WO2018167059A1 - A transapical heart port for insertion into a heart of a human or an animal subject - Google Patents
A transapical heart port for insertion into a heart of a human or an animal subject Download PDFInfo
- 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
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- heart
- port
- housing
- transapical
- slab
- Prior art date
Links
- 210000002216 heart Anatomy 0.000 title claims abstract description 225
- 241001465754 Metazoa Species 0.000 title claims abstract description 14
- 238000003780 insertion Methods 0.000 title claims abstract description 13
- 230000037431 insertion Effects 0.000 title claims abstract description 13
- 239000000463 material Substances 0.000 claims abstract description 25
- 230000002439 hemostatic effect Effects 0.000 claims abstract description 18
- 239000008280 blood Substances 0.000 claims abstract description 15
- 210000004369 blood Anatomy 0.000 claims abstract description 15
- 230000013011 mating Effects 0.000 claims description 2
- 210000001519 tissue Anatomy 0.000 description 25
- 239000007943 implant Substances 0.000 description 9
- 238000000034 method Methods 0.000 description 9
- 210000003709 heart valve Anatomy 0.000 description 8
- 238000001356 surgical procedure Methods 0.000 description 8
- 238000010009 beating Methods 0.000 description 7
- 210000000038 chest Anatomy 0.000 description 7
- 238000007789 sealing Methods 0.000 description 7
- 230000000747 cardiac effect Effects 0.000 description 6
- 210000005003 heart tissue Anatomy 0.000 description 6
- 210000005240 left ventricle Anatomy 0.000 description 5
- 230000005923 long-lasting effect Effects 0.000 description 5
- 210000005241 right ventricle Anatomy 0.000 description 5
- 235000019994 cava Nutrition 0.000 description 4
- 238000007872 degassing Methods 0.000 description 4
- 210000005245 right atrium Anatomy 0.000 description 4
- 210000001765 aortic valve Anatomy 0.000 description 3
- 238000007675 cardiac surgery Methods 0.000 description 3
- 210000005246 left atrium Anatomy 0.000 description 3
- 210000004115 mitral valve Anatomy 0.000 description 3
- 210000001147 pulmonary artery Anatomy 0.000 description 3
- 210000003492 pulmonary vein Anatomy 0.000 description 3
- CURLTUGMZLYLDI-UHFFFAOYSA-N Carbon dioxide Chemical compound O=C=O CURLTUGMZLYLDI-UHFFFAOYSA-N 0.000 description 2
- 210000000709 aorta Anatomy 0.000 description 2
- 238000013459 approach Methods 0.000 description 2
- 210000004072 lung Anatomy 0.000 description 2
- 230000002685 pulmonary effect Effects 0.000 description 2
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 description 1
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 1
- 238000005452 bending Methods 0.000 description 1
- 210000004204 blood vessel Anatomy 0.000 description 1
- 229910002092 carbon dioxide Inorganic materials 0.000 description 1
- 239000001569 carbon dioxide Substances 0.000 description 1
- 230000008878 coupling Effects 0.000 description 1
- 238000010168 coupling process Methods 0.000 description 1
- 238000005859 coupling reaction Methods 0.000 description 1
- 239000007789 gas Substances 0.000 description 1
- 230000023597 hemostasis Effects 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 230000002045 lasting effect Effects 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 238000004519 manufacturing process Methods 0.000 description 1
- 230000002503 metabolic effect Effects 0.000 description 1
- 230000003387 muscular Effects 0.000 description 1
- 235000015097 nutrients Nutrition 0.000 description 1
- 210000000056 organ Anatomy 0.000 description 1
- 229910052760 oxygen Inorganic materials 0.000 description 1
- 239000001301 oxygen Substances 0.000 description 1
- 229920001296 polysiloxane Polymers 0.000 description 1
- 210000003102 pulmonary valve Anatomy 0.000 description 1
- 238000005086 pumping Methods 0.000 description 1
- 239000011780 sodium chloride Substances 0.000 description 1
- 230000008733 trauma Effects 0.000 description 1
- 210000000591 tricuspid valve Anatomy 0.000 description 1
- 210000003462 vein Anatomy 0.000 description 1
- 230000000007 visual effect Effects 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- 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
- 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
- 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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Abstract
Transapical heart port for insertion into a heart of a human or an animal subject, said transapical heart port comprising: a port housing (11) having a length dimension and a diameter dimension and comprising a first, proximal housing end and a housing 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 a hemostatic valve (25) 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 (20) 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.
Description
TITLE
A transapical heart port for insertion into a heart of a human or an animal subject. FIELD OF THE INVENTION
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. BACKGROUND OF THE INVENTION
Many cardiac surgical procedures require access to the interior of the heart. Transapical approaches to cardiac surgery can allow cardiac surgeons and interventional cardiologists to access the interior of the heart via the apex. Through such access, a surgeon can, for example, replace or repair a mitral or aortic valve or can perform other surgical procedures. The application of the instruments or transcatheter delivery systems within the heart is performed through the punctured hole in the apex part of the heart, which punctured hole is dilated.
