Source: http://www.google.com/patents/US20030032855?dq=6,373,753
Timestamp: 2017-12-18 04:00:32
Document Index: 409549640

Matched Legal Cases: ['art.\n7', 'art.\n17', 'art 5', 'art 5', 'art 5', 'art 5', 'art 5', 'art 5', 'art 5', 'art 5', 'art 5', 'art 5', 'art 5']

Patent US20030032855 - Electrically-controllable multi-fingered resilient heart compression devices - Google Patents
Soft, multi-fingered resilient robotic fingers for selectively assisting heart ventricles or other organ to produce internal pressure and to pump blood, in synchrony with the systolic contraction of the ventricle or organ, as well as providing arrhythmia control of a beating heart. The apparatus is electrically-controlled...http://www.google.com/patents/US20030032855?utm_source=gb-gplus-sharePatent US20030032855 - Electrically-controllable multi-fingered resilient heart compression devices
Publication number US20030032855 A1
Application number US 10/244,857
Also published as US6464655, US7198594
Publication number 10244857, 244857, US 2003/0032855 A1, US 2003/032855 A1, US 20030032855 A1, US 20030032855A1, US 2003032855 A1, US 2003032855A1, US-A1-20030032855, US-A1-2003032855, US2003/0032855A1, US2003/032855A1, US20030032855 A1, US20030032855A1, US2003032855 A1, US2003032855A1
US 20030032855 A1
1. An implantable organ compression apparatus for selectively assisting blood pumping through an organ, the apparatus comprising:
at least one finger, wherein said at least one finger comprises a metal hydride sponge encapsulated with a first bladder that is inflated and deflated with hydrogen gas causing said at least one finger to compress and release the organ; and
at least one thermoelectric cell for cyclically heating and cooling said metal hydride sponge causing said hydrogen gas to desorb and absorb into said first bladder.
2. The invention of claim 1 wherein said hydrogen gas is used to push a piston to inflate a second bladder containing a biocompatable gas to inflate and deflate said first bladder.
3. The invention of claim 1 wherein said at least one finger further comprises a pressure sensor.
4. The invention of claim 1 wherein said at least one finger further comprises a motion sensor.
5. The invention of claim 1 further comprising a control apparatus for controlling the at least one thermoelectric cell.
6. The invention of claim 5 wherein said controller comprises a microprocessor to control the at least one thermoelectric cell to operate in synchrony and harmony with natural systolic and diastolic motions of a heart.
7. The invention of claim 1 further comprising an energy source.
8. The invention of claim 1 where said metal hydride sponge comprises a member from the group consisting of LaNi, TiFe, MgNi, and TiMn.
9. The invention of claim 1 where the organ comprises the aorta.
10. The invention of claim 1 comprising a plurality of fingers comprising a peristaltic compression on said organ.
11. The invention of claim I wherein said implantable organ compression apparatus comprises and endoscopically implantable organ compression apparatus.
12. An implantable organ compression apparatus for selectively assisting blood pumping through the organ, the apparatus comprising:
at least one finger, wherein said at least one finger comprises an electroactive polymer sensor and actuator; and
a controller for cyclically activating and deactivating said actuator for compressing and releasing compression from the organ, and for monitoring said sensor.
13. The invention of claim 12 wherein said at least one finger comprises affixing said at least one finger to the organ.
14. The invention of claim 12 wherein said electroactive polymer sensor and actuator comprises a polymeric artificial muscle.
15. The invention of claim 12 where the organ comprises the aorta.
16. The invention of claim 12 wherein said controller comprises a microprocessor to control the actuator cell to operate in synchrony and harmony with natural systolic and diastolic motions of the heart.
17. The invention of claim 12 comprising a plurality of fingers comprising a peristaltic compression on said organ.
18. The invention of claim 1 wherein said implantable organ compression apparatus comprises and endoscopically implantable organ compression apparatus.
