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WO1998036792A1 - Systeme vanne a bille pour dispositif d'assistance cardiaque et procede de fabrication - Google Patents

Systeme vanne a bille pour dispositif d'assistance cardiaque et procede de fabrication Download PDF

Info

Publication number
WO1998036792A1
WO1998036792A1 PCT/AU1998/000103 AU9800103W WO9836792A1 WO 1998036792 A1 WO1998036792 A1 WO 1998036792A1 AU 9800103 W AU9800103 W AU 9800103W WO 9836792 A1 WO9836792 A1 WO 9836792A1
Authority
WO
WIPO (PCT)
Prior art keywords
valve
ball
ball valve
assist device
preform
Prior art date
Application number
PCT/AU1998/000103
Other languages
English (en)
Inventor
Geoff Tansley
John Woodard
John Begg
Original Assignee
Micromedical Industries Limited
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 Micromedical Industries Limited filed Critical Micromedical Industries Limited
Priority to AU59751/98A priority Critical patent/AU5975198A/en
Publication of WO1998036792A1 publication Critical patent/WO1998036792A1/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
    • A61F2/02—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
    • A61F2/2421—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 with non-pivoting rigid closure members
    • A61F2/2424—Ball valves
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/165—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart
    • A61M60/178—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable in, on, or around the heart drawing blood from a ventricle and returning the blood to the arterial system via a cannula external to the ventricle, e.g. left or right ventricular assist devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/40—Details relating to driving
    • A61M60/424—Details relating to driving for positive displacement blood pumps
    • A61M60/427—Details relating to driving for positive displacement blood pumps the force acting on the blood contacting member being hydraulic or pneumatic
    • A61M60/43—Details relating to driving for positive displacement blood pumps the force acting on the blood contacting member being hydraulic or pneumatic using vacuum at the blood pump, e.g. to accelerate filling
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/80—Constructional details other than related to driving
    • A61M60/855—Constructional details other than related to driving of implantable pumps or pumping devices
    • A61M60/89—Valves
    • A61M60/894—Passive valves, i.e. valves actuated by the blood
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/10—Location thereof with respect to the patient's body
    • A61M60/122—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body
    • A61M60/126—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel
    • A61M60/148—Implantable pumps or pumping devices, i.e. the blood being pumped inside the patient's body implantable via, into, inside, in line, branching on, or around a blood vessel in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M60/00—Blood pumps; Devices for mechanical circulatory actuation; Balloon pumps for circulatory assistance
    • A61M60/20—Type thereof
    • A61M60/247—Positive displacement blood pumps
    • A61M60/253—Positive displacement blood pumps including a displacement member directly acting on the blood
    • A61M60/268—Positive displacement blood pumps including a displacement member directly acting on the blood the displacement member being flexible, e.g. membranes, diaphragms or bladders

