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WO2009113964A2 - Dispositif amélioré et procédé d’implantation d’une prothèse - Google Patents

Dispositif amélioré et procédé d’implantation d’une prothèse Download PDF

Info

Publication number
WO2009113964A2
WO2009113964A2 PCT/SG2009/000083 SG2009000083W WO2009113964A2 WO 2009113964 A2 WO2009113964 A2 WO 2009113964A2 SG 2009000083 W SG2009000083 W SG 2009000083W WO 2009113964 A2 WO2009113964 A2 WO 2009113964A2
Authority
WO
WIPO (PCT)
Prior art keywords
members
heart valve
connectors
prosthesis assembly
assembly according
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/SG2009/000083
Other languages
English (en)
Other versions
WO2009113964A3 (fr
Inventor
Theodoros Kofidis
Uwe Klima
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Individual
Original Assignee
Individual
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 Individual filed Critical Individual
Publication of WO2009113964A2 publication Critical patent/WO2009113964A2/fr
Publication of WO2009113964A3 publication Critical patent/WO2009113964A3/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
    • A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
    • A61F2/2409—Support rings therefor, e.g. for connecting valves to tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/006—Additional features; Implant or prostheses properties not otherwise provided for modular

Definitions

  • the invention relates to implantation devices for repairing and/or replacing damaged tissue and particularly, damaged heart valves.
  • Treatment of advanced, symptomatic valve disease includes valve repair and/or replacement using prosthetic valves, which include but are not limited to biological and mechanical valves.
  • Valvular heart disease involves the failure or deterioration of a heart valve.
  • the predisposing causes may be congenital or acquired with the latter including result of disease or other external factors, with the result being a stenotic or regurgitant valve, or a combination of both.
  • surgery may be required to either repair the valve or replace it with a prosthetic valve such as a biologic or mechanical valve.
  • mitral valve replacement When a mitral valve is destroyed by disease, a so-called mitral valve replacement has to be carried out in most cases.
  • This procedure involves cutting out the destroyed natural valve and the placement of approximately 10 to 14 stitches into the surrounding tissue. Thereby, important structures, such as the hearts conduction system or coronary vessels may be injured.
  • the insertion of the sutures involves reinforcement with felts made by prosthetic material.
  • the mentioned procedure usually lasts 3-4 hours. However, in many cases replacement may not be warranted as the damage may be repairable. Nevertheless, the means of repair such as suturing of tissue are time
  • the invention provides a heart valve prosthesis assembly comprising a first member; a second member, and; connectors for coupling the first and second members so as to clamp tissue associated with a native valve ring associated with a damaged native heart valve such that said tissue is intermediate said first and second members.
  • the invention provides a method for implanting a heart valve prosthesis assembly comprising the steps of: positioning a first member on an upstream portion of a native valve ring associated with a damaged native heart valve; positioning a second member on a downstream portion of the native valve ring; coupling the first and second members using connectors, and so; clamping tissue associated with the native valve ring such that said tissue is intermediate said first and second members. Accordingly, an assembly according to the present invention can be implanted far more rapidly than alternatives such as suturing a valve to the native valve ring, or performing repairs through suturing.
  • clamping refers to the two members encompassing at least a portion of the tissue and applying a positive pressure to it so as to achieve a reliable engagement.
  • the degree of clamping pressure may vary based on factors including, but not limited to, degree of deterioration, required application and the materials of the members and/or connectors used.
  • the connectors may penetrate the tissue, and so enhancing the engagement of the assembly through bearing of the connectors against the tissue, and not merely the clamping pressure.
  • the connectors may be external to the tissue and so engagement relies on clamping pressure. This may be particularly useful where the remaining native valve ring is too small to support the required bearing force that a penetrative connector may apply.
  • connectors may be screw threaded for screw threaded engagement with one or both of said members. This may permit a more rapid implantation through using an electrical device to activate the screws, much like an electric screw driver. Further, a screw threaded arrangement may also permit a controllable means of adjusting the relative position of the members, and consequently control the clamping pressure applied to the tissue, both in terms of degree of pressure, but also uniformity around the periphery of the members.
  • the connectors may be pins arranged to engage one or both members through penetrating said one or both members and then being plastically deformable. This may facilitate a quick penetration of the tissue and so add to the speed with which the assembly may be placed.
  • the connectors may be sharp pointed members having a screw thread, and so retain benefits of controlled clamping pressure with easy penetration of the tissue.
  • the connectors may include rods arranged for press fit engagement with one or both of said members.
  • the rods may also have a sharp point to facilitate penetration.
