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WO2019092031A1 - Instrument pour couper des valves cardiaques - Google Patents

Instrument pour couper des valves cardiaques Download PDF

Info

Publication number
WO2019092031A1
WO2019092031A1 PCT/EP2018/080493 EP2018080493W WO2019092031A1 WO 2019092031 A1 WO2019092031 A1 WO 2019092031A1 EP 2018080493 W EP2018080493 W EP 2018080493W WO 2019092031 A1 WO2019092031 A1 WO 2019092031A1
Authority
WO
WIPO (PCT)
Prior art keywords
head
rod
instrument
instrument according
cutting
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/EP2018/080493
Other languages
English (en)
Inventor
Giampaolo ZOFFOLI
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Medical Instruments SpA
Original Assignee
Medical Instruments SpA
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Medical Instruments SpA filed Critical Medical Instruments SpA
Publication of WO2019092031A1 publication Critical patent/WO2019092031A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/32—Surgical cutting instruments
    • A61B17/3205—Excision instruments
    • A61B17/32053—Punch like cutting instruments, e.g. using a cylindrical or oval knife
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/00234—Surgical instruments, devices or methods for minimally invasive surgery
    • A61B2017/00238—Type of minimally invasive operation
    • A61B2017/00243—Type of minimally invasive operation cardiac
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00743—Type of operation; Specification of treatment sites
    • A61B2017/00778—Operations on blood vessels
    • A61B2017/00783—Valvuloplasty
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00946—Material properties malleable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22051—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
    • A61B2017/22065—Functions of balloons
    • A61B2017/22069—Immobilising; Stabilising
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
    • A61B2017/22097—Valve removal in veins
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/36—Image-producing devices or illumination devices not otherwise provided for
    • A61B90/361—Image-producing devices, e.g. surgical cameras
    • A61B2090/3614—Image-producing devices, e.g. surgical cameras using optical fibre

