WO1998030271A1

WO1998030271A1 - Apparatus for cardiac treatment

Info

Publication number: WO1998030271A1
Application number: PCT/IL1998/000008
Authority: WO
Inventors: Jacob Platzker; Menachem Scher; Amnon Kritzman
Original assignee: Pulscare Ltd.
Priority date: 1997-01-13
Filing date: 1998-01-07
Publication date: 1998-07-16
Also published as: AU5339398A; IL120000A0

Abstract

A cardiac treatment apparatus is provided, comprising an inflatable balloon (3) for massaging a patient's heart (14); an expandable structural member connected to the balloon, the expandable structural member being capable of adopting a predetermined three-dimensional shape, thereby providing a predetermined three-dimensional shape to the inflatable balloon (3); an internal guiding member (2) for insertion into the patient's chest cavity through an incision, the guiding member (2) for receiving the inflatable balloon (3), and the expandable structural member therein. Preferably, the expandable structural member is in the form of a wire having a predetermined path of expansion and capable of adopting a predetermined three-dimensional shape upon emerging from the internal guiding member (2). The apparatus further includes an external guiding member (2) for positioning substantially on the patient's sternum (13), the external guiding member (2) being firmly connected to the internal guiding member (2) so as to provide effective guidance of the internal guiding member (2) within the patient's chest cavity.

Description

APPARATUS FOR CARDIAC TREATMENT

FIELD AND BACKGROUND OF THE INVENTION

The present invention relates to devices for cardiac treatment, and more particularly to such devices which include means for massaging the heart during situations wherein the patient's heart fails to supply a required amount of blood to the patient's body.

When the patient's heart fails to supply the blood required for the normal functioning of the internal body organs, a state known as "Multi-organ failure" may occur, which is usually fatal, leading to the patient's death. This state occur suddenly, like during a heart attack which hinder the ability of the heart to contract and then the patient enters a state of shock, accompanied with a drastic decrease in blood pressure and a disturbance in the heart rate. The patient loses consciousness and enters a hazardous state. Without a resuscitation intervention, an irreversible damage occurs, followed by death.

Heretofore, when the "Multi-organ failure" was detected, the medical personnel immediately applied the Cardio-Pulmonary Resuscitation (CPR) procedure. The procedure comprises a number of redefined segments which are performed in a predefined sequence and timing. This includes respiration stimulation directly or using an artificial respiration means, and cardiac massage. Cardiac massage consists in manually applying a varying pressure on the chest, usually at the rate of about 60 per minute. The purpose of the massage is to squeeze the heart and thus to improve the ability of the heart to contract and to re-start its normal operation. The problem with the above detailed prior art cardiac massage procedure is that the heart is not easily accessible from the outside, since the sternum and ribs are acting as a barrier. This barrier interferes with the cardiac massage and decreases its efficiency. Still, the cardiac massage achieves at times its goal of restoring the blood supply and blood pressure, with concurrent improvement in the respiratory function.

Another resuscitation method includes cardiac defibrillation, that is application of an electrical energy to stimulate the heart. This is no always effective, and may cause damage to the heart and to other internal organs, because of the strong voltages being used.

Another resuscitation method includes open chest surgery. This procedure is more difficult to perform, and the patient's recovery period is longer.

Still more difficult procedures involve heart transplantation. This attempted when it is difficult to stimulate the heart to perform as desired.

It is an objective of the present invention to provide for a device for applying a more effective cardiac massage, to restore the normal functioning of the heart during a heart failure state.

Further, it is an objective of the present invention to provide a cardiac assist device which can be used in non-emergency cases so as to provide effective massaging of the heart, preferably under the monitoring of X-ray imaging.

SUMMARY OF THE INVENTION

According to the present invention there is provided an inflatable balloon which is inserted into the chest cavity, to perform cardiac massage when the heart is failing to provide the required blood supply to the body.

According to one aspect of the present invention, the device includes balloon mounted inside a rigid guide, to form a structure which requires only a small incision to be made in the body, about 1 cm diameter, for its insertion. The balloon is contained in the guide, in its deflated state. Thus no large wounds are left after the treatment, and the patient can recover faster, with less suffering. Although this is an invasive procedure, the intervention is minimal.

According to a second aspect of the present invention, the device includes a balloon shaped such as to be capable of massaging the heart, while being periodically inflated and deflated.

According to a third aspect of the present invention, the massage is performed either by changing the pressure in the balloon, or by applying a varying force on the balloon from the outside.

