Patent Application
20070149990
The invention relates generally to medical devices and procedures, and more particularly to a medical device for use in medical procedures associated with a spine.
Known medical devices are configured to percutaneously access an intervertebral disc to perform a variety of different medical procedures. Some known medical devices are configured to remove tissue from within the interior of an intervertebral disc. Other known medical devices are configured to provide some type of cutting means to tear or loosen tissue within the intervertebral disc. There are also known medical devices configured to provide a suction or vacuum force to assist in the removal of tissue from within the intervertebral disc.
Although medical devices that provide vacuum force are known and other medical devices that provide cutting functions are known, a need exists for an improved medical device that can provide both a cutting and vacuum force within the same device.
Apparatuses and methods for accessing a nucleus of an intervertebral disc through the annulus are disclosed herein. In one variation, an apparatus includes an elongate body having a collapsed configuration and an expanded configuration. The elongate body has a cutting portion at a distal portion of the elongate body, and the cutting portion defines an opening in the elongate body. The distal portion of the elongate body is configured to be inserted into a nucleus of an intervertebral disc when the elongate body is in the collapsed configuration. The cutting portion of the elongate body is configured to disrupt at least a portion of tissue within the nucleus of the intervertebral disc when the elongate body is in the expanded configuration. The elongate body is configured to capture the portion of tissue within the opening of the elongate body when the elongate body is moved from the expanded configuration to the collapsed configuration while disposed within the nucleus of the intervertebral disc.
The invention is described with reference to the accompanying drawings. In the drawings, like reference numbers indicate identical or functionally similar elements.
In one embodiment, a medical device includes an elongate body having a collapsed configuration and an expanded configuration. The elongate body has a cutting portion at a distal portion of the elongate body, and the cutting portion defines an opening in the elongate body. The distal portion of the elongate body is configured to be inserted into a nucleus of an intervertebral disc when the elongate body is in the collapsed configuration. The cutting portion of the elongate body is configured to disrupt at least a portion of tissue within the nucleus of the intervertebral disc when the elongate body is in the expanded configuration. The elongate body is configured to capture the portion of tissue within the opening of the elongate body when the elongate body is moved from the expanded configuration to the collapsed configuration while disposed within the nucleus of the intervertebral disc.
In another embodiment, an apparatus includes a cannula that defines a lumen, and an elongate body having a collapsed configuration and an expanded configuration. The elongate body is configured to be movably disposed within the lumen of the cannula when the elongate body is in the collapsed configuration. The elongate body has a cutting portion at a distal portion of the elongate body, and the cutting portion defines an opening in the elongate body. The distal portion of the cannula is configured to be inserted into an interior portion of an intervertebral disc when the elongate body is in the collapsed configuration. The cutting portion of the elongate body is configured to disrupt at least a portion of tissue within the interior of the intervertebral disc when the distal portion of the elongate body is moved outside of the lumen of the cannula and within the interior of the intervertebral disc while the elongate body is in the expanded configuration. The elongate body is configured to capture the portion of tissue within the opening of the elongate body when the elongate body is moved from the expanded configuration to the collapsed configuration.
A medical device (also referred to herein as an “apparatus”) can be used in a variety of minimally-invasive medical procedures such as disc nucleus replacement. The following description discusses the use of the medical device in an intervertebral disc procedure, but it should be understood that the medical device can be used in procedures on other areas of a body, including other tissue, such as bone structures, collagen tissues and/or soft tissue areas.
The term “cannula” is used here to mean a component of the medical device or apparatus having one or more passageways configured to receive a medical device therethrough and provide access to an interior portion of an intervertebral disc. For example, the cannula can be substantially tubular. The cannula can have a variety of different shapes and sizes, such as having a round or octagonal outer perimeter.
As used in this specification 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 end of a medical device inserted inside the patient's body would be the distal end of the medical device, while the end of the medical device outside the patient's body would be the proximal end of the medical device.
The cutting member 38 can be embodied in a variety of different manners, as will be described below, and is configured to loosen, disrupt and/or tear tissue within the interior portion (e.g., nucleus) of the intervertebral disc D. The cutting member 38 can be disposed on an outer surface of elongate body 30 or within an interior portion of elongate body 30. The cutting member 38 can also be formed on an edge or perimeter defined by one or more openings 46 on a wall of the elongate body 30. The opening(s) 46 can be located at a variety of different locations on the elongate body 30. The opening(s) 46 is configured such that tissue from within the intervertebral disc D can be pulled through the opening(s) 46 and into the internal passageway via the suction force supplied through the internal passageway 36. The tissue removed from the intervertebral disc D can be collected in a container 42 coupled to the elongate body 30. In some embodiments, the suction force can pull or draw a portion of tissue into the elongate body, and the cutting member can sever that portion of tissue from the remainder of the tissue.
