Patent Application
20230380818
Not Applicable
Not Applicable
Not Applicable
Not Applicable
The present invention relates generally to biological tissue sampling, and more particularly to a device capable of incising, capturing, displacing, and retaining tissue samples providing practitioners an ascendant manner to perform tissue sampling and methods therefore.
There are a number of conventional ways for excising tissue samples. One of the primary reasons practitioners may obtain biological tissue samples is to perform a medical procedure known as a biopsy. A practitioner may perform a biopsy to analyze properties of the biological tissue sample. Analysis of excised tissue samples can provide diagnostic information about the tissue sample. Furthermore, the analysis can inform practitioners and medical teams in determining appropriate course of treatment for a patient. Conventional systems and methods for excising tissue samples can create an incision in the tissue sample but have no means of extracting the tissue sample after performing the incision using a singular device. For example, in the cases of excisional biopsies, a practitioner may create an incision on a patient's skin using one tool, such as a scalpel, and require another tool to extract the tissue sample, such as forceps.
Conventional systems and methods also lack the capability to consistently create uniform sized incisions in the tissue sample, retain the excised tissue sample, or eject the excised tissue sample after it has been cut using a singular device. Additionally, conventional systems and methods fail to meet the needs of the industry due to their inability to interchange fixtures on demand to perform tissue excision procedures. For example, a practitioner may need to change the size of the blade while performing an excisional biopsy due to varying textures and thickness within the tissue sample.
Thus, a need yet exists for systems and methods, capable of creating controlled, uniform incisions and extractions of tissue samples on demand by practitioners. The need is addressed by the present invention, and it is to such systems and methods that the present invention is primarily directed.
In an exemplary embodiment of the present invention, a device may comprise an instrument body, a cutting and capturing assembly, and a biasing mechanism. The instrument body may comprise an activation end and an implementation end. The cutting and capturing assembly may be located proximally to the activation end of the instrument body. The cutting and capturing assembly may be configured to cut an element, capture the element, and displace the element, wherein at least a portion of the cutting and capturing assembly can be housed within the instrument body. The biasing mechanism may be configured to at least extend the cutting and capturing assembly from the implementation end of the instrument body upon reception of an extension activation signal.
In any of the embodiments disclosed herein, the cutting and capturing assembly and the biasing mechanism can be configured to be releasably attached to the instrument body.
In any of the embodiments disclosed herein, the implementation end of the instrument body can be configured to releasably attach fixtures.
In any of the embodiments disclosed herein, the cutting and capturing assembly can comprise at least two fixtures, a first fixture being a tubular sharp-edged tool configured to cut the element and a capturing mechanism configured to capture the element. The tubular sharp-edged tool can be further configured to be releasably attached to the instrument body.
In any of the embodiments disclosed herein, the capturing mechanism can comprise at least two tines and can be configured to be releasably attached to the biasing mechanism.
In any of the embodiments disclosed herein, the biasing mechanism can be further configured to retract the cutting and capturing assembly upon reception of a retraction signal.
In any of the embodiments disclosed herein, the cutting and capturing assembly can be further configured to retain the element. An element cut by the cutting and capturing assembly can be displaced from a cut location and at least a portion of the element may be retained within the instrument body upon reception of a retraction signal by the biasing mechanism.
In another exemplary embodiment of the present invention, a device can comprise an instrument body, a cutting and capturing assembly, and a biasing mechanism. The cutting and capturing assembly can be configured to cut an element, capture the element, and displace the element. At least a portion of the cutting and capturing assembly can be within the instrument body. The biasing mechanism can be configured to at least extend the cutting and capturing assembly upon reception of an activation signal.
In any of the embodiments disclosed herein, the instrument body can comprise at least one end configured to attach and release fixtures.
In any of the embodiments disclosed herein, the cutting and capturing assembly can comprise at least two fixtures. A first fixture can be a tubular sharp-edged tool. A second feature can be a capturing mechanism that may comprise at least two tines. The tubular sharp-edged tool can be configured to be releasably attached to the instrument body.
In any of the embodiments disclosed herein, the capturing mechanism can be further configured to be releasably attached to the biasing mechanism.
In any of the embodiments disclosed herein, the biasing mechanism can be further configured to be releasably attached to the instrument body. The biasing mechanism can further comprise an apparatus configured to be releasably attached to the biasing mechanism and receive the activation signal.
