WO2018167059A1 - Orifice cardiaque transapical destiné à être inséré dans le coeur d'un sujet humain ou animal - Google Patents

Orifice cardiaque transapical destiné à être inséré dans le coeur d'un sujet humain ou animal Download PDF

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Publication number
WO2018167059A1
WO2018167059A1 PCT/EP2018/056238 EP2018056238W WO2018167059A1 WO 2018167059 A1 WO2018167059 A1 WO 2018167059A1 EP 2018056238 W EP2018056238 W EP 2018056238W WO 2018167059 A1 WO2018167059 A1 WO 2018167059A1
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WO
WIPO (PCT)
Prior art keywords
heart
port
housing
transapical
slab
Prior art date
Application number
PCT/EP2018/056238
Other languages
English (en)
Inventor
Peyman SARDARI NIA
Original Assignee
Academisch Ziekenhuis Maastricht
Universiteit Maastricht
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 Academisch Ziekenhuis Maastricht, Universiteit Maastricht filed Critical Academisch Ziekenhuis Maastricht
Publication of WO2018167059A1 publication Critical patent/WO2018167059A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A61B17/3423—Access ports, e.g. toroid shape introducers for instruments or hands
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34—Trocars; Puncturing needles
    • A61B17/3417—Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating
    • A61B17/3421—Cannulas
    • A61B17/3423—Access ports, e.g. toroid shape introducers for instruments or hands
    • A61B2017/3425—Access ports, e.g. toroid shape introducers for instruments or hands for internal organs, e.g. heart ports

Definitions

  • a transapical heart port for insertion into a heart of a human or an animal subject.
  • the invention relates to a medical implant device, in particular to a transapical heart port for insertion into a heart of a human or an animal subject.
  • transapical heart port inserted in said punctured hole.
  • Such transapical heart port provides a safe and unrestricted passageway for a cardiac surgeons to perform heart surgeries and to pass surgical instruments in and out to and from the treatment site in the heart.
  • transapical heart port is provided with a hemostatic valve, hemostasis is maintained during the passing of instruments in and out of the heart. Due to this, once implanted the transapical heart port can remain in place for a lengthened period of time reducing or limiting tissue trauma and burden to the patient.
  • a transapical heart port according to the preamble of claim 1 is disclosed in WO2009/100198.
  • the transapical heart port is inserted through the punctured hole in the apex part of the heart and inflatable balloons are activated at both the interior and the exterior side of the apex part of the heart. Once both interior and exterior balloons are inflated, they conform to the interior and the exterior tissue wall of the heart and as a result secure the transapical heart port to the heart.
  • the transapical heart port of WO2009/100198 requires additional passageways through the port housing for inflating and deflating the interior and exterior balloons. This makes the design more complex in terms of manufacturing and operation.
  • the inflatable balloons require the use of an inflating medium, such as a gas (carbon dioxide) or a liquid (saline) to be introduced in the body and more in particular into the heart.
  • an inflating medium such as a gas (carbon dioxide) or a liquid (saline) to be introduced in the body and more in particular into the heart.
  • a body incompatible medium might cause health risks due to a rupture of leaking of the inflated balloons.
  • the invention aims to provide a solution for the above identified problems, allowing a transapical heart port to be inserted through the punctured hole in the apex part of the heart, with a simplified yet reliable securing technique to the tissue of the heart.
  • a transapical heart port for insertion into a heart of a human or an animal subject comprising:
  • a port housing having a length dimension and a diameter dimension and comprising a first, proximal housing end and a second, distal housing end, wherein
  • said port housing defines a housing channel extending along said length dimension between said first, proximal housing end and said second, distal housing end, wherein
  • said port housing is configured to be inserted with said first, proximal housing end into a heart of a human or animal subject at the apex of said heart, whereas said second, distal housing end of said port housing is configured to remain outside said heart of a human or animal subject, wherein
  • said housing channel is configured to provide repeated access to the interior of said housing heart through said housing channel, and wherein
  • hemostatic valve attached to said housing and located within said channel, said hemostatic valve being configured to reduce blood loss from said heart through said channel, wherein
  • said second, distal housing end comprises a securing portion configured to secure said second, distal housing end to an exterior region of said heart, said securing portion being configured as a slab-like element of a flexible material extending away from said second, distal housing end, wherein said flexible slab-like element is arranged to be sutured to said exterior region of said heart.