In this embodiment, the elongate body 30 can move axially within the cannula 20 (e.g., along an axis A defined by a longitudinal length of the cannula 20). In other embodiments, the elongate body can rotate within the cannula. In some embodiments, the elongate body can move both rotationally and axially. A power source (not shown) can be coupled to the elongate body 30 to provide automatic movement of the elongate body 30. In some embodiments, the elongate body 30 is moved manually.
The medical device 10 can be used to remove tissue from within the interior or nucleus of the intervertebral disc D, and produce a cavity within the intervertebral disc. In some applications, the cavity is such that the resulting cavity is similar to a partial discectomy. In other applications, the cavity is larger or similar to a total discectomy. The medical device 10 can be used to produce a cavity for subsequent placement of a prosthesis (e.g., artificial nucleus) or for insertion of biocompatible material, such as a polymer, hydrogel or other nucleus replacement material. Alternatively, the medical device 10 can be used to relieve pressure from within the intervertebral disc D. For example, in some cases, tissue within an intervertebral disc can be pushed outside of the disc, through, for example, a hole in a disc annulus. In such a case, the medical device 10 can be deployed to remove tissue from within the intervertebral disc resulting in space within the disc devoid of tissue. By removing tissue from within the disc, the tissue that had previously been pushed outside of the disc may be retracted back into the disc.
Various embodiments of the medical device will now be described. It should be understood that the embodiments described herein are examples that can be implemented alone or in combination with one or more other embodiments.
The elongate body 130 includes a proximal portion (not shown), a distal portion 134, and an internal passageway 136 (see
The elongate body 130 can be movably disposed within the lumen 126 of the cannula 120. A seal or grommet 144 disposed on an outer surface of the elongate body 130 provides a sealing fit between the elongate body 130 and the cannula 120, while at the same time permitting the elongate body 130 to move within the lumen 126 of the cannula 120. When the distal portion 134 of the elongate body 130 is positioned within the distal portion 124 of the cannula 120, the opening 146 can be at least partially aligned with one of the at least one windows 148.
In use, the cannula 120 can be inserted into an intervertebral disc such that the distal portion 124 is positioned within an interior of the disc. The elongate body 130 can be moved to a position within the cannula 120 such that the opening 146 at least partially aligns with a selected window 148. The suction power can suction tissue from within the interior of the disc at least partially through the window 148, and at least partially through the opening 146. The elongate body 130 can be moved within the lumen 126, for example, by either rotating the elongate body 130 about its longitudinal axis or pulling the elongate body 130 in the direction of its proximal end and/or its distal end such that opening 146 and window 148 move relative to each other from being at least partially aligned to being misaligned. In either situation, the cutting member 138 on the opening 146 can sever the tissue that is at least partially positioned within the opening 146 from the remaining tissue within the disc. Once the tissue is severed, the suction force can pull the tissue through the internal passageway 136. The cutting member 138 can also be used to tear, loosen or disrupt tissue within the intervertebral disc by moving the elongate body 130 relative to the cannula 120. Because the opening 146 can be positioned such that the opening 146 is at least partially aligned with a selected one of the windows 148, tissue can be removed from various directions within the intervertebral disc without having to reposition the cannula 130. In other words, by aligning opening 146 with a given window 148 from the various windows 148 disposed about the circumference of the medical device 110, tissue can be removed from an area adjacent to a particular portion of the medical device 110 circumference.
