WO1998012993A1 - Holder for heart valve prosthesis - Google Patents
Holder for heart valve prosthesis Download PDFInfo
- Publication number
- WO1998012993A1 WO1998012993A1 PCT/US1997/017199 US9717199W WO9812993A1 WO 1998012993 A1 WO1998012993 A1 WO 1998012993A1 US 9717199 W US9717199 W US 9717199W WO 9812993 A1 WO9812993 A1 WO 9812993A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- holder
- stem
- holder body
- implantation
- prosthesis
- Prior art date
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
- A61F2/2427—Devices for manipulating or deploying heart valves during implantation
Definitions
- heart valve replacement surgery is an involved procedure in which a sternotomy is performed and the chest cavity of the patient must be widely opened to provide access to the patient's heart. This provides a surgeon with direct, unobstructed access to the heart.
- the prosthesis is typically held at the end of an elongated handle which is aligned with the axis of the prosthesis.
- this procedure requires a prolonged patient recovery period to recover from the trauma suffered to the upper torso .
- Minimally invasive procedures have been developed wherein open heart surgery is performed through small incisions which eliminate the need for a traditional sternotomy.
- One such procedure is described in International Publication No. WO 94/18881, entitled METHOD FOR PERFORMING THORASCOPIC CARDIAC BYPASS PROCEDURES and WO 95/15715, entitled DEVICES AND METHODS FOR INTRACARDIAC PROCEDURES.
- elongated tools and/or trocars may be used to operate on the heart.
- this procedure can be used during heart valve replacement .
- minimally invasive implantation requires minimal rib spreading and implantation through a small opening.
- a holder for engaging a heart valve prosthesis during implantation includes a holder body and a stem.
- the stem is adapted to receive a handle used to manipulate the prosthesis during implantation.
- the stem is moveable between a standard implantation position and a low profile delivery position.
- One aspect of the invention includes a stem which articulates about a pivot which couples the stem to the holder body.
- Other aspects of the invention include a locking mechanism to maintain a position of the stem relative to the holder body.
- Figure 1 is an exploded perspective view of a positionable holder in accordance with one embodiment of the invention.
- Figures 2A and 2B are side views and bottom plan views, respectively, of a holder body shown in Figure 1.
- Figures 3A and 3B show perspective views of one embodiment of a holder body and a stem, respectively.
- Figures 4A and 4B show perspective views of one embodiment of a holder body and a stem, respectively.
- Figure 5A is a top perspective view of a positionable holder in accordance with another embodiment shown in a standard implantation position.
- Figure 5B is a top perspective view of the positionable holder of Figure 5A shown in a low profile delivery position.
- Figures 6A, 6B and 6C are top perspective, side plan and top plan views, respectively, of a positionable holder in accordance with another embodiment .
- Figure 7 is a top plan view of a positionable holder in accordance with another embodiment .
- Figure 8 is a side plan view of a locking mechanism for use with a positionable holder.
- Figure 9 is a side cross-sectional view of a locking mechanism in accordance with another embodiment.
- Figure 10 is a side cross-sectional view of a locking mechanism in accordance with another embodiment of the invention.
- Figure 11 is a perspective view of a positionable holder in accordance with another embodiment .
- Figure 12 is a top perspective view of a positionable holder in accordance with another embodiment .
- the present invention relates to a device which is used to position a heart valve prosthesis during implantation.
- the implantation may be through minimally invasive surgery, such as when performed through an incision smaller than that which is required for a traditional sternotomy, or using a more traditional implantation technique in which the axis of the valve is generally parallel with the axis of the handle to which it is attached during valve delivery.
- the device will be described generally with regard to its use with a bi -leaflet mechanical heart valve which has an annulus with a substantially annular aperture.
- Such a heart valve prosthesis is available from St. Jude Medical, Inc. of St. Paul, Minnesota.
- FIG. 1 is an exploded perspective view of a positionable holder 10 in accordance with one embodiment of the present invention. It will be understood that the holder of the present invention may be adapted for use with any type of prosthesis including mechanical and bioprosthetic valves, and repair devices, including annuloplasty rings, and such adaptation is considered to be within the scope of the present invention.
- Positionable holder 10 includes holder body 12, holder stem 14 and pivot pin 16.
- Holder body 12 includes a heart valve prosthesis engaging (distal) side 18 which provides occluder conforming surfaces 20, rim 22 and pivot guard receptacles 23.
