EXTERNAL FIXATION SYSTEM FOR PERCUTANEOUS DRAINAGE PROCEDURES

An external fixation system for percutaneous drainage procedures may include a base. The base may include a first side. The first side may be positioned adjacent an exterior surface of a subject during use. The base may include a first coupler coupled to the first side of the base. The base may include a second side opposite the first side. The base may include an opening extending through the first coupler and the base such that the first coupler is in fluid communication with the second side of the base. The first coupler may be couplable to a conduit during use such that the conduit is in fluid communication with the second side of the base. In some embodiments, the second side of the base may include a second coupler configured to facilitate the attachment of a drainage bag or a mechanism to flush or evacuate a drainage catheter during use.

The headings used herein are for organizational purposes only and are not meant to be used to limit the scope of the description. As used throughout this application, the word “may” is used in a permissive sense (i.e., meaning having the potential to), rather than the mandatory sense (i.e., meaning must). The words “include,” “including,” and “includes” indicate open-ended relationships and therefore mean including, but not limited to. Similarly, the words “have,” “having,” and “has” also indicated open-ended relationships, and thus mean having, but not limited to. The terms “first,” “second,” “third,” and so forth as used herein are used as labels for nouns that they precede, and do not imply any type of ordering (e.g., spatial, temporal, logical, etc.) unless such an ordering is otherwise explicitly indicated. For example, a “third die electrically connected to the module substrate” does not preclude scenarios in which a “fourth die electrically connected to the module substrate” is connected prior to the third die, unless otherwise specified. Similarly, a “second” feature does not require that a “first” feature be implemented prior to the “second” feature, unless otherwise specified.

It is to be understood the present invention is not limited to particular devices or biological systems, which may, of course, vary. It is also to be understood that the terminology used herein is for the purpose of describing particular embodiments only, and is not intended to be limiting. As used in this specification and the appended claims, the singular forms “a”, “an”, and “the” include singular and plural referents unless the content clearly dictates otherwise. Thus, for example, reference to “a linker” includes one or more linkers.

DETAILED DESCRIPTION

Definitions

The term “connected” as used herein generally refers to pieces which may be joined or linked together.

The term “coupled” as used herein generally refers to pieces which may be used operatively with each other, or joined or linked together, with or without one or more intervening members.

The term “directly” as used herein generally refers to one structure in physical contact with another structure, or, when used in reference to a procedure, means that one process effects another process or structure without the involvement of an intermediate step or component.

FIG. 1depicts an embodiment of external fixation system100for percutaneous drainage procedures. External fixation system100for percutaneous drainage procedures may include base110. The base may include first side120. The first side may be positioned adjacent an exterior surface of a subject during use. The base may include first coupler130coupled to first side120of base110. The base may include second side140opposite the first side. The base may include opening150extending through the first coupler and the base such that the first coupler is in fluid communication with the second side of the base. The first coupler may be couplable to conduit160during use such that the conduit is in fluid communication with the second side of the base.

In some embodiments, portions of the external fixation system may be formed from metallic and/or non-metallic materials. An external fixation system may be made of various materials including, but are not limited to, metals, metal alloys, silicon, plastic, polymers, ceramics and combinations thereof. Some external fixation system embodiments may include components made of materials that can be autoclaved and/or chemically sterilized. Some components of an external fixation system may be formed of materials unable to be autoclaved and/or chemically sterilized. Components unable to be autoclaved and/or chemically sterilized may be made of sterile materials and placed in working relation to other sterile components during assembly of an external fixation system. In some embodiments, an entire external fixation system may be made of materials that can be autoclaved and/or chemically sterilized so that the external fixation system is a reusable instrument. In other external fixation system embodiments, all or selected components of the external fixation system may be made of sterile, disposable materials so that all or components of the external fixation system are designed for single use.

In some embodiments, the base includes rim170extending out and around at least a portion of the base. The rim may function as a type of flange. The rim may function to inhibit the base from entering an interior of the subject as the rim will be larger than the opening through the skin of the subject. The rim may be in any number of shapes. The shape depicted in the accompanying drawings of a rim is that of a substantially circular shape but this should not be seen as limiting.

In some embodiments, the rim may include one or more openings180extending through the rim. The rim may include one or more openings180facilitating coupling of the base to the exterior surface of the subject during use. The openings may allow fasteners to be used to couple the rim and thereby the base to a subject. For example, sutures may be looped through the opening(s) coupling the rim to a subject. Other fasteners may be used, such as staples. In some embodiments, the base may be coupled to a subject using a hydrocolloid layer configured to absorb excess moisture around a perimeter of the base. In some embodiments, the base may be coupled to a subject using a double-sided hydrophilic adhesive layer configured to absorb excess moisture around the perimeter of the base. In some embodiments, the base may be coupled to a subject using a double-sided hydrophobic adhesive layer configured to repel excess moisture around the perimeter of the base.

The rim may include one or more openings such that cleaning of the exterior surface of the subject is facilitated during use. The openings may allow cleaning of an entry site at the skin level. The openings may allow a practitioner easier access to the skin below the rim allowing the practitioner to more easily disinfect the tissue around the base and rim.

In some embodiments, the base may include a membrane or luer lock connection in the back of the base to allow flushing of the tubes and/or connecting to an external drainage bag if needed. The base may include a fixation screw or lock in system to attach the base to the existing drain.

