Source: https://patents.google.com/patent/EP1520519A1
Timestamp: 2018-02-21 07:39:07
Document Index: 250577727

Matched Legal Cases: ['art 14', 'art 14', 'art 14', 'art 14', 'art 14', 'art 14']

EP1520519A1 - Heart wall tension reduction apparatus and method - Google Patents
EP1520519A1
EP1520519A1 EP20040078441 EP04078441A EP1520519A1 EP 1520519 A1 EP1520519 A1 EP 1520519A1 EP 20040078441 EP20040078441 EP 20040078441 EP 04078441 A EP04078441 A EP 04078441A EP 1520519 A1 EP1520519 A1 EP 1520519A1
EP20040078441
EP1520519B1 (en )
This application is a continuation-in-part of U.S. Application Serial No. 08/933,456, filed September 18, 1997, which in turn is a continuation-in-part of U.S. Application Serial No. 08/778,277, filed January 2, 1997. This application is related to U.S. Application Serial 09/123,977, filed on date even herewith and entitled "Transventricular Implant Tools and Devices" and U.S. Application Serial No. 09/124,321, filed on date even herewith and entitled "Stress Reduction Apparatus and Method," both of which are incorporated herein by reference.
Figure 2 is a transverse cross-section of the left and right ventricles of a human heart showing the placement of a balloon device in accordance with the present invention;
Figure 3 shows yet another alternative embodiment of the present invention deployed with respect to left ventricle 10 of human heart 14. Here a compression frame structure 300 is engaged with heart 14 at atraumatic anchor pads 310. A compression member 312 having an atraumatic surface 314 presses against a wall of left ventricle 10 to reduce the radius or cross-sectional area thereof.
Figure 4 is a transverse cross-sectional view of human heart 14 showing yet another embodiment of the present invention. In this case a clamp 400 having atraumatic anchor pads 410 biased toward each other is shown disposed on a wall of left ventricle 10. Here the radius or cross-sectional area of left ventricle 10 is reduced by clamping off the portion of the wall between pads 410. Pads 410 can be biased toward each other and/or can be held together by a locking device.
Each of the various embodiments of the present invention disclosed in Figures 1-4 can be made from materials which can remain implanted in the human body indefinitely. Such biocompatible materials are well-known to those skilled in the art of clinical medical devices.
Figure 17 is a partial vertical cross-section of human heart 14 showing left ventricle 10 and left atrium 22. As shown in Figure 7, heart 14 includes a region of scar tissue 24 associated with an aneurysm or ischemia. As shown in Figure 7, the scar tissue 24 increases the radius or cross-sectional area of left ventricle 10 in the region affected by the scar tissue. Such an increase in the radius or cross-sectional area of the left ventricle will result in greater wall stresses on the walls of the left ventricle.
Figure 19 is a vertical cross-sectional view of left ventricle 10 and left atrium 22 of heart 14 in which a splint 16 has been placed. As shown in Figure 9, splint 16 includes an alternative anchor 26. The anchor 20 is preferably an elongate member having a length as shown in Figure 9 substantially greater than its width (not shown). Anchor bar 26 might be used to reduce the radius or cross-sectional area of the left ventricle in an instance where there is generalized enlargement of left ventricle 10 such as in idiopathic dilated cardiomyopathy. In such an instance, bar anchor 26 can distribute forces more widely than anchor 20.
Figure 22 is a cross-sectional view of a capture ball anchor 30. Capture ball anchor 30 can be used in place of anchor 20. Capture ball anchor 30 includes a disk portion 32 to distribute the force of the anchor on the heart wall, and a recess 34 for receiving a ball 36 affixed to an end of tension member 18. Disk 32 and recess 34 include a side groove which allows tension member 38 to be passed from an outside edge of disk 32 into recess 34. Ball 36 can then be advanced into recess 34 by drawing tension member 18 through an opening 38 in recess 34 opposite disk 32.
