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WO2025019759A2 - Dispositif de guidage chirurgical - Google Patents

Dispositif de guidage chirurgical Download PDF

Info

Publication number
WO2025019759A2
WO2025019759A2 PCT/US2024/038710 US2024038710W WO2025019759A2 WO 2025019759 A2 WO2025019759 A2 WO 2025019759A2 US 2024038710 W US2024038710 W US 2024038710W WO 2025019759 A2 WO2025019759 A2 WO 2025019759A2
Authority
WO
WIPO (PCT)
Prior art keywords
guide
calibration
passage
support
pin
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.)
Pending
Application number
PCT/US2024/038710
Other languages
English (en)
Other versions
WO2025019759A3 (fr
Inventor
David HEHEMANN
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.)
Metrohealth Ventures LLC
Original Assignee
Metrohealth Ventures LLC
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 Metrohealth Ventures LLC filed Critical Metrohealth Ventures LLC
Publication of WO2025019759A2 publication Critical patent/WO2025019759A2/fr
Publication of WO2025019759A3 publication Critical patent/WO2025019759A3/fr
Pending legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B17/16—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans
    • A61B17/17—Guides or aligning means for drills, mills, pins or wires
    • A61B17/1739—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body
    • A61B17/1775—Guides or aligning means for drills, mills, pins or wires specially adapted for particular parts of the body for the foot or ankle

Definitions

  • This disclosure generally relates to a surgical guidance device for a subtalar joint fusion for a subject’s foot. This disclosure also generally relates to a method for fusing a subtalar joint of a subject’s foot.
  • Certain medical conditions can often result in damage to the subtalar joint and require surgery to repair and fuse the joint.
  • Subtalar joint fusion surgeries typically include preparing the subtalar joint by removing cartilage from corresponding joint surfaces of the talus and calcaneus and then fenestrating the subchondral bone. Once the subtalar joint has been prepared, medical hardware is typically inserted to aid in bone-on-bone apposition and eventual fusion of the talus and calcaneus.
  • the medical hardware may be inserted into the subject’s foot in a stepwise fashion with a guide pin being inserted first, a drill being inserted over the guide pin to drill along a target path, and then a screw or other fastening device being inserted into the subject’s foot along the drilled target path.
  • a surgical guidance device for a subtalar joint fusion of a subject's foot comprises a support member.
  • the support member has a support body and a support tip connected to an end of the support body.
  • the support tip is configured for selective engagement with at least a portion of the subtalar joint of the subject.
  • a calibration member is selectively adjustably mounted to the support body.
  • a guide member is selectively adjustably mounted to the calibration member.
  • the guide member has opposing first and second guide ends and a guide body extending between the first and second guide ends.
  • the guide body is configured to selectively receive a portion of the subject’s foot between the first and second guide ends. At least one of the first and second guide ends defines a guide passage configured to selectively receive a guide pin at least partially therethrough.
  • FIG. 1 is a perspective front view of a surgical guidance device according to one aspect of the present invention.
  • FIG. 2 is a perspective front view of an inserter member of the device of Fig. 1 ;
  • FIG. 3 is a perspective front view of a calibration member of the device of Fig. 1 ;
  • FIG. 4 is a perspective front view of a guide member of the device of Fig. 1 ;
  • Fig. 5 is a top view of the guide member of the device of Fig. 1 ;
  • Fig. 6 is a top view of an insert assembly of the device of Fig. 1 , including the insert assembly in an example use configuration;
  • Fig. 7 is an exploded perspective top view of the insert assembly of the device of Fig. 1 ;
  • Fig. 8 is a perspective front view of a first portion of an adapter of the device of Fig. 1 ;
  • FIG. 9 is an exploded perspective front view of a second portion of an adapter of the device of Fig. 1 ;
  • Fig. 10 is a rear view of the second portion of the adapter of Fig. 1 ;
  • Fig. 11 is a cross-sectional view taking along line 9-9 of Fig. 1 ; and [0017] Fig. 12 schematically illustrates the device of Fig. 1 in an example use configuration and environment.
  • the term “subject” can refer to any warm-blooded organism including, but not limited to, human beings, pigs, rats, mice, birds, cats, dogs, goats, sheep, horses, monkeys, apes, rabbits, cattle, farm animals, livestock, etc.
  • the term “user” can be used interchangeably to refer to an individual who prepares for, assists with, and/or performs a procedure.
  • the term “user” can also be used interchangeably to refer to an individual who prepares for, assists with, and/or performs the operation of a device.
  • phrases such as “between X and Y” can be interpreted to include X and Y.
  • the phrase “at least one of X and Y” can be interpreted to include X, Y, or a combination of X and Y.
  • the element may, at a particular time, include X, Y, or a combination of X and Y, the selection of which could vary from time to time.
  • the phrase “at least one of X” can be interpreted to include one or more Xs.
  • the invention comprises, consists of, or consists essentially of the following features, in any combination.
  • Fig. 1 illustrates a surgical guidance device 100 for a subtalar joint fusion of a subject’s foot.
  • the device 100 is at least partially designed to aid in a reproducible anatomical alignment of the subtalar joint and guide pin during a surgical procedure to fuse the subtalar joint.
