Patent Application
20140207188
The present invention relates to surgical suturing instruments, and more particularly to hand manipulated instruments for retrieving and passing a surgical suture through tissue.
Minimally invasive surgery, such as arthroscopic surgery, and open surgery performed in narrow body cavities require surgeons to use surgical instruments as extensions of their hands. Surgeons can use these instruments to internally close wounds, reattach separated tissue, form a new structure with transplanted tissue, provide support structures, among other procedures. Consequently, a number of procedures require a suture to be passed through tissue and retrieved from the exiting side.
Certain instruments exist to provide a surgeon the capability of passing a suture through multiple segments of tissue where it is not feasible or preferable to do so by hand. U.S. Pat. No. 6,077,277, U.S. Pat. No 7,704,262, and U.S. Pat. No. 8,066,718 describe some of these types of instruments. Several of these devices suffer from increased risk of failure due to a number of moving parts. Also, many of these moving parts unnecessarily increase the number of bacteria trapping surfaces, thereby increasing the risk of infection and complicating sterilization. Therefore, these instruments are characteristically employed as single-use devices. Further, many of the mechanisms of the prior art unduly constrain the ability of the surgeon to manipulate the mechanism and receive accurate feedback.
Another aspect of these instruments, which is partially due to their single-use nature, is that they are not precision engineered for optimal configuration. This has led to cannulated needles that are much larger in diameter than instruments used through their cannulated passageways. This can increase trauma to the tissue penetrated by the cannulated needle and can permit the suture retrieving device to move when not desired. Additionally, these cannulated needles can be susceptible to bending, which further dictates that they be disposable, single-use devices.
Therefore, there is a need for a surgical suturing system that has a simple, ergonomic operating mechanism that is reliable, reusable, and precision engineered to provide enhanced operational feedback, situational flexibility, and sterilization maintenance.
Disclosed herein are instruments for retrieving and passing a surgical suture through tissue. According to one aspect of the present invention, a suture retaining device includes an elongate body that has a cross section that is at least partially circular. The suture retaining device further includes a head portion joined to the elongate body. The head portion has a sidewall defining a cavity for receipt of a suture. The sidewall includes an internal surface that is at least partially flat, and the cavity is enclosed by the sidewall.
In alternate embodiments, the head portion can be collapsible and joined to the elongate body, with the head portion having a sidewall defining a cavity for receipt of a suture, the sidewall having an internal surface that is at least partially flat. The sidewall may form a diamond configuration that is collapsible. The head portion may be made from a memory metal, such as nitinol.
Another aspect of the present invention is a suture retaining device including an elongate body that is at least partially helical. The suture retaining device includes a head portion joined to the elongate body. The head portion has a sidewall that defines a cavity for receipt of a surgical suture. The sidewall has an internal surface that is at least partially flat. In one embodiment, the elongate body may comprise a double helix. In another aspect of the present invention, the elongate body may be configured as a helix and an elongate rod. The helix may be wound about the elongate rod.
A further aspect of the present invention is a suture passing device including a body having a distal end, a proximal end, and an outer surface. The suture passing device further includes an internal passageway extending through the body from the distal end to the proximal end. Also included is a contoured portion that defines a recess in the body. The recess extends radially from the outer surface to the internal passageway. The contoured portion may be homogenous or constructed of uniform composition throughout.
In one embodiment, the contoured portion may include a ridge that is substantially perpendicular to the internal passageway. The ridge may include a depression that is aligned with the internal passageway. The body may be tapered for conformity to a hand grip.
According to another aspect of the present invention, the suture passing device may include a needle having a cannulated passageway in fluid communication with the internal passageway of the handle. The distal end of the body may be configured to connect to a cannulated needle, wherein connecting the distal end of the body to the cannulated needle places the internal passageway in fluid communication with the cannulation of the cannulated needle. The suture passing device may include a suture retaining device that is slidably and rotatably engaged with the internal passageway of the suture passing device.
In one aspect of the present invention, a suture passer device includes a body having a distal end, a proximal end, and an outer surface. The suture passer device also includes an internal passageway extending through the body from the distal end to the proximal end. Additionally, a contoured portion defines a recess in the body. The recess extends radially from the outer surface to the internal passageway. Also included is a needle having a cannulated passageway in fluid communication with the internal passageway of the handle.