- Distal side 18 is adapted to generally conform to a mitral heart valve prosthesis, although distal side 18 may be adapted for use with an aortic valve.
- occluders of the prosthesis are held in a substantially closed position such that they are protected within a body of the prosthesis during delivery and implantation.
- Holder body 12 includes open portion 24 formed in proximal face 28. Suture openings 30 and pin receptacle 31 are formed through holder body 12.
- Positioning detents 32 are formed in side walls 34 formed by open portion 24.
- Holder stem 14 includes distal end 40 adapted for coupling to holder body 12 and proximal end 42 adapted for coupling to a handle (not shown in Figure 1) .
- Distal end 40 includes pin receptacle 44 and positioning protrusion 46.
- Proximal end 42 includes finger grips 50, handle opening 52 and slot 54. Finger grips 50 may be grasped by fingers of a surgeon and used to manipulate the prosthesis and apply torque to the prosthesis during the implantation procedure.
- stem 14 and pivot pin 16 are assembled such that pin receptacles 31 and 44 are aligned and stem 14 is secured to holder body 12 with pivot pin 16 through receptacles 31 and 44.
- stem 14 articulates relative to holder body 12 about pivot pin 16.
- Positioning protrusion 46 is shaped to generally conform to positioning detents 32 such that stem 14 is locked in position relative to holder body 12 in one of positioning detents 32.
- positioning detents 32 provide five different locking positions. However, any number of detents at any desired position may be employed.
- Positionable holder 10 is typically shipped with stem 14 at a 90° angle relative to the plane that includes the annulus formed by holder body 12, i.e., parallel to the axis of the prosthesis.
- standard implantation position refers generally to the position used to implant a prosthetic heart valve through traditional implantation techniques such as a sternotomy.
- Stem 14 can be articulated about pivot pin 16 such that it is aligned substantially parallel with the plane that includes the annulus of holder body 12 and generally perpendicular to the axis of the prosthesis.
- low profile delivery position refers generally to the position which is useful in minimally invasive implantation techniques in which the heart valve prosthesis is delivered through a small opening and implanted in the patient.
- an elongated handle is adcp ed to be received in handle opening 52 of stem 14. Pins carried on the handle are received in slot 54 such that torque may be transmitted from the handle to the stem to thereby rotate the heart valve.
- the invention may be used with any type of handle having any appropriate coupling mechanism for coupling to stem 14.
- the holder body 12 can be pivoted using an appropriate elongated surgical instrument such that it is moved into the appropriate implantation position and properly presented to the natural tissue annulus of the patient's heart.
- FIGs 2A and Figure 2B are side and bottom plan views, respectively, of holder body 12.
- Suture openings 30 extend through body 12 to suture slot 60 shown in Figure 2B.
- a suture may be threaded through openings 30 so that the sutures are positioned to apply a small amount of pressure to occluders of the prosthesis to maintain the occluders in a closed position.
- such sutures may be used to couple the prosthesis (not shown) to the holder body by stitching the sutures through a suture cuff of the prosthesis. After the prosthesis has been secured to the tissue annulus of the patient's heart, the sutures are cut such that the positionable holder 10 may be withdrawn from the chest cavity.
- FIGS 3A and 3B show perspective views of another embodiment of a holder body 12 and stem 14, respectively, in accordance with the invention. Generally, where possible, similar numbers have been used to identify similar elements in this description.
- Holder body 12 of the embodiment of Figure 3A includes slot 70 and pivot 72.
- Holder 14 of Figure 3B includes snap flc pin 75 adapted to be received in pivot 72.
- Detent 32 maintains stem 14 in either the standard implantation or low profile delivery position by engagement with positioning protrusion 46.
- Stop 74 (see Figure 1) of holder body 12 prevents rotation of stem 14 past the low profile implantation location.
- Figure 4A is a perspective view of holder body 12 and Figure 4B is a perspective view of stem 14 in accordance with another embodiment.
- side wall 34 includes octagonal pivot recess 76 which is adapted to receive star shaped protrusion 78 of stem 14 shown in the perspective view of Figure 4B.
- the stem may be positioned generally at angles of 0°, 45°, 90°, 135° and 180° relative to holder body 12 and the hexagonal shape of recess 76 provides a locking mechanism in these positions .
- Figure 5A is a top perspective view of another embodiment of positionable holder 10.
