DEVICE AND SYSTEM FOR REMOVING TISSUE ABOVE A SUBCUTANEOUS SKIN ABSCESS AND / OR DRAINING A SUBCUTANEOUS SKIN ABSCESS - Patent application

Abstract

A device for removing tissue above and / or draining a subcutaneous skin abscess, the device comprising a tissue engaging component, a container configured to house at least a portion of the tissue engaging component, and a cutting element configured to cut tissue of a patient, the tissue engaging component configured to engage tissue cut by the cutting element such that movement of the tissue engaging component into a receiving volume of the container causes movement of at least a portion of the tissue cut by the cutting element into the receiving volume.

Description

[Technical field]

[0001] This application claims priority from Australian Provisional Patent Application No. 2021903549, filed on November 5, 2021, the disclosure of which is incorporated herein by reference in its entirety.

[0002] Some embodiments relate to devices or systems for removing tissue above and / or draining a subcutaneous skin abscess. Some embodiments of the present disclosure relate generally to devices for removing tissue. In particular, some embodiments of the present disclosure relate to devices for removing a portion of a patient's skin. Some embodiments of the present disclosure relate generally to percutaneous drainage devices. In particular, some embodiments of the present disclosure relate to devices for accessing and draining a fluid collection located under or within a patient's skin. [Background technology]

[0003] Each year, many patients (e.g., millions) visit emergency rooms seeking medical assistance for skin and soft tissue infections. A significant number of these infections are subcutaneous abscesses (also called subcutaneous cutaneous abscesses), which are accumulations or pools of pus and dead tissue trapped under the skin. Patients presenting with this common skin condition usually experience pain and may also present with fever or chills.

[0004] Treatment of subcutaneous collections of fluid, such as skin abscesses, is a commonly performed medical procedure. Some abscesses are "simple" or "pointing" and nearly break through the skin. These abscesses can typically be treated in an outpatient setting with local anesthetic via an incision and drainage procedure. After administration of the local anesthetic, a small incision is made at the site to penetrate the skin. The contents of the abscess can then be allowed to leak out by draining through the incision, sometimes assisted by manual squeezing of the contents by the clinician. The contents of the abscess can spurt upwards and outwards when excised, and clinicians typically use personal protective equipment to reduce the risk of self-contamination.

[0005] Currently, many complex and / or deep (more than 2 cm below the surface of the skin) skin abscess cases presented to hospitals are treated with surgery and under general anesthesia in an operating room. Surgical treatment largely solves the abscess problem, but creates a series of new problems. Patients undergoing surgical abscess treatment typically require a multi-day hospital stay. Patients must fast before surgery and face the risks associated with administering general anesthesia. Surgical treatment of abscesses requires an incision that must be long and deep enough to allow access to the abscess cavity. Typically, the incision extends the entire diameter of the abscess, and therefore scarring may be a concern for the patient. Furthermore, the use of longitudinal forces to penetrate the skin and tissue to reach the abscess carries the risk of inadvertently penetrating the underlying tissue structures.

[0006] Thus, surgical treatment of abscesses is economically costly for the healthcare system involved and the patient, and also carries risks associated with surgery and administration of general anesthesia.

[0007] Other medical procedures may similarly require access to a site of fluid collection within the patient's body to drain fluid, which may be a liquid or gas, and at least some of these medical procedures share similar problems and risks as deep skin abscess drainage procedures.

[0008] Any discussion of documents, acts, materials, devices, articles or the like which has been included in this specification should not be construed as an admission that any or all of such matters formed part of the substrate of the prior art or were common general knowledge in the field relevant to the present disclosure as they existed prior to the priority date of each of the appended claims.

[0009] Throughout this specification, the term "comprise" or variations such as "comprises" or "comprising" will be understood to imply the inclusion of a stated element, integer or step, or group of elements, integers or steps, but not the exclusion of any other element, integer or step, or group of elements, integers or steps. Summary of the Invention

[0010] According to a first aspect of the present disclosure, a device for removing tissue above a subcutaneous skin abscess is provided. The device may include a tissue engaging component comprising a piercing portion, a barb, and a shaft, a container configured to house at least a portion of the tissue engaging component, and a cutting element configured to incise tissue of a patient, the tissue engaging component configured to engage tissue incised by the cutting element such that movement of the tissue engaging component into a receiving volume of the container causes movement of at least a portion of the tissue incised by the cutting element into the receiving volume.

[0011] In some embodiments, the cutting element is configured to cut open a skin surface of the patient and excise a skin plug from the epidermis and dermal tissue of the patient, In some embodiments, the tissue engaging component is configured to engage the skin plug incised by the cutting element such that movement of the tissue engaging component into the receiving volume of the container causes movement of at least a portion of the skin plug incised by the cutting element into the receiving volume.

[0012] In some embodiments, the container has a proximal end and a distal end, and the cutting element has a cutting location where the cutting element projects outwardly from the distal end of the container. The cutting element may have a cutting edge at the distal end for cutting open the skin surface and cutting into the epidermis and dermal layers of the skin. The cutting element may present a horizontal cutting plane. In some examples, the cutting element may be cylindrical. In some examples, the cutting element defines a cutting lumen through which the tissue engaging component may project.

[0013] The cutting element may be used to make an incision around the epidermis and a portion of the skin tissue to form a skin plug that may be extracted by the tissue engaging component. In some examples, the cutting element has a length of 4 mm to 10 mm, in some examples, 5 mm to 10 mm, in some examples, 5 mm to 8 mm, and in some examples, about 7 mm. If the cutting element defines a cutting lumen, the diameter of the cutting lumen defines the dimensions of the skin plug. In some examples, the cutting element has an outer diameter of 3 mm to 6 mm, in other examples, 4 mm to 6 mm, in other examples, 3 mm to 5.5 mm, and in yet other examples, 4.5 mm to 5.5 mm, and in some examples, about 5 mm.

[0014] In some embodiments, the tissue engaging component shaft may have a diameter of between 1 mm and 3 mm. In some embodiments, the gap between the tissue engaging component and the inner diameter of the cutting element may be at least 1 mm, in some instances at least 2 mm, in some instances between 1 mm and 3 mm, in other instances between 2 mm and 3 mm, and in still other instances between 2 mm and 2.5 mm. The presence of a gap between the tissue engaging component and the cutting element allows the tissue engaging component to remove a skin plug having a diameter or dimension larger than the diameter of the tissue engaging component into the receptacle.

[0015] The tissue engaging component may have a hypodermic syringe shape. The tissue engaging element has a shaft, a piercing portion, and at least one barb. The piercing portion may be a sharp point or a tapered blade at a distal end of the shaft. The barb may be configured to engage tissue pierced by the piercing portion and pull the skin plug away from the surrounding tissue when the skin plug is retracted. The(or each) barb may be angled away from the piercing portion at the distal end and extend radially outwardly towards the proximal end. The(or each) barb may be configured to hook and hold tissue when the tissue engaging portion is retracted and moved towards the proximal end of the container. The(or each) barb may be integrally formed with the shaft of the tissue engaging portion. The(or each) barb may be positioned behind the piercing portion, for example, within 3 mm to 1.5 cm of the sharp distal end of the piercing portion.

[0016] The (or each) barb may have one or more edges that face away from the piercing portion toward the proximal end of the tissue engaging component. In some examples, the barb may be formed by a spike or hook-like protrusion from the shaft, such as a protrusion that points toward the distal end of the shaft. In other examples, the barb may be formed by a recess in the body of the shaft. The barb acts to capture and pull the epidermis and skin tissue as the tissue engaging portion is retracted into the receptacle. Thus, the barb can engage and remove a skin plug that has been incised by the cutting element. The device is designed such that the cutting element cuts the skin, epidermis and skin layers to form a skin plug before or at the same time that the tissue engaging portion engages the skin plug. In this way, the connection of the skin plug to the tissue of the epidermis and skin layers can be severed by the cutting element. This allows the skin plug to be extracted by retraction of the tissue engaging component (e.g., by the barb engaging the skin plug) because the pull of the tissue engaging component is stronger than the connection of the skin plug to the tissue (e.g., subcutaneous fat) below. Thus, the device has a "cut and then grasp" approach, in contrast to other types of devices, such as morcellators, which grasp tissue, draw it into a container, and only break the connection after the tissue has been removed from the body.

[0017] In some instances, the barbs are formed by recesses in the tissue removal component shaft. In some instances, the shaft has an internal lumen and the recesses are cut across the lumen, thereby creating barbs that include sharp edges that face back toward the proximal end. This provides a particularly effective structure for engaging and removing tissue.

[0018] In some embodiments, the tissue engaging component defines a tissue engaging component lumen extending between the first tissue engaging component opening and the second tissue engaging component opening.

[0019] In some embodiments, the tissue engaging component defines a barb opening that is fluidly connected to the tissue engaging component lumen.

[0020] In some embodiments, the device further comprises a plunger configured to move longitudinally of the container, the container configured to accommodate at least a portion of the plunger, such that movement of the plunger causes movement of the tissue engaging component.

[0021] In some embodiments, movement of the plunger causes movement of the dissection element.

[0022] In some embodiments, the tissue engaging component is configured to connect to the plunger and the cutting element is configured to connect to the plunger, and the tissue engaging component and the cutting element are separate components that are independently connectable to the plunger.

[0023] In some embodiments, the plunger is configured to be moved between a first position in which at least a portion of the tissue engaging component and at least a portion of the cutting element are exposed, and a second position in which the tissue engaging component and the cutting element are contained within the storage volume of the container.

[0024] In some embodiments, the cutting element comprises a cylindrical cutting sharp, and the cutting element extends from the cutting end portion to a second end portion to define a cutting lumen.

[0025] In some embodiments, the tissue engaging component extends through the incision lumen such that the piercing portion and barbs are exposed beyond the incision lumen.

[0026] In some embodiments, the container defines a receiving volume and a distal volume, the container comprising a container rim extending radially inwardly of the container and defining an internal container cavity, the container rim being between the receiving volume and the distal volume, the internal container cavity fluidly connecting the receiving volume and the distal volume.

[0027] In some embodiments, there may be a single plunger, in other embodiments, the plunger is a first plunger and the tissue removal device further comprises a second plunger configured to connect to the first plunger such that, when connected, movement of the second plunger causes corresponding movement of the first plunger, the second plunger configured to be moved between an initial position where the second plunger is connected to the first plunger connecting portion of the first plunger and a plunger connected position where the second plunger is connected to the second plunger connecting portion of the first plunger, and between the plunger connected position and a retracted position.

[0028] In some embodiments, the second plunger comprises a second plunger connector configured to allow connection of the second plunger and the first plunger.

[0029] In some embodiments, the second plunger connector comprises a second plunger connector member.

[0030] In some embodiments, the first plunger connection portion defines a first plunger connection hole configured to receive a portion of the second plunger connector member when the second plunger is in the initial position, and the second plunger connection portion defines a second plunger connection hole configured to receive a portion of the second plunger connector member when the second plunger is in the plunger connection position.

[0031] In some embodiments, the container comprises a container body lumen extending between a first container body opening and a second container body opening, and a first cap defining a first container outlet, the first cap configured to receive a tissue engaging component and an incising element such that at least a portion of the tissue engaging component and at least a portion of the incising element extend outside the container through the first container outlet, the first cap configured to be removably connectable to the container body.

[0032] In some embodiments, the dissection element is configured to extend through the first container outlet.

[0033] In some embodiments, the tissue removal device further comprises a first container cap configured to removably connect to the container body to block the first container body opening, and a second container cap configured to removably connect to the container body to block the second container body opening.

[0034] In some embodiments, the second plunger comprises an intermediate portion, a distal end portion, and a step where the intermediate portion meets the distal end portion.

[0035] In some embodiments, the outer dimension of the intermediate portion is greater than the outer dimension of the distal end portion to define a step.

[0036] In some embodiments, the second plunger comprises an angled wall, with a plane tangent to a surface of the angled wall transverse to a longitudinal direction of the second plunger.

[0037] In some embodiments, the tissue removal device further comprises a plunger sleeve comprising a first sleeve connector member and a second sleeve connector member, the plunger sleeve configured to accommodate at least a portion of the first plunger and at least a portion of the second plunger within the plunger sleeve volume.

[0038] In some embodiments, the container is configured to receive a plunger sleeve within the receiving volume. The plunger sleeve may receive the plunger. In some cases, the plunger sleeve may receive the dissection element and / or tissue engaging component when they are retracted into the container. The plunger or a sealing component connected to the plunger may form a seal with the plunger sleeve to create a negative pressure when the plunger is retracted, thereby facilitating aspiration of fluid or abscess contents into the container. The plunger sleeve may include a locking mechanism that releasably locks the plunger, tissue engaging component and / or dissection element in a dissection state in which the tissue engaging component and / or dissection element are fixed relative to the container and protrude from the distal end of the container. Thus, in the dissection state, the dissection element and / or tissue engaging component can dissect or penetrate the patient's skin surface and underlying tissue. The locking mechanism may allow the plunger, tissue engaging component and / or dissection element to be unlocked from the dissection state, thereby allowing them to be retracted into the container and / or plunger sleeve. In other embodiments, there may be no plunger sleeve and the plunger may directly contact the inner wall of the container. In some examples, the plunger sleeve may be an integral part of the container, while in other examples, the plunger sleeve may be a separate component that fits inside the container and / or may be secured to the inner wall of the container.

[0039] In some embodiments, the first sleeve connector member is configured to be moved between a first position in which the first sleeve connector member is configured to abut an end of the first plunger to prevent movement of the first plunger relative to the plunger sleeve, and a second position in which the first sleeve connector member is configured to allow movement of the first plunger relative to the plunger sleeve.

[0040] In some embodiments, the second sleeve connector member is configured to be moved between a first position in which the second sleeve connector member is configured to abut against a container rib in the container body to prevent movement of the sleeve and first plunger relative to the container body, a second position in which the second sleeve connector member is configured to abut against a step to prevent movement of the second plunger relative to the plunger sleeve, and a third position in which the second sleeve connector member is configured to allow movement of the second plunger relative to the plunger sleeve.

[0041] In some embodiments, the first sleeve connector member is integrally formed with the plunger sleeve and is bendable, and the second sleeve connector member is integrally formed with the plunger sleeve and is bendable.

[0042] In some embodiments, the first sleeve connector member includes a first protrusion configured to abut the ends of the first plunger and the second plunger, and the second sleeve connector member includes a second protrusion configured to abut a shoulder portion of the second plunger.

[0043] In some embodiments, the second sleeve connector member is biased toward the first position such that longitudinal movement of the intermediate portion of the second plunger away from the first container outlet moves the second sleeve connector member to the first position.

[0044] In some embodiments, the second plunger comprises a plunger locking system configured to lock the second plunger in a retracted position.

[0045] In some embodiments, the plunger locking system comprises a first elongated locking member and a second elongated locking member configured to abut the container rim when the second plunger is in the retracted position, thereby locking the second plunger in the retracted position.

[0046] In some embodiments, the tissue removal device further comprises a plunger latch system comprising a plunger sleeve, a first latch member pivotally mounted to the plunger sleeve, and a second latch member pivotally mounted to the plunger sleeve.

[0047] In some embodiments, the first latch member is pivotable between a first position in which the first latch member is configured to abut against the container rim to prevent movement of the plunger sleeve through the inner container hole and a second position in which the first latch member is configured to allow movement of the plunger sleeve through the inner container hole.

[0048] In some embodiments, the second plunger comprises a first latch member protrusion configured to contact the first latch member at an actuation end of the first latch member and to pivot the first latch member from the first position to the second position upon longitudinal movement of the second plunger toward the plunger.

[0049] In some embodiments, the second latch member is pivotable between a first position in which the second latch member is configured to abut the plunger and prevent movement of the plunger relative to the plunger sleeve, and a second position in which the second latch member is configured to allow movement of the plunger relative to the plunger sleeve.

[0050] In some embodiments, the plunger sleeve is configured to abut the container rim upon longitudinal movement of the plunger sleeve towards the distal volume.

[0051] In some embodiments, the tissue removal device further comprises a plunger sleeve comprising a plunger sleeve rim extending radially inwardly of the plunger sleeve defining an inner plunger sleeve bore, the plunger sleeve defining a first plunger sleeve opening and a plunger sleeve receiving volume between the first plunger sleeve opening and the inner plunger sleeve bore, the plunger sleeve configured to receive at least a portion of the plunger within the plunger sleeve receiving volume.

[0052] In some embodiments, the dissection element is attached to the plunger sleeve.

[0053] In some embodiments, the plunger is rotatable relative to the plunger sleeve and / or the container.

[0054] In some embodiments, the plunger includes a plunger keying feature and the plunger is rotatable from a first position in which the plunger keying feature is configured to abut the plunger sleeve rim to prevent movement of the plunger through the inner plunger sleeve bore to a second position in which the plunger keying feature is configured to allow movement of the plunger through the inner plunger sleeve bore.

[0055] In some embodiments, the plunger keying feature further comprises an elongated locking member configured to abut the plunger sleeve rim when the plunger is in the first retracted position, thereby preventing movement of the plunger relative to the plunger sleeve.

[0056] In some embodiments, the tissue engaging component is contained within the plunger sleeve volume when the first plunger is in the first retracted position.

[0057] In some embodiments, the plunger sleeve includes an elongated plunger sleeve blocking member configured to abut the plunger sleeve rim when the plunger is in the second retracted position, thereby preventing movement of the plunger sleeve relative to the container.

[0058] In some embodiments, the plunger comprises a sealing component, such as, but not limited to, an O-ring. In some examples, the plunger comprises an O-ring and an O-ring groove configured to receive the O-ring.

[0059] In some embodiments, the O-ring is configured to seal with an inner surface of the plunger sleeve.

[0060] In some embodiments, the plunger comprises a plunger keying feature configured to abut the container rim to prevent movement of the plunger through the inner container bore.

[0061] In some embodiments, the plunger is rotatable from a first position in which the plunger keying feature is configured to abut the container rim and prevent movement of the plunger through the inner container hole, to a second position in which the plunger keying feature is configured to allow movement of the plunger through the inner container hole.

[0062] In some embodiments, the plunger keying feature comprises an elongated locking member configured to abut the container rim when the plunger is in the retracted position, thereby preventing movement of the plunger relative to the container.