As with the previous embodiments, the elongate body 230 can be movably disposed within the lumen 226 of the cannula 220. The internal passageway 236 can also be coupled to a source of suction or vacuum power, as previously described. In this embodiment, the elongate body 230 has a predetermined coiled configuration when the elongate body 230 is unrestrained. When the elongate body 230 is restrained, such as when the elongate body 230 is largely disposed within the lumen 226 of the cannula 220, the elongate body 230 will be in a substantially straightened configuration, as shown in
Also, in some embodiments, a guide wire 258 can be coupled to the elongate body 230 to assist in straightening or uncoiling the elongate body 230 as shown in
The elongate body 330 includes a proximal portion (not shown), a distal portion 334, and an internal passageway 336 (see
The elongate body 330 can be movably disposed within the lumen 326 of the cannula 320. In use, the cannula 320 can be inserted into an intervertebral disc such that the distal portion 324 of the cannula 320 is positioned within an interior or nucleus N of the disc. The elongate body 330 can be extended axially through the lumen 326 such that at least a portion of the distal portion 334 of the elongate body 330 is extended into the nucleus N. The vacuum or suction power can suction tissue from within the nucleus N through the opening 346. For example, the elongate body 330 can be moved within the lumen 326 by either rotating the elongate body 330 or axially moving the elongate body 330. In either situation, the cutting members 338 can tear, disrupt and/or loosen tissue within the nucleus N. The suction power can be used to suction the torn, disrupted or loosened tissue through opening 346 and the internal passageway 336. In some embodiments, the suction can be performed simultaneously with the movement of the elongate body 330. In an alternative embodiment, the elongate body 330 can include multiple additional openings (not shown) proximate the cutting members 338 (i.e., along the outer surface of elongate body 330). This would allow tissue to be suctioned laterally or radially through the wall of elongate body 330.
As with the previous embodiments, the internal passageway 436 can be coupled to a source of suction or vacuum power and the elongate body 430 can be moveably disposed within a lumen of a cannula (not shown). In use, the elongate body 430 can be inserted into an opening created within an intervertebral disc, or other tissue, either through a cannula or through a channel created by different device, such as a stylet. The elongate body 430 can be moved axially allowing the cutting member 438 to loosen or tear tissue within a nucleus of an intervertebral disc. Simultaneous with the cutting, the tissue can be suctioned through an opening 446 on the distal end of the elongate body 430 and through the internal passageway 436. As tissue is suctioned into the internal passageway 436, the cutting member 438 can mince the tissue and reduce the size of the tissue fragments for easier transport through the lumen 436. In some embodiments, the suction force can draw at least a portion of tissue from within the intervertebral disc and into the passageway of the elongate body. A cutting member disposed within the passageway can then sever the portion of the tissue from the remaining tissue in the disc when the elongate body is moved (e.g., rotated). In an embodiment having one or more irrigation lumens 460, an irrigation solution can be introduced into the nucleus of the intervertebral disc to help loosen tissue to be suctioned. As discussed previously, the irrigation solution can be introduced into the disc at various rates. For example, the irrigation solution can be introduced into the nucleus intermittently or in pulses, or in a continuous flow or stream.
In some embodiments, the distal end portion 434 can be configured to bend or flex as shown in
In use, the elongate body 530 can be extended into an intervertebral disc as previously described and moved (e.g., rotated) such that the cutting member 538 can loosen or tear tissue within a nucleus of the intervertebral disc. Tissue can simultaneously be suctioned through the internal passageway 536 via the opening 546 and/or the opening 568. The elongate body 530 can be used in with a cannula, as described in previous embodiments. In such an embodiment, the cutting member 538 can be collapsible such that as the elongate body 530 is pulled through the cannula, the cutting member 538 can collapse to a size that can fit within a lumen of the cannula. The cutting member 538 can be constructed, for example, with one or more flexible metals, flexible metal alloys, flexible shape-memory materials, and/or flexible polymeric materials.
A medical device 610 illustrated in
In use, with a cannula providing percutaneous access to the interior nucleus of an intervertebral disc, the elongate body 830 can be inserted through the cannula in the collapsed configuration until the distal portion 834 having the cutting members 838 is disposed within the nucleus and extending distally from the cannula. The elongate body 830 can then be moved to the expanded configuration by actuating the pull rod 831. Once in the expanded configuration, the elongate body 830 can be moved by rotating or moving the elongate body 830 in a back-and-forth manner. As the elongate body 830 is moved, the cutting members 838 can loosen tissue within the nucleus of the intervertebral disc. In some embodiments, tissue can be suctioned through the elongate body 830 as described in the previous embodiments.
In some embodiments, tissue can be captured within the openings produced by the expansion of the cutting members 838 and/or within the internal passageway of the elongate body 830. The elongate body 830 can then be collapsed, trapping the tissue within the openings of the elongate body 830. The elongate body 830 can then be removed from the intervertebral disc via the cannula.