In any of the embodiments disclosed herein, the cutting and capturing assembly can be further configured to bias between at least three states upon reception of the activation signal.
In any of the embodiments disclosed herein, the cutting and capturing assembly can comprise at least two fixtures, wherein a first fixture may be a tubular sharp-edged tool and the second feature may be a capturing mechanism. The cutting and capturing assembly can be further configured to operate in a first retracted state that may enable at least the first fixture to be available.
In any of the embodiments disclosed herein, the cutting and capturing assembly can comprise at least two fixtures, wherein a first fixture may be a tubular sharp-edged tool and the second feature may be a capturing mechanism. The cutting and capturing assembly can be further configured to operate in a second state that may enable the first fixture and second fixture to be available.
In any of the embodiments disclosed herein, the cutting and capturing assembly can comprise at least two fixtures, wherein a first fixture may be a tubular sharp-edged tool and the second feature may be a capturing mechanism. The cutting and capturing assembly can be further configured to operate in a third state that may enable the first fixture and at least a portion second fixture to be available.
In another exemplary embodiment of the present invention, an interchangeable biopsy punch device may comprise a longitudinal housing that may comprise a first end. The first end may comprise an internal mechanical fixture and a second end that can be compatible with interchangeable components. The interchangeable biopsy punch device may comprise a linear actuator, which may comprise a ledge adapted to the first end of the housing, a detachable tubular cutlass, which may comprise a first end that can adapt to the second end of the housing and a second end that may comprise a blade. The interchangeable biopsy punch device may comprise an extendable prong within the housing, which can include a first end adapting into the linear actuator and a second end that may comprise a plurality of members. The interchangeable biopsy punch device may comprise a detachable cap that can adapt to the linear actuator and a coiled spring that may be proximate to the first end of the extendable prong. The coiled spring may be entrapped between the linear actuator ledge and the internal mechanical fixture proximate the first end of the longitudinal housing.
In any of the embodiments disclosed herein, the first end of the detachable tubular cutlass can be adapted to the second end of the longitudinal housing through compatible threading. The second end of the detachable tubular cutlass can be curved.
In any of the embodiments disclosed herein, the first end of the extendable prong can be adapted to the linear actuator through compatible threading. The second end of the detachable tubular cutlass can be configured to create an incised tissue sample.
In any of the embodiments disclosed herein, the linear actuator can be configured to release the extendable prong upon reception of an activation signal by the linear actuator.
In any of the embodiments disclosed herein, the coiled spring can be configured to receive the activation signal from the linear actuator ledge at the first end of the extendable prong.
In any of the embodiments disclosed herein, the second end of the extendable prong can be configured to move along the longitudinal axis of the longitudinal housing proximally to an incised tissue sample.
In any of the embodiments disclosed herein, the linear actuator can be configured to retract the extendable prong upon reception of a retraction signal by the linear actuator.
In any of the embodiments disclosed herein, the second end of the extendable prong can be further configured to remove and retain an incised tissue sample within the longitudinal housing upon reception of a retraction signal to the linear actuator by the detachable cap.
In any of the embodiments disclosed herein, the second end of the extendable prong can be further configured to eject an incised tissue sample from the longitudinal housing upon reception of an activation signal from the linear actuator.
These and other objects, features, and advantages of the present invention will become more apparent upon reading the following specification in conjunction with the accompanying drawings. These and other aspects of the present disclosure are described in the Detailed Description below and the accompanying drawings. Other aspects and features of embodiments will become apparent to those of ordinary skill in the art upon reviewing the following description of specific, exemplary embodiments in concert with the drawings. While features of the present disclosure may be discussed relative to certain embodiments and figures, all embodiments of the present disclosure can include one or more of the features discussed herein. Further, while one or more embodiments may be discussed as having certain advantageous features, one or more of such features may also be used with the various embodiments discussed herein. In similar fashion, while exemplary embodiments may be discussed below as device, system, or method embodiments, it is to be understood that such exemplary embodiments can be implemented in various devices, systems, and methods of the present disclosure.
The above and further aspects of this invention are further discussed with reference to the following description in conjunction with the accompanying drawings, in which like numerals indicate like structural elements and features in various figures. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating principles of the invention. The figures depict one or more implementations of the inventive devices, by way of example only, not by way of limitation.