  • the assembly may also include a valve fitting mounted to one or both of said members for replacement of the native heart valve. Further, the valve fitting may be selectively releasable from said one or both members. Accordingly, on deterioration of the valve fitting over time, it may easily be replaced, and so shorten subsequent procedures in the future.
  • the means of releasable engagement may include any one of: cooperating screw threads, a bayonet fixture, a press fit or a friction grip, each of which have advantage depending on factors such as, but not limited to speed of attachment, reliability of fixture and preference of the surgeon.
  • At least one of said members may comprise a plurality of discreet portions, each portion coupled to the opposed member through said connectors.
  • the upstream member may be a series of discrete portions, which each act as anchor to anchor the second member.
  • the members may comprise at least two parts, said parts being in sliding engagement such that the size of each member is selectively adjustable through said sliding engagement prior to coupling to the opposed member.
  • the sliding engagement may be selectively adjustable, such as incorporating a screw thread arrangement.
  • the members may be included a uni-directional arrangement such that the parts can be slid towards each other, but preventing from moving away. This may provide the advantage of controlling the size and shape of the mitral valve, or the void mentioned previously.
  • valve fitting, valve support and coupling means will be materials compatible with implantation devices and surgery. These will include, but are not limited to, surgical steel, Teflon, stainless steel, cobalt-chromium alloys, titanium and alloys thereof, tantalum, polyethylene and polypropylene, nitinol.
  • Figure 1 is a sectional view of a heart
  • Figure 2 is a schematic view of the prosthesis according to one embodiment of the present invention
  • Figure 3 is an isometric view of a valve repair assembly according to one embodiment of the present invention
  • Figure 4 is an isometric view of a valve replacement assembly according to one embodiment of the present invention
  • Figure 5 is a sectional elevation view of the valve repair assembly of Figure 3
  • Figure 6 is a sectional elevation view of the valve replacement assembly of Figure 4
  • Figure 7 is a plan view of an adjustable member according to one embodiment of the present invention, and;
  • Figure 8 is a sectional elevation view of an adjustable assembly according to one embodiment of the present invention.
  • the invention provides for an assembly arranged to facilitate repair or replacement of a mitral valve.
  • the assembly facilitates the placement of the assembly, and so shortens the time required for the surgical procedure.
  • the assembly may comprise relatively stiff materials to aid in the structural integrity of the prosthesis assembly.
  • the assembly according to this embodiment may be more suited to open heart surgery.
  • the assembly may comprise more flexible materials such that the key components of the assembly may be contracted whilst being maneuvered to the correct position before expanding out to their proper functional size ready for implantation.
  • the assembly according to the present invention comprises two members for positioning on either side of the native valve ring with connectors coupling the two members so as to clamp or group the native valve ring and so secure the prosthesis in place.
  • Figures 1 and 2 identify the location and schematic arrangement of the components comprising the invention. Accordingly Figure 1 shows a cut-away view of the heart 1 identifying the location of the mitral valve 2.
  • the prosthesis according to the present invention may be adapted for use with the tricuspid valve also.
  • FIG. 2 shows a schematic view of one embodiment of the present invention.
  • the prosthesis 5 incorporates two members 15, 16 placed on either side of the native valve ring 25.
  • the two members 15, 16 are coupled through connectors 20 which in this embodiment penetrate the native valve ring 25 in order to achieve said coupling.
  • a valve fitting 10 is further mounted to the members 15, 16. It follows that this embodiment is arranged to fulfill the replacement function of the present invention. It will be appreciated that the invention also includes application to the repair of the mitral valve rather than replacement which will be described in more detail below.
  • Figures 3 and 5 are directed to an assembly according to one embodiment of the present invention related to repair.
  • the assembly 30 includes a first member 35 and a second member 40 having connectors 45 coupling the two members.
  • the members are arranged such that the first member 35 is located on an upstream side of the mitral valve 2 with the second member 40 located on the downstream side.
  • the members clamp the native valve ring 25 and apply a compressive force through tightening of the fasteners 45.
  • the fasteners are pins mounted to the first ring 35 and arranged to penetrate holes 50 in the second ring 40 such that coupling occurs on the subsequent deformation of the rings, having passed through the holes 50.
  • An important advantage of the present invention is providing a more rapid means of repairing, or replacing, the mitral valve and in so doing, this embodiment achieves the result by placing the first member 35 and penetrating the native valve ring 25 with the connectors 45.
  • the pins are sharp enough to penetrate the tissue and project from the upper surface of the native valve ring 25.
  • the second member 40 fits over the pins 45 through the holes 50 which are subsequently deformed so as to couple the two members 35, 40.
  • the second member 40 presses into the native valve ring 25 and further draws the first ring toward it through its engagement with the connectors 45. Accordingly the native valve ring 25 is compressed between the two members 35, 40 to create a positive engagement with the valve tissue.
