Patent Grant
7942843
The present invention, in some embodiments thereof, relates to a device for inserting medical implants into tissue and, more particularly, but not exclusively, to a device for inserting soft tissue markers.
Soft tissue implants include markers that are used to mark the site of a biopsy or another surgical procedure or medical treatment, for defining the location of the procedure or treatment before it is performed, or for marking a location where the procedure or treatment was performed, for future follow up medical procedures. Soft tissue implants also include therapeutic implants, for example for brachytherapy. The implant, whether it is used as a marker or for another purpose, is often inserted using a device that comprises a hollow needle or other cannulus structure, with a sharpened end for penetrating to a desired location in the tissue, and with the implant loaded into a channel inside the cannulus. The device may or may not be part of an instrument that is also used for the surgery or biopsy. The device sometimes has an obstruction that prevents the implant from accidentally leaving the device before the operator of the device is ready to implant it, so that it can be positioned precisely, and means for removing or circumventing the obstruction, and inserting the implant into the tissue, when it is properly positioned. An example of such a device with an obstruction is shown in
U.S. Pat. No. 6,261,243, to Burney et al, describes a cannulus for inserting a soft tissue marker, with an opening in the side of the cannulus. A sliding cover prevents the marker from leaving the cannulus until the cannulus is properly positioned.
US Patent Application Publication No. 2004/0236213, to Jones et al, describes a device with a cannulus holding a soft tissue marker, and a plug made of wax covering an opening at the end. The marker is pushed from behind by a stylet, which pushes hard enough to push the plug out of the cannulus, allowing the marker to emerge.
A similar device is described in U.S. Pat. No. 7,247,160 to Seiler et al, but instead of pushing the marker and the plug forward out of the cannulus, the cannulus is pulled back, while using the stylet to hold the marker and plug in place. This breaks the plug free from the cannulus, leaving the marker and the plug is place in the tissue, and may allow more accurate placement of the marker than if the cannulus is held in place and the marker and plug are pushed forward.
U.S. Pat. No. 7,047,063, to Burbank, describes a device for inserting a marker into soft tissue, in which the marker is placed in a cannulus that has a closed petalled end. When the marker is pushed from behind by a stylet, the marker pushes open the petals at the end of the cannulus, allowing the marker to emerge.
U.S. Pat. No. 6,402,677, to Jacobs, describes a device for inserting brachytherapy seeds into soft tissue. The seeds are placed in a cannulus, which has an end that is partly blocked by an obstruction. A stylet pushes the brachytherapy seeds with enough force to go past the obstruction, and leave the cannulus.
Soft tissue markers, as well as brachytherapy implants, are sometimes formed in the shape of a helical coil. Such implants are described, for example, in U.S. Pat. Nos. 6,261,243 and 7,047,063, cited above, and in US Patent Application Publication No. 2004/0073107 to Sioshansi, as well as International Publication No. WO00/24332 to Cortese, and U.S. Pat. No. 6,371,904 to Sirimanne.
An aspect of an embodiment of the invention concerns a device for inserting an easily deformed medical implant, with a restraining element that keeps the implant from leaving the device accidentally, but allows the implant to leave the device when relatively little force is exerted on it, so it will not be damaged.
There is thus provided, in accordance with an exemplary embodiment of the invention, a device for inserting into body tissue an implant with a medical function, with a channel passing at least partly through the implant, the device comprising:
a) a cannulus with a distal end, and with a channel sized to hold the implant;
b) a pusher with a channel passing through it, the pusher sized to be situated inside the channel of the cannulus behind the implant, and adapted to push the implant through the distal end of the cannulus into the tissue;
c) a restraining element that extends through the channel of the pusher and at least partly through the channel of the implant when they are so situated in the channel of the cannulus, which restrains the implant from accidentally exiting the cannulus, but allows the implant to exit the distal end of the cannulus when it is pushed with a force small enough so as not to damage the function of the implant in the tissue.
Optionally, the implant is a soft tissue marker.
Optionally, the implant comprises a helical coil.
Optionally, the channel of the implant extends all the way through the implant.
Optionally, the restraining element has a distal end that extends past the distal end of the implant when the implant and pusher are so situated, hut not past the distal end of the cannulus, and the distal end of the restraining element restrains the implant from sliding off the restraining element.
Optionally, the distal end of the restraining element bends to one side, but is flexible enough to straighten sufficiently so that the implant can slide off it, when the implant is pushed with said force.