  • the device 100 generally includes a support member 102 at least partially configured to manipulate and/or hold a predetermined position of one of the calcaneus and talus relative to the other of the calcaneus and talus, a calibration member 104 at least partially configured to permit the device 100 to be fitted to a subject’s particular anatomy, and a guide member 106 at least partially configured for guiding medical instruments relative to the subject’s anatomy.
  • the support member 102 includes an elongate support body 208 that extends along a central support axis 210 of the support member 102.
  • the support body 208 may be cylindrical in cross-section, though the support body 208 may be configured to have any other desired cross-sectional shape (such as, e.g., square, rectangular, triangular, elliptical, etc.).
  • a diameter of the support body 208 may be in the range of, e.g., from 2 mm to 10 mm, preferably from 3 mm to 8 mm, more preferably from 4 mm to 6 mm, and most preferably from 4.5 mm to 5.5 mm.
  • a length of the support body 208, measured along the central support axis 210, may be in the range of, e.g., from 5 cm to 20 cm, preferably from 7 cm to 16 cm, more preferably from 9 cm to 14 cm, and most preferably from 1 1 cm to 13 cm.
  • the support member 102 also includes a support tip 212 configured for selective engagement with at least a portion of the subtalar joint of the subject’s foot.
  • the support tip 212 may be engaged with the subtalar joint by being at least partially inserted into a least a portion (e.g., into the sinus tarsi) of the subtalar joint.
  • the shape of the support tip 212 is designed so as to be suitable for such engagement/insertion. In the example configuration shown in Figs.
  • the support tip 212 is substantially bullet-shaped in that the support tip 212 includes a frustrum portion 212a, an ogive portion 212c, and a cylindrical portion 212b interposed along the central support axis 210 between the frustrum and ogive portions 212a, 212c.
  • the apex 214 of the ogive portion 212c which extends away from the support body 208, may be spherically or otherwise blunted so as to provide for a substantially atraumatic insertion into and/or engagement with the subtalar joint.
  • a length of the support tip 212, measured along the central support axis 210, may be in the range of, e.g., from 0.5 cm to 10 cm, preferably from .75 cm to 3 cm, more preferably from 1 cm to 2.5 cm, and most preferably from 1 .5 cm to 2 cm.
  • a diameter of a portion of the frustrum portion 212a and/or the cylindrical portion 212b may be in the range of, e.g., from 6 mm to 16 mm, preferably from 8 mm to 14 mm, and more preferably from 10 mm to 12 mm.
  • the diameter of a portion of the frustrum portion 212a and/or the cylindrical portion 212b may also be larger than that of the support body 208 in some configurations of the device 100.
  • the support tip 212 may be connected to a first end 216 of the support body 208 at the frustrum portion 212a.
  • the support tip 212 may be connected to the first end 216 via being integrally formed with the support body 208 as a single monolithic piece.
  • the frustrum portion 212a may be removably connected to the first end 216 via a snap-fit feature, a quick-connect feature, threads, a press-fit or frictional engagement, any other suitable feature or mechanism for providing such removable connection, or any combination thereof.
  • the support member 208 may include a support handle 218 (e.g., an ergonomic support handle 218) for such purposes.
  • the support handle 218 may be connected to a portion of the support body 208 spaced apart from the support tip 212. In the example configuration shown in Figs. 1 -2, the support handle 218 is connected to a second end 220 of the support body 208 opposite the support tip 212. In some device configurations, the support handle 218 may be connected to the second end 220 via being integrally formed with the support body 208 as a single monolithic piece.
  • the support handle 218 may be removably connected to the second end 220 via a snap-fit feature, a quick-connect feature, threads, a press-fit or frictional engagement, any other suitable feature or mechanism for providing such removable connection, or any combination thereof.
  • a length of the support handle 218, measured along the central support axis 210, may be in the range of, e.g., from 5 cm to 20 cm, preferably from 7 cm to 17 cm, more preferably from 8 cm to 15 cm, and most preferably from 9 cm to 12 cm.
  • the calibration member 104 includes an elongate calibration body 322 that extends along a central calibration axis 324 of the calibration member 104.
  • the calibration body 322 may be cylindrical in crosssection, though the calibration body 322 may be configured to have any other desired cross-sectional shape (such as, e.g., square, rectangular, triangular, elliptical, etc.).
  • a diameter of the calibration body 322 may be in the range of, e.g., from 2 mm to 10 mm, preferably from 3 mm to 8 mm, and most preferably from 4.5 mm to 6.5 mm.
  • a length of the calibration body 322, measured along the central calibration axis 324, may be in the range of, e.g., from 2 cm to 18 cm, preferably from 3 cm to 16 cm, more preferably from 4 cm to 14 cm, and most preferably from 6 cm to 10 cm.
  • the calibration member 104 and its calibration body 322 may be selectively adjustably mounted to the support body 208.
  • the calibration member 104 may include a calibration connector 326 selectively connected to a chosen end 328 of the calibration body 322.
  • the calibration connector 326 may be connected to the chosen end 328 via being integrally formed with the calibration body 322 as a single monolithic piece.
  • the calibration connector 326 may be removably connected to the chosen end 328 via a snap-fit feature, a quick-connect feature, threads, a press- fit or frictional engagement, any other suitable feature or mechanism for providing such removable connection, or any combination thereof.