A further aspect of the present invention is a suture retaining device including a length of material having two end portions and an intermediate portion between the end portions. Each end portion has a circular cross section and at least a portion of the intermediate portion has a flattened cross section. The cross section of the end portions can be the same or different, and either can be square, triangular, oval, or any other shape instead of circular. The length of material is bent into a configuration in which the intermediate portion forms a head portion having a closed loop and the end portions together form a body.
A further aspect of the present invention is a suture retaining device including a length of material having two end portions and an intermediate portion between the end portions. At least a portion of the intermediate portion has a flattened cross section. The length of material is bent into a configuration in which the intermediate portion forms a head portion having a closed loop and wherein the end portions are wound together to form a body.
In accordance with other embodiments of the aforementioned two aspects, the end portions can be configured in a double helix construction to form the body. The end portion can be configured such that one end portion is substantially linear and the other end portion is substantially helical and wound about the linear end portion. The head portion can be generally formed into a diamond configuration. At least the head portion can be made from a memory metal. The memory metal can be nitinol.
As used herein, when referring to the surgical instruments of the present invention, the term “proximal” means closer to the surgeon or in a direction toward the surgeon, and the term “distal” means more distant from the surgeon or in a direction away from the surgeon. The term “lateral” means away from the midline of the surgical instrument of the present invention.
The suture shuttle 100 may be made from any biocompatible material, such as titanium, stainless steel, plastic, ceramic, etc. However, at least the head portion 110 is preferably made from a memory metal, for example nitinol, to aid in the collapsibility and re-expansion of the head portion 110.
The diamond shaped nature of head portion 110 and the fact that shuttle 100 is comprised of a memory metal allows head portion 110 to press outwardly against the inside passageways of the suture passer handle 200 and cannulated needle 300, as described below. This outward pressure provides a frictional force that enhances the ability of shuttle 110 to maintain its position within the passageways of handle 200 and needle 300, even if the device is held in a vertical orientation that may otherwise permit shuttle 100 to slide out of the device.
As shown in
Alternatively, the body 140 may also be composed of a single rod with a circular cross section (not shown), either monolithically connected with or separately attached to head portion 110. In this scenario, the head portion may be attached to the single rod in any number of ways recognized by those skilled in the art, for example a portion of the rod can be split, flattened and welded to form the head portion. The cylindrical nature of the elongate body 140 may be realized in the form of a rod of a circular cross section with a single helix wrapped around the rod (not shown). The head portion 110 could be formed in the same manner as the double helix embodiment, with the exception that only one portion of the wire-like structure is twisted with respect to itself.
In a preferred embodiment, suture shuttle 100 is manufactured by first providing a single length of material having a circular cross section. The portion of the material that is to form head portion 110 is flattened into a rectangular cross section. The portion of the material that comprises body 140 remains circular in cross section. The rectangular cross section of the material at head portion 110 can be formed by hammering or otherwise flattening the circular cross section of the initially provided material. The length of material can then be bent so that the portion with the flat cross section is shaped into head portion 110, as shown in
In alternative embodiments, a suture shuttle in accordance with the present invention can include a head portion 110 at each end of the shuttle. Thus, both of the leading and trailing can be configured to include head portions 110, which can be of the same or different sizes. Additional embodiments can be configured such that the head portion 110 is actually disposed along the length of the body of the shuttle rather than at one end thereof. Multiple head portions 110 can be disposed on shuttle, at either or both ends or only along a middle portion thereof.
The body 210 may be ergonomically shaped to fit comfortably within a hand of a user, such as having a gradual taper. The internal passageway 230 extends throughout the suture passer handle 200 from the proximal end to the distal end, and is dimensioned to accommodate the elongate body 140 of the suture shuttle 100 described above. In one embodiment, internal passageway 230 is defined by a substantially uniform cylindrical passage provided through handle 200. The portions of handle 200 coinciding with the cylindrical passage define the boundaries of internal passageway 230 and serve to enclose its entire circumference, thereby simplifying loading of suture shuttle 100 into internal passageway 230.
