Double walled fixed length stent like apparatus and methods of use thereof

Abstract

A new medical apparatus for deployment within an anatomical blood vessel and methods of use thereof. The apparatus comprising: a first tubular wall; and a second tubular wall, placed within the first tubular wall; wherein the first and second tubular walls are firmly connected at their edges, therefore restricted to have same overall longitudinal length; and wherein the second tubular wall is configured to be partially constricted towards its inner radial axis, while maintaining its overall longitudinal length.

Claims

1. A medical apparatus for deployment within an anatomical blood vessel comprising: a first tubular wall; and a second tubular wall, placed within the first tubular wall, the second tubular wall comprising a plurality of sections, one or more of said plurality of sections comprising struts, and wherein the second tubular wall is configured to be partially constricted towards its inner radial axis, while maintaining its overall longitudinal length by deformation of one or more of said struts, under a constriction force said first and second tubular walls forming a diametrical reducer.

2. The medical apparatus of claim 1, wherein said first and second tubular walls are firmly connected at their edges, therefore restricted to have the same overall longitudinal length.

3. The medical apparatus of claim 2, wherein at least one of the first and the second tubular walls comprises binding elements at its edges, configured for the connection of the first and the second tubular walls one to another.

4. The medical apparatus of claim 1, wherein the plurality of sections comprise strut elements and connecting elements; and wherein struts of the connecting elements are configured to be deformed, when a constriction force is applied.

5. The medical apparatus of claim 1, wherein at least some of the sections are arranged in one or both of: rows; and a ring-like configuration.

6. The medical apparatus of claim 1, wherein the sections' motion comprises at least one of: deformation, translation, rotation, twist, contraction, conversion and collapse.

7. The medical apparatus of claim 1, further comprising a constricting element configured to constrict a circumference of a portion of the second tubular wall.

8. The medical apparatus of claim 1, wherein the constriction provides the second tubular wall with a radial neck section, configured for reduction of the effective diameter of the anatomical blood vessel, and wherein at least a portion of the second tubular wall is coated with a coating material.

9. The medical apparatus of claim 1, wherein the first and second tubular walls are concentric.

10. The medical apparatus of claim 1, wherein material of the first and second tubular walls comprises at least one of the group consisting of: Nitinol, stainless steel, Titanium, Cobalt-Chromium alloy, Tantalum alloy, polymer, Platinum alloy and any combination thereof.

11. The medical apparatus of claim 1, wherein the first tubular wall is made of a first material and the second tubular wall is made of a second material.

12. The medical apparatus of claim 1, wherein at least one of the first and second tubular walls are manufactured by a laser cut process.

13. The medical apparatus of claim 1, wherein the ratio between the medical apparatus's longitudinal length and diameter of the first tubular wall is smaller than three (3).

14. The medical apparatus of claim 1, wherein the medical apparatus is reversibly collapsible and configured to be delivered into the anatomic vessel via a catheter.

15. A method of use of an apparatus configured for reduction of effective diameter of an anatomic vessel, the method comprising: providing a medical apparatus having a second tubular wall placed within a first tubular wall, wherein the second tubular wall includes a plurality of sections one or more of said plurality of sections comprising struts; wherein the second tubular wall is configured to be partially constricted towards its inner radial axis, while maintaining its overall longitudinal length by deformation of one or more of said struts, under a constriction force; deploying the medical apparatus within an anatomical blood vessel; and constricting at least a portion of the second tubular wall with said constriction force, to initiate said deformation of said one or more of said struts, thereby providing the second tubular wall with a radial neck section, while maintaining its overall longitudinal length, said first and said second tubular walls forming a diametrical reducer.

16. The method of claim 15, wherein the constricting is provided, while the medical apparatus is within the anatomic vessel.

17. The method of claim 15, wherein the step of providing comprises partially constricting the second tubular wall.

18. The method of claim 15, wherein the step of providing comprises at least partially coating the second tubular wall.

19. The method of claim 15, wherein the step of providing comprises connecting both the first- and the second-tubular walls at their edges, thereby restricting the first- and the second-tubular walls to have the same overall longitudinal length.

