Source: http://www.google.com/patents/US20030050682?dq=6335678
Timestamp: 2017-12-18 20:53:53
Document Index: 24188230

Matched Legal Cases: ['art.\n21', 'Application No. 60', 'art 42', 'art 42', 'art 42', 'art 114']

Patent US20030050682 - Device for improving cardiac function - Google Patents
A method and a device for improving cardiac function are provided. The device is packaged in a collapsed state in an end of a catheter. Portions of a frame construction of the device spring outwardly when the catheter is withdrawn from the device. Anchoring formations on the frame construction secure...http://www.google.com/patents/US20030050682?utm_source=gb-gplus-sharePatent US20030050682 - Device for improving cardiac function
Publication number US20030050682 A1
Application number US 10/212,033
Also published as US6852076, US7279007, US7303526, US20030050685, US20030163191
Publication number 10212033, 212033, US 2003/0050682 A1, US 2003/050682 A1, US 20030050682 A1, US 20030050682A1, US 2003050682 A1, US 2003050682A1, US-A1-20030050682, US-A1-2003050682, US2003/0050682A1, US2003/050682A1, US20030050682 A1, US20030050682A1, US2003050682 A1, US2003050682A1
Inventors Hugh Sharkey, Serjan Nikolic
Original Assignee Sharkey Hugh R., Nikolic Serjan D.
Patent Citations (98), Referenced by (74), Classifications (28), Legal Events (9)
US 20030050682 A1
1. A device for improving cardiac function, comprising:
a frame construction that is movable from a collapsed state, wherein the frame construction has a small cross-dimension to allow the frame construction to be fed through a tubular passage with a small diameter into a heart, to an expanded state wherein the frame construction, after leaving the tubular passage and having been located in an installed position in an endocardial cavity of the heart, has a cross-dimension substantially larger than the small diameter of the tubular passage and approximating a cross-dimension of the endocardial cavity where the frame construction is positioned;
at least two anchor formations connected to the frame construction, each anchor formation having at least one anchoring portion that is positioned and capable of anchoring to tissue of a myocardium of the heart, and so anchor the frame construction in the installed position to the myocardium, the anchoring portions being spaced from one another to allow for positioning of the frame construction at a select angle relative to the endocardial cavity; and
a membrane being in a folded condition while being fed through the tubular passage, and in an unfolded condition after leaving the tubular passage, in the unfolded condition having an area substantially larger than a cross-sectional area of the tubular passage and being secured to the frame construction in a position to substantially form a division between volumes of the endocardial cavity on opposing sides of the membrane.
2. The device of claim 1, comprising a third anchor formation, anchor portions of the anchor formations being positioned at corners of a triangle to allow for positioning of the frame construction with the membrane in a select plane relative to the endocardial cavity.
3. The device of claim 1, wherein the anchoring portions have sharp ends that penetrate the myocardium.
5. The device of claim 4, wherein at least some of the anchoring hooks are distal anchoring hooks on a distal portion of the frame construction and rotate into the myocardium while a catheter forming the tubular passage is withdrawn off the frame construction.
6. The device of claim 5, wherein partial withdrawal of the catheter off a distal portion of the frame construction causes expansion of the distal portion of the frame construction and movement of the distal anchoring hooks away from a center line of the tubular passage, so that the sharp ends of the distal anchoring hooks move into contact with the myocardium, and further withdrawal of the catheter off the frame construction causes rotation of the distal anchoring hooks into the myocardium.
8. The device of claim 4, wherein at least some of the anchoring hooks are proximal anchoring hooks on a proximal portion of the frame construction, the proximal portion of the frame construction expanding after leaving the tubular passage, expansion of the proximal portion of the frame construction causing movement of the proximal anchoring hooks away from a center line of the tubular passage so that the proximal anchoring hooks move into contact with the myocardium.
13. The device of claim 12, wherein the support frame is sufficiently strong to support the membrane when a ventricular pressure acts on the membrane.
14. The device of claim 13, wherein the ventricular pressure is at least 60 mm Hg.
15. The device of claim 12, wherein the support frame, when the main frame is in the collapsed state, is collapsed into an elongated arrangement extending along a length of the tubular passage.
16. The device of claim 15, wherein the support frame has at least two elements that pivot relative to one another in a scissor-like manner.
17. The device of claim 1, wherein the membrane is within the frame construction when the frame construction is in the collapsed state.
