WO2019152500A2 - Soulèvement auriculaire réglable en taille - Google Patents

Soulèvement auriculaire réglable en taille Download PDF

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Publication number
WO2019152500A2
WO2019152500A2 PCT/US2019/015825 US2019015825W WO2019152500A2 WO 2019152500 A2 WO2019152500 A2 WO 2019152500A2 US 2019015825 W US2019015825 W US 2019015825W WO 2019152500 A2 WO2019152500 A2 WO 2019152500A2
Authority
WO
WIPO (PCT)
Prior art keywords
fingers
atrial
lift
central hub
retractor
Prior art date
Application number
PCT/US2019/015825
Other languages
English (en)
Other versions
WO2019152500A3 (fr
Inventor
Takeshi Tsubouchi
Original Assignee
Terumo Cardiovascular Systems 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 Terumo Cardiovascular Systems Corporation filed Critical Terumo Cardiovascular Systems Corporation
Publication of WO2019152500A2 publication Critical patent/WO2019152500A2/fr
Publication of WO2019152500A3 publication Critical patent/WO2019152500A3/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B17/0206—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors with antagonistic arms as supports for retractor elements
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831—Material properties
    • A61B2017/00946—Material properties malleable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/02—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors
    • A61B2017/0237—Surgical instruments, devices or methods, e.g. tourniquets for holding wounds open; Tractors for heart surgery