This application is based on U.S. Provisional Application Serial No. 60/124,840, entitled “Electrically-Controllable Multi-Fingered Resilient Heart Compression Devices”, filed on Mar. 17, 1999, and is a divisional application of U.S. patent application Ser. No. 09/626,038, entitled “Electrically-Controllable Multi-Fingered Resilient Heart Compression Devices”, filed on Mar. 15, 2000, the teachings of which are incorporated herein by reference.
There presently exists no implantable heart compression device to help patients suffering from congestive heart failure (CHF), a progressive disease often precipitated by acute myocardial infarction. All artificial heart or left ventricular assist devices have either not worked in the past or are just temporary solutions for patients needing a donor heart for transplant. Existing devices generally feature blood flow pathways made from non-biological materials that often damage blood cells and blood proteins and produce clots, thereby presenting a generic risk thromboembolism in the circulatory system. In fact, blood clots cause most of the deaths reported after implantation of an artificial heart or assist device. The majority of these patients have a normal right ventricle; however, most have a left ventricle that has been damaged in specific regions. Therefore, there is a need for a heart compression device designed to assist the weak muscles of a failing heart that augments the heart's pumping power. This device could also incorporate pacemaker and implantable cardioverter/defibrillator technology for treating patients who also suffer from such electrical dysfunctions as bradycardia or tachyarrhythmias. Current Left Ventricular Assist Device (LVAD) devices are heavy and generally have to be attached to a cart to be dragged around by the patient. In addition, they lack a satisfactory implantable energy source, requiring patients to be constantly tethered to an external power source. Previous attempts to provide ventricular assistance have ranged from artificial hearts (e.g., the Jarvik-7), to devices which directly pump the blood, via an artificial pathway inserted through the ventricular wall to devices which exert pressure on the outside of the heart. Historically, heart-compression devices involve some form of flexible bladder within a support structure such that expansion of the bladder presses on the ventricle and facilitates expulsion of blood. These types of devices are disclosed in U.S. Pat. Nos. 3,587,567 to Schiff; 3,371,662 to Heid, et al.; 4,048,990 to Goetz; and 4,192,293 to Asrican. U.S. Pat. No. 4,506,658 to Casile discloses a truncated conical structure of sac-lined rigid panels separated by contractible and expandable sections. Another type of cardiac assist system is designed to compress all or part of the heart by alternately tightening and releasing a circumferential compression band. For example, U.S. Pat. No. 4,304,225 to Freeman teaches the use of a flexible strap which is fixed to a contoured plastic block and which would pass across the back of the heart. In response to electrical pulses, a motor assembly alternately reels in and releases the flexible strap, thereby forcing fluid from the organ. This prior art device is ineffective because a pressure of between 20 and 70 mm Hg in the volume under the strap pumps blood from the right ventricle but not the left, since 70 mm Hg or more is required for blood to exit the left ventricle into the aorta. Freeman also discloses the use of a tubular compression sleeve that substantially encircles the heart and which comprises a series of interconnected expandable elliptical chambers. In use, a liquid solution is pumped into the sleeve from a supply chamber, causing the elliptical chambers to expand radially inward to compress the heart in its systolic phase. The solution then is released from the sleeve back to a supply chamber, permitting the heart to expand in its diastolic phase. These bladder-type devices can lead to a buildup of blood in the lungs, producing pulmonary complications. U.S. Pat. No. 4,583,523 to Kleinke and Freeman illustrates another prior art heart assist mechanism. This device compresses the aorta, not the left ventricle, and it compresses during the diastolic phase of cardiac contraction instead of the systolic phase. There is no means to monitor the adequacy of left ventricular stroke volume.