[0063] In some embodiments, the plunger comprises an O-ring and an O-ring groove configured to receive the O-ring.

[0064] In some embodiments, the O-ring is configured to seal with an inner surface of the container.

[0065] In some embodiments, the dissection element is attached to the container.

[0066] In some embodiments, the plunger comprises a frangible portion configured to cause the plunger to break.

[0067] In some embodiments, the second plunger comprises a frangible portion configured to cause the second plunger to break.

[0068] In some embodiments, the tissue removal device further comprises a locking element configured to engage the plunger to prevent movement of the plunger.

[0069] In some embodiments, the tissue removal device further comprises a locking element configured to engage the second plunger to prevent movement of the second plunger.

[0070] According to a second aspect of the present disclosure, a device for treating a subcutaneous skin abscess is provided, which may be referred to as a tissue removal device and may include a plunger with a plunger sealing surface, a container configured to house at least a portion of the plunger, the plunger sealing surface configured to seal with an inner surface of the container to prevent fluid flow between the plunger sealing surface and the inner surface of the container, and a cutting element connected to the container, the cutting element configured to cut tissue of a patient, the cutting element defining a cutting element opening, the plunger configured to be moved away from the cutting element to generate a suction pressure at the cutting element opening.

[0071] In some embodiments, the tissue removal device further comprises a pair of opposing stabilizing members, an outer surface of each of the pair of opposing stabilizing members configured to contact the patient's skin to stabilize the tissue removal device during use.

[0072] In some embodiments, the container comprises a stabilizing member.

[0073] In some embodiments, the stabilizing member extends radially away from the central axis of the container.

[0074] In some embodiments, the plunger includes an elastomeric sealing portion.

[0075] In some embodiments, the plunger comprises an O-ring and an O-ring groove configured to receive the O-ring.

[0076] In some embodiments, the O-ring constitutes the plunger sealing surface.

[0077] In some embodiments, the plunger comprises a frangible portion configured to cause the plunger to break.

[0078] In some embodiments, the dissection element comprises a cylindrical dissection sharp extending from the dissection end portion to the second end portion and defining a dissection lumen.

[0079] In some embodiments, a device is provided comprising a tissue engaging component comprising a tapered protrusion, a container configured to house at least a portion of the tissue engaging component, and a cutting element configured to incise tissue of a patient, wherein the tissue engaging component is configured to engage tissue incised by the cutting element such that movement of the tissue engaging component into the receiving volume of the container causes movement of at least a portion of the tissue incised by the cutting element into the receiving volume.

[0080] In some embodiments, the tapered protrusion is configured to engage tissue incised by the incision element such that movement of the tissue engagement component into the receiving volume of the container causes movement of at least a portion of the tissue incised by the incision element into the receiving volume.

[0081] In some embodiments, the tapered protrusion tapers from a base to a point.

[0082] In some embodiments, the tissue engaging component defines a tissue engaging component lumen extending between the first tissue engaging component opening and the second tissue engaging component opening, and the tapered protrusion protrudes into the tissue engaging component lumen.

[0083] In some embodiments, the tissue engaging component defines a tissue engaging opening that is fluidly connected to the tissue engaging component lumen.

[0084] In some embodiments, the tissue removal device comprises a plurality of tapered protrusions and a plurality of tissue engaging openings.

[0085] In some embodiments, the tissue removal device further comprises a plunger configured to move longitudinally of the container, the container configured to receive at least a portion of the plunger, such that movement of the plunger causes movement of the tissue engaging component.

[0086] In some embodiments, the tissue removal device further comprises a plunger interface component, the tissue engagement component being connected to a first end portion of the plunger interface component and the plunger being connected to a second end portion of the plunger interface component.

[0087] In some embodiments, the plunger is configured to be moved between a first position in which at least a portion of the tissue engaging component is disposed within a volume defined by the incision element and a second position in which the tissue engaging component is contained within a storage volume of the container.

[0088] In some embodiments, the dissection element comprises a cylindrical dissection sharp extending from the dissection end portion to the second end portion and defining a dissection lumen.

[0089] In some embodiments, the container defines a receiving volume and a distal volume, the container comprising a container rim extending radially inwardly of the container and defining an internal container cavity, the container rim being between the receiving volume and the distal volume, the internal container cavity fluidly connecting the receiving volume and the distal volume.

[0090] In some embodiments, the dissection element is attached to the container.

[0091] In some embodiments, the plunger comprises an O-ring and an O-ring groove configured to receive the O-ring.

[0092] In some embodiments, the O-ring is configured to seal with an inner surface of the container.

[0093] In some embodiments, the plunger comprises a frangible portion configured to cause the plunger to break.

[0094] According to a third aspect of the present disclosure, a percutaneous drainage device for draining a subcutaneous skin abscess is provided. The percutaneous drainage device may include a cannula defining a cannula lumen extending between a first cannula opening and a second cannula opening, a penetrating component configured to be slidably received within the cannula, the penetrating portion configured to penetrate tissue of a patient to thereby enable introduction of the first cannula opening to a subcutaneous fluid collection site, and a penetrating component lumen extending between the first penetrating component opening and the second penetrating component opening, the penetrating component lumen configured to receive a guidewire.

[0095] In some embodiments, the cannula includes a recess and the penetrating component includes a protrusion feature, the recess configured to receive the protrusion feature when the penetrating component is received within the cannula, thereby preventing rotation of the cannula relative to the penetrating component.

[0096] In some embodiments, the piercing portion comprises a piercing portion that tapers towards the piercing end of the piercing component.

[0097] In some embodiments, the penetrating portion is configured to extend through the first cannula opening and be driven into the patient's tissue by rotation of the penetrating component, thereby driving the cannula into the patient's tissue.

[0098] In some embodiments, the percutaneous drainage device further comprises a cap defining a cap lumen extending from a first cap opening to a second cap opening, the cap lumen configured to receive the cannula and the penetrating component.

[0099] In some embodiments, the cap lumen comprises a first tapered portion extending from the first cap opening toward the second cap opening, wherein a cross-sectional area of ​​the first tapered portion decreases as the first tapered portion extends from the first cap opening toward the second cap opening, a second tapered portion, wherein a cross-sectional area of ​​the second tapered portion increases as the second tapered portion extends away from the first cap opening toward the second cap opening, and a third tapered portion extending from the second tapered portion toward the second cap opening, wherein a cross-sectional area of ​​the third tapered portion increases as the third tapered portion extends away from the second tapered portion toward the second cap opening.

[0100] In some embodiments, the cap lumen includes a guide portion extending between the first tapered portion and the second tapered portion.

[0101] In some embodiments, the first penetrating component opening is aligned with a guide portion of the cap cavity when the penetrating component is received within the cap.

[0102] In some embodiments, the cap comprises a cap groove extending from the first cap opening to the second cap opening, the cap groove configured to allow passage of a guidewire from the cap lumen to the outside of the cap.

[0103] In some embodiments, the penetrating component includes a gripping portion, the gripping portion defining a second penetrating component opening.

[0104] In some embodiments, the percutaneous drainage device further comprises a penetrating component cap configured to removably engage the penetrating component and allow selective occlusion of the second penetrating component opening.

[0105] In some embodiments, the cannula defines a cannula thread.

[0106] In some embodiments, the percutaneous drainage device further comprises a collar configured to releasably engage the cannula and be movable longitudinally of the cannula.

[0107] In some embodiments, the percutaneous drainage device further comprises a connection component comprising a collar engagement portion configured to releasably engage the collar and an extension portion extending radially from the collar contact portion, the extension portion configured to connect to tissue of the patient.

[0108] According to a fourth aspect of the present disclosure, there is provided a percutaneous drainage device for draining a subcutaneous skin abscess, the percutaneous drainage device comprising: a cannula defining a cannula lumen extending between a first cannula opening and a second cannula opening, a penetrating component configured to be slidably received within the cannula lumen, the penetrating component including a penetrating portion configured to penetrate tissue of a patient thereby enabling introduction of the first cannula opening to the subcutaneous fluid collection site, and a collar, the collar including: The cannula may include a collar configured to releasably engage the cannula and be movable longitudinally of the cannula, and a connection component including a collar engagement portion configured to releasably engage the collar and an extension portion extending radially from the collar engagement portion, the extension portion configured to connect to tissue of a patient.

[0109] In some embodiments, the collar is configured to be movable longitudinally of the cannula while engaged with the cannula.

[0110] In some embodiments, the cannula defines a cannula thread and the collar includes a collar lumen configured to receive the cannula and cooperate with the cannula thread, such that rotation of the collar relative to the cannula causes movement of the collar in the longitudinal direction of the cannula and movement of the collar in the longitudinal direction of the cannula is prevented without rotation of the collar relative to the cannula.

[0111] In some embodiments, the collar defines a peripheral hole.

[0112] In some embodiments, the collar defines a channel between the inner and outer channel walls.

[0113] In some embodiments, the channel is an annular channel that extends around at least a portion of the cannula lumen.

[0114] In some embodiments, the cannula lumen extends between the first collar opening and the second collar opening, the inner channel wall extends further from the first collar opening than the outer channel wall, and the inner channel wall is configured to contact the cannula.

[0115] In some embodiments, the cannula defines a cannula flange, and the inner channel wall is configured to contact the cannula threads and the cannula flange.

[0116] In some embodiments, the collar engagement portion defines a collar engagement portion opening configured to allow passage of the penetrating component and the cannula.

[0117] In some embodiments, the collar engagement portion comprises a collar engagement protrusion configured to be received by the collar and inhibit relative movement between the collar and the collar engagement portion.

[0118] In some embodiments, the collar engagement protrusion is an annular protrusion configured to be received by a channel in the collar.

[0119] In some embodiments, the collar engagement portion includes a locating protrusion configured to be received by the peripheral hole and to inhibit rotation of the collar engagement portion relative to the collar.

[0120] In some embodiments, the extension portion comprises an adhesive portion configured to adhere to the patient's skin.

[0121] The features of the first and second aspects of the present disclosure may be freely combined or used together. The features of the third and fourth aspects of the present disclosure may be freely combined or used together. A fifth aspect of the present disclosure provides a system or kit of parts for treating a subcutaneous skin abscess, comprising a first device according to the first or second aspect together with a second device according to the third or fourth aspect. The system or kit of parts may further comprise a guidewire for guiding the second device to the subcutaneous skin abscess.

[0122] A sixth aspect of the present disclosure provides a device for removing tissue above a subcutaneous skin abscess, comprising: a cutting element configured to cut open a patient's skin surface and excise a skin plug from the patient's epidermis and skin tissue; a tissue engaging component for engaging the skin plug; and a container configured to house at least a portion of the tissue engaging component, wherein the tissue engaging component is movable relative to the container and configured to engage with the skin plug incised by the cutting element, such that movement of the tissue engaging component into the housing volume of the container causes movement of at least a portion of the skin plug incised by the cutting element into the housing volume.

[0123] The tissue engaging component may be hypodermic syringe shaped. In some embodiments, the tissue engaging component comprises a piercing portion, a barb, and a shaft. The piercing portion may be at a distal end of the shaft and configured to pierce the skin and tissue of the patient, and the barb may be positioned on the shaft behind the piercing portion and configured to hook the patient's tissue for pulling and removing a skin plug incised by the incision element when the tissue engaging component is retracted or moved into the receptacle.

[0124] In other embodiments, the tissue engaging component may include a pair of jaws having a skin-piercing distal end and jaw teeth for grasping tissue.

[0125] In other embodiments, the tissue engaging portion may comprise a cylindrical component defining a lumen between a distal end and a proximal end thereof, the cylindrical component comprising a plurality of apertures and a tapered protrusion associated with each aperture, the tapered protrusions projecting radially inwardly of the tissue engaging component toward the proximal end thereof, the tapered protrusions may act to capture and engage a skin plug as the tissue engaging component is retracted and to pull the skin plug back into the receptacle.

[0126] The sixth aspect may use any of the features of the first to fifth aspects described above, except where the features are mutually exclusive. [Brief description of the drawings]

[0127] Embodiments of the present disclosure will now be described, by way of example only, with reference to the accompanying drawings.

[0128] [Figure 1A] FIG. 1 is a schematic diagram of a shallow subcutaneous skin abscess. [Figure 1B] FIG. 1 is a schematic diagram of a deep subcutaneous skin abscess. [Figure 1C] 1 shows a device used to cut a skin plug in the first stage of draining a shallow subcutaneous skin abscess, according to some embodiments. [Figure 1D] 1D illustrates a second stage of draining a shallow subcutaneous skin abscess, in which the device of FIG. 1C is used to drain pus from the abscess, according to some embodiments. [Figure 1E] 1D is a cross-sectional view illustrating the dissection of a skin plug by the device of FIG. 1C, according to some embodiments. [Figure 1F] 13A-13C show a first stage of draining a deep subcutaneous skin abscess, where a first device is used to cut open a skin plug, according to some embodiments. [Figure 1G] 13 illustrates a second stage of draining a deep subcutaneous skin abscess, where a second device is guided by a guidewire towards the abscess, according to some embodiments. [Figure 1H] 13 illustrates a third stage of draining a deep subcutaneous skin abscess, with the cannula of the second device secured to the skin surface by a collar, according to some embodiments. [Figure 1I] 13 illustrates a fourth stage of draining a deep subcutaneous skin abscess, with a retraining device attached to the collar to further secure the cannula of the second device, according to some embodiments. [Figure 2A] 1 shows a perspective view of a tissue removal device according to some embodiments. [Figure 2B] 2B shows an exploded view of the tissue removal device of FIG. 2A according to some embodiments. [Figure 2C] 2B shows a perspective view of the container body of the tissue removal device of FIG. 2A, with the container body rendered transparent, according to some embodiments. [Diagram 3] 2B shows a cross-sectional view of the container of the tissue removal device of FIG. 2A, which corresponds to a side view of the container, according to some embodiments. [Figure 4A] 2B shows a top view of the tissue removal device of FIG. 2A in a first state, showing a cross-sectional plane, according to some embodiments. [Figure 4B] 4B shows a side view of the tissue removal device of FIG. 2A in a first state as cross-sectioned according to the cross-sectional plane of FIG. 4A, according to some embodiments. [Figure 5A]2B illustrates a side view of the tissue removal device of FIG. 2A in a first state, showing a second cross-sectional plane, according to some embodiments. [Figure 5B] 5B shows a top view of the tissue removal device of FIG. 2A in a first state as cross-sectioned according to the second cross-sectional plane of FIG. 5A, according to some embodiments. [Figure 6A] 2B shows a top view of the tissue removal device of FIG. 2A in a second state, showing a cross-sectional plane, according to some embodiments. [Figure 6B] 6B shows a side view of the tissue removal device of FIG. 2A in a second state, as cross-sectioned according to the cross-sectional plane of FIG. 6A, according to some embodiments. [Figure 7A] 2B illustrates a side view of the tissue removal device of FIG. 2A in a second state, showing a second cross-sectional plane, according to some embodiments. [Figure 7B] 7B shows a bottom view of the tissue removal device of FIG. 2A in a second state when cross-sectioned according to the cross-sectional plane of FIG. 7A, according to some embodiments. [Figure 8A] 2B shows a top view of the tissue removal device of FIG. 2A in a third state, showing a cross-sectional plane, according to some embodiments. [Figure 8B] 8B shows a side view of the tissue removal device of FIG. 2A in a third state, as cross-sectioned according to the cross-sectional plane of FIG. 8A, according to some embodiments. [Figure 9A] 2B shows another side view of the device of FIG. 2A with the tissue removal device in a third state, showing a cross-sectional plane, according to some embodiments. [Figure 9B] 9B shows a bottom view of the tissue removal device of FIG. 2A in a third state, as cross-sectioned according to the cross-sectional plane of FIG. 9A, according to some embodiments. [Figure 10A] 2B shows a top view of a portion of the tissue removal device of FIG. 2A in a fourth state, showing a cross-sectional plane, according to some embodiments. [Figure 10B] 10B shows a side view of a portion of the tissue removal device shown in FIG. 10A as cross-sectioned according to the cross-sectional plane of FIG. 10A, according to some embodiments. [Figure 11A] 2B illustrates a top view of the second portion of the tissue removal device of FIG. 2A in a fourth state, showing a second cross-sectional plane, according to some embodiments. [Figure 11B] 11B shows a side view of a second portion of the tissue removal device shown in FIG. 11A as sectioned according to a second cross-sectional plane of FIG. 11A, according to some embodiments. [Figure 12A] 1 shows a perspective view of another tissue removal device, according to some embodiments. [Figure 12B] 12B shows a bottom view of the tissue removal device of FIG. 12A according to some embodiments. [Figure 12C] 12B shows a side view of the tissue removal device of FIG. 12A according to some embodiments. [Figure 12D] 12B shows a perspective view of a portion of the tissue removal device of FIG. 12A in a fourth state, according to some embodiments. [Figure 13] 12B shows an exploded view of the tissue removal device of FIG. 12A according to some embodiments. [Figure 14A] 12B shows a side view of the tissue removal device of FIG. 12A showing a cross-sectional plane of the tissue removal device in a first state according to some embodiments. [Figure 14B] 12B shows a side view of the tissue removal device of FIG. 12A showing a cross-sectional plane of the tissue removal device in a second state according to some embodiments. [Figure 14C] 12B shows a side view of the tissue removal device of FIG. 12A showing a cross-sectional plane of the tissue removal device in a third state according to some embodiments. [Figure 15A] 12B shows a side view of a portion of the tissue removal device of FIG. 12A, showing a cross-sectional plane of the portion of the tissue removal device in a third state, according to some embodiments. [Figure 15B] 12B shows a side view of a portion of the tissue removal device of FIG. 12A showing a cross-sectional plane of the portion of the tissue removal device in a fourth state, according to some embodiments. [Figure 16A] 1 shows a perspective view of another tissue removal device, according to some embodiments. [Figure 16B] 16B shows an exploded view of the tissue removal device of FIG. 16A according to some embodiments. [Figure 17A] 16B shows top and back views of the tissue removal device of FIG. 16A according to some embodiments. [Figure 17B] 16B shows side and rear views of the tissue removal device of FIG. 16A according to some embodiments. [Figure 17C] 16B shows another perspective view of the tissue removal device of FIG. 16A according to some embodiments. [Figure 18A] 16B shows a side view of the tissue removal device of FIG. 16A showing a cross-sectional plane of the tissue removal device in a first state according to some embodiments. [Figure 18B] 16B shows a top view of the tissue removal device of FIG. 16A showing a cross-sectional plane of the tissue removal device in a first state according to some embodiments. [Figure 19] 1 illustrates an exploded view of a percutaneous drainage device, according to some embodiments. [Figure 20] 20 shows a perspective view of the cannula, piercing component, and collar of the percutaneous drainage device of FIG. 19 according to some embodiments. [Figure 21] 20 illustrates a sequence of steps for using the percutaneous drainage device of FIG. 19 according to some embodiments. [Figure 22] 20 shows a perspective view and a top view of the percutaneous drainage device of FIG. 19 according to some embodiments. [Diagram 23] 20 shows a first side view and a second side view of the percutaneous drainage device of FIG. 19 according to some embodiments. [Figure 24A] 1 shows another example of a device for removing tissue above and / or draining a subcutaneous skin abscess. [Figure 24B] 1 shows another example of a device for removing tissue above and / or draining a subcutaneous skin abscess. [Figure 24C] 1 shows another example of a device for removing tissue above and / or draining a subcutaneous skin abscess. [Figure 24D] 1 shows another example of a device for removing tissue above and / or draining a subcutaneous skin abscess. [Figure 24E] 1 shows another example of a device for removing tissue above and / or draining a subcutaneous skin abscess. [Figure 24F] 1 shows another example of a device for removing tissue above and / or draining a subcutaneous skin abscess. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0129] Part 1: Overview of devices and systems for removing tissue above and / or draining subcutaneous skin abscesses Figures 1A and 1B show examples of subcutaneous skin abscesses in layers below the surface of the skin. Figure 1A shows a shallow skin abscess 1A that typically occurs in the dermis, while Figure 1B shows a deep skin abscess 1B that may form between the dermis and the underlying muscle in the subcutaneous fat layer. The abscess is typically filled with pus 3, which may contain a mixture of liquid and solid material. It is desirable to drain the abscess to prevent further infection.