- stem 14 includes a recess 100 which receives opposing protrusions 102 which act as locking mechanisms.
- C-ring 101 spreads protrusions 102 and snap into recesses 100.
- C-ring 101 is secured at region 99.
- the remainder of ring 101 is free to bend and flex.
- the hinging/pivot mechanism can be any appropriate method.
- the relative shapes of recess 100 and protrusions 102 provide a locking mechanism to secure holder 10 in the standard implantation position as shown in Figure 5A.
- Figure 5B is a top perspective view of positionable holder 10 in accordance with the embodiment of Figure 5A showing stem 14 in the low profile position. In this position, stem 14 fits into open portion 24. Recess portion 106 of stem 14 abuts stop 74 of holder body 12. Protrusions 102 may be modified to act as a locking mechanism to secure stem 14 in a low profile position.
- Figures 6A, 6B and 6C show top perspective, side plan and top plan views, respectively, of a positionable holder 10 in accordance with another embodiment shown in three different positions.
- elongated spring members 120 are received in slots 122 on holder body 12.
- Elongated spring members 120 are coupled to stem 14 near proximal end 42.
- stem 14 is secured in the standard implantation position.
- spring members 120 are pushed inward, toward stem 14, to thereby disengage slots 122, as shown in Figure 6B.
- Figure 6B also shows stem 14 articulated at an angle somewhere between the standard implantation position and the low profile implantation position.
- Figure 6C shows positionable holder 10 with stem 14 in the low profile implantation position. Note that by adding additional slots 122, stem 14 may be selectively locked in multiple positions relative to holder body 12.
- Figure 7 is a top plan view of positionable holder 10 in accordance with another embodiment.
- stem 14 includes elongated members 150 which carry extensions 152. Extensions 152 fit into recesses 154 formed in holder body 12. Holder body 12 is secured to stem 14 between extensions 152 which may pivot in recesses 154.
- FIG 8 is a side plan view showing one example of a locking mechanism in accordance with the present invention for use with positionable holder 10.
- stem 14 is spring loaded by torsional spring member 160 about a pivot formed at pivot pin 16.
- a suture 162 is secured to stem 14 at suture attachment 164 and to holder body 12 at suture attachment 166.
- stem 14 is shown in the low profile implantation position. When suture 162 is cut, spring 160 urges stem 14 into the upright, standard implantation position.
- FIG. 9 is a cross-sectional view of another embodiment of a pivoting and locking mechanism for positionable holder 10 in accordance with the invention.
- a socket wall 170 extends around distal portion 40 of stem 14.
- This embodiment could encompass a captive ball and socket design that allows infinite articulation of stem 14 along multiple axes. Further, it will be understood that, although a ball and socket allows two degrees of freedom, it also constitutes one type of pivot. If discreet positioning is desired, this can be accomplished using a plurality of recesses or indentations 172 formed around a circumference of ball 173 of distal portion 40 of stem 14 and are shaped to receive nub 174.
- Nub 174 and indentations 172 secure stem 14 at a number of angular positions between the standard implantation position shown in Figure 9 and the low profile implantation position shown in phantom in Figure 9. A slight elastic deformation of nub 174 allows movement between adjacent indentations 172. Further, the position of indentations 172 and nub 174 could easily be reversed.
- Figure 10 is a side cross-sectional view of a locking mechanism which could be used in combination with the pivoting mechanism in Figure 9 or any other embodiment herein for use with positionable holder 10.
- distal portion 40 of stem 14 includes a ball 173 which is received in a socket 182 formed in holder body 12.
- a nub 184 carried in recess 186 is received in an indentation 172 and urged in a direction toward ball 173 by spring 188, thereby locking stem 14 in a selected position relative to holder 12.
- a pin 190 is positioned to actuate nub 184 when button 192 is pressed to thereby disengage nub 184 from indentation 172 formed in ball 173. Depressions or recesses may be used as alternatives to the nubs or indentations shown herein.
- Figure 11 is a perspective view of holder 10 in accordance with another embodiment.
- stem 14 is offset from the axis of holder 10 and is carried between extensions 220.
- extensions 220 can be movably attached to both body 12 and stem 14 and locked in place by any of the locking mechanisms described herein. Note that this particular embodiment provides a very low profile when in the low profile delivery position.
