Patent Application
20240041506
The invention generally relates to devices for use in connection with medical procedures that involve fixing one or more implants (such as a surgical screw) into one or more bones of a patient.
Orthopedics is a medical specialty concerned with the correction of deformities or functional impairments of the skeletal system, in particular the extremities and the spine, and associated structures, such as muscles and ligaments, of a human (or other type of mammal) patient. Some orthopedic surgical procedures require surgeons to secure a device to one or more bones of a patient. For example, in some procedures, a surgeon may span and secure one or more bones, or pieces of a single bone, using a bone plate and one or more fasteners, such as screws. Other bone-related surgical procedures, however, may not require a bone plate and may instead solely rely on the use of one or more screws to, for example, secure a transplanted tendon.
In any of a variety of bone-related surgical procedures, before an implant or plate, or simply a screw itself, can be attached to bone, an opening is typically drilled into that bone to accommodate the screw. With the opening or hole in place, the surgeon can more easily select a screw of the appropriate length. However, selecting a screw of appropriate length is critical. If the selected screw is too long, for example, the distal end of the screw may pass through the end of the drilled hole and cause damage to the bone and/or protrude entirely through the bone, which can have deleterious effects, such as damage to surrounding tissue and/or pain and discomfort, or more serious complications, for the patient. For example, in some instances, the bone may abut against soft tissues that may be harmed if the screw is too long and that may result in irritation of or damage to those soft tissues. Additionally, a screw that protrudes through the bone may be tactilely felt by the patient, may prevent soft tissues (e.g., tendons, ligaments, or muscles) from moving over the bone surface as intended, or may even pierce the skin which can lead to serious infection and/or other complications.
The selection of an appropriate length screw is particularly important in spinal fixation procedures, such as lumbar sacral fusion and the correction of spinal deformities such as scoliotic curves. As an example, a screw mounted in the pedicle portion of the human spine should not extend to a point where the screw contacts the spinal cord itself, an event that can cause irreparable nervous system damage including paralysis. Accordingly, the determination of a length of the hole is important for choosing a screw of the appropriate length.
During the act of drilling into a bone, the surgeon is typically capable of recognizing the resistance on the drill to determine when the drill has penetrated through the bone. Because the simple act of drilling does not provide an exact measurement of the depth of the bone itself, a depth gauge is commonly employed for directly measuring the depth of the hole from the top, drilling side of the bone to the bottom, opposite side of the drilled hole.
There are known tools to measure the depth of a through hole in bone or the depth of a bore in bone. Some such tools use a central probe member with a barb at a distal end, and they also use a sleeve or channel member. The probe is inserted into the drilled pilot through hole in the bone while the surgeon attempts to find the opposite surface with the distal barb. More specifically, the probe is inserted to a depth greater than the depth of the pilot hole so that the barb is beyond the opposite side of the bone with the pilot hole drilled through it, at which point the surgeon finds the surface by hooking the barb to the opposite side. The probe is received in the sleeve or channel member and may reciprocate relative thereto. The channel member has graduated markings along a portion of its length, typically in inches and/or millimeters. A marker is laterally secured to the probe such that, as the probe shifts relative to the channel, the marker indicates the relative shift between the probe and the channel. Accordingly, once the distal end of the probe has been secured to the opposite side of the bone, the channel member is shifted relative to the probe and toward the bone until the channel member abuts the surface of the bone. The depth gauge is then read by visually examining graduated markings indicated by the probe marker.
A user of such a known depth gauge can experience problems. As an initial point, the components of such a gauge typically are made of surgical-grade stainless steel, and the graduated markings are embossed therein. The brightness of the operating room lights on such a highly reflective surface can make the markings difficult to read. The markings commonly are in small increments, such as millimeters, and surgeons often have trouble differentiating between the markings, or noting partial increments. Reading such a gauge often requires carefully holding the depth gauge as the reading is taken, and a surgeon's effort to examine closely the reading may result in a loss of securement or purchase of the barb on the bone, thus necessitating a re-measurement and subsequent loss of time. Furthermore, proper reading of the markings requires a surgeon's eyes to be properly aligned with the markings. That is, a proper view of the measurement requires the surgeon to view the gauge from a lateral point of view so that the view of the probe marker aligned with the graduated markings is proper and not distorted by the surgeon's elevated, standing perspective. Therefore, it is often necessary for the surgeon to bend over while using these gauges to view an accurate reading. If the depth gauge is tilted to make the reading easier, the sleeve will shift relative to the probe, thus making the measurement inaccurate and possibly also causing the distal end/barb of the probe to become unsecured. In addition, removal of the depth gauge often causes the measurement to be lost. As the bone is essentially clamped, by light pressure, between the distal end of the channel member and the distal end/barb of the probe, it is often necessary to retract the channel member from the bone surface to extract the probe from the pilot hole. Another problem with using such a known depth gauge is that it is cleaned and reused in multiple subsequent orthopedic surgical procedures, but the cleaning process can be inadequate in properly sterilizing the depth gauge such that an infection can occur in a patient.