[0130] 1A and 1B show that beneath the surface of the skin 10 are the epidermis layer 20, the dermis layer 30, the subcutaneous fat layer 40, and the muscle layer 50. The epidermis 20 is the layer immediately beneath the skin surface and typically has a thickness of up to 1 mm, while the dermis layer typically extends further below the skin surface by 1-4 mm. In the context of the present disclosure, a superficial skin abscess refers to an abscess that has a depth of up to about 2 cm beneath the skin surface and occurs within the dermis layer 30 and the subcutaneous fat layer 40, but not further, as shown, for example, in FIG. 1A. A deep skin abscess refers to an abscess that has a depth of more than 2 cm beneath the skin surface and extends into the subcutaneous fat layer 40, as shown, for example, in FIG. 1B. Subcutaneous skin abscesses are distinct from abscesses of visceral organs, such as in the abdominal cavity (including the intestines, stomach, and liver), in that subcutaneous skin abscesses do not extend beyond the subcutaneous fat layer into underlying muscle or other tissues. For example, subcutaneous skin abscesses lie entirely above and do not extend into the muscle layer 50. Cysts and abscesses in internal organs are always below the subcutaneous fat layer, and often below the muscle layer as well.

[0131] 1A and 1B, blood vessels 70 may extend through the subcutaneous fat layer 40, and hair follicles 60 and associated hairs may extend from the subcutaneous fat layer to the surface of the skin. There may be swollen tissue 2 surrounding the pus 3 of the skin abscess, the swollen tissue 2 being formed from tissue of surrounding layers such as the dermis and / or subcutaneous fat.

[0132] The present disclosure relates to a device for draining subcutaneous skin abscesses. In some examples, the device is suitable for draining subcutaneous skin abscesses extending up to 6 cm below the skin surface.

[0133] Skin abscesses that are very large, deep, or have thick or non-homogeneous contents may be difficult to drain and achieve clinical resolution of. Some skin abscesses can be drained percutaneously by inserting a needle, catheter, or other suitable drain through the skin into the abscess to remove or drain the fluid collection, but such drains may become blocked with the contents of the abscess and stop flowing before the entire contents are removed. The patient then requires additional treatment, which may include an incision and a drainage operation to open the abscess using the incision. Some of the devices disclosed in the present application facilitate access to subcutaneous skin abscesses by removing a layer of skin over the abscess and / or facilitating the entry of a cannula into the abscess in a safe manner that does not require inpatient surgery, and / or using suction to direct the flow of the abscess contents into a container or cannula.

[0134] This disclosure contemplates two different types of percutaneous drainage devices for draining subcutaneous skin abscesses. Examples of a first type of percutaneous drainage device are shown in Figures 2A-11, 12-15, and 16A-18B. Examples of a second type of percutaneous drainage device are shown in Figures 19-23.

[0135] The first type of percutaneous drainage device 100 includes a container 102, a tissue engaging component 222, and a cutting element 208. In some examples, the tissue engaging component 222 is in the form of a hypodermic syringe. The cutting element 208 can be curved and in some examples is in the form of a cylindrical blade. In some examples, the cutting element 208 defines a lumen surrounding at least a portion of the tissue engaging component 222. The cutting element 208 extends outwardly from a distal end of the container and can be used to cut away a piece of skin and underlying layers to form a "skin plug." The tissue engaging portion 222 can penetrate the skin plug and be attached to the skin plug and used to remove the skin plug when the tissue engaging portion is retracted into the container. The first type of percutaneous drainage device can be used to remove the skin plug. Removing the skin plug can allow the first device to directly access a shallow skin abscess or can provide an opening through which a second type of device can reach a deeper abscess.

[0136] FIG. 1C illustrates how a first type of percutaneous drainage device may be used to drain a shallow abscess. A shallow skin abscess may develop in the dermis and may be visible at the skin surface (referred to as a "pointing" abscess). The cutting element 208 is used to cut a piece of skin, for example by placing a blade (cutting element) on the skin surface and rotating while pressing downwards, the cutting element may create a defect in the skin layer, which may take the form of a circular cut in the skin surface, epidermis and dermis. Because the cutting element can cut by rotating, not just pressing like a scalpel blade, this causes less discomfort and is also safer, as there is less chance of accidentally cutting a body part that is not intended to be cut. The cutting element may form a blade with a cutting edge at the distal end. The distal end of the cutting element is tapered or beveled to form a sharp cutting edge. However, the incision edges may present a horizontal or flat incision plane. For example, when the device is held with the container 102 perpendicular to the skin surface, the incision edges of the incision element may be substantially horizontal to the skin. For example, as shown in FIG. 2A, the incision element 208 has incision edges that form a horizontal plane that is substantially perpendicular to the longitudinal axis of the container. This is in contrast to the tissue removal component 222, which has angled incision edges more similar to a scalpel. In the example of FIG. 2A, the incision element 208 is cylindrical and defines a lumen, so that the incision edges form a circle that contacts the skin when the device is used to cut the skin surface. A horizontal or flat incision plane improves safety and allows for consistency and predictability of the depth of the skin that is cut.

[0137] The piece of skin, epidermis and dermis within the cut may be referred to as a "skin plug." The tissue engaging portion 222 may penetrate the skin plug and the barbs of the tissue engaging portion may engage or attach to the skin plug. The cutting element and tissue engaging portion may be pressed into the skin deep enough to contact the skin abscess to be drained. The tissue engaging portion 222 may then be retracted into the container 102, as shown in FIG. 1D. When retracted, the tissue engaging portion 222 may take the skin plug with it and leave an opening through which the contents of the skin abscess, e.g., pus 3, may flow into the container. In this manner, a shallow subcutaneous skin abscess may be drained. FIG. 1E is a cross-sectional view showing an example of a portion of skin 10 cut by the device 100. The cutting element 208 may form a circular cut out that defines the amount of internal tissue or "skin plug" 25, and the tissue engaging component 222 may engage and grasp and hold the skin plug 25 so that the skin plug 25 may be removed by retracting the tissue engaging component. From the above, it will be appreciated that the first device is configured to first use the cutting element to cut a volume of tissue (the "skin plug") so that the skin plug is separated from the surrounding tissue, and then use the tissue engaging component to pull the skin plug out. This differs from other devices, such as morcellators, which first grasp the tissue (often through a pre-existing hole cut with a knife) and then sever the connection of the grasped tissue to the body after the tissue and grasping element are withdrawn.

[0138] In some examples, the cutting element 208 may have a length of 5-10 mm, in other examples 5-8 mm, and in some examples about 7 mm. This is assumed to be long enough to cut into the dermis and create a skin plug, but not so long that it extends too deeply into the subcutaneous fat. In some examples, the cutting element 208 may have an outer diameter of 3 mm-6 mm, in some examples 4 mm-6 mm, in some examples 3 mm-5.5 mm, in other examples approximately 4.5 mm-5.5 mm, and in some examples about 5 mm. The diameter of the cutting element determines the size of the skin plug. The diameter of the cutting element must be sufficient to create a skin plug large enough to provide access and / or facilitate subcutaneous skin abscess drainage. Thus, the diameter of the cutting element may be 3 mm or more, especially if there is significant viscous fluid to drain. If the diameter exceeds 6 mm, tissue scarring is a concern.

[0139] The diameter of the cutting element should be sufficient to allow the tissue engaging component to pull a skin plug of a larger diameter than the tissue engaging component through the cutting element lumen. In some examples, the tissue engaging component may have a diameter of 1 mm to 3 mm. The tissue engaging component may extend into the lumen of the cutting element, and in some examples, the clearance between the shaft of the tissue engaging component and the inner diameter of the cutting element may be 1 mm to 3 mm, in some examples 2 mm to 3 mm, and in still other examples 2 mm to 2.5 mm.

[0140] In the example of FIGS. 1C-1D, both the cutting element 208 and the tissue engaging component 222 are retractable into the container 102. For example, the cutting element and tissue engaging component may be attached to or mechanically coupled to a plunger 190 received within the container. The plunger may then be movable toward the distal end of the container such that the tissue engaging component and the cutting element protrude from an opening at the distal end of the container, and toward the proximal end of the container such that the tissue engaging component and the cutting element are retracted into the container. The device may be configured to generate negative pressure or suction when the tissue engaging component is retracted into the container. This may help initiate the flow of pus, and / or other contents of the skin abscess, into the container. Because pus in a skin abscess may include a mixture of solids and liquids and may be relatively viscous, suction may be required to initiate the flow of pus from the abscess into the container.

[0141] In some examples, the plunger, or a sealing component (such as an O-ring) connected to the plunger, may seal with an interior portion of the container, such that a negative pressure or vacuum is created by the plunger being withdrawn toward the proximal end of the container when the tissue engaging element is retracted. The plunger or sealing component may seal with an inner wall of the container, a sleeve received within the container, or another interior portion of the chamber that forms a chamber for receiving the contents of the abscess. The plunger may include one or more parts and may be movable by a handle 260. The cutting element 208 and tissue engaging component 222 may be configured to adopt multiple states, including a cutting state and a retractable state. In the cutting state, the cutting element and tissue engaging component may be fixed relative to the container, e.g., locked in place, at a position extending from the distal end of the container. When in the cutting state, the cutting element and tissue engaging component do not retract when pressed against and / or into the skin, and therefore may be used to cut the skin, epidermis, and dermis layers. In the retractable state, the dissection element and tissue engaging component may be moved relative to the container for retraction into the container.

[0142] In some instances, the tissue engaging component and cutting element may be completely removed from the container. This may be conveniently accomplished by retracting the plunger, tissue engaging component, and cutting element all the way through the container and out through an opening at the proximal end of the container. The two ends of the container may then be closed, for example, by end caps. This allows the container to store the removed tissue and / or abscess contents to be sent for analysis. In such cases, it may be desirable to remove the cutting element and tissue engaging component so that no sharp blades or edges are left in the sample.

[0143] In other examples, the tissue engaging component and the cutting element may be retractable but not detachable, which may be sufficient if the device is not used for pathology to provide a sample for analysis. In some examples, the tissue engaging component may be retractable but the cutting element may be non-retractable. For example, the cutting element may be fixed to the outside of the container or to a part of the container other than the plunger. In such cases, the non-retractable cutting element may be permanently fixed or may be removable.

[0144] The first type of percutaneous drainage device shown in Figures 1C and 1D can be referred to as a tissue removal device because it removes tissue. Figures 1C and 1D show a process for draining a shallow subcutaneous skin abscess, while Figures 1F-1I show an example of a process for draining a deep skin abscess. In this case, the skin abscess extends into the subcutaneous fatty tissue, and in some cases, the deep skin abscess may be completely contained within the subcutaneous fatty tissue and not visible from the skin surface. Because deep subcutaneous skin abscesses extend deeper, e.g., 4 cm or more below the skin surface, they are more difficult to drain, and two separate devices may be used.

[0145] The first step of the evacuation process is shown in FIG. 1F and uses a first type of device 100 as described above in connection with FIGS. 1C-1E, further examples of which are shown in FIGS. 2A-11, 12-15, and 16A-18B. In this step, the incision edge and tissue removal component 102 of the first device are used to resect one or more layers of tissue above the abscess. In the example of FIG. 1F, the epidermis layer and a portion of the dermis layer are resected. However, a portion of the dermis layer may remain depending on the depth of the dermis layer (typically 4-5 mm) and the length of the incision edge 208. In some examples, the incision edge may cut into the subcutaneous fatty tissue, but in many cases this may be avoided for safety reasons to minimize discomfort and the risk of cutting something other than fatty tissue. The skin plug may then be removed as described above with reference to FIGS. 1C-1E. In some cases, suction may also be used to remove or extract the tissue.

[0146] Subsequent steps shown in Figures 1G-1I use a second type of percutaneous drainage device 2200. The second type of percutaneous drainage device includes a cannula 2202 defining an internal cavity and a penetrating component 2212 slidably engageable with the internal cavity of the cannula. The penetrating component 2212 has a puncturing end that can penetrate the subcutaneous adipose tissue of the patient and slides through the open end of the cannula to facilitate the entry of the cannula into the patient. The cannula may have threads on the outside to facilitate entry into the subcutaneous adipose tissue by rotation. One example of the second type of percutaneous drainage device is shown in Figures 16-20.

[0147] In some instances, as shown in FIG. 1G, a guidewire 2228 may be introduced through the opening 12 created by removing the skin plug with the first device. The guidewire may be used to locate the abscess. Whether or not a guidewire is used, the second device 2200 may then be introduced into the opening and rotated or driven downward into the tissue to contact the abscess. If a guidewire is used, the penetrating component may have an internal bore or lumen through which the guidewire may pass. A cap 2250 on the upper portion of the penetrating component may be opened to allow passage of the guidewire. The guidewire may be removed through the bore, after which the cap 2250 may be closed to seal the bore. The penetrating component 2212 may then be retracted and withdrawn through the cannula lumen. The penetrating component may form a tight seal with the cannula lumen such that retraction of the penetrating component through the cannula creates a negative pressure or vacuum that helps initiate the flow of pus 3 or other material from the abscess into the cannula. When the cap 2250 is closed, the bore of the penetrating component is sealed and air cannot enter the bore of the penetrating component from above, allowing a vacuum or negative pressure to be maintained.

[0148] FIG. 1H shows the situation after the cannula 2202 has been driven down to the abscess and the piercing component 2212 has been withdrawn and removed. Pus or other contents of the abscess can now flow upward from the cannula and be collected in a bag or other collection vessel. Draining the abscess may take hours or days depending on the size and contents of the abscess. The cannula may have a collar 2254 that may be positioned on the skin surface to secure the cannula in place. If necessary, cut the cannula to size by cutting the end portion that extends above the skin surface. As shown in FIG. 1I, a retaining strap 2304 may be attached to the collar 2254 to secure the cannula 2202 in place. In this way, the patient can go home and return later to remove the retaining strap, collar, and cannula once the abscess has been drained.

[0149] In some examples, the first device 100 and the second device 2200 may be provided together as a system or kit of parts for use in draining a subcutaneous skin abscess. In some examples, the first and second devices may be provided together with a guidewire, collar and / or retaining strap. These devices may be used to drain shallow and / or deep subcutaneous skin abscesses in an outpatient setting without the need for hospitalization, inpatient surgery, or general anesthesia, as described above. While the overarching principles have been described above, some examples are described in more detail below. It should be understood that any of the following examples may incorporate one or more features described above. Furthermore, features of one example may be combined with or applied to another example, unless the disclosure expressly states otherwise or logic dictates otherwise.

[0150] Part 2: Example of a First Device 100 2A-11B illustrate one example of a first type of device 100, according to some embodiments. The device 100 is configured to allow removal of a portion of a patient's skin, epidermal and / or dermal tissue above a subcutaneous skin abscess and / or allow drainage of the subcutaneous skin abscess. In some embodiments, the device 100 is configured to allow removal of a portion of the patient's tissue. Thus, the device 100 may be referred to as a percutaneous drainage device, a tissue removal device, or a tissue removal device 100.

[0151] In some embodiments, the tissue removal device 100 is configured to be used to allow removal and / or removal of a portion of a patient's skin. The device 100 may be useful and will be primarily described in the context of draining shallow skin abscesses or improving access to deeper skin abscesses. Some abscesses may form deep within the subcutaneous tissue of a patient. The tissue removal device 100 may be used to remove a portion of the patient's skin, epidermis and skin tissue layers above the subcutaneous abscess, improving the ease with which the abscess can be accessed, for example for drainage.

[0152] It should be understood, however, that device 100 may have utility in improving access to any subcutaneous area or any subcutaneous fluid collection, which may contain liquid and / or gas. In the context of abscess drainage, "fluid collection" refers to a collection of pus, liquefied tissue, solid tissue, and / or any other associated material that is held within the confines of a tissue wall (e.g., the wall of a subcutaneous fluid collection).