  • the flexible slab-like element is pliable and conforms to the exterior tissue wall of the heart, and due to its flexibility the slab-like element and the transapical heart port conform to the movements due to the beating of the heart.
  • said slab-like element comprises multiple wing-shaped slab parts for securing to said exterior region of said heart.
  • the multiple wing-shaped slab parts serve as multiple points of attachment guaranteeing security and safety during the access of the interior of the heart through the transapical heart port when performing cardiac surgery.
  • the multiple points of attachment also prevent accidental movement of the transapical heart port.
  • the slab-like element slab parts comprises one or more a suturing openings provided along its outer periphery for accommodating a suturing thread.
  • said slab-like element is provided with a center opening for accommodating said second, distal housing end of said port housing.
  • Accommodating the port housing in the center of the slab-like element guarantees a proper, symmetric alignment of the transapical heart port relative to each point of attachment or securing of the securing portion sic the flexible slab-like element with the tissue wall of the exterior of the heart. As such this configuration allows flexion during the movement/beating of the heart of the transapical heart port.
  • said center opening has a diameter of approximately 10- 25 mm.
  • said slab-like element comprises a stocking-like extension attached to said center opening and said second, distal housing end of said port housing.
  • the stocking-like extension furthermore allows for a flexible bending or movement of the second, distal housing end extending outside the heart. In particular it will allow the second, distal housing end extending outside the heart to move freely for intracardial manipulation by any instrument brought into the ventricle through the transapical heart port.
  • said stocking-like extension exhibits an elongated dimension extending halfway said housing channel towards said second, distal housing end, thus creating a significant contact surface between the securing portion and the port housing.
  • said stocking-like extension and said slab-like element are made from the same flexible material, but in another example said stocking-like extension is made from a different material in particular a woven material.
  • the stocking- like extension is made from a different material which is more flexible than the material of the slab-like element, thus allowing a maximum freedom of movement of the second, distal housing end extending outside the heart to move freely for intracardial manipulation by any instrument brought into the ventricle through the transapical heart port.
  • Figure 1 a human heart provided with a transapical heart port
  • Figure 2 an example of a transapical heart port according to the invention
  • FIGS. 3a and 3b examples of a dilatation trocar element for implanting the transapical heart port according to the invention
  • FIGS. 4a and 4b another example of a transapical heart port according to the invention.
  • FIG. 5 a detail of the transapical heart port of Figures 4a and 4b;
  • FIG. 6 another example of a transapical heart port according to the invention.
  • proximal and distal are to be considered in relation to the location of the heart of the human subject in which the transapical heart port is to be inserted or implanted.
  • proximal is to be understood as meaning “closest to the heart” or “in a direction towards the heart” or “inside the heart”.
  • distal is to be understood as meaning “farthest from the heart” or “in a direction away from the heart” or “outside the heart”.
  • Figure 1 shows a front albeit schematic view of a human heart 100, and as such the left side of Figure 1 corresponds with the right side of the body of the human subject and vice versa.
  • the heart is a muscular organ in human and other animal subjects, responsible for pumping blood through the blood vessels of the circulatory system of said subject. Together with the blood pumped or circulated through the body of the human or animal subject oxygen and nutrients are provided to the several parts of the body, and the circulated blood also assists in the removal of metabolic wastes.
  • a transapical heart port is to be used with a human heart.
  • a human heart 100 is divided into four chambers, named the upper left atrium 103a and the upper right atrium 102a and the lower left ventricle 103b and the lower right ventricle 102b.
  • the upper right atrium 102a receives predominately deoxygenated blood from the body's two major veins, the inferior venae cava 104a and the superior venae cava 104b.
  • the upper right atrium 102a is connected to the lower right ventricle 102b via the tricuspid heart valve 108a and from the lower right ventricle 102b blood is pumped via the pulmonary heart valve 108b towards the lungs via the pulmonary arteries 105.
