Source: https://patents.google.com/patent/US20050113632
Timestamp: 2018-02-26 02:27:34
Document Index: 276938052

Matched Legal Cases: ['art 14', 'art 14', 'art 14', 'art 14', 'art 14', 'art 14', 'art 14', 'art 14', 'art 14', 'art 14', 'art 14', 'art 14', 'art 14', 'art 14', 'art 14', 'art 14', 'art 14', 'art 14', 'art.\n8', 'art.\n35', 'art.\n36', 'art.\n39']

US20050113632A1 - Implantable heart assist devices and methods - Google Patents
US20050113632A1
US20050113632A1 US10958184 US95818404A US2005113632A1 US 20050113632 A1 US20050113632 A1 US 20050113632A1 US 10958184 US10958184 US 10958184 US 95818404 A US95818404 A US 95818404A US 2005113632 A1 US2005113632 A1 US 2005113632A1
US10958184
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.
FIG. 3 is a cross sectional view taken generally along line 3-3 of FIG. 2;
FIG. 3A is a cross sectional view similar to FIG. 3, but illustrating optional inflatable bladders for providing a pump assist to the heart;
FIG. 1 illustrates a heart assist device 10 constructed in accordance with the invention and schematically illustrated implanted within a patient 12 in surrounding relation to the patient's heart 14. A power supply 16, such as an electric or pneumatic power supply, is operatively connected to heart assist device 10 for reasons to be discussed below. As generally shown in FIG. 2, heart 14 has four chambers. The right atrium 18 receives blood flowing through veins in the patient's body. The right ventricle 20 pumps the blood to the lungs of the patient through the pulmonary artery 22. The left atrium 24 receives oxygenated blood flowing back from the patient's lungs through the pulmonary vein and the left ventricle 28 pumps this blood out through the aorta 30 to the patient's body. The right and left ventricles 20, 28 compress simultaneously during this pumping action and, in a normal heart, anywhere between about 50% and 80% of the blood in these chambers will be expelled as described above. In a heart weakened, for example, due to heart attack or other conditions, the efficiency of the heart will be reduced and, therefore, heart assist device 10 will be used to increase the pumping action or expulsion of blood from the right and left ventricles 20, 28. An interventricular septum 32 separates the right and left ventricles 20, 28.
As further shown in FIGS. 2 and 3, device 10 preferably comprises a plurality of flexible tensile members 40 a through 40 f. In this embodiment, a flexible tensile member 40 a is adapted to be wrapped circumferentially around left ventricle 28, as is another flexible tensile member 40 b. A tensile member 40 c may interconnect tensile members 40 a and 40 b as shown. A similar system is shown with tensile members 40 d, 40 e and 40 f extending along the outside of right ventricle 20. Each of these tensile members is effectively connected to the other to form an integrated unit by connection to an internal support anchor member 42. In this embodiment, support member 42 comprises a plate surgically inserted into right ventricle 20 and bearing against interventricular 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. Once plate 42 is implanted through a suitable incision into right ventricle 20, flexible tensile members 40 a, 40 b, 40 d and 40 e may be sutured thereto as shown in 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 flexible tensile members 44, 46, 48, 50 may be used to control the movements of the heart muscle as device 10 is used to assist with the pumping action as described further below. Two tensile members 44, 46 may be secured between the annulus 52 of mitral valve 54 and the apex 56 of left ventricle 28. A button 58 may be used at the apex for securement purposes and may bear against the intersections of tensile members 40 c, 40 f. Transverse internal tensile members 48, 50 may extend crosswise as best shown in FIG. 3 between the outer wall of left ventricle 28 and the interventricular septum 32. Tensile members 48, 50 may be secured to any of the outer tensile members, as well as to plate 42 at opposite ends, or may be secured to the walls of the heart itself. Similar internal tensile members may be used in the right ventricle, although this is not preferred for the reason that it may not be necessary as the motion of the right ventricle is primarily in a direction toward the interventricular septum. Also, it will be understood that tensile members 44, 46 may be secured in other ways within 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 assist device 10′ taking the form of a modified version of device 10 shown in FIGS. 2 and 3. Device 10′ includes various elements having like reference numerals in FIG. 3, but adds an inflatable bladder 47 which may be positioned between flexible tensile member 40 a and the outside wall of left ventricle 28. Bladder 47 is connected through a suitable conduit 49 to a fluid pump which may direct air or other fluid into bladder 47 in a cyclical manner. Inflation and subsequent deflation of bladder 47 will contract left ventricle 28 against the support provided by internal support member 42 to expel blood and subsequent deflation will allow left ventricle 28 to expand and refill with blood. Alternatively, an internal bladder 53 may be provided and cyclically inflated and deflated, as shown, to expel blood from left 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).
FIG. 6 illustrates another alternative heart support and assist device 80 formed by a generally spiral shaped tensile member 82 extending around heart 14. Tensile member 82 preferably comprises an outer hollow member 84 and an inner movable cable 86 connected at one end to a suitable actuator 88 affixed to a jacket 90 and at an opposite end being rigidly affixed by a connector 92 to jacket 90. An upper end of jacket 90 may be suitably connected to heart 14, as through stitching 94. As shown in FIG. 6, two coils of the spiral tensile member 82 extend into right ventricle 20 and bear against interventricular septum 32 before exiting heart 14 and again extending around the outside of jacket 90. The remaining upper and lower sets of coils extend around the outside of jacket 90. This configuration is intended to compress both the right and left ventricles 20, 28 of heart 14, while focusing on left 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 on cable 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 of tensile 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 two halves 102, 104 which together receive a patient's heart 14. Each half 102, 104 is respectively comprised of an outer shell and innerinflatable bladder combination 106, 108 and 110, 112.
