A volume of fluid can sometimes gather within a cavity location in a patient's body due to medical conditions such as cancer. In such situations, a medical practitioner can use a catheter or other body cavity access device to drain such fluid from the patient's body. Such a catheter can be a transcutaneously inserted catheter that is introduced into the body cavity such that a first portion, such as a distal end, is positioned in the body cavity of a patient while a second portion, such as a proximal end or proximal region, is positioned transcutaneously outside of a patient's body.
Infection of the tissue at an insertion site or within a body cavity of the patient may occur during the insertion, use, and/or removal of a catheter from the body of a patient. The patient's skin, initially punctured by a needle or other transcutaneous access instrument to allow the insertion of a catheter through the skin and into an existing body cavity (such as the pleural space or abdominal space) may be exposed to infectious agents such as bacteria, viruses, fungi, and other infectious agents disposed on and about the exterior surface of the skin. Such infectious agents may be drawn into the insertion site or body cavity through a contact with the exterior surface of a catheter with the skin, during the insertion, implementation, and removable of the catheter past the skin barrier.
The infectious agents, can lead to inflammation and cell destruction in the tissues surrounding the body cavity, or other remote infection sites.
The disclosed device, system and method provides a solution to the shortcomings of such conventional catheters through the provision of an infectious agent-preventing antimicrobial feature that is coupled to the catheter such as via a coating or via a material that is used to manufacture the catheter. The antimicrobial feature thwarts the communication of infectious agents such as bacteria and viruses into the flesh below an insertion site, such as within a pre-existing body cavity in which the catheter is positioned.
In one aspect, there is disclosed an antimicrobial catheter comprising: an elongated body adapted to be inserted into a body cavity of a patient that is not vascular or the urethra, the elongated body having at least one interior lumen defined by a sidewall forming the elongated body, the elongated body having an exterior circumferential surface extending between a first end of the elongated body and a second end of the elongated body; and an antimicrobial surface positioned along the circumferential surface, wherein the antimicrobial surface is configured to inhibit pathogens.
In another aspect, there is disclosed a method of draining fluid from a body cavity, comprising: inserting a catheter into the body cavity, wherein the body cavity is a pre-existing cavity that is present prior to insertion of the catheter, and wherein the catheter comprises: an elongated body adapted to be inserted into a body cavity of a patient, the elongated body having at least one interior lumen defined by a sidewall forming the elongated body, the elongated body having an exterior circumferential surface extending between a first end of the elongated body and a second end of the elongated body; and an antimicrobial surface positioned along the circumferential surface, wherein the antimicrobial surface is configured to inhibit inhibiting pathogens; and using the catheter to drain fluid out of the body cavity.
The details of one or more variations of the subject matter described herein are set forth in the accompanying drawings and the description below. Other features and advantages of the subject matter described herein will be apparent from the description and drawings, and from the claims.
Disclosed herein is an antimicrobial coated catheter system for internal, non-vascular body cavities. Such body cavities typically are non-communicating (in a natural state that has not been manually intervened) to the outside of a patient and can be, for example, chest cavities and abdominal cavities although other cavities are within the scope of this disclosure. The cavity can be transcutaneously accessed using a catheter, such as for the purpose of drainage (like pleural or peritoneal drainage) or fluid exchange like peritoneal dialysis. Vascular or urinary antimicrobial catheters already exist but not for these cavity drainage applications.
The catheter can be made of any of a variety of materials and can be coated with an antimicrobial material. In a nonlimiting implementation, the catheter can be silicon, polyurethane, or Polytetrafluoroethylene (PTFE). The antimicrobial agent that coats the catheter can be silver, antimicrobial agents chlorhexidine, triclosan, or antibiotics like nitrofural, minocycline-rifampin in non-limiting examples. The antimicrobial agent in the coating can be eluting or non-eluting.
The catheter device provides a solution to the shortcomings in prior art through the provision of an antimicrobial exterior surface of catheter devices employed to communicate through the skin and to the body cavity. An antimicrobial surface area is positioned upon the catheter, such as along the entire length of the catheter or along one or more portions of the catheter. The one or more portions can be, for example, one or both distal ends of a catheter or a portion of the catheter that is located within the body cavity when the catheter is transcutaneously positioned in the body cavity. In this manner, during any communication of the catheter device through the skin, and into the patient, bacteria, viruses and other infectious occupants of the exterior and any underlying layers of skin, have direct contact with the antimicrobial coating.
