WO2022244011A1

WO2022244011A1 - A system for percutaneous valve implantation

Info

Publication number: WO2022244011A1
Application number: PCT/IN2021/050628
Authority: WO
Inventors: Alok RANJAN
Original assignee: Ranjan Alok
Priority date: 2020-08-01
Filing date: 2021-06-28
Publication date: 2022-11-24

Abstract

The present invention relates to a system for percutaneous valve replacement. The system (100) comprises a balloon expandable prosthetic valve (102), and a single balloon (104) with differential inflation, the balloon expandable prosthetic valve (102) is operatively disposed over the single balloon (104) with differential inflation, wherein the single balloon (104) with differential inflation comprising a distal portion (104d), a middle portion (104m) extending from an operative back end of the distal portion (104d), and a proximal portion (104p) extending from an operative back end of the middle portion (104m). A method for replacement of the percutaneous valve employing the system (100) is also disclosed. The system (100) of the present invention is capable of deploying the valve with precision, thereby reducing complication rates. The valve design is compact which reduces obstructions to arteries.

Description

A SYSTEM FOR PERCUTANEOUS VALVE IMPLANTATION

FIELD OF THE INVENTION

The present invention relates to placement of percutaneous valve. More particularly, the present invention relates to a system for percutaneous valve placement.

BACKGROUND OF THE INVENTION A percutaneous valve placement or percutaneous valve implantation surgery involves a minimally invasive procedure, wherein a deceased heart valve is replaced by a mechanical valve. Percutaneous valve implantation is performed on those patients who are at high risk for an open-heart surgery. For example, the percutaneous valve replacement is performed in those patients with serious heart valve disease or with those patients with significant other coexisting conditions that exclude open-heart surgery.

The percutaneous valve implantation is achieved by employing a percutaneous valve replacement system. A typical conventional percutaneous valve replacement system comprises a prosthetic valve and a valve delivery system. The prosthetic valve can be developed from bovine or porcine pericardial tissue and is essentially a bio- prosthetic system. The delivery system is crucial in the placement of the prosthetic valve across a native valve annulus. The delivery system is desired to precisely place the prosthetic valve across the native valve annulus, and at the same time the delivery system is desired to be capable of being retrieved and repositioned. Further, it should not present any obstruction to the flow through the coronary arteries. Attempts have been made in the past to develop percutaneous valve replacement systems which provide at least the above-mentioned features or facilities. At present, the changes in the prosthetic valve design, the facility to retrieve the prosthetic valve, and the radiological / echocardiographic guidance have helped in precise placement and in avoiding complications. It is estimated that a compact prosthetic valve design and a precise placement would aid in improving the results further.

The conventional valve delivery system can be classified into two types, namely, a balloon expandable and a self-expandable valve, which are currently being employed to perform the percutaneous valve replacement.

Another conventional valve delivery system comprises two expandable balloons which facilitates in anchoring the prosthetic valve across the valve annulus.

However, the existing conventional systems, described herein above, present one or more drawbacks. More specifically, the existing conventional systems are still not precise. Further, the existing conventional two balloon system are complex as they include use of two expandable balloon, which make the system bulky and difficult to handle.

Thus, there is felt a need for overcoming one or more drawbacks associated with the conventional and provide a system for percutaneous valve placement system which is compact, easy to handle, and less complex as compared to the existing conventional percutaneous valve replacement system.

OBJECTS OF THE INVENTION

Some of the objects of the presently disclosed invention, of which at the minimum one object is fulfilled by at least one embodiment disclosed herein are as follow:

An object of the present invention is to provide an alternative, which overcomes at least one drawback encountered in the existing prior art; Another object of the present invention is to provide a percutaneous valve placement system;

Still another object of the present invention is to provide a percutaneous valve placement system which is compact, and easy to handle; and Yet another object of the present invention is to provide a percutaneous valve placement system which is relatively less complex as compared with the existing percutaneous valve replacement systems.

Other objects and benefits of the present invention will be more apparent from the following description which is not intended to bind the scope of the present invention.

SUMMARY OF THE INVENTION

The present invention relates a system for percutaneous valve implantation, and a method for implantation of the percutaneous valve.