Definitions

  • the present invention relates to an instrument for cutting heart valves.
  • the human heart has four interconnected chambers, which are, in the order in which the blood passes through them, the right atrium, the right ventricle, the left atrium, and the left ventricle.
  • each atrium and the respective ventricle and also between each ventricle and the corresponding downstream vessel (the pulmonary artery and the aorta), there are corresponding valves, the function of which is to control blood flow, mainly in order to prevent the blood from circulating in the direction opposite to the normal direction.
  • valves indicated above are made up of two or three flaps of filamentous connective tissue, known as cusps, which, pushed by the variations in pressure inside the heart, are capable of opening or closing the respective orifice.
  • the surgeon immediately after having completed the cutting, the surgeon has to spend more time removing the fragments one by one, taking the maximum of care in order to prevent even one of them from remaining in the organ, from where it could enter the bloodstream and cause an embolism.
  • the aim of the present invention is to solve the above mentioned problems, by providing an instrument that ensures workable methods of cutting heart valves.
  • an object of the invention is to provide an instrument that makes it possible to cut and removing the cusps of a heart valve, in a short time.
  • Another object of the invention is to provide an instrument that enables a rapid and effective cutting of the cusps of a heart valve, without risks for the surrounding tissues during the cutting step.
  • Another object of the invention is to provide an instrument that makes it possible to rapidly and completely remove the fragments of the cut cusps of a heart valve.
  • Another object of the invention is to provide an instrument that ensures a high reliability of operation and which removes the cusps while preparing the organ for the best reception of the prosthetic device.
  • Another object of the invention is to provide an instrument that adopts an alternative technical and structural architecture to those of conventional instruments.
  • Another object of the invention is to provide an instrument that can be easily implemented using elements and materials that are readily available on the market.
  • Another object of the invention is to provide an instrument that has low costs and is safely applied.
  • Figure 1 is a side view of the instrument according to the invention, in the first limit configuration
  • Figure 2 is a view from above of the instrument in Figure 1 , in the first limit configuration
  • Figure 3 is a front elevation view of the instrument in Figure 1 , in the first limit configuration
  • Figure 4 is a side view of the instrument in Figure 1, in a different mutual arrangement of the rods.
  • the reference numeral 1 generally designates an instrument designed for cutting heart valves. More precisely, in the preferred application, the instrument 1 is intended to be used by a heart surgeon to carry out in a practical and easy manner the cutting (and, as will be seen, also the removal) of the cusps of one of the heart valves, made necessary by their calcification (or other disease), and so enable their replacement with a prostheses.
  • the instrument 1 comprises a first rod 2, which can be gripped at a proximal end 2a thereof and which is provided at a distal end thereof (therefore at the opposite end to the proximal end 2a) with a first, female head 3.
  • the instrument 1 comprises a second rod 4, which has a second, male head 5 at a distal terminal portion thereof (therefore at the opposite end to the proximal end 2a of the first rod 2 and proximate to the distal end of the latter).
  • the second head 5 forms a cutting edge 5 a with a transverse contour that corresponds to the contour of a mouth 3 a formed by the first head 3.
  • transverse contour that corresponds to evidently means that the shapes of the respective contours (if observed in the axial direction, as in the view in Figure 3) practically coincide, just as the respective dimensions are practically identical (apart from a minimal difference).
  • the second rod 4 can move coaxially and reversibly with respect to the first rod 2, at least from a first limit configuration to a second limit configuration.
  • the heads 3, 5 are mutually spaced apart (for example by a few centimeters).
  • the second head 5 is at least partially accommodated in the first head 3.
  • the subsequent transition from the first configuration to the second configuration activated by the heart surgeon (or other user) determines the cutting of one or more cusps of the valve (and preferably of all the cusps).
  • the cutting edge 5a which, by virtue of its chosen transverse contour that corresponds to the contour of the mouth 3 a, skims the latter during the transition and, acting like a die cutter, carries out the desired cutting, thus already achieving the set aim.
  • the cutting edge 5a (and therefore also the mouth 3a) has a circular transverse cross-section (or in any case a closed polygon/curve), so as to be able to cut all the cusps of the valve to be replaced with a single action.
  • the first rod 2 is internally hollow, so as to define a duct for the slideable accommodation of a section of the second rod 4, adjacent to the distal terminal portion of the latter. So effectively, while the distal terminal portion of the second rod 4, where the second head 5 is located, protrudes externally from the first rod 2, an adjacent section of the second rod 4, which optionally can extend up until the respective proximal final portion (as in the accompanying figures), is accommodated in the first rod 2.
  • the rods 2, 4 are rigid, and therefore do not have the possibility to modify their progression (straight or even curved, if the requirements indicate it) or other dimensional and shape parameters.
  • a rigid material is chosen solely for the first rod 2 and for the distal terminal portion of the second rod 4, thus giving the remaining part of the latter an elastic behavior for example.
  • At least one segment of the first rod 2 is malleable (with the remaining part rigid, or even having different properties).
  • a “malleable” segment evidently means that such segment is made of a plastically deformable material or in any case that it is made in such a way as to ensure such behavior, which is in contrast with elastic behavior, and which envisages maintaining the deformation (and thus the shape) obtained, when the stress that caused it is removed.
  • the distal terminal portion of the second rod 4 will preferably be rigid, in order to allow the correct introduction of the second head 5 into the valve to be replaced.