  • oxygenated blood is returned via the pulmonary veins 106 and enters the upper left atrium 103a. Via the mitral heart valve 108c said blood enters the lower left ventricle 103b, from which the oxygenated blood is pumped via the aortic heart valve 108d into the aorta 107 and the circulatory system of the human.
  • a surgeon can, for example, replace or repair a mitral valve 108c or the aortic valve 108d or can perform other surgical procedures.
  • the application of the instruments or transcatheter delivery systems within the heart is performed through a punctured hole 101 c being provided in the heart tissue wall 101 b in or near the apex part 101 a of the heart 100, which punctured hole 101 c is dilated.
  • transapical heart port inserted in said punctured hole 101 c.
  • Such transapical heart port provides a safe and unrestricted passageway for a cardiac surgeons to perform heart surgeries and to pass surgical instruments in and out to and from the treatment site in the heart 100.
  • FIG. 1 an example of a transapical heart port implanted at the apex 101 a of the heart 100 is denoted with reference numeral 10.
  • the transapical heart port 10 is positioned at the apex 101 a at the left heart side of the heart 100 allowing access to the lower left ventricle 103b and the mitral valve 108c and the aortic valve 108d.
  • the transapical heart port 10 could also be positioned at the right heart side of the heart 100 allowing access to the lower right ventricle 102b and the tricuspid valve 108a and the pulmonary valve 108b.
  • the transapical port 10 can be deployed in the human body and positioned through an exterior region 101 b at the apex 101 a of the heart by implementing known deployment techniques, which techniques are not discussed in this patent application.
  • the transapical heart port 10 comprises a port housing 1 1 .
  • Port housing 1 1 has a length dimension L and a diameter dimension D (see Figure 2) forming an open housing channel 1 1 c between a first, proximal housing end 1 1 a and a second, distal housing end 1 1 b.
  • the first, proximal housing end 1 1 a is inserted first through the punctured hole or opening 101 c at or near the apex 101 a into the heart 100.
  • the first, proximal housing end 1 1 a is located inside the heart 100 (in Figure 1 in the lower left ventricle 103b), whereas the second, distal housing end 1 1 b is located outside the heart 100 and inside the thorax of the human subject.
  • the housing bore or passageway or channel 1 1 c provides a safe, unrestricted but moreover a reusable passageway for access to the interior of the heart 104.
  • the transapical heart port 10 comprises a hemostatic valve 25 attached to the housing 1 1 and located within the housing channel 1 1 c.
  • the hemostatic valve 25 serves to reduce blood loss from the heart 100 through the housing channel 1 1 c into the thorax of the human subject.
  • Securing the transapical heart port to the tissue of the heart 100 is important in order to avoid reduce blood loss from the heart 100 into the thorax through the punctured hole 101 c and outside the port housing 1 1.
  • the present invention provided a transapical heart port with a simplified yet reliable securing technique to the tissue of the heart.
  • transapical heart port 10 comprises a port housing 1 1 having a length dimension L and a diameter dimension D.
  • the diameter D of the port housing 1 1 can be in the range of approximately 10-25 mm.
  • the overall length dimension L of the port housing 1 1 is approximately 50-75 mm, in particular approx. 60 mm.
  • the port housing 1 1 forms an open housing channel 1 1 c which extends between a first, proximal housing end 1 1 a and a second, distal housing end 1 1 b.
  • the first, proximal housing end 1 1 a is inserted first through the punctured hole or opening 101 c whereas the second, distal housing end 1 1 b remains outside the heart 100 and in the thorax of the human subject.
  • a hemostatic valve 25 is positioned configured to reduce blood loss from the interior of the heart 100 through the house channel 1 1 c into the thorax of the human subject.
  • Reference numeral 26 denotes a distal sealing valve, sealing the second, distal housing end 1 1 b from the thorax, once implanted.
  • the hemostatic valve 25 together with the distal sealing valve 26 also allows a safe, unrestricted and reusable passage way through the house channel 1 1 c towards the interior of the heart 100 whilst minimizing any blood loss whilst performing the heart chirurgical procedures.
  • a proper, long lasting securing of the transapical heart port 10 to the tissue wall 101 b of the heart 100 is essential for the proper functioning of the transapical heart port 10 as well for the health of the human patient.
