WO2008024563A2 - Medical device with expansion mechanism - Google Patents

Medical device with expansion mechanism Download PDF

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Publication number
WO2008024563A2
WO2008024563A2 PCT/US2007/072952 US2007072952W WO2008024563A2 WO 2008024563 A2 WO2008024563 A2 WO 2008024563A2 US 2007072952 W US2007072952 W US 2007072952W WO 2008024563 A2 WO2008024563 A2 WO 2008024563A2
Authority
WO
WIPO (PCT)
Prior art keywords
elongate body
distal end
end portion
lumen
elongate
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.)
Ceased
Application number
PCT/US2007/072952
Other languages
English (en)
French (fr)
Other versions
WO2008024563A3 (en
Inventor
Meera Sankaran
Gregory B. Arcenio
Arthur S. Hsieh
Derek Rothwell
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.)
Medtronic PLC
Medtronic Spine LLC
Original Assignee
Kyphon SARL
Kyphon Inc
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 Kyphon SARL, Kyphon Inc filed Critical Kyphon SARL
Priority to JP2009519610A priority Critical patent/JP2009542422A/ja
Priority to EP07840360A priority patent/EP2037818A2/en
Publication of WO2008024563A2 publication Critical patent/WO2008024563A2/en
Publication of WO2008024563A3 publication Critical patent/WO2008024563A3/en
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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
    • A61B17/1662—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans for particular parts of the body
    • A61B17/1671—Instruments for performing osteoclasis; Drills or chisels for bones; Trepans for particular parts of the body for the spine
    • 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
    • A61B17/1613—Component parts
    • A61B17/1615—Drill bits, i.e. rotating tools extending from a handpiece to contact the worked material
    • A61B17/1617—Drill bits, i.e. rotating tools extending from a handpiece to contact the worked material with mobile or detachable parts
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00—Surgical instruments, devices or methods
    • A61B2017/00831—Material properties
    • A61B2017/00867—Material properties shape memory effect
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B2217/00—General characteristics of surgical instruments
    • A61B2217/002—Auxiliary appliance
    • A61B2217/005—Auxiliary appliance with suction drainage system

