Patent Application
20210275154
The present disclosure relates generally to devices used to perform a biopsy procedure, specifically a bone biopsy procedure. More specifically, the present disclosure relates to devices used to drill into a bone to obtain a core tissue sample of a bone lesion and/or bone marrow.
The embodiments disclosed herein will become more fully apparent from the following description and appended claims, taken in conjunction with the accompanying drawings. These drawings depict only typical embodiments, which will be described with additional specificity and detail through use of the accompanying drawings in which:
A bone biopsy device may include a handle assembly, a coax assembly, and a power pack. The handle assembly may include a housing configured to hold an inner cannula. The inner cannula may extend distally from the housing and may be configured to receive a core tissue sample. A trocar with a penetrating tip may be slidably disposed within a lumen of the inner cannula. The housing may include an extension member that is configured to displace the trocar relative to the inner cannula from a retracted configuration to an extended configuration where the trocar can drill into a bone. A motor and a transmission may rotate the trocar. In certain instances, the transmission may include a worm drive. In other instances, the transmission may include a plurality of spur gears. The inner cannula and trocar may be configured to remain part of the handle assembly (e.g., coupled to the housing) before, during, and after a biopsy procedure. The coax assembly may be selectively detachable from the handle assembly. The coax assembly may include an outer coax cannula extending distally from a coax connector. The inner cannula may be partially disposed within a lumen of the outer coax cannula. The outer coax cannula can be rotated by the motor. A tip of the outer coax cannula may be a cutting tip (e.g., a trephine tip) and be configured to saw into a bone lesion and/or bone marrow. The power pack may be selectively removable from the handle assembly such that the power pack may be a reusable component. The power pack may comprise a power source, a controller, and a connector. The power pack and/or controller may also comprise a printed circuit board. In some instances, the motor may also be selectively removable from the handle assembly such that the motor may also be a reusable component (for instance, the motor may be selectively removable with the power pack).
The bone biopsy device may be used by a practitioner to obtain a core tissue sample of a bone lesion and/or bone marrow. In other instances, the bone biopsy device may be used to obtain a core tissue sample of other tissues within a patient, such as a soft tissue sample. In use, the trocar and outer coax cannula may be rotated by the motor and drilled into the cortical bone layer adjacent to a lesion and/or bone marrow. The trocar may be retracted, and the outer coax cannula rotated to saw a core tissue sample of the lesion and/or bone marrow that is collected in the inner cannula. The outer coax cannula may be removed from the inner cannula and an intermediate cannula can be used to actuate a part-off tab to aid in retaining a core tissue sample within the inner cannula. The trocar can later be advanced within the inner cannula to eject the core tissue sample. A needle or aspiration needle can also be inserted into the outer coax cannula to collect or aspirate bone marrow, blood, and/or tissue cells. A needle could also be inserted into the outer coax cannula to infuse or inject a substance (such as a medicament) into the patient.
Embodiments may be understood by reference to the drawings, wherein like parts are designated by like numerals throughout. It will be readily understood by one of ordinary skill in the art having the benefit of this disclosure that the components of the embodiments, as generally described and illustrated in the figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description of various embodiments, as represented in the figures, is not intended to limit the scope of the disclosure but is merely representative of various embodiments. While the various aspects of the embodiments are presented in drawings, the drawings are not necessarily drawn to scale unless specifically indicated.
It will be appreciated that various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure. Many of these features may be used alone and/or in combination with one another.
The phrase “coupled to” refers to any form of interaction between two or more entities, including mechanical, electrical, magnetic, electromagnetic, fluid, and thermal interaction. Two components may be coupled to each other even though they are not in direct contact with each other. For example, two components may be coupled to each other through an intermediate component.
The directional terms “distal” and “proximal” are given their ordinary meaning in the art. That is, the distal end of a medical device means the end of the device furthest from the practitioner during use. The proximal end refers to the opposite end, or the end nearest the practitioner during use. As specifically applied to the bone biopsy device, the proximal end of the device refers to the end nearest the handle and the distal end refers to the opposite end, the end nearest the end of the outer coax cannula. Thus, if at one or more points in a procedure a physician changes the orientation of the device, as used herein, the term “proximal end” always refers to the handle end of the device (even if the distal end is temporarily closer to the physician).