20. The method of claim 15, wherein the step of deploying comprises delivering the medical apparatus into an anatomical blood vessel via a catheter.

21. A medical apparatus for deployment within an anatomical blood vessel comprising: a first tubular wall; and a second tubular wall, placed within the first tubular wall, the second tubular wall comprising a plurality of sections comprising: strut element sections and connecting element sections, and having an inner radial axis and an overall longitudinal length; wherein the first and second tubular walls are connected; and wherein the second tubular wall is configured to be: partially constricted towards said inner radial axis, while maintaining said overall longitudinal length; by deformation of said connecting element sections which moves at least some of the strut element sections one relative to another; wherein said medical apparatus including said first and second tubular walls forms a diametrical reducer.

22. The medical apparatus of claim 21, wherein said deformation rotates one or more of said plurality of sections with respect to each other about a longitudinal axis of said second tubular structure.

23. The medical apparatus of claim 22, wherein said strut element sections are connected by said connecting element sections, wherein said deformation rotates one or more of said strut element sections with respect to another one or more of said strut sections.

24. The medical apparatus of claim 23, wherein said second tubular wall is connected at its edges to said first tubular walls.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The subject matter regarded as the invention is particularly pointed out and distinctly claimed in the concluding portion of the specification. The invention, however, both as to organization and method of operation, together with objects, features, and advantages thereof, may be understood by reference to the following detailed description when read with the accompanying drawings in which:

(2) FIG. 1 conceptually depicts a stent like medical apparatus having first and second tubular walls, according to some embodiments of the invention;

(3) FIGS. 2A and 2B conceptually depict a flattened image and picture image of a second tubular wall, respectively, according to some embodiments of the invention;

(4) FIG. 3 conceptually depicts a first tubular wall, according to some embodiments of the invention;

(5) FIG. 4 conceptually depicts a stent like medical apparatus, in a constricted configuration, according to some embodiments of the invention;

(6) FIG. 5A conceptually depicts a medical apparatus crimped within a delivery system, according to some embodiments of the invention;

(7) FIG. 5B conceptually illustrates a crimped second tubular wall, according to some embodiments of the invention;

(8) FIGS. 6A and 6B conceptually illustrate a non-limiting schematic example for a second tubular wall, according to some embodiments of the invention;

(9) FIGS. 6C and 6D conceptually illustrate non-limiting flattened schematic examples for second tubular walls, according to some embodiments of the invention;

(10) FIG. 7 conceptually depicts a stent like medical apparatus having a first tubular wall and a second coated tubular wall, according to some embodiments of the invention; and

(11) FIG. 8 conceptually demonstrates a method of use of an apparatus configured for a reduction of an effective diameter of an anatomic vessel, according to some embodiments of the invention.

(12) It will be appreciated that for simplicity and clarity of illustration, elements shown in the figures have not necessarily been drawn to scale. For example, the dimensions of some of the elements may be exaggerated relative to other elements for clarity. Further, where considered appropriate, reference numerals may be repeated among the figures to indicate corresponding or analogous elements.

DETAILED DESCRIPTION OF THE PRESENT INVENTION

(13) The following description is provided, alongside all chapters of the present invention, so that to enable any person skilled in the art to make use of the invention and sets forth the best modes contemplated by the inventor of carrying out this invention. Various modifications, however, will remain apparent to those skilled in the art, since the generic principles of the present invention have been defined specifically to provide a medical apparatus configured to reduce a diameter of a blood vessel for treating or at least reducing the severity of a congestive failure of the heart, such as but not limited to: systolic heart failure, diastolic heart failure, left ventricle (LV) heart failure, right ventricle (RV) heart failure, congenital defects of the heart for which surgical pulmonary artery banding (PAB) is used, and any other condition which requires pulmonary artery banding (PAB).

(14) As used herein, in one embodiment, the term “about”, refers to a deviance of between 0.0001-5% from the indicated number or range of numbers. In one embodiment, the term “about”, refers to a deviance of between 1-10% from the indicated number or range of numbers. In one embodiment, the term “about”, refers to a deviance of up to 25% from the indicated number or range of numbers.