  • a further advantage of this positive engagement may lead to a strengthening of the native valve ring 25 minimizing or preventing prolapsing of the valve. Further this may increase the surface contact 3 between the bicuspid leaves of the mitral valve and so preventing leakage through the valve. Further still, should damage to the chordae such as rupture or stretching of said tendrils, then reinforcing the native valve ring 25 may minimize the effects of a lack of support by the chordae to the valve.
  • said first member so as to position the first member 35 around the chordae, said first member may be in two or more parts which can be assembled around the chordae and so in circle and reinforce the valve. On assembly, the connectors which as mentioned in this case are pins, can then penetrate the native valve ring and so continue the repair procedure.
  • the second mentioned application is replacement of the mitral valve where damage to the valve or surrounding tissue is such that repair is not practical.
  • the assembly of the first member 60 and second member 65 and subsequent connection may further include a valve fitting 75 mounted to the assembly.
  • valve fittings are known in the art but are mounted directly to the native valve ring 25 through sutures, leading to an extended surgical procedure.
  • the valve fitting 75 may be pre-mounted to the second member 65 and so, on coupling the first and second members 60, 65, the valve 75 is consequently also placed.
  • the advantage of placing the valve within a short period of time is similar to that of repair in terms of placement of the prosthesis.
  • the replacement prosthesis assembly 55 comprises, in this embodiment, a first member 60 coupled to a second member 65 through connectors 70.
  • the connectors in this case are pins for penetrating the native valve ring 25 and so clamping the native valve ring between the first and second members 60, 65.
  • Mounted to the second member 65 is a valve fitting 75 which in this case, for replacement of the mitral valve, is a bileaflet mechanical valve.
  • the valve fitting 75 may be releasably engaged with the second member 65 rather than integrally connected. A releasable engagement of the valve fitting 75 permits subsequent replacement of the valve to be a simple matter of disengaging the valve fitting 75 from the second member 65 and reengaging a new valve fitting.
  • Such releasable engagement may include a screw thread or a press fit arrangement.
  • the releasable engagement may be a combination of these such as a bayonet fitting whereby the valve fitting is rotated into engagement with the second member 65 until it reaches a resilient press fit arrangement and so click into place.
  • the invention may include an arrangement to clamp the native valve ring. Not only can this have a beneficial effect on repairing a deteriorated mitral valve or supporting the native valve ring for a case where the mitral valve has been replaced but such adjustability may also permit adaptation of the assembly 90 where the mitral valve is not of a standard shape.
  • Figures 7 and 8 show embodiments where the first and second members may permit adjustability within each member as shown in Figure 7 and also adjustability relative to the first and second member as shown in Figure 8. It should be noted that the invention include separate embodiments, one having adjustability as shown in Figure 7, and another embodiment having adjustability as shown in Figure 8. In a still further embodiment, both the adjustability of Figure 7 and Figure 8 may be included.
  • each member 90 comprises a two part construction 95, 100 whereby the two parts are in sliding engagement with each other, with the first part 95 having a projection 115 arranged to fit within a corresponding recess 120 in the second part 100.
  • the length of the projection 1 15 may be such that the two parts can slide freely relative to each other and so accommodate a range of sizes.
  • the means of moving the two parts 95, 100 may vary such as having a wretched effect whereby moving the two parts together 105, 110 is unidirectional, i.e. an arrangement where once engaged, can only move towards each other but not retracted. This effect may be achieved through profiling of the projections 115 and recess 120 or other such means as will be clear to the skilled person.
  • the two parts 95, 100 may be positioned and then fixed relative to each other by engagement of the connectors penetrating the native valve ring. In the case of the connectors being integral with a first member 90, once the connectors have penetrated the native valve ring, no further movement will be possible and so fixing the relative position of the two parts.
  • the two parts may engage the native valve ring through penetrating the connectors into the tissue. Then by pushing the two parts together, may contract the opening to a more desired size.
  • the void left by the removal of the mitral valve may be adjusted through first engaging the two parts 95, 100 and then moving said parts relative to each other so as to control the size and shape of this void.
  • Figure 8 shows a further embodiment whereby once the members 125, 130 are engaged through a connector 135, the relative position of the members 125, 130 may be adjusted through adjusting the connectors.
  • the connectors 135 are screw threaded and so are in screw thread engagement with the members 125, 130.
  • the two members 125, 130 will be drawn together 145, 150 and so controlling the clamping force applied to the native valve ring.
  • this clamping force may have beneficial effects in repairing the mitral valve or reinforcing the remaining native valve ring following removal of the mitral valve.
  • the material of the members forming the prosthesis may be plastically deformable so as to mold to the shape of the native valve ring and/or mitral valve for further engagement with said tissue.