Definitions

  • an expandable member is configured to disrupt tissue in a biological body when in an expanded configuration and rotated relative to the biological body.
  • An actuator is coupled to the expandable member and is configured to bias the expandable member into the expanded configuration.
  • the actuator is configured to move the expandable member into a collapsed configuration when the actuator is actuated.
  • the biological body can be, for example, a vertebra or a n intervertebral disc.
  • a medical device includes an actuator configured to bias an expandable member into a collapsed configuration and move the expandable member to an expanded configuration upon actuation.
  • FIG. 12 is a side view shown partially in cross-section of a portion of a medical device shown in an expanded configuration.
  • FIG. 24 is a side perspective view of the portion of the medical device of FIG.
  • FIG. 28 is a side perspective view of a medical device according to an embodiment of the invention shown in an expanded configuration.
  • FIG. 29 is a side perspective view of the elongate member of the medical device of FIG. 28.
  • FIG. 28 shown in an expanded configuration.
  • FIG. 34 is a side view of a medical device according to an embodiment of the invention shown in a collapsed configuration.
  • FIG. 35 is a side view of the medical device of FIG. 34 shown in an expanded configuration.
  • FIGS. 36-38 are each a flowchart illustrating a method according to different embodiments of the invention
  • an apparatus in one embodiment, includes a first expandable member configured to disrupt a body when in an expanded configuration and rotated relative to the body.
  • a second expandable member is disposed within the first expandable member and is configured to block at least a portion of disrupted portions of the body from being disposed within the first expandable member.
  • an apparatus in one embodiment, includes a first elongate body having a distal end portion.
  • the distal end portion has a plurality of cutting portions, a collapsed configuration and an expanded configuration.
  • the plurality of cutting portions is configured to disrupt at least a portion of tissue within a biological body when the distal end portion is in the expanded configuration.
  • a second elongate body is movably coupled to the first elongate body.
  • An actuator is operatively coupled to a proximal end portion of the second elongate body and configured to bias the second elongate body such that the distal end portion of the first elongate body is in the expanded configuration.
  • the actuator is configured to move the second elongate body such that first elongate body is in the collapsed configuration when the actuator is actuated.
  • a method includes rotating a distal end portion of an expandable medical device within a biological body such that at least a portion of tissue within the biological body is disrupted.
  • the distal end portion of the medical device defines a plurality of openings in communication with an interior region.
  • a distal end portion of an elongate member is moved distally within a lumen of the medical device and into the interior region of the distal end portion of the medical device.
  • the elongate member is configured to displace tissue fragments from the interior region.
  • a fluid is introduced into the interior region of the medical device via the elongate member.
  • a method includes inserting a medical device in a collapsed configuration at least partially into a biological body.
  • the medical device has a sheath and an elongate body at least partially disposed within a lumen of the sheath.
  • the sheath is moved proximally such that a distal end portion of the elongate body is disposed outside of the lumen of the sheath and within the biological body.
  • the distal end portion of the elongate body has a plurality of cutting portions.
  • the method also includes rotating the medical device such that the cutting portions of the distal end portion of the elongate body disrupt at least a portion of tissue within the biological body.
  • the distal end portion 134 is at least partially disposed within the distal end portion 132 of the first elongate body 122.
  • the first elongate body 122 defines an interior region or volume 142 that is larger when the first elongate body 122 is in the expanded configuration (FIGS. 3, 5 and 9) than when it is in the collapsed configuration (FIGS. 2, 4 and 8).
  • the first elongate body 122 can be formed, for example, from a tubular member that has slits cut (e.g., laser cut) in a wall of the distal end portion 132 to form the arms 140.
  • the first elongate body 122 is also formed with a shape memory material, such as nitinol, such that the distal end portion 132 is biased to the expanded configuration.
  • the distal end portion 134 of the second elongate body 124 is disposed within the distal end portion 132 of the first elongate body 122.
  • the distal end portion 134 of the second elongate body 124 can be formed such that the second elongate body 124 expands to a slightly larger size than the interior region 142 of the first elongate body 122 and the distal end portion 134 of the second elongate body 124 expands partially into the openings 148 defined by the arms 140.
  • FIGS. 20 and 21 illustrate an embodiment of a medical device having a pull-rod that can be used to actuate the medical device between a collapsed configuration and an expanded configuration.
  • a handle of the medical device is gripped to move the medical device to an expanded configuration and released to move the medical device to a collapsed configuration.
  • a medical device 520 includes an elongate body 522 movable between a collapsed configuration as shown in FIG. 20, and an expanded configuration as shown in FIG. 21.
  • the elongate body 522 defines a lumen (not shown) and has a distal end portion 532 that includes multiple arms 540 that define openings 548 therebetween.
  • An edge of the arms 540 define cutting portions 554.
  • FIG. 22 illustrates an embodiment of a medical device similar to the medical device 220 (see FIGS. 14 and 15), except in this embodiment, the medical device includes only a single elongate body that is movable between a collapsed and expanded configuration by actuation of a sheath.
  • a medical device 620 includes an elongate body 622 disposed within a lumen (not shown) of a sheath 630. The elongate body 622 is movable between a collapsed configuration (not shown) and an expanded configuration as shown in FIG. 22.
  • the elongate body 622 has a distal end portion 632 that includes multiple arms 640 that define openings 648 therebetween.
  • the arms 640 define cutting portions 654 disposed on an edge of the arms 640.
  • the elongate body 622 defines an interior region or volume 649 that is larger when the elongate body 622 is in the expanded configuration than when it is in the collapsed configuration.