As depicted in an exploded view of the bone biopsy device 100 of
The handle housing 111 may be formed of two separate halves that may be coupled using any suitable technique. For example, the separate halves may be coupled using a snap fit, welding, gluing, fasteners, pins, etc. The handle housing 111 may include any suitable polymeric and/or metallic material, such as polycarbonate, acrylonitrile butadiene styrene, polycarbonate acrylonitrile butadiene styrene copolymer, nylon, acetal, polyethylene (e.g., such as high-density polyethylene and/or low-density polyethylene), silicone, thermoplastic elastomers, steel, stainless steel, aluminum, ceramic, and combinations thereof. The polymers may also be reinforced with other materials, such as glass or aramid fibers. The handle housing 111 may be formed using any suitable technique, such as injection molding, thermoforming, machining, 3D printing, etc. The handle housing 111 can include a plurality of pockets or recesses configured to hold or retain at least some of the components of the handle assembly 110.
In the depicted embodiment, the motor 122 may be disposed within the grip portion 113 of the handle housing 111. The motor 122 may be any suitable type of rotatory motor. For example, the motor 122 may be a DC brushed motor, a DC brushless motor, a stepper motor, a servo motor, a pneumatic motor, or an AC powered motor, etc. The motor 122 may also be bi-directional. The motor 122 can include a drive shaft 123 extending from the motor 122. The motor 122 may rotate the drive shaft 123 at a speed ranging from about 0 rpm to about 50,000 rpm, or from about 15 rpm to about 20,000 rpm. The motor 122 can be electrically coupled to the power source 182 and to the motor activation switch 124.
As illustrated, the transmission 125 can be primarily disposed within the grip portion 113 of the handle housing 111. The transmission 125 can be operably coupled to the motor 122. In the illustrated embodiment, the transmission 125 includes a pinion gear 126, a reduction gear 129, a trocar gear 127, and a coax gear 128. The pinion gear 126 can be fixedly coupled to the drive shaft 123 and rotated by the motor 122. The reduction gear 129 can engage with and be driven by the pinion gear 126. In other embodiments, the transmission 125 may not include the reduction gear 129 such that the pinion gear 126 engages directly with the trocar gear 127 and the coax gear 128.
The reduction gear 129 is shown to include a distal pinion gear 130 and a proximal pinion gear 131 disposed at a proximal end of a shaft. The distal pinion gear 130 can engage with and drive the coax gear 128, and the proximal pinion gear 131 can engage with and drive the trocar gear 127. The trocar gear 127 may be operably coupled to the trocar 160 such that the trocar 160 is rotated by the trocar gear 127. The coax gear 128 may be operably coupled to an outer coax cannula 173 such that the coax cannula 173 is rotated by the coax gear 128. In the depicted embodiment, the trocar gear 127 and the coax gear 128 have a similar diameter and/or number of teeth such that the coax trocar 160 and the coax cannula 173 can be rotated at a similar speed. In other embodiments, the trocar gear 127 and the coax gear 128 may differ in diameter and/or number of teeth such that the trocar 160 and the coax cannula 173 can be rotated at different speeds. For example, the trocar gear 127 may have a smaller diameter and/or fewer teeth than the coax gear 128 resulting in the trocar 160 rotating at a higher speed than the coax cannula 173. An inverse configuration is also within the scope of this disclosure. In other embodiments, an intermediate gear may engage with the reduction gear 129 and the trocar gear 160 or the coax gear 128 to cause the trocar gear 160 and the coax gear 128 to rotate in opposite directions.
The gears 126, 127, 128, 129, 130, 131 may be formed from any suitable rigid or semi-rigid material, such as polycarbonate, acrylonitrile butadiene styrene, polycarbonate acrylonitrile butadiene styrene copolymer, nylon, acetal, polyethylene (e.g., high density polyethylene and/or low density polyethylene), silicone, thermoplastic elastomer, steel, stainless steel, aluminum, brass, ceramic, and combinations thereof. The polymers may be reinforced with other materials, such as glass or aramid fibers.
In some embodiments, a gear reduction ratio of the transmission 125 may range from about 100:1 to about 1:1, from about 80:1 to about 10:1, from about 50:1 to about 20:1, or from about 40:1 to about 30:1. In other words, the trocar 160 and the coax cannula 173 may be rotated at a range of from about 0 rpm to about 4,000 rpm, from about 0 rpm to about 1,000 rpm, from about 0 rpm to about 500 rpm, or from about 200 rpm to about 300 rpm. A delivered torque force may range from about 0.01 Nm to about 2 Nm, from about 0.5 Nm to about 1 Nm, or from about 0.5 Nm to about 0.75 Nm.