The following detailed description should be read with reference to the drawings, in which like elements in different drawings are identically numbered. This description enables one skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives, and uses of the invention, including what is presently believed to be the best mode of carrying out the invention. Any one or more of the teachings, expressions, versions, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, versions, examples, etc. that are described herein. The following-described teachings, expressions, versions, examples, etc. should therefore not be viewed in isolation relative to each other. Various suitable ways in which the teachings herein may be combined will be readily apparent to those skilled in the pertinent art in view of the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.
It must also be noted that, as used in the specification and the appended claims, the singular forms “a,” “an” and “the” include plural references unless the context clearly dictates otherwise. For example, reference to a component is intended also to include composition of a plurality of components. References to a composition containing “a” constituent is intended to include other constituents in addition to the one named.
Also, in describing the exemplary embodiments, terminology will be resorted to for the sake of clarity. It is intended that each term contemplates its broadest meaning as understood by those skilled in the art and includes all technical equivalents which operate in a similar manner to accomplish a similar purpose.
By “comprising” or “containing” or “including” is meant that at least the named compound, element, particle, or method step is present in the composition or article or method, but does not exclude the presence of other compounds, materials, particles, method steps, even if other such compounds, material, particles, method steps have the same function as what is named.
It is also to be understood that the mention of one or more method steps does not preclude the presence of additional method steps or intervening method steps between those steps expressly identified. Similarly, it is also to be understood that the mention of one or more components in a composition does not preclude the presence of additional components than those expressly identified.
The materials described as making up the various elements of the invention are intended to be illustrative and not restrictive. Many suitable materials that would perform the same or a similar function as the materials described herein are intended to be embraced within the scope of the invention. Such other materials not described herein can include, but are not limited to, for example, materials that are developed after the time of the development of the invention.
For illustrative purposes, examples of the present disclosure may be directed toward surgical systems and methodologies to describe various embodiments of the device (100). However, it should be appreciated that the utility of the device (100) within the present disclosure is not solely limited to these applications. The device (100) of the present disclosure can assist in incising, extracting, capturing, displacing, and retaining tissue samples. In an exemplary embodiment of the device (100), the device (100) may comprise a push button (200), a top cap (300), an instrument body (400), a cutting and capturing assembly (500,600), which can comprise a cutting tip (500) and a claw assembly (600), and a spring (700).
The push button (200) of the device (100) may comprise a button top chamfer (201), a button lip (202), an inner threaded section (203) and a shaft (204). As one skilled in the art will appreciate, the push button (200) can be understood as a type of biasing mechanism. Biasing mechanisms can apply an input into a device or system to affect the output behavior of said device or system. Examples of biasing mechanisms can include but are not limited to switches, buttons, cams, sliders, and the like known in the art. It should be appreciated that a degree of the button top chamfer (201), a size and diameter of the button lip (202), a depth of the threading in the inner threaded section (203), dimensions of the inner threaded section (203) and dimensions of the shaft (204) of the push button (200) can be user configurable, based on a desired design specification. In some embodiments, the push button (200) of the device (100) may be configured to transition the device (100) between one or more states via application of a downward force applied uniformly to the button top chamfer (201).
The top cap (300) of the device (100) may comprise a cap knurling (301), a cap through hole (302), and threading (303) In some embodiments, the threading (303) of the top cap (300) may be male threading and be disposed below the cap knurling (301) of the top cap (300). For example, the top cap (300) can be configured to cooperatively mate with the instrument body (400) via compatible mating of the male threading (303) of the top cap (300) with female threading of the instrument body (400). It should be appreciated that a depth of the threading (303), a pitch of the cap knurling (301), and a diameter of the cap through hole (302) can be user configurable, based on a desired design specification.
The instrument body (400) of the device (100) may comprise knurled sections (401), a non-knurled section (402), a through hole (403), a top threaded section (404), a bottom threaded section (405), and an internal ledge (406). As one skilled in the art will appreciate, knurling is a type of manufacturing process used to create a pattern on a surface by displacing or deforming the surface. The knurled sections (401) of the instrument body (400) can be advantageous for a practitioner as they provide ergonomic support for gripping the device (100) while in use. It should be appreciated that pitches of the knurled sections (401) can be user configurable, based on a desired design specification.
The non-knurled section (402) of the instrument body (400) may be a section of the instrument body (400) that does not have any knurled texture pattern. In some embodiments, the non-knurled section (402) may be disposed between the knurled sections (401). It should be appreciated, that placement of the knurled sections (401) in relation to the non-knurled section (402) may be user configurable, based on a desired design specification.