A depth gauge that is superior to known depth gauges is a single-use, disposable depth gauge that can be used in orthopedic surgical procedures and that is known as the EDG® depth gauge. The EDG® depth gauge is by EDGe Surgical, Inc. of Chicago, Illinois (edgesurgical.com), and the EDG® device has a digital display that provides to a user a readout of the device's depth measurement on an OLED (organic light-emitting diode) display screen. EDGe Surgical, Inc. owns patents directed to depth gauges with digital displays including, for example, U.S. Pat. Nos. 7,895,767, 10,132,607, and 10,151,570, as well as the priority U.S. Pat. No. 11,504,169.
A depth gauge with a bone probe (such as any of the versions of a single-use, disposable depth gauge disclosed in priority U.S. Pat. No. 11,504,169, which is incorporated herein in its entirety) can have a portion of its bone probe in an off-axis configuration. For example, the probe of a depth gauge can be bent, curved, or angled at a certain point along the length of the probe. That bend, curve, or angle of the probe of the depth gauge can be made during the manufacturing or assembly process of the depth gauge, such that the depth gauge is delivered to the end user (for example, an orthopedic surgeon or a nurse) in sterile packaging with the bend already present in the probe of the packaged depth gauge. Alternatively, the depth gauge can be packaged and delivered to the end user with a straight or substantially straight probe and with a tool (also provided in the sterile packaging, or else in sterile packaging that is separate from the sterile packaging containing the depth gauge) for use by the end user to bend the probe of the depth gauge before the end user uses (and/or during the time the end user is using) the depth gauge in an orthopedic medical procedure on a patient. The tool used in the process of manufacturing and/or assembling the depth gauge to bend the probe of the depth gauge can be referred to as a manufacturing tool, and the tool designed for use by an end user of the depth gauge to bend the probe of the depth gauge can be referred to as an end-user tool.
An end user (such as an orthopedic surgeon) would be able to use the manufacturing tool to bend a straight or substantially straight probe of a depth gauge if the manufacturing tool was provided to the end user, and a person involved in the manufacturing and/or assembly of the depth gauge would be able to use the end-user tool to bend the probe of a depth gauge if the end-user tool was provided to that manufacturing-assembly person, but the manufacturing tool is designed specifically for use by the manufacturing-assembly person to bend the probe of the depth gauge before the finished depth gauge is sealed in sterile packaging, and the end-user tool is designed specifically for use by an end-user person to bend the probe of the depth gauge after the finished depth gauge is removed from sealed sterile packaging. While each of the manufacturing tool and the end-user tool is designed to be used by a person to bend a portion of a probe of a depth gauge, the end-user tool generally is simpler in its construction, and simpler to use, when compared to the manufacturing tool. The end-user tool is designed to be used when held in the hand of an end user of the depth gauge device (such as an orthopedic surgeon or a nurse in an operating room), and the manufacturing tool is designed to be placed on a desktop or workbench surface and used by a manufacturing and/or assembly person (such as a technician located in a medical device manufacturing and/or assembly facility or room).
Either of the tools can be used to bend the probe at one or more locations or areas along the longitudinal axis of the probe. The probe generally will start in a straight or substantially straight longitudinal configuration before one of the tools is used to place one or more bends at one or more locations or areas along the probe's length, but the probe already could have some curve or angle to it before the tool is used on the probe. Whether or not the probe already has some bend(s) to it before the tool is used on the probe, the probe typically will have some longitudinal flexibility to it. This flexibility of the probe provides a “feel” to the end user (for example, a surgeon) during examination of a hole in a bone with the probe, but the bend(s) created in the length of the probe by use of one of the tools provides the end user with even greater tactile feel or feedback when using a bent-probe depth gauge in a medical procedure.
