The present disclosure relates generally to a needle grasping and manipulating device, for example holding a suture needle for suturing tissue at a surgical site.
It is common surgical practice for a physician to join various tissues by passing a needle with attached suture through the tissue. The suture is then tied to hold the tissues in place. Plier-like instruments for gripping and holding suture needles are known in the art—one existing instrument for passing a needle through tissue is a needle holder which usually has a pair of movable, opposed jaws connected to a pair of handles. The handles in turn have a scissor configuration with a locking ratchet mechanism to maintain gripping pressure on the needle held in the jaws of the needle holder. The arms are designed to permit relative pivotal movement between a first closed jaw position wherein the jaw assemblies or units are adjacent to one another and a second open position wherein the jaw assemblies or units are spaced from one another far enough to permit a needle to be inserted therebetween. The jaws are adapted to grasp and hold securely a curved suture needle, whereby pivotal movement of the jaw while in the first closed position causes the suture needle to swing in a corresponding direction for a stitching operation.
Needle holder jaws commonly have a tungsten carbide, serrated surface in a diamond or cross-hatched pattern to enhance the firmness with which the needle is grasped to prevent shifting of the needle while in use. The ratchet mechanism between the scissor handles is locked as the handles close, thereby maintaining firm gripping pressure on the suture needle. Despite this construction, needles are frequently subject to twisting or slipping in the jaws of needle holders as they pass through tissue. Normally the surgeon releases the ratchet mechanism only after the needle has safely passed through the tissue. If the needle is not placed correctly when given to the surgeon or if the needle moves while being used, the surgeon has to stop suturing to take the needle out of the needle holder for the needle to be repositioned. This is time consuming and also puts the surgeon and the operating room staff at risk of a needle stick injury.
Thus, there is a need in the art for a surgical needle holder that can easily adjust the position of a needle both before and as it passes through tissue, in order to minimize time spent intra-operatively adjusting a suture needle and to reduce risk of injury to surgical professionals. The present invention satisfies this need.
In one aspect, a needle holder comprises first and second handles, each handle comprising a finger loop at a proximal end of the handle, an arm fixedly attached to the finger loop, extending toward a distal end of the handle and defining a longitudinal axis, and a jaw fixedly attached to the arm, extending along the longitudinal axis toward the distal end of the handle, and a sliding pivot joint connecting the first and second handles at a connection point between the arms and the jaws, the sliding pivot joint configured to allow the first and second handles to move rotationally with respect to one another about a rotational axis orthogonal to the longitudinal axis at the connection point, and/or translationally with respect to one another along the longitudinal axis. In one embodiment, each handle further comprises a slot positioned between the arm and the jaw parallel to the longitudinal axis. In one embodiment, the needle holder further comprises a pin positioned in the slots and joining the two handles together at the connection point.
In one embodiment, the pin comprises two halves removably connected to one another. In one embodiment, the first and second handles each further comprise a ratcheting mechanism directly connected to the finger loops, the ratcheting mechanisms each comprising a set of grooves, the grooves in the first handle configured to mate with the grooves of the second handle. In one embodiment, the grooves are parallel to the longitudinal axis. In one embodiment, each ratcheting mechanism further comprises a second set of grooves perpendicular to the first set of grooves. In one embodiment, the needle holder comprises a material selected from the group consisting of titanium, carbon steel, aluminum, stainless steel, and tungsten carbide. In one embodiment, each jaw comprises a frictional surface comprising a set of gripping elements, the gripping elements directly contacting one another when the jaws are closed.
In one embodiment, the set of gripping elements comprise ridges having a shape selected from the group consisting of triangular, square, rounded, or eccentric. In one embodiment, the set of gripping elements comprises a material selected from the group consisting of titanium, carbon steel, aluminum, stainless steel, and tungsten carbide. In one embodiment, the set of gripping elements directly contact one another when the jaws are closed, but do not interfere with a sliding motion of the needle holder when a needle is positioned between the gripping elements.
In another aspect, a method of grasping a needle comprises the steps of positioning a needle between jaws of a needle grasping device having two handles, closing the jaws of the grasping device around the needle by rotating the two handles about a rotational axis at a connection point, thereby gripping the needle between the jaws, and moving one of the jaws along a longitudinal axis, thereby rotating the needle.
