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WO2002030326A2 - Implant transmyocardique stabilise - Google Patents

Implant transmyocardique stabilise Download PDF

Info

Publication number
WO2002030326A2
WO2002030326A2 PCT/US2001/031729 US0131729W WO0230326A2 WO 2002030326 A2 WO2002030326 A2 WO 2002030326A2 US 0131729 W US0131729 W US 0131729W WO 0230326 A2 WO0230326 A2 WO 0230326A2
Authority
WO
WIPO (PCT)
Prior art keywords
conduit
vessel
implant according
implant
myocardium
Prior art date
Application number
PCT/US2001/031729
Other languages
English (en)
Other versions
WO2002030326A3 (fr
WO2002030326A8 (fr
Inventor
Guy P. Vanney
Robert A. Eno
Dale M. Groth
Original Assignee
Heartstent Corporation
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 Heartstent Corporation filed Critical Heartstent Corporation
Priority to AU2001296796A priority Critical patent/AU2001296796A1/en
Publication of WO2002030326A2 publication Critical patent/WO2002030326A2/fr
Publication of WO2002030326A3 publication Critical patent/WO2002030326A3/fr
Publication of WO2002030326A8 publication Critical patent/WO2002030326A8/fr

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
    • A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/94—Stents retaining their form, i.e. not being deformable, after placement in the predetermined place
    • 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
    • A61F2/2493—Transmyocardial revascularisation [TMR] devices
    • 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
    • A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2220/0008—Fixation appliances for connecting prostheses to the body