The bend (or bends) in the probe gives (or give) the depth gauge device a feature that will allow an end user (such as a surgeon or a nurse) to feel very well the interior side wall(s) of a drilled hole in a bone of a patient (when the probe is inserted into the hole and the depth gauge is manually manipulated by the end user) and/or to feel very well when the distal end of the probe emerges from the opposite end of the hole and catches on the lip of that opposite-side exit aperture of the hole. The user's tactile experience when using the depth gauge in a medical procedure is enhanced when the probe of the depth gauge is bent off-axis by a certain angle (or any particular angle within a certain range of angles) or curve, and that is why it is important to provide the end user with a depth gauge having a pre-bent probe and/or to provide the end user with the ability to bend the probe of a depth gauge after the depth gauge is removed from its sterile packaging.
In accordance with one aspect of the invention, a method involves bending a probe of a depth gauge by disposing within a tool at least a portion of the probe of the depth gauge and then operating the tool to bend the probe at a location along a length of the portion of the probe disposed within the device. The bent-probe depth gauge is then removed from the tool and can be either packaged for delivery to an end user (such as an orthopedic surgeon or unit at a hospital or surgery center) or else used by the end user in a medical procedure on a patient.
In accordance with another aspect of the invention, a device is designed for use by an end user (before and/or during a medical procedure on a patient) to bend a probe of a depth gauge after the depth gauge is removed from sterile packaging. The device comprises a first member, a second member, and a connector portion. The first member has a free end, a length, and a width, with the length of the first member being greater than the width of the first member. The second member has a free end, a length, and a width, with the length of the second member being greater than the width of the second member. The first and second members are disposed opposite each other with space between the first and second members, where the space is for receiving at least a portion of the probe of the depth gauge. The connector portion is disposed opposite the free ends of the first and second members to connect the first and second members, and the connector portion is configured to allow the first and second members to move to increase or decrease the space between the first and second members. A bend is created in the probe at a location along a length of the portion of the probe received within the space when the end user causes the first and second members to move and decrease the space between the first and second members. The connector portion can define an aperture through which the portion of the probe of the depth gauge passes to occupy at least a portion of the space. The first member, second member, and connector portion of the device can be formed as a single piece by an injection molding process, and the single piece can be formed of a thermoplastic material.
In accordance with yet another aspect of the invention, a device is designed for bending a probe of a depth gauge before the depth gauge is sealed in sterile packaging (for later removal from that packaging in connection with a medical procedure to be performed on a patient). The device comprises a base and a lever. The base is configured to be disposed on a work surface, and the base defines a channel for receiving at least a portion of the probe of the depth gauge. The lever is pivotally coupled to the base to allow the lever to move with respect to the base when the base is disposed on the work surface. A bend is created in the probe at a location along a length of the portion of the probe received within the channel when the lever is moved toward the channel of the base. A person involved in the manufacturing and/or assembly of the bent-probe depth gauge can be the one to push down on the lever to move it toward the base's channel and thereby create the bend in the probe. The base of the device also can define a different channel for receiving at least a portion of a body or handle of the depth gauge. The device can include a hinge pin disposed through the lever and received within the base to allow the lever to move with respect to the base. The base also can include a sliding member movable from an open position to a closed position, where the portion of the probe is able to be received within the channel when the sliding member is in the open position and held in place in the channel when the sliding member is in the closed position. A bottom of the base can have four feet for contacting the work surface when the base is disposed on the work surface. The base of the device also can include a form member with a curved surface for creating the bend in the probe when the lever is moved toward the channel of the base, and the lever of the device can include a roller member for pushing on the location along the length of the portion of the probe received within the channel to cause the bend to occur at that location and according to the curved surface of the form member when the lever is moved toward the base's channel. The device can be formed of one or more metals, or the device can be formed of one or more alloys.
These and other aspects and details of devices and tools according to the invention will become clearer by referring to the following parts of this document, and various methods of making and using such tools and devices will become clearer as well. The entirety of this document illustrates tools, devices, and methods that embody the invention, but the invention is not limited only to the specific tools, devices, and methods disclosed herein. Various ideas and combinations that can be derived from the contents of this document (including both the text and the accompanying drawings) are to be considered as disclosed and included herein.