- FIG 12 is a top perspective view of holder 10 in accordance with another embodiment which is similar to the pivoting embodiment shown in Figure 7.
- holder body 12 includes a tab 230 carried on beam 232.
- Stem 14 includes elongated members 150 which carry extensions 152.
- a spring member 234 is wrapped around extensions 152 and is coupled to elongated members 150 at tab 236.
- Stem 14 includes tab stop 238 aligned with tab 230 to maintain stem 14 in the low profile implantation position as shown in Figure 12.
- an elongated surgical member may be pressed against tab 230 by moving the elongated surgical member along recessed guide area 240. This action causes tab 230 to disengage tab stop 238 whereby spring member 234 causes stem 14 to articulate into the standard implantation position.
- members 150 may snap into any portion of body 12 such as along sides of body 12. Further, any type of moveable attachment may be used.
- Holder bodies in accordance with the present invention may be moved relative to the stem using any appropriate technique. Further, during a minimally invasive implantation, the surgeon may articulate the positionable holder back to the standard implantation position after introducing the positionable holder and the prosthesis into the chest cavity of the patient. This articulation may be performed using any technique.
- One simple technique is to use an elongated surgical instrument to push the holder body into position.
- an actuator which extends along the handle and provides a direct linkage to the holder body could also be used to control remote positioning. Such remote positioning may be through any appropriate technique including elongated members, sutures, twisting motions, spring elements, etc.
- the holder body and stem of the present invention are made of polyphenylsulfone, such as Radel ® .
- This material is biocompatible , durable and well suited for injection molding techniques which help reduce manufacturing costs.
- other materials and manufacturing techniques are considered within the scope of the present invention.
- any type of holder body shape or design may be implemented along with any type of stem or other element which supports the holder body during implantation.
- any appropriate mechanism to allow articulation or relative movement between the stem and holder body may be employed as may any locking mechanism.
- pivoting attachment mechanism is intended to include any attachment technique which allows articulation of the stem relative to the holder body, even those which have never been explicitly described.
- locking mechanism is intended to include anything which may be used to lock or selectively lock the relative positions of the stem and holder body.
- the invention may also be used with bioprosthetic valves and annuloplasty repair devices.
- the invention allows relative movement between a stem and a body of a holder which may be locked in position.
- the invention allows articulation through the holder using existing tools and can be used for both standard and low profile implantation techniques.
- the invention can also be used to adjust the prosthesis to conform to the anatomy of the patient as necessary. Torque may be applied through the holder to rotate the prosthesis. In the standard implantation position, the holders may be retrofit for use in existing packages.
Landscapes
- Health & Medical Sciences (AREA)
- Cardiology (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic 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
Description
Claims
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
JP10515892A JP2001501111A (en) | 1996-09-25 | 1997-09-25 | Artificial heart valve holder |
EP97943567A EP0928171A1 (en) | 1996-09-25 | 1997-09-25 | Holder for heart valve prosthesis |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US08/719,568 US5814101A (en) | 1996-09-25 | 1996-09-25 | Holder for heart valve prosthesis |
US08/719,568 | 1996-09-25 |
Publications (1)
Publication Number | Publication Date |
---|---|
WO1998012993A1 true WO1998012993A1 (en) | 1998-04-02 |
Family
ID=24890549
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1997/017199 WO1998012993A1 (en) | 1996-09-25 | 1997-09-25 | Holder for heart valve prosthesis |
Country Status (4)
Country | Link |
---|---|
US (1) | US5814101A (en) |
EP (1) | EP0928171A1 (en) |
JP (1) | JP2001501111A (en) |
WO (1) | WO1998012993A1 (en) |
