US20080009877A1 - Medical device with expansion mechanism - Google Patents

Abstract

Apparatuses and methods for accessing a tissue and expanding an apparatus within the tissue are disclosed herein. In one embodiment, 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. After rotating the distal end portion of the medical device, 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. In some embodiments, after the rotating, a fluid is introduced into the interior region of the medical device via the elongate member.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS
• This application claims priority to U.S. Provisional Patent Application Ser. No. 60/818,996, entitled “Medical Device With Dual Expansion Mechanism,” filed Jul. 7, 2006, the entire disclosure of which is herby incorporated by reference. This application is related to U.S. Patent Application entitled “Medical Device With Dual Expansion Mechanism,” Attorney Docket No. KYPH-021/01US 305363-2104, and U.S. patent application entitled “Medical Device With Expansion Mechanism,” Attorney Docket No. KYPH-021/02US 305363-2206, both filed on same date as this application, the entire disclosures of which are hereby incorporated by reference in their entirety.
BACKGROUND
• The invention relates generally to medical devices and procedures, including, for example, a medical device for percutaneously accessing a tissue and expanding the device with a dual expansion mechanism.
• Known medical devices are configured to access percutaneously a vertebra or other area of a spine to perform a variety of different medical procedures. Some known medical devices are configured to remove tissue from within the interior of a vertebra or intervertebral disc. Other known medical devices are configured to provide some type of cutting means to tear, disrupt and/or loosen tissue within a vertebra or intervertebral disc.
• In some medical procedures, while a medical device is cutting tissue, disrupted or cut material, such as tissue within a vertebra, can become lodged within the device making it difficult to collapse the device for extraction from the vertebra.
• A need exists for an apparatus and method for disrupting tissue within a biological body, such as tissue within a vertebra, that can be expanded and collapsed within the biological body.
SUMMARY OF THE INVENTION
• Apparatuses and methods for accessing a tissue and expanding an apparatus within the tissue are disclosed herein. In one embodiment, 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. After rotating the distal end portion of the medical device, 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. In some embodiments, after the rotating, a fluid is introduced into the interior region of the medical device via the elongate member.
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a schematic illustration of a medical device according to an embodiment of the invention.
• FIG. 2 is a partial cross-sectional view of a portion of a medical device shown in a collapsed configuration.
• FIG. 3 is a partial cross-sectional view of a portion of the medical device ofFIG. 2 shown in an expanded configuration.
• FIG. 4 is a side view of a portion of an expandable member of the medical device ofFIGS. 2 and 3 shown in a collapsed configuration.
• FIG. 5 is a side view of the portion of an expandable member ofFIG. 4 shown in an expanded configuration.
• FIG. 6 is a side view of a portion of an expandable member of the medical device ofFIGS. 2 and 3 shown in a collapsed configuration.
• FIG. 7 is a side view of the portion of an expandable member ofFIG. 6 shown in an expanded configuration.
• FIG. 8 is a cross-sectional view of the portion of the medical device ofFIG. 2 taken along line8-8 inFIG. 2.
• FIG. 9 is a is a cross-sectional view of the portion of the medical device ofFIG. 3 taken along line9-9 inFIG. 3.
• FIG. 10 is a side view of a medical device including a cut-away view of the handle according to an embodiment of the invention shown in a collapsed configuration.
• FIG. 11 is a side view of the medical device ofFIG. 10 shown in an expanded configuration.
• FIG. 12 is a side view shown partially in cross-section of a portion of a medical device shown in an expanded configuration.
• FIG. 13 is a cross-sectional view of the medical device ofFIG. 12 taken along line13-13 inFIG. 12.
• FIG. 14 is a side view of the medical device ofFIG. 12 including a cut-away view of the handle shown in a collapsed configuration.
• FIG. 15 is a side view of the medical device ofFIG. 14 shown in an expanded configuration.
• FIG. 16 is a side view of a portion of a medical device according to another embodiment of the invention.
• FIG. 17 is a cross-sectional view of the medical device ofFIG. 16 taken along line17-17 inFIG. 16.
• FIG. 18 is a side view of a medical device according to an embodiment of the invention shown in an expanded configuration.
• FIG. 19 is a side view of the medical device ofFIG. 18 shown in a collapsed configuration.
• FIG. 20 is a side view of a medical device according to an embodiment of the invention shown in a collapsed configuration.
• FIG. 21 is a side view of the medical device ofFIG. 20 shown in an expanded configuration.
• FIG. 22 is aside view of a medical device including a cut-away view of the handle according to an embodiment of the invention shown in an expanded configuration.
• FIG. 23 is a side perspective view of a portion of a medical device according to another embodiment of the invention shown in an expanded configuration.
• FIG. 24 is a side perspective view of the portion of the medical device ofFIG. 23 shown in a collapsed configuration.
• FIG. 25 is a side perspective view of a portion of a medical device according to another embodiment of the invention shown in an expanded configuration.
• FIG. 26 is a side perspective view of a portion of a medical device according to another embodiment of the invention shown in an expanded configuration.
• FIG. 27 is a side perspective view of a portion of a medical device according to another embodiment of the invention shown in an expanded configuration.
• 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 ofFIG. 28.
• FIG. 30 is a side perspective view of a distal portion of the medical device ofFIG. 28 shown in an expanded configuration.
• FIG. 31 is a side perspective view of a medical device according to an embodiment of the invention shown in an expanded configuration.
• FIG. 32 is a side perspective view of the elongate member of the medical device ofFIG. 31.
• FIG. 33 is a side perspective view of a distal portion of the medical device ofFIG. 31 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 ofFIG. 34 shown in an expanded configuration.
• FIGS. 36-38 are each a flowchart illustrating a method according to different embodiments of the invention
DETAILED DESCRIPTION
• The devices and methods described herein are configured for percutaneous deployment within an interior area of a patient's body, such as within a hard tissue area (e.g., bone structure) or soft tissue area of a patient. In some embodiments, the apparatus and methods disrupt, sever, and/or cut a portion of a tissue within a tissue area. In some embodiments, the apparatus and methods create a cavity within the tissue area. For example, a medical device according to an embodiment of the invention includes an expandable member that can be expanded while disposed within a tissue and rotated or otherwise caused to move such that a cutting portion disposed on the expanded member cuts tissue within the tissue area of the patient.
• In some embodiments a medical device as described herein can be used to distract soft tissue, bone, or other biological material. For example, a medical device according to some embodiments that can be used to prepare a bone, such as a vertebral body, for insertion of an inflation balloon tamp (IBT). The medical device can be used, for example, to scrape biological material within the bone to form a cavity to allow a user to more easily insert the IBT and reduce the likelihood of ruptures to the balloon during inflation. The medical devices described herein can include a whisk-like member formed with, for example, a super-elastic nitinol tube. The medical device can include flared portions at a distal end that are formed by laser-cut slits or notches in the sidewall of the tube. The slits or notches can be evenly spaced around a diameter of the tube, or spaced at different distances from around the tube. The flared portion can be actuated between a collapsed configuration for insertion into a body, and an expanded configuration for use in distracting, scraping, tearing, etc. biological material within a tissue or biological structure.
• In some embodiments, the flared portions can be actuated using a sheath. In some embodiments, the flared portions can be actuated using a pullrod or a pushrod. In other embodiments, both a sheath and a pullrod or a pushrod can be used to actuate the flared portions. Some embodiments of a medical device include two members that have flared portions. The size of the flared portions can be varied to accommodate the formation of different sized cavities. For example, the size and/or pitch of the flared portions can be varied; the number and location of the flared portions can also be varied. In some embodiments, a medical device can have flared portions only on one side of the medical device. The medical device and flared portions can thus be sized or tailored for use in different medical procedures, and in different areas of anatomy.
• In one embodiment, an apparatus 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.
• In another embodiment, an elongate body includes a distal end portion having an expanded configuration and a collapsed configuration. At least a portion of a flexible member having an expanded configuration and a collapsed configuration is disposed within the distal end portion of the elongate body. A reservoir is in fluid communication with the flexible member. An actuator is coupled to the reservoir. The actuator is configured to actuate the elongate body between its collapsed configuration and its expanded configuration while simultaneously actuating movement of fluid contained within the reservoir and the flexible member to actuate the flexible member between its collapsed configuration and its expanded configuration.
• In one embodiment, an apparatus 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.
• In one embodiment, 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. After rotating the distal end portion of the medical device, 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. In some embodiments, after the rotating, a fluid is introduced into the interior region of the medical device via the elongate member.
• In one embodiment, an apparatus includes a first elongate body that includes a distal end portion having 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.
• In one embodiment, an apparatus includes a sheath defining a lumen and an elongate body at least partially disposed within the lumen of the sheath. The elongate body has a distal end portion that has a collapsed configuration and an expanded configuration. A rod is movably disposed within a lumen of the elongate body. An actuator is coupled to the sheath and the rod and configured to bias the sheath into a first position and the rod into a first position such that the distal end portion of the elongate body is in the expanded configuration.