In an implementation, the catheter uses bio-compatible surface coating in combination with the antimicrobial exterior surface coating. For example, by positioning a thin surface area of titanium on the exterior circumferential surface of polyurethane and other catheters in combination with an antimicrobial coating, the device and method herein renders conventional catheters into catheters with increased bio-compatibility as well as prevents the introduction of surface bacteria into the insertion site.
Any of a variety of antimicrobial materials may be employed. In addition to materials recited above, other example materials include one or a combination of antimicrobial materials from a group including nitrofurazone-coated silicone or silver or silver ions or silver nano-particles in a coating, or copper or copper bearing materials in a coating, chlorhexidine incorporated hydroxylapatite coatings, chlorhexidine-containing polylactide coatings on an anodized surface, and polymer and calcium phosphate coatings with chlorhexidine, and aluminum and aluminum ions. However, in other implementations the catheter may be impregnated or otherwise formed with antimicrobial materials and properties.
The catheter 305 is an elongated body having at least one internal lumen. The catheter 305 can be a cylindrical body with a single internal lumen that extends through the entire length of the catheter 305. In user, the distal end the catheter 305 is transcutaneously inserted into a patient's body and moved through the body so that the distal end is positioned within the body cavity 1015. Thus, the internal lumen of the catheter 305 fluidly communicates with the body cavity 1015. In this manner, the catheter 305 provides extracorporeal access to the body cavity 1015. Fluid of the body cavity 1015 can flow into the internal lumen of the catheter 305 and out of the catheter via an opening in the proximal end.
The catheter 305 can be formed of conventional materials such as polyurethane, silicone, or polytetrafluoroethylene (“PTFE”). However, it can also be formed of any material suitable for use in combination with the disclosed coating of an antimicrobial material for the purposes set forth in this disclosure. The catheter 305 can alternatively be formed all, or partially, itself of an antimicrobial impregnated material in a solid solution, or any other means to impart antimicrobial properties therein to communicate with the circumferential surface.
The antimicrobial coating may be applied by any conventional means known in the art such as vacuum chamber coating, plasma coating, employment of an antimicrobial material in an impregnated polymer or other carrier used as coatings, or impregnating the proximal and distal ends of the catheter itself, or other means which would occur to those skilled in the art. The antimicrobial materials could also include one or a combination of antimicrobial materials from a group including nitrofurazone-coated silicone or silver or silver ions or silver nano-particles, copper or copper bearing materials in a coating, or impregnated into the material forming the catheter, or shrunk wrapped. Other antimicrobial materials may be also placed adjacent in combination with the titanium such as one or a combination of, chlorhexidine incorporated hydroxylapatite coatings, chlorhexidine-containing polylactide coatings on an anodized surface, and polymer and calcium phosphate coatings with chlorhexidine, in a coating or mixed in a polymer coating.
In an embodiment, the antimicrobial feature is located at just the proximal portion or distal portion of the catheter 305. In the case of it being located at just a proximal portion, the antimicrobial portion protrudes from the insertion site communicating through the patient's skin, once the insertion procedure is complete. The placement of the coating on the proximal portion which communicates through the skin surface inhibits pathogen travel along the catheter surface and below the skin surface of the patient which is the first barrier to such intrusions.
The coating can be located on an exterior surface of the catheter, on an interior surface of the catheter, or on both the interior surface an exterior surface. In addition, the coating can be located on just a portion of the length of the catheter (such as along intermittent lengths of the catheter). In addition, the coating can be located and extend around an entire circumference of the catheter or along portions thereof either on the interior surface, the exterior surface, or both. The interior surface of the catheter can be a portion of the catheter that defines an internal lumen.
In another embodiment, the entire length of an exterior surface of the catheter 305 may additionally employ antimicrobial materials thereon singularly or in combination, or may have a titanium surface alone since it provides a means for encouraging lubricity. Alternatively, the titanium surface area on the entire circumferential surface may be employed in combination with one or a combination of the other noted antimicrobials herein.
In a non-limiting embodiment, the catheter 305 is configured pursuant to the body access system 105 described in
The valved connector 310, catheter 305, and sheath 315 are sized and shaped to be co-axially aligned and coupled to one another along a common long axis.