Definitions

  • This invention pertains to an implant for directing blood flow directly between a chamber of the heart and a coronary vasculature. More particularly, this invention pertains to such an implant with an enhanced design for securing placement of the implant.
  • the conduit is rigid and remains open for blood flow to pass through the conduit during both systole and diastole.
  • the conduit penetrates into the left ventricle in order to prevent tissue growth and occlusions over an opening of the conduit.
  • the fabric is described as a polyester cuff having interstitial spaces into which tissue may grow.
  • Implants such as those shown in the aforementioned patents include a portion to be placed within a coronary vessel and a portion to be placed within the myocardium.
  • the artery is incised by an amount sufficient to insert the implant.
  • the artery is ligated distal to an obstruction.
  • a transverse incision is made through the artery distal to the ligation. Tools and procedures for such an implantation are shown and described in commonly assigned and copending U.S.
  • the present invention is directed to an implant which resists forces tending to draw the implant into the heart chamber.
  • a transmyocardial implant for establishing a blood flow path through a myocardium wall between a heart chamber and a lumen of a coronary vessel residing at an exterior of said wall.
  • the implant includes a hollow conduit having a vessel portion and a myocardial portion.
  • the vessel portion is sized to be received within the lumen.
  • the myocardial portion is sized to extend from the vessel through the myocardium and into the chamber.
  • the conduit has an open first end and an open second end on respective ones of the vessel and myocardial portions to define a blood flow pathway within an interior of the conduit between the first and second end.
  • At least the myocardial portion of the conduit is formed of a conduit material sufficiently rigid to resist deformation and closure of the pathway in response to contraction of the myocardium.
  • An anchor is secured to the conduit and positioned to overlie and be secured to an epicardial surface of the myocardium when the vessel portion of the conduit is secured within the lumen.
  • FIG. 1 is a side elevation, schematic view of an implant without cuff in a heart wall and illustrating tilting following implant;
  • Fig. 2 is a side elevation view of an implant with an epicardial cuff
  • Fig. 3 is a top plan view of an implant of Fig. 2 with a first embodiment of an anchor
  • Fig. 4 is a side elevation view of the implant and anchor of Fig. 3;
  • Fig. 5 is a distal end elevation view of the implant and anchor of Fig. 3;
  • Fig. 6 is a top plan view of an implant of Fig. 2 with a second embodiment of an anchor;
  • Fig. 7 is a side elevation view of the implant and anchor of Fig. 6;
  • Fig. 8 is a distal end elevation view of the implant and anchor of Fig. 6;
  • Fig. 9 is a top plan view of an implant of Fig. 2 with a third embodiment of an anchor;
  • Fig. 10 is a side elevation view of the implant and anchor of Fig. 9;
  • Fig. 11 is a distal end elevation view of the implant and anchor of Fig. 9;
  • Fig. 12 is a side elevation, cross-sectional view of an implant of Fig. 2 with a fourth embodiment of an anchor.
  • the implant includes a conduit in the form of an L-shaped tube.
  • a conduit 10 is shown in Fig. 1.
  • the material of the conduit 10 is preferably a rigid material in order to withstand contraction forces of the myocardium.
  • the tube will have an outside diameter of about 2.5 millimeters and an internal diameter of about 1.5 millimeters to provide a wall thickness of about .5 millimeters.
  • the conduit 10 has a vessel portion 12 sized to be received within the lumen of a coronary vessel such as the lumen of a coronary artery (not shown in Fig. 1 but shown in U.S. Pat. No. 5,984,956) at an upper or epicardial surface 105.
  • the conduit 10 has a myocardial portion 14 extending at a right angle to the axis of vessel portion 12.
  • the myocardial portion 14 is sized to extend from the coronary artery directly through the myocardium 104 and protrude into the left ventricle 106 of a patient's heart.
  • the tube 10 is preferably formed of titanium or other smooth biocompatible material in order to resist tissue growth on the surfaces of the conduit 10. Titanium is a presently preferred material due its long-term use in the cardiovascular industry. Further, titanium is sufficiently rigid to withstand deformation forces caused by contraction of the myocardium 104 to avoid deformation of the tube 10 so that the tube 10 remains open during both diastole and systole. Since the titanium is resistant to thrombus formation, the titanium of the tube
  • a completed implant can include a tissue growth- inducing material secured to an exterior surface of the conduit 10. Not shown in Fig. 1 but illustrated in U.S. Pat. No. 5,984,956 as a polyester fabric cuff, the tissue- growth-inducing material has interstitial spaces into which tissue of the myocardium may grow.
  • Fig. 1 illustrates undesirable movement of the implant 10 after surgical placement.
  • the mechanics of the healing process and forces exerted on the device such as myocardial contraction urge the implant 10 into the myocardium 104 toward the left ventricle 106.
  • the implant 10 responds with the myocardial portion 14 rotating distally (as shown in phantom lines in Fig. 1).
  • the embodiments to be described all include a short cuff 52 preferably residing only in the upper one-half to one-third thickness of the myocardium near the epicardial surface.
  • Fig. 2 illustrates such a cuff 52.
  • the cuff 52 has a length that is no greater than half a length of the myocardial portion 14.
  • the cuff 52 has an axial length of 4 mm (compared with a 15 mm length for cuffs sized to extend the full thickness of the myocardium).
  • Such a shortened cuff for residence in the myocardium near the epicardial surface is conveniently referred to as an "epicardial cuff.
  • the remainder of the myocardial portion 14 not covered by the cuff 52 is highly polished to resist tissue attachment.
  • Figs. 3 - 5 illustrate an embodiment where the implant 10 includes a cape 60 for resisting downward movement of the proximal side of the implant 10 and distributing the forces of such resistance over large area.
  • all use modifications of an implant such as that shown in Fig. 2 with an epicardial cuff 52. Accordingly, elements of such implant 10 and cuff 52 in common with such embodiments are numbered identically throughout.
  • a polyester fabric cape 60 is attached to the implant 10 at the cuff 52 (e.g. by stitching the cape 60 to the cuff 52) and fans out in a plane perpendicular to the myocardial portion 14 and extending in the proximal direction of the implant 10 (i.e., in a direction opposite the distally extending vessel portion 12).
  • the collar 60 overlays a ring segment 62.
  • the ring segment is PTFE or other rigid material (which may be covered with a polyester fabric).
  • the outer perimeter of the cape 60 is sutured to the epicardial surface of the heart wall.
  • the implant 10 is subjected to forces urging the implant 10 into the myocardium, the cape 60 resists such a motion.
  • the load of such resistance is distributed in an arch by the ring segment 62.
  • the embodiment of Figs. 6 - 8 replaces the solid cape 60 with a restraint 60' defined by a plurality of straps 61.
  • the straps 61 extend outwardly proximally from the implant and perpendicular to the proximal-distal axis of the implant 10.
  • the straps 61 are polyester fabric and are. sutured to the epicardial surface.
  • the straps 61 are more resistant to bunching than the cape 60 of Figs. 3 - 5.
  • the straps 61 are stitched to the collar 52 and overlie a ring 62' similar to ring 62 of the previous embodiment.
  • the straps radiate outwardly and to the side.
  • the stabilizing clip 70 includes an arcuate, thin body 72 in the form of a flat plate bent to conform with the arcuate bend of the implant from the myocardial portion top the vessel portion.
  • a snap clip 74 fastens the body 72 to the implant by being press fit onto the implant 10.
  • Two support arms 76 are attached to the body 72.
  • the support arms 76 are positioned to be spaced apart on opposite sides of the vessel portion 12 and extend generally parallel to an upper edge of the vessel portion.
  • the support arms 76 extend beyond the vessel portion 12.
  • Suture pads 78 of polyester fabric are provided on the free ends of the support arms 76.
  • the arms 76 are symmetrical.
  • the arms can be asymmetrical with one longer than the other to span and clear any nearby vessels.
  • Fig. 12 illustrates a still further embodiment for immobilizing the implant 10.
  • a rigid support 80 is attached to the implant 10 and extends proximally.
  • the support 80 is shaped to approximate the shape of the vessel portion 12.
  • a suture 82 received in a groove 84 of a flexible mounting sleeve 86 anchors the support 80 to the implant 10.
  • a polyester sleeve 88 surrounds the support 80.
  • a suture (not shown) will surround the sleeve 88 to attach the support to the epicardial surface of the heart. As the implant 10 is urged to tilt, the support 80 abuts the heart and resists such tilting.