• In one embodiment, 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. After the inserting, 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.
• In one embodiment, 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. After the rotating, 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.
• In one embodiment, an apparatus includes an elongate body that includes a distal end portion having a collapsed configuration and an expanded configuration. The distal end portion of the elongate body defines a plurality of openings in communication with an interior region when the distal end portion of the elongate body is in the expanded configuration. An elongate member is movably disposable within a lumen of the elongate body. The elongate member is configured to move tissue fragments from the interior region and through the plurality of openings when the distal end portion is in the expanded configuration.
• It is noted that, as used in this written description and the appended claims, the singular forms “a,” “an” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, the term “a lumen” is intended to mean a single lumen or a combination of lumens. Furthermore, the words “proximal” and “distal” refer to direction closer to and away from, respectively, an operator (e.g., surgeon, physician, nurse, technician, etc.) who would insert the medical device into the patient, with the tip-end (i.e., distal end) of the device inserted inside a patient's body. Thus, for example, the catheter end inserted inside a patient's body would be the distal end of the catheter, while the catheter end outside a patient's body would be the proximal end of the catheter.
• The term “tissue” is used here to mean an aggregation of similarly specialized cells that are united in the performance of a particular function. For example, a tissue can be a soft tissue area (e.g., a muscle), a hard tissue area (e.g., a bone structure), a vertebral body, an intervertebral disc, a tumor, etc. The terms “body” and “biological body” are also referred to herein to have a similar meaning as the term tissue.
• The term “cutting portion” is used here to mean a component of an apparatus having at least one cutting surface and being configured to, for example, cut, sever, disrupt, scrape, or tear tissue. The cutting portion can be, for example, a cutting surface disposed on an elongate body, such as a cutting surface disposed on an edge of an expandable portion of an elongate body. The cutting portion can also be a separate component coupled to a medical device.
• The term “sheath” is used here to mean a component of the apparatus having one or more passageways configured to receive a device or other component. For example, a sheath can be substantially tubular. A sheath can be a variety of different shapes and size, such as having a round, square, rectangular, triangular, elliptical, or octagonal inner and/or outer perimeter. The sheath can be, for example, a cannula.
• FIG. 1 is a schematic illustration of a medical device according to an embodiment of the invention. Amedical device20 includes a firstexpandable member22 and a secondexpandable member24 disposed at least partially within an interior volume or region (not shown inFIG. 1) defined by the firstexpandable member22. The firstexpandable member22 can be for example, disposed on or incorporated with an elongate body. Likewise, the secondexpandable member24 can be disposed on or incorporated with an elongate body. A first cutting portion (not shown inFIG. 1) can be disposed on the firstexpandable member22, as will be described in more detail below with reference to specific embodiments. The cutting portion can be a separate component coupled to the firstexpandable member22 and/or secondexpandable member24, or a sharpened edge or surface defined by the firstexpandable member22 and/or secondexpandable member24.
• In some embodiments, the firstexpandable member22 can be disposed within a lumen of a third elongate body, such as asheath30, that can be used to move the firstexpandable member22 between a collapsed configuration and an expanded configuration. For example, the firstexpandable member22 can be formed with a shape-memory material, such as nitinol, and have an expanded preset configuration. The firstexpandable member22 can include multiple arms and have a whisk-type shape. For example, the firstexpandable member22 can be formed from a tubular member that has a portion with slits cut (e.g., laser cut) along an outer surface to define multiple arms. In some embodiments, the firstexpandable member22 can be a separate component coupled to an elongate body. For example, the arms can be formed as one or more separate components that are coupled to an elongate body. The firstexpandable member22 can be restrained in the collapsed configuration while disposed within a lumen of the sheath. When the firstexpandable member22 is released from or disposed outside of the lumen of the sheath, the firstexpandable member22 will be biased into its preset expanded configuration. Alternatively, the firstexpandable member22 can be formed with other material(s) such as a flexible material that will allow the firstexpandable member22 to be moved to an expanded configuration with the assistance of another component, such as a balloon disposed within an interior of the firstexpandable member22.
• As stated above, the secondexpandable member24 is at least partially disposed within an interior volume defined by the firstexpandable member22. The secondexpandable member24 has a collapsed configuration and an expanded configuration. The secondexpandable member24 can be formed at least in part, for example, from an expandable flexible material. For example, the secondexpandable member24 can include a balloon. In some embodiments, the secondexpandable member24 can alternatively be formed with a shape-memory material, such as nitinol, and include, for example, multiple expandable ribs similar to the arms described above for the firstexpandable member22. For example, the secondexpandable member24 can be formed with a tubular member having slits cut along an outer wall and have a whisk shape similar to the firstexpandable member22.
• Themedical device20 can also include anactuator26 that can be used to actuate the firstexpandable member22 and the secondexpandable member24 between their respective collapsed configurations and expanded configurations. In some embodiments, for example, as stated above, the firstexpandable member22 can be disposed within a lumen of thesheath30, and the secondexpandable member24 can be disposed within an interior region of the firstexpandable member22. Thesheath30 can be moved or actuated by theactuator26 between a first position and a second position. When thesheath30 is in the first position, the firstexpandable member22 and the secondexpandable member24 are constrained within the lumen of thesheath30 in their collapsed configurations. When thesheath30 is moved to its second position, the firstexpandable member22 and the secondexpandable member24 are each positioned outside of the lumen of thesheath30 such that the firstexpandable member22 and the secondexpandable member24 are moved to their respective expanded configurations. Theactuator26 can include a handle (not shown inFIG. 1) that can be actuated by a user to move the sheath between its first position and its second position.
• In some embodiments, theactuator26 can include anoptional reservoir28 that defines an interior region that can receive and contain a fluid therein. Thereservoir28 can be coupled to and in fluid communication with the secondexpandable member24. Thus, fluid can be received and contained within a closed fluid system defined at least in part by the secondexpandable member24 and thereservoir28. For example, thereservoir28 can be in fluid communication with the secondexpandable member24 with, for example, a shaft, hose or other member (not shown inFIG. 1). In such an embodiment, a volume of the fluid contained within the closed fluid system can be moved out of thereservoir28 while a volume of fluid will be moved into the secondexpandable member24 simultaneously with actuating the movement of thesheath30 into its second position. When thesheath30 is moved to its second position, the firstexpandable member22 is released and biased into its expanded configuration. The secondexpandable member24 will receive a volume of fluid from within the closed fluid system, causing the secondexpandable member24 to move to its expanded configuration. In some embodiments, the volume of fluid within the secondexpandable member24 when in the expanded configuration is such that the secondexpandable member24 in the expanded configuration has a slightly greater interior volume than an interior volume of the firstexpandable member22.
• In use, themedical device20 can be percutaneously inserted into a biological body or tissue of a patient, such as a vertebral body, with the firstexpandable member22 and the secondexpandable member24 in their collapsed configurations. In some embodiments, themedical device20 is inserted through a separate cannula used to gain access to a tissue site. Themedical device20 can be actuated, for example using a handle, to move the firstexpandable member22 and the secondexpandable member24 to their expanded configurations. With the firstexpandable member22 and the secondexpandable member24 in their expanded configurations and disposed within a tissue, themedical device20 can be rotated such that a cutting portion on the firstexpandable member22 and/or the secondexpandable member24 scrapes, or otherwise cuts tissue, such as cancellous bone, at the tissue site. The secondexpandable member24 can be used as a block to help prevent at least a portion of the scraped or disrupted tissue from entering into the interior region of the firstexpandable member22, as will be described in more detail below. Blocking at least a portion of the disrupted tissue from being disposed within the interior region of the firstexpandable member122 can assist in the collapsing and removal of the firstexpandable member122. The firstexpandable member22 and the secondexpandable member24 can then be actuated or moved to their collapsed configurations, to allow themedical device20 to be removed from the tissue.
• In some embodiments, amedical device20 includes only a single expandable member. In such an embodiment, the expandable member can be moved between an expanded configuration and a collapsed configuration using a sheath as described above, or with the use of a pushrod or a pullrod. In some embodiments, as sheath is used in conjunction with a pushrod or a pullrod. In some embodiments, amedical device20 includes an elongate member (not shown inFIG. 1). The elongate member can be used to clear tissue fragments (e.g., bone fragments) out of an interior region defined by the expandable member. The elongate member can also be configured to introduce fluid into the interior region and/or provide suction to remove tissue fragments from within the interior region of the expandable member.
• Having described above various general examples, several examples of specific embodiments are now described. These embodiments are only examples, and many other configurations of amedical device20 are contemplated.
