RU2815466C2 - Inflatable dilator - Google Patents

Abstract

FIELD: medical equipment.

SUBSTANCE: invention relates to an inflatable dilatation device. Inflatable dilatation device (10) comprises tubular frame (12) and an elongated inflatable first cylinder (14a). Tubular carcass (12) comprises the first carcass element (16), which passes in a zigzag manner along the circumference. Elongated inflatable first balloon (14a) is attached to first frame member (16) and extends in a zigzag manner along first frame member (16), as a result, inflation of first balloon (14a) causes joint expansion of first balloon (14a) and first frame element (16) in circumferential direction from compressed state to expanded state.

EFFECT: invention provides smaller relative movement of the cylinder and the frame.

20 cl, 3 dwg

Description

BACKGROUND OF THE ART

The present invention relates to an inflatable dilation device. More specifically, the present invention relates to an inflatable dilation device comprising a tubular frame and an inflatable balloon. Even more specifically, the present invention relates to an inflatable dilatation device, which contains: a frame comprising an element extending in a zigzag manner around a circumference; and an inflatable balloon attached to the zigzag frame member.

Various expanding structures in the form of frames and stents are known. For example,

in documents WO 2019/08695 8 “Technology of expanding sealing skirt for sealed endovascular prostheses”, WO 2016/013006 “Device in the form of a pulmonary artery implant and methods of its use”, WO 2003/057078 “Intravascular stent and method of use”, US 2018/ 0110634 "Endoluminal device and method", US 2013/0166010 "Hybrid balloon-expandable/self-expanding prosthesis for placement in a body vessel and method of manufacture", US 2006/0259137 "Minimally invasive valve replacement system", US 2004/0127972 "Permanent stent and dilator living organs", US 2001/0044648 "Radially expanding stent and delivery system", US 6013854 "Permanent stent and method of its manufacture", EP 0808613 "Tubular prosthesis made of curable material", EP 1799152 "Stent" and EP 1729684 "Device for Stent Installation" describes scaffolds or stents containing elements that extend in a zigzag manner to provide radial expansion of the scaffold or stent; in WO 2018/158635 "Stented valve", WO 2017/165840 "Vascular flow diversion", WO 2014/008460 "Methods, devices and systems for post-conditioning with thrombus removal", WO 2012/047308 "Variable circumferential bridging stent design and methods" its use", US 2005/0131512 "Stent Delivery Catheter", US 2016/0113789 "Flexible Loop Stent" and CA 2462479 "Modified Delivery Device for Covered Medical Devices" describe scaffolds or stents that contain a first element extending in a zigzag pattern to providing radial expansion of the frame or stent, and second elements extending longitudinally from the apices formed by the first element; And

in WO 2017/151569 “Perfusion balloon with internal valve”, WO2016/013006 “Pulmonary artery implant device and methods for its use”, WO2014/158816 “Catheter system with balloon-controlled filter sheath and maintaining fluid flow”, US2015/ 0272732 "Reinforced inflatable medical devices", US2012/0143239 "Device for the removal of blood clots and methods for their removal", US2012/0109179 "Intravascular devices and balloons for use therewith", US5985307 "Device for non-occlusive localized delivery of drugs and method for such delivery" and US5458575 "Perfusion Catheter Having a Cylindrical Array of Balloons" describe either inflatable balloons that are longitudinally aligned or an inflatable balloon that extends in a zigzag pattern around the circumference to form a tube.

One disadvantage of known inflatable dilation devices that contain a frame and an inflatable balloon is that when the dilation device expands, the relative movement of the balloon and adjacent parts of the frame requires either self-stabilization of the balloon through contact with adjacent parts of the frame, or connecting elements that extend between the parts balloon. Known dilatation devices, which contain an inflatable balloon extending in a zigzag circumferential pattern relative to a tubular frame, are not sufficiently stable if the balloon is only attached to and supported by the frame.