  • the transapical heart port For securing the transapical heart port 10 to the heart tissue of the heart, the transapical heart port comprises a securing portion denoted with reference numeral 20 which securing portion 20 is attached to the port housing 1 1.
  • the securing portion 20 is manufactured from a flexible material configured as a slab-like element 21.
  • the flexible material of the securing portion 20 is preferably made from a flexible, easy sterilized silicone or /plastic material.
  • the slab-like element 21 being made from said flexible material will allow the port housing 1 1 of the transapical port 10 to move freely by either the movements induced by the beating of the heart 100 or due to the manipulation of any instrument inserted through the distal sealing valve 26 and the hemostatic valve 25 and the housing channel 1 1 c into the heart 100.
  • the flexible material of the slab-like element 21 is pliable and conforms to the exterior tissue wall 100 and 1 b of the heart 100 and as such it will conform to the movements due to the beating of the heart 100.
  • the slab-like element 21 comprises multiple, here four wing-shaped slab parts denoted with reference numerals 21 a-21 b-21 c-21 d. It is noted that in this example the slab-like element 21 comprises a rectangular or square configuration wherein each corner is formed by a wing-shaped slab part 21 a-21 d. However it is also noted that the slab-like element 21 can be configured as a triangle or even a pentagon configuration having three or five wing-like slab-parts respectively. Each wing-shaped slab part 21 a-21 d is configured to be secured to the exterior region 101 b of the tissue wall of the heart 100.
  • a suturing technic For securing the wing-shaped slab parts of the slab-like element 21 to the tissue 101 b of the heart 100 a suturing technic can be used.
  • a suturing thread is sutured to the exterior tissue wall 101 b and allows a simple yet safe and long-lasting attachment to the tissue wall by means of a purse-string suturing technique.
  • Normally two purse-string sutures are placed and the heart is punctured in the middle of these two purse-string sutures for insertion of the transapical heart port.
  • the purse-strings as placed are used to enclose the transapical heart port that is brought into the heart and once the transapical heart port is removed after the surgical procedures are being performed, the purse-string sutures are knot together in order to closed the punctured hole.
  • Each wing-shaped slab part 21 a-21 d of the slab-like element 21 is provided along its outer periphery or circumference 21f with a suturing opening 22a-22b-22c-22d as well as a suturing slit 23a-23b-23c-23d for providing an attachment or securing means for attaching the suturing thread with each wing-shaped slab part 21 a-21 d.
  • the suturing slits 23a-23d run from each suturing opening 22a-22d towards the outer periphery of the securing portion 20/slab-like element 21 and the relevant suturing thread can be guided through the suturing slits 23a-23d and the suturing openings 22a-22d for a proper attachment of the wing-shaped slab parts 21 a-21 b and as such the slab-like element 21 to the exterior tissue wall 101 b of the heart 100.
  • the wing- shaped slab parts 21 a-21 d abut against and extend along a significant amount of tissue surface of the heart 100 and provide a proper attachment with the heart.
  • each wing- shaped slab part 21 a-21 b abuts against the exterior tissue region 101 b of the heart 100 and extends away from said port housing 1 1 along the tissue surface of the heart 100 a secure, yet pliable attachment is obtained allowing flexion of the overall transapical heart port assembly 10 during movements and beating of the heart 100.
  • the securing portion 20/the slab-like element 21 is provided with a center opening 21 e for accommodating the port housing 1 1.
  • the second, distal housing end 1 1 b of the port housing 1 1 extends through the center opening 21 e over a length dimension L1 , which length dimension L1 is preferably equal to or less than half the overall length dimension L of the port housing 1 1 .
  • the overall length dimension L being approx. 50-75 mm and preferably 60 mm
  • the length dimension L1 of the second, distal housing end 1 1 b extending through the center opening 21 e amounts approximately 25-35 mm, more in particular 25-30 mm.
  • the inner diameter of the center opening 21 e is more or less conformal to the outer diameter D of the port housing 1 1 and amounts approximately 5-15 mm.
  • the thickness dimension d of the slab-like element 21 is approximately 5 mm, whereas the square shaped securing portion 20 as shown in Figure 2 has a length dimension of 15 mm till 45 mm.