  • the calibration connector 326 may have an inner calibration passage 330 extending therethrough in a direction that is orthogonal or otherwise at an angle relative to the central calibration axis 324.
  • the calibration member 104 may be selectively slidably attached to the support body 208 by receiving the support body 208 slidably within the calibration passage 330.
  • the calibration passage 330 thus may have a diameter that is at least slightly larger than the diameter of the support body 208.
  • the diameter of the calibration passage 330 may be in the range of from 1 mm to 12 mm, preferably from 2 mm to 10 mm, more preferably from 3 mm to 8 mm, and most preferably between 4 mm to 6 mm.
  • the support body 208 may also be selectively rotatably received within the calibration passage 330.
  • the calibration member 104 is also rotatably attached and rotatable relative to the support body 208. Accordingly, the position of the calibration member 104 relative to the support body 208 may be adjusted by selectively sliding the calibration member 104 along (arrow A in Fig. 1 ) and/or selectively circumferentially rotating calibration member 104 about (arrow B in Fig. 1 ) the support body 208 and the central support axis 210 relative to the support member 102.
  • the calibration member 104 may be selectively maintained in the desired position/orientation via one or more first locking features 132.
  • the first locking feature(s) 132 comprises a first thumbscrew 132a and a radially extending and complementarily threaded first opening 132b in the calibration connector 326. A portion of the first thumbscrew 132a extends through the first opening 132b and toward the calibration passage 330 where the first thumbscrew 132a at least partially contacts and/or is located adjacent to the received support body 208.
  • the first thumbscrew 132a may be urged into or further into contact with the support body 208 to compress the support body 208 between the first thumbscrew 132a and an internal calibration surface 334 (Fig. 3) of the calibration connector 326 to such a degree that the calibration member 104 and the support member 102 are substantially prevented from moving relative to one another.
  • the first locking feature(s) 132 may additionally or alternatively include dimensioning the calibration passage 330 and/or the support body 208 such that the calibration member 104 can only slide/rotate relative to the support member 102 under an applied predetermined force.
  • the guide member 106 includes opposing first and second guide ends 436, 438 and a guide body 440 extending between the first and second guide ends 436, 438.
  • the guide body 440 is configured to selectively receive a portion of the subject's foot (e.g., the portion of the subject’s foot that includes the subtalar joint) between the first and second guide ends 436, 438.
  • the guide body 440 may be configured such that a length between the first and second guide ends 436, 438 is suitable for receiving a portion of the subject’s foot between the first and second guide ends 436, 438.
  • the guide end-to-guide end length thus may be in the range of, e.g., from 5 to 35 cm, preferably from 10 to 30 cm, more preferably between 15 to 25 cm, and most preferably between 17 and 23 cm.
  • the shape of the guide body 440 may also be configured such that a portion of the subject’s foot may be received between the first and second guide ends 436, 438.
  • the guide body 440 of Figs. 1 and 4-5 thus can be arcuate to at least partially provide the receiving functionality, though the guide body 440 may be more angular and/or squared off in some device configuration.
  • the device 100 may include multiple substitutable guide members 106 with variously sized and/or shaped guide bodies 440, with each guide member 106 corresponding to various subject anatomies.
  • the first and second guide ends 436, 438 each define a guide passage 442 extending therethrough, though the guide member 104 may be configured such that only a selected one of the first and second guide ends 436, 438 includes a guide passage 442.
  • the guide passages 442 may be mutually coaxially aligned such that their shared guide passage axis 444 intersects a portion of the subject’s foot when the subject’s foot is inserted between the first and second guide ends 436, 438.
  • the guide passages 442 may also be configured to simultaneously or sequentially receive one or more medical instruments (e.g., a guide pin, a drill bit, an inserter pin, and/or a fastener).
  • the device 100 may also or instead include at least one insert assembly 646 where each feature of the insert assembly 646 may be configured to selectively receive a corresponding medical instrument.
  • Figs. 6 illustrates an example insert assembly 646 removably inserted into the guide passage 442 of the first guide end 436, though the below description is equally applicable to an insert assembly 646 being removably inserted into the guide passage 442 of the second guide end 438, since the guide passages 442 may be similarly dimensioned and the insert assembly 646 may be configured so as to be insertable into each/either of the guide passages 442.
  • the insert assembly 646 may include a drill bit insert 748 having a bit body 750 and a bit head 752.
  • the bit body 750 is configured to be removably insertable into the guide passage 442, and thus has an outer diameter that is at least slightly smaller than the diameter of the guide passage 442.
  • An outer diameter of the bit head 752, however, is at least slightly larger than the guide passage 442 so as to prevent passage of the bit head 752 into the guide passage 442. Therefore, when the drill bit insert 748 is fully inserted into the guide passage 442, a portion of the bit head 752 may contact an external end face 654 of the first guide end 436 and a portion of the bit body 750 may extend into and/or beyond an opposite internal end face 656 of the first guide end 436.
  • the drill bit insert 748 defines an inner bit passage 758 extending through the bit body and head 750, 752.
  • the bit passage 758 is configured to selectively receive a drill bit of a drill at least partially therethrough.