According to a fourth aspect of the present invention, the device performs a more effective cardiac massage, by locating the balloon close to the heart, where the sternum and ribs do not act as a barrier. Actually, the sternum and ribs aid the massage by providing a support base for the balloon, while the balloon applies the desired force on the heart during the cardiac massage.

According to a fifth aspect of the present invention, the balloon can shaped for effective massage, or a plurality of balloons may be used. In the latter case, the balloons may be inflated in a predefined sequence, to massage the various parts of the heart to achieve the desired therapeutical effect. Pressure may, be applied sequentially to the left and the right chambers of the heart. According to a sixth aspect of the present invention, the device can be implanted, to be left in the body and later activated to perform the cardiac massage immediately when required. For that purpose, the device may include a cardiac activity sensor, which detects cardiac failure and immediately activates the cardiac massage. According to a seventh aspect of the present invention, the device includes a balloon with means for massage in both the heart and the lungs.

According to an eighth aspect of the present invention, the device is shaped like a cast surrounding the heart, to better massage the heart.

According to a ninth aspect of the present invention, the inflating balloon holds electrodes for electrical stimulation of the heart. This allows to bring the electrical energy directly to the heart, with the benefit that a lower energy is required than that which is required for externally applied defibrillation. Another benefit is that no major surgery procedure is required, only a small cut to insert the guide. Further according to the present invention there is provided apparatus for cardiac treatment, comprising: (a) an inflatable balloon for massaging a patient's heart; (b) an expandable structural member connected to the balloon, the expandable structural member being capable of adopting a predetermined three-dimensional shape, thereby providing a predetermined three dimensional shape to the inflatable balloon; (c) an internal guiding member for insertion into the patient's chest cavity through an incision, the guiding member for receiving the inflatable balloon and the expandable structural member therein.

Preferably, the expandable structural member features a predetermined path of expansion. Preferably, the expandable structural member is in the form of a wire capable of adopting a predetermined three dimensional shape upon emerging from the internal guiding member. Alternatively, the expandable structural member is in the form of a net of wires capable of adopting a predetermined three dimensional net shape upon emerging from the internal guiding member. Preferably, the apparatus further includes an external guiding member for positioning substantially on the patient's sternum, the external guiding member being firmly connected to the internal guiding member so as to provide effective guidance of the internal guiding member within the patient's chest cavity. Preferably, the external guiding member includes a securing member for fixing the guiding members at a required position. The securing member may be in the form of a springy rod connected to said external guiding member. Alternatively, the securing member may include a screwing element. Alternatively, the securing member may be include a connector connectable to a strap, the strap for fastening around the patient's body. Further, the internal guiding member may include a sealing member having slots, the sealing member being slidable on the internal guiding member.

According to further features of preferred embodiments of the invention described below, the apparatus further includes a substantially elongated accommodating member for accommodating the inflatable balloon and the expandable structural member, the accommodating member featuring a slot for receiving a movable handle member therein, the handle member being connected to the expandable structural member.

Preferably, the handle member includes a passageway extending therethrough, the passageway being in fluid communication with the inflatable balloon and with an inflating system. Preferably, the accommodating member is detachable. According to another embodiment, the expandable structural member is in the form of two spreadable arms having a common axis. The opening of the arms may be manually controlled by means of a screwing member. Alternatively, the opening of the arms may be manually controlled by means of a piston member. According to still further features in preferred embodiments of the invention described below, the inflatable balloon is specifically manufactured so as to adopt a predetermined three dimensional shape such as an expandable accordion shape.

The present invention successfully addresses the shortcomings of the presently known configurations by providing cardiac treatment apparatus which enables controlled and accurate positioning of an inflatable balloon between the heart and sternum of a patient while eliminating the risk of possible damage to the patient's internal organs.

Specifically, the present invention addresses the shortcomings of the presently known configurations by providing a cardiac treatment apparatus including an expandable structural member capable of adopting a predetermined three dimensional shape, preferably through a predetermined path of expansion, the expandable structural member serving as a frame to an inflatable balloon so as to provide a predetermined three dimensional shape to the balloon. By having a predetermined path of expansion, the expandable structural member appropriately spreads the inflatable balloon within the patient's chest cavity prior to inflation.

Further, the present invention successfully addresses the shortcomings of the presently known configurations by providing such cardiac treatment apparatus having a guiding assembly, the guiding assembly including an internal guiding member for insertion into the patient's body through an incision, and an external guiding member for positioning on the patient's sternum so as to ensure accurate positioning of the internal guiding member, and therefore the inflatable balloon, within the patient's chest cavity.