Access to the interior of the heart through said dilated punctured hole is facilitated by using a 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.
More importantly, as the 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. Furthermore 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. The presence of a body incompatible medium might cause health risks due to a rupture of leaking of the inflated balloons.
DESCRIPTION OF THE INVENTION
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.
According to the invention, a transapical heart port for insertion into a heart of a human or an animal subject is proposed, said transapical heart port 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
a 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.
Herewith a simplified design of a transapical heart port is obtained, which design provides an accurate, long lasting and secure implant and attachment of the heart port in the apex part of the 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.
In an example of the transapical heart port according to the invention 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.
In particular a simple, yet safe and long lasting attachment technique of the transapical heart port is established, as each of said wing-shaped slab parts exhibits a first slab surface for abutment against said exterior region of said heart by means of suturing. This does not require complex positioning and attachment designs such as inflatable balloons.
In yet another example which allows for a simple suturing technique, the slab-like element slab parts comprises one or more a suturing openings provided along its outer periphery for accommodating a suturing thread..
According to a further example 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.
In an embodiment said center opening has a diameter of approximately 10- 25 mm.
For an improved, and secure connection between the port housing of the transapical heart port and the securing portion, 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.
In particular 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.
Preferably 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. In particular 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. BRIEF DESCRIPTION OF THE DRAWINGS
The invention will now be described in more detail with reference to the accompanying drawings, which drawings show in:
Figure 1 a human heart provided with a transapical heart port; Figure 2 an example of a transapical heart port according to the invention;
Figures 3a and 3b examples of a dilatation trocar element for implanting the transapical heart port according to the invention;
Figures 4a and 4b another example of a transapical heart port according to the invention;
Figure 5 a detail of the transapical heart port of Figures 4a and 4b;
Figure 6 another example of a transapical heart port according to the invention.
DETAILED DESCRIPTION OF THE INVENTION
For a better understanding of the invention like parts in the drawings are to be denoted with like reference numerals.
In the detailed description below as well as in the claims various parts are denoted with the classification "proximal" and "distal". These classifications 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. Hence the classification "proximal" is to be understood as meaning "closest to the heart" or "in a direction towards the heart" or "inside the heart". Similarly "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.
The subject of this patent application, 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.
From the lungs 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.
Many cardiac surgical procedures require access to the interior of the heart 100. Transapical approaches to cardiac surgery can allow cardiac surgeons to access the interior of the heart via the apex 101 a. Through such access, 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.
Access to the interior of the heart through said dilated punctured hole 101 c is facilitated by using a 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.
In Figure 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 hart side of the heart 100 allowing access to the lower left ventricle 103b and the mitral valve 108c and the aortic valve 108d. Similarly it is observed, that 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.
As shown in Figure 1 , but also in relation to Figure 2 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. As seen in Figure 1 , when inserted or positioned, 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.
Thus, after implant, 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. Although not shown in Figure 1 for visual purposes, 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.
An example of a transapical heart port in accordance with the invention is depicted in Figure 2. As outlined in relation to the Figure 1 in Figure 2 the 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. As already explained previously, once inserted or positioned inside the tissue wall 101 b of the heart 100, 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.
Inside the housing channel 1 1 c of the port housing 1 1 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.
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.
In this embodiment 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. 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. Hereto 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.
As the securing portion 20 is now properly secured to the heart tissue wall 101 b by means of the suturing threads a proper but further more lasting attachment of the transapical heart port 10 against the tissue wall of the heart 100 is obtained. 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. As 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. In particular 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 . With 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 (and in fact also extending through the punctured hole 101 c and out of the heart) 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.
For a proper attachment of the securing portion 20/slab-like element 21 to the port housing 1 1 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.
In another example the stocking-like extension is made from a different material compared to the material of which the slab-like element is manufactured. In particular 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. In particular 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.
In order to prevent said small amount of false air to be drawn into the
ventricle of the heart 100 - which is of course highly undesirable due to health concerns - due to the insertion of an instrument via the distal sealing valve 26 and the hemostatic valve 25, 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.
In both examples as shown in Figures 3a and 3b 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.
In the aforementioned embodiment 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.
Figures 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.
The latter connection is shown in Figure 6, with the 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). Here it is possible to interchange both port housing elements 1 1 1 and 1 1 -2, with port housing elements having a diameter of the open housing channel 1 1 c which differ from each other. 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. As already explained previously, once inserted or positioned inside the tissue wall 101 b of the heart 100, 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.
Analogue to the embodiment of Figure 2 also in this example of Figures 4a- 4b and 6 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. In this example 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.
As shown in Figure 6 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.
Similarly, 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. With 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 (and in fact also extending
through the punctured hole 101 c and out of the heart) 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.
For a proper attachment of the securing portion 20/slab-like element 21 to the port housing 1 1 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.