  • the insert assembly 646 may also include a guide pin insert 760 having a pin body 762 and a pin head 764.
  • the pin body 762 is configured to be removably insertable into the bit passage 758, and thus has an outer diameter that is at least slightly smaller than the diameter of the bit passage 758.
  • An outer diameter of the pin head 764 is at least slightly larger than the bit passage 758 so as to prevent passage of the pin head 764 into the bit passage 758. Therefore, when the guide pin insert 760 is fully inserted into the bit passage 758, a portion of the pin head 764 may contact a portion of the bit head 752 and a portion of the pin body 762 extends into the bit passage 758.
  • the guide pin insert 760 defines an inner pin passage 766 extending through the pin body and head 762, 764.
  • the pin passage 766 is configured to selectively receive a guide pin at least partially therethrough.
  • the insert assembly 646 may also include an elongate indicator pin 768 having an indicator head 770, an indicator tip 772 and an indicator body 774 interposed between the indicator head and tip 770, 772.
  • the indicator body and tip 774, 772 are configured to be removably insertable into the pin passage 766.
  • An outer diameter of the indicator head 770 is at least slightly larger than the pin passage 766 so as to prevent passage of the indicator head 770 into the pin passage 766. Therefore, when the indicator pin 768 is fully inserted into the pin passage 766, a portion of the indicator head 770 may contact a portion of the pin head 764 and a portion of the indicator body 774 extends into the pin passage 766.
  • the length of the indicator body 774 may be configured such that at least a portion of the indicator tip 112. (and, optionally, at least a portion of the indicator body 774) extends past the bit and pin passages 758, 766 so as to be left uncovered by each of the drill bit insert 748 and the guide pin insert 760.
  • the first and second guide ends 436, 438 may also include an opening or slit 476. As shown in Fig. 4, each slit 476 extends in a direction parallel or substantially parallel to the shared guide passage axis 444 from the external end face 654 of a corresponding one of the first and second guide ends 436, 438 to an internal end face 656 of the corresponding one of the first and second guide ends 436, 438.
  • Each slit 476 also extends in a direction perpendicular to the shared guide passage axis 444 from an exterior intermediate surface 478 of a corresponding one of the first and second guide ends 436, 438 to a corresponding one of the guide passages 442, where each exterior intermediate surface 478 extends along the shared guide passage axis 444 between corresponding external and internal end faces 654, 656.
  • Each slit 476 is configured to permit the selective passage of a guide pin therethrough so that the guide member 106 (and, thus, the device 100) may be removed from an in-use guide pin without having to substantially disturb the placement/orientation of the in-use guide pin.
  • the guide member 106 is selectively adjustably mounted to the calibration member 104 via an adapter 180.
  • the adapter 180 may be a multi-piece construction having a calibration sliding portion 882 and a guide rotating portion 984 selectively connected to the calibration sliding portion 882.
  • the calibration sliding portion 882 includes a sliding body 886 having an inner sliding passage 888 for selectively receiving the calibration body 322 slidably therein to slidably and rotatably attach the calibration sliding portion 882 (and, thus, the adapter 180 and guide member 106) to the calibration body 322.
  • the sliding passage 888 extends along the central calibration axis 324.
  • the sliding passage 888 may have a diameter that is at least slightly larger than the diameter of the calibration body 322.
  • the diameter of the sliding passage 888 may be in the range of from 1 mm to 12 mm, preferably from 2 mm to 10 mm, more preferably from 3 mm to 8 mm, and most preferably between 4 mm to 7.3 mm.
  • the calibration sliding portion 882 may also include a sliding projection 890 that extends along a rotation or projection axis 892 in a direction perpendicular to that of the extension of the sliding passage 888.
  • the projection axis 892 may also extend perpendicularly to the central calibration axis 324 when the calibration sliding portion 882 is joined to the calibration member 104.
  • the guide rotating portion 984 may be rotatably connected to the calibration sliding portion 882 for rotation about the projection axis 892 relative to the calibration sliding portion 882.
  • the guide rotating portion 984 may include a rotating projection 994 having an inner projection passage 1096 for selectively rotatably receiving at least a portion of the sliding projection 890 therein.
  • the rotating projection 994 extends from a rotating body 998 of the guide rotating portion 984.
  • the rotating body 998 may be a multi-piece construction having a first and second rotating body portions 998a, 998b.
  • the first rotating body portion 998a defines a first channel 9100a (e.g., a semi-circular first channel 9100a) and one or more first tabs 9102a.
  • the first rotating body portion 998a includes two first tabs 9102a extending in opposite directions away from the first channel 9100a.
  • Each first tab 9102a may include at least one first connecting opening 9104a and at least one (here, two) first support opening 9106a, though at least one of the first tabs 9102a may be constructed without any first connecting openings 9104a and/or first support openings 9106a.
  • the second rotating body portion 998b substantially mirrors the first rotating body portion 998a, though only the first rotating body portion 998a has the rotating projection 994 extending therefrom.
  • the second rotating body portion 998b of Figs. 1 and 9-11 includes a second channel 9100b and two second tabs 9102b.