Other previous attempts to provide ventricular assistance have ranged from artificial hearts (e.g., the Jarvik-7), to devices which directly pump the blood via an artificial pathway inserted through the ventricular wall, to devices which exert pressure on the outside of the heart. Most frequently, these latter pressure-exerting devices involve some form of flexible bladder within a support structure such that expansion of the bladder presses on the ventricle and facilitates expulsion of blood. These types of devices are disclosed in U.S. Pat. Nos. 3,233,607 to Bolie; 3,279,464 to Kline; 3,587,567 to Schiff; 3,371,662 to Heid, et al.; 4,048,990 to Goetz; 4,192,293 to Asrican; 3,455,298 to Anstadt; 4,690,134 to Snyder; 5,169,381 to Snyder; 5,256,132 to Snyder; 4,731,076 to Noon et al.; and 4,957,477 to Lundbäck. U.S. Pat. No. 4,506,658 to Casile discloses a truncated conical structure of sac-lined rigid panels separated by contractible and expandable sections. U.S. Pat. No. 4,621,617 to Sharma shows another similar device which is electromagnetically controlled and comprises a pair of hinged compression members. Further, U.S. Pat. No. 4,536,893 to Parravicini teaches using two segmented sacs, selectively fed by a pumping fluid to compress the right and left ventricles separately. In general, bladder systems have various shortcomings. These include the possibility of catastrophic bladder fluid leakage (as a result of the fluid pressures involved), a propensity for damaging the heart surface due to poor fixation and/or rubbing of the bladder against the heart's surface, and the unnatural convex form presented to the heart's surface during systolic bladder expansion. U.S. Pat. No. 4,583,523 to Kleinke and Freeman illustrates a heart assist mechanism that compresses the aorta, rather than a ventricle, and it compresses during the diastolic phase of cardiac contraction instead of the systolic phase.
Other prior art references of relevance to the present invention are: U.S. Pat. No. 5,250,167 to Adolf, et al., and 5,389,222 to Shahinpoor in connection with electrically controllable polymeric actuators; Y. Wakisaka, et al., “Application of Hydrogen Absorbing Alloys to Medical and Rehabilitation Equipment”, IEEE Trans. on Rehabilitation Engineering, Vol. 5, No. 2, pp.148-157 (1997); M. Shahinpoor, “Ionic Polymer Metal Composition as Biomimetic Sensors and Actuators”, in Polymer Sensors and Actuators, edited by Y. Osada and D. DeRossii, Springer-Verlag Publishing, Springer (1999); and M. Shahinpoor, Y. Bar-Cohen, J. O. Simpson, J. Smith, “Ionic Polymer Metal Composites (IPMC's) as Biomimetic Sensors, Actuators and Artificial Muscles—a Review”, J. Smart Mater Structures, Vol. 7, pp 15-30 (1998).
[0022]FIG. 1 is a perspective view of a preferred embodiment of the invention;
[0023]FIG. 2 is a schematic diagram of the preferred embodiment as shown in FIG. 1 showing the undulation role of the flexible stem and more detailed drawings of the compression fingers as well as schematically illustrating the exemplary control means and actuating means for the invention;
[0024]FIG. 3 is a view showing the similarity of the operation of said apparatuses and invention to an arm and hand resting on its elbow on a support surface and squeezing a heart;
[0025]FIG. 4 is a schematic illustration of another embodiment of the compression fingers without the supporting structure and the stem;
[0026]FIG. 5(a) illustrates the operation of the compression fingers due to linear motion of the spindle and the effect of the two pivotal hinges and a slot in the base of the fingers;
[0027]FIG. 5(b) illustrates the operation of the compression fingers due to linear motion of the spindle, and the effect of the three pivotal hinges and no slot in the base of the fingers;
[0028]FIG. 6(a) depicts the arrangement of the soft finger bumps and the pressure sensors to selectively compress different parts of the heart and sense the imparting compression pressure;
[0029]FIG. 6(b) depicts another embodiment of the compression device using collapsible multi-fingered metal-hydride finger actuators;
[0030]FIG. 6(c 1) is a cross sectional view of the embodiment in FIG. 6(b) in a collapsed configuration allowing endoscopic insertion of the device inside a patient's rib-cage;
[0031]FIG. 6(c 2) is a side view of the embodiment in FIG. 6(b) in a collapsed configuration allowing endoscopic insertion of the device inside a patient's rib-cage;
[0032]FIG. 6(d) depicts another embodiment of the invention using artificial muscles;
[0033]FIG. 7 illustrates the general arrangement of the invention placed inside the body of a patient;
[0035]FIG. 9 depicts another embodiment of the compression fingers used as a peristaltic compression pump for the aorta; and
[0036]FIG. 10 illustrates the use of the invention in creating peristaltic pressure pump for the aorta to enhance blood circulation.