Definitions

  • the present invention relates to a ball valve system for a heart-assist device and a method of manufacture therefore and, more particularly, to such a system particularly suited for certain types of ventricular assist device .
  • the ventricular assist device is a particular type of heart-assist device which is utilised to provide a mechanically pumped bypass for at least a portion of the blood intended to flow through a ventricle (usually the left ventricle) .
  • the ventricular assist device is designed to provide a pulsatile flow in conformity with blood flow provided by a healthy human heart .
  • a common problem with all forms of ventricular assist device is the necessity to minimise deleterious effects upon the blood passed through the device. In this connection it is important to minimise the occurrence of thrombogenesis and of blood trauma.
  • ventricular assist device (a Chang-type device) is illustrated in Fig. 2 and comprises a diaphragm type pump for urging the blood in a pulsatile manner in combination with one way valves at the entry and exit. It is no less important in this type of ventricular assist device than any other that the abovementioned problems of thrombogenesis and blood trauma are minimised. It is an object of the present invention to provide a ventricular assist device, a valve system therefore and a method of manufacture thereof which seek to address or minimise the abovementioned problems.
  • a Chang-type device comprises a diaphragm type pump for urging the blood in a pulsatile manner in combination with one way valves at the entry and exit.
  • a ball valve for a heart assist device comprising a casing including guide means adapted to allow a ball occluder located therein to move between a valve closed position and a valve open position.
  • said guide means comprises a plurality of ribs extending inwardly so as to provide ball occluder supporting surfaces whereby said ball occluder is supported as it moves between said valve closed position on an inlet side of a centre line XX of said valve casing and a valve open position on an outlet side of said centre line XX of said valve casing.
  • Preferably three said ribs extend equicircumferentially from an inside surface of said valve casing.
  • an interior surface of said casing includes a spline profile portion adapted to smooth out the blood flow variations in an axial direction.
  • a ventricular assist device operating in combination with the ball valve of any previous claim.
  • said ventricular assist device is a Chang-type ventricular assist device.
  • said ventricular assist device is a bladder-type ventricular assist device.
  • a method of manufacture of a ball valve housing for a heart assist device said ball valve housing manufactured by a blow molding method and including a first step of providing a preform, heating said preform to a predetermined temperature in an even manner, applying pressure to the internal walls of said preform whereby said preform expands to conform against the walls of a die enclosing said preform.
  • Preferably said preform is heated evenly. In one preferred form even heating is achieved by rotation of said preformed during heating.
  • a pulsatile heart bypass pump comprising the combination of VAD and ball valve described above.
  • Fig. 1 is a side section view of a prior art ball valve
  • Fig. 2 illustrates a VAD and valve combination in accordance with a first embodiment of the invention
  • Fig. 3 illustrates views of the design of a ball valve suitable for use with the VAD and ball valve combination of Fig. 2
  • Fig. 4 illustrates apparatus suitable for the manufacture of a ball valve sleeve in accordance with an embodiment of the invention
  • Fig. 5 illustrates perspective views of a ball valve sleeve made according to the method of Fig. 4 whilst retaining the functional dimensions of the ball valve of Fig. 3, and Fig. 6 illustrates side views of an alternative VAD which can be combined with the ball valve according to a further embodiment of the invention.
  • Fig. 1 illustrates a prior art ball valve 10 arrangement suitable for use in a flow line 11A,11B.
  • This ball valve is described in biomaterials 16, 245-249 "Development of a Ceramic Conduit Valve Prosthesis for Corrective Cardiovascular Surgery" by C R Gentle and G D Tansley.
  • the application of such a valve to a VAD for example of the type generally illustrated in Fig. 2, is not a trivial matter.
  • the VAD can introduce swirling effects into the blood flow which, in turn, can cause instability in the ball occluder 12 rendering valve operation highly inefficient and, in the process, causing blood trauma.
  • Desirable features of a ball valve and VAD combination include : Positive opening and closing operation of the valve;
  • a VAD and ball valve combination 13 comprising a diaphragm pump 14 having a pump chamber 15 profiled in the style of the Chang device having a diaphragm 16 urged by an air chamber 17 supplied via air source 18.
  • a vacuum applied to diaphragm 16 blood is drawn through inlet valve 19 into pump chamber 15.
  • pressure applied to diaphragm 16 by air in air chamber 17 introduced via air source 18 blood is expelled through outlet valve 20 thereby bypassing to a predetermined extent the pumping operation of heart 21.
  • the VAD and ball valve combination 13 relies entirely on efficient one way valve operation of inlet valve 19 and outlet valve 20.
  • FIG. 3 A casing centre line XX is defined as shown in Fig. 3.
  • This "centre line” XX lies in a plane where, with the ball occluder 35 aligned so its centre line coincides with the centre line XX the cross sectional area available for blood flow around the occluder 35 in this position is equal to the cross sectional area available for blood flow at the inlet side 38 of the valve casing 22.
  • the centre line XX also coincides with an internal profile of the valve casing 22 which forms a cylindrical portion defined by second straight cross section 48.
  • a series of spline points are defined as nominated in Fig. 3 from which a spline profile portion 23 of the internal circumferential wall 24 is defined.
  • the balance of the wall is defined in a first straight cross section 25, second straight cross-section 48, a first radius cross section 26 and a second radius cross section 27.
  • first, second and third support ribs 28, 29 and 30 aligned in axial direction YY and placed equidistantly circumferentially within valve casing 22.
  • cross sections of the three ribs are identical with the cross section of rib 30 clearly defined in Fig. 3 and comprising a linear runner portion 31 followed by a rising ramp portion 32 and culminating in a raised seat portion 33 on the outlet side 34 of valve casing 22.
  • the purpose of the ribs 28, 29, 30 is to provide a guide surface comprising the top surfaces of the three inwardly facing ribs for the ball occluder 35 as it traverses in axial direction YY from its closed position 36 on inlet side 38 of valve casing 22 through to its open position 37 near outlet side 34 of valve casing 22 at which position further axial movement in the direction of outlet side 34 is prevented by the raised seat portions 33 of the ribs 28, 29, 30 acting on the surface of ball occluder 35 against the urging of blood flow (not shown) from inlet side 38 to outlet side 34.
  • the centre line SS of ball occluder 35 is offset from valve casing centre line XX in the direction of outlet side 34 by an offset distance OD.
  • the offset distance OD is approximately 2.5mm for a valve casing of the dimensions illustrated in Fig 3.
  • a method of manufacture of valve casing 22 is disclosed with reference to the apparatus shown.
  • the underlying method is a blow molding operation wherein a preform 41 is first heated to a working temperature and then expanded under the action of compressed air acting on the inside walls of the preform so that it expands to conform to the shape of a die which encloses the preform 41.
  • heating is provided by a ring heater 42 applied to the outside of the preform 41 while it is slowly rotated between mandrels 43 mounted on a lathe 4 .
  • Compressed air to blow the preform is provided through a slippering arrangement 45 which communicates via mandrel 43 with the interior of preform 41.
  • the die 46 is made in two halves 46A and 46B mounted in opposing relationship for closure about preform 41 prior to blowing of the preform by injection of compressed air from compressed air source 47.
  • the resulting ball valve 39 has smooth internal surfaces which conform to the dimensions and profiles provided with reference to Fig. 3 in a functional sense.
  • the blow molding process provides improved rounding and smoothness over what is illustrated in Fig. 3 whilst retaining the functionality inherent in the design features described with reference to Fig. 3.
  • the end result of the blow molding operation is a unitary valve casing 22 for the ball valve 39 having no internal abrupt edges as illustrated in Fig. 5.
  • the preform is a tube of dimension 19mm internal diameter with a 1.5mm wall thickness and a length of approximately 60mm.
  • Preferred materials are polyurethane or ABS or clear polycarbonate or clear acrylic. Dimensions may have to be adjusted depending on the material used and, of course, the dimensions of the valve casing 22.
  • the ball valve 39 is utilised as both an inlet valve 19 and an outlet valve 20 on a Chang-type VAD 40 as generally illustrated in Fig. 2 operating to pump blood in a pulsatile manner as described earlier in the specification.
  • Fig. 6 illustrates an alternative form of VAD 49 which provides pulsatile flow by alternate compression and decompression of a bladder 50 operating in conjunction with one way valves 51,52.
  • the ball valve of the present invention appropriately modified with respect to the dimension OD can be applied with advantage to this type of VAD.