  • Each second tab 9102b may include the same number of connecting and support openings 9104b, 9106b as its corresponding one of the first tabs 9102a such that when the first and second rotating body portions 998a, 998b are joined together, each of the first connecting and support openings 9104a, 9106a of the first tabs 9102a is mutually aligned with corresponding second connecting and support openings 9104b, 9106b of the second tabs 9102b.
  • the conjoined first and second rotating body portions 998a, 998b may be selectively maintained connected to, and in direct contact with, one another via one or more connecting fasteners 9108 (here, two) extending through the associated first and second connecting openings 9104a, 9104b.
  • the connecting fasteners 9108 may be at least partially threaded and may threadably engage complementary threads of at least one of the first and second connecting openings 9104a, 9104b when inserted therein.
  • the first and second rotating body portions 998a, 998b have been shown as utilizing a threaded connecting fastener 9108 and threaded hole 9104a/9104b engagement, in other device configurations, the first and second rotating body portions 998a, 998b may additionally or instead be selectively retained connected to one another via any other suitable engagement mechanism, such as, but not limited to, a magnetic engagement, hook and loop engagement, a nail and nail hole engagement, a snap-fit engagement, an adhesive engagement, a screw and nut engagement, a split pin engagement, a button engagement, a press-fit engagement, any other suitable engagement, or any combination thereof.
  • the first and second rotating body portions 998a, 998b may be formed integrally together as a single piece instead of being formed separately and then connected to one another.
  • the first and second channels 9100a, 9100b of the conjoined first and second rotating body portions 998a, 998b may also form a single inner rotating passage 11110 for selectively receiving the guide body 440 therein.
  • the dimensions of the rotating passage 11110 and/or the guide body 440 may be configured such that the guide member 106 is tiltably rotated about a tilt axis 1 1112, which is defined by at least one of the rotating passage 11110 and the guide body 440, relative to the guide rotating portion 984.
  • the guide body 440 may also be pivotably rotatable about a pivot axis 1114, which intersects the shared guide passage axis 444 and is substantially perpendicular to the tilt axis 11112, relative to the guide rotating portion 984.
  • the device 100 may be configured such that the guide member 106 may be tiltably rotated about the tilt axis 11112 and/or pivotably rotated about the pivot axis 1114 freely or substantially freely. Alternatively or additionally, guide member may be locked in a desired rotational position about the tilt axis 11112 and/or the pivot axis 11 14 via one or more second locking features 11115.
  • the second locking feature(s) 11 115 may comprise dimensioning the rotating passage 11 110 and/or the guide body 440 such that the guide member 106 can only tiltably rotate about the tilt axis 11112 and/or pivotably rotate about the pivot axis 1114 relative to the guide rotating portion 984 of the adapter 180 under a predetermined applied force.
  • the guide member 106 may be substantially maintained in a desired position relative to the guide rotating portion 984 when no force is applied to the guide member 106 and when a force lesser than the predetermined force is applied to the guide member 106.
  • the second locking feature(s) 11115 may comprise the first and second rotating body portions 998a, 998b and the connecting fasteners 9108.
  • the device 100 may be configured such that the guide member 106 may (or, may only) be tiltably rotated about the tilt axis 11112 and/or pivotably rotated about the pivot axis 1114 when the at least one of the connecting fasteners 9108 is not fully or substantially threaded into its associate first and second connecting openings 9104a, 9104b.
  • a connecting fastener 9108 may be “loosened” to permit the guide member 106 to tiltably and/or pivotably rotate, and then “tightened” to substantially (or at least partially) prevent the guide member 106 from tiltably and/or pivotably rotating relative to the guide rotating portion 984 from a desired position/orientation.
  • the second locking feature(s) 11115 may comprise a second thumbscrew (not shown) and a complimentary threaded second opening (not shown) in at least one of the first and second rotating body portions 998a, 998b. This thumbscrew-and-opening second locking feature 11115 may function substantially similarly to that of the thumbscrew-and-opening first locking feature 132 discussed above.
  • the guide member 106 may also be slidable along and rotatable about the calibration body 322 (and the central calibration axis 324) via the calibration sliding portion 882 of the adapter 180, and rotatable about the projection axis 892 via the guide rotating portion 984 of the adapter 180.
  • the guide member 106 may be selectively maintained in the desired position/orientation via one or more third locking features 11116.
  • the third locking feature(s) 11116 comprises a third thumbscrew 11116a and a radially extending and complementarily threaded third opening 11116b in the sliding body 886 of the adapter 180.
  • a portion of the third thumbscrew 11116a extends through the third opening 11 116b and toward the sliding passage 888 where the third thumbscrew 11116a at least partially contacts and/or is located adjacent to the received calibration body 322.
  • the third thumbscrew I H 16a may be urged into or further into contact with the calibration body 322 to compress the calibration body 322 between the third thumbscrew 11116a and an internal sliding surface 11118 of the sliding body 886 to such a degree that the calibration sliding portion 882 and the calibration body 322 are substantially prevented from moving relative to one another.
  • the third locking feature(s) 11116 may additionally or alternatively include dimensioning the sliding passage 888 and/or the calibration body 322 such that the sliding body 886 can only slide/rotate relative to the calibration body 322 under an applied predetermined force.
  • the guide member 106 may be selectively maintained in the desired position/orientation via one or more fourth locking features 11120.