The top threaded section (404) and the bottom threaded section (405) of the instrument body (400) can be disposed on a first end and a second of the instrument body (400), respectively. In some embodiments, both the top threaded section (404) and the bottom threaded section (405) may be configured with uniform female threading. The top threaded section (404) and the bottom threaded section (405) may also be configured to cooperatively mate with fixtures of the device (100) that are configured with male threading. It should be appreciated that a depth of the threading for the top threaded section (404), a diameter of the top threaded section (404), a depth of the threading for the bottom threaded section (405), and a diameter of the bottom threaded section (405) can be user configurable, based on a desired design specification.
The through hole (403) of the instrument body (400) can extend throughout the length of the instrument body (400). In some embodiments, the through hole (403) may extend from the top threaded section (404) to the bottom threaded section (405) with a diameter equal to a diameter of the top threaded section (404) and a diameter of the bottom threaded section (405) The diameter of the through hole (403) can be user configurable, based on a desired design specification.
The internal ledge (406) of the instrument body (400) can be disposed within the instrument body (400). In some embodiments, the internal ledge (406) may be disposed proximally to the top threaded section (404) of the instrument body and distally from the bottom threaded section (405) of the instrument body (400). The internal ledge (406) may also circumferentially protrude within the instrument body (400), having a diameter that can be smaller than a diameter of the top threaded section (404) or the bottom threaded section (405). It should be appreciated that a length that the internal ledge (406) protrudes within the instrument body (400), a position of the internal ledge (406) within the instrument body (400), and a shape of the internal ledge (406) can be user configurable, based on a desired design specification.
The cutting tip (500) of the cutting and capturing assembly (500, 600) may comprise a sharpened outer edge (501), a knurled section (502), a threaded section (503), and a through hole (504). In some embodiments the sharpened outer edge (501) of the cutting tip (500) may be a tubular blade, cylindrical sharpened outer edge, and the like that can be configured to make an incision in a tissue sample. In some embodiments, the sharpened outer edge (501) of the cutting tip (500) may be a blunt edge, which can be configured to create incisions within a tissue sample. The sharpened outer edge (501) may be disposed beneath the knurled section (502), protruding a desired length. It should be appreciated that dimensions of the sharpened outer edge (501) of the cutting tip (500) can be user configurable, based on a desired design specification. Varying the size, shape, or dimensions of the sharpened outer edge (501) of the cutting tip (500) can be advantageous for a practitioner as it can allow the device (100) to incise different tissue sample sizes, thicknesses, and textures.
The knurled section (502) of the cutting tip (500) may be disposed between the threaded portion (503) and the sharpened outer edge (501). The knurled section (502) of the cutting tip (500) can be advantageous for a practitioner as it can provide ergonomic support for gripping the device (100), specifically while performing an incision in a tissue sample with the sharpened outer edge (501). It should be appreciated that a pitch of the knurled section (502) of the cutting tip (500) can be user configurable, based on a desired design specification.
The threaded section (503) of the cutting tip (500) may be disposed above the sharpened edge (501) and the knurled section (502). In some embodiments, the threaded portion (503) of the cutting tip (500) may be configured with male threading, wherein the male threading of the threaded section (503) of the cutting tip (500) can compatibly mate with sections of the device (100) configured with female threading. It should be appreciated that a depth of the threading in the threaded portion (503) can be user configurable, based on a desired design specification.
The through hole (504) of the cutting tip (500) can extend throughout the length of the cutting tip (500). In some embodiments, the through hole (504) may extend from the threaded section (503) to the sharpened outer edge (501) with a diameter equal to a diameter of the threaded section (503) and a diameter of the sharpened outer edge (501). It should be appreciated that the diameter of the through hole (504) of the cutting tip (500) can be user configurable, based on a desired design specification.
The claw assembly (600) of the cutting and capturing assembly (500, 600) may comprise claw tines (601), a claw crimp point (602), a threaded section (603), and a claw tubular body (604). The claw tines (601) can be configured to capture an excised tissue sample from the site. In some embodiments, the claw tines (601) may operate in a closed position, wherein the claw tines (601) are not extended, and an open position, wherein the claw tines (601) are fully extended. In some embodiments, the claw tines (601) may be tensioned and may expand in an open configuration once tension is relieved from the claw tines (601). It should be appreciated that the number of claw tines (601), shape of the claw tines (601), and the material composition of the claw tines (601) are user configurable, based on a desired design specification. In some embodiments, the claw assembly (600) may comprise two or more claw tines (601), which can be configured to capture and retain a tissue sample when performing a tissue excision procedure.
