Assembly for placement of a cardiac, aortic or arterial implant with stimulation assistance by a peripheral venous or arterial catheter

Abstract

An assembly for placement of a cardiac, aortic or arterial implant. The assembly includes an insertion sheath of an introducer or of a delivery catheter, which is of a size smaller than that of an introducer, intended to be introduced into an artery of a human body. The metal support of an electrode of the external cardiac stimulator being integrated into the insertion sheath of a peripheral venous or arterial accessory catheter, or a sleeve around the accessory catheter, which is introduced into the peripheral vein or artery of a patient. The sheath of the accessory catheter or the sleeve is therefore directly in contact with a peripheral vein or artery of the patient.

Claims

1. An assembly for placement of a cardiac, aortic or arterial implant, comprising: a device forming an introducer or a valve delivery catheter comprising at least one tubular insertion sheath, intended to be introduced into an artery of a human body; an accessory catheter intended to be introduced into a peripheral vein or artery of the human body; a sleeve adapted to be engaged around the accessory catheter, the sleeve being made of electrically conductive material over at least part of its outer periphery, such that, when the accessory catheter is introduced into the peripheral vein or artery of the human body, the conductive periphery of the sleeve is in contact with the subcutaneous tissue of the body or with the wall of the artery or of the vein, the sleeve additionally comprising an electrical connection to an electrode of a cardiac stimulator outside the body; a guidewire intended to be introduced into the tubular sheath of the introducer or of the delivery catheter for advancing the implant, the guidewire comprising a metal part additionally serving as a connection to the other electrode of the external cardiac stimulator.

2. The assembly as claimed in claim 1, the electrode of the cardiac stimulator connected to the electrically conductive sleeve engaged around the insertion sheath of the accessory catheter being the anode, while the one connected to the metal part of the guidewire introduced into the introducer or the delivery catheter is the cathode.

3. The assembly as claimed in claim 1, in which the electrically conductive sleeve is formed as one piece made of conductive material, for example carbon.

4. The assembly as claimed in claim 3, the sleeve being formed by a sheath comprising on its outer periphery an electrically conductive coating.

5. The assembly as claimed in claim 3, the sleeve being elastic so as to be able to engage on peripheral venous or arterial catheter sheaths of different diameters, typically external diameters of between 0.2 and 2.2 mm.

6. The assembly as claimed in claim 1, constituting an assembly for replacement of a cardiac valve by a percutaneous route, the guidewire being adapted for the advance of an artificial valve intended to replace the cardiac valve.

7. An assembly for placement of a cardiac, aortic or arterial implant, comprising: a device forming an introducer or a valve delivery catheter comprising at least one tubular insertion sheath, intended to be introduced into an artery of a human body; an accessory catheter, intended to be introduced into a peripheral vein or artery of the human body, the accessory catheter comprising at least one tubular insertion sheath and at least one electrically conductive element, of which a distal portion is exposed on at least one part of the outer periphery of the sheath in such a way as to be in contact with the subcutaneous tissue of the body or with the peripheral vein or artery, and of which a proximal portion, accessible from the outside of the body, comprises an electrical connection so as to serve as a connection to an electrode of a cardiac stimulator outside the body; a guidewire intended to be introduced into the tubular sheath of the introducer or of the delivery catheter for advancing the implant, the guidewire comprising a metal part additionally serving as a connection to the other electrode of the external cardiac stimulator.

8. The assembly as claimed in claim 7, the electrode of the cardiac stimulator connected to the accessory catheter being the anode, while the one connected to the metal part of the guidewire inserted into the introducer or the delivery catheter is the cathode.

9. The assembly as claimed in claim 7, in which the electrically conductive element of the accessory catheter is a wire or a metal band housed at least partially within the thickness of the sheath, of which a distal portion is exposed at the outer periphery of the sheath.

10. The assembly as claimed in claim 9, the cross section of the wire or of the metal band being between 0.25 and 5 mm.sup.2.