One or more internal support members 114, 116 extend generally between halves 102, 104 through heart 14. Support members 114, 116 are intended to extend through one or both of the left and right ventricles (not shown) of 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 114, 116 may, for example, be one or more rigid plates or flexible straps, or other suitable support members.
Respective connectors 118, 120 may be provided to affix halves 102, 104 together. In this illustrative example, connectors 118 extend through holes 114 a, 116 a in support members 114, 116 and into connectors 120 of half 104 to connect device 100 firmly against heart 14. Additional connectors or other means may be used to ensure that device 100 remains in position around heart 14. Once in position, bladders 108, 112 may be cyclically inflated and deflated to compress the left and right ventricles of heart 14 while the opposite side of one or each of the ventricles is supported by members 114, 116. A pump 124 may be connected to bladders 108, 112 for selectively inflating and deflating bladders 108, 112 with an appropriate fluid, such as air or liquid. Again, pump 124 may be activated in correspondence with the patient's heart rhythm, such as through the use of a conventional electrical pacing device.
FIG. 9 illustrates a passive heart support device 150 shown implanted on a heart 14 and, specifically, around left ventricle 28. Support device 150 includes a flexible mesh or web material 152 serving as an external support member around left ventricle 28 and a plurality of internal support members 154, 156, 158 extending through right ventricle 20 and against interventricular septum 32. Internal support members 154, 156, 158 may be attached to mesh or web element 152 in numerous ways, such as by stitching or other quicker connection means. At least one end of internal support members 154, 156, 158 will be detached from mesh or web element 152 for extension through right ventricle 20 during implantation and then adjusted for tightness on heart 14 and secured to mesh or web element 152 preferably at an opposite side of the heart. If necessary, an external sheath 160, which may be elastic in nature, may receive heart 14 after attaching device 150, as a further securement means. Sheath 160 may include an open end 162 and a closed end 164.
FIG. 11 illustrates another alternative passive support device 170 comprising an external support portion 172, which may again be another flexible mesh or web element 172 and internal support member 174, 176. In this embodiment, support member 176 extends only partially along the interventricular septum 32 and internal support member 174 extends through septum 32 and connects with external support member 172 at one end and internal support member 176 at an opposite end. Support members 174 and 176 may be separate members which are connected together or may be a single integral member, as shown. Additional support members 178, 180, shown in phantom, may be optionally used in addition to or as an alternative to internal support member 174.
FIGS. 12, 12A and 13A-B illustrate a partially catheter-based implantation device and method. Specifically, a catheter 190 having a sharpened portion 192 is introduced from a vein 194, for example, originating in the groin of the patient. Catheter 190 enters right atrium 18 and pierces through wall 18 a into right ventricle 20. A heart 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 for heart 14. Catheter 190 may be used to introduce opposite ends of support device 200 through opposite walls of right ventricle 20, as shown in FIG. 13A. Piercing member 192 may, for example, extend to fully pierce through the wall of the heart, or device 200 itself may pierce through the wall of heart 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 is end 204. A tool 210 may be introduced through a small port hole in the patient's chest and includes a hook member 212. Tool 210 extends through loop 204 and hook 212 may be used to grasp looped end 202 to pull it through looped end 204. Looped end 204 is then tightened as shown in FIG. 13B so that an internal portion 200 a of device 200 lies against septum 32 within right ventricle 20 and another portion 200 b of device 200 lies on the external surface of heart 14 adjacent left ventricle 28.
FIG. 15 illustrates another alternative heart support device 240 comprised of three flexible support members 242, 244, 246 extending around the outside of left ventricle 28. Portions 242 a, 244 a and 246 a extend through the wall of the heart into right ventricle 20 and connect with a support plate 248 lying against septum 32.
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:
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.
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.
securing the heart support member adjacent the interventricular septum within the right ventricle.
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.
US10958184 2000-10-03 2004-10-04 Implantable heart assist devices and methods Abandoned US20050113632A1 (en)
US09677981 US6808483B1 (en) 2000-10-03 2000-10-03 Implantable heart assist devices and methods
US10958184 US20050113632A1 (en) 2000-10-03 2004-10-04 Implantable heart assist devices and methods
US20050113632A1 true true US20050113632A1 (en) 2005-05-26
ID=24720886
US09677981 Expired - Fee Related US6808483B1 (en) 2000-10-03 2000-10-03 Implantable heart assist devices and methods
US10958184 Abandoned US20050113632A1 (en) 2000-10-03 2004-10-04 Implantable heart assist devices and methods
US (2) US6808483B1 (en)
EP (1) EP1322229A2 (en)
WO (1) WO2002028450A3 (en)
US20170021073A1 (en) * 2008-10-10 2017-01-26 Peter Forsell Heart help device, system, and method
EP1322229A2 (en) 2003-07-02 application
US6808483B1 (en) 2004-10-26 grant
WO2002028450A2 (en) 2002-04-11 application
WO2002028450A3 (en) 2002-08-15 application