In accordance with one aspect of the present invention, a system for percutaneous valve implantation is disclosed. The system comprising a balloon expandable prosthetic valve, and a single balloon with differential inflation, the balloon expandable prosthetic valve is operatively disposed over the single balloon with differential inflation.

In accordance with one embodiment of the present invention, the single balloon with differential inflation comprises a distal portion, a middle portion extending from an operative back end of the distal portion, and a proximal portion extending from an operative back end of the middle portion. In accordance with one embodiment of the present invention, each of the distal portion, and the proximal portion inflation is more than the inflation of the middle portion.

In accordance with one embodiment of the present invention, the middle portion of the single balloon with differential inflation is inflated after the inflation of the distal portion, and the proximal portion. In accordance with one embodiment of the present invention, the distal portion is inflated before the proximal portion.

In accordance with one embodiment of the present invention, the length of each of the distal portion, the middle portion, the proximal portion is independently in the range of 10 mm to 50 mm.

In accordance with one embodiment of the present invention, the single balloon with differential inflation is similar to an Inoue balloon.

In accordance with another aspect of the present invention, a method for implantation of the percutaneous valve employing the system of the present invention is disclosed.

The method comprises the following steps, which are described herein below:

In the first step, the prosthetic valve is provided and prepared. The prosthetic valve can be the one that is available in the known art and which is being employed for replacement of the diseased valve in a human heart. In the second step, the single balloon with differential inflation is provided in slenderize state.

In the third step, the prosthetic valve is disposed on to the single balloon or crimped on the single balloon in ‘slenderized’ state on the middle part of the single balloon (which is supposed to be inflated at the last). The middle part is having a diameter as per the diameter of the prosthetic valve, which ensures that the prosthetic valve opens uniformly.

In the fourth step, the native valve that needs replacement is crossed with a guide wire as a standard step in any other balloon expandable transcatheter valve implantation procedure.

In the fifth step, after crossing the native valve may be predicated if required using an in-situ guidewire and appropriate size balloon.

In the sixth step, the prosthetic valve is crossed in ‘slenderize’ or 'semi slenderize' position over the guide wire.

In the seventh step, the shape of the balloon stretching tube is modified to take curve around arch of aorta and ascending aorta (in case of retrograde transcatheter aortic valve implantation).

In the eighth step, once across the native valve, the balloon stretching tube is removed leaving behind the assembly comprising the prosthetic valve and the single balloon operably disposed over the wire.

In the ninth step, the distal part/portion of the balloon is inflated and is pulled back to hitch it across the native valve. Arrangements can be made at this step to retrieve the valve in case the position is not optimal. In the tenth step, once the optimal position is confirmed, the balloon is further inflated to expand the proximal part of the balloon. Further, if the prosthetic valve can be retrieved till this stage, then the success rate of implantation is enhanced. In the eleventh step, further inflation of the balloon deploys the valve at the desired level with full inflation of middle part and the underlying balloon.

In the twelfth step, that is post deployment, the balloon is deflated and removed.

Optionally, a further dilatation of the valve can be performed if required, by a regular balloon of optimal size.

The steps of inflation and deployment can be performed with rapid LV pacing for precise control of deployment.

BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWING

The present invention will now be described with the help of the accompanying drawing, in which:

FIG. 1 depicts a schematic side view of an existing conventional prosthetic valve known in the art;

FIG. 2a depicts a photograph of a side view of an existing conventional prosthetic valve known in the art; FIG. 2b depicts a photograph of a top view of the prosthetic valve of FIG. 2a;

FIG. 3 depicts a photograph of a conventional balloon expandable prosthetic valve along with a portion of the valve delivery system;

FIG. 4 depicts a photograph of a conventional balloon expandable prosthetic valve along with a portion of the valve delivery system, wherein the balloon expandable prosthetic valve is crimped on a balloon; FIG. 5a, and FIG. 5b depict steps involved in a conventional percutaneous valve implantation procedure, after placement of a guide wire in a distal chamber and native valve preparation;

FIG. 6 depicts a typical self-expandable percutaneous valve known in the art; FIG. 7a, FIG. 7b, and FIG. 7c depict different parts of a typical self-expandable percutaneous valve delivery system of FIG. 6;

FIG. 8a to FIG. 8e depict an Inoue balloon which is characterized by having differential inflation property in accordance with the embodiments of the present invention; and FIG. 9a to FIG. 9e depict the steps involved in deployment of a prosthetic valve, after placement of guide wire in distal chamber and native valve preparation, in accordance with the embodiments of the present invention.