In an embodiment of the invention, the restraining element comprises a wire.
Optionally, a distal end of the restraining element is enlarged, but is configured so that the implant can slide off it, when the implant is pushed with said force.
Optionally, the restraining element restrains the implant by friction against a surface of the channel of the implant.
In an embodiment of the invention, the function of the implant comprises folding on itself to define a volume with a smallest dimension greater than the diameter of the channel of the cannulus, when the implant is inserted into the tissue.
Optionally, the restraining element is least indirectly coupled to the cannulus, such that the restraining element does not move along the cannulus when the pusher pushes the implant through the distal end of the cannulus.
Optionally, the device also includes a handle, wherein the cannulus and the restraining element are anchored in the handle at their proximal ends.
Optionally, the device also includes a handle adapted to be held by an operator with one hand when using the device to insert the implant in the tissue.
There is further provided, in accordance with an exemplary embodiment of the invention, a method of inserting a medical implant into tissue, comprising:
a) loading the implant into a channel of a cannulus, with a restraining element extending at least part way through a channel in the implant, restraining the implant from leaving the cannulus accidentally before insertion into the tissue;
b) inserting a distal end of the cannulus into the tissue; and
c) pushing the implant out of the distal end of the cannulus, with a large enough force so that the implant moves past the restraining element, but with a small enough force so that the implant is not damaged and functions properly in the tissue.
Optionally, proper functioning of the implant in the tissue comprises the implant folding on itself when inserted into the tissue, to define a volume with smallest dimension greater than the diameter of the cannulus.
Unless otherwise defined, all technical and/or scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which the invention pertains. Although methods and materials similar or equivalent to those described herein can be used in the practice or testing of embodiments of the invention, exemplary methods and/or materials are described below. In case of conflict, the patent specification, including definitions, will control. In addition, the materials, methods, and examples are illustrative only and are not intended to be necessarily limiting.
Some embodiments of the invention are herein described, by way of example only, with reference to the accompanying drawings. With specific reference now to the drawings in detail, it is stressed that the particulars shown are by way of example and for purposes of illustrative discussion of embodiments of the invention. In this regard, the description taken with the drawings makes apparent to those skilled in the art how embodiments of the invention may be practiced.
In the drawings:
The present invention, in some embodiments thereof, relates to a device for inserting medical implants into tissue and, more particularly, but not exclusively, to a device for inserting soft tissue markers.
An aspect of an embodiment of the invention concerns a device with a cannulus, for inserting a medical implant, for example a soft tissue marker, into soft tissue, and with a restraining element that restrains the implant from leaving the device accidentally, but allows the implant to be pushed gently out of the device into the tissue. The restraining element extends at least part way through a channel in the implant, and through a channel in a pusher, situated behind the implant, that pushes the implant out of the cannulus, and the restraining element is optionally directly or indirectly anchored to the cannulus. The pushing needed to overcome the restraint of the restraining element is gentle enough so that the implant is not damaged, and can still perform its function in the tissue. For example, the implant is a soft tissue marker that is designed to fold on itself, as a result of the force it encounters when it is inserted into the tissue, defining a volume that is greater in diameter than the channel of the cannulus, making the marker more stable within the tissue and more visible in medical imaging. Such markers are described in related PCT Patent Application No. PCT/IL2007/000214, cited above. Particularly in a case where the implant is easily deformable, it may be advantageous not to push on it too hard before it is inserted into the tissue.
Optionally, the restraining element is a wire that extends through the channel in the implant to its distal end, and has a bend at the end that restrains the implant from sliding off it and exiting the cannulus, but the wire is flexible enough, and the channel in the implant is wide enough, so that the implant can be pushed past the bent end of the wire with relatively little force. Optionally, whether or not the restraining element extends to the distal end of the implant, it uses friction with the channel through the implant, in order to restrain the implant from moving past it.
It should be noted that prior methods of restraining an implant before it is ready to be implanted, such as those described above, are generally not well suited to an implant that is designed to fold on itself and define an increased volume, when it leaves the cannulus. When the implant has to push against a wax plug, or a petalled end, for example, in order to exit the cannulus, a relatively large force is generally applied to the implant. A large pushing force is generally needed, because the plug or other barrier is designed not to fail accidentally. If the implant is easily deformable, as it may tend to be if it is designed to fold on itself when it exits the cannulus, then the large pushing force may deform the implant before it leaves the cannulus. Such deformation may actually prevent the implant from leaving the cannulus, and if it does leave the cannulus, it may not fold properly after it leaves the cannulus. Such an implant may also not fold on itself if the cannulus is pulled away from the implant, rather than pushing the implant out of the cannulus. And having such an implant exit the cannulus from an opening on the side may also not to be suitable, since it may not fold properly.