The tension member, in a preferred embodiment, articulates with respect to the anchor pad to reduce bending of the tension member at the pad. This can be accomplished by a ball and socket joint shown in Figure 22, for example. The tension member itself can be made more flexible or bendable by providing a multi-filament tension member such as a braided or twisted wire cable tension member. A multifiber filament structure of numerous smaller wires can then easily, while reducing the stress level on any individual wire as compared to a solid wire of the same diameter as the multifilament bundle. Such a multi-filament tension member can be made from biocompatible materials such as, but not limited to, stainless steel, Nitinol, titanium alloys, LCP (liquid crystal polymer), SpectraTM fiber, kevlar fiber, or carbon fiber. In a preferred embodiment, the multi-filament structure is coated or covered to substantially seal the multi-filament structure. Coatings such as silicone, urethane or PTFE are preferred.
In use, the various embodiments of the present invention are placed in or adjacent the human heart to reduce the radius or cross-section area of at least one chamber of the heart. This is done to reduce wall stress or tension in the heart or chamber wall to slow, stop or reverse failure of the heart. In the case of the splint 16 shown in Figure 1, a cannula can be used to pierce both walls of the heart and one end of the splint can be advanced through the cannula from one side of the heart to the opposite side where an anchor can be affixed or deployed. Likewise, an anchor is affixed or deployed at the opposite end of splint 16. Additional methods for splint placement are described in more detail in U.S. Application Serial No. 09/123,977, filed on date even herewith and entitled "Transventricular Implant Tools and Devices" and incorporated herein by reference.
Figure 38 shows various parameters of the Figure 1 cross-section of the splinted idealized heart chamber of Figure 37. Where 1 is the length of the splint between opposite walls of the chamber, R2 is the radius of each lobe,  is the angle between the two radii of one lobe which extends to opposite ends of the portion of the splint within chamber 48 and h is the height of the triangle formed by the two radii and the portion of the splint within the chamber 48 (R1 is the radius of the cylinder of Figure 36). These various parameters are related as follows:
h = R2 COS (/2)
1 = 2 R2 SIN (/2)
R2=R1π/(2π-)
From these relationships, the area of the figure eight cross-section can be calculated by: A2 = 2π(R2)2 (1-/2π) + hl
Where chamber 48 is unsplinted as shown in Figure 36 A1, the original cross-sectional area of the cylinder is equal to A2 where  = 180°, h = 0 and 1 = 2R2. Volume equals A2 times length L and circumferential wall tension equals pressure within the chamber times R2 times the length L of the chamber.
Figures 39 and 40 show a hypothetical distribution of wall tension T and pressure P for the figure eight cross-section. As  goes from 180° to 0°, tension Ts in the splint goes from 0 to a 2T load where the chamber walls carry a T load.
When a splint is actually placed on the heart, along an alignment such as those shown in Figure 35, the length 1 between the two pads as measured along the tension member is preferably 0.4 to about 0.8 and more preferably between about 0.5 to about 0.7 and most preferably about 0.6 times the distance along the length of the tension member at end diastole if the pads were not secured to the tension member and provided no resistance to expansion of the heart. A more detailed discussion of tension member length can be found in U.S. Application Serial No. 09/123,977, filed on date even herewith and entitled ''Transventricular Implant Tools and Devices" which is incorporated herein by reference.
Other aspects of the invention include a transventricular splint comprising an elongate member having two axially disposed ends and substantially atraumatic anchors disposed at each end, such that the length of the tension member between the anchors is about 1 to 4 inches. Additional aspects of the transventricular splint include:
an elongate member comprising a multi-filament tension member;
a radiopaque tension or elongate member;
a radiopaque marker on the tension or elongate member;
an echocardiograph tension or elongate member;
an echogenic marker on the tension or elongate member;
the tension or elongate member having a substantially antithrombogenic surface;
the tension or elongate member having a substantially antithrombogenic coating;
the length of the tension or elongate member being between about 0.6 and 2.0 inches; and
the diameter of the tension or elongate member being between about 0.01 and 0.02 inches.
It will be understood that this disclosure, in many respects, is only illustrative. Changes may be made in details, particularly in matters of shape, size, material, and arrangement of parts without exceeding the scope of invention. Accordingly, the scope of the invention is as defined in the language of the appended claims.