11. An assembly for placement of a cardiac, aortic or arterial implant, comprising: a device forming an introducer or a valve delivery catheter comprising at least one tubular insertion sheath, intended to be introduced into an artery of a human body; an accessory catheter intended to be introduced into a peripheral vein or artery of the human body; a sleeve adapted to be engaged around the accessory catheter, the sleeve being made of electrically conductive material over at least part of its outer periphery, such that, when the accessory catheter is introduced into the peripheral vein or artery of the human body, the conductive periphery of the sleeve is in contact with the subcutaneous tissue of the body or with the wall of the artery or of the vein, the sleeve additionally comprising an electrical connection to an electrode of a cardiac stimulator outside the body; a guidewire intended to be introduced into the tubular sheath of the introducer or of the delivery catheter for advancing the implant, the guidewire comprising a metal part additionally serving as a connection to the other electrode of the external cardiac stimulator; wherein said assembly constitutes an assembly for placement of an aortic endoprosthesis or carotid stent, the guidewire being adapted for the advance of the endoprosthesis or stent, or the guidewire being independent of the one which delivers the prosthesis or the balloon but which is coupled to another guidewire in contact with the patient's heart.

12. An assembly for placement of a cardiac, aortic or arterial implant, comprising: a device forming an introducer or a valve delivery catheter comprising at least one tubular insertion sheath, intended to be introduced into an artery of a human body; an accessory catheter, intended to be introduced into a peripheral vein or artery of the human body, the accessory catheter comprising at least one tubular insertion sheath and at least one electrically conductive element, of which a distal portion is exposed on at least one part of the outer periphery of the sheath in such a way as to be in contact with the subcutaneous tissue of the body or with the peripheral vein or artery, and of which a proximal portion, accessible from the outside of the body, comprises an electrical connection so as to serve as a connection to an electrode of a cardiac stimulator outside the body; a guidewire intended to be introduced into the tubular sheath of the introducer or of the delivery catheter for advancing the implant, the guidewire comprising a metal part additionally serving as a connection to the other electrode of the external cardiac stimulator, wherein said assembly constitutes an assembly for placement of an aortic endoprosthesis or carotid stent, the guidewire being adapted for the advance of the endoprosthesis or stent, or the guidewire being independent of the one which delivers the prosthesis or the balloon but which is coupled to another guidewire in contact with the patient's heart.

Description

DETAILED DESCRIPTION

(1) Other advantages and features of the invention will become clearer on reading the detailed description of the invention, which is given by way of a non-limiting example and with reference to the accompanying figures, in which:

(2) FIG. 1 is a perspective view of an introducer according to the prior art, intended to be introduced into a femoral artery in the groin region of a patient;

(3) FIGS. 2A to 2C show, in partial longitudinal sectional views, various steps involved in sliding a valve catheter into the introducer according to FIG. 1, in order to fit an artificial valve in place as a replacement for a defective native aortic valve;

(4) FIG. 3 shows, in a schematic perspective view from outside a patient, the step involving the placement of a valve catheter and of the cardiac stimulation electrodes according to the prior art;

(5) FIG. 4 is a schematic perspective view of a delivery catheter according to the prior art, intended to be introduced directly into the artery of a patient without the need for an introducer;

(6) FIG. 5 illustrates schematically the use of an assembly according to the invention with a venous catheter according to the invention and with a prosthetic valve delivery catheter introduced directly into an artery of a patient.

(7) In the description below, and in the whole of the present application, the terms “distal” and “proximal” are used with reference to the body of a patient whose defective native aortic valve is replaced by an artificial aortic valve. Thus, the distal end of an introducer is the end situated farthest inside the patient during the operation for replacement.

(8) To simplify matters, the same elements in an assembly according to the invention and in an assembly according to the prior art are designated by the same references.

(9) It should be noted that the various elements are not necessarily shown to scale.

(10) FIG. 1 shows an introducer 1 for replacing a heart valve by a transfemoral route.

(11) Between its proximal end 10 and its distal end 11, this introducer 1 of generally tubular shape comprises a nozzle 12 which is continued by at least one outer tubular sheath 13 formed of two tubular portions 14, 15, from proximal to distal, considered with respect to the introduction into a femoral artery of a patient on whom an operation is to be performed, that is to say from the top downward in FIG. 1.

(12) The nozzle 12 generally incorporates within it a set of leaktight valves to provide hemostasis, that is to say to ensure that the blood is retained inside the patient's blood vessels during the intervention.