[0037]FIG. 1 shows the preferred embodiment of the present invention. Heart 5, (cardiac muscle) is being compressed by a plurality of soft compression fingers 3, each finger 3 containing a soft outer cover 4. FIG. 1 shows the associated major arteries and veins such as the superior vena cava 5(a), the inferior vena cava 5(b), the pulmonary artery 5(c), the pulmonary vein 5(d) and the aorta 5(e) as well as the coronary arteries 5(f). The multi-fingered soft and resilient robotic heart-compression devices equipped with a flexible stem 10 include soft compression fingers 3 equipped with a soft outer cover 4 that surround heart 5. The soft outer cover 4 is preferably made from soft spongy silicon rubber and can also be in the form of polymer gels or water-filled bladders. Each finger 3 is preferably equipped with pressure monitoring electrodes 4(a) for monitoring the compression of the cardiac muscle 5 to simulate normal pumping action of the myocardium muscle. The preferred apparatus comprises a central platform 7 and a support column 2 mounted on a base platform 1 to enable soft compression fingers 3 to pivotally move in harmony about hinge 14, such pivoting actions are allowed by finger slot 6, the central platform slot 7(a) and central platform pin 7(b) as well as the pulling action of cable 9 inside a cable guide (the flexible stem) 10 linearly actuating the central platform stem 8 through the support platform cylindrical slot 13. The actuation cable 9 is activated by robotic linear actuation mechanism 11 housed inside the abdomen base support assembly 12.
[0038]FIGS. 1 and 2 also show that the preferred heart compression assembly 30 is also equipped with support washers 15(a) and 15(b) to stabilize the laterally flexible but longitudinally inflexible cable guide 10 or the stem to allow free undulation of the stem in the presence of a resilient (spring-loaded) collar 16. Upon compression of the heart 5, the potential energy stored in the resilient collar 16 will quickly retract soft compression fingers 3 upon completion of the compression cycle to allow the diastolic expansion of heart 5 to proceed with no obstruction and to completely release heart 5 from the soft compression fingers 3 in case of any breakdown of the heart compression assembly. In the preferred embodiment, all components are preferably fabricated from bio-compatible materials and are all operating below the endurance limit of the materials to make sure no fatigue failure of any component occurs under such oscillatory loading/unloading cycles. The preferred compression assembly 30 further includes a control structure 12(b) and 12(c) that are well known in the art for electromagnetically controlling the operation of heart compression assembly as well as to monitor the actual pressure applied to the cardiac muscles 5. As shown in FIG. 2, the soft compression fingers can also have finger bumps 4(b) to enhance localized compression of ventricles. Base support assembly 12 houses a power source for the device, such as at least one long lasting battery 12(a), which can be transcutaneously recharged from outside the patient's body (not shown). Within the base support assembly 12 is control circuitry 12(b) which preferably includes a microprocessor for the robotic actuations of the linear actuator 11, to preferably provide a pulsating current of the order of 50 to 200 pulses per minute to correspond with the natural pulsations of heart 5. The base support assembly 12 can also have the microprocessor trigger the sino-atrial (SA) or atrio-ventricular (AV) nodal activity of the heart 5.
[0039]FIG. 3 demonstrates how the preferred embodiment functions similarly in the from of a human arm 17 resting on its elbow 18 on a platform 19 and holding the heart 5 in a hand 20 between the human fingers 40 of hand 20 and squeezing and releasing the heart muscle 5.
[0040]FIG. 4 depicts an alternative embodiment without the exemplary undulating supporting stem 10 in FIGS. 1 and 2, showing the central platform 7, the base platform 1, finger support column 2, soft compression fingers 3, soft outer cover 4, sensing electrodes 4(a), soft finger bumps 4(b), central platform stem 8, actuating cable 9, finger slot 6, pivoting hinge 14, central platform slot 7(a), and central platform pins 7(b), as well as base platform bushing slot 13, for supporting the compression device within the mammalian body.