A potential advantage of using a restraining element that is anchored to the cannulus, and passes through a channel in the implant and in the pushing element, is that the restraining element cannot easily break off or otherwise fail, but only a small force may be needed to overcome the restraining element when the implant is pushed out of the cannulus. This behavior is in contrast to that of a wax plug, for example, which may easily break off prematurely, if it requires only a small force to push it off the cannulus.
For purposes of better understanding some embodiments of the present invention, as illustrated in
In other prior art devices, cannulus 102 is held in place, while stylet 110 pushes implant 108 and plug 106 forward, out of cannulus 102 through distal end 104. This may require even more force than pulling the cannulus back, since the marker and plug must overcome the pressure of the tissue, in addition to the force needed to detach the plug from the cannulus. The end result is the same, with the marker and plug remaining in the tissue.
As noted above, the device and method shown in
Before explaining at least one embodiment of the invention in detail, it is to be understood that the invention is not necessarily limited in its application to the details of construction and the arrangement of the components and/or methods set forth in the following description and/or illustrated in the drawings and/or the Examples. The invention is capable of other embodiments or of being practiced or carried out in various ways.
Referring now to the drawings,
When device 200 has been positioned in the soft tissue, at a location where implant 208 is to be inserted, then pusher 210 is pushed forward against implant 208, as shown in
When pusher 210 is pushed forward against implant 208, implant 208 moves forward, over restraining element 212. Relatively little force is needed to make implant 208 do this, since it takes relatively little force to slightly decrease the bend in restraining element 212, so implant 208 can fit over it. Although implant 208 may compress somewhat even from this relatively small force, it does not deform to such an extent, when it is still inside cannulus 202, that it will be unable to fold on itself when it leaves cannulus 202.
Optionally, the force needed to push the implant past the restraining element, in device 200 or any other embodiment of the invention, is greater than the weight of the implant, or greater than 2 times or 5 times or 10 times or 20 times or 50 times or 100 times the weight of the implant. The weight of the implant is, for example, 0.5 milligrams, or 1 milligram, or 2 milligrams, or 5 milligrams, 10 milligrams, or a greater or lesser or intermediate weight. Optionally, the force needed to overcome the restraining element is less than a force needed to deform the implant irreversibly. Optionally the force needed to overcome the restraining element, plus the greatest force that would normally be needed to overcome any friction of the implant with the cannulus, is less than a force needed to deform the implant irreversibly, or at least less than a force needed to deform the implant irreversibly to such an extent that it will not fold properly when it leaves the cannulus.
Restraining element 212 is optionally stiff enough so that its distal bend will not unbend under the weight of implant 208 during handling of the device, allowing implant 208 to fall out if device 200 is held with distal end 204 facing downward. But restraining element is flexible enough so that it will unbend in response to a force on implant 208 that will not prevent implant 208 from functioning properly when it is inserted in the tissue, folding on itself to form an increased volume.
In the embodiment shown in
It should be noted that, for restraining elements 212 and 312 as well, the end of the restraining element need not extend past the end of implant 208, but the end of the restraining element can restrain implant 208 from moving by friction between the restraining element and the inner surface of implant 208, and/or by pushing implant 208 against the inner surface of cannulus 202, and using friction between implant 208 and cannulus 202 to restrain implant 208 from sliding out of cannulus 202.
In device 500 shown in
Enlarged end 514 could have a number of different possible configurations, and the shape shown in
Showing implant 208 in the form of a coil is
Optionally the channel through the implant does not extend through the whole length of the implant, but is blocked at the distal end, or at another location, and the restraining element does not extend distally past the location where the channel is blocked.
Optionally, the channel through the implant is not completely surrounded by the implant azimuthally, but is open in one direction, with the channel comprising an axially oriented slot or indentation in the implant. In this case, the geometry of the implant, the restraining element and the cannulus prevents the restraining element from slipping out of the channel of the implant, when the implant is still in the cannulus. In fact, a helical implant, with the end turns of the helix open, is a special case of such a geometry, with the “slot” being the spiral space between adjacent turns of the helix. Alternatively, for example if the implant is a cylindrical shell, or a helical coil with closed end turns, the implant topologically surrounds the restraining element, which cannot slip out of the channel of the implant except by moving forward off the distal end of the restraining element.