  • the segment can be chosen in a central region of the first rod 2, or it can coincide with the proximal end 2 a, or extend from a central region up until the proximal end 2a or the like (even until it wholly or partially affects the distal portion).
  • At least the central portion of the second rod 4 (the portion accommodated in the malleable segment of the first rod 2) comprises a plurality of braided metal cables, preferably (but not exclusively) wrapped in a protective sheath.
  • the sheath facilitates the sliding of the second rod 4 with respect to the first rod 2, even if the latter is variously folded or deformed, at its malleable segment.
  • the first head 3 is shaped like an axially symmetrical cup (preferably with a circular cross- section), so as to define a receptacle 3b for the at least partial accommodation of the second head 5 (when it slides up until the second limit configuration, as in Figure 4).
  • Such receptacle 3b is therefore open outward right at the mouth 3a, effectively defined by an internal edge of the side wall of the first cup- shaped head 3.
  • the first head 3 has a transverse bulk that exceeds that of the second head 5.
  • first head 3 with a coaxial flange of non-traumatic material (or indeed made from the same material as the first head), so as to cover it externally and to effectively serve as a spacer, a centering device, and a separator of the cutting edge 5a from the surrounding tissues.
  • the receptacle becomes a kind of space for collecting the cut fragments of the cusps, which automatically end up inside it, thus guarding against the danger of their being dispersed outside, forcing the heart surgeon and his or her team to conduct a bothersome search, which would lengthen the time of the operation in a most undesirable manner.
  • the cutting edge 5a is constituted by the undulated profile, directed toward the first head 3, of a blade wrapped around the longitudinal axis of the second rod 4 (which in any case coincides with the axis of the first rod 2).
  • the choice of the undulated profile is of undoubted interest, as it ensures optimal modes of cutting, not least in light of the peculiar shape structure of the cusps of heart valves.
  • the second head 5 comprises, at the opposite end to the cutting edge 5 a, a wedge 5b (conical or frustum- shaped) which tapers progressively outward.
  • the frustum shape structure ensures a non-traumatic insertion through the valve to be replaced; by contrast, a conical shape structure makes it possible to perforate tissues to be removed and in any case improves the capacity for penetration of the instrument 1 according to the invention.
  • wedge 5b in any shape adopted, enables the facilitated insertion of the rods 2, 4 into the heart valve to be replaced and/or into the blood vessel leading to the valve.
  • the instrument 1 In order to enable more convenient modes of using the instrument 1 according to the invention, it comprises a lever 6 for controlling the movement of the second rod 4 between the limit configurations.
  • Such lever 6 is articulated to a contoured handle 7, which is integrally coupled to the proximal end 2a of the first rod 2.
  • handle 7, in addition to having an ergonomic shape, effectively resembles a kind of "pistol", precisely in order to enable more practical modes of use by the user, who can in fact easily grasp it and handle it, for the removal of the valve to be replaced.
  • the instrument 1 comprises a tube 8, which is applied externally to the first rod 2 (parallel to it) and which leads to a balloon 9 wrapped stably around the first head 3.
  • the balloon 9 can be temporarily inflated, thus facilitating the optimal anchoring of the first head 3 to the surrounding anatomical tissues. This evidently guards against the danger that, during the step of removing the valve, the instrument 1 (and the heads 3, 5 in particular) could move with respect to the ideal placement.
  • the balloon 9 also contributes to keeping the surrounding tissues (particularly the coronary tissues) spaced apart from the cutting edge 5a, with evident benefits.
  • the instrument 1 can comprise a central channel, which is provided coaxially in the second head 5 and is open outward (on the end opposite that of the first head 3).
  • the channel can thus accommodate an auxiliary tool of the type of a video camera, a light source, a net for collecting loose fragments, and the like.
  • a video camera makes it possible to display, including remotely, images of the blood vessel, of the heart cavity and of the heart valve to be replaced, before and/or during and/or after the operation of cutting and removal.
  • Accommodating a light source (which can be carried by the video camera) in turn enables better vision during the introduction of the instrument 1 (especially if the surgical operation is being carried out using minimally-invasive techniques).
  • a user typically, but not exclusively, a heart surgeon
  • the instrument 1 for cutting and removing the cusps of a heart valve.
  • the user grips the instrument 1 at the handle 7 and progressively inserts the shanks 2, 4 into the preselected blood vessel, until the valve and the cusps to be removed are reached.
  • the user needs to take care to place the instrument 1 so that the valve is interposed between the heads 3, 5 (arranged in the first limit configuration): the second head 5 must pass beyond the cusps (in doing this, the user is assisted by the wedge 5b) while the first head 3 is kept on the other side. Then, by acting on the lever 6, the user causes the passage of the second rod 4 toward the second limit configuration, with which, as seen, the cutting of the cusps is achieved, when the cutting edge 5 a skims the mouth 3 a.
  • the instrument 1 does not only perform the cutting of the valve (of the cusps) but also conveniently removes them, in that while the second rod 4 is being brought to the second limit configuration, the cut fragments fall automatically into the receptacle 3b, which is closed by the second head 5, partially accommodated in it.
  • the user can thus extract the instrument 1, in order to obtain in an evidently convenient and rapid manner, the cutting and also the removal of the heart valve.
  • the instrument 1 it is possible to completely remove the heart valve with a single maneuver, with a (preferably) circular cutting, easily and without the dispersion of part of the cut tissue. This makes it possible to reduce, by several tens of minutes with respect to conventional methods, the overall time required for operations to replace heart valves with artificial heart valves.
  • the increased bulk of the first head 3 makes it possible to carry out a rapid and effective cutting of the cusps, without any risk for the surrounding tissues in the cutting step.
  • the balloon 9 also contributes to such functionality, and moreover ensures the stable locking in place.
  • the materials employed, as well as the dimensions, may be any according to requirements and to the state of the art.