[0041]FIG. 5(a) shows how the soft compression fingers 3 function in the preferred embodiment. Soft compression fingers 3, central platform slot 7(a), finger slot 6, and central platform pin 7(b), allow the linear motion 21 of the central platform 7 to be converted to radial swinging motion 22 of the soft compression fingers 3, as shown.
[0042]FIG. 5(b) depicts another embodiment of the arrangement of soft compression fingers 3 for the conversion of linear robotic actuator motion to radial swinging motion of the soft compression fingers 3. In this embodiment there is no central platform slot in conjunction with two hinges 7(a) and 14 but three hinges 2(a), central platform pin 7(b) and 3(a), as well as a connecting link 3(b) to allow the linear motion 21 of the central platform 7 to be converted to the swinging radial motion 22 of the soft compression fingers 3.
[0043]FIG. 6(a) depicts compression assembly 30, compressing heart 5, and the associated main arteries and veins 5(a), 5(b), 5(c), 5(d), 5(e), and 5(f) in the presence of finger bumps 4(b) to selectively apply compression to various regions of the myocardium and arteries and veins as the need arises.
[0044]FIG. 6(b) depicts another preferred embodiment of the compression assembly 30 in the form of collapsible assembly of fingers, made with a metal hydride hydrogen sponge such as LaNi, TiFe, MgNi, and TiMn groups, encapsulated by bladder-type contourable and inflatable fingers 4 that can be inflated by hydrogen gas 4(c) while still equipped with sensors 4(a) and bump 4(b). In this embodiment, Peltier thermoelectric cells 3(c) may be used to heat and cool the fingers to cause them to desorb or absorb hydrogen gas into the fingers, thus providing cyclic compression of the heart by means of the power source 3(f) via conducting wires 3(e). The metal hydride fingers in this embodiment are connected to each other by a collapsible base 3(d).
[0046]FIG. 6(d) depicts another preferred embodiment of the invention in the form of collapsible and endoscopically implantable assembly of soft fingers 3 made with electroactive polymer sensors and actuators that can be directly electrically powered and computer-controlled by wires 3(e) and power source 3(f). In this preferred embodiment, the polymeric artificial muscles can be sutured or bonded to the myocardium 5 by suturing methods 4(d) known to those skilled in the art.
[0047]FIG. 7 depicts the general arrangement of the compression assembly 30 implanted inside a human body 42 such that the base support assembly 12 is housed in the base of the abdomen 44 with flexible stem 10 extending to the soft compression fingers 3 and the compression assembly in the chest 46. This arrangement allows the compression assembly to perform its intelligent compression of the heart muscle 5 while maintaining a flexible undulation for the heart 5 and to allow heart 5 to make lateral motion as needed while being compressed by the soft compression fingers 3.
[0048]FIG. 8(a) and 8(b) depict another advantage of the proposed embodiments, in the sense that such compression embodiments allow both linear motion 21 for the compression of the heart as well as torsional motion 23 for the heart muscle, if that need arises.
[0049]FIG. 9 depicts a general arrangement for the soft compression fingers 3 to compress the aorta 5(e) rather than the heart muscle 5, to create robotically controlled peristaltic compression of the aorta 5(e) to enhance blood circulation in the patient's body. FIG. 10 depicts a general configuration of a smaller version of the device with suitably arranged soft compression fingers 3 with soft covers 4 to create peristaltic compression 24 of the aorta 5(e) or descending aorta 5(g).
WO2004075953A1 * Feb 24, 2004 Sep 10, 2004 Scimed Life Systems, Inc. Cardiac assist device with electroactive polymers
WO2016044654A1 * Sep 17, 2015 Mar 24, 2016 Soft Robotics, Inc. Soft robotic actuator attachment hub and grasper assembly, reinforced actuators, and electroadhesive actuators
Cooperative Classification A61M1/1068, A61M1/12, A61M1/1049, A61M1/1067, A61M1/1055, A61M1/1086, A61M1/127