Landscapes

  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Cardiology (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

L'invention concerne un implant transmyocardique destiné à créer une voie d'écoulement sanguin à travers le myocarde, entre une cavité cardiaque et une lumière d'un vaisseau coronaire situé à un emplacement extérieur à ladite paroi. L'implant transmyocardique comprend un conduit creux comportant une partie de vaisseau et une partie de myocarde. La partie de vaisseau est dimensionnée pour loger à l'intérieur de la lumière. La partie de myocarde est dimensionnée pour traverser le myocarde depuis le vaisseau et pénétrer à l'intérieur de la cavité. Le conduit présente une première extrémité ouverte et une seconde extrémité ouverte disposées sur des extrémités respectives de la partie de vaisseau et de la partie de myocarde pour délimiter une voie d'écoulement du sang à l'intérieur du conduit, entre la première extrémité et la seconde extrémité. Au moins la partie de myocarde du conduit est formée d'un matériau de conduit suffisamment rigide pour résister à la déformation et à la fermeture de la voie lorsque le myocarde se contracte. Le matériau du conduit est résistant à la formation de thrombus. Un stabilisateur est fixé au conduit et placé de manière à chevaucher une surface épicardique du myocarde et s'y arrimer lorsque la partie de vaisseau du conduit est fixé solidement à l'intérieur de la lumière.
PCT/US2001/031729 2000-10-11 2001-10-10 Implant transmyocardique stabilise WO2002030326A2 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU2001296796A AU2001296796A1 (en) 2000-10-11 2001-10-10 Transmyocardial implant with anchor element

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US30416500P 2000-10-11 2000-10-11
US68625100A 2000-10-11 2000-10-11
US09/686,251 2000-10-11
US60/304,165 2000-10-11

Publications (3)

Publication Number Publication Date
WO2002030326A2 true WO2002030326A2 (fr) 2002-04-18
WO2002030326A3 WO2002030326A3 (fr) 2002-09-06
WO2002030326A8 WO2002030326A8 (fr) 2003-11-13

Family

ID=26973847

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2001/031729 WO2002030326A2 (fr) 2000-10-11 2001-10-10 Implant transmyocardique stabilise

Country Status (2)

Country Link
AU (1) AU2001296796A1 (fr)
WO (1) WO2002030326A2 (fr)

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6854467B2 (en) 2000-05-04 2005-02-15 Percardia, Inc. Methods and devices for delivering a ventricular stent
US6949118B2 (en) 2002-01-16 2005-09-27 Percardia, Inc. Encased implant and methods
US6976990B2 (en) 2001-01-25 2005-12-20 Percardia, Inc. Intravascular ventriculocoronary bypass via a septal passageway
US7008397B2 (en) 2002-02-13 2006-03-07 Percardia, Inc. Cardiac implant and methods
US7033372B1 (en) 1999-08-04 2006-04-25 Percardia, Inc. Corkscrew reinforced left ventricle to coronary artery channel
US7101402B2 (en) 1998-09-10 2006-09-05 Percardia, Inc. Designs for left ventricular conduit
US7326219B2 (en) 2002-09-09 2008-02-05 Wilk Patent Development Device for placing transmyocardial implant