  • the transapical port 10 comprises a stocking-like extension 24, an edge 24a of said stocking-like extension being attached to the circumference of the center opening 21 e. Furthermore the stocking-like extension 24 is also attached to the second, distal housing end of the port housing 1 1. It is noted that the stocking-like extension 24 exhibits an elongated dimension which extends approximately halfway the housing channel 1 1 towards the second, distal housing end 1 1 b.
  • the stocking-like extension 24 and the slab-like element 21 are preferably made from the same flexible material, which is pliable and allows flexion to conform to the exterior tissue wall of the heart but also to accommodate and conform to the movements of the heart during beating as well as due to the insertion of instruments through the housing channel 1 1 c to and from the interior of the heart 100.
  • the stocking-like extension is made from a different material compared to the material of which the slab-like element is manufactured.
  • the material of which the stocking-like extension is manufactured is a woven material which allows for a proper securing to the second, distal housing end 1 1 b but also allows flexion due to the any movements of the heart and/or due to the insertion of instruments though the housing channel 1 1 c.
  • Reference numeral 27 denotes a de-airing cannula which can also be positioned inside the housing channel 1 1 c.
  • the de-airing cannula 27 positioned proximal to the heart with reference with the hemostatic valve 25 allowing the degassing of the inner volume of the housing channel 1 1 c shortly after the implant of the transapical heart port 10 into the heart. This because prior to the implant or insertion of the transapical heart port 10 into the heart 100, the housing channel 1 1 c will contain a certain amount of false air, which has to be degassed prior to the use of the transapical heart port for surgical purposes.
  • a degassing tube (not shown) is to be connected to the de-airing cannula 27.
  • the small amount of false air contained inside the volume of the housing channel 1 1 c defined between the hemostatic valve 25 and the first, proximal housing end 1 1 a can be degassed via said degassing tube by opening the de-airing tap 27a.
  • Figures 3a and 3b disclose two examples of a dilatation trocar element 50 used for applying the punctured hole 101 c at or near the apex 101 a of the heart 100.
  • the dilatation trocar element 50 is provided with a hollow longitudinal design having a proximal end 50a and a distal end 50b.
  • the proximal end 50a is provided with a sharp proximal tip 51 in the example of Figure 3a whereas in the example of Figure 3b the proximal tip 51 is a blunt tip.
  • the hollow dilatation trocar element 50 is provided with a guidance implant wire 52 allowing a proper guidance of the dilatation trocar element 50 towards the heart and also for allowing the dilatation trocar element after puncturing the exterior tissue wall 101 b near the apex 101 a of the heart 100 to retraced the dilatation trocar element 50 out of the heart 100.
  • Both the sharp tip 51 as depicted in Figure 3a as well as the blunt tip 51 as shown in Figure 3b allow for a proper puncturing of the tissue wall 101 b in order to create a punctured hole 101 c near the apex 101 a of the heart.
  • the heart port and in particular the port housing 1 1 is manufactured as a one-part element, with of the securing portion 20/slab- like element 21 being attached to it.
  • FIGS. 4a and 4b as well as Figure 6 show other examples of the transapical heart port, now denoted with reference numeral 100.
  • the transapical heart port 100 comprises a port housing 1 1 , which is modular composed of at least a first port housing element 1 1 -1 and a second port housing element 1 1 -2.
  • the first port housing element 1 1 -1 exhibits the first or proximal end 1 1 a of the complete port housing, the first, proximal housing end 1 1 a again serving to be inserted first through the punctured hole or opening 101 c at or near the apex 101 a into the heart 100.
  • the first port housing element 1 1 -1 moreover exhibits a first port housing element distal end 1 1 -1 b, which can cooperate or mate with a second port housing element proximal end 1 1 -2a of a second port housing element 1 1 -2.
  • the cooperation or mating between both first and second port housing elements 1 1 -1 ; 1 1 -2 can be established by means of a click or snap connection or by means of a bayonet lock/coupling or by means of a screw thread connection.