Landscapes

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

Abstract

Vanne à bille pour un dispositif d'assistance ventriculaire, ladite vanne à bille comportant un boîtier (22). Ledit boîtier peut comporter des nervures (28-30) destinées à fournir une surface de guidage lorsque l'obturateur sous forme de bille se déplace entre une position fermée et une position ouverte de la vanne. Dans un mode de réalisation particulier, la ligne centrale de la bille d'obturation est décalée par rapport à la ligne centrale du boîtier de vanne lorsque cette dernière est en position ouverte.
PCT/AU1998/000103 1997-02-19 1998-02-19 Systeme vanne a bille pour dispositif d'assistance cardiaque et procede de fabrication WO1998036792A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU59751/98A AU5975198A (en) 1997-02-19 1998-02-19 Ball valve system for heart-assist device and method of manufacture

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
AUPO5224A AUPO522497A0 (en) 1997-02-19 1997-02-19 Ball valve system for heart-assist device and method of manufacture
AUPO5224 1997-02-19

Publications (1)

Publication Number Publication Date
WO1998036792A1 true WO1998036792A1 (fr) 1998-08-27

Family

ID=3799528

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/AU1998/000103 WO1998036792A1 (fr) 1997-02-19 1998-02-19 Systeme vanne a bille pour dispositif d'assistance cardiaque et procede de fabrication

Country Status (2)

Country Link
AU (1) AUPO522497A0 (fr)
WO (1) WO1998036792A1 (fr)

Cited By (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2371988A (en) * 2001-02-08 2002-08-14 Tayside Flow Technologies Ltd Valve
WO2004105828A3 (fr) * 2003-05-30 2005-01-06 Innovamedica S A De C V Dispositif d'assistance ventriculaire pneumatique universel
US7217236B2 (en) 2003-05-30 2007-05-15 Innovamedica S.A. De C.V. Universal pneumatic ventricular assist device
EP1503821A4 (fr) * 2002-02-21 2007-05-30 Design Mentor Inc Pompe pour liquides physiologiques
US8771164B2 (en) 2008-03-28 2014-07-08 Vitalmex Internacional S.A. De C.V. Fluid pumping ventricular assist device and components with static seal
US8852072B2 (en) 2008-02-08 2014-10-07 Heartware, Inc. Ventricular assist device for intraventricular placement
WO2022182331A1 (fr) * 2021-02-23 2022-09-01 Ventriflo, Inc. Ensemble pompe-soupape pour pompe à fluide pulsatile
US11547846B2 (en) 2021-02-23 2023-01-10 Ventriflo, Inc. Pump-valving assembly for a pulsatile fluid pump

Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3886948A (en) * 1972-08-14 1975-06-03 Hakim Co Ltd Ventricular shunt having a variable pressure valve
US4302854A (en) * 1980-06-04 1981-12-01 Runge Thomas M Electrically activated ferromagnetic/diamagnetic vascular shunt for left ventricular assist
WO1989010763A1 (fr) * 1988-05-03 1989-11-16 Nimbus Medical, Inc. Pompe a sang axisymetrique transvalvulaire a haute frequence
EP0449786A1 (fr) * 1990-03-20 1991-10-02 Ministero Dell' Universita' E Della Ricerca Scientifica E Tecnologica Dispositif d'assistance cardiaque
US5059176A (en) * 1989-12-21 1991-10-22 Winters R Edward Vascular system steerable guidewire with inflatable balloon
GB2255394A (en) * 1991-05-03 1992-11-04 Galram Technology Ind Ltd Heart valve
US5332403A (en) * 1992-08-17 1994-07-26 Jack Kolff LVAD with t-shape and unidirectional valve
US5397351A (en) * 1991-05-13 1995-03-14 Pavcnik; Dusan Prosthetic valve for percutaneous insertion
WO1997002850A1 (fr) * 1995-07-10 1997-01-30 Medicard Ltd. Systeme d'assistance cardiaque

Patent Citations (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3886948A (en) * 1972-08-14 1975-06-03 Hakim Co Ltd Ventricular shunt having a variable pressure valve
US4302854A (en) * 1980-06-04 1981-12-01 Runge Thomas M Electrically activated ferromagnetic/diamagnetic vascular shunt for left ventricular assist
WO1989010763A1 (fr) * 1988-05-03 1989-11-16 Nimbus Medical, Inc. Pompe a sang axisymetrique transvalvulaire a haute frequence
US5059176A (en) * 1989-12-21 1991-10-22 Winters R Edward Vascular system steerable guidewire with inflatable balloon
EP0449786A1 (fr) * 1990-03-20 1991-10-02 Ministero Dell' Universita' E Della Ricerca Scientifica E Tecnologica Dispositif d'assistance cardiaque
GB2255394A (en) * 1991-05-03 1992-11-04 Galram Technology Ind Ltd Heart valve
US5397351A (en) * 1991-05-13 1995-03-14 Pavcnik; Dusan Prosthetic valve for percutaneous insertion
US5332403A (en) * 1992-08-17 1994-07-26 Jack Kolff LVAD with t-shape and unidirectional valve
WO1997002850A1 (fr) * 1995-07-10 1997-01-30 Medicard Ltd. Systeme d'assistance cardiaque

Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US7112220B2 (en) 2001-02-08 2006-09-26 Tayside Flow Technologies Limited Valve
GB2371988B (en) * 2001-02-08 2002-12-24 Tayside Flow Technologies Ltd Valve
GB2371988A (en) * 2001-02-08 2002-08-14 Tayside Flow Technologies Ltd Valve
US7850593B2 (en) 2002-02-21 2010-12-14 Design Mentor, Inc. Fluid pump
EP1503821A4 (fr) * 2002-02-21 2007-05-30 Design Mentor Inc Pompe pour liquides physiologiques
US7217236B2 (en) 2003-05-30 2007-05-15 Innovamedica S.A. De C.V. Universal pneumatic ventricular assist device
WO2004105828A3 (fr) * 2003-05-30 2005-01-06 Innovamedica S A De C V Dispositif d'assistance ventriculaire pneumatique universel
US8852072B2 (en) 2008-02-08 2014-10-07 Heartware, Inc. Ventricular assist device for intraventricular placement
US9173984B2 (en) 2008-02-08 2015-11-03 Heartware, Inc. Ventricular assist device for intraventricular placement
US9579437B2 (en) 2008-02-08 2017-02-28 Medtronic HeartWare, Inc. Ventricular assist device for intraventricular placement
US9956333B2 (en) 2008-02-08 2018-05-01 Heartware, Inc. Ventricular assist device for intraventricular placement
US8771164B2 (en) 2008-03-28 2014-07-08 Vitalmex Internacional S.A. De C.V. Fluid pumping ventricular assist device and components with static seal
US8869395B2 (en) 2008-03-28 2014-10-28 Vitalmex Internacional S.A. De C.V. Fluid pumping device and components with static seal
WO2022182331A1 (fr) * 2021-02-23 2022-09-01 Ventriflo, Inc. Ensemble pompe-soupape pour pompe à fluide pulsatile
US11547846B2 (en) 2021-02-23 2023-01-10 Ventriflo, Inc. Pump-valving assembly for a pulsatile fluid pump

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