It is an object of the present invention to overcome this disadvantage by providing an inflatable dilatation device which comprises:

a tubular frame containing a first element that extends in a zigzag manner around the circumference; And

a zigzag inflatable balloon that follows the first frame element and is attached to it,

to thereby ensure that the expansion of the dilatation device after inflation of the balloon results in less relative movement of the balloon on the one hand and the parts of the frame that support the balloon on the other hand.

SUMMARY OF THE PRESENT INVENTION

According to a preferred embodiment of the present invention, there is provided an inflatable dilatation device which comprises:

a tubular frame comprising a first frame element that extends in a zigzag manner around the circumference; And

elongated inflatable first balloon, which

attached to the first frame element; And

runs zigzag along the first frame element,

whereby inflation of the first balloon causes a joint expansion of the first balloon and the first frame element circumferentially from a compressed state to an expanded state.

Typically, the frame further comprises a group of second frame members that extend longitudinally in a first axial direction from apexes on a first side of the first frame member.

Typically, the frame further comprises a third frame element that: extends in a zigzag manner around the circumference and is axially spaced from a second side of the first frame element.

Preferably, the frame further comprises a group of fourth frame elements that extend longitudinally between the longitudinally aligned apexes on a first side of the first and third frame elements and the longitudinally aligned apexes on a second side of the first and third frame elements.

Typically, the inflatable dilatation device further includes an elongated inflatable second balloon that

attached to the third frame element; And

runs zigzag along the third frame element,

As a result, inflation of the second balloon causes a joint expansion of the second balloon and the third frame element along the circumference from a compressed state to an expanded state.

Typically, the frame further comprises a group of fifth frame members that extend longitudinally in a second axial direction from apexes on a second side of the third frame member.

Preferably

the vertices on both sides of the first balloon correspond to the vertices on both sides of the first frame element; And

the vertices on both sides of the second balloon correspond to the vertices on both sides of the third frame element.

Typically the tubular frame additionally contains:

a first ring at a first axial end of the tubular frame; And

a second ring at the second axial end of the tubular frame,

wherein the first and second rings do not expand in accordance with the expansion of the first or second frame elements.

Usually,

a group of second frame elements extends from the first frame element to the first ring; And

a group of fifth frame elements extends from the third frame element to the second ring.

Preferably, the second, fourth and fifth frame elements are linear.

Usually

the first balloon is glued to the first frame element; and the second balloon is glued to the third frame element. Usually,

between each alternating rotation of the first frame element, the first balloon is glued to the first frame element in at least 3 places that are spaced from each other; And

between each alternating rotation of the third frame element, the second balloon is glued to the third frame element in at least 3 places that are spaced from each other.

Preferably

the first balloon defines, at a first axial end of the first balloon, an inlet port for inflating the first balloon in use; And

the second balloon defines, at a first axial end of the second balloon, an inlet port for inflating the second balloon in use.

Usually

the first balloon defines, at a second axial end of the first balloon, an inlet port for inflating the first balloon during use; And

the second balloon defines, at a second axial end of the second balloon, an inlet port for inflating the second balloon in use.

Typically, the first container and the second container are in fluid communication with each other to equalize the pressure in the first and second containers during use.

Preferably,

when the first balloon is in an expanded state, the first balloon forms an angle of at least 30 degrees in each rotation of the first balloon; And

when the second balloon is in an expanded state, the second balloon forms an angle of at least 30 degrees in each rotation of the second balloon.

Usually,

when the first balloon is in an expanded state, at least 60% of the axial length of the first balloon is spaced laterally from adjacent portions of the first balloon; And

when the second balloon is in an expanded state, at least 60% of the axial length of the second balloon is spaced laterally from adjacent portions of the second balloon.

Typically, both the first and second cylinders are located radially in the frame.

Preferably, the first and second cylinders are made of polyester (eg polyethylene terephthalate, PET), polyamide (eg PA 12) or polytetrafluoroethylene (PTFE).

Typically the frame is made of nitinol.

BRIEF DESCRIPTION OF GRAPHIC MATERIALS

The present invention will now be described in more detail by way of example only with reference to the accompanying drawings, in which:

FIG. 1 is a perspective view of an inflatable dilatation device in accordance with a preferred embodiment of the present invention in a compressed state; FIG.