Definitions

  • Minimally-invasive cardiac surgery is often used to repair or replace cardiac valves such as the mitral valve. After an incision is made through an atrial wall, the atrial tissue needs to be retracted in order to provide sufficient access to the valve.
  • Conventional retractors for providing the needed“Atrial Lift” are typically comprised of a shaft supporting a spatula- shaped or arch- shaped retractor body or blade at its distal end attached to a support arm that is anchored to a fixed support at its other end. Multiple retractors may be necessary, but space is extremely limited around a surgical site. During valve surgery, optimal retraction is obtained by adjusting the position of the retractor(s). Moreover, the retraction will often need to be re-adjusted during a surgical procedure as different areas of the mitral valve are being repaired/sutured.
  • kits containing retractor bodies over a range of sizes together with devices for securing the bodies is typically used during a procedure. Tasks associated with the selection of components, storage and maintenance of kits having multiple components over a range of sizes available at the ready, and the assembling of components into a desired configuration results in added complexity and waste.
  • Preferred embodiments of the invention include a shaft to penetrate through the chest wall and a retractor body with two adjustable fingers.
  • the retractor body can be connected to the shaft from within the chest cavity.
  • the fingers can be spread laterally according to a desired width profile (before or after placement into the chest cavity), and then are used to pull up on the atrial wall to create an open space and good visibility into the atrium.
  • the use of two adjustable fingers avoids the need for selecting or interchanging blades of different sizes and can reduce the number of retraction units and support arms.
  • the adjustable fingers include malleable support tethers for adjusting a lateral separation of the fingers as well as an axial pivot position.
  • a ball and socket connection between the retractor body and a shaft affixed to the retractor body is configured to permit a wide range of angles and positioning of the retractor body in order to accommodate various positions while being controlled through the fixed chest hole.
  • mounting of the ball on the retractor body can be adjustably located along a retention slot extending in the direction of the fingers.
  • the configuration and placement of the retractor has many degrees of freedom such as length (distance from shaft to finger), angular directions, swivel, and a width of finger separation to hold the atrial wall.
  • Figure 1 shows a mitral valve 10 seen in a left atrium 12 after an atriotomy having an incision 11.
  • An atrial lift retractor 13 inserted into the chest cavity has a blade 14 providing retraction force via a shaft 15.
  • Blade 14 has a width that is selected from a set of blades in order to match the size of the atriotomy and
  • Shaft 15 may be introduced into the chest cavity via an intercoastal puncture, for example.
  • the connection between blade 14 and shaft 15 provides a fixed mounting angle (e.g., a right angle) which limits the choices for positioning of the shaft and/or stabilizer arms being connected, which may make the surgical procedure more difficult.
  • a first embodiment of a dual-fingered atrial lift system 20 has a retractor body 21 mountable at the end of a shaft 22.
  • Retractor body 21 has a central anchor section 23 supporting a stud 24 having a ball 25 at its distal end adapted to connect to shaft 22.
  • a pair of generally flat fingers or spatulas 26 and 27 are linked to anchor section or hub 23 by serpentine arms or tethers 28 and 29, respectively.
  • Serpentine paths of arms 28 and 29 may initially be generally coplanar with fingers 26 and 27 and with each other. Slightly upturned ends 26 A and 27 A of fingers 26 and 27 are adapted for holding the atrial wall during retraction.
  • Fingers 26 and 27 may be constructed of strips of malleable metal (e.g., stainless steel, titanium, nickel-titanium, aluminum, tin, and other alloys) coated with thermoplastic or a soft silicone rubber and having a nonslip nibbed surface. Center holes in fingers 26 and 27 provide for easy grasping of the fingers by tools after being placed in the surgical site in order to spread them apart or together. Body 21 may also support a malleable side finger 30 to selectably push away tissues (e.g., surrounding muscle tissues, blood vessels, or leaflet of the mitral valve), which may likewise be rubber coated.
  • malleable metal e.g., stainless steel, titanium, nickel-titanium, aluminum, tin, and other alloys
  • Center holes in fingers 26 and 27 provide for easy grasping of the fingers by tools after being placed in the surgical site in order to spread them apart or together.
  • Body 21 may also support a malleable side finger 30 to selectably push away tissues (e.g., surrounding muscle tissues, blood vessels, or leaflet of
  • Anchor section 23, arms 28 and 29, and side finger 30 are likewise preferably formed of strips or wires of malleable metal as continuations of or joining with the malleable metal strips of fingers 26 and 27, and also coated with soft silicone rubber or other biocompatible covering.
  • the serpentine shape of arms 28 and 29 facilitates multiple degrees of freedom for manipulating the spreading and/or rotation of fingers 26 and 27 relative to anchor section 23 (e.g., unbending of serpentine arms 28 and 29 facilitates spreading fingers 27 and 28 farther apart to adjust the overall width to match the anatomy to be retracted). Therefore, a single unit can be easily adjusted by the user to match a patient’s anatomy and the particular orientations of the anatomy with respect to the formation of the chest cavity.
  • Stud 24 and ball 25 may be formed of a rigid steel joined to anchor section 23, and they provide for connection via a socket 31 at the end of shaft 22.
  • ball 25 snaps into socket 31 when socket 31 is in a relaxed configuration which allows ball 25 to be rotationally captured in socket 31.
  • Ball 25 rotates freely in order to allow adjustable orientation of retractor body 21 at the end of shaft 22.
  • socket 31 is placed into a clamping configuration which locks ball 25 into a fixed position.
  • the capture/release/locking mechanism of socket 31 can be comprised of a known configuration such as the quick-connect feature used in a commercially-available stabilizer arm sold as the HerculesTM stabilizer arm sold by Terumo Cardiovascular Systems of Ann Arbor, Michigan.
  • a longitudinally-extending part of shaft 22 can be formed as a narrow malleable rod for subcutaneous penetration into a chest cavity (e.g., an intercoastal puncture) as shown in Figure 4 or can be comprised of a stabilizer arm 32 (e.g., the HerculesTM stabilizer arm) as shown in Figure 5. In either case, shaft 22 is adjustable to achieve an optimal orientation as needed by the user.
  • a HerculesTM stabilizer is shown in full in Figure 12, wherein an arm 32 of nested links has a quick-connect socket 31 on one end and a handle 33 on the other end. Handle 33 is mounted to a grip 34 which is adapted to connect to a fixed structure such as a sternal retractor or MICS retractor. Rotation of handle 33 tightens or loosens a cable passing through arms 32 and connecting socket 31 and handle 33, with the resulting tension controlling whether the links and quick connect socket are locked or movable.
  • the malleability of the various components can be determined according to the materials selected and the material thickness to obtain a balanced between adjustability and rigidity so that sufficient retraction forces can be generated while allowing easy manual reconfiguration.
  • the desired deformability may vary for different sections of retractor 21.
  • the malleability of side finger 30 is preferably calibrated to be easily adjusted manually by the surgeon while providing sufficient strength to hold back tissue and vessels to clear the target area.
  • the strength of fingers 26 and 27 and serpentine arms 28 and 29 must be sufficient to transmit the desired pulling force to be applied to the atrial wall.
  • FIGS. 6-10 show an alternative embodiment of an atrial lift retractor 40 using a jaw-type clutch which pivots to adjust the overall retraction width.
  • L-shaped retractor fingers 41 and 42 each has an upturned end 43 and 44 (for grasping the atrial wall) opposite from a hinge end 45 and 46.
  • Hinged ends 45 and 46 are connected to one end of a coupling bar 47, acting as a central pivot hub.
  • a pivot mechanism 50 connects hinge ends 45 and 46 with bar 47 at the central hub.
  • mechanism 50 can be comprised of interlocking teeth on mating surfaces of hinge ends 45 and 46 and bar 47, wherein tightening a screw 52 compresses the toothed surfaces to lock fingers 41 and 42 in a desired orientation (i.e., at a fixed angular opening that provides an effective width of the retractor to fit the section of atrial wall to be lifted).
  • a head 53 of screw 52 may be comprised of an Allen socket for receiving an Allen wrench (not shown) to tighten or loosen screw 52 which is received in a nut 54.
  • screw 52 and nut 54 could be used to provide a fixed amount of clearance that allows hinge ends 45 and 46 to freely pivot.
  • a spring (not shown) could be arranged to provide expansion of hinge ends 45 and 46 and bar 47 along screw 52 when there is no loading on fingers 41 and 42. The spring could be retained in a notch or otherwise placed to urge bar 47 toward nut 54 and hinge end 45 toward screw head 53.
  • mechanism 50 is comprised of a swivel control unit such as a worm gear or a bevel gear.
  • a swivel control unit such as a worm gear or a bevel gear.
  • a corresponding tool such as an Allen wrench could be provided as part of a kit with the retractor.
  • Ball stud 49 has a stud 55 extending between a ball 56 and a mounting block 57 that grasps bar 47 at a desired location along slot 48.
  • a set screw (not shown) within block 57 is tightened to lock ball stud 49 at any desired position along slot 48.
  • Ball 56 is adapted to fit into a socket on a shaft 58 (Figure 9).
  • Figure 9 shows fingers 41 and 42 spread apart to provide an increased width.
  • a malleable side finger can also be added for this embodiment (e.g., as a curved blade or stalk extending from one of the fingers or central hub).
  • Figure 11 shows an alternative embodiment for adjusting the location of ball stud 49 along slot 48.
  • a mounting block 59 is adapted to slide along slot 48.
  • a threaded bore within block 59 receives a threaded adjustment shaft 60 which can be turned using an Allen wrench to move ball stud 49 along slot 48.
  • Figure 13 and 14 show side-entry embodiments wherein a thin, malleable rod 61 acts as a hybrid stud or mounting shaft for the ball of a ball joint.
  • Rod 61 has a dual-finger retractor 62 at one end, wherein rod 61 attaches with retractor 62 to extend parallel to a plane defined by pivotable fingers 63 and 64.
  • rod 61 includes a gripper or handle 65 with a shaft 66 extending to a ball 67. Handle 65 assists a user in snapping ball 67 into a socket 68 of a stabilizer arm 69 and when adjusting retractor 62 into a desired position.
  • a ball 70 is formed at the end of rod 61.
  • Rod 61 can have a length adapted to be long enough to extend through a puncture to be grasped externally or short enough to remain inside the chest cavity to be grasped internally, for example.