  • the fourth locking feature(s) 11 120 comprises a fourth thumbscrew 11120a, a radially extending and complementarily threaded fourth opening 11120b in the rotating projection 994 of the adapter, and an annular notch 11120c in the sliding projection 890.
  • a portion of the fourth thumbscrew 11120a extends through the fourth opening 11120b and into the projection passage 1096 where the fourth thumbscrew 11120a is located adjacent to and/or at least partially in the annular groove 1 1120c.
  • the fourth thumbscrew 11120a may be urged into or further into contact with an end wall 11120d of the annular groove 11120c to compress the sliding projection 890 between the fourth thumbscrew 11120a and an internal projection passage surface 11122 of the rotating projection 994 to such a degree that the guide rotating portion 984 and the calibration sliding portion 882 are substantially prevented from rotating relative to one another.
  • the fourth locking feature(s) 11120 may additionally or alternatively include dimensioning the projection passage 1096 and/or the sliding projection 890 such that the guide rotating portion 984 can only rotate relative to the calibration sliding portion 882 under an applied predetermined force. Furthermore, it should be noted that guide rotating portion 984 may be selectively substantially prevented from undesirably egressing from the projection passage 1096 when the fourth thumb screw 11120a extends at least partially into the annular notch 11120c. [0055] Therefore, in view of the above, the guide member 106 may be selectively (1 ) slid along the support body 208 (and the central support axis 210) via the calibration member 104 (arrow A in Fig.
  • At least one of the support member 102, the calibration member 104, the guide member 106, the adapter 180, the insert assembly 646, and/or at least one of the individual features thereof is formed at least partially from stainless steel, carbon fiber, or any other suitable surgical grade material.
  • at least one of the support member 102, the calibration member 104, the guide member 106, the adapter 180, the insert assembly 646, and/or at least one of the individual features thereof is single use and formed at least partially from a disposable surgical grade material, such as, e.g., polyethylene.
  • the support handle 218 may be formed at least partially from any suitable composite and/or synthetic material that is heat stable and/or can be cleaned for reuse such as, but not limited to, cotton textile-phenolic resin, plastic, or rubber.
  • an example method for using the device 100 of the present disclosure in a subtalar joint fusion procedure includes inserting the support tip 212 at least partially into a portion of a subtalar joint SJ of the subject’s foot FO.
  • the support tip 212 may be at least partially inserted into the sinus tarsi ST of the subtalar joint SJ and remain inserted throughout use of the device 100.
  • at least one of the calcaneus C and the talus T may be manipulated relative to the other to stabilize the subtalar joint SJ, reduce the size of the subtalar joint SJ, and/or reposition the calcaneus C relative to the talus T during use of the device 100.
  • the device 100 may be calibrated to the subject’s anatomy via at least one of adjusting a position of the calibration member 104 (and, thus the target guide 106) relative to the support member 102 (e.g., via sliding and/or rotating the calibration member 104), and adjusting a position of the guide member 106 relative to the calibration member 104 (e.g., via sliding and/or rotating the guide member 106 along/about the central calibration axis 323).
  • the position of the calibration member 104 relative to the support member 102 may be selectively locked via the first locking feature 132, and the position of the guide member 106 along/about the calibration member 104 may be selectively locked via the third locking feature 11116.
  • the guide member 106 may then be positioned such that a portion of the subject’s foot FO that includes the subtalar joint SJ is between the first and second guide ends 436, 438.
  • the guide member 106 is also positioned with the shared guide passage axis 444 being aligned with a predetermined target path TP that is cooperatively defined along the calcaneus C, the subtalar joint SJ, and the talus T of the subject’s foot FO.
  • the positioning of the guide member 106 may be accomplished via rotating the guide member 106 about the projection axis 892, rotatably pivoting the guide member 106 about the pivot axis 1114, and/or tiltably pivoting the guide member 106 about the tilt axis 11112.
  • the sliding/rotation discussed in the calibration step may also be utilized to assist the user in this guide member positioning step.
  • the position of the guide member 106 may be locked via at least the fourth locking feature 11120 and, when provided, the second locking feature 11115.
  • At least a portion of the device 100 may be fixed to the subject via one or more support pins 12124, though only one support pin 12124 is shown in Fig. 12.
  • Each support pin 12124 may be inserted through an associated pair of first and second support openings 9106a, 9106b and into a portion (e.g., the calcaneus C and/or talus T) of the subject’s foot FO to anchor at least a portion of the device 100 to the subject.
  • the guide member 106 While the device 100 is anchored, the guide member 106 may still be selectively rotatably pivoted about the pivot axis 1114 and/or tiltably pivoted about the tilt axis 11116 as desired.
  • an insert assembly 646 may be inserted into each of the guide passages 442.
  • a drill bit insert 748 and a guide pin insert 760 of a first insert assembly 646a may be inserted into the guide passage 442 of the second guide end 438 such that they the pin passage 766 is aligned with the predetermined target path TP on a bottom, heel or calcaneus side of the subject’s foot FO. Therefore, via the pin passage 766 of the first insert assembly 646a, the user is able to visualize an ingress point for a guide pin 12126 that is to be inserted along the predetermined target path TP.