In one embodiment, the jaw is moved by moving one of the handles along the longitudinal axis. In one embodiment, the handle is moved along the longitudinal axis by sliding the handle along a pin positioned in a slot at the connection point. In one embodiment, the method further comprises locking the two handles into a fixed rotational position about the rotational axis by locking a ratcheting mechanism positioned on each handle. In one embodiment, the method further comprises sliding one of the jaws along the longitudinal axis while the two handles are locked in the fixed rotational position about the rotational axis. In one embodiment, the method further comprises releasing the two handles from the fixed rotational position by disengaging the ratcheting mechanism.
In one embodiment, the method further comprises the locking the two handles into a fixed translational position with respect to one another along the longitudinal axis by locking a ratcheting mechanism on each handle. In one embodiment, the method further comprises releasing the two handles from the fixed translational position by disengaging the ratcheting mechanism. In one embodiment, the method further comprises inserting the needle into a tissue of a subject. In one embodiment, the method further comprises the step of releasing the needle from the needle grasping device and re-engaging the grasping device to the needle at another position on the needle.
The foregoing purposes and features, as well as other purposes and features, will become apparent with reference to the description and accompanying figures below, which are included to provide an understanding of the invention and constitute a part of the specification, in which like numerals represent like elements, and in which:
It is to be understood that the figures and descriptions of the present invention have been simplified to illustrate elements that are relevant for a clear understanding of the present invention, while eliminating, for the purpose of clarity, many other elements found in related systems and methods. Those of ordinary skill in the art may recognize that other elements and/or steps are desirable and/or required in implementing the present invention. However, because such elements and steps are well known in the art, and because they do not facilitate a better understanding of the present invention, a discussion of such elements and steps is not provided herein. The disclosure herein is directed to all such variations and modifications to such elements and methods known to those skilled in the art.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, exemplary methods and materials are described.
As used herein, each of the following terms has the meaning associated with it in this section.
The articles “a” and “an” are used herein to refer to one or to more than one (i.e., to at least one) of the grammatical object of the article. By way of example, “an element” means one element or more than one element.
“About” as used herein when referring to a measurable value such as an amount, a temporal duration, and the like, is meant to encompass variations of ±20%, ±10%, ±5%, ±1%, and ±0.1% from the specified value, as such variations are appropriate.
Throughout this disclosure, various aspects of the invention can 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, 2.7, 3, 4, 5, 5.3, 6 and any whole and partial increments therebetween. This applies regardless of the breadth of the range.
One aspect of the present invention relates to a needle holder with finger-loop handles, having a ratchet locking mechanism connected to two scissoring arms by the fulcrum that in turn connect to opposing jaws that hold the suture needle. In one embodiment, the needle holder has an overlapping fulcrum and elongated ratchet locking mechanism, and an additional locking mechanism in the grooves of a traditional ratchet design. In some embodiments a needle holder includes a sliding mechanism, configured to manipulate and move needles along any plane parallel to the longitudinal axis of the device. The sliding mechanism enables increased movement, which means the needle can be rotated up to 360 degrees while in the jaws. Certain embodiments include a second locking mechanism that will secure the needle holder sliding position in place once the needle has been moved to the desired position.
The disclosed design allows quick placement and adjustment of the needle in the holder and maintains proper, secure alignment of the needle to the jaws of the needle holder. This provides the surgeon with an implement to facilitate driving a needle suture in difficult conditions of long reaching tissues or limited space, such as when reaching down into body cavities or intra-orally, and to adjust the direction of the needle while actively suturing. This will make it easier for surgeons to handle and manipulate the instrument in relatively small and sometimes minute increments and degrees while suturing and not have to readjust the needle with the surgeon's hand to get better angulation for placement of a suture. The sliding system configuration in the needle holder adds more control of a suturing operation by increasing comfort.