FIG. 2 is a perspective view of the inflatable dilation device shown in FIG. 1 in an expanded state; And

FIG. 3 is a perspective view of an inflatable dilatation device in accordance with an alternative embodiment of the present invention in an expanded state.

DESCRIPTION OF THE PRESENT INVENTION

Referring to FIGS. 1 and 2, the inflatable dilatation device 10 includes a frame 12 and inflatable balloons 14.

In use, the dilatation device 10 can be used with a catheter (which contains pressurizing means) to expand a stent in a patient's artery.

The frame 12 is tubular having first and second axial ends 12a and 12b, respectively. For convenience, the first axial end 12a will be referred to as the proximal end and the second axial end 12b will be referred to as the distal end. The frame 12 contains the following.

The first element is 16, which runs zigzag around the circumference. In this description, the term "zigzag" is intended to mean "a line or route having alternating right and left turns." Turns left and right do not have to be sharp; this definition is intended to include the sinusoidal shape. When the frame 12 is in a compressed state, each "turn" is an acute angle turn, forming an apex at each turn.

A first ring 18 at the first axial end 12a (i.e., proximal end) of the tubular frame 12.

A second ring 20 is at the second axial end 12b (i.e., distal end) of the tubular frame 12.

A group of linear second elements 22 that extend from apexes on a first side (i.e., proximal side) of the first frame element 16 in a longitudinal direction in a first axial direction (i.e., toward the first axial end 12a (i.e., proximal end) of the frame 12) to the first ring 18. For clarification, the expression “first side of the first element 16” is intended to refer to the side of the first element 16 that is formed by the vertices proximal to the first axial end 12a of the frame 12; and the expression "second side of the first member 16" is intended to mean the side of the first member 16 that is formed by the vertices proximal to the second axial end 12b of the frame 12. Moreover, in this specification, the phrase "extends in the longitudinal direction" is intended to mean "extends laterally axial end of the frame 12" and is not limited by second elements 22 that extend axially parallel to each other.

A third element 24 that extends in a zigzag manner around the circumference and is axially spaced from the second side (ie, distal side) of the first frame element 16. As shown in FIGS. 1 and 2, the vertices on the first side (ie, proximal side) of the first frame member 16 are longitudinally/axially aligned with the vertices on the first side (ie, proximal side) of the third frame member 24; and the vertices on the second side (ie, the distal side) of the first frame element 16 are aligned in the longitudinal/axial direction with the vertices on the second side (ie, the distal side) of the third frame element 24. As with the first frame member 16, the first side of the third frame member 24 is likewise intended to designate the side of the third frame member 24 that is formed by vertices proximal to the first axial end 12a of the frame 12; and a second side of the third member 24 is intended to designate a side of the third member 24 that is formed by vertices proximal to the second axial end 12b of the frame 12.

A group of linear fourth elements 26 that extends longitudinally between the axially aligned apexes formed by the first and third frame elements 16 and 24. In other words, a group of fourth elements 26 extends between the longitudinally/axially aligned apexes on the first side (i.e., proximal side) of the first and third frame elements 16 and 24 and the longitudinally aligned apexes on the second side (i.e., distal side) of the first and third frame elements 16 and 24.

A group of linear fifth elements 28 that extends from the vertices on the second side (i.e., distal side) of the third frame element 24 in a longitudinal direction, in a second axial direction (i.e., toward the second axial end 12b (i.e., distal end) of the frame 12) to the second ring 20.

Preferably, the first, second, third, fourth and fifth elements 16, 22, 24, 26 and 28 are laser cut from a single nitinol tube.

It will be understood that the rings 18 and 20 cannot expand in accordance with the expansion of the first and/or third frame members 16 and 24 when the frame 12 expands from the compressed state shown in FIG. 1 to the expanded state shown in FIG. 2.

