Hemostasis valve device for injecting a medical material into a patient, and related method

The device according to the invention includes a hollow body delimiting an inner passage. It further includes an assembly for maintaining the material in position in the inner passage.The maintaining assembly includes a radially compressible member delimiting, when idle, a through passage aperture of the material, and a radial compression member compressing the compressible member, radially movable relative to an axis of the passage aperture to outwardly compress the compressible member.It includes a member for actuating the or each compression member, radially movable relative to the body to cause the compression member to go from a radially retracted position, in which the section of the passage aperture is maximal, to a position radially deployed in the compressible member, in which the section of the passage aperture is minimal.

The present invention relates to a hemostasis valve device intended for inserting a medical material into a patient, comprising:a hollow body delimiting an inner passage for inserting the material extending between a proximal opening and a distal opening;a sealing valve, positioned in the inner passage, the sealing valve having at least one central passage that is sealed when idle;an opening member for the central passage of the valve, movable relative to the body between an idle position, in which the valve is sealed, and an open position of the valve.

Such a device is intended in particular to perform interventional cardiology and interventional radiology operations. It is in particular intended to provide blood sealing during the insertion of medical devices into the body of a patient.

The medical material is for example a catheter, a guide wire, a guide, a balloon catheter that is crimped or non-crimped of a stent, a rotary milling tool covered with diamond microcrystals, for example Rotablator®, or a combination of these devices.

This medical material is generally inserted into the body of the patient through the vascular system, in particular through a vein or artery, to convey them to the precise location of the operation in the patient's body.

To prevent leaks of bodily fluids, in particular blood, during the insertion of the material, it is necessary to place a hemostasis valve device of the aforementioned type at the insertion point of the material in the patient. U.S. Pat. No. 5,324,271 describes one example of a hemostasis valve device.

This device includes a proximal valve, intended to perform sealing around the material when it is inserted into the body. It further includes a distal valve, formed by a sleeve. The sleeve is axially compressible by an actuating member that can be screwed on the body.

The distal valve can be actuated once the material is inserted through the inner passage. To perform the sealing, the practitioner must screw the actuating member, which may be tedious to perform.

Furthermore, the axial compression of the valve makes it possible to achieve sealing around the device, but does not guarantee effective axial maintenance of the medical material in the device. Furthermore, the practitioner cannot easily determine whether the screwing that has been done is sufficient to ensure sealing around the material, or even to maintain the material itself.

One aim of the invention is therefore to obtain a hemostasis valve device that guarantees good sealing while preserving mobility of the material and, if needed, at a precise moment of the procedure, effective maintenance of the material it contains, while being easy and quick to use.

To that end, the invention relates to a device of the aforementioned type, characterized in that the device further includes an assembly for maintaining the material in position in the inner passage of the body, the maintaining assembly including:a radially compressible member positioned in the inner passage, the compressible member delimiting, when idle, a crossing passage aperture of the material;at least one radial compression member for radially compressing the compressible member, radially movable relative to an axis of the passage aperture to outwardly compress the compressible member;a member for actuating the or each compression member, radially movable relative to the body to cause the compression member to go from a radially retracted position, in which the section of the passage aperture is maximal, to a position radially deployed position in the compressible member, in which the section of the passage aperture is minimal.

The device according to the invention may comprise one or more of the following features, considered alone or according to any technically possible combination:the actuating member is movable in rotation around a longitudinal axis A-A′ of the body,the actuating member is movable only in rotation around the longitudinal axis A-A′ of the body, without translation relative to the body,it includes at least two opposite compression members, the actuating member being capable of simultaneously moving the compression members from their radially retracted position toward their radially deployed position,the compressible member includes an elastic sleeve which, when idle, delimits the passage aperture, the thickness of the sleeve, considered perpendicular to the axis of the passage aperture, being greater than 50% of the maximal transverse expanse of the passage aperture,the compressible member is formed from a material having a hardness comprised between 15 Shore A and 25 Shore A,the or each compression member includes a jaw having a concave surface intended to lean on a convex outer surface of the compressible member,the opening member of the valve is mounted movable in translation on the actuating member, the opening member being movable jointly with the actuating member during its movement between the first position and its second position,the valve includes a pierced body, in particular a pierced body made up of two pierced discs assembled one on the other, the pierced body delimiting a plurality of covering shutters, the opening member comprising a hollow actuating sleeve that inserts between the shutters to open the central passage of the valve,it includes means for locking the actuating member in position in its second position,the valve is positioned between the proximal opening of the body and the compressible member,the actuating member is mounted movable in rotation relative to the body around an axis D-D′ perpendicular to the longitudinal axis A-A′ of the body,the compressible member is positioned axially separated from the sealing valve along the hollow body.