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Surgery (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un instrument pour couper des valves cardiaques, comprenant une première tige (2), qui peut être saisie au niveau d'une extrémité proximale (2a) et est disposée au niveau d'une extrémité distale avec une première tête femelle (3). L'instrument (1) comprend également une seconde tige (4), qui a, au niveau d'une partie terminale distale, une seconde tête mâle (5), qui forme un bord de coupe (5a) avec un contour transversal qui correspond au contour d'une embouchure (3a) formée par la première tête (3). La seconde tige (4) peut se déplacer de manière coaxiale et réversible par rapport à la première tige (2) au moins à partir d'une première configuration limite, dans laquelle les têtes (3, 5) sont espacées l'une de l'autre, vers une seconde configuration limite, dans laquelle la seconde tête (5) est au moins partiellement logée dans la première tête (3), pour la coupe d'au moins une cuspide d'une valve cardiaque à remplacer, suite à l'introduction préliminaire au moins de la seconde tête (5) dans la valve et la transition subséquente de la première à la seconde configuration.
PCT/EP2018/080493 2017-11-09 2018-11-07 Instrument pour couper des valves cardiaques Ceased WO2019092031A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
IT102017000127620 2017-11-09
IT201700127620 2017-11-09

Publications (1)

Publication Number Publication Date
WO2019092031A1 true WO2019092031A1 (fr) 2019-05-16

Family

ID=61527164

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2018/080493 Ceased WO2019092031A1 (fr) 2017-11-09 2018-11-07 Instrument pour couper des valves cardiaques

Country Status (1)

Country Link
WO (1) WO2019092031A1 (fr)

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3837345A (en) * 1973-08-31 1974-09-24 A Matar Venous valve snipper
US5234450A (en) * 1989-07-28 1993-08-10 Jacob Segalowitz Valvulotome catheter
US5304189A (en) * 1992-04-09 1994-04-19 Lafeber Company Venous valve cutter for in situ incision of venous valve leaflets
US5527327A (en) * 1992-06-08 1996-06-18 Intramed Laboratories, Inc. Valvulotome
US20120226269A1 (en) * 1996-10-22 2012-09-06 Cox James L Surgical System and Procedure for Treatment of Medically Refractory Atrial Fibrillation
US20140228843A1 (en) * 2009-04-06 2014-08-14 Michael J. O'Donnell System and method for resecting a valve
US20150088246A1 (en) * 2012-03-14 2015-03-26 Universite Catholique De Louvain Device for excision of heart valve
WO2017157884A1 (fr) * 2016-03-14 2017-09-21 Université Catholique de Louvain Dispositif d'excision propre d'une valvule cardiaque

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3837345A (en) * 1973-08-31 1974-09-24 A Matar Venous valve snipper
US5234450A (en) * 1989-07-28 1993-08-10 Jacob Segalowitz Valvulotome catheter
US5304189A (en) * 1992-04-09 1994-04-19 Lafeber Company Venous valve cutter for in situ incision of venous valve leaflets
US5527327A (en) * 1992-06-08 1996-06-18 Intramed Laboratories, Inc. Valvulotome
US20120226269A1 (en) * 1996-10-22 2012-09-06 Cox James L Surgical System and Procedure for Treatment of Medically Refractory Atrial Fibrillation
US20140228843A1 (en) * 2009-04-06 2014-08-14 Michael J. O'Donnell System and method for resecting a valve
US20150088246A1 (en) * 2012-03-14 2015-03-26 Universite Catholique De Louvain Device for excision of heart valve
WO2017157884A1 (fr) * 2016-03-14 2017-09-21 Université Catholique de Louvain Dispositif d'excision propre d'une valvule cardiaque

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