(15) According to some embodiments, the term “a” or “one” or “an” refers to at least one.

(16) According to some embodiments the present invention provides a stent like medical apparatus for deployment within an anatomical blood vessel, as demonstrated at least in FIG. 1, which is configured to reduce the effective diameter of an anatomical blood vessel.

(17) According to some embodiments, the medical apparatus 100 comprises: a first tubular wall 110 (also noted as outer tubular wall); and a second tubular wall 120 (also noted as inner tubular wall), placed within the first tubular wall; wherein the first- and second-tubular walls are firmly connected (one to another) at their proximal- and distal-edges 131,132, therefore restricted to have same overall longitudinal length (L); and wherein the second tubular wall is configured to be partially constricted 121 towards its inner radial axis, while maintaining its overall longitudinal length; it is therefore that the combination of the first and second tubular walls forms a diametrical reducer.

(18) According to some embodiments, the constriction process may be applied after the deployment of the apparatus within an anatomical blood vessel.

(19) According to some embodiments, the constriction is provided while the medical apparatus is within the anatomic vessel. According to some embodiments, the constriction provides the second tubular wall with a radial neck section, configured for reduction of the effective diameter of the anatomical blood vessel. According to some embodiments, at least a portion of the second tubular wall is coated with a coating material, as further demonstrated in FIG. 7, 760.

(20) According to some embodiments, in addition to the coating of the second tubular wall, two bands of coating on the proximal and distal ends of the first tubular wall can be applied, configured to create a fluid seal with the coating of the second tubular wall, as further demonstrated in FIG. 7, 770.

(21) The coating material can be selected, for a non-limiting example, from: silicone elastomers, urethane containing polymers (such as polyurethane, silicone-polyurethane, polycarbonate urethanes, and silicone polycarbonate urethanes), PTFE (polytetrafluoroethylene), ePTFE (expanded PTFE), PLA (including PLGA, PLLA), xenograft or allograft tissue (such as pericardial tissue).

(22) According to some embodiments, the second tubular wall comprises a plurality of section elements, wherein at least some of the section elements are configured to allow a motion of at least some of the section elements one relative to another, when a constriction force is applied.

(23) Reference is now made to FIGS. 2A and 2B, which schematically demonstrate a second tubular wall, according to some embodiments of the invention. FIG. 2A illustrates a flattened second tubular wall, shown after the process of laser cutting, according to some embodiments of the invention. FIG. 2B depicts a picture of a second tubular wall after constriction due to a constriction force (F), according to some embodiments of the invention.

(24) As shown in both FIGS. 2A and 2B the second tubular wall 220 comprises, according to some embodiments, a plurality of connected section elements 221, 222, wherein at least some of the section elements are configured to be deformed when a force, for example a constriction force (F), is applied thereon. The deformed section elements allow a motion of some of the section elements one relative to another, therefore configured to allow a constriction of at least a part of the second tabular wall. Consequently, the deformed section elements allow the second tubular wall to expand its path length (Lp), during the radial constriction, while maintaining its overall longitudinal length (L).

(25) According to some embodiments the plurality of section elements can all have a similar shape and/or configuration. According to other embodiments the plurality of section elements can have a variety of shapes and/or configurations.

(26) According to some embodiments, the plurality of section elements can comprise strut elements 221 and connecting elements 222, as demonstrated in FIGS. 2A and 2B. The connecting elements are configured to be deformed when a constriction force (F) is applied, and thereby configured to allow an increase in the distance between the strut elements rows/rings. The deformation of the connecting elements consequently allows the constriction of at least a part of the second tubular wall, with an increased path length (Lp), while maintaining its overall longitudinal length (L). According to some embodiments, the strut elements 222 can also be deformed by the constricting force, however in a much smaller deformation extent than of the connecting elements.

(27) In the examples of FIGS. 2A and 2B, the increased distance between the strut elements is enabled by twisting of rows/rings of strut elements, one relative to the other via the connecting elements, as demonstrated by the marked arrows in the flattened schematic illustration in FIG. 2A. In other embodiments, and as demonstrated in FIGS. 6C and 6D, the increased distance between the strut elements is enabled by extension of the connecting elements 622,632.