DETAILED DESCRIPTION

All the terms and expressions, which may be technical, scientific, or otherwise, as used in the present invention have the same meaning as understood by a person having ordinary skill in the art to which the present invention belongs, unless and otherwise explicitly specified.

In the present specification, and the claims, the articles “a”, “an”, and “the” include plural references unless the context clearly dictates otherwise. The term “comprising” as used in the present specification and the claims will be understood to mean that the list following is non-exhaustive and may or may not include any other extra suitable features or elements or steps or constituents as applicable. Further, the terms “about” or “approximately” used in combination with ranges relating to sizes of parts, or any other physical properties or characteristics, are meant to include small variations that may occur in the upper and/or lower limits of the ranges of the sizes. The present invention relates to a system for percutaneous valve implantation and a method for implantation of percutaneous valve employing the system of the present invention.

The present invention is described with reference to the accompanying drawing, wherein FIG. 1 depicts a schematic side view of an existing conventional prosthetic valve known in the art, FIG. 2a depicts a photograph of a side view of an existing conventional prosthetic valve known in the art, FIG. 2b depicts a photograph of a top view of the prosthetic valve of FIG. 2a, FIG. 3 depicts a photograph of a conventional balloon expandable prosthetic valve along with a portion of the valve delivery system, FIG. 4 depicts a photograph of a conventional balloon expandable prosthetic valve along with a portion of the valve delivery system, wherein the balloon expandable prosthetic valve is crimped on a balloon, FIG. 5a, and FIG. 5b depict steps involved in a conventional percutaneous valve replacement procedure, after placement of a guide wire in a distal chamber and native valve preparation, FIG. 6 depicts a typical self- expandable percutaneous valve known in the art, FIG. 7a, FIG. 7b, and FIG. 7c depict different parts of a typical self-expandable percutaneous valve delivery system of FIG. 6, FIG. 8a to FIG. 8e depict an Inoue balloon which is characterized by having differential inflation property in accordance with the embodiments of the present invention, and FIG. 9a to FIG. 9e depict the steps involved in deployment of a prosthetic valve, after placement of guide wire in distal chamber and native valve preparation, in accordance with the embodiments of the present invention.

In accordance with one aspect of the present invention, a system (100) for implantation of percutaneous valve or prosthetic valve (102) is disclosed. In proposed art, the prosthetic valve component remains the same as it is in the prior art. It is delivery system which is being addressed in the present invention. The delivery system is a balloon expandable system. The prosthetic valve is mounted on the balloon and the whole assembly is placed across the diseased native valve (valve which needs replacement) with the help of guide wires as shown in the figures accompanying specification.

In accordance with the embodiments of the present invention a single balloon with differential balloon inflation characteristics is employed. An example of such a balloon is Inoue balloon. The inflation technique of Inoue valve is depicted in FIG. 8a to FIG. 8e. In accordance with the embodiments of the present invention, the Inoue balloon anchors the balloon precisely due to its differential inflation technique.

The present invention employs a similar balloon which is designed to precisely place or position of the bio-prosthetic valve across the native valve annulus. All the four valves in human heart can be addressed using the system of the present invention. The middle part of balloon (which inflates last), according to the present invention is longer as compared with the existing Inoue balloon to accommodate the prosthetic valve to be implanted or replaced. Once placed across the native valve into a distal chamber, the distal part of the balloon is inflated first and once the distal part is fully inflated the whole assembly is pulled back so as to anchor it on the native valve. Further pulling of assembly is not possible as the stenosed valve prevents it. Now the system according to the present invention is further inflated leading to inflation of proximal part of balloon. This fixes the whole assembly and further displacement of the prosthetic valve assembly is not be possible. Once the whole assembly is fixed, the final inflation is done thereafter. This deploys the bio-prosthetic valve in proper position. The balloon thereafter is deflated and is taken out leaving the bio-prosthetic valve in its proper place. If required, the bio-prosthetic valve can be further dilated to optimal size as per the native valve annulus. If bio-prosthetic valve can be retrieved till the second stage of balloon inflation it helps to achieve success in almost all cases. The bio-prosthetic valve can have a more compact design than the existing valves as the precise placement helps to reduce the size of the prosthetic valve. If the bio-prosthetic valve design is more compact, the obstruction to adjoining structures (mainly coronary arteries) is even less than the conventional prior art systems. The other complication rates should be comparable with existing systems. More specifically, with reference to the accompanying drawings, the system