(13) The tubular sheath 13 may be extensible or non-extensible in order to permit the passage of a surgical intervention device such as a valve catheter, as is explained below. The material from which the sheath 13 is made is a biocompatible material such as silicone. It may also be made of Teflon® or of polyurethane. The sheath may advantageously be covered on the outside with a hydrophilic layer and on the inside with a layer having a low coefficient of friction in order to facilitate the sliding of an intervention device.

(14) The introducer 1 illustrated in FIG. 1 likewise comprises an integrated rinsing device 16 with faucets, commonly referred to as a flush, for rinsing the inside of the introducer 1 by means of a suitable rinsing liquid.

(15) All the elements of the introducer 1 that are present in the proximal or outer zone Z.sub.E are intended to remain outside the patient's body, while the entire distal portion 15 of the sheath 13 defining the distal zone Z.sub.1 is intended to be introduced into a femoral artery of the patient.

(16) The introducer 1 illustrated is, for example, the one sold commercially under the trade name “Edwards eSheath introducer set”, which is sold commercially by Edwards Lifesciences.

(17) FIGS. 2A to 2C show the advance of a valve catheter 2, composed of a guidewire 20 and of an assembly 21 formed by an artificial valve fixed to a radial expansion stent and an inflatable balloon for effecting this expansion, inside the distal portion 14 of the tubular sheath of the introducer 1 already introduced into a femoral artery A.

(18) The tip of the assembly 21 makes it possible to easily penetrate the deficient native aortic valve.

(19) It will be seen from these figures that, the further the valve catheter 2 slides, the portion 15 of the tubular sheath temporarily deforms radially to form a slight protuberance 150. When the tubular sheath is not extensible, it does not deform radially.

(20) It will be seen from FIG. 3 that the hand M of a surgeon introduces the valve catheter 2 into the introducer 1 already introduced into the femoral artery of a patient, with the nozzle 12 protruding outside of the body C.

(21) This introduction of the valve catheter 2 allows the assembly 21 to be brought to the level of the deficient calcified aortic valve that is to be replaced.

(22) Normally, as is likewise shown in FIG. 3, a clip 3 known as a crocodile clip is fixed by being clipped onto the guidewire 20 of the valve catheter 2. This clip 3 is connected to the cathode of a cardiac stimulator (not shown) situated outside of the body C.

(23) A needle (not shown) is likewise inserted into the subcutaneous tissues of the body C of the patient on whom a procedure is to be performed. A metal wire 4 is fixed on this needle.

(24) A crocodile clip 5 is likewise fixed by being clipped onto the metal wire 4.

(25) This clip 5 is connected to the anode of the cardiac stimulator outside the body.

(26) Thus, when the artificial valve is at the level of the natural aortic valve that is to be replaced, and before putting the artificial valve itself into place, i.e. before inflating the balloon and thus expanding the stent to which the valve is fixed, the surgeon first of all effects rapid ventricular stimulation of the left ventricle.

(27) To do this, an electrical signal is delivered between the cathode and the anode by way of the clips 3 and 5, with the balloon serving as electrical insulator between these two electrodes.

(28) FIG. 4 illustrates a delivery catheter 1′ which may be introduced directly into the artery of a patient without the need for an introducer. More precisely, the catheter 1′ comprises a nozzle 12, which is continued by an insertion sheath 13. The nozzle 12 comprises a port 18 for inflation/deflation of a balloon 7 at the distal end 11, which makes it possible to expand a prosthetic valve (not shown).

(29) Faced with numerous operations for replacing an aortic valve via a femoral route of the kind that has been briefly described, and in particular faced with the precise and delicate placement of the additional supplementary needle, and also the placement and retention of the connecting crocodile clips on two spaced-apart supports, the inventor of the present invention has thought to integrate the metal wire 4 directly in an introducer 1 or in a delivery catheter 1′. This solution is described and claimed in the patent application WO2016/162315 A1.

(30) Although this solution affords many advantages compared to the technique according to the prior art, it nonetheless has an important disadvantage, namely that of requiring the production of specific introducers or delivery catheters.

(31) Thus, the inventor has first considered integrating the function of the metal wire not in a specific introducer or delivery catheter but instead in an existing peripheral venous catheter 1″.