18. The device of claim 1, wherein the membrane is at least 3 cm in diameter.
19. A device for improving cardiac function, comprising:
a membrane that is movable from a folded condition, wherein the membrane can be fed through a tubular passage having a small cross-sectional area, to an unfolded condition after leaving the tubular passage, in the unfolded condition the membrane having an area substantially larger than the cross-sectional area of the tubular passage and being located in a position wherein the membrane forms a division between volumes of an endocardial cavity on opposing sides of the membrane;
a frame construction that is movable from a collapsed state, wherein the frame construction has a small cross-dimension to allow the frame construction to be fed through a tubular passage with a small diameter into the heart, to an expanded state wherein the frame construction, after leaving the tubular passage and having been located in an installed position in an endocardial cavity of the heart, has a cross-dimension substantially larger than the small diameter of the tubular passage and approximating a cross-dimension of the endocardial cavity where the frame construction is positioned, the frame construction being deformable into various non-circular shapes to allow for positioning thereof in endocardial cavities having differing non-circular shapes;
at least one anchor formation connected to the frame construction, the anchor formation having at least one anchoring portion that is positioned and capable of anchoring to tissue of a myocardium of the heart, and so anchor the frame construction in the installed position to the myocardium.
20. The device of claim 19, wherein the frame construction includes a main frame surrounding a vertical axis and comprising a sequence of sections that alternate in upward and downward directions, expansion of the frame construction moving the sections apart.
21. A device for improving cardiac function, comprising:
a membrane that is movable from a folded condition, wherein the membrane can be fed through a tubular passage having a small cross-sectional area, to an unfolded condition after leaving the tubular passage, in the unfolded condition the membrane having an area substantially larger than the cross-sectional area of the tubular passage and being located in a position wherein the membrane forms a division between volumes of a ventricular cavity of a heart on opposing sides of the membrane;
a frame construction that is movable from a collapsed state, wherein the frame construction has a small cross-dimension to allow the frame construction to be fed through a tubular passage with a small diameter into the heart, to an expanded state wherein the frame construction, after leaving the tubular passage and having been located in an installed position in the ventricular cavity, has a cross-dimension substantially larger than the small diameter of the tubular passage and approximating a cross-dimension of the ventricular cavity where the frame construction is positioned, the frame construction including a support frame next to and supporting the membrane, the support frame being sufficiently strong to support the membrane when a ventricular pressure of a healthy human being acts on the membrane; and
22. The device of claim 21, wherein the ventricular pressure is at least 60 mm Hg.
23. The device of claim 21, wherein the support frame, when the main frame is in the collapsed state, is collapsed into an elongated arrangement extending along a length of the tubular passage.
24. The device of claim 23, wherein the support frame has at least two elements that pivot relative to one another in a scissor-like manner.
The present patent application is a continuation-in-part application of prior U.S. patent application Ser. No. 09/635,511, filed on Aug. 9, 2000, which claims priority from U.S. Provisional Patent Application No. 60/147,894 filed on Aug. 9, 1999, and are incorporated herein by reference in their entirety.
[0012]FIG. 1A is a perspective view of a main frame of a device, according to an embodiment of the invention, for improving cardiac function;
[0013]FIG. 1B is a view similar to FIG. 1A, illustrating the main frame in hidden lines and further illustrating in solid lines a support frame of the device mounted to the main frame;
[0014]FIG. 1C is a top plan view illustrating a membrane of the device secured on top of the support frame;
[0015]FIG. 2A is a cross-sectional side view of a heart, a catheter that is inserted into a left ventricle of the heart, and the device as it is packaged within an end of the catheter;
[0016]FIG. 2B is a perspective view illustrating a device manipulating apparatus within the end of the catheter;
[0020]FIG. 6 is a top plan view illustrating a larger device, according to another embodiment of the invention, mounted in a lower portion within a left ventricle of a heart;
[0022]FIG. 8 is a cross-sectional side view illustrating a sheet that is curved to substantially conform to an inner wall of a heart;
[0023]FIG. 9 is a cross-sectional end view on 9-9 in FIG. 8;
[0024]FIG. 10 is a cross-sectional side view illustrating a device that is used for closing off a small ventricle of a heart; and
[0025]FIG. 11 is a cross-sectional side view illustrating the same device as in FIG. 10, used for closing off a large ventricle of a heart.
[0026]FIGS. 1A, 1B, and 1C illustrate components of a device 10, according to an embodiment of the invention, for improving cardiac function. The device 10 includes a frame construction 12, a plurality of anchoring formations 14, and a membrane 16. The frame construction 12 includes a main frame 18 and a support frame 20 secured to the main frame 18. The membrane 16 is secured on top of the support frame 20.
[0033]FIG. 1C also shows the membrane 16, in an unfolded condition, secured on the elements 32 of the support frame 20. An edge 40 of the membrane 16 is secured to the elements 32. Two of the elements 32 form a cross below a center of the membrane 16, and the other four elements 32 support the membrane 16 between the cross and the edge 40. Collapse of the support frame 20 folds the membrane 16 into an elongated folded arrangement extending along the elongated arrangement formed by the collapsed support frame 20. The membrane 16 is made of a biocompatible foldable material, for example Gore-Tex®, poly-ethylene terephthalate, or polypropylene mesh.