With reference still to
As shown in
The internal lumen of the cannula 315 is sized and shaped to co-axially receive the needle 320 of the catheter 305. In this manner, the sheath 315 and catheter 305 can be co-axially aligned when the needle 320 is inserted into the cannula 325. The needle 320 can have a length that is longer than the length of the cannula 325 so that a distal end of the needle 320 pokes out of the distal end of the cannula in the assembled device, such as shown in
As shown in
As shown in the proximal view of
The outer housing 405 of the valved connector 310 defines an internal lumen that contains several components of the valved connector 310, wherein the components control fluid flow through the valved connector 310.
With reference to
The internal components further include a round first seal disk 610 made of a malleable material that can seal with the piston 605 when in contact therewith. The first seal disk 610 has a slit 710 that extends through the seal disk 610. The seal disk is made of a material such that the slit seals shut in a default state and can also be deformed and/or forced open such as when contacted with sufficient force by the distal end of the piston. The slit 710 is sized to receive therethrough the needle 320 of the catheter 305.
The internal components further include a separator disk 615 positioned in a juxtaposed, contacting relationship with the first seal disk 610 and a second seal disk 620. The separator disk 615 is interposed between the first seal disk 610 and second seal disk 620 in the assembled state, as shown in
The second seal disk 620 also has a central aperture 720 that is sized and shaped to snugly receive therethrough the needle 320 of the catheter 305. The second seal disk 620 is also made of a resilient, flexible material.
With reference still to
Although
In use, the valved connector 310 is coupled to the sheath 315 such as by attaching the distal interface 410 of the valved connector 310 to the threaded interface 340 at the proximal end of the sheath 315. As mentioned, the distal interface 410 can be rotatably attached in a threaded manner to the threaded interface 340 to securely attach the valved connector 310 to the sheath 315. As mentioned, when attached as such, the internal lumen of the cannula 325 co-axially aligns with the internal lumen of the valved connector 310. In this manner, the valved connector 310 controls fluid flow (such as by inhibiting, permitting, or blocking flow) through the sheath 315 and valved connector based upon the state of the internal components of the valved connector. In an alternate embodiment, the valve connector 310 is integrally formed as part of the sheath 315.
The valved connector 310 can be opened for fluid flow therethrough by coupling a secondary device, such as the catheter 305, to the valved connector 310. As the secondary device, such as the catheter 305, is inserted into the valved connector 310, a portion of the secondary device directly or indirectly deforms the slit 710 to thereby open the slit 710 and allow fluid flow therethrough. The process of coupling secondary device to the valved connector 310 and sheath 315 is now described in the example context of coupling the catheter 305 to the valved connector 310 and sheath 315.
The catheter 305 is coupled to the valved connector 310 by inserting the needle 320 of the catheter 305 into the internal lumen of the valved connector 310 so that the sheath 315, valved connector 310, and catheter 305 collectively form a single assembly, as shown in
This is described in more detail with reference to
The distal end of the piston 605 moves distally (through the neck of the main body 405) so that it contacts the first seal disk 610. The distal end of the piston 605 exerts a force om the first seal disk 610 so as to deform the first seal disk 610 in a manner that opens the slit 710 (
This creates a fluid passageway within the valved connector 310 through the slit 710 in a region that surrounds the needle 320 with the fluid passageway collectively formed by formed by the central apertures 720 and 715 (
While this specification contains many specifics, these should not be construed as limitations on the scope of an invention that is claimed or of what may be claimed, but rather as descriptions of features specific to particular embodiments. Certain features that are described in this specification in the context of separate embodiments can also be implemented in combination in a single embodiment. Conversely, various features that are described in the context of a single embodiment can also be implemented in multiple embodiments separately or in any suitable sub-combination. Moreover, although features may be described above as acting in certain combinations and even initially claimed as such, one or more features from a claimed combination can in some cases be excised from the combination, and the claimed combination may be directed to a sub-combination or a variation of a sub-combination. Similarly, while operations are depicted in the drawings in a particular order, this should not be understood as requiring that such operations be performed in the particular order shown or in sequential order, or that all illustrated operations be performed, to achieve desirable results. Only a few examples and implementations are disclosed. Variations, modifications and enhancements to the described examples and implementations and other implementations may be made based on what is disclosed.
This application claims priority to U.S. Patent Application No. 62/888,877, filed Aug. 19, 2019, entitled “VALVE ASSEMBLY FOR BODY ACCESS DEVICE”, the content of which is hereby incorporated by reference herein in its entirety.
Filing Document | Filing Date | Country | Kind |
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PCT/US20/46762 | 8/18/2020 | WO |
Number | Date | Country | |
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62888877 | Aug 2019 | US |