Each balloon 14 is elongated, being initially constructed as a linear, cylindrical balloon, and is made of polyester (eg, polyethylene terephthalate, PET), polyamide (eg, PA 12) or polytetrafluoroethylene (PTFE). Both bladders 14 are positioned radially within the frame 12. The first bladder 14a is attached to the first frame member 16 and the second bladder 14b is attached to the third frame member 24. More specifically, the first balloon 14a is adhered to the first frame member 16 at at least three locations (which are spaced apart) between each adjacent pair of vertices formed by the first frame member 16 (i.e., between each alternating rotation of the first frame member 16). ; and the second balloon 14b is adhered to the third frame member 24 at at least three locations (which are spaced apart) between each adjacent pair of vertices formed by the third frame member 24 (ie, between each alternating rotation of the third frame member 24). The balloons 14a and 14b follow their respective frame members 16 and 24, thereby adopting a corresponding zigzag shape, with the balloons 14 forming bends at the apices of the first and third frame members 16 and 24.

It will be understood that the bends (otherwise known as vertices) on both sides (i.e., proximal and distal sides) of the first balloon 14a correspond to the vertices on both sides (ie, proximal and distal sides) of the first frame member 16, and the bends (otherwise known as referred to as vertices) on both sides (ie, proximal and distal sides) of the second balloon 14b correspond to vertices on both sides (ie, proximal and distal sides) of the third frame member 24.

When inflating (i.e. increasing the pressure) of the cylinders 14, the increased pressure in the bends formed by the cylinders 14 causes the cylinders to “straighten”, thus expanding the cylinders 14 circumferentially from the compressed state shown in Fig. 1 to the expanded state, shown in figure 2. Since the balloons 14 are attached to the first and third frame members 16 and 24, expansion of the balloons 14 from a compressed state to an expanded state causes the first and third frame members 16 and 24 to expand circumferentially (and therefore radially expand the frame 12 and dilation device 10) together. with the first and second cylinders 14a and 14b from the compressed state shown in FIG. 1 to the expanded state shown in FIG. 2.

With respect to each balloon 14, when the balloon 14 is in an expanded state, the balloon forms an (internal) angle of at least 30 degrees (preferably 40 degrees) at each rotation of the balloon (i.e., at each bend/vertex), and at least At least 60% (preferably 65%) of the axial length of the balloon 14 is spaced laterally from (i.e., not in contact with) adjacent portions of the balloon 14. When the balloon 14 is in a compressed state, the balloon 14 forms an (internal) angle of less than 5 degrees (preferably zero degrees) at every turn of the balloon (ie at every bend/vertex) (ie adjacent parts of the balloon 14 run parallel to each other).

Each cylinder 14 has an inlet port at each axial end of the cylinder 14 for increasing the pressure in the cylinder 14 during use. In addition, both cylinders 14a and 14b are in fluid communication with each other to equalize the pressure in the cylinders 14a and 14b during use.

Since the first and second balloons 14a and 14b on the one hand, and the first and third frame elements 16 and 24 on the other hand, extend in a zigzag manner around the circumference and follow each other respectively, it will be understood that the expansion of the dilatation device 10 from a compressed state to the expanded state does not cause significant relative movement of the first and second balloons 14a and 14b and their respective first and third frame members 16 and 24. This reduction in the relative movement of the cylinders 14, on the one hand, and the first and third frame elements 16 and 24, on the other hand, provides the cylinders 14 with stable support only by the first and third frame elements 16 and 24. That is, for each bladder 14, no connections are required to connect portions of the balloon 14 to other portions of the balloon 14, and there is no need for portions of the balloon 14 between bends/apex to contact adjacent portions of the balloon 14 to maintain stability.

According to a non-limiting embodiment of the inflatable dilation device 10:

frame 12

Made from super-elastic nitinol;

is tubular with a diameter of 5.6 mm and a wall thickness of 0.229 mm;

laser cut to form a first element 16, first and second rings 18 and 20, second elements 22, a third element 24, fourth elements 26 and fifth elements 28; And

electropolished and sanded;

inflatable cylinders 14

Made from resilient nylon 12 material;

have an outer diameter of 5 mm;

have a single wall thickness of 17 microns;

have a total inflated length of 252 mm and a zigzag length of 21 mm;

are two zigzag inflatable balloons 14 that are axially spaced apart, each zigzag inflatable balloon 14 having six bends;

attached to frame 12 using cyanoacrylate glue; And

each of them has tapered sections with an outer diameter of 1.2 mm, preferably two such tapered sections per inflatable balloon 14.