  • first port housing element distal end 1 1 -1 b and the second port housing element proximal end 1 1 -2a being provided with cooperating inner screw thread 1 1 1 (provided at the inner surface of the hollow first port housing element distal end 1 1 -1 b) and outer screw thread 1 12 (provided at the outer surface of the hollow second port housing element proximal end 1 1 -2a).
  • inner screw thread 1 1 1 provided at the inner surface of the hollow first port housing element distal end 1 1 -1 b
  • outer screw thread 1 12 provided at the outer surface of the hollow second port housing element proximal end 1 1 -2a
  • Interchangeable port housing elements with different dimensions as to the port housing channel diameter 1 1 c or to the length dimension of for example the first port housing element 1 1 -1 allow to adapt the surgical procedures to be performed depending on the patient, etc.
  • the modular composed port housing 1 1 forms an open housing channel 1 1 c which extends between the first, proximal housing end 1 1 a of the first port housing element 1 1 -1 and the second, distal housing end 1 1 b of the second port housing element 1 1 -2.
  • the first, proximal housing end 1 1 a is inserted first through the punctured hole or opening 101 c whereas the second, distal housing end 1 1 b remains outside the heart 100 and in the thorax of the human subject.
  • a securing portion 200/the slab-like element 21 is provided with a center opening 21 e for accommodating the port housing 1 1.
  • the securing portion 200/the slab-like element 21 is depicted in more detail in Figure 5 and differs from the example depicted in Figure 2.
  • the securing portion 200/the slab-like element 21 has a circular slab configuration and is mounted (interconnected) with the second port housing element 1 1 -2.
  • the second port housing element 1 1 -2 is provided in its housing with a circumferential attachment slit or groove 29 in which groove the stocking-like extension 24 of the securing portion 200/the slab-like element 21 is to be accommodated by means of clamping or another attachment technique.
  • the second or distal housing end 1 1 b of the second port housing element 1 1 -2 extends through the center opening 21 e over a length dimension L1 , which length dimension L1 is preferably equal to or less than half the overall length dimension L of the modular composed port housing 1 1.
  • the length dimension L1 of the second, distal housing end 1 1 b extending through the center opening 21 e amounts approximately 25-35 mm, more in particular 25-30 mm.
  • the inner diameter of the center opening 21 e is more or less conformal to the outer diameter D of the port housing 1 1 and amounts approximately 5-15 mm.
  • the thickness dimension d of the circular slab-like element 200/21 is approximately 5 mm, whereas the circular shaped securing portion 21 as shown in Figure
  • 4-5 has a diameter dimension of 15 mm till 45 mm.
  • the transapical port 10 comprises an extension 24, an edge 24a of said extension 24 being attached to the circumference of the second port housing element 1 1 -2 and preferable said edge 24a is accommodated in the circumferential attachment slit or groove 29 thereof ( Figure 6).
  • the extension 24 and the slab-like element 21 are preferable made as a one-part element of a flexible material, which is pliable and allows flexion to conform to the exterior tissue wall of the heart but also to accommodate and conform to the movements of the heart during beating as well as due to the insertion of instruments through the housing channel 1 1 c to and from the interior of the heart 100.
  • the slab-like element 21 is provided around its outer periphery or circumference 21f (circular circumference) with several suturing openings 22 as well as suturing slits 23 for providing an attachment or securing means for attaching a suturing thread with the slab-like element 21 for a proper attachment of the circular slab-like element 21 to the exterior tissue wall 101 b of the heart 100 in a similar manner as with the example as shown in Figure 2.
  • suturing inserts 28 are accommodated in the suturing openings 22.
  • the suturing inserts 28 are preferably made for a more durable, less flexible material (or enforced material) as the material of the slab-like element 21 and as such the suturing insert 28 serve as an anchor attachment for the suturing thread further guaranteeing a more secure and long lasting attachment to the heart tissue.
  • reference numeral 27 denotes a de-airing cannula which can also be positioned inside the housing channel 1 1 c.
  • the de-airing cannula 27 positioned proximal to the heart with reference with the hemostatic valve 25 allowing the degassing of the inner volume of the housing channel 1 1 c shortly after the implant of the transapical heart port 10 into the heart.
  • the housing channel 1 1 c will contain a certain amount of false air, which has to be degassed prior to the use of the transapical heart port for surgical purposes.