The invention also relates to a method for axially maintaining a medical material, of the type comprising the following steps:providing a device as described above, the medical material being inserted through the inner insertion passage, the radially compressible member occupying an idle configuration in which the passage aperture occupies a maximal transverse section;moving the actuating member from its first position to its second position;radially moving the or each radial compression member to radially deform the compressible member and press the compressible member against the medical material.

The invention also relates to a percutaneous treatment method comprising the following steps:providing a device as described above, and a medical material intended to be inserted into the body of the patient;advantageously, actuating the opening member of the passage to free the passage and inserting the material into the central passage of the valve;actuating the member to close the passage through the valve;extracting the medical material through the distal opening and inserting it in the body of the patient;actuating the actuating member from its first position toward its second position to move the or each compression member from its retracted position to its radially deployed position;compressing the compressible member to apply the compressible member around the material while reducing the section of the passage aperture.

Hereafter, the terms “proximal” and “distal” are to be understood as being relatively closer to the operator, and relatively further from the operator, respectively.

A first kit10according to the invention is shown inFIG. 1.

As illustrated byFIG. 1, the treatment kit10according to the invention includes at least one medical material12intended to be inserted into the body of a patient, and a hemostasis valve device14according the invention, to facilitate and monitor the inserted of the medical material12into the body of the patient.

The kit10according to the invention is advantageously contained in at least one sterile packaging16diagrammatically illustrated inFIG. 1.

The material12is intended to be inserted into the body of the patient, using a vein or artery.

The medical material12intended to be inserted into the patient is in particular used during operations on the vascular system of the patient, in particular in interventional cardiology and interventional radiology.

In particular, in the example illustrated inFIG. 1, the medical material comprises a guide catheter20, a guide wire18, a guide, a balloon catheter22that is crimped or non-crimped of a stent, a Rotoblator®.

Depending on the material12that is inserted, and the number of devices inserted at the same time, the radial expanse of the material12is quite variable.

As will be seen below, the hemostasis valve device14is adapted to accommodate material12having quite different radial expanses, for example, comprised between 0.25 mm and 2 mm.

As illustrated byFIGS. 2 and 3, the hemostasis valve device14according to the invention includes a generally tubular hollow body30delimiting an inner passage32for inserting material.

The device14further includes an elastic sealing valve34, of the “push and pull” type, and a mechanism36for axial locking of the valve34.

The device14also comprises a member38for opening the valve34and an assembly40for axially maintaining material12in the inner passage32.

As illustrated byFIGS. 2 to 4, the body30includes a principal tubular element42and, advantageously, a transverse tapping44for inserting a liquid product into the inner passage32. It is provided with a tip44, in particular a tip mounted freely rotating at the distal end of the tubular element42.

In reference toFIG. 2, the body30includes a proximal portion46that houses the elastic valve34, an intermediate portion48to guide the axial maintaining assembly40, and a distal portion50bearing the tip44.

The proximal portion46is generally cylindrical. It delimits proximal openings52for retaining the locking mechanism36and distal windows54for the passage of the compression members of the axial maintaining assembly40.

The proximal openings52and the distal windows54radially pass through the proximal portion46to emerge in the inner passage32.

In the example shown inFIG. 2, the body30delimits two distal windows54positioned across from one another, on either side of the axis A-A′ of the body.

In reference toFIG. 4, the proximal portion46advantageously delimits, in the inner passage32, a proximal annular shoulder56for axially locking the elastic valve34.

The intermediate portion48includes an annular collar60protruding radially outward, for guiding the axial maintaining assembly40. The collar60has at least one guide track62angularly delimited by end-of-travel stops64.

The intermediate portion48delimits, in the inner passage32, a distal annular shoulder66for retaining the axial maintaining assembly40. The distal windows54emerge transversely in the inner passage32between the proximal shoulder56and the distal shoulder66.

At its distal end, the distal portion50has retaining elements68for the tip44, and an annular housing70for receiving a sealing gasket72(seeFIG. 4).

The rotating tip44is intended to be mounted in rotation around the retaining elements68at the distal end, with interposition of the seal72received in the housing70.

As illustrated byFIG. 5, the transverse tapping44protrudes laterally relative to the axis A-A′ of the body30, from the distal portion50of the tubular element42. It has an axis B-B′ inclined by a non-zero angle relative to the axis A-A′. The angle formed by the axis A-A′ of the body30and the axis B-B′ of the tapping is for example comprised between 45° and 90°.