• FIGS. 2-11 illustrate a medical device according to an embodiment of the invention. As shown inFIG. 2, amedical device120 includes a firstelongate body122 disposed within alumen136 of asheath130, and a secondelongate body124 disposed at least partially within alumen138 of the firstelongate body122. The secondelongate body124 also defines a lumen146 (shown inFIGS. 8 and 9).FIGS. 2 and 3 are each a side view of a portion of themedical device120 showing thesheath130 in cross-section and the firstelongate body122 in partial cross-section. The firstelongate body122 has a collapsed configuration, as shown inFIGS. 2 and 4, and an expanded configuration as shown inFIGS. 3 and 5. The secondelongate body124 has a collapsed configuration, as shown inFIGS. 2 and 6 and an expanded configuration as shown inFIGS. 3 and 7. In this embodiment, the firstelongate body122 has an expandable member disposed at adistal end portion132 that includesmultiple arms140 that defineopenings148 therebetween. The firstelongate body122 also includes cuttingportions154 disposed on thearms140 of the firstelongate body122. The secondelongate body124 is a flexible member that has an expandable member, such as a flexible membrane at adistal end portion134. For example, the flexible membrane can be a balloon. Thedistal end portion134 is at least partially disposed within thedistal end portion132 of the firstelongate body122.
• The firstelongate body122 defines an interior region orvolume142 that is larger when the firstelongate body122 is in the expanded configuration (FIGS. 3, 5 and9) than when it is in the collapsed configuration (FIGS. 2, 4 and8). The firstelongate body122 can be formed, for example, from a tubular member that has slits cut (e.g., laser cut) in a wall of thedistal end portion132 to form thearms140. The firstelongate body122 is also formed with a shape memory material, such as nitinol, such that thedistal end portion132 is biased to the expanded configuration.
• Thedistal end portion134 of the secondelongate body124 also defines aninterior region144, as best shown in the cross-sectional view ofFIG. 9, that is larger when the secondelongate body124 is in the expanded configuration than when in the collapsed configuration. As stated above, in this embodiment, thedistal end portion134 of the secondelongate body124 is a flexible member, such as a balloon. In some embodiments, the secondelongate body124 is monolithically formed. In alternative embodiments, different portions of the secondelongate body124 are formed with different materials. For example, in some embodiments, the secondelongate body124 is formed entirely with a flexible material. In another alternative embodiment, thedistal end portion134 is formed with a flexible material and the remaining portion of the secondelongate body124 is formed with a non-flexible material.
• As shown inFIGS. 2, 3,9 and10, thedistal end portion134 of the secondelongate body124 is disposed within thedistal end portion132 of the firstelongate body122. In some embodiments, thedistal end portion134 of the secondelongate body124 can be formed such that the secondelongate body124 expands to a slightly larger size than theinterior region142 of the firstelongate body122 and thedistal end portion134 of the secondelongate body124 expands partially into theopenings148 defined by thearms140.
• Themedical device120 also includes anactuator126 as shown inFIGS. 10 and 11. Theactuator126 includes ahandle150 that can be actuated by a user and ahousing152.FIGS. 10 and 11 show themedical device120 with a portion of thehousing152 removed so that a portion of an interior of themedical device120 can be viewed.FIG. 10 illustrates themedical device120 in a collapsed configuration andFIG. 11 illustrates themedical device120 in an expanded configuration. Thehandle150 is operatively coupled to thesheath130 and also to areservoir128 and aslide member168. Thereservoir128 defines aninterior region129. Thereservoir128 can receive and contain a fluid within theinterior region129, and is in fluid communication with the secondelongate body124 through ashaft156 and through thelumen146 of the secondelongate body124. In some embodiments, theshaft156 is formed integrally with the secondelongate body124. In some embodiments, the shaft is disposed at least partially outside of thehousing150. Thus, the secondelongate body124, thereservoir128, and theshaft156 define a closed fluid system as will be described in more detail below. Aplunger158, such as a medical syringe plunger, is disposed within thereservoir128. Theplunger158 and theslide member168 are coupled to a spring (not shown), such as a compression spring, disposed within acompartment160. Theplunger158 is also coupled to thehandle150 via apivot arm162. The spring biases thehandle150 into an open position as shown inFIG. 11.
• To move themedical device120 from the expanded configuration to the collapsed configuration, the user grips thehandle150 of theactuator126 such that thehandle150 is moved toward thehousing152 as shown inFIG. 10. This action will move thesheath130 distally to a first position in which adistal end164 of thesheath130 is positioned substantially over thedistal end portion132 of the first elongate body122 (e.g., thedistal end portion132 is disposed at least partially within thelumen136 of the sheath130). This action will collapse thedistal end portion132 of the firstelongate body122. Simultaneously, theplunger128 will be moved toward thespring compartment160 and at least partially compress the spring. A volume of fluid in thedistal end portion134 of the secondelongate body124 will be drawn out of thedistal end portion134 and a volume of fluid will be drawn into thereservoir128. In other words, a portion of the fluid within the closed fluid system will be caused to move to thereservoir128. The fluid movement out of thedistal end portion134 allows thedistal end portion132 of the firstelongate body122 to collapse over thedistal end portion134 of the secondelongate body124. Thus, in the collapsed configuration, a volume of fluid within thedistal end portion134 of the secondelongate body124 is less than a volume of fluid in thedistal end portion134 when the secondelongate body124 is in the expanded configuration. A volume of fluid within thereservoir128 when thedistal end portion134 of the secondelongate body124 is in the collapsed configuration is greater than a volume of fluid in thereservoir128 when thedistal end portion134 of the secondelongate body124 is in the expanded configuration.
• In the collapsed configuration, themedical device120 can be inserted into a tissue of a patient, such as a vertebral body. For example, themedical device120 can be inserted through an access cannula (not shown) while the user holds thehandle150 against thehousing152 as shown inFIG. 10. While disposed within the tissue, the user can release thehandle150, which will allow the spring to bias thehandle150 back to the open position, as shown inFIG. 11. This action will move thedistal end164 of thesheath130 proximally such that the firstelongate body122 is disposed outside thelumen136 of thesheath130 as shown inFIG. 11. When thedistal end portion132 of the firstelongate body122 is no longer constrained by thesheath130, thedistal end portion132 will be automatically biased to the expanded configuration. Simultaneously, theplunger128 will move away from the spring compartment160 (e.g., due to the biasing force of the spring) and force fluid out of thereservoir128 and into theshaft156. With thedistal end portion132 of the firstelongate body122 in the expanded configuration, thedistal end portion134 of the secondelongate body124 can receive a volume of fluid that has been pushed out of thereservoir128 and move to its expanded configuration.
• In the expanded configuration, themedical device120 can be rotated or otherwise moved within the tissue such that the cuttingportions154 disposed at thedistal end portion132 of the firstelongate body122 scrape, tear, or otherwise disrupt tissue, such as cancellous bone, within the tissue. Thedistal end portion134 of the secondelongate body122 will block at least a portion of the scraped, tom or disrupted tissue from entering into theinterior region142 of the firstelongate body122.
• To move themedical device120 back to the collapsed configuration, the user again grips thehandle150, such that thehandle150 is moved closer to thehousing152, as shown inFIG. 10. This will again move themedical device120 to the collapsed configuration as described above. The user can then remove themedical device120 from the tissue, for example, through an access cannula.
• Although the firstelongate body122 has been described as being formed with a shape-memory material having a preset expanded configuration, in alternative embodiments, the firstelongate body122 can be formed with other materials that do not have shape-memory characteristics. In such an embodiment, the firstelongate body122 can be moved to its expanded configuration by actuation of the secondelongate body124 to its expanded configuration. For example, the secondelongate body124 can be moved to an expanded configuration as fluid is received within the interior region of the secondelongate body124 as described above. As this occurs, the expansion of the secondelongate body124 will also cause the firstelongate body122 to expand. To collapse the firstelongate body122, thehandle150 can be gripped by the user as described above, which will move thesheath130 distally over thedistal end portion132 of the firstelongate body122 and collapse thedistal end portion132 of the firstelongate body122. In one variation, the firstelongate body122 can be formed with a shape-memory material and biased into a collapsed configuration. In this embodiment, when the secondelongate body124 is collapsed, the firstelongate body122 will be biased back to its collapsed configuration without the use of a sheath.
• Although the actuation of themedical device120 has been described as gripping thehandle150 to move themedical device120 to the collapsed configuration, and releasing thehandle150 to move themedical device120 to the expanded configuration, in alternative embodiments, thehandle150 can be actuated in an opposite manner. For example, a medical device can be configured such that the user can grip the handle against the housing to move the medical device to the expanded configuration and release the handle to move the medical device to the collapsed configuration. In other alternative embodiments, the handle can be actuated with linear movement. For example, the handle can extend parallel to an axis defined by the first elongate body and/or the second elongate body such that rather than gripping the handle against the housing to actuate the medical device, the user actuates the handle with linear motion similar to movement of a syringe.
• In yet another embodiment, themedical device120 can be actuated using a reservoir that is in fluid communication with the second elongate body through an elongate shaft. In such an embodiment, the reservoir and second elongate body can define a closed fluid system as described above where a volume of fluid is moved into the distal end portion of the second elongate body to move the distal end portion to an expanded configuration and drawn out of the distal end portion to move the distal end portion to a collapsed configuration. In this embodiment, to actuate the second elongate body from a collapsed configuration to an expanded configuration, a user can squeeze the reservoir such that a volume of fluid is pushed out of the reservoir and a volume of fluid is moved into the distal end portion of the second expandable member.