  • the elongate body 622 can be formed in the same manner as described in the previous embodiment, for example, from a tubular member that has slits cut in the distal end portion 632 to form the arms 640.
  • the elongate body 622 is also formed with a shape memory material, such as nitinol, such that the distal end portion 632 can be biased to assume the expanded configuration.
  • FIGS. 25-27 each illustrate a distal end portion of further embodiments of a medical device having both a rod and a sheath for actuation of the medical device between an expanded configuration and a collapsed configuration.
  • Each of the medical devices described with reference to FIGS. 25-27 can include an actuator as described above to actuate both the rod and the sheath and to move the elongate body between an expanded configuration and a collapsed configuration.
  • Each of the medical devices of FIGS. 25-27 can be used to disrupt tissue, and can also be used as a fracture reduction device as described above.
  • a medical device 820 includes an elongate body 822, a sheath 830 and a rod 825.
  • the elongate body 822 is disposed within a lumen (not shown) of the sheath 830.
  • the rod 725 is disposed within a lumen (not shown ) of the elongate body 822.
  • the elongate body 822 can be formed with a shape memory material, such as nitinol, in the same manner as described for previous embodiments, such that it is preset to assume an expanded configuration as shown in FIG. 25.
  • a distal end (not shown) of the rod 825 is coupled to a distal end 827 of the elongate body 822, and a proximal end (not shown) of the rod 825 is coupled to an actuator (not shown).
  • the distal end 827 is tapered such that it can be used to penetrate tissue. In such an embodiment, a separate tool to penetrate tissue is unnecessary.
  • the actuator can be for example, an actuator as described above for previous embodiments.
  • the sheath 830 is also coupled at a proximal end (not shown) to the actuator. The actuator can be used to move both the rod 825 and the sheath 830 in the same manner as described for the previous embodiments, to move the medical device 820 between a collapsed configuration and an expanded configuration.
  • FIGS. 28-33 illustrate two embodiments of a medical device having an elongate member that can be used to clear bone or other tissue out from within an interior region of the expandable portion of the medical device.
  • a medical device 1120 includes a sheath 1130 coupled to an actuator 1126, and an elongate body 1122.
  • the elongate body 1122 is at least partially disposed within a lumen (not shown) of the sheath 1130.
  • the elongate body 1122 includes a distal end portion 1132 having multiple arms 1140 that define openings 1148 and an interior region 1149.
  • the arms 1140 can be formed in the same manner as described for previous embodiments.
  • the interior region 1149 is in communication with a lumen (not shown) defined by the elongate body 1122 that extends to a proximal end of the elongate body 1122.
  • the actuator 1126 includes a housing 1152, a handle 1150 and a pivot arm 1162.
  • the actuator 1126 can be used in the same manner as described previously to actuate or translate the sheath 1130 proximally and distally, which in turn moves the distal end portion 1132 of the elongate body 1122 between a collapsed configuration and an expanded configuration.
  • the medical device 1120 also includes an elongate member 1174, as best shown in FIG. 29.
  • the elongate member 1174 is movably disposable within the lumen of the elongate body 1122 as shown in FIGS. 28 and 30. As shown in FIG. 28, the elongate member 1174 can be inserted through an opening 1176 in the housing 1152, and extend through the lumen of the elongate body 1122. A distal end portion 1178 of the elongate member 1174 can exit the lumen of the elongate body at a location within the interior region 1149.
  • the elongate member 1174 can be used to push or move tissue fragments from within the interior region 1149 and out through the openings 1148 defined by the arms 1140.
  • the elongate member 1174 can include a handle 1173 that can be grasped by a user to assist in moving the elongate member 1174 proximally and/or distally within the lumen of the elongate body 1122.
  • the elongate member 1174 can have a length such that a distal end 1171 of the elongate member 1174 can extend to a distal end of the elongate body 1122, while the handle 1173 is disposed proximally of the housing 1152.
  • the distal end 1171 of the elongate member 1174 is shown substantially flat or planar, in alternative embodiments, the distal end 1171 can be rounded or curved.
  • the distal end 1171 can also include a trocar, bevel, of other sharp tip to cut though tissue, such as bone, as it pushes fragments out of the interior region 1149.
  • the elongate member can be moved between its collapsed and configurations with, for example, an actuator.
  • the actuator can include a trigger to manually actuate the elongate member.
  • the actuator can be motorized such that it can be actuated automatically.
  • the elongate member 1274 defines an interior lumen (not shown) and multiple openings 1275 at a distal end portion 1278.
  • the distal end portion 1278 of the elongate member 1274 can exit the lumen of the elongate body 1222 within the interior region 1249 as shown in FIG. 33.
  • the elongate member 1274 can be used in the same manner as described above for elongate member 1174 to push, displace, dislodge, or move tissue fragments from within the interior region 1249 and out through the openings 1248 defined by the arms 1240.
  • a fluid such as a saline solution, can be introduced into the lumen of the elongate member 1274, through the openings 1275 and into the interior region 1249.
  • FIGS. 34 and 35 illustrate an embodiment of a medical device having a different type of actuator than previously described.
  • a medical device 1320 includes an elongate body 1322, a sheath 1330 and an actuator 1326.
  • the elongate body 1322 includes a distal end portion 1332 that has multiple arms 1340 that can move between a collapsed configuration and an expanded configuration.
  • the arms 1340 define openings 1348 and an interior region 1449.
  • the sheath 1330 defines a lumen (not shown), through which the elongate body 1322 is disposed.
  • the actuator 1326 includes a first member 1365 operatively coupled to a second member 1367 via a pair of biasing mechanisms 1363.
  • the biasing mechanisms 1363 can include, for example a spring (not shown) configured to bias the actuator 1326 into a first configuration.
  • the first member 1365 and the second member 1367 are biased into a first position relative to each other, as shown in FIG. 34.