The transverse tapping44delimits an auxiliary passage74for injecting liquid. The passage74emerges, upstream outside the device14, and downstream in the inner passage32.

The inner passage32extends between a proximal opening76situated at the proximal end of the tubular element42, and a distal opening78situated at the tip44.

The diameter of the passage32in the proximal portion46, upstream from the locking shoulder56, is greater than the diameter of the passage32in the intermediate portion48, between the first locking shoulder56and the distal shoulder66. The diameter of the passage32in the distal portion50is smaller than the diameter of the passage32in the intermediate portion48.

As illustrated byFIGS. 2, 3 and 6, the elastic valve34is made of a pierced body80. The pierced body80is slitted in its center to delimit a central passage82, which is sealed when idle.

As illustrated inFIG. 11, the pierced body80is formed by an assembly of two discs80A,80B, advantageously connected to each other by a hinge80C. The discs80A,80B are for example integral. The proximal disc80A has a thickness that is greater than that of the distal disc80B. The distal disc80B is kept pressed against the proximal disc80A by the axial locking mechanism36.

The pierced body80thus includes a plurality of shutters84, elastically movable between a sealed position of the central passage82, in which they are deployed transversely relative to the axis of the pierced body80, and a contracted position freeing the central passage82.

The sealed position of the shutters84forms their idle configuration. The valve34is therefore capable of spontaneously returning to the sealed position when it is not biased.

In this example, the elastic valve34extends transversely at the proximal opening76of the passage32. Alternatively, the valve34extends inside the passage32.

In reference toFIGS. 2 and 4, the axial locking mechanism36includes a spacer90and a locking ring92placed on either side of the valve34.

The valve34bears on a ring94of the spacer.

The locking ring92includes a proximal bearing ring96on the valve34and retaining members98to axially fix the locking ring92and the spacer90, and to keep the valve34fixed between those elements.

The ring92includes outer radial stops100to fix it axially on the body30.

The spacer90is wedged against the proximal openings52using two radial stops100A.

The retaining members98are formed by tabs. The tabs98delimit housings102for receiving a stop104secured to the spacer90.

Thus, the valve34is kept gripped between the spacer90and the locking ring92. The locking ring92also provides axial locking by mechanical stacking of the valve34and the spacer90on the body30.

In one alternative, the axial locking mechanism36has no spacer90, the valve34being pressed directly on the shoulder56.

According to the invention, the maintaining assembly40includes a compressible member110intended to engage with the material inserted into the passage32to retain it axially. The maintaining assembly40further includes at least one radial compression member112, radially movable relative to the compressible member110, and at least one actuating member114of each radial compression member112.

The compressible member110is in this example formed by a cylindrical sleeve120delimiting a passage aperture122for the material. The sleeve120is advantageously made with a base of a flexible material, for example a material having a hardness comprised between 15 Shore A and 25 Shore A, in particular equal to 20 Shore A.

To accommodate different materials with varying radial expanses, the sleeve120has a radial thickness e1 greater than the transverse expanse of the aperture122that it delimits when idle. Thus, the thickness e1 of the sleeve120is for example greater than 1.5 times the half-diameter of the aperture122.

In the embodiment shown inFIG. 2, the aperture122is also cylindrical. It has a diameter greater than 2.3 mm.

The thickness of the wall of the sleeve122is furthermore greater than 2 mm.

The length of the sleeve120, considered between its ends along the axis A-A′, is for example greater than 8 mm. It is in particular larger than 3 times the diameter of the aperture122when idle.

As will be seen below, the compressible member110can be deformed between a substantially cylindrical idle configuration, shown inFIGS. 1, 4, 5 and 6, in which the transverse section of the aperture122is maximal, and a radially deformed configuration, shown inFIG. 7, in which the transverse section of the aperture122is substantially zero, at least over an axial segment of the member110.

In this example, the compressible member110is mounted in the passage32while being axially wedged between the distal shoulder66and the spacer90. It extends across from the distal windows54.

In the example illustrated byFIGS. 2, 4 and 7, the axial maintaining assembly40includes a plurality of radial compression members112. In particular, the assembly40includes at least two members112positioned on either side of the axis A-A′, across from one another. The members112are situated in contact with an outer peripheral surface of the compressible member110.

Each radial compression member112is formed by a jaw130radially movable relative to the body30, between an idle retracted idle position, shown inFIG. 4, and a radially deployed position toward the axis A-A′, shown inFIG. 7.