• In such an embodiment, the distal end portion of the first elongate body can be formed with a shape-memory material and biased into a collapsed configuration. When the distal end portion of the second elongate body is moved to its expanded configuration, the first elongate body will also be moved to its expanded configuration by the inflation of the second expandable member. When the reservoir is released, a volume of fluid will be drawn back into the reservoir and a volume of fluid will be drawn out the distal end portion of the second elongate body, collapsing the distal end portion of the second elongate body. With the distal end portion of the second elongate body collapsed, the first elongate body will be biased back to its collapsed configuration.
• FIGS. 12-15 illustrate a medical device according to another embodiment. Amedical device220 includes a firstelongate body222 disposed within alumen236 of asheath230, and a secondelongate body224 disposed at least partially within alumen238 of the firstelongate body222. The secondelongate body224 also defines a lumen246 (shown inFIG. 13).FIGS. 12 and 13 are side views of a portion of themedical device220 showing thesheath230 in cross-section and the firstelongate body222 in partial cross-section. The firstelongate body222 has a collapsed configuration (not shown) and an expanded configuration as shown inFIGS. 12 and 13. The secondelongate body224 has a collapsed configuration (not shown) and an expanded configuration as shown inFIGS. 12 and 13.
• In this embodiment, the firstelongate body222 has adistal end portion232 that includesmultiple arms240 that defineopenings248 therebetween. The firstelongate body222 also includes cuttingportions254 disposed on thearms240 of the firstelongate body222. The secondelongate body224 has adistal end portion234 that definesmultiple ribs266 and is at least partially disposed within thedistal end portion232 of the firstelongate body222 such that theribs266 are in an offset relationship with thearms240. The secondelongate body224 also includes cuttingportions270 disposed on theribs266. In alternative embodiments, the secondelongate body224 does not include cutting portions.
• As with the previous embodiment, the firstelongate body222 defines an interior region or volume (not shown) that is larger when the firstelongate body222 is in the expanded configuration than when it is in the collapsed configuration. The firstelongate body222 can be formed in the same manner as described in the previous embodiment, for example, from a tubular member that has slits cut in thedistal end portion232 to form thearms240. The firstelongate body222 is also formed with a shape memory material, such as nitinol, such that thedistal end portion232 is biased to assume the expanded configuration.
• Thedistal end portion234 of the secondelongate body224 also defines an interior region (not shown) that is larger when the secondelongate body224 is in the expanded configuration than when in the collapsed configuration. In this embodiment, the secondelongate body224 is formed with a shape-memory material such that thedistal end portion234 has a preset expanded configuration. For example, thedistal end portion234 of the secondelongate body224 can be formed with slits cut along an outer wall to define theribs266. As shown inFIGS. 12 and 13, thedistal end portion234 of the secondelongate body224 is disposed within thedistal end portion232 of the firstelongate body222 such that theribs266 are disposed substantially within theopenings248 defined by thearms240.
• Themedical device220 also includes anactuator226 as shown inFIGS. 14 and 15. Theactuator226 includes ahandle250 that can be actuated by a user and ahousing252.FIGS. 14 and 15 show themedical device220 with a portion of thehousing252 removed so that a portion of an interior of themedical device220 can be viewed.FIG. 14 illustrates themedical device220 in a collapsed configuration;FIG. 15 illustrates themedical device220 in an expanded configuration. In this embodiment, thehandle250 is operatively coupled to thesheath230 as described in the previous embodiment, and also to aslide member268 via thepivot arm262. Theslide member268 is coupled to a spring (not shown), such as a compression spring, that is disposed within acompartment260. As with the previous embodiment, the spring biases thehandle250 to an open position as shown inFIG. 15.
• To move themedical device220 from the expanded configuration to the collapsed configuration, the user grips thehandle250 such that thehandle250 is moved toward thehousing252 as shown inFIG. 14. This action will move thesheath230 distally to a first position in which adistal end264 of thesheath230 is positioned substantially over thedistal end portion232 of the firstelongate body222. Thus, thedistal end portion232 of the firstelongate body222 and thedistal end portion234 of the secondelongate body224 will be constrained in their respective collapsed configurations within thelumen236 of thesheath230.
• In the collapsed configuration, themedical device220 can be inserted into a tissue of a patient, such as a vertebral body. For example, themedical device220 can be inserted through an access cannula. While disposed within the tissue, the user can release thehandle250 to move themedical device220 to the expanded configuration. With thehandle250 released, the spring will bias thehandle250 to the open position as shown inFIG. 15. This action will move thedistal end264 of thesheath230 proximally such that thedistal end portion232 of the first elongate body222 (and thedistal end portion234 of the secondelongate body224 disposed within the first elongate body222) is disposed outside thelumen236 of thesheath230, as shown inFIG. 15. When thedistal end portion232 of the firstelongate body222, and thedistal end portion234 of the secondelongate body224 are no longer constrained by thesheath230, thedistal end portion232 and thedistal end portion234 will be automatically biased to their respective expanded configurations.
• In the expanded configuration, themedical device220 can be rotated or otherwise moved within the tissue such that the cuttingportions254 of the firstelongate body222 and the cuttingportions270 of the secondelongate body224 scrape, tear, or otherwise disrupt tissue, such as cancellous bone, within the tissue. Because theribs266 of thedistal end portion234 of the secondelongate body222 are disposed in an offset relationship with the arms240 (i.e., disposed within the openings248) theribs266 will block at least a portion of the torn or disrupted tissue from entering into the interior region of the firstelongate body222.
• To move themedical device220 back to the collapsed configuration, the user again grips thehandle250, such that thehandle250 is moved closer to thehousing252, as shown inFIG. 14. This will again move themedical device220 to the collapsed configuration as described above. The user can then remove themedical device220 from the tissue, for example, through an access cannula.
• FIGS. 16 and 17 illustrate yet another embodiment of a medical device. Amedical device320 is constructed similar to themedical device120. For example, themedical device320 includes asheath330, a firstelongate body322 disposed within a lumen (not shown) of thesheath330, and a secondelongate body324 disposed within a lumen (not shown) of the firstelongate body322. In this embodiment, the firstelongate body322 includes adistal end portion332 havingmultiple arms340 and cuttingportions354 disposed on thearms340. In this embodiment, rather than being formed from a tubular member, thearms340 can be formed as one or more separate components, for example, with a flexible shape-memory material, such as nitinol, and coupled to the firstelongate body322.
• The secondelongate body324 includes a flexible membrane at adistal end portion334 that is disposed within thedistal end portion332 of the firstelongate body322. The secondelongate body324 also defines alumen346 as shown inFIG. 17. Thelumen346 can be used to communicate fluid between thedistal end portion334 of the secondelongate body324 and a reservoir (not shown) as previously described.
• In this embodiment, thedistal end portion332 is biased into an expanded configuration and includes fourarms340 that each include a hinge orbreak point372. Thebreak points372 fold when the firstelongate body324 is moved from a collapsed configuration to the expanded configuration. Themedical device320 can be moved between an expanded configuration and a collapsed configuration in a similar manner as described above formedical device120.
• In another alternative embodiment, a medical device can include a pull-rod to actuate the expansion of a first elongate body. In such an embodiment, a sheath would not be necessary. A pull-rod can be operatively coupled to the actuator such that the first elongate body can be actuated simultaneously with the actuation of the second elongate body. For example, in an embodiment with a second elongate body having a flexible member (e.g. balloon) disposed within a first elongate body having a whisk-type configuration, the flexible member can be configured with a passageway to receive the pull-rod therethrough. The pull-rod can be pulled proximally to move the first elongate body to the expanded configuration simultaneously with the inflation of fluid within the flexible member of the first elongate body. In an embodiment with a second elongate body having a whisk-type configuration instead of a balloon, the pull-rod can be configured to actuate simultaneously both the first elongate body and the second elongate body.
• In yet another embodiment, a medical device can include a second elongate body having a flexible membrane disposed within a whisk-type first elongate body. In this embodiment, the arms of the first elongate body are fixed to the flexible membrane. In such an embodiment, the sheath would not be necessary to actuate the first elongate body. For example, as the flexible membrane is inflated with fluid and moved to its expanded configuration as described above, the first elongate body would also be moved to its expanded configuration. To move the device to the collapsed configuration, the fluid can be withdrawn from the flexible membrane as described previously. As the fluid is evacuated from the flexible membrane, the first elongate body will also be drawn to its collapse d configuration.
• FIGS. 18 and 19 illustrate an embodiment of a medical device using a pushrod to actuate the medical device between a collapsed configuration and an expanded configuration. In this embodiment, amedical device420 includes anelongate body422 movable between a collapsed configuration as shown inFIG. 19, and an expanded configuration as shown inFIG. 18. Theelongate body422 defines a lumen (not shown) and has adistal end portion432 that includesmultiple arms440 that define openings448 therebetween. An edge of thearms440 define cuttingportions454. Themedical device420 also includes arod425 that is at least partially disposed within the lumen of theelongate body422. A distal end of therod425 is coupled to adistal end427 of theelongate body422.