[0153] The device 100 comprises a container 102. The container 102 comprises a container body 104. The container body 104 extends in a container longitudinal direction 105. The container body 104 comprises a first container body end portion 106. The first container body end portion 106 may be referred to as a lower container body end portion (or a lower end portion of the container body 104). The first container body end portion 106 may be referred to as a proximal container body end portion (or a proximal end portion of the container body 104). The container body 104 comprises a second container body end portion 108. The second container body end portion 108 may be referred to as an upper container body end portion (or an upper end portion of the container body 104). The second container body end portion 108 may be referred to as a distal container body end portion (or a distal end portion of the container body 104). The second container body end portion 108 may be referred to as an upper container body end portion because, in use, the second container body end portion 108 is higher relative to the patient's tissue than the first container body end portion 106. The second container body end portion 108 may be referred to as a distal container body end portion because, in use, the second container body end portion 108 is distal to the patient's tissue compared to the first container body end portion 106 (i.e., the proximal container body end portion). The container body 104 comprises an intermediate container body portion 107. The intermediate container body portion 107 is between the first container body end portion 106 and the second container body end portion 108.

[0154] The container body 104 defines a first container body opening 110. The first container body opening 110 is disposed at the first container body end portion 106. The first container body opening 110 is a circular opening. It will be appreciated that in some embodiments, the first container body opening 110 may take another shape, such as a rounded rectangle. The first container body opening 110 may be referred to as a lower container body opening. The first container body opening 110 may be referred to as a proximal container body opening. The container body 104 defines a second container body opening 112. The second container body opening 112 is disposed at the second container body end portion 108. The second container body opening 112 is a circular opening. It will be appreciated that in some embodiments, the second container body opening 112 may take another shape, such as a rounded rectangle. The second container body opening 112 may be referred to as an upper container body opening (because, in use, the second container body opening 112 is higher relative to the patient's tissue than the first container body opening 110). The second container body opening 112 may be referred to as a distal container body opening because, in use, the second container body opening 112 is distal to the patient's tissue compared to the first container body opening 110.

[0155] A container body lumen 114 extends between the first container body opening 110 and the second container body opening 112. In other words, the container body 104 defines the container body lumen 114. The container body lumen 114 extends from the first container body end portion 106 to the second container body end portion 108. The container body lumen 114 is generally cylindrical. That is, the container body lumen 114 is a cylindrical lumen. In some embodiments, the container body lumen 114 may have different profiles. For example, the container body lumen 114 may have a rectangular profile, a rounded rectangular profile, or a profile corresponding to another polygon. Alternatively, the container body lumen 114 may have an elliptical profile, or a profile corresponding to another curved shape. One or more features of the container body 104 may protrude into the container body lumen 114 in some areas. Thus, while generally cylindrical, some cross-sectional profiles of vessel body lumen 114 may include protrusions that result in the associated cross-sectional profile deviating from a circular profile. Vessel body 104 includes a vessel body inner surface 115. Vessel body inner surface 115 defines the cross-sectional profile of vessel body lumen 114 along its length. Vessel body inner surface 115 may be referred to as the inner surface of vessel body 104. Vessel body inner surface 115 is the inner surface of vessel 102.

[0156] Therefore, the container body 104 may be referred to as a hollow body. The container body 104 may be referred to as a barrel.

[0157] The tissue removal device 100 includes a first cap 116. The first cap 116 may be referred to as a first container outlet cap. The first cap 116 is configured to connect to the container body 104. In particular, the first cap 116 is configured to removably connect to the container body 104. The first cap 116 is configured to connect to the first container body end portion 106.

[0158] The first cap 116 defines a first container outlet 118. In particular, the first cap 116 defines a first opening 120 and a second opening 122. A first cap lumen 124 extends between the first opening 120 and the second opening 122. The first container outlet 118 may correspond to a portion or all of the first cap lumen 124.

[0159] The tissue removal device 100 includes a second cap 126. The second cap 126 may be referred to as a second container outlet cap. The second cap 126 is configured to connect to the container body 104. In particular, the second cap 126 is configured to removably connect to the container body 104. The second cap 126 is configured to connect to the second container body end portion 108.

[0160] The second cap 126 defines a second container outlet 128. In particular, the second cap 126 defines a first opening 130 and a second opening 132. A second cap lumen 134 extends between the first opening 130 and the second opening 132. The second container outlet 128 may correspond to some or all of the second cap lumen 134.

[0161] The container body 104 includes a first container body connection portion 136. The first container body connection portion 136 is configured to allow the first cap 116 to connect to the container body 104. The first container body connection portion 136 includes male threads of a screw thread connection. The first cap 116 includes female threads of a screw thread connection. It will be appreciated that in some embodiments, the first cap 116 may connect to the container body 104 using different types of connections. For example, the first cap 116 may connect to the container body 104 using an interference fit connection, a snap fit connection, or another type of connection.

[0162] The container body 104 includes a second container body connection portion 138. The second container body connection portion 138 is configured to allow the second cap 126 to connect to the container body 104. The second container body connection portion 138 includes male threads of a threaded connection. The second cap 126 includes female threads of a threaded connection. It will be appreciated that in some embodiments, the second cap 126 may connect to the container body 104 using different types of connections. For example, the second cap 126 may connect to the container body 104 using an interference fit connection, a snap fit connection, or another type of connection.

[0163] The container 102 includes a container rim 140. In particular, the container body 104 includes a container rim 140. The container rim 140 extends radially inwardly toward a container longitudinal axis of the container 102. The illustrated container 102 includes a first container rim 140A and a second container rim 140B. The first container rim 140A extends inwardly around a first portion of the inner circumference of the container body 104. The second container rim 140B extends inwardly around a second portion of the inner circumference of the container body 104.

[0164] In some embodiments, the container 102 includes one container rim 140. The container rim 140 may extend radially inwardly of the container 102. The container rim 140 may extend around the entire inner circumference of the container body 104.

[0165] The container 102 includes an elongated protrusion 182. In particular, the container body 104 includes the elongated protrusion 182. The elongated protrusion 182 extends radially inwardly of the container 102. That is, the elongated protrusion 182 extends toward a central longitudinal axis of the container body 104. The intermediate container body portion 107 includes the elongated protrusion 182.

[0166] The elongated protrusion 182 comprises a first elongated portion 184. The elongated protrusion 182 comprises a second elongated portion 186. The second elongated portion 186 is a tapered portion of the elongated protrusion 182. That is, the thickness of the elongated protrusion 182 decreases along the length of the second elongated portion 186. The second elongated portion 186 is between the container rim 140 and the first elongated portion 184. In particular, the second elongated portion 186 is between the container rim 140 and the first elongated portion 184 in the container longitudinal direction 105.

[0167] As illustrated, in some embodiments, the container body 104 includes a first elongate protrusion 182A and a second elongate protrusion 182B. The first elongate protrusion 182A can be on an opposite side of the container body 104 from the second elongate protrusion 182B.

[0168] The container 102 defines a receiving volume 144. The container 102 defines a distal volume 146. The container rim 140 is between the receiving volume 144 and the distal volume 146. The receiving volume 114 is between the first container outlet 118 and the container rim 140. An inner container bore 142 fluidly connects the receiving volume 144 and the distal volume 146. The first opening 120 of the first cap 116 and the second opening 132 of the second cap 126 are fluidly connected by the receiving volume 144, the inner container bore 142, and the distal volume 146.

[0169] As described herein, in one or more embodiments, the first cap 116 and / or the second cap 126 are removably connectable to the container body 104. In some embodiments, the tissue removal device 100 includes a first container cap (not shown). The tissue removal device 100 may also include a second container cap (not shown). The first container cap is configured to removably connect to the container body 104 as described with reference to the first cap 116. However, the first container cap does not include a lumen. The first container cap is configured to connect to the container body 104 to occlude the first container body opening 110 as described herein, e.g., to retain a fluid sample within the container 102. Similarly, the second container cap is configured to removably connect to the container body 104 as described with reference to the second cap 126. However, the second container cap does not include a lumen. The second container cap is configured to connect to the container body 104 and close the second container body opening 112, e.g., to retain a fluid sample within the container 102, as described herein.

[0170] The tissue removal device 100 may include a plunger sleeve 150. The plunger sleeve 150 includes a first sleeve end portion 170. The first sleeve end portion 170 may be referred to as a lower sleeve end portion (or a lower end portion of the plunger sleeve 150). The first sleeve end portion 170 may be referred to as a proximal sleeve end portion (or a proximal end portion of the plunger sleeve 150). The plunger sleeve 150 includes a second sleeve end portion 172. The second sleeve end portion 172 may be referred to as an upper sleeve end portion (or an upper end portion of the plunger sleeve 150). The second sleeve end portion 172 may be referred to as a distal sleeve end portion (or a distal end portion of the plunger sleeve 150).

[0171] The plunger sleeve 150 defines a first sleeve opening 152. The first sleeve opening 152 is disposed at the first sleeve end portion 170. The first sleeve opening 152 is a generally circular opening. It will be appreciated that in some embodiments, the first sleeve opening 152 may have another shape, such as a rounded rectangle. The first sleeve opening 152 may be referred to as a lower sleeve opening. The first sleeve opening 152 may be referred to as a proximal sleeve opening. The plunger sleeve 150 defines a second sleeve opening 154. The second sleeve opening 154 is disposed at the second sleeve end portion 172. The second sleeve opening 154 is a generally circular opening. It will be appreciated that in some embodiments, the second sleeve opening 154 may have another shape, such as a rounded rectangle. The second sleeve opening 154 may be referred to as an upper sleeve opening. The second sleeve opening 154 may be referred to as the distal sleeve opening.

[0172] A sleeve lumen 156 extends between the first sleeve opening 152 and the second sleeve opening 154. In other words, the plunger sleeve 150 defines the sleeve lumen 156. The sleeve lumen 156 extends from the first sleeve opening 152 to the second sleeve opening 154. The sleeve lumen 156 is generally cylindrical. In some embodiments, the sleeve lumen 156 may have a different profile. For example, the sleeve lumen 156 may have a rectangular profile, a rounded rectangular profile, or a profile corresponding to another polygon. Alternatively, the sleeve lumen 156 may have an elliptical profile, or a profile corresponding to another curved shape. Thus, the plunger sleeve 150 may be referred to as a hollow body. The plunger sleeve 150 includes a sleeve inner surface 157. The sleeve inner surface 157 defines the cross-sectional profile of the sleeve lumen 156 along its length. The sleeve inner surface 157 may be referred to as the inner surface of the plunger sleeve 150 .

[0173] The plunger sleeve 150 defines a plunger sleeve volume 151. The plunger sleeve volume 151 may correspond to a sleeve lumen 156.

[0174] The plunger sleeve 150 includes a mid-sleeve portion 160. The mid-sleeve portion 160 is between a first sleeve end portion 170 and a second sleeve end portion 172. The sleeve lumen 156 includes a mid-sleeve lumen portion 168. The mid-sleeve portion 160 defines the mid-sleeve lumen portion 168. The mid-sleeve lumen portion 168 is between the first sleeve opening 152 and the second sleeve opening 154.

[0175] The plunger sleeve 150 includes a first sleeve connector member 158. The plunger sleeve 150 includes an intermediate opening 160. In particular, the intermediate sleeve portion 160 includes an intermediate opening 160. The intermediate opening 160 extends through a wall of the plunger sleeve 150 and fluidly connects the sleeve lumen 156 to an area external to the plunger sleeve 150. The first sleeve connector member 158 protrudes from an intermediate opening wall 162 into the intermediate opening 160. The first sleeve connector member 158 is an elongated member. The first sleeve connector member 158 is integrally formed with the plunger sleeve 150. The first sleeve connector member 158 is bendable.

[0176] The first sleeve connector member 158 includes an elongated portion 159. The first sleeve connector member 158 includes a first protrusion 164. The first protrusion 164 protrudes perpendicular to the longitudinal direction of the first sleeve connector member 158. The first protrusion 164 protrudes radially inwardly of the plunger sleeve 150. The first protrusion 164 protrudes away from the elongated portion 159.

[0177] The first sleeve connector member 158 is movable between a first position and a second position. The first sleeve connector member 158 is shown in the first position in Figures 5A and 5B. The first sleeve connector member 158 is shown in the second position in Figures 7A and 7B. The first sleeve connector member 158 is biased toward the first position. That is, in the absence of significant force on the first sleeve connector member 158, the first sleeve connector member 158 moves toward or remains in the first position.

[0178] 2A-11B, in some embodiments, the plunger sleeve 150 comprises a plurality of first sleeve connector members 158A, B. In some embodiments, the plunger sleeve 150 comprises a pair of first sleeve connector members 158A, B. Each of the first sleeve connector members 158A, B can be as described herein with respect to the first sleeve connector member 158. The first sleeve connector members 158A, B can be on opposing sides of the plunger sleeve 150. That is, the plunger sleeve 150 can include a pair of opposing first sleeve connector members 158A, B.

[0179] The plunger sleeve 150 includes a second sleeve connector member 174. The plunger sleeve 150 includes a second sleeve connector member opening 176. In particular, the second sleeve end portion 172 includes the second sleeve connector member opening 176. The second sleeve connector member opening 176 can be a notch in the plunger sleeve 150. The second sleeve connector member 174 protrudes from a second sleeve connector member opening wall 178 into the second sleeve connector member opening 176. The second sleeve connector member 174 is an elongated member. The second sleeve connector member 174 is integrally formed with the plunger sleeve 150. The second sleeve connector member 174 is bendable.

[0180] The second sleeve connector member 174 includes a second elongated portion 181. The second sleeve connector member 174 includes a second protrusion 180. The second protrusion 180 protrudes perpendicular to the longitudinal direction of the second sleeve connector member 174. The second protrusion 180 protrudes radially inwardly of the plunger sleeve 150. The second protrusion 180 protrudes away from the second elongated portion 181.

[0181] The second sleeve connector member 174 is movable between a first position and a second position. The second sleeve connector member 174 is shown in the first position in Figures 4A and 4B. The second sleeve connector member 174 is shown in the second position in Figures 6A and 6B. The second sleeve connector member 174 is biased toward the second position. That is, in the absence of significant force on the second sleeve connector member 174, the second sleeve connector member 174 moves toward or remains in the second position.

[0182] 2A-11B, in some embodiments, the plunger sleeve 150 comprises a plurality of second sleeve connector members 174A,B. In some embodiments, the plunger sleeve 150 comprises a pair of second sleeve connector members 174A,B. Each of the second sleeve connector members 174A,B can be as described herein with respect to the second sleeve connector member 174. The second sleeve connector members 174A,B can be on opposing sides of the plunger sleeve 150. That is, the plunger sleeve 150 can include a pair of opposing second sleeve connector members 174A,B.

[0183] The plunger sleeve 150 includes a groove 188. The groove 188 is an elongated groove parallel to the longitudinal direction of the plunger sleeve 150. The groove 118 is configured to receive at least a portion of an elongated protrusion 182 of the container body 104. The groove 188 and the elongated protrusion 182 together form a tongue-and-groove connection that allows relative movement between the plunger sleeve 150 and the container body 104 in the container longitudinal direction 105 while preventing relative movement of the plunger sleeve 150 and the container body 104 in one or more directions perpendicular to the container longitudinal direction 105.

[0184] The container 102 is configured to receive the plunger sleeve 150. In particular, the container 102 is configured to receive the plunger sleeve 150 within the receiving volume 144.

[0185] The tissue removal device 100 includes a plunger 190. The plunger sleeve 150 is configured to receive at least a portion of the plunger 190. In other words, the plunger sleeve 150 is configured to accommodate at least a portion of the plunger 190. The plunger 190 is configured to move in the container longitudinal direction 105 when received within the plunger sleeve 150. The container 102 is configured to receive at least a portion of the plunger 190. In other words, the plunger 190 is configured to be received by the container 102.

[0186] The plunger 190 includes a first end portion 196. The first end portion 196 may be referred to as a lower end portion (or a lower end portion of the plunger 190). The first end portion 196 may be referred to as a proximal end portion (or a proximal end portion of the plunger 190). The plunger 190 includes a second end portion 198. The second end portion 198 may be referred to as an upper end portion (or an upper end portion of the plunger 190). The second end portion 198 may be referred to as a distal end portion (or a distal end portion of the plunger 190). The plunger 190 includes an intermediate plunger portion 200. The intermediate plunger portion 200 is between the first end portion 196 and the second end portion 198.

[0187] The plunger 190 comprises a sleeve contacting portion 192. In some embodiments, the sleeve contacting portion 192 is at a first end portion 196 of the plunger 190. In some embodiments, the sleeve contacting portion 192 is closer to the first end portion 196 of the plunger 190 than the second end portion 198 of the plunger 192. In some embodiments, the intermediate plunger portion 200 comprises the sleeve contacting portion 190. In some embodiments, the sleeve contacting portion is at the second end portion 198 of the plunger 190. In some embodiments, the sleeve contacting portion 192 is closer to the second end portion 198 of the plunger 190 than the first end portion 196 of the plunger 190.

[0188] The sleeve contacting portion 192 is configured to contact the plunger sleeve 150. In particular, the sleeve contacting portion 192 is configured to contact the sleeve inner surface 157. The sleeve contacting portion 192 is configured to slidably engage with the sleeve inner surface 157. That is, the plunger 190 is configured to be moved within the plunger sleeve 150 such that the sleeve contacting portion 192 slides along the sleeve inner surface 157. The plunger 190 is rotatable relative to the plunger sleeve 150.

[0189] In some embodiments, the sleeve contacting portion 192 is configured to sealingly engage the plunger sleeve 150. That is, the sleeve contacting portion 192 is configured to contact the sleeve inner surface 157 to impede the movement of fluid through the interface between the sleeve contacting portion 192 and the sleeve inner surface 157.

[0190] In some embodiments, the device may have a sealing component configured to seal with the interior chamber of the container and generate suction when moved toward the proximal end as the tissue engaging component is retracted into the container. This may help to draw tissue and / or viscous fluids from the subcutaneous skin abscess into the container. For example, the sealing component may be an O-ring or ridge on the plunger. The sealing component may seal with the interior wall of the container or the plunger sleeve if the device has a plunger sleeve.