The contoured portion forms a recess 226 in the body 210 near the distal end of the suture passer handle 200. The recess 226 extends radially into the suture passer handle 200 so that the internal passageway 230 is exposed when viewing the contoured portion 220. When a suture shuttle 100 is loaded into the suture passer handle 200 via the internal passageway 230, the recess 226 allows the surgeon to have controllable access to the elongate body 140 of the suture shuttle 100, such that a thumb or finger of the surgeon can be used to contact suture shuttle 100 to pass it through passageway 230. The contoured portion 220 is formed near the distal end so that the surgeon can grip the proximal portion of the body 210 while using his or her thumb to manipulate the suture shuttle 100.
A ridge 222 is provided by contoured portion 220 within recess 226 that runs along the contoured portion 220 in a direction that is generally perpendicular to the internal passageway 230. In this way, ridge 222 can be configured to abut, or even to slightly coincide with or overlap, the substantially uniform cylindrical passage that defines passageway 230. That is, ridge 222 can be configured such that it would abut or overlap an imaginary boundary of the cylindrical passage that would extend between the sections of the passageway 230 located in the proximal and distal aspects of body 210.
In one embodiment, ridge 222 overlaps or intersects the cylindrical passage that defines passageway 230. Such a configuration of ridge 222 allows the generally cylindrically configured elongate body 140 of suture shuttle 100 to rest against ridge when shuttle 100 is disposed within passageway 230 adjacent ridge 222. The slight pressure of ridge 222 against shuttle 100, and the friction imparted on shuttle 100 by ridge 222, aids in maintaining shuttle 100 at a particular location within handle 200. Manipulation of shuttle 100 is even further enhanced by the texture created by the double helix of the elongate body 140 where the suture shuttle 100 is utilized. All aspects of this overall configuration between the mating of ridge 222 and shuttle 100 allow for the location of shuttle 100 with respect to handle 200 to be generally maintained absent purposeful manipulation by the surgeon. That is, the configuration of ridge 222 and the frictional aspects of the devices tend to prevent movement of shuttle 100 along passageway 230. The surgeon is therefore given greater control in utilizing shuttle 100 exactly as dictated by a particular procedure without the need to concentrate on holding the position of shuttle 100 throughout the procedure.
The ridge 222 may have a depression 224 that is aligned with the internal passageway. This depression 224 provides a reference point and guide for the surgeon's finger and suture shuttle 100 while the ridge 222 provides overall support to the elongate body 140 as it spans the contoured portion 220. This support ensures that the suture shuttle 100 does not bend during advancement of the suture shuttle 100 by the surgeon. Both the ridge 222 and depression 224 are ergonomically designed to provide optimum comfort and ease of use during tedious procedures.
One advantage of the configuration of suture passer handle 200 is that it does not necessarily rotationally constrain the suture shuttle 100 when it is loaded into the suture passer handle 200, aside from normal frictional forces. Thus, the surgeon may optionally use his or her thumb to rotate the suture shuttle 100 with respect to passageway 230 while it is loaded into the suture passer handle. This rotational ability is further aided by the depression 224 by providing a resistive surface to roll the suture shuttle 100 while simultaneously preventing bending of the elongate body 110. Additionally, the rounded feature of the elongate body 140, as has been previously described, allows for smooth rotation, thereby limiting the work a surgeon's wrist must perform, and providing the surgeon added flexibility in retrieving a suture. Additionally, the rounded feature allows for smooth tracking during axial translation along the contoured portion 220. Because the suture passer handle allows for tactile manipulation of the suture shuttle by the surgeon, resistive and dynamic feedback to the surgeon is not hindered by a mechanical structure, thereby improving operational feedback.
As shown in
Referring to
Additionally, the suture passer needle has been configured to resist bending during repeated use.
This configuration along with the optimization of the internal dimensions of the suture passer needle 300 has led to an approximately twenty-five percent reduction in the external diameter of the suture passer needle 300 from that of certain existing instruments, thereby reducing the trauma introduced to tissue by the suture passer needle 300. The reduction in diameter from that of certain existing instruments is illustrated by comparing
Further illustrated by
Also included in a kit with one or more suture passer needles can be a reusable suture passer handle, such as handle 200, and one or more suture shuttles, such as shuttle 100. This gives the surgeon flexibility in selecting the most appropriately configured suture passer needle for use in a surgical procedure with a suture passer handle adapted to connect with each of the various needles, with each of the resulting constructs being adapted for use with a suture shuttle, such as shuttle 100.
