The object of the invention is a medical device for percutaneous medical procedures, comprising a catheter part and an improved handle provided with a rotatable proximal part.

Devices in the form of percutaneous endovascular systems are known and have an essentially known design, the invention relating to the field of devices which require the provision of controlled rotation of the catheter part of the device via a specially designed handle for the operator.

Examples of such endovascular devices are heart valve-containing systems, especially balloon endovascular systems containing a heart valve. More particularly, the invention relates to endovascular devices for replacing a native heart valve with a replacement valve, the device comprising components known in the field and an innovative handle, provided with technical means to ensure correct delivery and positioning of the heart valve at the target site in the patient’s body. The system with the valve is introduced using minimally invasive percutaneous methods, and the catheter part of the system is controlled by handle elements with ergonomic control parts dedicated to the operator, which remain outside the patient's body during the procedure.

The invention relates in particular to a handle included in a system for implanting a valve expandable on a balloon, comprising a compliant (elastic) or non-compliant balloon that has a folded position, of minimal dimensions, i.e. smaller diameter, and an unfolded position, with a larger diameter when the balloon is inflated during the valve implantation procedure. When the balloon is expanding to an inflated position, the valve takes on its desired unfolded shape.

Devices of this type are presented, for example, in the Polish application descriptions of the same applicant PL-P.430463 and PL-P.430936. As presented, the endovascular device for heart valve implantation comprises an assembly of balloon tubes to which a balloon is attached and on which a heart valve is clamped, an outer tube assembly, a handle with knobs on the proximal side and a distal soft tip. The balloon is preferably a formable balloon comprising, in its collapsed state, with a smaller diameter compared to the inflated balloon, a constriction contained entirely in the middle part of the balloon, said constriction being limited on the distal and proximal sides by

SUBSTITUTE SHEET (RULE 26) bulges. The endovascular system also comprises a Y-type tip (connector) with at least two entrances into two channels of the system - a balloon inflation channel and a guide channel. The handle of the system, the adjustment knobs and the tip with entrances to channels of the system together constitute a proximal part for the operator, and this part remains outside the patient’s body during the implantation of a valve. The outer tube assembly is constructed of an outer tube, in which a dual-channel tube is placed over a specified length. The dual-channel tube has a first channel with a diameter larger than the diameter of the second channel. The first channel carries the balloon tube assembly, while the second channel, with a smaller diameter, is a tie channel, which carries a tie stretched between a mechanism controlled by the operator using a knob and a controllable distal end of the outer tube, thus its bend being reached. The system can comprise markers visible via imaging techniques, indicating the position of particular crucial elements of the system, e.g. the beginning and the end of the balloon, the beginning and the end of the middle part of the balloon, edges of the bulges of the formable balloon, etc.

In the course of heart valve implantation, there is a need to position the valve in a precisely defined position relative to the longitudinal axis of the catheter part of the device, and it is therefore desirable to provide controllable rotation of the entire inner tube assembly provided with the balloon-seated valve.

The invention may also relate to a dedicated handle for other devices comprising, in the distal part, elements requiring precise, adjustable and controllable positioning with respect to the longitudinal axis of the device, i.e. these may include, among others, cutting balloon catheters, incision catheters, catheters for laser ablative angioplasty and other ablative procedures, percutaneous devices for implantation of stents requiring precise positioning in blood vessels, e.g. at the site of bifurcation, catheters provided with electrodes, etc. Preferably, the device relates to a balloon system for implanting a heart valve that is seated on an inner tube assembly, which is then a balloon tube assembly.

From international patent application WO2006138173A2, a delivery system is known, comprising a selectively controllable section connected to the distal end of a balloon catheter comprising a valve positioned on an expandable balloon located along the distal end of the balloon catheter, the bending of the controllable section of the catheter being achieved by a tie actuated by a rotating handle assembly.

International patent applications WO2012142189A1 and WO2013175468A2 generally mention that the possibility of controlled rotation of a heart valve catheter in an endovascular valve implantation system is provided.

From international patent application WO2016168062A1 a valve prosthesis assembly is known, comprising a valve provided with fixing anchors, which is provided with rotational movement and the fixing elements on the valve are configured to also rotate when the valve element is radially expanded.