BRIEF DESCRIPTION OF THE DRAWINGS

The invention is herein described, by way of example only, with reference to the accompanying drawings, wherein:

Fig. 1 is a partially broken view illustrating the method of insertion the wide between the ribs and the heart;

Fig. 2 is a side view illustrating the location of the balloon between the ribs and the heart in the chest cavity;

Fig. 3 illustrates a balloon having a simple structure and its placement close to the heart; Fig. 4 illustrates a balloon including means for performing massage of each of the right and the left chamber of the heart, in its inflated state;

Fig. 5 illustrates a balloon including means for performing massage on each chamber of the heart, in a packed configuration;

Fig. 6 details a balloon in contact with the heart and performing massage using an externally generated force; Fig. 7 illustrates an implantable balloon for cardiac massage;

Fig. 8 details a balloon with means for massaging both the heart and lunges;

Fig. 9 details a balloon shaped like a cast surrounding the heart; Fig. 10 is a perspective view of a preferred embodiment of a device according to the present invention including a guiding assembly and an expandable structural member capable of adopting a predetermined three dimensional shape;

Figs 1 1 and 12 are perspective views of packed and partially expanded configurations of a device according to the present invention;

Fig. 13 illustrates the usage of a device according to the present invention;

Fig. 14 shows another embodiment of a device including a guiding assembly and an expandable structural member. Fig. 15 shows a preferred embodiment of a guiding assembly according to the present invention;

Fig. 16. shows a preferred embodiment of a balloon according to the present invention;

Figs. 17 and 18 are perspective views of another embodiment of a device according to the present invention including spreadable arms.

DETAILED DESCRIPTION OF THE INVENTION

A preferred embodiment of the present intention will now be described way of example and with reference to the accompanying drawings. Referring to Fig. 1, an example of apparatus and method for cardiac treatment according to the present invention are shown. A partially broken view of the patient's body 1 is illustrated, detailing the insertion of guide 2 between the ribs 12 and the heart 14. Usually, during cardiac assist procedure, the cardiac massage has a limited effectiveness since the massage is external, such that the ribs 12 and sternum 13 present a barrier between the therapist.

According to the present invention, a guide 2 is inserted into the patient's body 1 through an opening 15 in the body. Opening 15 is a small incision, the size of about 1 cm, made for the purpose of inserting the guide 2 therethrough into the body 1. Guide 2 may be a rigid tube, preferably metallic, and shaped such as to be adapted to be inserted into the body 1 in the fatty space between heart 14 and ribs 12, as shown. An inflatable balloon (not shown) contained in the guide 12 is next inflated, such as to perform the cardiac massage while the balloon is close to the heart 14, with optional contact with the heart 14.

This physical closeness between the massage performing means (the balloon) and the heart 14 results in a more effective cardiac massage which has better chance to restore the normal functioning of the heart during a heart failure state, to restore the required blood supply to the body.

The shape of guide 2 is adapted to the internal human anatomy such as to bring the end of guide 2 to the desired location close to the heart 14, as detailed above. Several sizes of the device may be required, to adapt to children and adults of various sizes. The diameter and cross-section of the guide 2 is such as to contain a balloon to be detailed below. An opening (not shown) in guide 2 and close to its end allows the balloon contained in guide 2 to expand out of the guide when it is inflated.

To insert guide 2 into the body 1 according to the present invention, only a small incision is to be made in the body. This device and method leaves no large wounds after the treatment, and the patient can recover faster with less suffering. No large scars are left. Although this is an invasive procedure, the intervention is minimal.

In one embodiment of the present invention, guide 2 is used only for the insertion and extraction of the balloon, with guide 2 being removed during the actual cardiac massage performance. To allow the inflation of the balloon, guide 2 has openings on its sides (not shown) or is openable. In another embodiment, the guide 2 is left in place as illustrated in Fig. 1, and may have an additional function, that is to transfer an externally generated force or moment to the heart.

Referring to Fig. 2, a cross-sectional side view of the patient's body 1 is detailed, illustrating the location of the inflatable balloon 3 between the sternum 13 or ribs (not shown) and the heart 14, in the chest cavity. Opening 15 in the body 1 is an incision used for the insertion of the guide (not shown) which positions the balloon 3 into the location as shown. Balloon 3 has preferably a size similar to that of the heart 14.

Tube means 32 connected between the balloon 3 and actuator means including pressure generating means (not shown) located external to the body 1, is used to transfer a fluid pressure to balloon 3, to periodically and alternately inflate and deflate it. This change in the pressure inside balloon 3 results in a change in its shape, which results in the desired cardiac massage.