(28) According to some embodiments, at least some of the section elements are arranged in rows or rings-like configuration 223. The rings 223 are configured to move one relative to another, during the constriction.

(29) According to some embodiments, the motion of the section elements comprises at least one of: translation, deformation, rotation, twist, contraction, conversion and collapse.

(30) According to some embodiments, at least one of the first and the second tubular walls comprises binding elements 224,314 at its edges, configured for the connection of the first and the second tubular walls one to another. According to some embodiments, the connection can be by a suture, adhesion, welding, mechanical connection, or any other means of connection.

(31) Reference is now made to FIG. 3, which demonstrates a first tubular wall, according to some embodiments of the invention. The first tubular wall 310 as demonstrated comprises binding elements 314 at its edges, configured for the connection of the first and the second tubular walls one to another. According to some embodiments the first tubular wall further comprises at least one grip element 340 (and 740, FIG. 7), at least at one edge thereof. The grip element is configured to be pulled and thereby assist in loading the medical apparatus, for its insertion into a delivery system, as further demonstrated in FIG. 5A, and/or for re-sheathing of the apparatus into the delivery system during the process of deployment into the target vessel.

(32) Reference is now made to FIG. 4, which demonstrates a medical apparatus 400 comprising the first tubular wall 410 and the second tubular wall 420 bound together at both their proximal and distal ends via their binding elements 414,424, and where the medical apparatus is shown in a partially constricted configuration. According to some embodiments, the apparatus further comprises a constricting element 430 configured to constrict a circumference of a portion of the second tubular wall 420.

(33) According to some embodiments the constriction of the second tubular wall can be provided before- and/or after- the deployment of the apparatus within the vessel; therefore, can be provided with an initial constricted state and/or constricted in real time to a final constricted state, respectively.

(34) Reference is now made to FIGS. 5A and 5B, which demonstrate a stent-like medical apparatus 500, according to some embodiments of the invention. As demonstrated the stent-like medical apparatus is configured for a reversible collapse and therefore configured to be delivered into the anatomic vessel via a catheter tube. FIG. 5A demonstrates the collapsed/crimped apparatus 500 within the delivery catheter 550, whereas FIG. 5B demonstrates only the collapsed second tubular wall 520, within the delivery catheter 550, which is hidden by the first tubular wall at FIG. 5A. According to some embodiments, the overall longitudinal length (Lc) of the collapsed/crimped apparatus is larger than the overall longitudinal length (L) of the non-collapsed apparatus, (Lc>L).

(35) According to some embodiments, the overall longitudinal lengths of first and second tubular walls are the same whether in a crimped configuration (in a delivery catheter), a deployed configuration (in a vessel), or a constricted configuration (having an hourglass shape).

(36) According to some embodiments, at least one of the outer and inner tubular walls is made of a collapsible memory shape material, therefore self-expanding material. According to some embodiments, at least one of the outer and inner tubular walls is manufactured by laser cut process.

(37) According to some embodiments, the ratio N (N=LI D.sub.out) between the medical apparatus's 100 longitudinal length (L), as demonstrated in FIG. 1, and the diameter of the outer tubular wall (D.sub.out) is smaller than a predetermined numeral selected from the group consisting of: 3, 2.5, 2, 1.5, 1, 0.5, 0.3 and any ratio within their range. According to a preferred embodiment, N is smaller than 1.5.

(38) According to some embodiments, the first and second tubular walls are concentric. According to some embodiments, the medical apparatus is axisymmetric.

(39) According to some embodiments, the material of the outer and inner tubular walls comprises at least one from the group consisting of: Nitinol, stainless steel, Titanium, Cobalt-Chromium alloy, Tantalum alloy, polymer (ePTFB, PU, etc.), Platinum alloy and any combination thereof.

(40) According to some embodiments, the outer tubular wall is made of a first material and the inner tubular wall is made of a second material. According to some embodiments, the outer and inner tubular walls are made of the same material.