The claw crimp point (602) of the claw assembly (600) may be disposed between a first end of the claw tubular body (604) and a second end of the claw tubular body (604). In some embodiments, the claw crimp point (602) may be disposed proximal to the claw tines (601) of the claw assembly (600). As one skilled in the art will appreciate, crimping is a method of j oining one or more pieces of material together through deforming one or more pieces of material. In some embodiments, the claw crimp point (602) can be configured to be a joint mating two sections of the claw tubular body (604) of the claw assembly (600).
The threaded section (603) of the claw assembly (600) may be disposed at an end of the claw tubular body (604) opposite the claw tines (601). In some embodiments, the threaded section (603) of the claw assembly (600) may be configured with male threading. For example, male threading of the threaded section (603) of the claw assembly (600) can compatibly mate with areas of the device (100) configured with female threading. It should be appreciated that a depth of the threading in the threaded portion (603) can be user configurable, based on a desired design specification.
The claw tubular body (604) of the claw assembly may be configured with the threaded section (603) on a first end of the claw tubular body (604) and claw tines (601) on a second end of the claw tubular body (604). In some embodiments, the claw tubular body (604) may have a uniform tubular shape. It should be appreciated that a length of the claw tubular body (604) of the claw assembly (600) and a geometry of the claw tubular body (604) can be user configurable, based on a desired design specification.
The spring (700) of the device (100) may be disposed within the instrument body (400). As one skilled in the art will appreciate, mechanical springs are elastic devices that can store potential mechanical energy, when compressed, and release said potential mechanical energy, when decompressed. In some embodiments, the spring (700) may be disposed atop the internal ledge (406) of the instrument body (400), wherein the internal ledge (406) may be configured to operate as a seat for the spring (700).
In an exemplary embodiment, the components of the device (100) may be assembled as follows: (1) The cutting tip (500) can be screwed onto the bottom threaded section (405) of the instrument body (400); (2) The spring (700) can be inserted into the instrument body (400) and can be placed on the internal ledge (406) within the instrument body (400); (3) The claw tubular body (604) of the claw assembly (600) can be pushed into the instrument body (400) through the through hole (504) of the cutting tip (500) and the spring (700); (4) The push button (200) can threaded into the threaded section (603) of the claw assembly (600) via the inner threaded section (203) of the push button (200); (5) The top cap (300) can be screwed onto the top threaded portion (404) of the instrument body (400) with the button top chamfer (202) of the push button (200) passing through the through hole (302) of the top cap (300). It should be appreciated that the push button (200), top cap (300), instrument body (400) and cutting tip (500) can all be made of surgical grade stainless steel, or another suitable material commonly known within the art.
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It is to be understood that the embodiments and claims disclosed herein are not limited in their application to the details of construction and arrangement of the components set forth in the description and illustrated in the drawings. Rather, the description and the drawings provide examples of the embodiments envisioned. The embodiments and claims disclosed herein are further capable of other embodiments and of being practiced and carried out in various ways. Also, it is to be understood that the phraseology and terminology employed herein are for the purposes of description and should not be regarded as limiting the claims.
Accordingly, those skilled in the art will appreciate that the conception upon which the application and claims are based may be readily utilized as a basis for the design of other structures, methods, and systems for carrying out the several purposes of the embodiments and claims presented in this application. It is important, therefore, that the claims be regarded as including such equivalent constructions.
Furthermore, the purpose of the foregoing Abstract is to enable the United States Patent and Trademark Office and the public generally, and especially including the practitioners in the art who are not familiar with patent and legal terms or phraseology, to determine quickly from a cursory inspection the nature and essence of the technical disclosure of the application. The Abstract is neither intended to define the claims of the application, nor is it intended to be limiting to the scope of the claims in any way.
This application claims the benefit of U.S. Provisional Application Ser. No. 63/365,333, filed on 26 May 2022, which is incorporated herein by reference in its entirety as if fully set forth below.
| Number | Date | Country | |
|---|---|---|---|
| 63365333 | May 2022 | US |