The device with balloon 3 performs a more effective cardiac massage, since the balloon 3 is close to the heart 14, while the sternum 13 and ribs (not shown) do not act as a barrier anymore. Actually, the sternum 13 and ribs aid the massage by providing a support base for the balloon 3, to keep the balloon in place while the balloon 3 applies the desired force on the heart 14 during the cardiac massage.

The balloon 3 may be inflated using a liquid or a gas medium. A gas like air results in a more soft and tender touch; the disadvantages are that a larger volume of fluid is to be transferred through tube 32, to reach the desired pressure and force. Suitable means should be included in the device, to prevent air release or leakage into the body 1, which may have undesired effects.

A liquid like water may be used to apply a larger force during the massage. A smaller volume of fluid needs be inserted into balloon 3 during each cycle of the massage, since the liquid is practically incompressible. Even if some of the water leaks into the body, no harm is usually done if the water is sterile.

According to a specific configuration, balloon 3 may include a plurality of chambers, wherein a portion of the chambers is inflated by gas and the other portion is inflated by liquid.

In accordance with another aspect of the present invention, the inflating balloon 3 holds electrodes 61 and 62 for electrical stimulation of the heart 14. One or more electrodes can be used. If only one electrode is used, then the circuit is closed with the other electrode (not shown) being connected externally to the body, on the patient's back for example. Electrodes 61, 62 are connected to a source of electrical energy (not shown) external to the patient's body, through electrical cables or connectors (not shown) running in parallel with tube 32.

This novel combination, of electrode 61 attached to an inflatable balloon 3, allows to bring the electrical energy directly to the heart 14, with the benefit that a lower energy is required than that which is required for externally applied defibrillation. Thus, less damage is done to the body during the procedure.

Another benefit is that no major surgery procedure is required, only small cut to insert the guide (not shown), which serves to insert balloon 3. One should keep in mind that the heart performs a complex movement during its normal operation, including both an inflation/deflation movement and a rotation about its axis. The balloon should not interfere with these movements.

One method to achieve this is to prevent continuous contact between balloon and heart. Thus, the balloon is alternately inflated and deflated, such as to both massage the heart and not to stop its movement. This method is also usable for defibrillation purposes - the high voltage electrical pulse is applied while the balloon is inflated and momentarily touching the heart or being close thereto. The balloon recedes afterwards, such as not to interfere with the heart movement. Another method is to mount the balloon on a movable base (not shown) which allows the lateral movement and/or the rotation of the balloon, to allow its movement together with the heart. This can be accomplished using a guide or linear sliding bearings or similar device for the line movement, and a rotary joint or rotary bearings for the rotational movement of the balloon.

Referring to Fig. 3, balloon 3 is shown in its inflated state, with heart 14 underneath the balloon 3. Balloon 3 may actually touch the heart 14, in which case it should include a soft smooth surface such as not to harm the heart 14. In another implementation, the shape of the guide (not shown) and the size and shape of balloon 3 are such that there is no contact between balloon 3 and heart 14 . but the massage is applied through a soft layer of tissue in the body.

Tube means 32 is used to transfer a variable pressure to balloon 3 from the outside to sequentially inflate and deflate it, such as to perform the desired cardiac massage. A vibrating pump as known in the art may be used to generate the variable pressure as desired.

Referring to Fig. 4, a more complex structure of balloon 3 is detailed. Here balloon 3 includes an inner left chamber balloon 33 and inner right chamber balloon 34 which come into contact with or are close to the heart (not shown). Balloons 33, 34 are made of a soft and smooth material, and are kept constantly in an inflated state, such as to present a soft, gentle touch to the heart to prevent damage.

Outer left chamber balloon 35 and outer right chamber balloon 36 can be individually inflated and deflated through tube means 325 (to transfer pressure to balloon 35) and tube means 326 to (transfer pressure to balloon 36). in a preferred embodiment, balloons 35 and 36 are alternately inflated, to alternately apply a pressure on the left chamber and the right chamber of the heart (not shown) through balloons 33 and 34, respectively. This applies a coordinated massage to the left and right chambers of the heart, to achieve the desired therapeutical effect. During the insertion of the balloon 3 into the patient's body (not shown), balloons 33, 34, 35, 36 are contained in guide 2 and balloon shell 23, which is made of a rigid material and supports the insertion the device. After the insertion of balloon 3, guide 2 and shell 23 may left in place or removed. Preferably, upper tip 24 of guide 2 should be rounded or should include a sharp point, to facilitate its insertion; the same considerations apply to the upper end of shell 23.