From international patent application WO2018144598A1 a medical device for implanting a heart valve is known, having a torque anchoring mechanism, the device comprising a valve seated on a balloon catheter, which is configured to rotate about a central longitudinal axis of the device such that the correspondingly shaped surface of the heart valve is also rotated.

The mentioned publications either only generally indicate the ability to rotate the catheter part of the medical device or describe quite complicated solutions based, for example, on the use of a tie (or multiple ties) for controlled rotation of the heart valve during its implantation.

Thus, given that the positioning of endovascular devices sometimes requires precise, controlled rotation of the catheter part, there is a need to develop structural improvements in this area.

A medical device for percutaneous medical procedures, comprising a catheter part and a handle provided with a rotatable proximal part, according to the invention, is characterised in that the catheter part is provided with an inner tube assembly fixed coaxially inside the body of the proximal part of the handle and led through the middle part of the handle and the distal part of the handle towards the distal end of the catheter part, wherein within the body there is an arrangement for controlled rotation, relative to the longitudinal axis a-a of the device, of the body including the inner tube assembly, comprising: a rotation locking disc located in the inner space of the body, slidably seated, via a longitudinal displacement tube, on the inner tube assembly, perpendicular to the longitudinal axis a-a of the device, provided on its proximal plane with radially arranged projections, the rotation locking disc, together with the longitudinal displacement tube on which it is mounted, having only one, longitudinal, degree of freedom of movement; an element receiving the said rotation locking disc, placed inside the body, parallel to the rotation locking disc, wherein the receiving element, on the side receiving the rotation locking disc, is equipped with a surface shaped to match the projections of the rotation locking disc; and at least one resilient element, placed in the inner space of the body, having a first position, resting, locking the rotational movement of the receiving element together with the entire body, and a second position, compressed, unlocking the rotational movement of the receiving element together with the entire body.

Preferably, the resilient element is one and consists of a spring seated around the longitudinal displacement tube and, further preferably, the resilient element is located in the locking chamber of the body.

Preferably, the proximal part of the handle comprises a knob for the longitudinal movement of the inner tube assembly.

Preferably, the rotation locking disc has between 30 and 120 projections.

Preferably, the inner tube assembly is a balloon tube assembly, more preferably the inner tube assembly comprises a balloon and a heart valve seated thereon.

Preferably, there is a sliding washer between the resilient element and the rotation locking disc, and, preferably, the resilient element is seated in a rigid locking chamber which is an inner part of the body.

An embodiment of the object of the invention is presented in a drawing, wherein Fig. 1 shows a general view of a medical device comprising a handle and a catheter part with a heart valve seated on a balloon catheter, with the balloon being in its folded position, Fig. 2 shows a view of the medical device from Fig. 1 , comprising a handle and a catheter part with a heart valve seated on a balloon catheter, with the balloon being in its unfolded position, Fig. 3 shows elements of the medical device handle in an enlarged exploded view, obliquely from the proximal side, Fig. 4 shows elements of the device handle in an enlarged exploded view, obliquely from the distal side, Fig. 5 shows an enlarged view of the inside of the proximal part of the device handle in the position when the rotation locking disc is locked and adjacent to the element receiving the rotation locking disc, Fig. 6 shows an enlarged view of the inside of the proximal part of the device handle in the position when the rotation locking disc is unlocked and is distant from the element receiving the rotation locking disc.

The medical device for percutaneous medical procedures, in an embodiment according to the invention, comprises: on its distal side, a catheter part 2 provided with an inner tube assembly 3 with a proximal end 19 of the inner tube assembly and with an expandable balloon 5 seated on the inner tube assembly 3, on which a heart valve 4 is seated; an outer tube assembly 7 and a distal end 6; and on the proximal side, a handle 1 consisting essentially of three parts: a distal part 8 of the handle, an adjoining middle part 9 of the handle and, adjoining it from the operator's side, a proximal part 10 of the handle, which is provided with a body 11 containing a wider part from the extreme proximal side, passing into a narrower part located on the side of the middle part 9 of the handle, wherein an annular knob 23 is seated around the narrower part of the body 11, wherein the knob 23 is provided on its inner side with a thread (not shown in the drawings) cooperating with a threaded element (not shown in the drawings) located inside the middle part 9 of the handle, wherein together the two threaded elements, by rotation of the knob 23, provide longitudinal movement of the catheter part 2 of the device (movement in the proximal and distal directions). On the proximal side, the medical device is terminated with a Y-connector 20, providing communication with inner channels of the inner tube assembly, such as a guide channel or a balloon filling channel.