In many of the embodiments of the invention shown in
As used herein the term “about” refers to ±10%.
The terms “comprises”, “comprising”, “includes”, “including”, “having” and their conjugates mean “including but not limited to”. This term encompasses the terms “consisting of” and “consisting essentially of”.
The phrase “consisting essentially of” means that the composition or method may include additional ingredients and/or steps, but only if the additional ingredients and/or steps do not materially alter the basic and novel characteristics of the claimed composition or method.
As used herein, the singular form “a”, “an” and “the” include plural references unless the context clearly dictates otherwise. For example, the term “a compound” or “at least one compound” may include a plurality of compounds, including mixtures thereof.
Throughout this application, various embodiments of this invention may be presented in a range format. It should be understood that the description in range format is merely for convenience and brevity and should not be construed as an inflexible limitation on the scope of the invention. Accordingly, the description of a range should be considered to have specifically disclosed all the possible subranges as well as individual numerical values within that range. For example, description of a range such as from 1 to 6 should be considered to have specifically disclosed subranges such as from 1 to 3, from 1 to 4, from 1 to 5, from 2 to 4, from 2 to 6, from 3 to 6 etc., as well as individual numbers within that range, for example, 1, 2, 3, 4, 5, and 6. This applies regardless of the breadth of the range.
Whenever a numerical range is indicated herein, it is meant to include any cited numeral (fractional or integral) within the indicated range. The phrases “ranging/ranges between” a first indicate number and a second indicate number and “ranging/ranges from” a first indicate number “to” a second indicate number are used herein interchangeably and are meant to include the first and second indicated numbers and all the fractional and integral numerals therebetween.
It is appreciated that certain features of the invention, which are, for clarity, described in the context of separate embodiments, may also be provided in combination in a single embodiment. Conversely, various features of the invention, which are, for brevity, described in the context of a single embodiment, may also be provided separately or in any suitable subcombination or as suitable in any other described embodiment of the invention. Certain features described in the context of various embodiments are not to be considered essential features of those embodiments, unless the embodiment is inoperative without those elements.
Although the invention has been described in conjunction with specific embodiments thereof, it is evident that many alternatives, modifications and variations will be apparent to those skilled in the art. Accordingly, it is intended to embrace all such alternatives, modifications and variations that fall within the spirit and broad scope of the appended claims.
All publications, patents and patent applications mentioned in this specification are herein incorporated in their entirety by reference into the specification, to the same extent as if each individual publication, patent or patent application was specifically and individually indicated to be incorporated herein by reference. In addition, citation or identification of any reference in this application shall not be construed as an admission that such reference is available as prior art to the present invention. To the extent that section headings are used, they should not be construed as necessarily limiting.
This applications claims benefit under 35 U.S.C. §119(e) of U.S. Provisional Patent Application No. 61/089,571, filed on Aug. 18, 2008. This application is also related to PCT Patent Application No. PCT/IL2007/000214, filed on Feb. 15, 2007, which is a Continuation-In-Part of PCT Patent Application No. PCT/IB2006/052771, filed on Aug. 10, 2006 and PCT Patent Application No. PCT/IB2006/052770, filed on Aug. 10, 2006, and which claims priority from U.S. Provisional Patent Application No. 60/773,931, filed on Feb. 16, 2006, U.S. Provisional Patent Application No. 60/773,930, filed on Feb. 16, 2006 and U.S. Provisional Patent Application No. 60/804,178, filed on Jun. 8, 2006. It is also related to PCT Patent Application No. PCT/IL2005/000871, filed on Aug. 11, 2005, PCT Patent Application No. PCT/IL2005/001101, filed on Oct. 19, 2005, U.S. Provisional Patent Application No. 60/600,725, filed on Aug. 12, 2004, U.S. Provisional Patent Application No. 60/619,792, filed on Oct. 19, 2004, U.S. Provisional Patent Application No. 60/619,897, filed on Oct. 19, 2004, U.S. Provisional Patent Application No. 60/619,898, filed on Oct. 19, 2004, U.S. patent application Ser. No. 11/463,664, filed on Aug. 10, 2006 and U.S. patent application Ser. No. 11/463,659, filed on Aug. 10, 2006. The disclosure of each of these applications is incorporated herein by reference.
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