  • the sheath 1330 is coupled to the first member 1365 and/or the second member 1367, such that when the actuator 1326 is biased into the first configuration, the sheath 1330 is moved distally, and a distal end portion 1364 of the sheath 1364 is disposed over at least a portion of the distal end portion 1332 of the elongate body 1322. This action causes the arms 1340 of the distal end portion 1332 to collapse sufficiently to insert the medical device through, for example, an access cannula.
  • FIG. 36 is a flowchart illustrating a method according to an embodiment of the invention.
  • a method includes at 80, disposing a distal end portion of a first elongate body while in a collapsed configuration at least partially into an interior of a vertebra.
  • the first elongate body has a cutting portion disposed on a distal end portion.
  • the first elongate body is expanded to an expanded configuration at 82.
  • a second elongate body that is disposed within a lumen of the first elongate body is moved from a collapsed configuration to an expanded configuration at 84.
  • the first elongate body is rotated while in the expanded configuration such that the cutting portion disrupts cancellous bone within the interior portion of the vertebra.
  • the second elongate body is configured to prevent at least a portion of disrupted cancellous bone from being disposed within the first elongate body during the rotating of the first elongate body.
  • the expanding includes moving a volume of fluid from a reservoir to an interior portion of the second elongate body.
  • the first elongate body includes a plurality of arm members, and the second elongate body is configured to prevent at least a portion of disrupted cancellous bone from entering into an interior portion defined by the plurality of arm members during the rotating.
  • FIG. 37 is a flowchart illustrating a method according to another embodiment of the invention.
  • a method includes at 81, inserting a medical device in a collapsed configuration at least partially into a biological body.
  • the biological body can be, for example, a vertebra or an intervertebral disc.
  • at least a portion of tissue within the biological body can be penetrated with a distal end of the elongate body.
  • the medical device can have a sheath and an elongate body at least partially disposed within a lumen of the sheath.
  • the distal end of the elongate body can include a plurality of cutting portions.
  • the sheath is moved proximally such that a distal end portion of the elongate body is disposed outside of the lumen of the sheath and within the biological body. Once outside of the lumen of the sheath, the distal end portion of the elongate body can assume a biased expanded configuration.
  • a rod that can optionally be disposed within a lumen of the elongate body can be moved proximally such that the distal end portion of the elongate body is moved to an expanded configuration. In such an embodiment, the rod can be moved simultaneously or sequentially with the moving of the sheath at 83.
  • the medical device can be rotated such that the cutting portions of the distal end portion of the elongate body disrupt at least a portion of tissue within the biological body.
  • the distal end portion of the elongate body in the expanded configuration can be used to distract at least a portion of tissue within the biological body.
  • a fluid can optionally be injected through a lumen of the rod and into an interior region defined by the distal end portion of the elongate body.
  • tissue fragments can optionally be suctioned from an interior region defined by the distal end portion of the elongate body through a lumen of the rod and to a location outside of the biological body.
  • the rod can be moved distally such that the distal end portion of the elongate body is moved to a collapsed configuration.
  • the sheath can be moved distally until at least a portion of the distal end portion of the elongate body is disposed within the lumen of the sheath.
  • the distal end portion of the medical device is rotated within the biological body such that at least a portion of tissue within the biological body is disrupted.
  • the distal end portion of the medical device can include multiple arms configured to disrupt tissue when rotated.
  • a distal end portion of an elongate member can be moved distally within a lumen of the medical device and into the interior region of the distal end portion of the medical device.
  • the elongate member can displace tissue fragments from the interior region.
  • the medical device can include multiple arms that define the interior region when the medical device is in the expanded configuration, and tissue fragments can be displaced through openings defined by the multiple arms of the distal end portion of the medical device.
  • a fluid can optionally be introduced into the interior region of the medical device via the elongate member.
  • the elongate member can define a lumen through which fluid can be introduced.
  • tissue fragments can optionally be suctioned out of the interior region and through a lumen defined by the elongate member.
  • the medical device for any of the embodiments may be constructed with any suitable material used for such a medical device.
  • the elongate bodies for any embodiments can be formed with nitinol, superelastic nitinol, or other shape-memory material.
  • the elongate bodies, the rods, the elongate members and the sheaths can each be formed with various biocompatible metal materials, such as stainless steel, titanium, titanium alloy, surgical steel, metal alloys, or suitable biocompatible plastic materials, such as various polymers, polyetheretherketone (PEEK), carbon fiber, ultra-high molecular weight (UHMW) polyethylene, etc., or various elastic materials, flexible materials, various rubber materials, or combinations of various materials thereof.
  • the cutting member can likewise be constructed with suitable biocompatible metals or plastics.
  • the flexible expandable member can be formed with various flexible or expandable materials such as plastics (e.g., various polymers) and/or rubber materials having flexible or expandable characteristics.
  • first elongate body and the second elongate body can each be moved between their collapsed and expanded configurations by means other than those described herein.
  • a medical device according to an embodiment described herein can be actuated with a separate actuator or device.
  • any of the embodiments of a medical device can include a ratchet mechanism operatively coupled to the actuator. This would allow the medical device to be actuated or expanded/collapsed at different increments and /or sizes.
  • a medical device according to the invention can use more than one type of actuator.
  • a medical device can include a pushrod or a pullrod and a movable sheath in combination.
  • Various types of different handles can also be used.