Each jaw130has an outer radial surface132intended to cooperate with the actuating member114, and an inner radial surface134intended to press on the compressible member110.

In the example shown inFIG. 2, the inner radial surface134of each jaw130is concave. The concave inner surface134thus has a shape substantially complementary to the convex outer peripheral surface of the sleeve120on which it is pressed.

Each jaw130is inserted through a distal window54. It is guided in radial translation toward the axis A-A′ in the window54, between the idle retracted position and the radially deployed position.

In the idle retracted position, as shown inFIG. 4, each jaw130is advantageously positioned separated from the passage32. It is pressed on the outer peripheral surface of the compressible member110, without exerting significant force on this surface. The compressible member110is therefore kept in its idle configuration.

In the deployed position, each jaw130is radially deployed toward the axis A-A′ in the inner passage32. It radially compresses, toward the axis A-A′, the compressible member110to produce local gripping of the sleeve120and sealing of the aperture122.

In this example, the actuating member114is mounted movably relative to the body30, exclusively in rotation around the axis A-A′, between a first idle position and a second actuating position of each radial compression member112.

The actuating member114is generally formed by a tubular element138. It includes a distal actuating wheel140and, in this example, a proximal portion142for guiding and blocking the valve opening member38.

The actuating member114inwardly has an actuating cam144for each radial compression member112.

The tubular member138is mounted in rotation on the body30around the axis A-A′ while being guided by the collar60.

The wheel140protrudes radially relative to the proximal portion142. It outwardly covers the collar60. It is provided with outer orifices for receiving the fingers of an user.

The wheel140has complementary stops145, visible inFIG. 10, intended to cooperate with the end-of-travel stops64to limit the travel of the actuating member114between the first position and the second position.

Each cam144has a radial expanse increasing toward the axis A-A′ while moving angularly around the axis A-A′. It is positioned in contact with a radial compression member112.

Thus, each cam144is capable of cooperating with the compression member112and gradually moving that member112radially toward the axis A-A′ during the rotation of the actuating member114around the axis A-A′.

In this example, the proximal portion142comprises guides150for the movement of the opening member38and an axial stop152for retaining the member38. The guides150extend parallel to the axis A-A′. They are formed by longitudinal ribs. The annular stop152is formed by an outer shoulder.

The opening member38of the valve34here is mounted sliding on the actuating member114. It has an outer peripheral wall160, an inner actuating sleeve162, and a skirt164connecting the peripheral wall160to the actuating sleeve162.

The peripheral wall160is slidingly mounted along the axis A-A′ relative to the body30.

In this example, the wall160caps the proximal portion142of the actuating member114. It has a distal locking rim166intended to cooperate axially with the retaining stop152.

The actuating sleeve162coaxially extends with the axis A-A′ in the peripheral wall160. It emerges through a proximal opening168for inserting the material12through a distal opening170situated at its free edge172.

The opening member38is movable in translation along the axis A-A′, between an idle proximal position and a distal position opening the valve34.

In the proximal position, shown inFIG. 5, the rim166is positioned in contact with the retaining stop152to limit the proximal movement of the opening member38. The distal edge172of the actuating sleeve162is situated in contact with the valve34, without being inserted inside the central passage82.

The shutters36of the valve34then occupy their idle deployed position. The valve34seals the passage32.

In the distal position, shown inFIG. 6, the opening member38has moved along the axis A-A′ relative to the body30toward the distal end of the body30.

The rim166has separated from the stop152while moving toward the distal end of the body30.

In this example, the rim166axially abuts against the wheel140. The skirt164abuts against the ring92.

The sleeve162has been inserted through the central passage82of the valve34while separating the shutters84from the axis A-A′.

A freed continuous passage therefore extends from the proximal opening168, through the sleeve162, as far as the distal opening170to emerge in the passage32.

In this position, the valve34is open and the medical material12can be inserted through the device14.

The operation of the kit10according to the invention will now be described.

Initially, a guide catheter (not shown) is inserted into the vascular system of the patient.

The hemostasis valve device14is then connected to a free end of the guide catheter using the rotating tip44.

Likewise, a liquid injection assembly, for example a coronarography set, is mounted on the tapping44.

Next, debubblizing of the device14is done, to avoid introducing air into the vascular system.

Then, the medical material12is inserted through the inner passage32. To that end, the operator first actuates the opening member38to cause it to go from its proximal position to its distal position.

During this transition, he inserts the sleeve162through the central passage of the valve34and frees a continuous passage for the insertion of the material12. Then, he causes the material12to pass through the sleeve162and through the inner passage32of the body30, to reach the distal opening78.