Referring to Fig. 5 , the device detailed with reference to Fig. 4 above is illustrated in its contracted state, prior to insertion into the patient's body. The balloon including its various parts (not shown) is contained in the rigid structure formed by guide 2 and shell 23. Upper tip 24 of guide 2 is rounded, to facilitate its insertion.

Tube means 325 and 326, which are connected to the balloon as detail above, are inserted together with guide 2 and balloon shell 23, with ends of tube means 325 and 326 being left outside of the patient's body, to transfer the fluid pressure as required.

Referring to Fig. 6, another embodiment of the present invention is detailed. Here, the massage is performed by approving a varying force the inner balloon 37 from the outside. In this embodiment, guide 2 is left inside the body 1 during the application of the cardiac massage. Guide 2 also serves to transfer an external force 28 applied about external axis of rotation 27 to the heart 14, through balloon 37. Opening 15 is used for guide 2 insertion into patient's body 1. under sternum 13 and close to the heart 14. Tube means (not shown) are used to inflate balloon 37 after its insertion into the patient's body, and deflate it prior to extraction after the treatment.

Referring to Fig. 7, an implantable device is detailed. The device contained in enclosure 4 and including balloon 37 is implanted, to be left in the body and later activated to perform the cardiac massage immediately when required. For that purpose, the device may include a cardiac activity sensor (not shown), which detects cardiac failure and immediately activates the cardiac massage.

Inner balloon 37 is made of a soft material, such as not to damage the heart 14 which is located underneath the balloon 37. The device is preferably inserted using a guide (not shown), between the heart 14 and sternum 13.

Sealed enclosure 4 is made of a flexible material, and includes electrical motor and gear means 41 , with rotating arms 42. Motor 41 is mounted on rigid support 43, which includes attaching means 44 to attach the device to sternum 13 and or ribs (not shown). The device can be left in the patient's body, it remaining in an inactive state (only monitors the heart activity, without performing cardiac massage), until a heart failure state is detected. When a heart failure is detected, then motor means 41 is activated to massage the heart 14, such as to restore it to normal operation. Fig. 8 details a balloon with means for massaging both the heart and the lungs. One advantage is the simultaneous stimulation of both the heart and the lungs, while generating a pressure differential between the chest cavity and the lungs.

Another advantage is that a sizeable quantity of blood is contained in lungs. The pressure applied to the lungs results in blood circulation, with blood flowing from the lungs into the right chamber of the heart. This achieves a more effective massage, to restore blood circulation in the patient.

To achieve this combined massage, the device contains balloon shell 23 which is inserted into the patient's body as detailed above. Tube means 325 is used to transfer fluid pressure to inner balloon 37, used to perform heart massage. Tube means 326 is used to transfer fluid pressure to left lung massage wing 382 and right lung massage wing 383, for combined heart and lungs massage. Additional tubes (not shown) may be used, to better control the inflation of parts of the above mentioned balloons, to achieve a more precise and focused massage effect.

In a preferred embodiment, the heart massage is synchronised with the EKG, for example using sensing electrodes (not shown) attached to balloon 37 or externally to the patient's body. Referring to Fig. 9, which details a spherically-shaped cast 5 surrounding the heart like a glove, cast 5 comprises a plurality of long and narrow balloons 52 which, in the inflated state, form the generally spherical cast. Opening 53 in the upper part of cast 5 is used to insert cast 5, in its inflated state, around the heart (not shown) such that the heart is enclosed within the cast 5. In this position, cast 5 can be used to perform a massage over the whole perimeter of the heart.

In a preferred embodiment, the heart massage is synchronised with the EKG, for example using sensing electrodes (not shown) attached to the cast 5 or externally to the patient's body. It is possible to activate cast 5 synchronously with the EKG, but sometimes this is not necessary, since it suffices to apply an intermittent massage. For example, one inflation/deflation cycle of cast 5 may be done for every third EKG pulse, to achieve a massage ratio 1 :3. The desired ratio may be decided upon by the medical personnel during the treatment.

Again, the complex movement performed by the heart during its normal operation should be taken into consideration. As detailed above with reference to Fig. 2, the movement includes both an inflation/deflation movement and a rotation about its axis. The methods used above are to be used also with the cast 5, such as the cast 5 should not interfere with these movements.

There is a natural tendency of cast 5 to slip down and out of the heart, both because of the force reacting to the force applied to the heart, and the gravity (weight of the cast 5). To solve that problem, the device is anchored to the ribs using anchor and support means 45, which are attached to the (not shown) sternum and/or chest cavity.