Landscapes

  • Health & Medical Sciences (AREA)
  • Cardiology (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Transplantation (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

La présente invention concerne un ensemble prothèse de valve cardiaque comprenant les éléments suivants : un premier élément; un second élément; et des connecteurs destinés à raccorder le premier élément et le second élément pour fixer un tissu associé à un anneau de valve native lié à une valve cardiaque native endommagée, de telle sorte que ledit tissu se trouve entre ledit premier élément et ledit second élément.
PCT/SG2009/000083 2008-03-12 2009-03-09 Dispositif amélioré et procédé d’implantation d’une prothèse Ceased WO2009113964A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
SG200802052-1A SG155783A1 (en) 2008-03-12 2008-03-12 An improved device and method for implantation of a prosthesis
SG200802052-1 2008-03-12

Publications (2)

Publication Number Publication Date
WO2009113964A2 true WO2009113964A2 (fr) 2009-09-17
WO2009113964A3 WO2009113964A3 (fr) 2009-11-05

Family

ID=41065694

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/SG2009/000083 Ceased WO2009113964A2 (fr) 2008-03-12 2009-03-09 Dispositif amélioré et procédé d’implantation d’une prothèse

Country Status (2)

Country Link
SG (1) SG155783A1 (fr)
WO (1) WO2009113964A2 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2012158968A3 (fr) * 2011-05-18 2013-04-11 Thoratec Corporation Protecteur d'aiguille, ensemble et méthode d'implantation d'un système d'assistance cardiaque
WO2012174383A3 (fr) * 2011-06-15 2013-04-25 Edwards Lifesciences Corporation Dispositifs et procédés d'ancrage de prothèse de valvule cardiaque
JP2013539395A (ja) * 2010-09-01 2013-10-24 ムバルブ・テクノロジーズ・リミテツド 心臓弁支持構造体
US9682180B2 (en) 2009-11-15 2017-06-20 Thoratec Corporation Attachment system, device and method

Family Cites Families (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5593435A (en) * 1994-07-29 1997-01-14 Baxter International Inc. Distensible annuloplasty ring for surgical remodelling of an atrioventricular valve and nonsurgical method for post-implantation distension thereof to accommodate patient growth
US6059827A (en) * 1998-05-04 2000-05-09 Axya Medical, Inc. Sutureless cardiac valve prosthesis, and devices and methods for implanting them
US6419696B1 (en) * 2000-07-06 2002-07-16 Paul A. Spence Annuloplasty devices and related heart valve repair methods
US7335213B1 (en) * 2002-11-15 2008-02-26 Abbott Cardiovascular Systems Inc. Apparatus and methods for heart valve repair
JP4740963B2 (ja) * 2005-02-28 2011-08-03 メドテンティア インターナショナル リミテッド オイ 心臓弁の機能改善装置

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US9682180B2 (en) 2009-11-15 2017-06-20 Thoratec Corporation Attachment system, device and method
JP2013539395A (ja) * 2010-09-01 2013-10-24 ムバルブ・テクノロジーズ・リミテツド 心臓弁支持構造体
WO2012158968A3 (fr) * 2011-05-18 2013-04-11 Thoratec Corporation Protecteur d'aiguille, ensemble et méthode d'implantation d'un système d'assistance cardiaque
US8827887B2 (en) 2011-05-18 2014-09-09 Thoratec Corporation Assembly and method of implanting a heart assist system
US9555177B2 (en) 2011-05-18 2017-01-31 Thoratec Corporation Needle guard, assembly and method of implanting a heart assist system
WO2012174383A3 (fr) * 2011-06-15 2013-04-25 Edwards Lifesciences Corporation Dispositifs et procédés d'ancrage de prothèse de valvule cardiaque
US8840664B2 (en) 2011-06-15 2014-09-23 Edwards Lifesciences Corporation Heart valve prosthesis anchoring device and methods

Also Published As

Publication number Publication date
WO2009113964A3 (fr) 2009-11-05
SG155783A1 (en) 2009-10-29

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