(100) comprises a balloon expandable prosthetic valve (102), and a single balloon (104) with differential inflation, the balloon expandable prosthetic valve (102) is operatively disposed over the single balloon (104) with differential inflation.

In accordance with one embodiment of the present invention, the single balloon (104) with differential inflation comprising a distal portion (104d), a middle portion

(104m) extending from an operative back end of the distal portion (104d), and a proximal portion (104p) extending from an operative back end of the middle portion

(104m). In accordance with one embodiment of the present invention, each of the distal portion (104d), and the proximal portion (104p) inflation is more than the inflation of the middle portion (104m).

In accordance with one embodiment of the present invention, the middle portion (104m) of the single balloon (104) with differential inflation is inflated after the inflation of the distal portion (104d), and the proximal portion (104p). In accordance with one embodiment of the present invention, the distal portion (104d) is inflated before the proximal portion (104p).

In accordance with one embodiment of the present invention, the length of the middle portion (104m) is in the range of 10 mm to 30 mm.

In accordance with one embodiment of the present invention, the length of the distal portion (104d) and the proximal portion (104p) is each independently in the range of 20 mm to 50 mm.

In accordance with one embodiment of the present invention, the single balloon (104) with differential inflation is an Inoue balloon.

In accordance with another aspect of the present invention, a method for replacement of percutaneous valve or prosthetic valve (102), using the system (100) of the present invention, is disclosed.

The method comprising the following steps (see FIG. 7a, FIG. 7b, FIG. 7c, FIG. 8a, FIG. 8b, FIG. 8c, FIG. 8d, FIG. 8e, FIG. 9a, FIG. 9b, FIG. 9c, FIG. 9d, FIG. 9e (1), and FIG. 9e(2)): In the first step, the prosthetic valve (102) is provided and prepared. The prosthetic valve (102) can be the one that is available in the known art and which is being employed for replacement of the diseased valve in a human heart.

In the second step, the single balloon (104) with differential inflation is provided in slenderize state.

In the third step, the prosthetic valve (102) is disposed on to the single balloon (104) or crimped on the single balloon (104) in ‘slenderized’ state on the middle part (104m) of the single balloon (104) (which is supposed to be inflated at the last) (FIG. 4). The middle part (104m) is having a diameter as per the diameter of the prosthetic valve (102), which ensures that the prosthetic valve (102) opens uniformly.

In the fourth step, the native valve that needs replacement is crossed with a guide wire as a standard step in any other balloon expandable transcatheter valve replacement procedure (FIG. 9).

In the fifth step, after crossing the native valve may be predilated if required using an in-situ guidewire (already in place in LV / other chamber to guide placement of new the prosthetic valve (102)).

In the sixth step, the prosthetic valve (102) is crossed in ‘slenderize’ or 'semi slenderize' position over the guide wire (FIG. 9).

In the seventh step, the shape of the balloon stretching tube is modified to take curve around arch of aorta and ascending aorta (in case of transcatheter aortic valve replacement) (FIG. 9). In the eighth step, once across the native valve, the balloon stretching tube is removed leaving behind the assembly comprising the prosthetic valve (102) and the single balloon (104) operably disposed over the wire.

In the ninth step, the distal part/portion (104d) of the balloon (104) is inflated and is pulled back to hitch it across the native valve. Arrangements can be made at this step to retrieve the valve in case the position is not optimal.