Referring to
An extension member 140 may be slidingly coupled to and extend proximally from the handle housing 111. The extension member 140 may also be slidingly coupled to the trocar tube 117. The extension member 140 is depicted to include an end cap 141 coupled to a proximal end of the extension member 140 and having a hollow distally extending portion. The end cap 141 may include a passage 145 through an end wall in axial alignment with the trocar 160 and configured for passage of a guidewire through the bone biopsy device 100 when in use, as will be described below. When the extension member 140 is displaced from a proximal position toward a distal position (e.g., by moving the extension member 140 distally), a distal end of the end cap 141 engages the protrusion 162 to displace the trocar 160 from the retracted configuration toward the extended configuration as the end cap 141 slides over the trocar tube 117. The extension member 140 may be selectively locked in the distal position by rotating the extension member 140 in a first direction such that an extension locking member 142 rotationally engages with a distally facing surface of an inner flange 149 of the handle housing 111. As depicted, the extension locking member 142 is disposed on an outer surface of the extension member 140. In other embodiments, the locking member 142 may form any other type of selective locking engagement, such as a snap fit, a press fit, a bayonet lock, etc.
The extension member 140 may be unlocked from the distal position when the extension member 140 is rotated in a second direction to align the locking member 142 with a gap between portions of the inner flange 149. When aligned, the locking member 142 can pass through the gap as the extension member 140 is displaced proximally. A resilient member or compression spring 146 may be disposed within the hollow portion of the end cap 141 with a distal end contacting a proximal end of the trocar tube 117 and a proximal end contacting the end wall of the end cap 141. The resilient member 146 can be compressed when the extension member 140 is displaced to the distal position. When the extension member 140 is unlocked from the distal position, the resilient member 146 may decompress and apply a proximally directed force to the extension member 140 to bias and/or cause the extension member 140 and the trocar 160 to be displaced proximally to the proximal position and retracted configuration, respectively. An inner flange or washer 144 of the extension member 140 may engage the protrusion 162 to displace the trocar 160 proximally. In certain embodiments, the trocar 160 may be slightly retracted as the extension member 140 is rotated and prior to displacement to the retracted configuration by the spring 146. This slight retraction may cause the trocar tip 161 to break free from tissue allowing the spring 146 to have a lower spring force.
In the illustrated embodiment, the handle housing 111 and the extension member 140 include indicia to indicate a status of the extension member, locked or unlocked. For example, the handle housing 111 may include an arrow 115 disposed at a proximal end of the handle housing 111 and the extension member 140 may include symbols 116 of a locked lock and an unlocked lock that are circumferentially spaced apart. When the extension member 140 is in a locked distal position the arrow 115 aligns with the locked lock symbol 116. When the extension member 140 is in an unlocked distal position following rotation of the extension member 140, the arrow 115 is aligned with the unlocked lock symbol 116. Other suitable indicia are contemplated within the scope of this disclosure.
The inner cannula 150, as depicted in the illustrated embodiment of
In the depicted embodiment of
As shown in
As depicted in the illustrated embodiment of
When coupled, the outer coax cannula 173 extends distally from and is rotated by the coax gear 128. The inner cannula 150 and the intermediate cannula 156 are coaxially disposed within a lumen 177 of the outer coax cannula 173. The inner cannula 150 may not extend beyond a distal end of the outer coax cannula 173. The outer coax cannula 173 may include a cutting tip 178, such as a trephine tip having a plurality of teeth 179 configured to rotate and saw a hole into a bone lesion and/or bone marrow when the outer coax cannula 173 is rotated. In some embodiments, the teeth 179 may be in alignment with a longitudinal axis of the outer coax cannula 173. In other embodiments, the teeth 179 may be alternatingly biased inwardly and outwardly relative to the longitudinal axis.
In the illustrated embodiment, a depth limiting member 180 is slidably coupled to the outer coax cannula 173. The depth limiting member 180 may be used to indicate an insertion depth of the outer coax cannula 173 into the patient that may correlate to a core tissue sample length. In some embodiments, the depth limiting member 180 may be rotated with the outer coax cannula 173. In other embodiments, the depth limiting member 180 may be held by a user while the outer coax cannula 173 is rotated to help guide the outer coax cannula 173 into the patient.