Citations (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5287861A (en) 1992-10-30 1994-02-22 Wilk Peter J Coronary artery by-pass method and associated catheter
US5409019A (en) 1992-10-30 1995-04-25 Wilk; Peter J. Coronary artery by-pass method
US5429144A (en) 1992-10-30 1995-07-04 Wilk; Peter J. Coronary artery by-pass method
WO1998008456A1 (fr) 1996-08-26 1998-03-05 Transvascular, Inc. Procedes et dispositifs de revascularisation transmyocardique coronarienne directe
US5755682A (en) 1996-08-13 1998-05-26 Heartstent Corporation Method and apparatus for performing coronary artery bypass surgery
US5984956A (en) 1997-10-06 1999-11-16 Heartstent Corporation Transmyocardial implant
US6029672A (en) 1998-04-20 2000-02-29 Heartstent Corporation Transmyocardial implant procedure and tools

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
FR1514319A (fr) * 1967-01-11 1968-02-23 Dispositif pour l'implantation dans la région apicale du coeur d'un ventricule artificiel
US5655548A (en) * 1996-09-16 1997-08-12 Circulation, Inc. Method for treatment of ischemic heart disease by providing transvenous myocardial perfusion
CA2320956A1 (fr) * 1998-02-13 1999-08-19 Ventrica, Inc. Procedes et dispositifs assurant un flux sanguin transmyocardiaque au systeme vasculaire arteriel cardiaque
US20010041902A1 (en) * 1998-02-13 2001-11-15 Michael J. Lynch Anastomotic methods and devices for placing a target vessel in fluid communication with a source of blood
WO2000021463A1 (fr) * 1998-10-13 2000-04-20 Ventrica, Inc. Dispositifs et methodes utilises pour effectuer un pontage coronarien transmyocardique
AU777443B2 (en) * 1999-08-04 2004-10-14 Percardia, Inc. Methods and apparatus for direct coronary revascularization

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5287861A (en) 1992-10-30 1994-02-22 Wilk Peter J Coronary artery by-pass method and associated catheter
US5409019A (en) 1992-10-30 1995-04-25 Wilk; Peter J. Coronary artery by-pass method
US5429144A (en) 1992-10-30 1995-07-04 Wilk; Peter J. Coronary artery by-pass method
US5755682A (en) 1996-08-13 1998-05-26 Heartstent Corporation Method and apparatus for performing coronary artery bypass surgery
US5944019A (en) 1996-08-13 1999-08-31 Heartstent Corporation Closed chest coronary bypass
WO1998008456A1 (fr) 1996-08-26 1998-03-05 Transvascular, Inc. Procedes et dispositifs de revascularisation transmyocardique coronarienne directe
US5984956A (en) 1997-10-06 1999-11-16 Heartstent Corporation Transmyocardial implant
US6029672A (en) 1998-04-20 2000-02-29 Heartstent Corporation Transmyocardial implant procedure and tools

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7101402B2 (en) 1998-09-10 2006-09-05 Percardia, Inc. Designs for left ventricular conduit
US7033372B1 (en) 1999-08-04 2006-04-25 Percardia, Inc. Corkscrew reinforced left ventricle to coronary artery channel
US6854467B2 (en) 2000-05-04 2005-02-15 Percardia, Inc. Methods and devices for delivering a ventricular stent
US6976990B2 (en) 2001-01-25 2005-12-20 Percardia, Inc. Intravascular ventriculocoronary bypass via a septal passageway
US6949118B2 (en) 2002-01-16 2005-09-27 Percardia, Inc. Encased implant and methods
US7008397B2 (en) 2002-02-13 2006-03-07 Percardia, Inc. Cardiac implant and methods
US7326219B2 (en) 2002-09-09 2008-02-05 Wilk Patent Development Device for placing transmyocardial implant

Also Published As

Publication number Publication date
WO2002030326A3 (fr) 2002-09-06
AU2001296796A1 (en) 2002-04-22
WO2002030326A8 (fr) 2003-11-13

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