(32) Such a venous catheter 1″ can be of a small diameter, typically 2 mm or less, and of a short length. It meets the standards applying to peripheral intravascular catheters. It will be recalled here that the primary function of a peripheral venous catheter is to deliver a liquid for rehydration of the patient, a drug treatment or a transfusion.

(33) More particularly, in the context of a TAVI, the arterial catheter 1″ makes it possible to perform a control angiography, on the one hand in order to check the positioning of the prosthetic aortic valve, and on the other hand in order to verify the absence of complications, in particular of vascular complications, or even to manage them. (The primary function of a peripheral venous catheter is to deliver a liquid for rehydration of the patient, a drug treatment or a transfusion).

(34) According to the invention, the insertion sheath of a peripheral arterial catheter 1″ incorporates at the periphery a wire or an electrically conductive band of very small thickness, typically of the order of a millimeter or less, which adds only a little thickness to a conventional venous catheter sheath and therefore does not impede the advance of the latter during its introduction into an artery or peripheral vein V.

(35) In practice, a surgeon or interventionalist seeking to perform an operation for replacement of a cardiac stimulation valve, with cardiac stimulation concomitant with the placement of the prosthetic valve, begins by positioning the peripheral venous or arterial catheter 1″ in such a way that the conductive element of its sheath will touch either a subcutaneous zone of the patient or the wall of the peripheral vein or artery of the patient.

(36) Once this positioning has been carried out, the introducer 1 or the delivery catheter 1′ can be introduced in the usual way by the surgeon.

(37) Once the positioning of the introducer 1 or of the catheter 1′ in the femoral artery A has been completed, the electrical connection 6 can be connected directly to the anode of an external cardiac stimulator 9 by way of a connection wire 90.

(38) Usually, a clip such as the crocodile clip 3 shown in FIG. 3 can in turn be fixed by clipping it to the guidewire 20 of an introducer 1 or of a valve catheter 1′. This clip is connected to the cathode of the external cardiac stimulator by way of a connection wire 91.

(39) Thus, the temporary cardiac stimulation for performing the desired cardiac shutdown can take place between the cathode, connected electrically to the guidewire 20, and the anode, connected electrically to the electrically conductive element of the peripheral venous catheter 1″.

(40) FIG. 5 provides a schematic view of all the elements in question, namely the use of an assembly with delivery catheter 1′ for the delivery of a prosthetic valve 10 through the aortic arch of a patient and with a peripheral venous catheter 1″ according to the invention.

(41) As can be seen in FIG. 5, the catheter 1′ is introduced from the femoral artery and a guidewire 20 is introduced directly into the delivery catheter 1′. The distal end 21 of the guidewire 20 winds up on itself when coming into contact with the endothelium of the left ventricle of the patient. This distal end 21 of the guidewire 20 at all times ensures the electrical contact and therefore the passage of the current from the cathode of the external cardiac stimulator 9 via the electrical connection wire 91.

(42) The passage of the current to the anode of the cardiac stimulator 9 is for its part ensured by the conductive sheath of the peripheral venous catheter 1″ and therefore in contact with the subcutaneous tissue of the patient or the peripheral vein and connected moreover to the electrical connection wire 90.

(43) The invention is not limited to the examples that have just been described; it is in particular possible to combine features of the examples illustrated within variants that are not illustrated.

(44) Other variants and improvements may be contemplated without thereby departing from the scope of the invention.

CITED REFERENCES

(45) [1]: «Registry of Transcatheter Aortic-Valve Implantation in High-Risk Patients», Gilard et al; the New England Journal of Medicine: pp 1705-1715 [2]: «Left Ventricular Guidewire Pacing to Simplify Aortic Balloon Valvuloplasty», Susanne Navarini et al; Catheterization and Cardiovascular Interventions 73: pp 426-427 (2009) [3]: «A novel Approach for Transcoronary Pacing in a Porcine Model», Roland Prodzinsky et al; Journal of Invasive Cardiology 24(9): pp 451-455 (2012) [4]: «Optimizing of Transcoronary Pacing in a Porcine Model», Konstantin M. Heinroth, et al, Journal of Invasive Cardiology 21, pp 634-638 (2009)