An inflatable dilation device PO in accordance with an alternative (less preferred) embodiment of the present invention is shown in FIG. 3 in an expanded state. The PO dilatation device in accordance with an alternative embodiment of the present invention is generally similar to the dilation device 10 in accordance with the preferred embodiment of the present invention shown in FIGS. 1 and 2. However, in accordance with this alternative embodiment of the PO dilatation device (which likewise contains frame 112 and inflatable cylinders 114) the following is assumed.

• The first element 116 of the frame 112 extends in a zigzag manner around the circumference, the zigzags having a first wavelength.

• The third element 124 of the frame 112 extends in a zigzag pattern around the circumference, the zigzags having a wavelength similar to the first wavelength.

• The first balloon 114a is attached to the first frame member 116, the first balloon 14a extending in a zigzag manner around the circumference, and the zigzags formed by the first balloon 114a having a second wavelength that is greater than the first zigzag wavelength of the first frame member 116. More specifically, the second wavelength of the first balloon 114a is approximately three times the first wavelength of the zigzags of the first frame element 116. It will be understood that on each side of the first balloon 114a and the first frame member 116, the vertices of the first balloon 114a are aligned with and bonded to every third vertex of the first frame member 116.

• Similarly, the second balloon 114b is attached to the third frame member 124, the second balloon 14b extending in a zigzag manner around the circumference, the zigzags formed by the second balloon 114b having a second wavelength that is greater than the first wavelength of the zigzags of the third frame member 124. More specifically, the second wavelength of the second balloon 114b is approximately three times the first wavelength of the zigzags of the third frame member 124. It will be appreciated that on each side of the second balloon 114b and the third frame member 124, the vertices of the second balloon 114b are aligned with and bonded to every third vertex of the third frame member 124.

Optionally, the first inflatable balloon 114a could be adhered to the first frame member 116 at additional intersection points of the first inflatable balloon 114a and the first frame member 116 between the vertices of the first inflatable balloon 114a/first frame member 116.

Likewise, the second inflatable balloon 114b could optionally be adhered to the third frame member 124 at additional intersection points of the second inflatable balloon 114b and the third frame member 124 between the vertices of the second inflatable balloon 114b/third frame member 124.

It will also be understood (although this embodiment is not shown) that instead of the second wavelength of the first and second balloons 114a and 114b being three times the first wavelength of the first and third frame members 116 and 124, respectively, the first wavelength of the first and the third frame members 116 and 124 may be three times the second wavelength of the first and second cylinders 114a and 114b, respectively. In such an embodiment, with respect to each side of the first and third frame members 116 and 124 and the first and second cylinders 114a and 114b, the apices of the first and third frame members 116 and 124 may coincide with every third vertex of the first and second cylinders 114a and 114b, respectively, and be glued To her.

When comparing the dilation device 10 in accordance with a preferred embodiment of the present invention and the dilation device PO in accordance with an alternative embodiment of the present invention, the following will also be understood.

• The peaks formed by the first and third frame members 116 and 124, in accordance with an alternative embodiment of the present invention, are steeper/sharper than the peaks formed by the first and third frame members 16 and 24, in accordance with a preferred embodiment of the present invention.

• The first and third frame elements 116 and 124 in accordance with an alternative embodiment of the present invention further form seats 130 that increase the surface area of the first and third frame elements 116 and 124 along portions of their lengths spaced from the apexes. These seats 130 provide increased surface area for the first and second inflatable balloons 114a and 114b to adhere to the first and third frame members 116 and 124, respectively.