• As with the previous embodiment, theelongate body422 can be formed with a shape-memory material, such as nitinol, and configured such that thedistal end portion432 of theelongate body422 is biased into the expanded configuration as shown inFIG. 18. Theelongate body422 can be formed in the same manner as described in the previous embodiment, for example, from a tubular member that has slits or windows cut in thedistal end portion432 to form thearms440. When theelongate body422 is in the expanded configuration, thearms440 define an interior region or volume449 that is larger than when theelongate body422 is in the collapsed configuration.
• Therod425 is coupled at aproximal end431 to anactuator426. Theactuator426 includes ahandle450 and ahousing452.FIG. 18 shows themedical device420 with a portion of thehousing452 removed so that a portion of an interior of themedical device420 can be viewed. In this embodiment, thehandle450 is operatively coupled to therod425, which is used to move theelongate body422 between its expanded and collapsed configurations. Thehandle450 is coupled to aslide member468 via apivot arm462. Theslide member468 is also coupled to a spring (not shown), such as a compression spring, that is disposed within acompartment460. Theslide member468 can move or translate back-and-forth in the direction of arrows A-A as the spring moves between a biased position and a compressed position. As with the previous embodiment, the spring biases thehandle450 to an open position as shown inFIG. 18 when the spring is in its biased position. When thehandle450 is in the open position, therod425 will be moved proximally to a position as shown inFIG. 18. This will at least partially collapse the distal end portion432 (e.g., the arms440) of theelongate body422.
• To move theelongate body422 from the expanded configuration to the collapsed configuration, the user grips thehandle450 such that thehandle450 is moved toward thehousing452, as shown inFIG. 19. This action will compress the spring, and move therod425 distally, which in turn will extend or collapse the distal end portion432 (e.g., arms440) of theelongate body422.
• In the collapsed configuration, themedical device420 can be inserted into a tissue of a patient, such as a vertebral body. For example, a user can grip thehandle450, as described above, and insert themedical device420 through an access cannula and to a desired location within a tissue. While disposed within the tissue, the user can release thehandle450 to move themedical device420 to the expanded configuration. With thehandle450 released, the spring will bias thehandle450 to the open position as shown inFIG. 18 and move therod425 proximally such that thedistal end portion432 of theelongate body422 is moved to the expanded configuration. In the expanded configuration, themedical device420 can be rotated or otherwise moved within the tissue such that the cuttingportions454 of thearms440 scrape, tear, or otherwise disrupt tissue, such as cancellous bone, within the tissue.
• To move themedical device420 back to the collapsed configuration, the user again grips thehandle450, such that thehandle450 is moved closer to thehousing452, as shown inFIG. 19. This will again move themedical device420 to the collapsed configuration as described above. The user can then remove themedical device420 from the tissue, for example, through an access cannula.
• 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. In this embodiment, 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. Amedical device520 includes anelongate body522 movable between a collapsed configuration as shown inFIG. 20, and an expanded configuration as shown inFIG. 21. Theelongate body522 defines a lumen (not shown) and has adistal end portion532 that includesmultiple arms540 that define openings548 therebetween. An edge of thearms540 define cutting portions554. Themedical device520 also includes arod525 that is at least partially disposed within the lumen of theelongate body522. A distal end (not shown) of therod525 is coupled to adistal end527 of theelongate body522 and aproximal end531 of therod525 is coupled to anactuator526.
• As with the previous embodiment, theelongate body522 can be formed with a shape-memory material, such as nitinol. In this embodiment, theelongate body532 can be configured such that thedistal end portion532 of theelongate body522 is biased into the collapsed configuration as shown inFIG. 20. Theelongate body522 can be formed in the same manner as described in the previous embodiment, for example, from a tubular member that has slits or windows cut in thedistal end portion532 to form thearms540. When theelongate body520 is in the expanded configuration, thearms540 define an interior region or volume549 that is larger than when theelongate body522 is in the collapsed configuration.
• Theactuator526 includes ahandle550 and ahousing552.FIG. 20 shows themedical device520 with a portion of thehousing552 removed so that a portion of an interior of themedical device520 can be viewed. In this embodiment, thehandle550 is operatively coupled to therod525, which is used to move theelongate body522 between its expanded and collapsed configurations. Thehandle550 is coupled to aslide member568 via apivot arm562. Theslide member568 is also coupled to a spring (not shown), such as a compression spring, that is disposed within acompartment560. Theslide member568 can move or translate back-and-forth as in the previous embodiment, as the spring moves between a biased position and a compressed position. The spring in its biased position, biases thehandle550 to an open position as shown inFIG. 20, and therod525 will be moved distally to a position as shown inFIG. 20. In this position, theelongate body522 will be in its collapsed configuration.
• To move theelongate body522 from the collapsed configuration to the expanded configuration, the user grips thehandle550 such that thehandle550 is moved toward thehousing552, as shown inFIG. 21. This action will compress the spring, and move therod525 proximally, which in turn will cause the distal end portion532 (e.g., arms540) of theelongate body522 to move to its expanded configuration.
• As with the previous embodiments, when in the collapsed configuration, themedical device520 can be inserted into a tissue of a patient, such as a vertebral body. For example, themedical device520 can be inserted through an access cannula and to a desired location within a tissue. While disposed within the tissue, the user can grip thehandle550 to move themedical device520 to the expanded configuration. In the expanded configuration, themedical device520 can be rotated or otherwise moved within the tissue such that the cutting portions554 of thearms540 scrape, tear, or otherwise disrupt tissue, such as cancellous bone, within the tissue. In this embodiment, to move themedical device520 back to the collapsed configuration, the user releases thehandle550.
• FIG. 22 illustrates an embodiment of a medical device similar to the medical device220 (seeFIGS. 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. Amedical device620 includes anelongate body622 disposed within a lumen (not shown) of asheath630. Theelongate body622 is movable between a collapsed configuration (not shown) and an expanded configuration as shown inFIG. 22.
• In this embodiment, theelongate body622 has adistal end portion632 that includesmultiple arms640 that defineopenings648 therebetween. Thearms640 define cuttingportions654 disposed on an edge of thearms640. As with the previous embodiments, theelongate body622 defines an interior region orvolume649 that is larger when theelongate body622 is in the expanded configuration than when it is in the collapsed configuration. Theelongate body622 can be formed in the same manner as described in the previous embodiment, for example, from a tubular member that has slits cut in thedistal end portion632 to form thearms640. Theelongate body622 is also formed with a shape memory material, such as nitinol, such that thedistal end portion632 can be biased to assume the expanded configuration.
• Themedical device620 also includes anactuator626 that includes ahandle650 that can be actuated by a user and ahousing652. In this embodiment, thehandle650 is operatively coupled to thesheath630 and to aslide member668 via thepivot arm662. Theslide member668 is coupled to a spring (not shown), that biases thehandle650 to an open position as shown inFIG. 22. With thehandle650 is moved to its open position, thesheath630 of themedical device620 will be moved proximally such that adistal end664 of thesheath630 uncovers at least a portion of thedistal end portion632 to be moved to the expanded configuration.
• To move themedical device620 from the expanded configuration to the collapsed configuration, the user grips thehandle650 such that thehandle650 is moved toward thehousing652. This action will move thesheath630 distally to a position (not shown) in which thedistal end664 of thesheath630 is positioned substantially over thedistal end portion632 of the firstelongate body622. Thus, thedistal end portion632 of theelongate body622 will be constrained in its collapsed configuration within the lumen of thesheath630.
• As with the previous embodiments, when in the collapsed configuration, themedical device620 can be inserted (e.g., through an access cannula) and into a tissue of a patient. While disposed within the tissue, the user can release thehandle650 to move themedical device620 to the expanded configuration. This action will move thedistal end664 of thesheath630 proximally such that thedistal end portion632 of theelongate body622 is disposed outside the lumen of thesheath630, and automatically biased to its expanded configuration, as shown inFIG. 22. In the expanded configuration, themedical device620 can be rotated or otherwise moved within the tissue such that the cuttingportions654 of theelongate body622 scrape, tear, or otherwise disrupt tissue, such as cancellous bone, within the tissue. Themedical device620 can then be moved back to the collapsed configuration to remove themedical device620 from the tissue.
• FIGS. 23 and 24 each illustrate a distal end portion of an embodiment of a medical device that can be used to disrupt tissue as described above, and can also be used to reduce a fracture of a vertebra. Amedical device720 includes both a pushrod and a sheath for actuation of themedical device720 between a collapsed configuration and an expanded configuration. When deployed within a tissue in an expanded configuration, themedical device720 is capable of applying force to surrounding tissue, including bone such that at least a portion of the tissue is distracted.
• Specifically, as shown inFIG. 23, themedical device720 includes anelongate body722, asheath730 and arod725. As with themedical device620, theelongate body722 is movably disposed within a lumen (not shown) of thesheath730. As with themedical devices420 and520, therod725 is disposed within a lumen (not shown ) of theelongate body722.
• Theelongate body722 can be formed with a shape memory material, such as nitinol, in the same manner as described for previous embodiments. Theelongate body722 includes adistal end portion732 that includesarms740 that can be formed by cutting slots or windows into a wall of theelongate body722. Thearms740 define openings748 and aninterior region749. Thearms740 also include a cutting portion754 disposed, for example, on an edge of thearms740.