As depicted in the illustrated embodiment of
In certain embodiments, following a bone biopsy procedure, the power source 182 may be selectively removed from the bone biopsy device 100 and the handle assembly 110 and outer coax assembly 170 can be disposed of in a safe manner. As previously mentioned, the motor 122 can also be selectively removed from the handle assembly 110 if desired. When removed, the power source 182 and/or motor 122 may be refurbished for use in a subsequent procedure. Refurbishment may include cleaning, sterilizing, recharging or replacing the power source 182 and/or motor 122, etc. Alternatively, the power source 182 (and/or motor 122) may be disposed of in an environmentally friendly manner.
In use, the bone biopsy device 100 can be used to obtain a core tissue sample from a bone lesion and/or bone marrow.
As depicted in
In the illustrated embodiment, the handle assembly 110 also includes a core tissue sample length scale 114 disposed along the extension member 140. The scale 114 may include a plurality of indices, e.g., lines, spaced equidistance apart. In some embodiments, a distance between the lines may be 0.5 millimeter, one millimeter, two millimeters, etc. The scale 114, in cooperation with the extension member 140, may be used to determine the length of a core tissue sample that is contained within the lumen 153 of the inner cannula 150. For example, the extension member 140 and the trocar 160 may be displaced distally until the penetrating tip 161 engages with the core tissue sample 106 and the practitioner feels increased resistance to displace the extension member 140. A portion of the handle housing 111 may be adjacent to one line of the scale 114 that correlates with a length of the core tissue sample 106.
In some instances, as depicted in
In certain instances, a trocar assembly 190 may be selectively coupled to the coax assembly 170 to facilitate manual positioning of the coax assembly 170 prior to using the powered bone biopsy device. As illustrated in
In other embodiments, the trocar assembly 190 can be used to reposition or redirect the coax assembly 170 within the bone lesion and/or bone marrow to obtain subsequent tissue samples. For instance, after using the powered bone biopsy device (as previously discussed), the trocar assembly 190 can be inserted into and coupled to the coax assembly 170 to aid in manually repositioning and/or redirecting the coax assembly 170 prior to obtaining a subsequent core tissue sample or tissue sample using the powered bone biopsy device 100 or an aspiration needle 107.
Any methods disclosed herein comprise one or more steps or actions for performing the described method. The method steps and/or actions may be interchanged with one another. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order and/or use of specific steps and/or actions may be modified.
References to approximations are made throughout this specification, such as by use of the term “substantially.” For each such reference, it is to be understood that, in some embodiments, the value, feature, or characteristic may be specified without approximation. For example, where qualifiers such as “about” and “substantially” are used, these terms include within their scope the qualified words in the absence of their qualifiers. For example, where the term “substantially perpendicular” is recited with respect to a feature, it is understood that in further embodiments, the feature can have a precisely perpendicular configuration.
Similarly, in the above description of embodiments, various features are sometimes grouped together in a single embodiment, figure, or description thereof for the purpose of streamlining the disclosure. This method of disclosure, however, is not to be interpreted as reflecting an intention that any claim require more features than those expressly recited in that claim. Rather, as the following claims reflect, inventive aspects lie in a combination of fewer than all features of any single foregoing disclosed embodiment.
The claims following this written disclosure are hereby expressly incorporated into the present written disclosure, with each claim standing on its own as a separate embodiment. This disclosure includes all permutations of the independent claims with their dependent claims. Moreover, additional embodiments capable of derivation from the independent and dependent claims that follow are also expressly incorporated into the present written description.
Without further elaboration, it is believed that one skilled in the art can use the preceding description to utilize the invention to its fullest extent. The claims and embodiments disclosed herein are to be construed as merely illustrative and exemplary, and not a limitation of the scope of the present disclosure in any way. It will be apparent to those having ordinary skill in the art, with the aid of the present disclosure, that changes may be made to the details of the above-described embodiments without departing from the underlying principles of the disclosure herein. In other words, various modifications and improvements of the embodiments specifically disclosed in the description above are within the scope of the appended claims. Moreover, the order of the steps or actions of the methods disclosed herein may be changed by those skilled in the art without departing from the scope of the present disclosure. In other words, unless a specific order of steps or actions is required for proper operation of the embodiment, the order or use of specific steps or actions may be modified. The scope of the invention is therefore defined by the following claims and their equivalents.
This application claims priority to U.S. Provisional Application No. 62/984,685, filed on Mar. 3, 2020 and titled, “BIOPSY DEVICE AND RELATED METHODS,” which is hereby incorporated by reference in its entirety.
| Number | Date | Country | |
|---|---|---|---|
| 62984685 | Mar 2020 | US |