  • a drill bit insert 748, a guide pin insert 760, and an indicator pin 768 of a second insert assembly 646b may be inserted into the guide passage 442 of the first guide end 436 such that the indicator tip 772 is adjacent to and/or in contact with the portion of a top of the subject’s foot and/or leg L that the predetermined target path TP intersects. Therefore, via the indicator tip 772 of the second insert assembly 646b, the user is able to visualize an egress point for the guide pin 12126.
  • the guide pin 12126 may then be inserted through the pin passage 766 of the first insert assembly 646a and into the subject’s foot FO along the predetermined target path TP to extend the guide pin 12126 at least partially through all of the calcaneus C, the subtalar joint SJ, and the talus T. This insertion may occur while or after the indicator pin 768 is still in position or after at least the indicator pin 768 of the second insert assembly 646b has been at least partially withdrawn from the guide passage 442 of the first guide end 436. After the guide pin 12126 is inserted, the guide pin insert 760 of the first insert assembly 646a may be removed, leaving the drill bit insert 748 in the guide passage 442 of the second guide end 438.
  • a drill bit of a drill may then be inserted over the guide pin 12126, through the bit passage 758, and into the subject’s foot FO to drill along the predetermined target path TP.
  • a screw or other fastening device (not shown) is subsequently inserted into the subject’s foot FO along the drilled predetermined target path TP to aid in calcaneus-on-talus apposition for the eventual fusion of the calcaneus C and talus T.
  • the screw/fastening device may be placed while the guide pin 12126 is inserted or after the guide pin 12126 has been removed. Furthermore, the device 100 may be removed from the inserted guide pin 12126 before or after the predetermined target path TP is drilled by removing the support pin(s) 12124 and manipulating the device 100 such that the inserted guide pin 12126 is passed through at least one of the slits 476. The guide pin 12126 may thus remain inserted in the subject’s foot FO along the predetermined target path TP while the device 100 is removed.
  • the device 100 may be manipulated as appropriate relative to the subject’s foot FO such that the shared guide passage axis 444 is aligned with a plurality of predetermined target paths TP throughout use of the device 100.
  • a surgical guidance device for a subtalar joint fusion of a subject’s foot comprises a support member.
  • the support member has a support body and a support tip connected to an end of the support body.
  • the support tip is configured for selective engagement with at least a portion of the subtalar joint of the subject.
  • a calibration member is selectively adjustably mounted to the support body.
  • a guide member is selectively adjustably mounted to the calibration member.
  • the guide member has opposing first and second guide ends and a guide body extending between the first and second guide ends.
  • the guide body is configured to selectively receive a portion of the subject’s foot between the first and second guide ends. At least one of the first and second guide ends defines a guide passage configured to selectively receive a guide pin at least partially therethrough.
  • Aspect 2 The device of Aspect 1 , wherein the support tip is engaged by being at least partially inserted into at least a portion of the subtalar joint of the subject.
  • Aspect 3 The device of any of Aspects 1 -2, wherein the support tip is configured to be maintained in engagement with the subtalar joint throughout use of the device, the support tip being configured for manipulating one of the calcaneus and the talus relative to the other to at least one of stabilize the subtalar joint, reduce the size of the subtalar joint, and reposition the calcaneus relative to the talus throughout use of the device.
  • Aspect 4 The device of any of Aspects 1 -3, wherein at least a portion of the support tip is ogive-shaped, with an apex extending away from the support body.
  • Aspect 5 The device of any of Aspects 1 -4, wherein the calibration member includes a calibration body and a calibration connector selectively connected to a chosen end of the calibration body, the calibration connector having a calibration passage extending therethrough, the calibration member being selectively slidably attached to the support body by receiving the support body slidably within the calibration passage.
  • Aspect 6 The device of any of Aspects 1 -5, wherein the calibration body is selectively slidably mounted to the support body and selectively rotatable with respect to the support body.
  • Aspect 7 The device of any of Aspects 1 -6, including a locking feature configured to selectively maintain a predetermined position of the calibration member with respect to the support body.
  • Aspect 8 The device of any of Aspects 1 -7, wherein each of the first and second guide ends has a guide passage extending therethrough, the guide passages of the first and second guide ends being mutually coaxially aligned.
  • Aspect 9 The device of any of Aspects 1 -8, including an adapter for selectively slidably mounting the guide member to the calibration member.
  • Aspect 10 The device of Aspect 9, wherein the adapter includes at least one support opening extending therethrough, the at least one support opening being configured to receive a support pin for at least partially anchoring the device to the subject.
  • Aspect 11 The device of Aspect 9, wherein the adapter includes a calibration portion selectively slidably mounted to the calibration member and a guide portion selectively connected to the guide body, the guide portion being selectively rotatably connected to the calibration portion for rotation relative to the calibration portion.
  • Aspect 12 The device of Aspect 11 , wherein the selectively rotational connection between the guide portion and the guide member is at least one of:
  • Aspect 13 The device of any of Aspects 11 -12, including:
  • a first locking feature configured to selectively maintain a predetermined position of the adapter with respect to the calibration member
  • a second locking feature configured to selectively maintain a predetermined rotational position of the guide member with respect to the calibration portion.