• A distal end (not shown) of therod725 is coupled to adistal end727 of theelongate body722, and a proximal end (not shown) of therod725 is coupled to an actuator (not shown). The actuator can be for example, an actuator as described above for previous embodiments. Thesheath730 is also coupled at a proximal end (not shown) to the actuator. The actuator can be used to move both therod725 and thesheath730 in the same manner as described for previous embodiments to move themedical device720 between a collapsed configuration and an expanded configuration.
• In this embodiment, thedistal end portion732 of theelongate body722 is pre-set (or biased) into the expanded configuration. In use, to insert themedical device720 into a tissue, a handle (not shown) of the actuator can be gripped such that thesheath730 and therod725 are both moved or translated distally (e.g., substantially simultaneously). As shown inFIG. 24, adistal end764 of thesheath730 will move to a position covering at least a portion of thedistal end portion732 of theelongate body722 causing thedistal end portion732 to at least partially collapse. Simultaneously, as therod725 is moved distally, therod725 will cause thedistal end portion732 of theelongate body722 to straighten to the collapsed configuration. Once at the desired location at a tissue site, the handle of the actuator can be released, which will cause therod725 andsheath730 to move proximally. Thedistal end portion732 of theelongate body722 will then be unconstrained by thesheath730 and allowed to assume its biased expanded configuration, as shown inFIG. 23. At the same time, therod725 will force thedistal end portion732 of theelongate body722 to the expanded configuration. Thus, therod725 will increase the rate at which, and the force with which thedistal end portion732 of theelongate body722 will move to the expanded configuration.
• The use of both thepushrod725 andsheath730 to actuate the movement of theelongate body722 from the collapsed configuration to the expanded configuration, allows themedical device720 to apply a greater force to the surrounding tissue during actuation. This can be beneficial, for example, when used in hard bone such as vertebral end plates.
• 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 toFIGS. 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 ofFIGS. 25-27 can be used to disrupt tissue, and can also be used as a fracture reduction device as described above.
• As shown inFIG. 25. amedical device820 includes an elongate body822, asheath830 and arod825. The elongate body822 is disposed within a lumen (not shown) of thesheath830. Therod725 is disposed within a lumen (not shown ) of the elongate body822. The elongate body822 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 inFIG. 25. The elongate body822 includes adistal end portion832 that includes arms840 that can be formed by cutting slots or windows into a wall of the elongate body822. The arms840 defineopenings848 and aninterior region849. The arms840 also include a cutting portion854 disposed, for example, on an edge of the arms840.
• A distal end (not shown) of therod825 is coupled to adistal end827 of the elongate body822, and a proximal end (not shown) of therod825 is coupled to an actuator (not shown). In this embodiment, thedistal end827 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. Thesheath830 is also coupled at a proximal end (not shown) to the actuator. The actuator can be used to move both therod825 and thesheath830 in the same manner as described for the previous embodiments, to move themedical device820 between a collapsed configuration and an expanded configuration.
• In an alternative embodiment, the rod can include an interior lumen with an opening in communication with the lumen at both a distal end and a proximal end of the rod. In such an embodiment, the distal end of the elongate body can define an opening in communication with the opening in the rod. Fluid can be introduced through the lumen of the rod and into a tissue via the distal openings of the rod and the elongate body. The lumen of the rod, and the distal openings in both the rod and the elongate body can also be used for suction of material out of the tissue. In some embodiments, the distal end of the elongate body can have multiple openings. For example, a syringe can be coupled to a proximal end of the rod and can be used to introduce a saline solution and/or to provide suction to remove, for example, tissue fragments from within the interior region of the distal end portion (e.g., expanded portion) of the elongate body.
• FIG. 26 illustrates amedical device920 that includes asheath930, anelongate body922 and arod925. Themedical device920 is constructed in the same manner as described above for the previous embodiment except in this embodiment, therod925 has a smaller diameter than the embodiments of a rod (e.g.,825,725) described above. The smaller diameter ofrod925, for example, provides additional space within a lumen of theelongate body922 for the insertion of other devices, or for the addition of functions to themedical device920. For example, a suction device and/or an irrigation device can be coupled to a proximal end of theelongate body922 and provide for the introduction of fluid through the lumen of the elongate body and into a tissue, and/or removal of tissue (e.g., bone fragments, nucleus material), and/or fluid (e.g., irrigation fluid) out of the tissue. In some embodiments, a separate device that provides suction and/or irrigation can be inserted through the lumen of theelongate body922.
• FIG. 27 illustrates amedical device1020 that includes asheath1030, anelongate body1022 and arod1025. Themedical device1020 is constructed in the same manner as described above for the previous embodiments except in this embodiment, therod1025 defines a lumen (not shown) and at least onewindow1031 in communication with the lumen. The lumen of therod1025 can provide for the insertion of other devices, or for the addition of functions to themedical device1020. For example, an irrigation device can be coupled to a proximal end of therod1025 and provide for the introduction of fluid through the lumen of the elongate body and into a tissue.
• In some embodiments, a suction device can be coupled to a proximal end of the rod and provide suction force to removal tissue (e.g., bone fragments, nucleus material), and/or fluid (e.g., irrigation fluid) out of the tissue. For example, as themedical device1020 is used to cut or disrupt tissue, the cut or disrupted portions of tissue can be drawn through the window(s)1031 and into the lumen of therod1025. In some embodiments, other tools, such as a rod with threaded distal portion can be introduced through the lumen of therod1025 and used to remove trapped tissue fragments (e.g., bone fragments). For example, the rod can be rotated such that tissue fragments are captured by the threaded portion of the rod through the window(s)1031.
• 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. As shown inFIGS. 28-33, amedical device1120 includes asheath1130 coupled to an actuator1126, and anelongate body1122. As with previous embodiments, theelongate body1122 is at least partially disposed within a lumen (not shown) of thesheath1130. Theelongate body1122 includes adistal end portion1132 havingmultiple arms1140 that defineopenings1148 and aninterior region1149. Thearms1140 can be formed in the same manner as described for previous embodiments. Theinterior region1149 is in communication with a lumen (not shown) defined by theelongate body1122 that extends to a proximal end of theelongate body1122.
• As with previous embodiments, the actuator1126 includes a housing1152, a handle1150 and apivot arm1162. The actuator1126 can be used in the same manner as described previously to actuate or translate thesheath1130 proximally and distally, which in turn moves thedistal end portion1132 of theelongate body1122 between a collapsed configuration and an expanded configuration.
• In this embodiment, themedical device1120 also includes anelongate member1174, as best shown inFIG. 29. Theelongate member1174 is movably disposable within the lumen of theelongate body1122 as shown inFIGS. 28 and 30. As shown inFIG. 28, theelongate member1174 can be inserted through anopening1176 in the housing1152, and extend through the lumen of theelongate body1122. Adistal end portion1178 of theelongate member1174 can exit the lumen of the elongate body at a location within theinterior region1149. Theelongate member1174 can be used to push or move tissue fragments from within theinterior region1149 and out through theopenings1148 defined by thearms1140. For example, when themedical device1120 is used to scrape or disrupt tissue as described above for previous embodiments, tissue fragments can possibly become disposed within theinterior region1149. Theelongate member1174 can be moved distally to move at least a portion of the tissue fragments out of theinterior region1149 in some instances. Theelongate member1174 can be moved proximally and distally or removed and inserted repeatedly, as desired, to tamp out tissue fragments inside theinterior region1149. In some embodiments, theelongate member1174 can be actuated by an actuator such that it oscillates back and forth. In some embodiments, theelongate member1174 can be actuated such that it is moved distally as thedistal end portion1132 of theelongate body1122 is moved from the expanded configuration to the collapsed configuration.
• Theelongate member1174 can include ahandle1173 that can be grasped by a user to assist in moving theelongate member1174 proximally and/or distally within the lumen of theelongate body1122. Theelongate member1174 can have a length such that adistal end1171 of theelongate member1174 can extend to a distal end of theelongate body1122, while thehandle1173 is disposed proximally of the housing1152. Although thedistal end1171 of theelongate member1174 is shown substantially flat or planar, in alternative embodiments, thedistal end1171 can be rounded or curved. Thedistal end1171 can also include a trocar, bevel, of other sharp tip to cut though tissue, such as bone, as it pushes fragments out of theinterior region1149.
• In alternative embodiments, an elongate member can have a collapsed configuration and an expanded configuration. For example, a distal end portion of the elongate member can have expandable arms similar to the distal end portion (e.g.,1132) of an elongate body (e.g.,1122). In such an embodiment, the elongate member can be moved from its collapsed configuration to its expanded configuration when the distal end portion of the elongate member is disposed within the interior region of the elongate body, and the expanded distal end portion of the elongate member can displace tissue fragments out of the interior region of the elongate body. In such an embodiment, 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. Alternatively, the actuator can be motorized such that it can be actuated automatically.
• FIGS. 31-33 illustrate amedical device1220 that is similar to themedical device1120. Themedical device1220 includes asheath1230 coupled to anactuator1226, and anelongate body1222. As with previous embodiments, theelongate body1222 is at least partially disposed within a lumen (not shown) of thesheath1230, and includes adistal end portion1232 havingmultiple arms1240. Thearms1240 defineopenings1248 and aninterior region1249. Thearms1240 can be formed in the same manner as described for previous embodiments. Theinterior region1249 is in communication with a lumen (not shown) defined by theelongate body1222, and that extends to a proximal end of theelongate body1222.