  • Reference numeral 1 1 -3 is an (optional) third element of the modular composed port housing 1 1 of the transapical heart port 100 (second example). It functions as a clamp ring which fits to the distal end 1 1 b of the second port housing element 1 1 -2 and clamps the hemostatic valve 25 and the distal sealing valve 26 in the second port housing element 1 1 -2.
  • this example of the transapical heart port 100 cooperates with a dilatation trocar element 50, designed similarly as shown in Figure 2 and Figures 3a-3b.
  • the dilatation trocar element 50 is provided with an economically shaped hand grip 50c further improving the handling of the dilatation trocar element 50 for applying the punctured hole 101 c at or near the apex 101 a of the heart 100.

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

Abstract

L'invention concerne un orifice cardiaque transapical destiné à être inséré dans le coeur d'un sujet humain ou animal, ledit orifice cardiaque transapical comprenant : un boîtier d'orifice (11) ayant une dimension de longueur et une dimension de diamètre et comprenant une première extrémité de boîtier proximale et une seconde extrémité de boîtier distale, ledit boîtier d'orifice définissant un canal de boîtier s'étendant le long de ladite dimension de longueur entre ladite première extrémité de boîtier proximale et ladite seconde extrémité de boîtier distale, ledit boîtier d'orifice étant configuré pour être inséré avec ladite première extrémité de boîtier proximale dans le coeur d'un sujet humain ou animal au sommet dudit coeur, tandis que ladite seconde extrémité distale dudit boîtier d'orifice est configurée pour rester à l'extérieur dudit coeur d'un sujet humain ou animal, ledit canal de boîtier étant configuré pour fournir un accès répété à l'intérieur dudit coeur de boîtier à travers ledit canal de boîtier, et une valve hémostatique (25) fixée audit boîtier et située à l'intérieur dudit canal, ladite valve hémostatique étant configurée pour réduire la perte de sang dudit coeur à travers ledit canal, ladite seconde extrémité de boîtier distale comprenant une partie fixation (20) configurée pour fixer ladite seconde extrémité de boîtier distale à une région extérieure dudit coeur, ladite partie de fixation étant configurée sous la forme d'un élément en forme de plaque d'un matériau flexible s'étendant loin de ladite seconde extrémité de boîtier distale, ledit élément de type plaque flexible étant conçu pour être suturé à ladite région extérieure dudit coeur.
PCT/EP2018/056238 2017-03-13 2018-03-13 Orifice cardiaque transapical destiné à être inséré dans le coeur d'un sujet humain ou animal WO2018167059A1 (fr)

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WO2021136822A2 (fr) 2019-12-30 2021-07-08 Syntach Ag Dispositif d'accès à un cœur, unité valve hémostatique amovible, et système comprenant une unité d'assistance cardiaque
WO2023183894A1 (fr) * 2022-03-23 2023-09-28 ConneX BioMedical, Inc. Appareil et procédé d'accès transcardiaque et d'administration de dispositif

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US20050137609A1 (en) * 2003-12-17 2005-06-23 Gerald Guiraudon Universal cardiac introducer
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WO2021136822A2 (fr) 2019-12-30 2021-07-08 Syntach Ag Dispositif d'accès à un cœur, unité valve hémostatique amovible, et système comprenant une unité d'assistance cardiaque
WO2021136585A1 (fr) * 2019-12-30 2021-07-08 Syntach Ag Dispositif d'accès pour un cœur, unité de valve hémostatique amovible et système et procédé de création d'un passage transapical sur un cœur battant
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EP4008277A1 (fr) 2019-12-30 2022-06-08 Syntach AG Système comprenant une unité d'assistance cardiaque
EP4008276A1 (fr) 2019-12-30 2022-06-08 Syntach AG Unité de valve hémostatique amovible et système comprenant une unité d'assistance cardiaque
EP4008278A1 (fr) 2019-12-30 2022-06-08 Syntach AG Dispositif d'accès à un coeur
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WO2023183894A1 (fr) * 2022-03-23 2023-09-28 ConneX BioMedical, Inc. Appareil et procédé d'accès transcardiaque et d'administration de dispositif

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