[0191] In some embodiments, the sleeve contacting portion 192 of the sleeve comprises one or more of a polymeric material and an elastomeric material. In some embodiments, the sleeve contacting portion 192 comprises an O-ring. That is, the sleeve contacting portion 192 may comprise an O-ring groove and an O-ring configured to be disposed within the O-ring groove. The O-ring may be configured to sealingly engage with the sleeve inner surface 157. In some embodiments, the O-ring comprises one or more of an elastomeric material, a polymeric material, a metallic material, and a ceramic material. Although an O-ring is referenced herein as an example, other types of sealing members may be used.

[0192] The plunger 190 includes a first plunger connecting portion 194. In particular, the second end portion 198 of the plunger 190 comprises the first plunger connecting portion 194. The first plunger connecting portion 194 defines a first plunger connecting hole 202. In some embodiments, the first plunger connecting portion 194 defines a plurality of the first plunger connecting holes 202. In the embodiment illustrated in FIGS. 1-11B, the first plunger connecting portion 194 defines a pair of opposing first plunger connecting holes 202A, B.

[0193] The plunger 190 includes a second plunger connection portion 204. In particular, the second end portion 198 of the plunger 190 includes the second plunger connection portion 204. The second plunger connection portion 204 defines a second plunger connection hole 206. In some embodiments, the second plunger connection portion 204 defines a plurality of the second plunger connection holes 206. In the embodiment illustrated in FIGS. 1-11B, the second plunger connection portion 204 defines a pair of opposing second plunger connection holes 206A, B.

[0194] The tissue removal device 100 comprises a cutting element 208. The cutting element 208 is configured to cut tissue of a patient. In particular, the cutting element 208 is configured to cut skin of a patient. The cutting element 208 may comprise a cylindrical cutting sharp. Thus, the tissue removal device 100 comprises a cylindrical cutting sharp. The cylindrical cutting sharp may be referred to as a biopsy punch. The cylindrical cutting sharp may be referred to as a biopsy sharp. The cutting element may have any of the dimensions or characteristics described above in part 1.

[0195] The cutting element 208 includes a cutting end portion 210. The cutting element 208 includes a second end portion 212. The second end portion 212 may be referred to as the second end portion of the cutting element 208. The second end portion 212 may be referred to as the distal end portion of the cutting element 208. The cutting element 208 includes a cutting end opening 214. The cutting element 208 includes a second end opening 216. The cutting element 208 extends from the cutting end portion 210 to the second end portion 212 and defines a cutting lumen 218. The cutting lumen 218 extends between the cutting end opening 214 and the second end opening 216. The cutting lumen 218 extends longitudinally of the cutting element 208. The cutting element 208 includes a cutting edge 220. The cutting edge 220 is sharpened to enable the cutting element 208 to cut tissue as the cutting element 208 moves toward and contacts tissue. In particular, the cutting edge 220 enables the cutting element 208 to cut tissue as the cutting element 208 is moved toward and into tissue in a longitudinal direction of the cutting element 208.

[0196] The dissection element 208 is configured to connect to the plunger 190. Similarly, the plunger 190 is configured to connect to the dissection element 208. In particular, the dissection element 208 is configured to connect to a first end portion 196 of the plunger 190. As illustrated in FIGS. 1-11B, the dissection element 208 is connected to the plunger 190. A longitudinal axis of the dissection element 208 may be coaxial with a longitudinal axis of the container 102. A longitudinal axis of the dissection element 208 may be coaxial with a longitudinal axis of the plunger 190. Movement of the plunger 190 causes movement of the dissection element 208.

[0197] In some embodiments, the dissection element 208 is configured to connect to the container 102. That is, the dissection element 208 may connect to the container 102 rather than connecting to the plunger 190. In particular, the dissection element 208 may connect to the first cap 116 at the first container outlet 118. The longitudinal axis of the dissection element 208 may be parallel to the container longitudinal direction 105.

[0198] The tissue removal device 100 includes a tissue engaging component 222. The tissue engaging component 222 is configured to engage tissue cut by the cutting element 208. In particular, the tissue engaging component 222 is configured to engage tissue cut by the cutting element 208 such that movement of the tissue engaging component 222 causes movement of at least a portion of the tissue cut by the cutting element 208. The tissue engaging component 222 may have any of the dimensions or characteristics described above in part 1. The gap between the tissue engaging component and the cutting element may be as described above in part 1.

[0199] The tissue engaging component 222 includes a piercing end portion 224. The tissue engaging component 222 includes a second end portion 226. The second end portion 226 may be referred to as the second end portion of the tissue engaging component 222. The second end portion 226 may be referred to as the distal end portion of the tissue engaging component 222. The tissue engaging component 222 is an elongated component that extends from the piercing end portion 224 to the second end portion 226.

[0200] The tissue engaging component 222 includes a penetrating portion 228. In particular, the penetrating end portion 224 includes the penetrating portion 228. The penetrating portion 228 is configured to penetrate tissue. In particular, the penetrating portion 228 is configured to penetrate tissue before the surrounding tissue is incised by the cutting element 208. The penetrating portion 228 may be in the form of a sharp portion of the tissue engaging component 222.

[0201] The tissue engaging component 222 includes barbs 230. The barbs 230 are configured to engage tissue.

[0202] The tissue engaging component 222 comprises a shaft 232. The shaft 232 is an elongated portion of the tissue engaging component 222.

[0203] In some embodiments, the tissue engaging component 222 is solid, i.e., the tissue engaging component 222 is not hollow.

[0204] In some embodiments, the tissue engaging component 222 defines a first tissue engaging component opening 234. The tissue engaging component 222 defines a second tissue engaging component opening 236. The tissue engaging component 222 extends from the piercing end portion 224 to the second end portion 226 and defines a tissue engaging component lumen 238. The tissue engaging component lumen 238 extends between the first tissue engaging component opening 234 and the second tissue engaging component opening 236. The tissue engaging component lumen 238 extends longitudinally of the tissue engaging component 222. The tissue engaging component 222 defines a barb opening 240. The barb opening 240 is fluidly connected to the tissue engaging component lumen 238.

[0205] The tissue engaging component 222 is configured to connect to the plunger 190. Similarly, the plunger 190 is configured to connect to the tissue engaging component 222. In particular, the tissue engaging component 222 is configured to connect to the first end portion 196 of the plunger 190. Thus, when connected, movement of the plunger 190 causes movement of the tissue engaging component 222. As illustrated in FIGS. 2A-11B, the tissue engaging component 222 is connected to the plunger 190. The longitudinal axis of the tissue engaging component 222 may be parallel to the container longitudinal direction 105. The longitudinal axis of the tissue engaging component 222 may be coaxial with the longitudinal axis of the plunger 190. The longitudinal axis of the tissue engaging component 222 may be coaxial with the longitudinal axis of the dissection element 208.

[0206] The tissue engaging component 222 and the cutting element 208 are separate components, i.e., the tissue engaging component 222 and the cutting element 208 are independently connectable to the plunger 190.

[0207] Tissue removal device 100 includes a second plunger 242. In some embodiments, plunger 190 may be referred to as first plunger 190. Second plunger 242 is configured to connect to plunger 190 such that, when connected, movement of second plunger 242 causes corresponding movement of plunger 190.

[0208] The second plunger 242 includes a first end portion 244. The first end portion 244 may be referred to as a lower end portion (or a lower end portion of the second plunger 242). The first end portion 244 may be referred to as a proximal end portion (or a proximal end portion of the second plunger 242). The second plunger 242 includes a second end portion 246. The second end portion 246 may be referred to as an upper end portion (or an upper end portion of the second plunger 242). The second end portion 246 may be referred to as a distal end portion (or a distal end portion of the second plunger 242). The second plunger 242 includes a middle second plunger portion 248. The middle second plunger portion 248 may be referred to as a middle portion of the second plunger 242. The intermediate second plunger portion 248 is between the first end portion 244 and the second end portion 246. The second plunger 242 comprises a step 250. In particular, the second plunger 242 comprises a step 250 where the intermediate second plunger portion 248 meets the second end portion 246. An outer dimension of the intermediate second plunger portion 248 is greater than an outer dimension of the second end portion 246 to define the step 250. For example, in some embodiments, a circumference of the intermediate second plunger portion 248 is greater than a circumference of the second end portion 246 to define the step 250.

[0209] The second plunger 242 includes an angled wall 243. A plane tangent to the surface of the angled wall 243 is transverse to the longitudinal direction of the second plunger 242.

[0210] The second plunger 242 includes a second plunger connector 252. In particular, the first end portion 244 of the second plunger 242 includes the second plunger connector 252. The second plunger connector 252 is configured to allow connection of the second plunger 242 and the plunger 190. In particular, the second plunger connector 252 is configured to allow connection of the second plunger 242 to the plunger 190.

[0211] The second plunger connector 252 includes a second plunger connector member 254. The second plunger connector member 254 includes an elongated portion 256. The elongated portion 256 may be referred to as the elongated portion of the second plunger connector member 254. The elongated portion 256 may be referred to as the elongated portion of the second plunger connector member. The second plunger connector member 254 includes a protrusion 258. The protrusion 258 may be referred to as a protrusion of the second plunger connector member 254. The protrusion 258 may be referred to as a second plunger connector member protrusion. The protrusion 258 protrudes perpendicular to the longitudinal direction of the second plunger connector member 254. The protrusion 258 protrudes radially outward of the second plunger 252.

[0212] 2A-11B, in some embodiments, the second plunger 242 comprises a plurality of second plunger connector members 254A, B. In some embodiments, the second plunger 242 comprises a pair of second plunger connector members 254A, B. Each of the second plunger connector members 254A, B can be as described herein with respect to the second plunger connector member 254. The second plunger connector members 254A, B can be on opposing sides of the second plunger 242. That is, the second plunger 242 can comprise a pair of opposing second plunger connector members 254A, B.

[0213] The second plunger 242 includes an actuation portion 260. The actuation portion 260 is configured to allow a user to actuate the second plunger 242. Specifically, the actuation portion 260 is configured to allow a user to move the second plunger 242 relative to the container 102.

[0214] The second plunger 242 includes a first groove 262. In particular, the second end portion 246 includes the first groove 262. The first groove 262 extends circumferentially around the second plunger 242. The first groove 262 can act as an indicator to highlight that the plunger 242 has been moved to a retracted position. The second plunger 242 includes a second groove 264. In particular, the second end portion 246 includes the second groove 264. The second groove 264 extends circumferentially around the second plunger 242. The first groove 262 is between the actuating portion 260 and the intermediate second plunger portion 248. The second groove 264 is between the actuating portion 260 and the intermediate second plunger portion 248. The second groove 264 is between the actuating portion 260 and the first groove 262.

[0215] The tissue removal device 100 includes a locking element 266. The locking element 266 is configured to engage with the second groove 264. In particular, a portion of the locking element 266 is configured to be received within the second groove 264. When received within the second groove 264, the locking element 266 is configured to contact the container 102 and prevent movement of the second plunger 242 relative to the container 102. In particular, the locking element 266 is configured to prevent movement of the actuating portion 260 towards the container 102. In some embodiments, the locking element 266 is configured to engage with the first groove 262.

[0216] During use, the components of tissue removal device 100 are movable between a number of positions. Movement of one or more of the components of removal device 100 can result in removal device 100 being moved between a number of states.

[0217] 2A, 4A, 4B, 5A, and 5B illustrate tissue removal device 100 in a first state. The first state is a pre-use state. That is, the first state is the state in which tissue removal device 100 is maintained prior to being used to remove tissue from a patient. In the first state, one or more of the components of tissue removal device 100 are in their respective first state positions. The first state may be referred to as an initial state. The first state may be referred to as an assembled state.

[0218] In a first state, the tissue engaging component 222 and the cutting element 208 are brought into contact with the patient's skin. The tissue removal device 100 is approached toward the patient's skin such that the tissue engaging component 222 penetrates the patient's skin, and the cutting element 208 cuts the patient's skin surrounding the tissue engaging component 222.

[0219] As described herein, the tissue removal device 100 includes a container 102, a first plunger 190, a second plunger 242, a plunger sleeve 150, a dissection element 208, and a tissue engaging component 222. The container 102 is configured to house at least a portion of the tissue engaging component 222. For example, as shown in Figures 2A, 4A, 4B, 5A, and 5B, in a first state, the container 102 houses a portion of the tissue engaging component 222. Specifically, the container 102 houses a second end portion 226 of the tissue engaging component 222. The container 102 also houses a portion of the shaft 232.

[0220] As described herein, the tissue engaging component 222 is configured to engage tissue cut by the cutting element 208. The tissue engaging component 222 is also configured to move with the movement of the plunger 190. In some embodiments, the tissue engaging component 222 is configured to engage tissue cut by the cutting element 208 such that movement of the tissue engaging component 222 into the receiving volume 144 of the container 102 causes movement of at least a portion of the tissue cut by the cutting element into the receiving volume 144.

[0221] The tissue engaging component 222 extends through the incision lumen 218. In particular, the tissue engaging component 222 extends through the incision lumen 218 such that the piercing portion 228 and the barb 230 are exposed beyond the incision lumen 218. The tissue engaging component 222 extends through the first container outlet 118. The incision element 208 extends through the first container outlet 118.

[0222] The plunger sleeve 150 is configured to receive at least a portion of the first plunger 190. The plunger sleeve 150 is configured to receive at least a portion of the second plunger 242. As shown in Figures 4A and 4B, in a first state, the plunger sleeve 150 is configured to receive the first plunger 190 within the sleeve bore 156. Similarly, the plunger sleeve 150 is configured to receive the second plunger 242 within the sleeve bore 156.

[0223] When tissue removal device 100 is in the first state, plunger 190 may be said to be in a first position. This may be the first position of plunger 190. The first position may be referred to as an initial position of plunger 190. The first position may be referred to as an assembled position of plunger 190.

[0224] When the tissue removal device 100 is in the first condition, the second plunger 242 may be said to be in a first position. This may be the first position of the second plunger 242. The first position may be referred to as an initial position of the second plunger 242. The first position may be referred to as an assembled position of the second plunger 242.

[0225] When the second plunger 242 is in the first position, the second plunger connector 252 is connected to the first plunger connecting portion 194. In particular, the protrusion 258 of the second plunger connector member 254 is received within the first plunger connecting hole 202. In other words, the first plunger connecting hole 202 is configured to receive a portion of the second plunger connector 254 when the second plunger 242 is in the first position. This prevents relative movement of the second plunger 242 with respect to the plunger 190.

[0226] As shown in Figures 5A and 5B, when the tissue removal device 100 is in the first state, the first sleeve connector member 158 is in a first position. In particular, each of the first sleeve connector members 158A,B is in their respective first position. In the first position, the first sleeve connector member 158 is configured to block movement of the first plunger 190 relative to the plunger sleeve 150. In particular, the first sleeve connector member 158 is configured to abut an end of the first plunger 190 to block movement of the first plunger 190 relative to the plunger sleeve 150 when the first plunger 190 moves away from the first container outlet 118. The first protrusion 166 of the first sleeve connector member 158 is configured to abut an end of the plunger 190.

[0227] 4A and 4B, when tissue removal device 100 is in the first condition, second sleeve connector member 174 is in a first position. In particular, each of second sleeve connector members 174A,B is in their respective first position. In the first position, second sleeve connector member 174 is configured to abut an outer surface of second plunger 242.

[0228] The tissue removal device 100 is used to engage and incise tissue of a patient when in the first condition. The tissue removal device 100 is moved towards the patient's tissue such that the container longitudinal direction 105 is generally perpendicular to the patient's tissue. The container 102 is moved towards the patient's tissue such that the piercing portion 228 penetrates the patient's tissue. The tissue engaging component 222 engages the tissue at the barb 230. The locking element 266 may engage the second groove 264 at this point. Further movement of the container 102 towards the tissue causes the incision element 208 to incise the tissue surrounding the tissue engaging component 222.

[0229] 6A-7B illustrate tissue removal device 100 in a second state. The second state is an intermediate state. That is, the second state is the state to which tissue removal device 100 is moved during use. A user moves second plunger 242 toward first container outlet 118 to move tissue removal device 100 from the first state to the second state. In the second state, one or more of the components of tissue removal device 100 are in their respective second state positions. The second state may be referred to as an intermediate state. The second state may be referred to as a first intermediate state.

[0230] When the tissue removal device 100 is in the second state, the second plunger 242 may be said to be in a second position. This may be the second position of the second plunger 242. The second position may be referred to as an intermediate position of the second plunger 242. The second position may be referred to as a first intermediate position of the second plunger 242. The second position may be referred to as a plunger connected position. The second plunger 242 is configured to be moved between the first position and the second position.

[0231] When the second plunger 242 is in the second position, the second plunger connector 252 is connected to the second plunger connecting portion 204 of the plunger 190. In particular, the protrusion 258 of the second plunger connector member 254 is received in the second plunger connecting hole 206. In other words, the second plunger connecting hole 206 is configured to receive a portion of the second plunger connector member 254 when the second plunger 242 is in the second position. The portion of the second plunger connector member 254 received by the second plunger connecting hole 206 is the same portion of the second plunger connector member 254 received by the first plunger connecting hole 202 when the second plunger 242 is in the first position. This prevents relative movement of the second plunger 242 with respect to the plunger 190. In other words, movement of the second plunger 242 causes a corresponding movement of the plunger 190.

[0232] 7A and 7B, when the tissue removal device 100 is in the second condition, the first sleeve connector member 158 is in a second position. In particular, each of the first sleeve connector members 158A,B is in their respective second position. In the second position, the first sleeve connector member 158 is configured to permit movement of the plunger 190 relative to the plunger sleeve 150. In particular, the first sleeve connector member 158 is configured to deflect outwardly to abut an exterior surface of the second plunger 242 and permit movement of the plunger 190 relative to the plunger sleeve 150 when the plunger 190 is moved away from the first container outlet 118. The first protrusion 166 of the first sleeve connector member 158 is configured to abut against the second plunger 242 to move the second plunger 242 from a first position to a second position as the second plunger 242 moves toward the first container outlet 118, pushing the first sleeve connector member 158 radially outward.

[0233] 6A and 6B, when the tissue removal device 100 is in the second condition, the second sleeve connector member 174 is in a second position. In particular, each of the second sleeve connector members 174A,B is in their respective second position. In the second position, the second sleeve connector member 174 is configured to abut the shoulder 250. The second sleeve connector member 174 is configured to abut the shoulder 250 to prevent movement of the second plunger 242 relative to the plunger sleeve 150 when the second plunger 242 is moved away from the first container outlet 118.