• Theactuator1226 includes ahousing1252, ahandle1250 and apivot arm1262. Theactuator1226 can be used in the same manner as described previously to actuate or translate thesheath1230 proximally and distally, which in turn moves thedistal end portion1232 of theelongate body1222 between a collapsed configuration and an expanded configuration.
• Themedical device1220 also includes anelongate member1274, as best shown inFIG. 32. Theelongate member1274 is movably disposable within the lumen of theelongate body1222. Theelongate member1274 is inserted through an opening (not shown) in thehousing1252, and extends through the lumen of theelongate body1222. In this embodiment, theelongate member1274 defines an interior lumen (not shown) andmultiple openings1275 at adistal end portion1278. Thedistal end portion1278 of theelongate member1274 can exit the lumen of theelongate body1222 within theinterior region1249 as shown inFIG. 33. Theelongate member1274 can be used in the same manner as described above forelongate member1174 to push, displace, dislodge, or move tissue fragments from within theinterior region1249 and out through theopenings1248 defined by thearms1240. In addition, a fluid, such as a saline solution, can be introduced into the lumen of theelongate member1274, through theopenings1275 and into theinterior region1249.
• Aproximal end1277 of theelongate member1274 includes ahandle1273 that includes a fitting1269. The fitting1269 can be, for example, a luer fitting molded into thehandle1273. The fitting1269 can be used to couple a syringe to theelongate member1274 that can be used to introduce fluid (e.g., saline) to theelongate member1274. In use, after themedical device1220 is used to scrape or disrupt tissue, theelongate member1274 can be used as described above to clear tissue fragments from theinterior region1249. Fluid can also be injected through theelongate member1274 and used to assist in clearing tissue fragments from within theinterior region1249 and out through theopenings1248. A device configured to provide suction can also optionally be coupled to the fitting1269 and used to suction tissue fragments out of theinterior region1249. In such an embodiment, depending on the type of tissue being disrupted, it may be desirable for theopenings1275 to be larger in size than shown inFIGS. 31 and 32 to allow the tissue fragments to pass through.
• FIGS. 34 and 35 illustrate an embodiment of a medical device having a different type of actuator than previously described. Amedical device1320 includes anelongate body1322, asheath1330 and anactuator1326. As shown inFIG. 35, theelongate body1322 includes adistal end portion1332 that has multiple arms1340 that can move between a collapsed configuration and an expanded configuration. The arms1340 defineopenings1348 and an interior region1449. Thesheath1330 defines a lumen (not shown), through which theelongate body1322 is disposed.
• Theactuator1326 includes afirst member1365 operatively coupled to asecond member1367 via a pair of biasingmechanisms1363. The biasingmechanisms1363 can include, for example a spring (not shown) configured to bias theactuator1326 into a first configuration. In the first configuration, thefirst member1365 and thesecond member1367 are biased into a first position relative to each other, as shown inFIG. 34. Thesheath1330 is coupled to thefirst member1365 and/or thesecond member1367, such that when theactuator1326 is biased into the first configuration, thesheath1330 is moved distally, and adistal end portion1364 of thesheath1364 is disposed over at least a portion of thedistal end portion1332 of theelongate body1322. This action causes the arms1340 of thedistal end portion1332 to collapse sufficiently to insert the medical device through, for example, an access cannula.
• In use, the user can insert themedical device1320 into a tissue site with theactuator1326 in the first configuration, as shown inFIG. 34. The user can then squeeze thefirst member1365 and thesecond member1367 together, which will move the actuator to a second configuration, as shown inFIG. 35. This action will draw thesheath1330 proximally, such that thedistal end portion1332 of theelongate body1322 is no longer constrained within thesheath1330 and can assume its expanded configuration. With thedistal end portion1332 of theelongate body1322 in the expanded configuration, themedical device1320 can be used to disrupt or scrape tissue as previously described. To remove themedical device1320 from the tissue, the user discontinues squeezing thefirst member1365 and thesecond member1367 together, which will move theactuator1326 to the first position as shown inFIG. 34.
• In an alternative embodiment, the elongate body can be movably coupled to the actuator, instead of the sheath. In such an embodiment, when the actuator is in the first configuration (e.g.,FIG. 34), the elongate body will be moved proximally such that a distal end portion of the elongate body is at least partially collapsed within a lumen of the sheath. When the actuator is moved to the second configuration (e.g.,FIG. 35), the elongate body will be moved distally, such that the distal end portion is disposed outside of the lumen of the sheath. Although not shown, this embodiment of a medical device can also include an elongate member, such aselongate member1174 or1274 discussed above.
• FIG. 36 is a flowchart illustrating a method according to an embodiment of the invention. In one example, a method includes at80, 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 at82. Simultaneously with expanding the first elongate body, 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 at84. At86, 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. In some embodiments, the expanding includes moving a volume of fluid from a reservoir to an interior portion of the second elongate body. In some embodiments, 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. In this example, a method includes at81, 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. In some embodiments, during the inserting, 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. At83 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. At85, in some embodiments, 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 at83.
• At87, with the distal end portion of the elongate body in the expanded configuration, 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. In some embodiments, 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.
• In some embodiments, at89, after rotating the medical device, 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. In some embodiments, after the rotating the medical device, at90 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. At91, in an embodiment having an optional rod, after rotating the medical device, the rod can be moved distally such that the distal end portion of the elongate body is moved to a collapsed configuration. At92, 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.
• FIG. 38 illustrates a method according to yet another embodiment of the invention. In this example, a method includes at93, inserting an expandable medical device in a collapsed configuration into a biological body, such as a vertebra or an intervertebral disc. The medical device can include, for example, an actuator that biases the medical device into an expanded configuration and that moves the medical device to the collapsed configuration when actuated. A distal end portion of the medical device defines a plurality of openings in communication with an interior region defined by the distal end portion of the medical device. In some embodiments, the medical device can include a tapered distal end that can penetrate tissue while inserting the medical device into the biological body. At94, the medical device is moved to an expanded configuration. For example, an actuator can be released to allow the medical device to assume a biased or pre-set expanded configuration.
• At95, 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. For example, the distal end portion of the medical device can include multiple arms configured to disrupt tissue when rotated. At96, after rotating the medical device, 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. For example, 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. In some embodiments, at97 a fluid can optionally be introduced into the interior region of the medical device via the elongate member. For example, the elongate member can define a lumen through which fluid can be introduced. In some embodiments, at98 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.
• While various embodiments of the invention have been described above, it should be understood that they have been presented by way of example only, and not limitation. Where methods and steps described above indicate certain events occurring in certain order, those of ordinary skill in the art having the benefit of this disclosure would recognize that the ordering of certain steps may be modified and that such modifications are in accordance with the variations of the invention. Additionally, certain of the steps may be performed concurrently in a parallel process when possible, as well as performed sequentially as described above. The embodiments have been particularly shown and described, but it will be understood that various changes in form and details may be made.
• For example, although various embodiments have been described as having particular features and/or combinations of components, other embodiments are possible having a combination or sub-combination of any features and/or components from any of embodiments as discussed above. For example, the 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. For example, a medical device according to an embodiment described herein can be actuated with a separate actuator or device.
• In addition, 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. For example, 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.
• Further, the various components of a medical device as described herein can have a variety of different shapes and or size not specifically illustrated. For example, the distal end portions of the first elongate body and the second elongate body can have a variety of different shapes and sizes. A distal end portion of an elongate body that has a flexible membrane configuration (e.g., a balloon) can be, for example, circular, oval, square, rectangular, triangular, oblong, peanut shaped, etc. In another example, a distal end portion of an elongate body having a whisk-type configuration can be, for example, square, rectangular, oval, circular, triangular, etc. A medical device according to the invention can include one or more elongate bodies, one or more expandable portions, and/or one or more actuators.
• Although the use of a medical device was described with a specific example of use within a vertebra, it should be understood that the medical device and methods described herein can be used in other areas of a patient, such as for example, within an intervertebral disc. For example, the medical device can be used in other areas within a spine, as well as other bone or soft tissue areas within a patient's body.