Referring to
Following the assembly of the suture passer handle 200 and suture passer needle 300, the suture shuttle 100 is loaded into the construct. The distal end of the suture shuttle 100, i.e. the head portion 110, can be slid through the internal passageway 230 at the proximal end of the suture passer handle 200 until head portion 110 resides within the suture passer needle 300. Alternatively, the proximal end of the shuttle 100 can be slid into the cannulated passage 340 at the distal end of suture passer needle 300 until head portion 110 resides within the suture passer needle 300. In either of these methods, care must be taken to move the initially inserted end of the shuttle 100 across the recess 226 so that the shuttle 100 is disposed within both the proximal and distal ends of internal passageway 230, as shown in
The surgeon then pierces tissue with needle tip 350 at the intended location and manipulates needle tip 350 into a position at which the suture shuttle 100 can be passed from the device. The suture shuttle 100 is then manipulated to extend out of cannulated passageway 340 away from needle tip 350. Doing this, the surgeon can use a thumb or finger to interact with shuttle 100 within recess 226 to move shuttle 100 either proximally or distally, or to rotate shuttle 100 with respect to cannulated passageway 340 as desired. The surgeon may then further manipulate the suture passer handle 200 or the suture shuttle 100 by further translating or rotating the suture shuttle 100, or any combination thereof, until cavity 120 is accessible to the surgeon for placing a suture therethrough. Such access can be either within the body or outside of the body, such as through a secondary cannula. The manipulation of shuttle 100 to provide access for placing a suture therethrough can be aided by the surgeon grasping shuttle 100, either by hand or with a grasping instrument such as forceps, to place head portion 110 in an accessible location. A suture is then passed through cavity 120, at which point the surgeon then retrieves the suture by retracting head portion 110 into needle head 320, thereby trapping the suture within cannulated passageway 340. This trapping is additionally facilitated by the diamond shape and collapsibility of the head portion 100 by promoting movement of the suture to the narrowest part of head portion 110 and/or pinching it with the flat inner surface 130 of sidewall 150 as head portion 110 is collapsed. The flatness of inner surface 130 provides additional surface area for increased gripping strength.
With the suture disposed through head portion 110 and within cannulated passageway 340, the trapped suture is then passed back through the pierced hole in the tissue by the surgeon retracting suture passer needle 300 out of the pierced tissue through manipulation of suture passer handle 200. At this point in the procedure, the surgeon can then remove the suture from the body, or can pass the suture back through the tissue at a different location by guiding needle tip 350 as described above.
Manipulation of the suture shuttle 100 can occur in several ways. One form of manipulation occurs by translating the suture shuttle 100 in extension or retraction. This can be performed by pressing the elongate body 140 against the depression 224 with a finger and then moving the finger in a distal or proximal direction, thereby translating the suture shuttle 100. This is particularly effective for fine, controlled adjustments. Translation can also be performed by pinching a portion of elongate body 140 that extends proximally from the proximal end of the suture passer handle 300, as shown in
Another form of manipulation is rotation of suture shuttle 100. This may be performed by pressing the elongate body 140 against the ridge 226, or more specifically within the depression 224 if provide to the ridge 226, with a finger and then moving the finger in a lateral direction, thereby rotating the suture shuttle 100. Rotation may also be performed by pinching a portion of the elongate body 140 that extends proximally from the proximal end of the suture passer handle 200 and then rolling the elongate body 140 between the fingers, thereby rotating the suture shuttle 100.
Although the invention herein has been described with reference to particular embodiments, it is to be understood that these embodiments are merely illustrative of the principles and applications of the present invention. It is therefore to be understood that numerous modifications may be made to the illustrative embodiments and that other arrangements may be devised without departing from the spirit and scope of the present invention as defined by the appended claims.
The present application claims the benefit of the filing date of U.S. Provisional Patent Application No. 61/755,654 filed Jan. 23, 2013, the disclosure of which is hereby incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 61755654 | Jan 2013 | US |