[0234] After the patient's tissue has been sufficiently cut and engaged using the cutting element 208 and the tissue engaging component 222, the user moves the second plunger 242 toward the first container outlet 118 to move the tissue removal device 100 from the first state to the second state.

[0235] 8A-9B illustrate tissue removal device 100 in a third state. The third state is an intermediate state. The third state may be referred to as a second intermediate state. The third state is the state to which tissue removal device 100 is moved during use. A user moves second plunger 242 to move tissue removal device 100 from the second state to the third state. In particular, a user moves second plunger 242 away from first container outlet 118 to move tissue removal device 100 from the second state to the third state. In the third state, one or more of the components of tissue removal device 100 are in their respective third state positions. A user moves second plunger 242 away from first container outlet 118 to move tissue removal device 100 from the second state to the third state.

[0236] Movement of the second plunger 242 away from the first container outlet 118 moves the tissue engaging component 222 and the cutting element 208 into the receiving volume 144. This, in turn, moves the tissue cut by the cutting element 208 and engaged by the tissue engaging component 222 into the receiving volume 144. The described operations may be performed on tissue above an abscess such that removal of the cut tissue may expose the abscess fluid. The fluid may be drained into the container 102. Additionally, movement of the second plunger 242 away from the first container outlet 118 may apply negative pressure to the hole created in the patient's tissue, thereby drawing the fluid into the container 102.

[0237] When tissue removal device 100 is in the third state, plunger 190 may be said to be in a second position. This may be the second position of plunger 190. The second position may be referred to as an intermediate position of plunger 190. Plunger 190 is configured to be moved between the first position and the second position.

[0238] When the plunger 190 is in the first position, at least a portion of the tissue engaging component 222 is exposed. That is, at least a portion of the tissue engaging component 222 extends outside the container 102. In particular, the first container outlet 118 is configured to receive the tissue engaging component 222 and the cutting element 208 such that at least a portion of the tissue engaging component 222 and at least a portion of the cutting element 208 extend outside the container 102 through the first container outlet 118. When the plunger 190 is in the second position, the tissue engaging component 222 is contained within the receiving volume 144 of the container 102. Additionally, the cutting element 208 is contained within the receiving volume 144.

[0239] When the tissue removal device 100 is in the third state, the second plunger 242 may be said to be in a third position. This may be a third position of the second plunger 242. The third position may be referred to as an intermediate position of the second plunger 242. The third position may be referred to as a second intermediate position of the second plunger 242. The third position may be referred to as a retracted position. The second plunger 242 is configured to be moved between the second position and the third position.

[0240] When the second plunger 242 is in the third position, the second plunger connector 252 is connected to the second plunger connecting portion 204. Thus, the plunger 190 moves with the movement of the second plunger 242.

[0241] 9A and 9B, when the tissue removal device 100 is in the third condition, the first sleeve connector members 158 are in the second position. In particular, each of the first sleeve connector members 158A,B are in their respective second positions.

[0242] As the second plunger 242 is moved away from the first container outlet 118, the plunger sleeve 150 is also moved away from the first container outlet 118 because the shoulder 250 of the second plunger 242 abuts the second protrusion 180 of the second sleeve connector member 174, causing the plunger sleeve 150 to move with the movement of the second plunger 242. As the plunger sleeve 150 is moved away from the first container outlet 118, the second sleeve connector member 174 is moved past the second elongated portion 186.

[0243] When the tissue removal device 100 is in the third position, the second sleeve connector member 174 contacts the second cap 126. This prevents further movement of the plunger sleeve 150 away from the first container outlet 118.

[0244] As shown in FIG. 8A and FIG. 8B, when the tissue retrieval device 100 is in the third state, the second sleeve connector member 174 is in a third position. The third position generally corresponds to the first position. Thus, when the tissue retrieval device 100 is in the third state, the second sleeve connector member 174 returns to the first position (i.e., bends outward). In particular, each of the second sleeve connector members 174A,B is in their respective first position. Moving the tissue retrieval device 100 from the second state to the third state moves the second sleeve connector member 174 from the second position to the third position. In particular, moving the second plunger 242 away from the first container outlet 118 causes the second elongated portion 181 of the second sleeve connector member 174 to contact the angled surface of the second cap 126. The angled surface is angled outward from the center of the second cap lumen 134. Thus, further movement of the second plunger 242 away from the first container outlet 118 bends the second sleeve connector member 174 outwardly as a result of interaction with the angled surface of the second cap 126. This, in turn, releases the second plunger 242 from the plunger sleeve 150. In other words, longitudinal movement of the intermediate second plunger portion 248 away from the first container outlet 118 moves the second sleeve connector member 174 from the second position to the first position.

[0245] 10A-11B illustrate the tissue removal device 100 in a fourth state. The fourth state is an end state. The fourth state is the state to which the tissue removal device 100 is moved during use. A user moves the second plunger 242 away from the first container outlet 118 to move the tissue removal device 100 from the third state to the fourth state. In the fourth state, one or more of the components of the tissue removal device 100 are in their respective fourth state positions. Movement of the second plunger 242 away from the first container outlet 118 withdraws the second plunger 242 and the plunger 190 from the second opening 132 of the second cap 126. This separates the second plunger 242 and the plunger 190 from the container 102. The plunger sleeve 150 abuts the second cap 126 and thus remains within the container 102.

[0246] When the tissue removal device 100 is in the fourth state, the plunger 190 may be said to be in a third position. This may be the third position of the plunger 190. The third position may be referred to as the outer position of the plunger 190.

[0247] When the tissue removal device 100 is in the fourth state, the second plunger 242 may be said to be in a fourth position. This may be the fourth position of the second plunger 242. The fourth position may be referred to as the outer position of the second plunger 242.

[0248] After separating plunger 190 and second plunger 242 from container 102, first cap 116 and second cap 126 may be removed. The first container cap may be connected to first container body end portion 106 and may close first container body opening 110. The second container cap may be connected to second container body end portion 108 and may close second container body opening 112 and may retain fluid within container 102.

[0249] In some embodiments, the first cap 116 and the second cap 126 are plugged rather than being removed and replaced with another set of caps. That is, a first plug may be connected to the first cap 116 to block the first container outlet 118. Similarly, a second plug may be connected to the second cap 126 to block the second container outlet 128.

[0250] 12A-15B illustrate another embodiment of a tissue removal device 1000, according to some embodiments.

[0251] 2A-11B, the dissection element is attached to the plunger, whereas in the embodiment of FIGS. 12A-15B, the dissection element 1108 is attached to the container 1002. Specifically, the dissection element 1108 is attached to the first cap 1016 of the container 1002. The dissection element 1108 extends away from the container body 1104 such that a portion of the dissection element 1108 is within the first container outlet 1018 and a portion of the dissection element 1108 is exposed outside the first container outlet 1018.

[0252] A result of this difference is that in the embodiment of the tissue removal device 1000 of Figures 12A-15B, the cutting element 1108 is not retracted into the containment volume 1044 when the plunger is pulled away from the first container outlet 1018 when moving the tissue removal device 1000 from the second state to the third state. The tissue removal device 1000 of Figures 12A-15B can otherwise be similar or the same as the tissue removal device of Figures 2A-11B.

[0253] Part 3: Further examples of the first device 1800 16A-18B illustrate a tissue removal device 1800, according to some embodiments. The tissue removal device 1800 is configured to allow removal of a portion of a patient's tissue. The tissue removal device 1800 is also configured to allow removal of a subcutaneous fluid of the patient. In some embodiments, the tissue removal device 1800 is configured to allow removal of a portion of a patient's tissue. Thus, the tissue removal device 1800 may be referred to as a tissue removal device 1800.

[0254] In some embodiments, the tissue removal device 1800 is configured to be used to enable removal and / or removal of a portion of a patient's skin. The tissue removal device 1800 may be useful and will be described primarily in the context of improving access to an abscess. Some abscesses may form relatively deep within a patient's skin, for example, within the patient's subcutaneous tissue. Targeted access to such an abscess may be difficult to use a surgical instrument, such as a scalpel. The tissue removal device 1800 is configured to enable removal of a portion of a patient's skin over a subcutaneous abscess, improving the ease with which the abscess can be accessed, for example for drainage.

[0255] However, it should be understood that tissue removal device 1800 may have utility in improving access to any subcutaneous area or any subcutaneous fluid collection, which may contain liquid and / or gas. In the context of abscess drainage, "fluid collection" refers to the collection of pus, liquefied tissue, and any other associated fluids that are retained within the confines of the abscess wall.

[0256] The tissue removal device 1800 comprises a container 1802. The container 1802 may, in one or more embodiments, be similar or the same as one or more of the containers described herein. The container 1802 comprises a container body 1804. The container body 1804 extends in a container longitudinal direction 1805. The container body 1804 comprises a first container body end portion 1806. The container body 1804 comprises a second container body end portion 1808. The container body 1804 comprises an intermediate container body portion 1807. The intermediate container body portion 1807 is between the first container body end portion 1806 and the second container body end portion 1808.

[0257] The container body 1804 defines a first container body opening 1810. The first container body opening 1810 is disposed at the first container body end portion 1806. The container body 1804 defines a second container body opening 1812. The second container body opening 1812 is disposed at the second container body end portion 1808.

[0258] The container body lumen 1814 extends between the first container body opening 1810 and the second container body opening 1812. In other words, the container body 1804 defines the container body lumen 1814. The container body lumen 1814 extends from the first container body end portion 1806 to the second container body end portion 1808. The container body lumen 1814 is generally cylindrical. That is, the container body lumen 1814 is a cylindrical lumen. In some embodiments, the container body lumen 1814 can have different profiles. For example, the container body lumen 1814 can have a rectangular profile, a rounded rectangular profile, or a profile corresponding to another polygon. Alternatively, the container body lumen 1814 can have an elliptical profile, or a profile corresponding to another curved shape. One or more features of the container body 1804 may protrude into the container body lumen 1814 in some areas. Thus, while generally cylindrical, some cross-sectional profiles of the container body lumen 1814 may include protrusions that result in the associated cross-sectional profile deviating from a circular profile. The container body 1804 includes a container body inner surface 1815. The container body inner surface 1815 defines the cross-sectional profile of the container body lumen 1814 along its length.

[0259] The tissue removal device 1800 includes a cap 1816. The cap 1816 is configured to connect to the container body 1804. The cap 1816 is configured to removably connect to the first container body end portion 1806. The cap 1816 includes a cap collar 1817. The cap collar 1817 defines a first container outlet 1818. In particular, the cap 1816 defines a first opening 1820 and a second opening 1822. A first cap lumen 1824 extends between the first opening 1820 and the second opening 1822. The first container outlet 1818 may correspond to the first cap lumen 1824. The cap collar 1817 extends outwardly away from the second opening 1822.

[0260] The cap 1816 comprises one or more stabilizing members. In the illustrated embodiment, the cap 1816 comprises a pair of opposing stabilizing members 1819, 1821. In particular, the cap 1816 comprises a first stabilizing member 1819 and a second stabilizing member 1821. The first stabilizing member 1819 extends radially outward relative to a longitudinal axis of the container 1802 away from a second opening 1822. The first stabilizing member 1819 may be referred to as an elongated stabilizing member. An outer surface 1823 of the first stabilizing member 1819 is configured to contact the patient's skin and stabilize the tissue removal device 1800 during use. The second stabilizing member 1821 extends radially outward relative to a longitudinal axis of the container 1802 away from the second opening 1822. The second stabilizing member 1821 may be referred to as an elongated stabilizing member. An outer surface 1825 of the second stabilizing member 1821 is configured to contact the patient's skin and stabilize the tissue removal device 1800 during use.

[0261] The container body 1804 comprises a container body connecting portion 1836. The container body connecting portion 1836 is configured to allow the cap 1816 to connect to the container body 1804. The cap 1816 comprises a cap connecting portion 1837. The cap connecting portion 1837 is configured to allow the cap 1816 to connect to the container body 1804. The container body connecting portion 1836 comprises male threads of a threaded connection. The cap connecting portion 1837 comprises female threads of a threaded connection. It will be appreciated that in some embodiments, the cap connecting portion 1837 may connect to the container body 1804 using different types of connections. For example, the cap connecting portion 1837 may connect to the container body 1804 using an interference fit connection, a snap fit connection, or another type of connection.

[0262] The container 1802 includes a container rim 1840. In particular, the container body 1804 includes a container rim 1840. The container rim 1840 extends inwardly around an inner circumference of the container body 1804. The container rim 1840 may extend around the entire inner circumference of the container body 1804.

[0263] The container 1802 defines a receiving volume 1844. The container 1802 defines a distal volume 1846. The container rim 1840 is between the receiving volume 1844 and the distal volume 1846. The receiving volume 1844 is between the first container outlet 1810 and the container rim 1840. An inner container bore 1842 fluidly connects the receiving volume 1844 and the distal volume 1846 through the container rim 1840. The first opening 1820 of the cap 1816 and the second container 1812 are fluidly connected by the receiving volume 1844, the inner container bore 1842, and the distal volume 1846.

[0264] The tissue removal device 1800 includes a cutting element 1908. The cutting element 1908 is configured to cut tissue of a patient. The cutting element 1908 can be the same as or similar to any one of the cutting elements described herein. Thus, the cutting element can include a cylindrical cutting sharp.

[0265] The cutting element 1908 includes a cutting end portion 1910. The cutting element 1908 includes the second end portion 1812. The cutting element 1908 includes a cutting end opening 1914. The cutting end opening 1914 may be referred to as a cutting element opening. The cutting element 1908 includes a second end opening 1916. The cutting element 1908 extends from the cutting end portion 1910 to the second end portion 1912 and defines a cutting lumen 1918. The cutting lumen 1918 extends between the cutting end opening 1914 and the second end opening 1916. The cutting element 1908 includes a cutting edge 1920. The cutting edge 1920 is sharpened to enable the cutting element 1908 to cut tissue as the cutting element 1908 moves toward and contacts tissue.

[0266] The dissection element 1908 is configured to connect to the container 1802. In particular, the dissection element 1908 is configured to connect to the cap 1816. The dissection element 1908 is configured to be attached to the cap collar 1817. The dissection element 1908 connects to the cap 1817 at a first opening 1820.

[0267] The tissue removal device 1800 includes a plunger 1890. The container 1802 is configured to receive at least a portion of the plunger 1890. In other words, the container 1802 is configured to accommodate at least a portion of the plunger 1890. The plunger 1890 is configured to move in a container longitudinal direction 1805.

[0268] The plunger 1890 includes a first end portion 1896. A dimension of the first end portion 1896 is greater than a dimension of the inner container bore 1842. As a result, the first end portion 1896 of the plunger 1890 does not pass through the inner container bore 1842. The plunger 1890 includes a second end portion 1898. The second end portion 1898 includes an actuating portion 1899. The plunger 1890 includes an intermediate plunger portion 1900. The intermediate plunger portion 1900 is between the first end portion 1896 and the second end portion 1898.

[0269] The plunger 1890 comprises a plunger sealing surface 1891. In some embodiments, the plunger 1890 is configured to sealingly engage the container 1802. That is, the plunger 1890 is configured to contact the container body inner surface 1815 to prevent movement of fluid through an interface between the portion of the plunger 1890 contacting the container body inner surface 1822 and the container body inner surface 1822. In other words, the plunger sealing surface 1891 is configured to seal with the container body inner surface 1822 to prevent fluid flow between the plunger sealing surface 1891 and the container body inner surface 1822.

[0270] In some embodiments, the relevant portion of the plunger 1890 comprises one or more of a polymeric material and an elastomeric material 1897. In some embodiments, the relevant portion of the plunger 1890 comprises an O-ring. That is, the plunger 1890 may comprise an O-ring groove and an O-ring configured to be disposed within the O-ring groove. The O-ring may be configured to sealingly engage with the container body inner surface 1815. Thus, the O-ring may comprise a plunger sealing surface 1891. In some embodiments, the O-ring comprises one or more of an elastomeric material, a polymeric material, a metallic material, and a ceramic material. The plunger 1890 is configured to be moved within the receiving volume 1844. In particular, the plunger 1890 is configured to be moved within the receiving volume 1844 in the container longitudinal direction 1805.

[0271] During use, the components of the tissue removal device 1800 are movable between a number of positions. Movement of one or more of the components of the removal device 1800 can cause the removal device 1800 to be moved between a number of states.

[0272] 18A illustrates a cross-sectional side view of tissue removal device 1800 in a first state. In the first state, plunger 1890 may be said to be in a first position. In the first position, plunger 1890 is closer to second container body end portion 1808 than to first container body end portion 1806.

[0273] The user moves the plunger 1890 to the first container body end portion 1806. This may be referred to as a second state of the tissue removal device 1800.

[0274] The user then moves the tissue removal device 1800 towards the patient's skin where the tissue is to be removed. The user contacts the cutting edge 1920 of the cutting element 1908 with the patient's skin while simultaneously pushing and rotating the tissue removal device 1800 so that the cutting element 1908 cuts the patient's skin. The user pushes the tissue removal device 1800 towards the patient's skin until the cap collar 1817 abuts the patient's skin. The stabilizing members 1819, 1821 may also contact the patient's skin to stabilize the tissue removal device 1800.

[0275] In some examples, the stabilizing portion may be 10-25 mm so as not to dig into the patient or be unwieldy. The stabilizing portion may have an oval shaped body that contacts the patient. The stabilizing portion may be formed from a material that is firm but flexible enough to conform to the skin and not be uncomfortable for the patient, such as, but not limited to, polypropylene. The diameter of the container bore may be, for example, 10-15 mm. In some examples, the container may have a length of 4 cm to 8 cm to accommodate the removed tissue as well as the pus and material drained from the abscess.

[0276] When the plunger sealing surface 1891 sealingly engages the container body inner surface 1815, a seal is formed between the patient's skin, the end of the cap collar 1817, and the plunger 1890. The suction pressure is a negative pressure. The suction pressure draws the tissue cut by the cutting element 1908 (and in some embodiments, fluid from an associated abscess) into the containment volume 1844.