Claims (25)

1. A method, comprising:

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 defining a plurality of openings in communication with an interior region; and

after the rotating, moving a distal end portion of an elongate member 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 configured to displace tissue fragments from the interior region.

2. The method ofclaim 1, further comprising:

inserting the medical device in a collapsed configuration into the biological body.

3. The method ofclaim 1, wherein the medical device has a collapsed configuration and an expanded configuration, the rotating being performed when the medical device is in the expanded configuration.

4. The method ofclaim 1, further comprising:

after the rotating, introducing a fluid into the interior region of the medical device via the elongate member.

5. The method ofclaim 1, further comprising:

simultaneously with the moving, introducing a fluid into the interior region of the medical device via the elongate member.

6. The method ofclaim 1, wherein the medical device includes a tapered distal end, the method further comprising:

prior to the rotating, penetrating tissue within the biological body with the tapered distal end of the medical device.

7. The method ofclaim 1, further comprising:

suctioning tissue fragments out of the interior region and through a lumen defined by the elongate member.

8. The method ofclaim 1, wherein the biological body is a vertebra.

9. The method ofclaim 1, wherein the biological body is an intervertebral disc.

10. An apparatus, comprising:

an elongate body, the elongate body including a distal end portion having a collapsed configuration and an expanded configuration,

the distal end portion of the elongate body defining a plurality of openings in communication with an interior region when the distal end portion of the elongate body is in the expanded configuration; and

an elongate member movably disposable within a lumen of the elongate body, the elongate member configured to move tissue fragments from the interior region, through the plurality of openings when the distal end portion is in the expanded configuration.

11. The apparatus ofclaim 10, further comprising:

a sheath, the elongate body at least partially disposed within a lumen of the sheath.

12. The apparatus ofclaim 10, wherein a proximal end of the elongate member includes a fitting configured to couple a syringe to the elongate member.

13. The apparatus ofclaim 10, wherein a proximal end of the elongate member includes a fitting configured to couple a suction device to the elongate member.

14. The apparatus ofclaim 10, wherein the elongate member defines a lumen and a plurality of openings on a distal end portion of the elongate member, the lumen of the elongate member configured to communicate a fluid to the interior region of the distal end portion of the elongate body to move tissue fragments out of the interior region.

15. The apparatus ofclaim 10, further comprising:

a sheath, the elongate body at least partially disposed within a lumen of the sheath; and

an actuator operatively coupled to the sheath, the actuator configured to bias the sheath into a first position in which the distal end portion of the elongate body is in the expanded configuration, the actuator configured to move the sheath to a second position in which the distal end portion of the elongate body is in the collapsed configuration.

16. The apparatus ofclaim 10, wherein a distal end of the elongate body defines an opening, the elongate member defines a lumen, a distal end of the elongate member defines an opening in communication with the opening at the distal end of the elongate body, the elongate member configured to communicate fluid from the lumen of the elongate member to a location outside of the elongate body.

17. The apparatus ofclaim 10, wherein the distal end portion of the elongate body includes a plurality of arms configured to disrupt tissue within a biological body.

18. A method, comprising:

inserting a distal end portion of a medical device at least partially into a biological body while the distal end portion of the medical device is in a collapsed configuration;

after the inserting, moving the distal end portion of the medical device to an expanded configuration;

after the moving, rotating the medical device such that a plurality of arms at the distal end portion of the medical device disrupt tissue within the biological body; and

moving an elongate member distally within a lumen of the medical device and into an interior region defined by the plurality of arms such that tissue fragments disposed within the interior region are moved through openings defined by the plurality of arms.

19. The method ofclaim 18, further comprising:

after the rotating, introducing a fluid into the interior region of the medical device through a lumen defined by the elongate member.

20. The method ofclaim 18, further comprising:

simultaneously with the moving the elongate member, introducing a fluid into the interior region of the medical device via the elongate member.

21. The method ofclaim 18, wherein the medical device includes a tapered distal end, the method further comprising:

prior to the moving the distal end portion of the medical device, penetrating tissue within the biological body with the tapered distal end of the medical device.

22. The method ofclaim 18, further comprising:

suctioning tissue fragments out of the interior region and through a lumen defined by the elongate member.

23. The method ofclaim 18, wherein the medical device includes an actuator configured to bias the medical device into the expanded configuration, the method further comprising:

actuating the actuator to move the medical device into the collapsed configuration before the inserting.

24. The method ofclaim 18, wherein the biological body is a vertebra.

25. The method ofclaim 18, wherein the biological body is an intervertebral disc.

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