Abstract

La présente invention concerne un rétracteur de soulèvement auriculaire fournissant un profil réglable pour adapter le rétracteur à une anatomie et à la configuration d'une cavité thoracique pour fournir une rétraction souhaitée pendant une réparation/un remplacement de valvule cardiaque. Le rétracteur comporte un moyeu central et des premier et second doigts s'étendant pivotants à partir du moyeu central. Les premier et second doigts sont réglables manuellement pour adopter une configuration fournissant une largeur de rétraction sélectionnable et pour maintenir la configuration contre des forces de rétraction lors du retrait du tissu auriculaire. Une unité de pivot à rotule est extensible depuis le moyeu central, et comporte une extrémité rotule conçue pour une capture dans une cavité d'un bras de fixation.
PCT/US2019/015825 2018-02-01 2019-01-30 Soulèvement auriculaire réglable en taille WO2019152500A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201862624870P 2018-02-01 2018-02-01
US62/624,870 2018-02-01

Publications (2)

Publication Number Publication Date
WO2019152500A2 true WO2019152500A2 (fr) 2019-08-08
WO2019152500A3 WO2019152500A3 (fr) 2020-04-30

Family

ID=67478508

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2019/015825 WO2019152500A2 (fr) 2018-02-01 2019-01-30 Soulèvement auriculaire réglable en taille

Country Status (1)

Country Link
WO (1) WO2019152500A2 (fr)

Family Cites Families (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3998217A (en) * 1975-01-13 1976-12-21 William E. Trumbull Surgical retractor device
US5613937A (en) * 1993-02-22 1997-03-25 Heartport, Inc. Method of retracting heart tissue in closed-chest heart surgery using endo-scopic retraction
CA2198036C (fr) * 1996-02-20 2000-12-05 Charles S. Taylor Plate-forme d'acces pour la dissection de l'artere thoracique interne
US6132370A (en) * 1996-04-26 2000-10-17 Genzyme Corporation Retractor-mounted coronary stabilizer
US6074343A (en) * 1999-04-16 2000-06-13 Nathanson; Michael Surgical tissue retractor
US6464634B1 (en) * 2000-09-27 2002-10-15 Depuy Acromed, Inc. Surgical retractor system
US6945933B2 (en) * 2002-06-26 2005-09-20 Sdgi Holdings, Inc. Instruments and methods for minimally invasive tissue retraction and surgery
US7481766B2 (en) * 2003-08-14 2009-01-27 Synthes (U.S.A.) Multiple-blade retractor
US8696560B2 (en) * 2006-05-02 2014-04-15 K2M, Inc. Minimally open retraction device
EP2124757B1 (fr) * 2007-02-15 2016-10-05 Martens, André Ghislain Annie Rétracteur atrial amélioré
US8979749B2 (en) * 2007-04-17 2015-03-17 K2M, Inc. Minimally open interbody access retraction device and surgical method

Also Published As

Publication number Publication date
WO2019152500A3 (fr) 2020-04-30

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