When the material12has been inserted, the operator returns the opening member38to its proximal position, which causes the shutters84of the valve34to go toward their deployed position through elastic biasing. The shutters84press sealably around the material12, ensuring sealing toward the distal end of the body30.

Once that is done, the operator can then modify the axial position of the medical material12while pulling or pushing axially the material12through the valve34, without any risk of leaking.

Once the material12is correctly positioned, the operator maneuvers the actuating member114. In this example, he rotates it around the axis A-A′, with no translational movement. This movement is therefore extremely easy and quick to perform relative to screwing.

During this movement, the cam144pivots around the axis A-A′ and moves angularly relative to each radial compression member112. The radial compression member112is therefore pushed radially toward the axis A-A′ by the cam144. This causes it to be pressed on the outer surface of the compressible member110and causes local compression of the compressible member110toward the radially deformed configuration.

The section of the central aperture122delimited by the sleeve120therefore decreases across from each member112, until the sleeve120is pressed around the medical material12to maintain it axially.

The sleeve120being made with a base of a sufficiently deformable and thick enough material, the operator therefore continues the rotating movement of the actuating member114until reaching the end of travel, in which the end-of-travel stops64come into contact with the complementary stops present in the actuating member114.

In light of the significant thickness of the sleeve120and the corresponding size of the aperture122, the compressible member110is capable of adapting to medical material with varying radial expanses, and providing sufficient gripping irrespective of the radial expanse of the material.

Furthermore, whatever the radial expanse of the material12inserted through the aperture122, the operator moves the actuating member114until its end of travel, which in all cases guarantees good strength of the material.

Then, a medical intervention may be performed using the material12.

A second kit180according to the invention is illustrated byFIGS. 8 and 9.

Unlike the first kit10, the actuating member114is formed by a button182pivoting around an axis D-D′ perpendicular to the axis A-A′ of the body30. As before, no screwing movement is necessary to cause the actuating member114to go from its first position to its second position. A simple rotation around the axis D-D′ suffices to perform that transition.

In this kit180, the opening member38can be moved independently of the actuating member114. It is thus mounted movable in translation directly on the body30.

As in the device14, there are two compression members112to close and open the aperture122. The movement of these members112is commanded by switching the actuating member114, which forms a rocker button.

More generally, this independent arrangement of the opening member38may also apply to the device described inFIGS. 1 to 7.

In one alternative, in light of the thickness of the sleeve120, and its deformability, the device14is capable of axially locking a plurality of materials12mounted in parallel relative to one another in the inner passage32, for example a guide wire, a guide wire and a catheter positioned parallel to the guide wire, two guide wires and a catheter, two guide wires and two catheters, or even a guide wire and a cutter of the Rotablator® type.

In one alternative, the device14includes the presence of means for locking the actuating member114in its second position, at the end of travel. This facilitates maneuvering by the operator, and guarantees that the operator performs effective tightening of the medical material12.

Advantageously, the actuating member114of the compressible member110is biased toward the first idle position in any intermediate position comprised between the first idle position and the second actuating position. This bias results from the local compression of the compressible member110by the jaws130in the second position.

Thus, the means for locking in position keep the actuating member114in the second position against the bias from the actuating member114toward the first position.

The first position and the second position of the actuating member constitute the only two stable positions of the actuating member114, which operates like a switch.

Thus, during operation, if the user unlocks the actuating member114by releasing the locking means, the actuating member114will spontaneously be brought toward the first position by deploying the compressible member110acting on the jaws130to deploy them radially, then by cooperation between the jaws130and the actuating member114.

When the actuating member is movable in rotation around the axis A-A′, its angular travel around the axis A-A′ between the first position and the second position is generally comprised between 90° and 150°. This travel is preferably comprised between 110° and 120° to allow simple and fast actuation of the member114.

This optimizes the movement of the jaws130in the windows54between their retracted idle position and their radially deployed position toward the longitudinal axis A-A′.

Preferably, and as illustrated inFIG. 2, each jaw130is movable in radial translation along an axis perpendicular to the axis A-A′ intersecting the axis A-A′.

The jaws130are separate, and have a maximal angular expanse smaller than 90°. They therefore make it possible to apply a very concentrated radial compression force on the radially compressible member110, with a minimal rotation of the actuating member114.

In another alternative, the radially compressible member110is formed from a material having a hardness comprised between 25 Shore A and 40 Shore A, advantageously between 26 Shore A and 35 Shore A.