[0034]FIG. 2A illustrates the device 10 that is inserted into a heart 42 by means of a catheter 44. The device 10 is collapsed and is inserted into an end of the catheter 44. The axis 24, shown vertically in FIGS. 1A and 1B, now extends along an axis of an elongated tubular passage 46 in the catheter 44. The device 10 is packaged with the distal anchoring screw 14A protruding from the end of the catheter 44. The catheter 44 is non-invasively steered through the aorta 48 and the aortic valve (not shown) into the left ventricle 52A of the heart 42. The other chambers of the heart 42 are the right ventricle 52B, the left atrium 50A, and the right atrium 50B.
[0043]FIGS. 4A and 4B illustrate pressures within the left atrium 50 and the left ventricle 52A, respectively, of a healthy human being. It can be seen that the peak left ventricular pressure, i.e., the pressure in the left ventricle 52A during the systolic portion, reaches approximately 120 mm Hg. This pressure acts directly on the membrane 16. It can be assumed that the pressure on an opposing side of the membrane 16, i.e., the side of the aneurysmic bulge 76, is close to zero. The support frame 20 supports the sheet 16 at a sufficient number of locations and is sufficiently strong to prevent the membrane 16 from collapsing during peak systolic pressure. An peak pressure in the region of 50 to 60 mm Hg for a sustained period of a few hours is generally regarded as being incompatible with life.
[0045]FIGS. 5A, 5B, and 5C illustrate one manner in which the support frame 20 and the membrane 16 can be positioned at a select angle relative to the myocardium 74. When comparing FIG. 5A with FIG. 3C, it can be seen that the catheter 44 is positioned closer to a right side (as viewed) of the myocardium 74. The distal anchoring hooks 14B on the right engage with the myocardium 74 before the distal anchoring hooks 14B on the left engage with the myocardium 74. Further withdrawal of the catheter 44, as shown in FIG. 5B, results in engagement of the distal anchoring hooks 14B on the left with the myocardium 74 at a location which is displaced by an offset distance 80 in a direction of an axis of the elongated tubular passage 46. When comparing FIG. 5C with FIG. 5B, it can be seen that, due to the offset distance 80, the support frame 20 is eventually at an angle of approximately 60° relative to the axis of the elongated tubular passage 46. Although not blocking a mouth of the aneurysmic bulge 76, this serves to illustrate that the membrane 16 can be positioned in different select planes, as may be required, due to the flexibility of the frame construction 12 and various virtual triangles that are formed by connecting locations where the anchoring formations 14 anchor to the myocardium 74.
[0048]FIG. 6 illustrates one such a larger device 110 that is inserted in the bottom of the left ventricle 152 of a heart 114. The main frame (not shown) of the device 110 is formed into a non-circular shape, so that an outline formed by corners 134 and 136 of a support frame of the device define a non-circular shape. A membrane 116 mounted on top of the support frame also defines a non-circular shape. The shape of the membrane 116 conforms approximately to a non-circular D-shape of the left ventricle 152 at a height where the membrane 116 is positioned. The same device 110 can be deformed into various different shapes, according to requirement.
[0049]FIGS. 7A and 7B illustrate a frame construction 212 and anchoring formations 214 of a device according to an alternative embodiment of the invention. The frame construction 212 includes a main frame 218 and a support frame 220. The main frame 218 has a plurality of segments 222 having distal ends connected to one another at a common location 224. Proximal portions of the segments 222 can collapse toward one another and spring outwardly away from one another. The anchoring formations 214 include a distal anchoring screw 214A secured at the common location 224, and proximal anchoring hooks 214B on proximal ends of the segments 222. The support frame 220 includes a plurality of elements 232. The elements 232 have ends that are pivotally connected to one another at a common location 254. An opposing end of each element 232 is slidably secured to a respective one of the segments 222. The manner in which the segments 222 of the main frame 218 collapse is simultaneously replicated by the manner in which the elements 232 of the support frame 220 collapse. In use, the distal anchoring screw 214A is first screwed into a myocardium. A catheter is then withdrawn from the frame construction 212. Once the catheter is entirely removed from the frame construction 212, the proximal anchoring hooks 214B spring outwardly and embed themselves into the myocardium. The support frame 220 simultaneously moves from its collapsed condition into its expanded condition. A membrane (not shown) is secured to, unfolded by, and supported by the support frame 220.
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International Classification A61B17/12, A61F2/82, A61M29/00, A61F2/04, A61F2/24, A61B17/00, A61N1/05
Cooperative Classification Y10S623/91, A61B17/12122, A61N1/05, A61B17/12172, A61B17/12022, A61B2017/1205, A61B2017/048, A61B2017/00243, A61B2017/00579, A61B2017/00592, A61B2017/044, A61B17/0057, A61B2017/00632, Y10S623/904, A61B17/00234, A61B2017/00597
European Classification A61B17/12P7W1, A61B17/12P, A61B17/12P5H, A61N1/05