As depicted in Figure 5 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. In order to improve the attachment of the slab-like element 21 to the heart 100 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.
Also in the example of the transapical heart port 100 of Figures 4a-4b-6 reference numeral 27 denotes a de-airing cannula which can also be positioned inside the housing channel 1 1 c. In particular 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.
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.
Also 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. In figure 4a 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.
LIST OF REFERENCE NUMERALS
100 human (living) heart
101 a apex of the heart
101 b exterior region (heart tissue wall) of said heart
101 c puncture hole in heart tissue wall 101 b
102a upper right atrium
102b lower right ventricle
103a upper left atrium
103b lower left ventricle
104a inferior venae cava
104b superior venae cava
105 pulmonary artery or arteries
106 pulmonary vein or veins
107 aorta
108a tricuspid heart valve
108b pulmonary heart valve
108c mitral heart valve
108d aortic heart valve
10 transapical heart port
1 1 port housing
1 1 -1 first port housing element (second embodiment)
1 1 -1 b distal end of first port housing element (second embodiment)
1 1 -2 second port housing element (second embodiment)
1 1 -2a proximal end of second port housing element (second embodiment)
1 1 -3 closure ring (second embodiment)
L length dimension of port housing 1 1
D diameter dimension of port housing 1 1
1 1 a first or proximal housing end
1 1 b second or distal housing end
1 1 c housing channel of port housing 1 1
20 securing portion (first embodiment)
21 slab-like element of securing portion (first embodiment)
21 a-21 d wing-shaped slab part of said slab-like element (first embodiment)
21 e center opening of slab-like element (first and second embodiment)
21f outer periphery of slab-like element (first and second embodiment)
22a-22d; 22 suturing opening (first and second embodiment)
23a-23d; 23 suturing slit (first and second embodiment)
200 securing portion (second embodiment)
d thickness of slab-like element (first and second embodiment)
24 stocking-like extension of slab-like element (first and second embodiment)
25 hemostatic valve
26 distal sealing valve
27 de-airing cannula
27a de-airing tap
28 suturing insert (second embodiment)
29 attachment slit for securing portion (second embodiment)
50 dilatation trocar element
50a proximal end of dilatation trocar element
50b distal end of dilatation trocar element
50c hand grip of dilatation trocar element
51 proximal tip of dilatation trocar element
52 guidance implant wire
X length dimension of dilatation trocar element
Y diameter dimension of dilatation trocar element
Claims
1 . A transapical heart port for insertion into a heart of a human or an animal subject, said transapical heart port 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 heart through said housing channel, and wherein
a 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.
2. A transapical heart port according to claim 1 , wherein said slab-like element comprises multiple wing-shaped slab parts for suturing to said exterior region of said heart.
3. A transapical heart port according to claim 2, wherein each of said wing- shaped slab parts exhibits a first slab surface for abutment against said exterior region of said heart by means of suturing.
4. A transapical heart port according to any one or more of the claims 1 -3, wherein the slab-like element comprises one or more suturing openings provided along its outer periphery for accommodating a suturing thread.
5. A transapical heart port according to any one or more of the preceding claims, wherein said slab-like element is provided with a center opening for accommodating said second, distal housing end of said port housing.
6. A transapical heart port according to claim 5, wherein said center opening has a diameter of approximately 10-25 mm.
7. A transapical heart port according to claim 5 or 6, wherein said slab-like element comprises a stocking-like extension attached to said center opening and said second, distal housing end of said port housing.
8. A transapical heart port according to claim 7, wherein said stocking-like extension exhibits an elongated dimension extending halfway said housing channel towards said second, distal housing end.
9. A transapical heart port according to claim 7 or 8, wherein said stocking- like extension and said slab-like element are made from the same flexible material.
10. A transapical heart port according to claim 7 or 8, wherein said stockinglike extension is made from a different material in particular a woven material.
1 1 . A transapical heart port according to any one or more of the preceding claims, further comprising a de-airing cannula connected at the second, distal housing end of the housing port.
12. A transapical heart port according to any one or more of the preceding claims, wherein the heart port is modular composed with the port housing being composed of a first port housing element and a second port housing element.
13. A transapical heart port according to claim 12, wherein the first port housing element and the second port housing element are provided with an interconnecting or mating screw thread.
14. A transapical heart port according to claim 12 or 13, wherein a port housing element is provided with a circumferential attachment slit for accommodating said stocking-like extension of the slab-like element.
15. A transapical heart port according to any one or more of the preceding claims, wherein each suturing opening is provided with a suturing insert.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
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EP17160597.5 | 2017-03-13 | ||
EP17160597 | 2017-03-13 |
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WO2018167059A1 true WO2018167059A1 (en) | 2018-09-20 |
Family
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Application Number | Title | Priority Date | Filing Date |
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PCT/EP2018/056238 WO2018167059A1 (en) | 2017-03-13 | 2018-03-13 | A transapical heart port for insertion into a heart of a human or an animal subject |
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WO (1) | WO2018167059A1 (en) |
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