The cast 5 can be inserted using an open heart procedure, or through a rigid guide inserted under the sternum as detail above. The pump used to move the fluid to inflate/deflate the balloons may be located in the body or may be external thereto. An external pump may be electrically activated or manual. It can be attached to the body, with a belt for example. For internal use, pumps using existing technology may be used, for example Intra - Aortic Balloon Pumps, IABP. Several such pumps may be installed, with coordinated operation for improved therapeutical effect.

Another embodiment of a device according to the present invention is shown in Figs. 10- 13. As shown in the figures, an expandable structural member 102 connected to balloon 100 is used for appropriately spreading and positioning balloon 100 within the chest cavity of a patient, so as to eliminate the risk of possible damage to the patient's internal organs such as lungs, blood vessels, and the heart itself upon introduction of the device.

As shown , expandable structural member 102 may be in the form of a wire preferably made of a material having self memory, such as Nitinol, or any other suitable material capable of adopting a predetermined three dimensional shape upon emerging from guide 104.

Preferably, expandable structural member 102 features a predetermined path of expansion so as to prevent damage to internal organs during expansion thereof. Expandable structural member 102 may be in the form of an internal frame contained within balloon 100 (as shown in Fig. 10), or alternatively, in the form of an external frame attached to a selected portion of balloon 100, so as to provide a predetermined three dimensional shape to balloon 100.

Expandable structural member 102 may be in the form of a net of wires (not shown) so as to provide a three dimensional net frame to balloon 100. Such configuration may be used for providing a balloon substantially enclosing the patient's heart.

As shown in the figures, a device according to the present invention may further include a guiding assembly for appropriately positioning expandable structural member 102 and balloon 100 within the patient's cavity. The guiding assembly includes an internal guiding member 104 for insertion into the patient's body through an incision, and an external guiding member 1 10 connected to or integrally made with integral guiding member 104, for positioning on the patient's sternum. External guiding member 1 10 may be connected to internal guiding member 104 by means of a cylindrical connector 1 1 1, the connector being secured to guiding member 104 by means of screwing connections.

External guiding member provides effective guidance of internal guiding member 104 within the patient's chest cavity and thereby appropriate positioning of expandable structural member 102 and balloon 100 between the patient's sternum and heart.

Internal guiding member 104 may be rigid or flexible.

As shown in Fig. 10, external guiding member 1 10 preferably includes a holding member, generally denoted as 1 12, for manual handling of the device by a surgeon. Holding member 1 12 may be in the form of an opening extending through the thickness of external guiding member 1 10 so as to provide convenient manipulation of the external guiding member.

Connected to external guiding member is a securing member 1 14 for anchoring the guiding assembly at a desired orientation with relation to the patient's chest cavity. As shown, securing member 14 may be in the form of a springy rod for positioning between external guiding member 1 10 and the patient's sternum.

Preferably, the process of insertion , guidance and anchoring of a device according to the present invention is continuously monitored by means of X-ray imaging.

As shown in Figs. 1 1 and 12, expandable structural member 102 and balloon 100 are preferably packed within a detachable elongated accommodating member 105 prior to usage. Preferably, accommodating member 105 features a slot 103 having a distal end 120a and proximal end 120b. Expandable structural member 102 and balloon 100 are preferably connected to a handle 108, the handle being movable within a slot 103 of accommodating member 105. Thus, as handle 108 is moved through slot 103 from its distal end 120a to its proximal end 120b, expandable structural member 102 and balloon 100 are pushed out of guiding member 104 (best shown in Fig. 12). Preferably, handle 108 includes a passageway 106 in fluid communication with balloon 100 for providing fluid such as air to the balloon.

Preferably, connected to internal guiding member 104 is a sealing member 1 16. Sealing member 1 16 includes slots for allowing opening and sliding thereof on internal guiding member 104, substantially as shown in Figs. 10 and 12.

According to another embodiment (not shown), sealing member 1 16 may be substantially rigid and pointed. Such configuration enables the use of sealing member 1 16 as a surgical tool for facilitating the insertion of guiding member 104 into the patient's chest cavity.

Referring to Fig. 10, as handle 108 is pushed through slot 103, expandable structural member 102 expands into a predetermined three dimensional shape, preferably through a predetermined path of expansion, thereby appropriately spreading balloon 100 between the patient's heart and sternum without damaging adjacent internal organs. After positioning of handle 108 at the proximal end of slot 103, accommodating member 105 is preferably disconnected from the guiding assembly so as to allow convenient manipulation of the device.