  • Aspect 14 The device of any of Aspects 1 -13, wherein the guide member is slidable along the support body via the calibration member, slidable along the calibration member, and at least one of:
  • Aspect 15 The device of any of Aspects 1 -14, including at least one of: [0089] a guide pin insert removably inserted in a selected guide passage, the guide pin insert defining a pin passage extending through the guide pin insert and being configured to selectively receive a guide pin at least partially therethrough;
  • a drill bit insert removably inserted in a selected guide passage, the drill bit insert defining a bit passage extending through the drill bit insert and being configured to selectively receive a drill bit at least partially therethrough;
  • an elongate indicator pin removably inserted at least partially through a selected guide passage, the indicator pin being configured for selective contact with a target location on the subject’s foot to indicate an ingress and/or egress point for the guide pin.
  • Aspect 16 The device of any of Aspects 1 -14, including an insert assembly, the insert assembly including:
  • a drill bit insert removably inserted in a selected guide passage, the drill bit insert defining a bit passage extending through the drill bit insert and being configured to selectively receive a drill bit at least partially therethrough;
  • a guide pin insert removably inserted in the bit passage, the guide pin insert defining a pin passage extending through the guide pin insert and being configured to selectively receive a guide pin at least partially therethrough;
  • an elongate indicator pin removably inserted at least partially through the pin passage, the indicator pin being configured for selective contact a target location on the subject’s foot to indicate an ingress and/or egress point for the guide pin.
  • Aspect 17 The device of any of Aspects 1 -16, wherein the guide member includes an opening extending from an exterior surface of at least one of the first and second guide ends to an associated guide passage, the opening being configured to permit the selective passage of the guide pin therethrough.
  • Aspect 18 The device of any of Aspects 1 -17, wherein the guide body extends arcuately between the first and second guide ends.
  • Aspect 19 The device of any of Aspects 1 -18, wherein the support member has a support handle connected a portion of the support body spaced apart from the support tip.
  • Aspect 20 The device of any of Aspects 1 -19, wherein the guide body is configured to selectively receive a portion of the subject's foot that includes the subtalar joint between the first and second guide ends.
  • Aspect 21 The device of any of Aspects 1 -20, wherein the support tip is engaged by being at least partially inserted into the sinus tarsi of the subtalar joint.
  • a method for fusing a subtalar joint of a subject’s foot comprising:
  • Aspect 23 The method of Aspect 22, including:
  • Any component could be provided with a user-perceptible marking to indicate a material, configuration, at least one dimension, or the like pertaining to that component, the user-perceptible marking potentially aiding a user in selecting one component from an array of similar components for a particular use environment.
  • a “predetermined” status may be determined at any time before the structures being manipulated actually reach that status, the “predetermination” being made as late as immediately before the structure achieves the predetermined status.
  • the term “substantially” is used herein to indicate a quality that is largely, but not necessarily wholly, that which is specified-a “substantial” quality admits of the potential for some relatively minor inclusion of a non-quality item.

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Medical Informatics (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Engineering & Computer Science (AREA)
  • Dentistry (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Surgical Instruments (AREA)

Abstract

Un dispositif de guidage chirurgical pour une fusion articulaire sous-astragalienne d'un pied d'un sujet comprend un élément de support. L'élément de support comprend un corps de support et une pointe de support reliée à une extrémité du corps de support. La pointe de support est configurée pour entrer sélectivement en contact avec au moins une partie de l'articulation sous-astragalienne. Un élément d'étalonnage est monté de manière réglable et sélective sur le corps de support. Un élément de guidage est monté de manière réglable et sélective sur l'élément d'étalonnage. L'élément de guidage présente des première et seconde extrémités de guidage opposées et un corps de guidage s'étendant entre les première et seconde extrémités de guidage. Le corps de guidage est configuré pour recevoir sélectivement une partie du pied du sujet entre les première et seconde extrémités de guidage. Au moins l'une des première et seconde extrémités de guidage définit un passage de guidage configuré pour recevoir sélectivement une broche de guidage au moins partiellement à travers celui-ci.
PCT/US2024/038710 2023-07-19 2024-07-19 Dispositif de guidage chirurgical Pending WO2025019759A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US202363527709P 2023-07-19 2023-07-19
US63/527,709 2023-07-19

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WO2025019759A2 true WO2025019759A2 (fr) 2025-01-23
WO2025019759A3 WO2025019759A3 (fr) 2025-04-24

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Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20120277745A1 (en) * 2009-04-21 2012-11-01 Emmanuel Lizee Systems and methods for positioning a foot in ankle arthrodesis
US9011503B2 (en) * 2009-07-14 2015-04-21 Neil Duggal Joint arthrodesis and arthroplasty
JP7712265B2 (ja) * 2019-09-12 2025-07-23 パラゴン２８・インコーポレイテッド インプラントガイド、デバイス、システムおよび使用方法
CN115281809A (zh) * 2022-08-12 2022-11-04 林焱斌 一种股骨颈轴心加压及侧方支撑钉板系统
CN218922719U (zh) * 2022-11-07 2023-04-28 重庆富沃思医疗器械有限公司 跟骨导向架
CN218979151U (zh) * 2022-11-15 2023-05-09 甘肃省中医院 一种具有导向功能的跟骨复位器

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