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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)
  • Prostheses (AREA)
PCT/US2007/072952 2006-07-07 2007-07-06 Medical device with expansion mechanism Ceased WO2008024563A2 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
JP2009519610A JP2009542422A (ja) 2006-07-07 2007-07-06 拡張機構を有する医療デバイス
EP07840360A EP2037818A2 (en) 2006-07-07 2007-07-06 Medical device with expansion mechanism

Applications Claiming Priority (8)

Application Number Priority Date Filing Date Title
US81899606P 2006-07-07 2006-07-07
US60/818,996 2006-07-07
US11/773,871 US9089347B2 (en) 2006-07-07 2007-07-05 Medical device with dual expansion mechanism
US11/773,876 2007-07-05
US11/773,871 2007-07-05
US11/773,872 US20080009876A1 (en) 2006-07-07 2007-07-05 Medical device with expansion mechanism
US11/773,876 US20080009877A1 (en) 2006-07-07 2007-07-05 Medical device with expansion mechanism
US11/773,872 2007-07-05

Publications (2)

Publication Number Publication Date
WO2008024563A2 true WO2008024563A2 (en) 2008-02-28
WO2008024563A3 WO2008024563A3 (en) 2008-11-27

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2007/072952 Ceased WO2008024563A2 (en) 2006-07-07 2007-07-06 Medical device with expansion mechanism

Country Status (4)

Country Link
US (3) US20080009876A1 (enExample)
EP (1) EP2037818A2 (enExample)
JP (1) JP2009542422A (enExample)
WO (1) WO2008024563A2 (enExample)

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US20080009875A1 (en) 2008-01-10
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