Fig. 13 illustrates the use of a device according to the present invention. As shown, internal guiding member 104 is introduced into the patient's chest cavity. External guiding member 1 10 is positioned substantially on the patient's sternum, thereby providing effective guidance of internal guiding member 104. Securing member 1 14 effectively anchors the device to the patient's body at a desired position. Expandable structural member 102 and inflatable balloon 100 are thus appropriately located between the patient's heart 1 16 and sternum 1 15. Preferably, after positioning and anchoring the device, a tubular element 107 is connected to passageway 106, tubular element 107 being connected to an inflating system for inflation and deflation of balloon 100. A sealing sticker attachable to the patient's body and specifically tailored to fit the dimensions of guiding member 104 may be used for eliminating the risk of possible contamination.

Referring now to Fig. 14, according to another embodiment, expandable structural member 102 preferably features a planar configuration such that balloon 100 is symmetrically inflated towards the heart and sternum of the patient.

Further as shown, external guiding member 1 10 may be fastened to the patient's body by means of screwing members 1 13a and 1 13b.

Referring to Fig. 15, according to yet another embodiment, external guiding member 1 10 may feature an elongated extension 1 10a for enabling a surgeon to rapidly and accurately position the device. Further, holding member

1 12 may include a handle member 1 12a for facilitating the manipulation of external guiding member 1 10.

As shown in Fig. 16, a balloon according to the present invention may be manufactured so as to adopt a predetermined three dimensional conformation. For example, the balloon may be manufactured so as to provide an expandable accordion conformation upon inflation.

Such balloon having a predetermined three dimensional conformation may be made of silicon or any other suitable material.

Referring to Figs. 17 and 18, a device according to the present invention may include spreadable arms 125a and 125b having a common axis 129, the arms for connection of an inflatable balloon 100 thereto. Such configuration provides effective spreading of the balloon within the patient's chest cavity.

As shown in Fig. 17, the extent of opening of arms 125a and 125b is preferably manually controlled by means of a screwing element 129 located externally to the patient's body. Alternatively, as shown in Fig. 18, the extent of opening of arms 125a and 125b is manually controlled by means of a piston element 130 located at the distal portion 124 of the device.

As shown in Fig. 17, the device may include a securing member 126 in the form of a ring element connected to or integrally made with the distal portion 124 of the device, the securing member including extensions 127 having openings 128 for connection of a strap thereto, the strap for fastening around the patient's body (not shown).

A device according to the present invention may be synchronised with any other device known in the art such as EKG monitor, pacemaker, ventilation system, and the like.

It will be appreciated that the above descriptions are intended only to serve as examples, and that many other embodiments are possible within the spirit and the scope of the present invention.

Claims

WHAT IS CLAIMED IS:

1. Apparatus for cardiac treatment comprising:

(a) inflatable balloon means including means for the performance of heart message; and

(b) rigid guide means with means for containing said balloon and shaped such as to allow the insertion of said balloon into the the patient body and the positioning of said balloon close to the heart of said patient, and further including means for allowing the inflation of said balloon.

2. Apparatus for cardiac treatment according to claim 1, wherein said balloon further includes actuator means for periodically inflating an deflating said balloon for changing the force applied to said heart to perform said massage.

3. Apparatus for cardiac treatment according to claim 2, wherein said actuator means further include sensing means for sensing the activity of said heart and for applying said force to the heart synchronously with said heart activity.

4. Apparatus for cardiac treatment according to claim 2 or 3, wherein said actuator means includes means adapted to be implanted in the patient's body.

5. Apparatus for cardiac treatment according to claim 2 or 3, wherein said actuator means are located outside the patient's body, and further including tubes connecting said balloon with said actuator for transferring a fluid under pressure therebetween.

6. Apparatus for cardiac treatment according to claim 1 , further including means for transferring a force generated outside of the body to said heart through said balloon, to perform said cardiac treatment by periodically applying said force to said heart.

7. Apparatus for cardiac treatment, comprising:

(a) inflatable balloon means including a plurality of balloon sections with each of said sections being separately inflatable thorough a tube connected thereto and to a variable pressure source; and

(b) rigid guide means for containing said balloon means and shaped such as to allow the insertion of said balloon into the patient's body and the positioning of said balloon close to the heart of said patient, and further including means for allowing the inflation of said balloon.