An apparatus for placement in a heart, the apparatus comprising:
an anchor disposed at each end of the elongate member configured to engage a wall of the heart so that the engaged walls remain in a non-contacting relationship.
The apparatus of claim 1, wherein at least one anchor includes a mechanism capable of securing the anchors to the wall.
The apparatus of claim 2, wherein the mechanism comprises a member capable of being advanced through the wall to secure the anchor to the wall.
The apparatus of claim 1 or 2, wherein the mechanism includes a biocompatible adhesive.
The apparatus of claim 2, wherein the mechanism includes a layer of material capable of promoting tissue ingrowth.
The apparatus of claim 5, wherein the material is a mesh material and/or is formed essentially of expanded PTFE.
The apparatus of any of claims 2-6, wherein the anchor includes a top layer of material connected to the layer of tissue ingrowth material.
The apparatus of claim 7, wherein the top layer is formed essentially of PTFE.
The apparatus of claim 2, wherein the mechanism includes an aperture extending through the anchor, the aperture being threaded to receive a screw for securing the anchor to the wall.
The apparatus of any of the preceding claims, wherein at least one anchor includes a mechanism capable of securing the member to the anchors.
The apparatus of claim 10, wherein the mechanism includes a set screw disposed within a passage of the anchor.
The apparatus of any of the preceding claims, wherein the anchors are disc-shaped pads.
The apparatus of any of the preceding claims, wherein the member is formed essentially of a material chosen from stainless steel, a titanium alloy, a nickel titanium alloy, a shape memory alloy, polymeric fibre, and carbon fibre.
The apparatus of any of the preceding claims, wherein the member has a length in the range of approximately 2.54 cm to approximately 10.15 cm.
The apparatus of any of the preceding claims, wherein the member is a braided wire.
The apparatus of any of the preceding claims, wherein the member is a twisted wire.
The apparatus of any of the preceding claims, wherein the member includes a coating.
The apparatus of claim 17, wherein the coating is formed essentially from one of silicone, urethane, PTFE, and carbon.
The apparatus of claim 17, wherein the coating includes a drug.
The apparatus of claim 17, wherein the coating is tissue ingrowth inducing.
The apparatus of claim 17, wherein the coating is formed essentially of collagen.
The apparatus of any of the preceding claims, wherein the member includes a core fiber extending along an axis of the member.
The apparatus of any of the preceding claims, wherein the member is radiopaque and/or echocardiograph compatible and/or MRI compatible.
The apparatus of any of the preceding claims further comprising a radiopaque marker and/or an echocardiograph compatible marker and/or a MRI compatible marker associated with the member.
The apparatus of any of the preceding claims, wherein the member is configured to extend transverse the left ventricle of the heart and avoid papillary muscles and arteries.
EP20040078441 1997-01-02 1999-07-27 Heart wall tension reduction apparatus Active EP1520519B1 (en)
EP19990937483 EP1143858A2 (en) 1998-07-29 1999-07-27 Heart wall tension reduction apparatus and method
EP19990937483 Division EP1143858A2 (en) 1997-01-02 1999-07-27 Heart wall tension reduction apparatus and method
EP1520519A1 true true EP1520519A1 (en) 2005-04-06
EP1520519B1 EP1520519B1 (en) 2010-03-24
EP20040078441 Active EP1520519B1 (en) 1997-01-02 1999-07-27 Heart wall tension reduction apparatus
EP19990937483 Withdrawn EP1143858A2 (en) 1997-01-02 1999-07-27 Heart wall tension reduction apparatus and method
WO (1) WO2000006026A3 (en)
WO2000006026A9 (en) 2000-08-10 application
US6261222B1 (en) 2001-07-17 grant
EP1143858A3 (en) application
DE69942183D1 (en) 2010-05-06 grant
US6045497A (en) 2000-04-04 grant
WO2000006026A2 (en) 2000-02-10 application
WO2000006026A3 (en) 2001-11-08 application
US6629921B1 (en) 2003-10-07 grant
EP1143858A2 (en) 2001-10-17 application
EP1520519B1 (en) 2010-03-24 grant