (en) | 2004-10-26 |
WO2002028450A2 (en) | 2002-04-11 |
AU2001289120A1 (en) | 2002-04-15 |
EP1322229A2 (en) | 2003-07-02 |
WO2002028450A3 (en) | 2002-08-15 |
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Legal Events
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