Families Citing this family (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE60035495T2 (en) * | 1999-04-28 | 2008-03-20 | St. Jude Medical, Inc., St. Paul | Aortic Heart Lobe Prosthesis Measurement and Marking Device |
US6364878B1 (en) | 1999-07-07 | 2002-04-02 | Cardiac Pacemakers, Inc. | Percutaneous transluminal ablation catheter manipulation tool |
US6602288B1 (en) * | 2000-10-05 | 2003-08-05 | Edwards Lifesciences Corporation | Minimally-invasive annuloplasty repair segment delivery template, system and method of use |
US7452376B2 (en) * | 2004-05-14 | 2008-11-18 | St. Jude Medical, Inc. | Flexible, non-planar annuloplasty rings |
US7938856B2 (en) * | 2004-05-14 | 2011-05-10 | St. Jude Medical, Inc. | Heart valve annuloplasty prosthesis sewing cuffs and methods of making same |
EP2433591B1 (en) * | 2004-05-14 | 2016-04-27 | St. Jude Medical, Inc. | Apparatus for holding an annuloplasty ring |
US20050278022A1 (en) * | 2004-06-14 | 2005-12-15 | St. Jude Medical, Inc. | Annuloplasty prostheses with improved anchoring structures, and related methods |
EP1778127B1 (en) * | 2004-07-19 | 2015-09-02 | St. Jude Medical, Inc. | Heart valve support and lid liner system and methods |
EP2185107B1 (en) * | 2007-09-07 | 2017-01-25 | Edwards Lifesciences Corporation | Active holder for annuloplasty ring delivery |
US20100076376A1 (en) * | 2008-09-19 | 2010-03-25 | Sorin Biomedica Cardio S. r. l. | Surgical tool for vascular exposure and access |
US8920493B2 (en) | 2011-09-16 | 2014-12-30 | St. Jude Medical, Cardiology Division, Inc. | Systems and methods for holding annuloplasty rings |
Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
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US3828787A (en) | 1972-09-08 | 1974-08-13 | Medical Inc | Collet for holding heart valve |
US4932965A (en) | 1988-12-19 | 1990-06-12 | Phillips Steven J | Artificial valve, and needle and suture holder and method of using same |
WO1994018881A1 (en) | 1993-02-22 | 1994-09-01 | Stanford Surgical Technologies, Inc. | Method for performing thoracoscopic cardiac bypass procedures |
WO1995015715A1 (en) | 1993-12-06 | 1995-06-15 | Heartport, Inc. | Devices and methods for intracardiac procedures |
US5578076A (en) | 1995-05-24 | 1996-11-26 | St. Jude Medical, Inc. | Low profile holder for heart valve prosthesis |
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US3860005A (en) * | 1972-09-08 | 1975-01-14 | Lawrence Anderson | Collet for holding heart valve |
SU990220A1 (en) * | 1981-06-15 | 1983-01-23 | Московский научно-исследовательский институт микрохирургии глаза | Iris retractor |
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IL78177A0 (en) * | 1986-03-17 | 1986-07-31 | Yoel Ovil | Prosthetic heart valve and instrument for attaching and/or removing same |
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US5403305A (en) * | 1993-04-08 | 1995-04-04 | Carbomedics, Inc. | Mitral valve prosthesis rotator |
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US5531785A (en) * | 1994-05-06 | 1996-07-02 | Autogenics, Inc. | Prosthetic heart valve holder |
US5443502A (en) * | 1994-06-02 | 1995-08-22 | Carbomedics, Inc. | Rotatable heart valve holder |
US5582607A (en) * | 1994-09-09 | 1996-12-10 | Carbomedics, Inc. | Heart valve prosthesis rotator with bendable shaft and drive mechanism |
-
1996
- 1996-09-25 US US08/719,568 patent/US5814101A/en not_active Expired - Lifetime
-
1997
- 1997-09-25 WO PCT/US1997/017199 patent/WO1998012993A1/en not_active Application Discontinuation
- 1997-09-25 JP JP10515892A patent/JP2001501111A/en active Pending
- 1997-09-25 EP EP97943567A patent/EP0928171A1/en not_active Withdrawn
Patent Citations (5)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3828787A (en) | 1972-09-08 | 1974-08-13 | Medical Inc | Collet for holding heart valve |
US4932965A (en) | 1988-12-19 | 1990-06-12 | Phillips Steven J | Artificial valve, and needle and suture holder and method of using same |
WO1994018881A1 (en) | 1993-02-22 | 1994-09-01 | Stanford Surgical Technologies, Inc. | Method for performing thoracoscopic cardiac bypass procedures |
WO1995015715A1 (en) | 1993-12-06 | 1995-06-15 | Heartport, Inc. | Devices and methods for intracardiac procedures |
US5578076A (en) | 1995-05-24 | 1996-11-26 | St. Jude Medical, Inc. | Low profile holder for heart valve prosthesis |
Also Published As
Publication number | Publication date |
---|---|
EP0928171A1 (en) | 1999-07-14 |
JP2001501111A (en) | 2001-01-30 |
US5814101A (en) | 1998-09-29 |
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