8. Apparatus for cardiac treatment according to claim 7, wherein said variable pressure sources include means for inflating said balloon sections in a predefined sequence, to individually massage the various parts of said heart to achieve the desired therapeutical effect.

9. Apparatus for cardiac treatment according to claim 7 or 8, wherein said balloon sections include means for applying a sequential pressure to the left and the right chambers of said heart.

10. Apparatus for cardiac treatment according to claim 7 or 8, wherein said variable pressure sources further include sensing means for sensing the activity of said heart and for applying said pressure synchronously with said heart activity.

1 1. Apparatus for cardiac treatment according to claim 1 or 7, mounted in container means suitable to be implanted into said patient's body and further including cardiac activity sensor means to detect cardiac failure and to immediately activate the cardiac treatment and/or massage.

12. Apparatus for cardiac treatment according to claim 1 or 7, further including means for coordinating the operation thereof with another life- support device.

13. Apparatus for cardiac treatment according to claim 7, wherein said balloon sections have an elongated shape and are connected to form a generally spherical cast or glove, of a shape and size such as to enclose said heart therein.

14. Apparatus for cardiac treatment according to claim 1 or 7, wherein said inflating balloon further holds electrodes for electrical stimulation of said heart.

15. Apparatus for cardiac treatment according to claim 1 or 7, wherein said balloon is mounted on movable base means to allow the lateral movement and/or the rotation of said balloon, to allow said balloon to move together with said heart.

16. Apparatus for cardiac treatment of the kind specified substantially as herein before described by way of example with reference to the accompanying drawings.

17. Apparatus for cardiac treatment, comprising:

(a) an inflatable balloon for massaging a patient's heart;

(b) an expandable structural member connected to said balloon, said expandable structural member being capable of adopting a predetermined three-dimensional shape, thereby providing a predetermined three dimensional shape to said inflatable balloon;

(c) an internal guiding member for insertion into the patient's chest cavity through an incision, said guiding member for receiving said inflatable balloon and said expandable structural member therein.

18. The apparatus of claim 17, wherein said expandable structural member is in the form of a wire capable of adopting a predetermined three dimensional shape upon emerging from said internal guiding member.

19. The apparatus of claim 18, wherein said wire is made ofNitinol.

20. The apparatus of claim 17, wherein said expandable structural member is in the form of a net of wires capable of adopting a predetermined three dimensional shape upon emerging from said internal guiding member.

21. The apparatus of claim 17, wherein said apparatus further includes an external guiding member for positioning substantially on the patient's sternum, said external guiding member being firmly connected to said internal guiding member so as to provide effective guidance of said internal guiding member within the patient's chest cavity.

22. The apparatus of claim 21 , wherein said external and internal guiding members are integrally made.

23. The apparatus of claim 17, wherein said internal guiding member is substantially rigid.

24. The apparatus of claim 17, wherein said internal guiding member is substantially flexible.

25. The apparatus of claim 17, wherein said external guiding member includes a securing member for fixing said guiding members at a required position.

26. The apparatus of claim 25, wherein said securing member is in the form of a springy rod connected to said external guiding member.

27. The apparatus of claim 25, wherein said securing member includes a screwing element.

28. The apparatus of claim 25, wherein said securing member includes a connector connectable to a strap, said strap for fastening around the patient's body.

29. The apparatus of claim 17, wherein said internal guiding member includes a sealing member having slots, said sealing member being slidable on said internal guiding member.

30. The apparatus of claim 17, further comprising a substantially elongated accommodating member for accommodating said inflatable balloon and said expandable structural member, said accommodating member featuring a slot for receiving a movable handle member therein, said handle member being connected to said expandable structural member.

3 1. The apparatus of claim 30, wherein said handle member includes a passageway extending therethrough, said passageway being in fluid communication with said inflatable balloon.

32. The apparatus of claim 30, wherein said accommodating member is detachable.

33. The apparatus of claim 17, wherein said expandable structural member is in the form of two spreadable arms having a common axis.

34. The apparatus of claim 34, wherein the opening of said arms is manually controlled by means of a screwing member.

35. The apparatus of claim 34, wherein the opening of said arms is manually controlled by means of a piston member.

36. The apparatus of claim 17, wherein said inflatable balloon is specifically manufactured so as to adopt a predetermined three dimensional shape.

37. The apparatus of claim 36, wherein said inflatable balloon features an expandable accordion shape.

38. The apparatus of claim 17, wherein said expandable structural member has a predetermined path of expansion.

39. The apparatus of claim 17, wherein said internal guiding member features a pointed tip so as to facilitate insertion thereof into the patient's body.