In the tenth step, once the optimal position is confirmed, the balloon (104) is further inflated to expand the proximal part (104p) of the balloon (104). Further, if the prosthetic valve can be retrieved then the success rate of replacement is enhanced. In the eleventh step, further inflation of the balloon (104) deploys the valve

(102) at the desired level with full inflation of middle part (104m) and the underlying balloon (104).

In the twelfth step, that is post deployment, the balloon (104) is deflated and removed. Optionally, a further dilatation of the valve (102) can be performed if required, by a regular balloon of optimal size.

The system and method of the present invention can be employed for deployment of the Mitral valve, pulmonary valve, and tricuspid valve in similar fashion (as described herein above) either through ‘antegrade’ or through retrograde approach. The aortic valve can also be deployed through ‘antegrade’ technique through transapical route or through transseptal approach. TECHNICAL ADVANCES AND ADVANTAGES OF THE INVENTION

The presently disclosed invention, as described herein above, provides several technical advances and advantages. The technical advances and advantages, which the present invention provides are listed herein below: The system of the present invention enables:

- Deployment of the prosthetic valve with more precision, thereby leading to decrease in overall complication rates;

- Compact design of the prosthetic valve thereby reducing the obstructions to adjacent structures including coronary arteries as compared with the conventional systems; and

- Designing of both antegrade and retrograde deployment techniques which helps to replace any stenosed cardiac valves.

Claims

I CLAIM:

1. A system (100) for percutaneous valve/prosthetic valve replacement, the system (100) comprising a balloon expandable prosthetic valve (102), and a single balloon (104) with differential inflation, the balloon expandable prosthetic valve (102) is operatively disposed over the single balloon (104) with differential inflation.

2. The system (100) as claimed in claim 1, wherein the single balloon (104) with differential inflation comprising a distal portion (104d), a middle portion (104m) extending from an operative back end of the distal portion (104d), and a proximal portion (104p) extending from an operative back end of the middle portion (104m).

3. The system (100) as claimed in claim 2, wherein each of the distal portion (104d), and the proximal portion (104p) inflation is more than the inflation of the middle portion (104m).

4. The system (100) as claimed in claim 2, wherein the middle portion (104m) of the single balloon (104) with differential inflation is inflated after the inflation of the distal portion ( 104d), and the proximal portion ( 104p) .

5. The system (100) as claimed in claim 2, wherein the length of the middle portion (104m) is in the range of 10 mm to 20 mm.

6. The system (100) as claimed in claim 2, wherein the length of the distal portion (104d) and the proximal portion (104p) is each independently in the range of 20 mm to 50 mm.

7. The system (100) as claimed in claim 4, wherein the distal portion (104d) is inflated before the proximal portion (104p).

8. The system as claimed in claim 1, wherein the single balloon (104) with differential inflation is an Inoue balloon.

9. A method for replacement of a percutaneous valve/prosthetic valve employing the system (100) as claimed in claim 1, the method comprising the following steps: - providing and preparing the prosthetic valve (102);

- providing the single balloon (104) with differential inflation in slenderize state;

- disposing the prosthetic valve (102) on to the single balloon (104) in slenderized state on the middle part (104m) of the single balloon (104); - crossing the native valve that needs replacement with a guide wire;

- predicating the native valve if required using an in-situ guidewire and an appropriately sized balloon;

- crossing the prosthetic valve (102) slenderized or semi slenderized position over the guide wire; - modifying the shape of the balloon stretching tube to take curve around arch of aorta and ascending aorta;

- removing the balloon stretching tube leaving behind the assembly comprising the prosthetic valve (102) and the single balloon (104) operably disposed over the wire; - inflating the distal part/portion (104d) of the balloon (104) followed by pulling back to hitch it across the native valve; - on confirming the optimal position inflating the balloon (104) to expand the proximal part (104p) of the balloon (104);

- deploying the valve (102) by further inflating the balloon (104) with full inflation of middle part (104m) and the underlying balloon (104); - deflating and removing the balloon (104) post deployment; and

- optionally, further dilatating the valve (102) employing, a regular balloon of optimal size.

Dated this 28 June 2021 For the Applicant

Khadilkar Murlidhar ShriKrishna

The Applicant’s Patent Agent IN/PA - 391

To,

The Controller of Patents,

The Patent Office,

At Mumbai