Referring now to
With reference to
The first handle and the second handle have matching notches on their opposing surfaces which engage one another, locking, as the finger loops are brought together. These notches are longitudinal to the needle holder. Such locking ratchet mechanisms are known in the art, but the elongated design allows for the needle holder to remain locked around the needle when a sliding maneuver is performed. While in some embodiments the finger loops are substantially round, in other embodiments the finger loops may have other shapes, for example rectangular, triangular, or a castrovie.
Another advantage of the disclosed design is that if the needle holder is closed tighter to engage the more proximal notches, it is configured to provide higher resistance when engaging the sliding mechanism to allow the surgeon to have more preference for the level of resistance when engaging the sliding mechanism. The vertical notches of the ratchet 602 are configured to prevent the handles from sliding relative to one another when the surgeon does not desire this additional function.
As shown in
As shown in
In one embodiment, the track has a length of between 5 mm and 20 mm, and can vary based on the overall size of the needle holder and location it is being used on the body. This is an average track length, but in some embodiments a device can have a track length as small as one millimeter, for example in embodiments that are used for very delicate procedures such as using needle holders for anastomosis of small arteries or nerves. As shown in
The finger loops 1 and 2 and arms 3 and 4 allow the surgeon to grasp the instrument and apply pressure to close it. Once closed, the ratchet mechanism locks to maintain the closed position while still allowing the two handles to slide in relation to each other. The ratchet mechanism can be further closed to engage a second locking mechanism to prevent the segments from sliding. The ratchet mechanism is opened by the surgeon applying opposing pressure to the finger loops. The pivot joint allows for ease of opening and closing the jaws. The needle holder jaws taper in both width and height to a terminal, rounded point. This pointed tip allows for good directional placement and visualization of needle position by the surgeon using the instrument. When the handles are slid relative to one another, the jaws will sometimes not be lined up depending on the desired rotation of the needle at any given time.
With regard to
With reference to
With reference to
In another aspect, the present disclosure includes methods of grasping and/or positioning a needle, for example using a device as disclosed herein. With reference now to
In some embodiments, the method may further comprise the step of locking two handles of a needle grasping device into a fixed position relative to one another along one or two axes. In one embodiment, each handle of the needle comprises a ratcheting mechanism having grooves extending in the longitudinal direction, the grooves on each handle configured to mate with one another when the grasping device is in a closed position. A method may comprise the step of closing the grasping device and mating the grooves in the respective handles, thereby holding the grasping device in substantially the same closed position when the handles are released. In such embodiments, a method may further comprise a step of sliding the two handles back and forth relative to one another along the longitudinal axis while the handles are locked together, along the longitudinal grooves. In some embodiments, the ratcheting mechanism further comprises a set of grooves perpendicular to the longitudinal grooves on each handle, and configured to further hold the handles in a fixed position along the longitudinal axis, for example when the two handles are slid along the longitudinal axis into a new position with respect to one another (and consequently in some embodiments, when a needle grasped between the jaws is rotated). A method of using the grasping device may then further comprise the step of moving the handles into a fixed position along the longitudinal axis and locking the handles in place by engaging the perpendicular grooves in each handle.
Methods related to the disclosed device may further include surgical steps, for example piercing a needle grasped between the handles through one or more tissues, releasing the grasping device from the needle, and re-engaging the grasping device to the needle at a position on the other side of the one or more tissues in order to pull the needle fully through the tissue, for example for placing a suture. In some embodiments, the needle may be rotated before, after, or during the piercing step, using the mechanism described above. In some embodiments, a method may include the step of locking the handles of the grasping device into a fixed position relative to one another, either to keep the opposing jaws at a fixed distance/grasping force with respect to one another, or to keep the handles at a fixed position with respect to one another along the longitudinal axis.
The disclosures of each and every patent, patent application, and publication cited herein are hereby incorporated herein by reference in their entirety. While this invention has been disclosed with reference to specific embodiments, it is apparent that other embodiments and variations of this invention may be devised by others skilled in the art without departing from the true spirit and scope of the invention. The appended claims are intended to be construed to include all such embodiments and equivalent variations.
This application claims priority to U.S. Provisional Patent Application No. 62/947,599, filed on Dec. 13, 2019, incorporated herein by reference in its entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/US20/64747 | 12/14/2020 | WO |
Number | Date | Country | |
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62947599 | Dec 2019 | US |