A medical device 910 is illustrated in
As with the previous embodiments, the elongate body 930 can be inserted through a cannula (not shown) to percutaneously access the interior region of an intervertebral disc. In use, the elongate body 930 can be inserted through the cannula in the collapsed configuration until the distal portion 934 having the cutting members 938 is disposed within the nucleus and extending distally from the cannula. Unlike the previous embodiment, the elongate body 930 assumes the expanded configuration without the aid of an actuating member, due to the cutting members 938 assuming their predefined form when released from the restraint of the cannula. In the expanded configuration, the elongate body 930 can be moved by rotating or moving the elongate body 930 in a back-and-forth manner. As the elongate body 930 is moved, the cutting members 938 can loosen or disrupt tissue within the nucleus of the intervertebral disc. In some embodiments, tissue can be suctioned through the elongate body 930 as described in the previous embodiments. In some embodiments, tissue can be captured within the space created by the cutting members 938. The elongate body 930 can then be pulled axially back into the cannula, which collapses the cutting members 938, trapping the tissue within cutting members 938. The elongate body 930 can then be removed from the intervertebral disc via the cannula.
The syringe assembly 774 is coupled to a handle assembly 788 via straps 790 or other known coupling methods. The handle assembly 788 includes a first arm 794, a second arm 796, and a locking mechanism 792. Locking mechanism 792 can be, for example, a snap fit, friction fit, latch mechanism, or any other suitable locking mechanism. The handle assembly 792 can be used to move the inner elongate body 778 within the lumen 780. When a bottom portion of the first arm 794 and a bottom portion of the second arm 796 are move apart from each other, a distal end portion 777 of the inner elongate body 778 will be positioned substantially at a distal end portion 775 of the outer elongate body 776, placing the syringe assembly 774 in a closed configuration (see
When the first arm 794 and the second arm 776 are moved together as shown in
The medical device 772 can be used to manually provide vacuum or suction power to the cannula 720 so that tissue can be removed from an interior of an intervertebral disc, similar to the procedures previously described. In use, the syringe assembly 774 is coupled to the valve 782 in the closed configuration, either before or after the cannula 720 has been percutaneously inserted into the intervertebral disc. The lever 784 is actuated to close the valve 782. The handle assembly 788 is actuated to move the syringe assembly 774 to the open configuration as shown in
In alternative embodiments, the medical device 772 can be used in conjunction with any of the embodiments of an elongate body described above, to manually provide suction or vacuum pressure to the internal passageway of the elongate body. In such an embodiment, the medical device 772 can be coupled to an elongate body 730 and provide a means to dispel the tissue from within the lumen 780 without having to disengage the syringe assembly 774 from the valve 782. This would allow the above described method of using the medical device 772 to be repeated as necessary to produce repeated vacuum forces within the internal passageway of the elongate body 730. For example, the valve 782 can be coupled to a transfer line 787, through which the tissue can be dispelled from the syringe assembly 774 as shown in
In another variation of the above embodiment, instead of the valve 782 being coupled to the transfer line 787, a second stop valve (not shown) can be coupled to the syringe assembly 774. The second stop valve can be opened to allow the tissue within lumen 780 to be dispelled in a similar manner as described above.
The medical device for any of the embodiments may be constructed with any suitable material used for such a medical device. For example, the elongate body and the cannula can be constructed with a biocompatible material, such as stainless steel or suitable plastic materials such as various polymers. The cutting member can likewise be constructed with suitable biocompatible metals or plastics.
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. Thus, the breadth and scope of the invention should not be limited by any of the above-described embodiments, but should be defined only in accordance with the following claims and their equivalents. While the invention has been particularly shown and described with reference to specific embodiments thereof, it will be understood that various changes in form and details may be made.
For example, in some embodiments, a cannula may or may not be included in the medical device. In any of the embodiments, the elongate body can include means to irrigate via one or more irrigation lumens. In some embodiments, a handle assembly is included and an actuation trigger coupled to the handle. In some embodiments, means for manually providing suction or vacuum power can be used as described in
This application claims priority to U.S. Provisional Application Ser. No. 60/697,536, entitled “Apparatus And Methods Of Tissue Removal Within A Spine,” filed Jul. 11, 2005, the disclosure of which is incorporated herein by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 60697536 | Jul 2005 | US |