Each of these twenty-two drawings is referenced again and explained in more detail below.
The invention relates to devices and methods for bending the probe of a depth gauge to create at least one bend in the probe of the depth gauge. The bent-probe depth gauge can be used (by, for example, an orthopedic surgeon, and before and/or during a medical procedure performed on a patient) to determine the depth of a bore hole or a through hole in a bone of the patient.
Turning to the drawings that are directed to the present invention,
The end-user tool 100 comprises a first arm or member 102 that has a free end 108, a length, and a width, where the length is greater than the width. The end-user tool 100 also comprises a second arm or member 104 that also has a free end 110, a length, and a width, where the length of the second member 104 also is greater than the width of the second member 104. The first and second members 102, 104 are disposed opposite each other with space 112 therebetween. At least a portion of the probe 12 of the depth gauge 10 can be received within the space 112. The end-user tool 100 also comprises a pivot or connector portion 106 that is disposed opposite the free ends 108, 110 of the first and second members 102, 104 to connect the first and second members 102, 104 and to allow the first and/or second members 102, 104 to move. The connector portion 106 is configured to allow the first and second members 102, 104 to move to increase or decrease the space 112 between the first and second members 102, 104. A bend is created in the probe 12 at a location along a length of the portion of the probe 12 that is received within the space 112 when the user manipulates the first and second members 102, 104 to cause the first and/or second members 102, 104 to move and decrease the space 112 between the first and second members 102, 104. It can be that the second member 104 is moved by the user toward the first member 102, that the first member 102 is moved by the user toward the second member 104, or that each of the first and second members 102, 104 moves toward the other one. Whatever movement of the first and/or second members 102, 104 that the user causes by the user's manipulation of the end-user tool 100 with the user's hand(s) can result in the space 112 between the first and second members 102, 104 decreasing such that a shaft 14 (see
The connector portion 106 of the end-user tool 100 can define an aperture 114 through which the shaft 14 of the probe 12 of the depth gauge 10 can pass to occupy at least a portion of the space 112. The first member 102 of the end-user tool 100 can include a guide member 116 for retaining and aligning at least a portion of the shaft 14 of the probe 12 when placed through the aperture 114 and into the space 112. The second member 104 of the end-user tool 100 can define a viewing window 118 that is disposed such that a user of the end-user tool 100 can see the portion of the shaft 14 of the probe 12 that is retained and aligned by the guide member 116.
The first member 102, second member 104, and connector portion 106 of the end-user tool 100 can be formed as a single piece, and the single piece can be created by, for example, an injection molding process. Injection molding is a known manufacturing process for producing parts (including various medical devices) by injecting a molten material (such as a thermoplastic material) into a pre-formed mold and then letting the injected material cool and harden to thereby take the shape of the mold. A thermoplastic material can be fed into a heated barrel, mixed in that barrel by a helical screw turning within the barrel, and moved out of the barrel and into the cavity of the mold, where the injected material cools and hardens into the shape of the mold's internal cavity. The thermoplastic material used to create the single-piece end-user tool 100 can be, for example, polyethylene, polypropylene, polystyrene, polymethyl methacrylate, polyvinyl chloride, a polyamide, a polycarbonate, some other thermoplastic material, or a combination of two or more thermoplastic materials.
Referring now to
Turning now to
After the end-user tool 100 has been used by a person to bend the distal portion 16 of the shaft 14 of the depth gauge 10, the entirety of the depth gauge 10 can be removed from the end-user tool 100. As shown in
The use of the end-user tool 100 to create a bend in the distal portion 16 of the shaft 14 of the probe 12 of the depth gauge 10, whatever that acute bend angle is, will give the depth gauge 10 a bent-probe feature that will allow an end user (such as a surgeon or a nurse) to feel very well the interior side wall(s) of a drilled hole in a bone of a patient (when the probe 12 is inserted into that hole and the depth gauge 10 is manually manipulated by the end user) and/or to feel very well when the distal end of the probe 12 emerges from the opposite end of the hole and catches on the lip of that opposite-side exit aperture of a through hole in the patient's bone. The user's tactile experience when using a bent-probe depth gauge in a medical procedure will be enhanced as compared to a depth gauge without a bent probe.