[0277] The user may cap the container 1802 as described herein.

[0278] Device 1800 may be modified to have tissue engaging components similar to those described in parts 1 and 2. The device in part 2 may be modified to have stabilizing portions as described above for device 1800.

[0279] Part 4: Example of a second device 2200 19 illustrates an exploded perspective view of a second device that may be used as a percutaneous drainage device 2200, according to some embodiments. Specifically, as described above with reference to FIGS. 1F-1I, the second device may be used to drain a deeper subcutaneous skin abscess after the first device has been used to excise at least a portion, but not necessarily all, of the dermis layer above the skin plug and subcutaneous abscess formed from the epidermis layer.

[0280] Thus, the percutaneous drainage device 2200 is applied to the drainage of subcutaneous fluid collections from a patient. The percutaneous drainage device 2200 is useful and will be primarily described in the context of draining abscesses. However, it should be understood that the percutaneous drainage device 2200 of the present disclosure has utility in gaining access to and draining any subcutaneous fluid collection, which may be liquid and / or gas.

[0281] The percutaneous drainage device 2200 comprises a cannula 2202. The cannula defines a cannula lumen through which pus and other fluids or contents, or subcutaneous skin abscesses, may be drained. The cannula lumen should have a diameter large enough that viscous fluids do not easily block the cannula. In some examples, the cannula lumen may have a diameter of 3 mm to 4 mm. The cannula 2202 comprises a first cannula end portion 2203. The first cannula end portion 2203 may be referred to as a lower cannula end portion (or a lower end portion of the cannula 2202). The first cannula end portion 2203 may be referred to as a proximal cannula end portion (or a proximal end portion of the cannula 2202). The cannula 2202 comprises a second cannula end portion 2205. The second cannula end portion 2205 may be referred to as the upper cannula end portion (or the upper end portion of the cannula 2202). The second cannula end portion 2205 may be referred to as the distal cannula end portion (or the distal end portion of the cannula 2202). The second cannula end portion 2205 may be referred to as the upper cannula end portion because, in use, the second cannula end portion 2205 is higher relative to the subcutaneous fluid pool than the first cannula end portion 2203. The second cannula end portion 2205 may be referred to as the distal cannula end portion because, in use, the second cannula end portion 2205 is distal to the subcutaneous fluid pool compared to the first cannula end portion 2203. The cannula 2202 comprises an intermediate cannula portion 2207. The intermediate cannula portion 2207 is between the first cannula end portion 2203 and the second cannula end portion 2205 .

[0282] The cannula 2202 defines a first cannula opening 2204. The first cannula opening 2204 may be referred to as a proximal cannula opening because, in use, the first cannula opening 2204 is proximal to the subcutaneous fluid collection. The cannula 2202 defines a second cannula opening 2206. The second cannula opening 2206 may be referred to as a distal cannula opening because, in use, the second cannula opening 2206 is distal to the subcutaneous fluid collection as compared to the first cannula opening 2204.

[0283] A cannula lumen 2208 extends between the first cannula opening 2204 and the second cannula opening 2206. In other words, the cannula 2202 defines a cannula lumen 2208. The cannula lumen 2208 extends from the first cannula end portion 2203 to the second cannula end portion 2205. The cannula lumen 2208 is generally cylindrical. In some embodiments, the cannula lumen 2208 may have a different profile. For example, the cannula lumen 2208 may have a rectangular profile, a rounded rectangular profile, or a profile corresponding to another polygon. Alternatively, the cannula lumen 2208 may have an elliptical profile, or a profile corresponding to another curved shape. The cannula 2202 includes a cannula inner surface 2210. The cannula inner surface 2210 defines the cross-sectional profile of the cannula lumen 2208 along its length. The cannula inner surface 2210 may be referred to as the inner surface of the cannula 2202.

[0284] Cannula 2202 includes a cannula flange 2240. Cannula flange 2240 defines a second cannula opening 2206. Second cannula end portion 2205 includes a cannula flange 2240. Cannula 2202 includes a recess 2242. In particular, cannula flange 2240 includes a recess 2242. Recess 2242 may be referred to as a cannula recess. In the illustrated embodiment, cannula flange 2240 includes a plurality of recesses 2242.

[0285] The cannula 2202 defines a cannula thread 2246. That is, at least a portion of an outer surface 2248 of the cannula 2202 may be threaded to provide the cannula thread 2246. The cannula thread 2246 may be referred to as a threaded surface. In the embodiment shown in the figures, a majority of the outer surface 2248 of the cannula 2202 is threaded. The cannula thread 2246 may assist in penetrating and driving the percutaneous drainage device 2200 into patient tissue.

[0286] The percutaneous drainage device 2200 comprises a penetrating component 2212. The penetrating component 2212 comprises a first penetrating component end portion 2214. The first penetrating component end portion 2214 may be referred to as a lower penetrating component end portion (or a lower end portion of the penetrating component 2212). The first penetrating component end portion 2214 may be referred to as a proximal penetrating component end portion (or a proximal end portion of the penetrating component 2212). The penetrating component 2212 comprises a second penetrating component end portion 2216. The second penetrating component end portion 2216 may be referred to as an upper penetrating component end portion (or an upper end portion of the penetrating component 2212). The second penetrating component end portion 2216 may be referred to as a distal penetrating component end portion (or a distal end portion of the penetrating component 2212). The penetrating component 2212 comprises an intermediate penetrating component portion 2218. The intermediate cannula portion 2218 is between the first penetrating component end portion 2214 and the second penetrating component end portion 2216 .

[0287] The penetrating component 2212 defines a first penetrating component opening 2220. The first penetrating component opening 2220 may be referred to as a proximal penetrating component opening. The penetrating component 2212 defines a second penetrating component opening 2222. The second penetrating component opening 2222 may be referred to as a distal penetrating component opening.

[0288] The penetrating component lumen 2224 extends between the first penetrating component opening 2220 and the second penetrating component opening 2222. In other words, the penetrating component 2212 defines the penetrating component lumen 2224. The penetrating component lumen 2224 extends from the first penetrating component end portion 2214 to the second penetrating component end portion 2216. The penetrating component lumen 2224 is generally cylindrical. In some embodiments, the penetrating component lumen 2224 may have a different profile. For example, the penetrating component lumen 2224 may have a rectangular profile, a rounded rectangular profile, or a profile corresponding to another polygon. Alternatively, the penetrating component lumen 2224 may have an elliptical profile, or a profile corresponding to another curved shape. The penetrating component 2212 includes a penetrating component inner surface 2226. The penetrating component inner surface 2226 defines a cross-sectional profile of the penetrating component lumen 2224 along its length. The penetrating component inner surface 2226 may be referred to as the inner surface of the penetrating component 2212. The penetrating component lumen 2224 is configured to receive a guidewire 2228.

[0289] The penetrating component 2212 includes a penetrating portion 2230. The penetrating portion 2230 is configured to penetrate tissue of a patient, thereby allowing the first cannula opening 2204 to be introduced into a subcutaneous fluid collection site. The penetrating portion 2230 includes threads 2232. The threads 2232 are tapered toward a penetrating end 2234 of the penetrating component 2212. The threads 2232 allow a user to pierce and drive the penetrating component 2212 into the patient's body as it rotates about its longitudinal axis, as described herein.

[0290] The penetrating component 2212 includes a shaft 2236. The shaft 2236 is an elongated shaft.

[0291] The penetrating component 2232 includes a gripping portion 2238. The gripping portion 2238 is configured to be gripped by a user. The gripping portion 2238 may be referred to as a handle. The gripping portion 2238 defines the second penetrating component opening 2222. The shaft 2236 is between the penetrating portion 2230 and the gripping portion 2238.

[0292] The penetrating component lumen 2224 comprises a first portion 2225 and a second portion 2227. The penetrating portion 2230 and the shaft 2236 define the first portion 2225. The gripping portion 2238 defines the second portion 2227. A cross-sectional area of ​​the second portion 2227 is greater than a cross-sectional area of ​​the first portion 2225. In other words, a cross-sectional area of ​​the penetrating component lumen 2224 defined by the gripping portion 2238 is greater than a cross-sectional area of ​​the penetrating component lumen 2224 defined by the penetrating portion 2230 and the shaft 2236. As a result, the second penetrating component opening 2222 is greater than the first penetrating component opening 2220.

[0293] In some embodiments, the piercing portion 2230 may be referred to as a piercing portion because, in some embodiments, the piercing portion 2230 is configured to pierce the skin of a patient.

[0294] The piercing component 2212 includes a protruding feature 2244. The protruding feature 2244 protrudes from the gripping portion 2238 of the piercing component 2212 toward the piercing portion 2230.

[0295] The penetrating component 2212 is configured to be received by the cannula 2202. The recesses 2242 of the cannula 2202 are configured to receive the protrusion features 2244 when the penetrating component 2212 is received within the cannula 2202, thereby preventing rotation of the cannula 2202 relative to the penetrating component 2212. The penetrating component 2212 includes a protrusion feature 2244 for each recess of the cannula 2202.

[0296] The penetrating component 2212 is configured to be slidably received within the cannula 2202. The penetrating component 2212 is movable between a first position and a second position. When in the first position, the penetrating component 2212 is received by the cannula 2202 concentric with the shaft 2236 of the penetrating component 2212. In the first position, the penetrating component 2212 extends through the first cannula opening 2204 and the second cannula opening 2206 (e.g., as shown in FIG. 20 ). When in the second position, the penetrating component 2212 is retracted from and separated from the cannula 2202. In the first position, the penetrating component 2212 may be located substantially within the cannula lumen 2208. The penetrating component 2212 may be prevented from rotating within the cannula lumen 2208 by the interaction between the recess 2242 and the protrusion feature 2244. The penetrating component 2212 may have a close tolerance with the cannula lumen 2208 .

[0297] The percutaneous drainage device 2200 includes a penetrating component cap 2250. The penetrating component cap 2250 is configured to removably engage the penetrating component 2212. In particular, the penetrating component cap 2250 is configured to removably engage the second penetrating component end portion 2216. The penetrating component cap 2250 allows for selective occlusion of the second penetrating component opening 2222.

[0298] 21 , the penetrating component cap 2250 is movable between a first position in which the second penetrating component opening 2222 is blocked and a second position in which the second penetrating component opening 2222 is unblocked. The penetrating component cap 2250 can be rotated about the flexible joint 2252 to be moved between the first and second positions. The penetrating component cap 2250 can connect to the penetrating component 2212 when in the first position via an interference fit, a snap fit, or another type of connection.

[0299] The percutaneous drainage device 2200 includes a collar 2254. The collar 2254 is configured to removably engage the cannula 2202. The collar 2254 is configured to be movable longitudinally of the cannula 2202 when engaged with the cannula 2202. The collar 2254 defines a first collar opening 2256. The first collar opening 2256 may be referred to as a proximal collar opening. The collar 2254 defines a second collar opening 2258. The second collar opening 2258 may be referred to as a distal collar opening.

[0300] The collar lumen 2260 extends between the first collar opening 2256 and the second collar opening 2258. In other words, the collar 2254 defines the collar lumen 2260. The collar lumen 2260 extends from the first collar opening 2256 to the second collar opening 2258. The collar lumen 2260 is generally cylindrical. In some embodiments, the collar lumen 2260 can have different profiles. For example, the collar lumen 2260 can have a rectangular profile, a rounded rectangular profile, or a profile corresponding to another polygon. Alternatively, the collar lumen 2260 can have an elliptical profile, or a profile corresponding to another curved shape. The collar 2254 includes a collar inner surface 2262. The collar inner surface 2262 defines a cross-sectional profile of the collar lumen 2260 along its length. The collar inner surface 2262 may be referred to as the inner surface of the collar 2254 .

[0301] As described herein, the cannula 2202 defines a cannula thread 2246. The cannula thread 2246 is male threaded. The collar 2254 defines a collar thread 2264. The collar thread 2264 is female threaded. That is, at least a portion of the collar inner surface 2262 may be threaded, providing the collar thread 2264. The collar thread 2264 may be referred to as a threaded surface. In the embodiment shown in the figures, a majority of the collar inner surface 2262 is threaded.

[0302] Collar threads 2264 are configured to cooperate with cannula threads 2246 to permit relative movement between collar 2254 and cannula 2202. When collar lumen 2260 is aligned with cannula 2202 (i.e., the longitudinal axis of cannula lumen 2208 is coaxial with the longitudinal axis of collar lumen 2260) and collar 2254 is contacted with first cannula end portion 2203, rotation of collar 2254 relative to cannula 2202 can cause the collar to engage cannula 2202. Specifically, collar threads 2264 engage cannula threads 2246 to permit longitudinal movement of collar 2254 relative to cannula 2202. That is, rotation of collar 2254 relative to cannula 2202 causes movement of collar 2254 in the longitudinal direction of cannula 2202. Because the collar threads 2254 contact the cannula threads 2246 , movement of the collar 2254 in the longitudinal direction of the cannula 2202 is prevented without rotation of the collar 2254 relative to the cannula 2202 .

[0303] The collar 2254 defines a peripheral hole 2266. In particular, the collar 2254 defines a plurality of peripheral holes 2266. In some embodiments, the peripheral holes 2266 can be used by a user to sew the collar to the patient's skin.

[0304] The collar 2254 includes an inner channel wall 2268. The inner channel wall 2268 is configured to contact the cannula 2202 when the collar 2254 is engaged with the cannula 2202. The collar 2254 includes an outer channel wall 2270. The collar 2254 defines a channel 2272. In particular, the collar 2254 defines the channel 2272 between the inner channel wall 2268 and the outer channel wall 2270. The channel 2272 is an annular channel. The channel 2272 extends around at least a portion of the collar lumen 2260. The inner channel wall 2268 extends further away from the first collar opening 2256 than the outer channel wall 2270. In other words, the height of the inner channel wall 2268 is greater than the height of the outer channel wall 2270.

[0305] The percutaneous drainage device 2200 includes a cap 2274. The cap 2274 defines a first cap opening 2276. The first cap opening 2276 may be referred to as a proximal cap opening. The cap 2274 defines a second cap opening 2278. The second cap opening 2278 may be referred to as a distal cap opening.

[0306] The cap lumen 2280 extends between the first cap opening 2276 and the second cap opening 2278. In other words, the cap 2274 defines the cap lumen 2280. The cap lumen 2280 extends from the first cap opening 2276 to the second cap opening 2278. The cap lumen 2280 is generally cylindrical. In some embodiments, the cap lumen 2280 may have a different profile. For example, the cap lumen 2280 may have a rectangular profile, a rounded rectangular profile, or a profile corresponding to another polygon. Alternatively, the cap lumen 2280 may have an elliptical profile, or a profile corresponding to another curved shape. The cap 2274 includes a cap inner surface 2282. The cap inner surface 2282 defines a cross-sectional profile of the cap lumen 2280 along its length. Cap inner surface 2282 may be referred to as the inner surface of cap 2274. Cap lumen 2280 is configured to receive cannula 2202 and piercing component 2212, as described herein.

[0307] Cap lumen 2280 includes a first tapered portion 2284. First tapered portion 2284 extends from first cap opening 2276 toward second cap opening 2278. A cross-sectional area of ​​first tapered portion 2284 decreases as first tapered portion 2284 extends from first cap opening 2276 toward second cap opening 2278.

[0308] The cap lumen 2280 includes a guide portion 2286. The guide portion 2286 extends from the first tapered portion 2284 toward the second cap opening 2278. The cross-sectional area of ​​the guide portion 2286 may be constant.

[0309] The cap lumen 2280 includes a second tapered portion 2288. The second tapered portion 2288 extends from the guide portion 2286 toward the second cap opening 2278. The cross-sectional area of ​​the second tapered portion 2288 increases as the second tapered portion 2288 extends from the guide portion 2286 toward the second cap opening 2278 (i.e., away from the first cap opening 2276). The guide portion 2286 is between the first tapered portion 2284 and the second tapered portion 2288.

[0310] The cap lumen 2280 includes a third tapered portion 2290. The third tapered portion 2290 extends from the second tapered portion 2288 toward the second cap opening 2278. The cross-sectional area of ​​the third tapered portion 2290 increases as the second tapered portion 2288 extends from the second tapered portion 2288 toward the second cap opening 2278 (i.e., away from the first cap opening 2276).

[0311] The cap 2274 includes a cap groove 2292. The cap groove 2292 extends from the first cap opening 2276 to the second cap opening 2278. The cap groove 2292 is configured to allow passage of the guidewire 2228 from the cap lumen 2280 to the outside of the cap 2274. In other words, the thickness of the cap groove 2292 is greater than the thickness of the guidewire 2228. The cap groove 2292 may be referred to as a longitudinal groove.

[0312] The percutaneous drainage device 2200 comprises a connecting component 2294. The connecting component 2294 comprises a collar engagement portion 2296. The collar engagement portion 2296 is configured to releasably engage with the collar 2254. The collar engagement portion 2296 defines a collar engagement portion opening 2300. The collar engagement portion opening 2300 is configured to allow passage of the piercing component 2212. The collar engagement portion opening 2300 is configured to allow passage of the cannula 2202. In other words, a dimension (e.g., diameter) of the collar engagement portion opening 2300 is greater than the corresponding dimensions (e.g., diameter) of the piercing component 2212 and the cannula 2202. The collar engagement portion 2296 comprises a collar engagement protrusion 2302. The collar engagement protrusion 2302 is configured to be received by the collar 2254 and to inhibit relative movement between the collar 2254 and the collar engagement portion 2296. The collar engagement protrusion 2302 is an annular protrusion. The collar engagement protrusion 2302 is configured to be received by the channel 2272 of the collar 2254.

[0313] In some embodiments, the collar engagement portion 2296 includes a locating protrusion (not shown) that can be configured to be received by one of the peripheral holes 2266 of the collar 2254 to prevent rotation of the collar engagement portion 2296 relative to the collar 2254.

[0314] The connecting component 2294 includes an extension portion 2298. The extension portion 2298 extends radially from the collar engagement portion 2296. The extension portion 2298 is configured to connect to tissue (e.g., skin) of a patient. The extension portion 2298 includes an adhesive portion 2304. The adhesive portion 2304 is configured to adhere to the patient. In particular, the adhesive portion 2304 is configured to adhere to the skin of the patient.