Claims (47)

1. An inflatable dilatation device containing: a tubular frame comprising a first frame element that extends in a zigzag manner around the circumference; And elongated inflatable first balloon, which attached to the first frame element; And runs zigzag along the first frame element, whereby inflation of the first balloon causes a joint expansion of the first balloon and the first frame element circumferentially from a compressed state to an expanded state. 2. The inflatable dilation device of claim 1, wherein the frame further comprises a plurality of second frame members that extend longitudinally in a first axial direction from apexes on a first side of the first frame member. 3. The inflatable dilatation device according to claim 2, characterized in that the frame further comprises a third frame element that extends in a zigzag manner around the circumference and is axially spaced from the second side of the first frame element. 4. The inflatable dilatation device of claim 3, wherein the frame further comprises a group of fourth frame members that extend longitudinally between the longitudinally aligned apexes on a first side of the first and third frame members and the longitudinally aligned apexes on the second side first and third frame elements. 5. An inflatable dilatation device according to claim 4, characterized in that it additionally contains an elongated inflatable second balloon, which attached to the third frame element; And runs zigzag along the third frame element, As a result, inflation of the second balloon causes a joint expansion of the second balloon and the third frame element along the circumference from a compressed state to an expanded state. 6. The inflatable dilation device of claim 5, wherein the frame further comprises a group of fifth frame members that extend longitudinally in a second axial direction from apexes on the second side of the third frame member. 7. Inflatable dilation device according to claim 6, characterized in that: the vertices on both sides of the first balloon correspond to the vertices on both sides of the first frame element; And the vertices on both sides of the second balloon correspond to the vertices on both sides of the third frame element. 8. Inflatable dilatation device according to claim 7, characterized in that the tubular frame additionally contains: a first ring at a first axial end of the tubular frame; And a second ring at the second axial end of the tubular frame, wherein the first and second rings do not expand in accordance with the expansion of the first or third frame elements. 9. Inflatable dilatation device according to claim 8, characterized in that: a group of second frame elements extends from the first frame element to the first ring; And a group of fifth frame elements extends from the third frame element to the second ring. 10. Inflatable dilatation device according to claim 9, characterized in that the second, fourth and fifth frame elements are linear. 11. Inflatable dilatation device according to claim 10, characterized in that: the first balloon is glued to the first frame element; And the second cylinder is glued to the third frame element. 12. Inflatable dilation device according to claim 11, characterized in that: between each alternating rotation of the first frame element, the first balloon is glued to the first frame element in at least 3 places that are spaced from each other; And between each alternating rotation of the third frame element, the second balloon is glued to the third frame element in at least 3 places that are spaced from each other. 13. Inflatable dilation device according to claim 12, characterized in that: the first balloon defines, at a first axial end of the first balloon, an inlet port for inflating the first balloon in use; And the second balloon defines, at a first axial end of the second balloon, an inlet port for inflating the second balloon in use. 14. Inflatable dilation device according to claim 13, characterized in that: the first balloon defines, at a second axial end of the first balloon, an inlet port for inflating the first balloon during use; And the second balloon defines, at a second axial end of the second balloon, an inlet port for inflating the second balloon in use. 15. The inflatable dilatation device according to claim 14, characterized in that the first balloon and the second balloon are in fluid communication with each other to equalize the pressure in the first and second balloons during use. 16. Inflatable dilation device according to claim 15, characterized in that: when the first balloon is in an expanded state, the first balloon forms an angle of at least 30 degrees in each rotation of the first balloon; And when the second balloon is in an expanded state, the second balloon forms an angle of at least 30 degrees in each rotation of the second balloon. 17. Inflatable dilation device according to claim 16, characterized in that: when the first balloon is in an expanded state, at least 60% of the axial length of the first balloon is spaced laterally from adjacent portions of the first balloon; And when the second balloon is in an expanded state, at least 60% of the axial length of the second balloon is spaced laterally from adjacent portions of the second balloon. 18. Inflatable dilatation device according to claim 17, characterized in that both the first and second balloons are located radially in the frame. 19. Inflatable dilatation device according to claim 18, characterized in that the first and second balloons are made of polyester, polyamide or polytetrafluoroethylene. 20. Inflatable dilatation device according to claim 19, characterized in that the frame is made of nitinol.