Having described the end-user tool 100 and how it is made and used, reference now is made to
Referring to
The hinge connection 206 of the manufacturing tool 200 can include a hinge pin 226 that is disposed through the lever 204 and that is received within receiving pin holes 224 in the base 202, to allow the lever 204 to move with respect to the base 202. The pin holes 224 of the base 202 can be formed in a portion 222 of the base 202 that also receives a portion of the lever 204 through which the hinge pin 226 is disposed.
The base 202 of the manufacturing tool 200 can include a hard-stop feature 209 which can be a threaded bolt or plug that extends up from a top surface of the base 202 and is positioned to engage a bottom surface of the lever 204 when the lever 204 is moved by the manufacturing-assembly person down toward the base 202. This hard-stop feature 209 prevents the lever 204 from being moved down toward the base 202 any more than is needed for the manufacturing tool 200 to create the desired bend in the shaft 14 of the probe 12 of the depth gauge 10.
The base 202 of the manufacturing tool 200 also can include a sliding member 214 that provides a sliding lock feature, and the base 202 also can include an insert 216 that provides the necessary surface configuration to achieve a desired bend angle in the distal portion 16 of the shaft 14 of the probe 12. The sliding member 214 can be moved from an open position to a closed position. When in the open position, the shaft 14 of the probe 12 can be received within the second channel 212. When the sliding member 214 is in the closed position, the shaft 14 is held in place in the second channel 212.
The lever 204 of the manufacturing tool 200 can include a roller member 218 configured to cooperate with the insert 216 of the base 202. When the manufacturing-assembly person pushes down on the lever 204, with the shaft 14 of the probe 12 in the second channel 212, a bend is created in the shaft 14 at the location of the roller member 218 and the insert 216.
Each of the base 202 and the lever 204 of the manufacturing tool 200, as well as some or all of the parts of the base 202 and the lever 204 (such as the adjustable bolt 209, the sliding member 214, the insert 216, the roller member 218, and the hinge pin 226), can be formed of one or more metals and/or one or more alloys, such as, for example, steel (including, for example, stainless, hard, carbide, mild, high speed), cast iron, titanium, nickel-based alloys, cobalt-chrome alloy, and/or hardened aluminum.
Focusing now on
It is noted that in
With the lever 204 pushed down toward the base 202 until it is stopped by the hard-stop feature 209, the distal portion 16 of the shaft 14 of the probe 12 of the depth gauge 10 is bent by being contacted from above by the roller member 218 of the lever 204 and from below by the insert 216 of the base 202, as shown in
As shown in
The use of the manufacturing tool 200 to create a bend in the distal portion 16 of the shaft 14 of the probe 12 of the depth gauge 10, whatever that acute bend angle is, will give the depth gauge 10 a bent-probe feature that will allow an end user (such as a surgeon or a nurse) to feel very well the interior side wall(s) of a drilled hole in a bone of a patient (when the probe 12 is inserted into that hole and the depth gauge 10 is manually manipulated by the end user) and/or to feel very well when the distal end of the probe 12 emerges from the opposite end of the hole and catches on the lip of that opposite-side exit aperture of a through hole in the patient's bone. The user's tactile experience when using a bent-probe depth gauge in a medical procedure will be enhanced as compared to a depth gauge without a bent probe.
The tools and related methods shown and described herein with reference to
This application is a continuation-in-part of, and claims the benefit of, and priority to, U.S. Non-Provisional application Ser. No. 17/971,096, filed on Oct. 21, 2022. U.S. Non-Provisional application Ser. No. 17/971,096 is a continuation of U.S. Non-Provisional application Ser. No. 16/810,320, filed on Mar. 5, 2020. U.S. Non-Provisional application Ser. No. 16/810,320 is now U.S. Pat. No. 11,504,169, issued on Nov. 22, 2022. U.S. Pat. No. 11,504,169 claims the benefit of, and priority to, U.S. Provisional Application No. 62/937,526, filed on Nov. 19, 2019, and 62/816,536, filed on Mar. 11, 2019. The entire contents of each of these four applications are incorporated herein by reference.
| Number | Date | Country | |
|---|---|---|---|
| 62937526 | Nov 2019 | US | |
| 62816536 | Mar 2019 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 16810320 | Mar 2020 | US |
| Child | 17971096 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 17971096 | Oct 2022 | US |
| Child | 18382772 | US |