[0315] 21 illustrates the sequence of steps for use of a percutaneous drainage device 2200. It will be appreciated that the sequence of steps may vary depending on the preferences of the clinician.

[0316] A subcutaneous fluid collection site (e.g., an abscess) or other fluid collection present within a patient is first located by a clinician. After administering a local anesthetic around the fluid collection site, a guidewire 2228 is directed toward the fluid collection site. The guidewire 228 may be positioned using the Seldinger technique.

[0317] The clinician can assemble the percutaneous drainage device 2200. That is, the clinician can place the percutaneous drainage device 2200 in an assembled state. In the assembled state, the collar 2254 is engaged with the cannula 2202. Specifically, the collar 2254 is engaged with the cannula threads 2246 such that the inner channel wall 2268 contacts the cannula threads 2246 and the cannula flange 2240. In other words, the collar 2254 is threaded the length of the cannula 2202 up to the cannula flange 2240. The penetrating component 2212 is received by the cannula 2202. Specifically, the penetrating component 2212 is received by the cannula 2202 through the second cannula opening 2206 such that the penetrating portion 2230 extends out of the first cannula opening 2204 and beyond the cannula 2202. The penetrating component cap 2250 may be opened, thereby opening the second penetrating component opening 2222. The assembled cannula 2202 and a portion of the penetrating component 2212 are received within the cap 2274. The first tapered portion 2284 of the cap 2274 is exposed and ready to receive an end of the guidewire 2228 and guide the guidewire 2228 through the penetrating component lumen 2224. In this state, the first penetrating component opening 2220 is aligned with the guide portion 2286 of the cap lumen 2280. In other words, the first penetrating component opening 2220 is aligned with the guide portion 2286 of the cap lumen 2280 when the penetrating component 2212 is received within the cap 2274.

[0318] A clinician may guide a guidewire 2228 from the first cap opening 2276 through the cap lumen 2280 and through the penetrating component lumen 2224 from the first penetrating component opening 2220 to the second penetrating component opening 2222.

[0319] The clinician may remove the cap 2274. Specifically, the clinician may remove the cannula 2202 and the penetrating component 2212 from the cap 2274, and then remove the cap 2274 from the guidewire 2228 by passing the guidewire 2228 through the cap groove 2292.

[0320] The clinician can then begin to drive the percutaneous drainage device 2200 into tissue. Specifically, the clinician can contact the penetrating portion 2230 with the patient's tissue, apply force longitudinally of the penetrating component 2212 toward the tissue, and rotate the gripping portion 2238. The cannula 2202 rotates with the rotation of the gripping portion 2238 due to cooperation of the recessed portion 2242 and the protruding feature 2244.

[0321] A user may be assisted in driving and positioning the percutaneous drainage device 2200 into a patient by imaging guidance, such as ultrasound or fluoroscopy. The threads 2232 of the penetrating component 2212 assist in the driving function of the percutaneous drainage device 2200, converting torsional energy into linear motion. Advantageously, this may provide greater positional control while reducing the need for downward force on the tissue. As the penetrating component 2212 is driven into tissue, the threads 2232 gently stretch the skin tissue over the cannula 2202, which may help reduce site morbidity. The threads on the surface of the cannula 2202 may also assist in driving the percutaneous drainage device 2200 further into the tissue and toward the target fluid collection site.

[0322] The clinician can determine that the first cannula opening 2204 has reached the target fluid collection site through imaging guidance. Once the first cannula opening 2204 has reached the abscess or target fluid collection site, the clinician can grasp the gripping portion 2238 of the penetrating component 2212 and pull it away from the patient's body to retract the penetrating component 2212 and remove it from the cannula 2202 through the second cannula opening 2206. The clinician can further confirm that the first cannula opening 2204 is properly positioned at the target fluid collection site by visually observing the presence of pus or other fluid upon retraction of the penetrating component 2212. The close tolerance between the penetrating component 2212 and the cannula 2202 can create a negative pressure during retraction of the penetrating component 2212 from the cannula 2202 to initiate the suction and flow of fluid collection from the abscess into the cannula lumen 2208. The cannula 2202 provides a withdrawal path through which the fluid contents of the target collection site may be drained from the patient's body.

[0323] At this point, collar 2254 can be moved longitudinally relative to cannula 2202 by rotating collar 2254 in the appropriate direction relative to cannula 2202. Collar 2254 can be moved toward the patient's skin so as to contact the patient's skin, thereby helping to hold cannula 2202 in the proper position.

[0324] The length of the cannula 2202 can be trimmed as needed. The cannula 2202 can be cut to size using a bladed instrument. The cannula 2202 can be trimmed so that the upper end of the cannula is flush with the upper surface of the collar 2254. Alternatively, a relatively short length of the cannula 2202 can extend above the upper surface of the collar 2254. The cannula 2202 is flexible.

[0325] The clinician may then connect the connection component 2294. The clinician may align the collar engagement protrusion 2302 with the channel 2272 of the collar 2254 and contact the connection component 2294 with the collar 2254 such that the collar engagement protrusion 2302 is received by the channel 2272. The clinician may adhere the connection component 2294 to the patient's skin using the adhesive portion 2304. In this manner, the cannula 2202 is secured to the patient's skin.

[0326] Once it is determined that the fluid collection has been sufficiently drained, the cannula 2202 may be removed from the patient. All components of the percutaneous drainage device 2200 may be discarded after use.

[0327] The percutaneous drainage device 2200 of the present disclosure, when placed percutaneously substantially as described above, advantageously provides channels and passageways for the drainage of a dense complex collection containing any combination of pus, debris, and necrotic tissue from within a subcutaneous abscess.

[0328] The percutaneous drainage device 2200 of the present disclosure conveniently provides all of the components necessary to present a minimally invasive therapy that can be used to treat an abscess or another fluid collection. The cannula 2202 can be positioned with precision using the guidewire 2228, allowing a clinician using the percutaneous drainage device 2200 to quickly and easily drain an abscess or other similar subcutaneous fluid collection in an environment that does not require hospitalization. Thus, the percutaneous drainage device 2200 of the present disclosure advantageously shifts the treatment of abscesses and other subcutaneous fluid collections from high-cost environments requiring hospitalization, operative time, and associated patient risks to a relatively low-cost outpatient procedure with reduced clinical care time and associated patient risks.

[0329] Alternative Percutaneous Drainage Device Embodiments Although the percutaneous drainage device 2200 is described herein as being used with a guidewire 2228, it will be appreciated that guidewires are not universally available and the percutaneous drainage device 2200 may be used without a guidewire. Thus, in some embodiments, the penetrating component 2212 does not include a penetrating component lumen 2224.

[0330] Fluid Collection and Drainage System A fluid accumulation and drainage system may be provided by the present disclosure. In particular, the fluid accumulation and drainage system may include any one of the tissue removal devices 100, 300, 600, 800, 1000, 1200, 1400, 1600, 1800 and / or 2000 described, as well as the percutaneous drainage device 2200 described herein.

[0331] There are several advantages to using one of the described tissue removal devices with the described percutaneous drainage device 2200. As described herein, the tissue removal device allows for the removal of tissue (e.g., skin) above the fluid collection. Some fluid collection may be deep within the patient. The described tissue removal device allows for the removal of the tougher layer of the patient's skin above the abscess. The percutaneous drainage device 2200 then allows the user to direct the described cannula 2202 through the deeper layer of skin to the abscess cavity. The described tissue removal device allows for the provision of a hole that is the smallest optimal size for the cannula 2202. That is, the hole is large enough to be able to receive the cannula 2202, but small enough that there is minimal excess size after receiving the cannula 2202, helping to minimize disfigurement and scarring for the patient. Additionally, the size of the hole is optimized to prevent the hole from healing too quickly (i.e., before the abscess is drained).

[0332] In some cases, it may be difficult to accurately position the cannula 2202 within the fluid reservoir, or it may be difficult to drive the percutaneous drainage device 2200 accurately and to a large enough depth through the patient's skin. In at least these cases, one of the described tissue removal devices can be used to remove tissue above the fluid reservoir before using the percutaneous drainage device 2200. This can reduce the amount of tissue that needs to be driven through the percutaneous drainage device 2200, increase the ease with which the fluid reservoir can be accessed, and reduce the likelihood that the percutaneous drainage device 2200 will be driven into the patient in an incorrect or non-optimized orientation.

[0333] A first device as described in Part 2 or Part 3 may be provided together with a second device as described in Part 4 as a set or system for treating a subcutaneous skin abscess. In some cases, the first and second devices may be provided together with a guidewire.

[0334] Two possible variations of the first device are now described. While the first device of parts 1 and 2 has been described as having a tissue engaging component shaped like a hypodermic syringe with a shaft, a piercing portion, and a barb, in the first variation, the tissue engaging component may comprise, instead of a shaft, a piercing portion, and a barb, a pair of jaws or tongues that grip the skin plug after it has been cut by the cutting element. The jaws may have sharp pointed distal ends for penetrating the tissue and may have one or more teeth for gripping the tissue.

[0335] In a second variation, instead of a shaft, a piercing portion, and a barb, the tissue engaging component may instead take the form of a cylindrical component having one or more shark teeth. The cylindrical component may define a lumen and may include one or more apertures and tapered protrusions (or shark teeth) adjacent each aperture, the tapered protrusions projecting radially inward into the lumen and pointing rearward away from the distal end of the cutting element toward the proximal end of the tissue engaging component. The tapered protrusions may thus act to engage and hold the skin plug incised by the cutting element, such that when the tissue engaging component is retracted into the receptacle, the skin plug incised by the cutting element is pulled back into the receptacle. The shark teeth may act as barbs to engage and pull the skin plug back into the receptacle. In other respects, the first device according to these variations may be similar or the same as the devices described above in the first and second parts of the description.

[0336] An example of the shark tooth variation of the first device is shown in Figures 24A-24F. The device comprises a container 2002, a cutting element 2108, which may be a cylindrical blade, a tissue engaging component 2122, and a plunger 2090 received within the container and movable longitudinally along the length of the container. The plunger 2090 may be coupled to the cutting element and / or the tissue engaging component to allow them to be retracted into the container.

[0337] The tissue engaging component 2122 comprises a tapered protrusion 2157. In particular, the tissue engaging component 2122 comprises a plurality of tapered protrusions 2157. One or more of the tapered protrusions 2157 are configured to engage with incised tissue. The tissue engaging component 2122 comprises one or more of the tapered protrusions 2157 that taper from a base 2159 to a point 2161. One or more of the tapered protrusions 2157 protrude into the tissue engaging component lumen 2138. That is, one or more of the tapered protrusions 2157 protrude radially inward. One or more of the tapered protrusions 2157 protrude radially inward toward a central axis of the tissue engaging component 2112.

[0338] The tissue engaging component 2112 comprises a tissue engaging opening 2163. In particular, the tissue engaging component 2122 comprises a plurality of tissue engaging openings 2163. One or more of the tissue engaging openings 2163 are formed in a wall of the tissue engaging component 2112. One or more of the tissue engaging openings 2163 extend through a wall of the tissue engaging component 2112. One or more of the tissue engaging openings 2163 are fluidly connected to the tissue engaging component lumen 2138. In some embodiments, a profile of one or more of the tissue engaging openings 2163 corresponds to a profile of the tapered protrusion 2157. That is, the outer profile of the associated tapered protrusion 2157 is the same as the peripheral profile of the associated tissue engaging opening 2163. The tissue engaging component 2122 and the dissection element 2108 may be separate components. That is, the tissue engaging component 2122 and the dissection element 2108 may be independently connectable to the plunger 2090. The plunger may form a sealing component that seals with the interior chamber of the container to create a negative pressure or vacuum when the plunger and tissue engaging component are retracted, causing suction and initiating the flow of fluid, pus or abscess contents into the container.

[0339] In some variations, the tissue engaging component may be integrated with the cutting element as one piece, for example, the cutting element may be cylindrical and define a cutting lumen between the skin-cutting distal edge of the cutting element and the second or proximal edge of the cutting element. The cutting element may have a plurality of shark teeth as described above (apertures and tapered projections pointing radially inward toward the proximal end). The tapered projections hook and pull tissue as the cutting element is retracted to pull the skin plug back into the receptacle. In other respects, the first device according to these variations may be similar or the same as the devices described above in parts one and two of the description.

[0340] All of the features of the various embodiments disclosed in this specification (including any of the accompanying claims, abstract, and drawings) may be combined in any combination, except combinations in which at least some of such features are mutually exclusive.

[0341] It will be appreciated by those skilled in the art that numerous variations and / or modifications may be made to the above-described embodiments without departing from the broad general scope of the present disclosure, and the present embodiments are therefore to be considered in all respects as illustrative and not restrictive.

Claims

1. 1. A device for removing tissue over a subcutaneous skin abscess, comprising: A hypodermic syringe-shaped tissue engaging component comprising: A shaft, a piercing portion at a distal end of the shaft; a hypodermic syringe-shaped tissue engaging component comprising a barb positioned on the shaft behind the piercing portion; a container configured to house at least a portion of the tissue engaging component; a cutting element comprising a cylindrical cutting sharp configured to cut open the patient's skin surface and sever the skin plug from the patient's epidermis and dermal tissue; the barbs of the tissue engaging component are configured to engage the skin plug cut by the cutting element and penetrated by the piercing portion, such that movement of the tissue engaging component into a receiving volume of the container causes movement of at least a portion of the skin plug cut by the cutting element into the receiving volume; a device wherein the cylindrical cutting sharp defines a cutting lumen, the tissue engaging component extends within the cutting lumen of the cylindrical cutting sharp, and there is a gap between the shaft of the tissue engaging component and an inner diameter of the cylindrical cutting sharp.

2. The device of claim 1, wherein the gap between the shaft of the tissue engaging component and the inner diameter of the cylindrical cutting sharp is between 1 mm and 3 mm.

3. 3. The device of claim 1 or 2, wherein the tissue engaging component protrudes through the incision lumen such that a portion of the tissue engaging component is exposed beyond the incision lumen, whereby the penetrating portion is configured to penetrate the patient's skin and tissue prior to incising the skin plug with the incision element.

4. a plunger configured to move longitudinally of the container; the container is configured to accommodate at least a portion of the plunger; The device of claim 1 , wherein movement of the plunger causes movement of the tissue engaging component.

5. 5. The device of claim 4, wherein the plunger is associated with a sealing member, and movement of the plunger to retract the tissue engaging component into the container causes retraction of the sealing member, creating a negative pressure or vacuum within the container so as to draw subcutaneous fluid or other contents into the container.

6. movement of the plunger causes movement of the cutting element; The device of claim 4 or 5, wherein the tissue engaging component and the dissecting element are connected to the plunger.

7. The plunger a first position in which at least a portion of the tissue engaging component and at least a portion of the dissection element are exposed; A device according to claim 4, wherein the device is configured to be moved between a first position and a second position in which the tissue engaging component and the dissection element are contained within the containment volume of the container.

8. the tissue engaging component defines a tissue engaging component lumen extending between a first tissue engaging component opening and a second tissue engaging component opening; The device of claim 1 , wherein the tissue engaging component defines a barb opening fluidly connected to the tissue engaging component lumen.

9. the container defines the receiving volume and a distal volume; the container comprising a container rim extending radially inwardly of the container and defining an inner container bore; the container rim is between the receiving volume and the distal volume; The device of claim 1 , wherein the inner container opening fluidly connects the receiving volume and the distal volume.

10. The device of claim 4 , further comprising a locking element configured to engage the plunger and prevent movement of the plunger.

11. The device of claim 1, wherein the dissection element has a length of between 4 mm and 10 mm.

12. The device of claim 1 , wherein the dissection element has an outer diameter of 3 mm to 6 mm.

13. The device of claim 1 or claim 12, wherein the shaft of the tissue engaging component has a diameter of between 1 mm and 3 mm.

14. The device of claim 1 , wherein the tissue engaging component is centrally positioned within the lumen of the cylindrical cutting sharp.

15. 1. A percutaneous drainage device for draining a subcutaneous skin abscess, comprising: a cannula defining a cannula lumen extending between a first cannula opening and a second cannula opening; a penetrating component configured to be slidably received within the cannula, a penetrating portion configured to penetrate tissue of a patient, thereby allowing introduction of the first cannula opening into a subcutaneous fluid collection site; a penetrating component comprising a penetrating component lumen extending between a first penetrating component opening and a second penetrating component opening, the penetrating component lumen configured to receive a guidewire; The percutaneous drainage device, wherein the percutaneous drainage device further comprises a penetrating component member configured to allow selective occlusion of the second penetrating component opening.

16. the cannula includes a recess; the piercing component comprises a protrusion feature; 16. The percutaneous drainage device of claim 15, wherein the recess is configured to receive the protrusion feature when the penetrating component is received within the cannula, thereby preventing rotation of the cannula relative to the penetrating component.

17. a cap defining a cap lumen extending from a first cap opening to a second cap opening, the cap lumen configured to receive the cannula and the piercing component; 17. The percutaneous drainage device of claim 16, wherein the cap comprises a cap groove extending from the first cap opening to the second cap opening, the cap groove configured to allow passage of a guidewire from the cap lumen to an exterior of the cap.

18. releasably engages the cannula; and 17. The percutaneous drainage device of claim 16, further comprising a collar configured to be movable longitudinally of the cannula.

19. a collar engagement portion configured to releasably engage the collar; an extension portion extending radially from the collar engagement portion, the extension portion configured to connect to the tissue of the patient; the cannula defining a cannula thread; the collar includes a collar lumen configured to receive the cannula and cooperate with the cannula threads, so that: rotation of the collar relative to the cannula causes translation of the collar in the longitudinal direction of the cannula; 20. The percutaneous drainage device of claim 18, wherein movement of the collar in the longitudinal direction of the cannula is prevented without rotation of the collar relative to the cannula.

20. A percutaneous drainage device as described in claim 16, wherein the penetrating component member is a penetrating component cap.

21. A percutaneous drainage device as described in claim 20, wherein the penetrating component cap is configured to removably engage with the penetrating component and enable selective blocking of the second penetrating component opening.

Images