The medical device has a central, longitudinal axis of symmetry a-a and with respect to this axis the individual elements mentioned above are located coaxially. In the wider part of the body 11 , located on the proximal side of the device, there are elements of the controlled rotation system, relative to the mentioned longitudinal axis a-a of the device, of the body 11 together with the inner tube assembly 3 mounted therein, which is equipped with a fixing element 21 , for example in the form of two symmetrical wings arranged on both sides of the proximal end of the inner tube assembly 19, which are seated in two shape- matched fixing slots 16, located inside the body 11 , symmetrically on both sides thereof. The arrangement of the fixing element 21 placed in the fixing slots 16 provides a rigid connection between the inner tube assembly 3 and the body 11, and consequently the rotation of the body 11 causes the inner tube assembly 3 to rotate.

The said rotational movement is ensured by the rotation system of the body 11, which comprises a rotation locking disc 12, located in its inner space, perpendicular to the longitudinal axis a-a of the device, which is equipped in its middle part with a fixing socket 25 in which a longitudinal displacement tube 18 is seated, perpendicular to the surface of the rotation locking disc 12. The fixing socket 25 and the longitudinal displacement tube 18 are located along the a-a axis of the device, and inside them, in a suitably dimensioned channel, the inner tube assembly 3 is guided coaxially and slidably. Rigidly assembled together, the rotation locking disc 12, the fixing socket 25 contained therein and the associated longitudinal displacement tube 18 move slidably, independently of the inner tube assembly 3.

The rotation locking disc 12 is provided, on at least part of the proximal plane, with radially arranged projections 13, i.e. a system of alternating projections 13 and grooves between them is formed, which ensure the locking (interlocking and engagement) of the rotation locking disc 12 by placing it in contact with the element 14, placed inside the body 11, receiving the said rotation locking disc 12, wherein the receiving element 14 is parallel to the rotation locking disc 12 and on the side receiving the rotation locking disc 12, is provided with a surface 15 shaped to match the projections 13. The surface 15 is matched in shape to the rotation locating disc 12 facing it. Both contacting surfaces: the surface of the rotation locking disc 12 and the receiving surface 15 of the receiving element 14 are perpendicular to the longitudinal axis a-a of the device and cooperate with each other to lock the entire body 11, preventing rotation of the body 11 together with the inner tube assembly 3 fixed therein. The position of the aforesaid locked body 11 is shown in Fig. 5.

The rotation locking disc 12 together with the fixing socket 25 axially fixed thereto, in which the longitudinal displacement tube 18 is permanently seated, are allowed to move only in the longitudinal direction (along the a-a axis) in the device, i.e. in the proximal-distal direction, and at the same time, the entire said system has an axial longitudinal channel running inside, in which there is a slidably seated inner tube assembly 3, which is provided with freedom of movement and the ability to rotate with the body 11 when the body 11 is unlocked, which is provided by at least one flexible element 17 located in the inner space of the body 11, which has the ability to reversibly change its position in the longitudinal direction (measured along the longitudinal axis of the device).

The flexible element 17 has a first, resting, position, locking the rotational movement of the receiving element 14 together with the entire body 11, wherein in this first position, as shown in Fig. 5, the flexible element 17 ensures that the receiving element 14 is pressed against the rotation locking disc 12, and a second, compressed (strained, tightened), position (shown in Fig. 6), unlocking the rotational movement of the receiving element 14 together with the entire body 11 , wherein in this second position, caused by a force applied by the operator longitudinally in the proximal direction by pulling the body 11 away from the remaining part of the handle 1, the receiving element 14 is moved away from the rotation locking disc 12 and releasing the body 11, which in this position can be rotated both clockwise and counterclockwise.