In some embodiments, the base may include a first coupler coupled to the first side of the base. In some embodiments, the first coupler may based upon a coupling mechanism including screw threads or coupling projections (e.g., teeth). Different attachments will allow the system to work with drains from 8-16 Fr. Once a conduit (e.g., a drainage catheter) is placed in the subject, an external portion is cut with sterile scissors. The cut end of the conduit may then be coupled to the base using the first coupler (e.g., a screw or a push in system). The base may be low profile and around 2 cm in diameter. The membrane in the center of the screw or fixation system will allow the patient to access the drain in case of blockage for flushing. In some embodiments, the base may be decoupled from the conduit. To exchange the conduits, the base is detached by, for example, either unscrewing or cutting the conduit adjacent to the base.

In some embodiments, the second side of the base may include second coupler190configured to facilitate the attachment of drainage bag200or a mechanism to flush or evacuate a drainage catheter during use. InFIG. 1the second coupler includes a luer lock type of connection in the back to allow flushings or connection to a drainage bag. In some embodiments, the second coupler may include a coupling mechanism including external screw threads, internal screw threads, a female luer fitting, a male luer fitting, a push-to-connect fitting, or a spring-tension loaded trap-door fitting.

In some embodiments, base110may include a low profile design wherein, for example, the opening extending through the base may function as a second coupler. The opening may allow the connection of the base to a drainage bag and facilitates the ability to flush the drain using normal saline and a syringe without the luer lock design. In some embodiments, a closure mechanism may be used to inhibit conveyance of fluids through the opening when desired (for example, when there is no drainage bag hooked up to the opening).FIG. 2depicts an embodiment of an external fixation system for percutaneous drainage procedures including closure mechanism210. A closure mechanism may include detachable soft plug to keep the profile of the system more flat (e.g., as depicted inFIG. 2).

FIGS. 3-4depict an embodiment of external fixation system100for percutaneous drainage procedures, wherein the external fixation system is coupled to conduit160, specifically as depicted in these embodiments the conduit includes a drainage catheter. Drainage catheters may function to drain excess and/or unwanted fluids out of a subject. Drainage catheters may allow care givers a means to evaluate a subject's health at least as relates to the drainage site and the fluids drained. The drainage catheter may be at least semi-flexible so as not to harm a subject upon insertion. The drainage catheter may include a plurality of openings220such that during use fluids may enter the catheter through the openings such that the fluids may be conveyed out of the subject through the catheter.

As mentioned previously an external fixation system may be coupled to a conduit positionable internally in a subject such as a drainage catheter using a first coupler. In some embodiments, a conduit may be coupled to the base of the external fixation system using sutures.FIG. 5depicts an embodiment of external fixation system100for percutaneous drainage procedures, wherein the external fixation system is coupled to a drainage catheter160using sutures230(the depiction shows the sutures before being tied off).

FIG. 5depicts sutures230that lock the tip of the catheter exiting through the opening in the base externally relative to the subject. The sutures are then tied over a bar in the inside of the base and cut. This system will prevent the adjustment of the shape of the pigtail located at the tip of the drainage catheter.

In some embodiments, a system may come with the conduit assembled with the base (e.g., glued in place).

FIG. 6depicts an embodiment of external fixation system100for percutaneous drainage procedures, wherein the external fixation system is coupled to drainage catheter160before the drainage catheter is positioned. Base110may be precoupled to the tube. In some embodiments, at least one suture is fixed between the screw and the tube. A second suture may be placed through a side hole in the base and exit through one of the side bars or spokes as depicted inFIG. 6. The bar may include small opening240(e.g., trap door), by pressing this segment, the suture will be fixed in placed keeping the loop of the pigtail formed. The cap in the back of the base may be attached to one of the bars using a line250.

In some embodiments, an operator may select the length of the conduit based on the patient's existing urinary or biliary drain. Different lengths and diameters of drain tubes may be fabricated to meet the patient's needs.

In some embodiments, method of installing an external fixation system for percutaneous drainage procedures may include advancing a drainage tube over a guidewire under fluoroscopic guidance. The wire may be removed. The operator may secure the locking mechanism by making a knot with the sutures that will be fixed to the transverse bar in the back of the base. The sutures will be cut with scissors and the cap will be attached. Another way to lock the pigtail consists of a suture that is fixed to the base, a second suture exits through the side of the base and it is locked by pressing on a securing bar that holds the suture in place.

FIG. 7depicts an embodiment of external fixation system100for percutaneous drainage procedures, wherein the external fixation system is coupled to a drainage catheter and “externally” to tissue260coupled to a drainage bag using the second coupler (e.g., a luer lock as depicted inFIG. 7). In some embodiments, the second coupler may include a coupling mechanism including external screw threads, internal screw threads, a female luer fitting, a male luer fitting, a push-to-connect fitting, or a spring-tension loaded trap-door fitting.

FIG. 8depicts an embodiment of external fixation system100for percutaneous drainage procedures, wherein the external fixation system is coupled to tissue260using sutures.FIG. 9depicts an embodiment of external fixation system100for percutaneous drainage procedures and a drainage catheter, wherein the external fixation system is coupled to tissue260using sutures. As is depicted the system may be coupled using at least two sutures. The sutures may couple the rim to a subject. First suture230amay couple the rim such that the system is inhibited from moving in at least a first direction. Second suture230bmay couple the rim such that the system is inhibited from moving in at least a second direction. The first and second directions may be different directions. The first and second directions may include longitudinally and laterally.

The devices described herein address the unmet need to secure the position of an in-dwelling drainage tube on a patient's skin both laterally and longitudinally and in a manner consistent with easy drainage, maintenance and cleaning of the placed catheter, patient's confidence and comfort and safety. The devices described herein allow the subject to have the drainage tube in a secure position without a very visible and unnecessary excess portion of the drain protruding well beyond the skin surface. This system will also prevent drainage tube dislodgement and skin infection and will allow easy drainage of fluids and flushing (cleaning) of the drain tube/catheter.