(41) Reference is now made to FIGS. 6A and 6B, which demonstrate a non-limiting schematic example for a second tubular wall 620 before (FIG. 6A) and after (FIG. 6B) its constriction. In this non-limiting example, the overall initial longitudinal length of the second tubular wall is 26 mm and its initial diameter before its constriction is 15 mm. After a partial constriction of the second tubular wall, by applying a circumference constriction force (F) its minimal diameter is 10 mm, while its overall longitudinal length is kept 26 mm, such that the path length (L.sub.p) of the second tubular wall has increased without an increase in its overall length (L).

(42) Reference is now made to FIGS. 6C and 6D, which schematically demonstrate two different non-limiting flattened schematic examples for second tubular walls, according to some embodiments of the invention. As shown, the second tubular wall 625,635 comprises, according to some embodiments, a plurality of strut elements 621,631 and a plurality of connecting elements 622,632. When a constriction force (F) is applied, at least some of the connecting elements are configured to be deformed and cause an increase in the distance between the strut elements rows/rings, therefore allowing a constriction of at least a part of the second tabular wall, with an increased path length, while maintaining its overall longitudinal length. The rows or rings-like configurations 623,633 are also demonstrated.

(43) Reference is now made to FIG. 7, which conceptually depicts a stent like medical apparatus 700 having a first tubular wall and a second coated tubular wall. According to some embodiments of the invention the medical apparatus 700 comprises: a first tubular wall 710 (also noted as outer tubular wall); and a second tubular wall 720 (also noted as inner tubular wall), placed within the first tubular wall;

(44) wherein the first- and second-tubular walls are firmly connected at their proximal and distal edges 714,724, therefore restricted to have same overall longitudinal length; and

(45) wherein the second tubular wall is configured to be partially constricted 730 towards its inner radial axis, while maintaining its overall longitudinal length;

(46) it is therefore that the combination of the first and second tubular walls forms a diametrical reducer.

(47) FIG. 7 further demonstrates that at least a portion of the second tubular wall 720 is coated with a coating material 760, for example by an ePTFE, such that the flow through the vessel will be guided through the second tubular wall. FIG. 7 further demonstrates that in addition to the coating of the second tubular wall, the proximal and distal ends of the first tubular wall can be coated 770, according to some embodiments of the invention, to create a fluid seal with the coating of the second tubular wall.

(48) Reference is now made to FIG. 8, which conceptually demonstrates a method of use of an apparatus configured for a reduction of an effective diameter of an anatomic vessel, according to any of the above-mentioned embodiments. The method 800 comprising: providing 810 a medical apparatus having a second tubular wall placed within a first tubular wall; deploying 820 the medical apparatus within an anatomical blood vessel; and constricting 830 at least a portion of the second tubular wall, thereby providing the second tubular wall with a radial neck section, while maintaining its overall longitudinal length.

(49) According to some embodiments, the step of providing further comprises partially constricting 811 the second tubular wall to an initial constricted state, which may be further constricted. According to some embodiments, the initial constriction is provided via a heating process; for example, by heat treatment of the Nitinol of the second tubular wall to maintain a specific shape; for example, to have a shape of an hourglass.

(50) According to some embodiments, the step of providing further comprises at least partially coating 812 the second tubular wall.

(51) According to some embodiments, the step of providing further comprises connecting 813 both the first- and the second-tubular walls at their edges, thereby restricting the first- and the second-tubular walls to have the same overall longitudinal length.

(52) According to some embodiments, the step of deploying comprises delivering 821 the medical apparatus into an anatomical blood vessel via a catheter, wherein the medical apparatus is provided in a crimped configuration, which is configured to expand back, once deployed out of the delivering catheter.

(53) According to some embodiments, a therapeutic result for the use of a medical apparatus as mentioned above, for patients with LV heart failure, can be at least one of the group consisting of: an increase in the left ventricle ejection fraction (LVEF); a decrease in the left ventricle end diastolic pressure (LVEDP); improvement in the clinical symptoms of heart failure; and any combination thereof.

(54) While certain features of the invention have been illustrated and described herein, many modifications, substitutions, changes, and equivalents will now occur to those of ordinary skill in the art. It is, therefore, to be understood that the appended claims are intended to cover all such modifications and changes as fall within the true spirit of the invention.