Thus, the operator of the device, through the movement of pulling back the body 11, overcomes the resistance of the resilient element 17, which compresses, and at the same time it is possible to provide a preset (determined by the shape of the body 11) distance between the receiving element 14 and the rotation locking disc 12. The operator must keep the body 11 in a position distanced from the rest of the handle to compensate for the compression of the spring element 17. In this position shown in Fig. 6, the body 11 moves away from the annular knob 23 and a slot is formed in which the protruding narrower part of the body 11 is visible.

The above-described movement of the resilient element 17 is ensured by providing the body 11 with a rigid locking chamber 24, permanently connected to this body, in which the resilient element 17 is seated and which provides a positioning space for this resilient element 17. By pulling back the body 11 including the locking chamber 24 contained therein, the resilient element 17 is compressed between the parallel surfaces brought closer together of the locking chamber 24 and the opposite distal surface of the rotation locking disc 12, optionally a sliding washer 22 may be provided between the rotation locking disc 12 and the resilient element 17 to ensure elimination of friction and resistance between the rotation locking disc 12 and the resilient element 17. The resilient element may be a spring or a resilient sleeve that is compressed under force, and resilient whiskers such as suitably bent ribbon plates or other elements may be used to provide a reversible compressed position of the resilient element when the longitudinal dimension of this element shortens and then, in the free state, returns to the extended dimension.

The rotation locking disc is provided, on at least part of the proximal plane, with radially arranged projections in an amount of 30 to 120, or 40 to 100, preferably 40 to 80, more preferably 60. With 60 projections, a body rotation by one projection is equivalent to an angular rotation of 6°.

The projections located on the rotation locking disc and on the element receiving this disc may take various forms, e.g. teeth, trapezoidal or rectangular projections. It will be obvious to specialists how to ensure the interlocking of two corresponding and facing surfaces: the rotation locking disc and the receiving element surface. The said projections on the rotation locking disc and the their shape-matched elements on the surface of the receiving element should be located on the entire periphery of these elements, radially around the longitudinal axis a-a of the device, at some distance from the inner tube assembly guided through the centre. As shown, for example, in Fig. 3, the rotation locking disc contains projections around its proximal surface, at its edge, at a preset distance from the inner tube assembly.

Fig. 3 and Fig. 4 show the individual components of the handle in an enlarged, exploded view, with the components being shown unconnected only to better illustrate the construction of the device. It will be obvious to specialists in the field that, for example, the Y-connector is connected to the inner tube assembly and the longitudinal displacement tube is seated in the fixing socket in the rotation locking disc.

For the purposes of the invention, directions proximal, closer to the operator, and distal, further away to the operator, are used traditionally, typically for this field of technology. Consequently, the terms used: distal direction, from the distal side, distal surface, etc. also refer to the space distant from the operator.

The elements of the medical device according to the invention can be made of typical, known materials intended for catheter applications. These can be plastics and metal alloys, although, for example, the resilient element and parts that are expected to be highly rigid, e.g. the rotation locking disc or the longitudinal displacement tube, can be made of metal (metal alloy).

The handle of the medical device has ergonomic dimensions and shapes, e.g. the body of the proximal part of the handle has two opposite recesses designed for the ergonomic positioning of two fingers. The diameter of the handle ranges from 35 to 45 mm.

The device according to the invention can comprise various accessories for the distal part of the catheter part, which can be designed for a variety of medical procedures requiring controlled rotation of the inner tube assembly. Preferably, the medical device is a heart valve implantation device, in which case the inner tube assembly may include a balloon tube assembly. Thus, the term 'inner tube assembly' should be understood broadly, as an assembly passed through the catheter device in its inner space.

Designations in the drawings: a-a - longitudinal axis of the device

1 - handle

2 - catheter part of the device

3 - inner tube assembly

4 - valve

5 - balloon

6 - distal end

7 - outer tube assembly

8 - distal part of the handle

9 - middle part of the handle

10 - proximal part of the handle

11 - body of the proximal part of the handle

12 - rotation locking disc

13 - projections

14 - receiving element

15 - shape-matched surface

16 - fixing slot

17 - resilient element

18 - longitudinal displacement tube

19 - proximal end of the inner tube assembly - Y-connector - fixing element - sliding washer - knob of the proximal part of the handle - locking chamber - fixing socket