巴西专利BR112015003645B1 CATHETER SET WITH SEPTUM AND SEPTUM ACTUATOR

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专利摘要:
a blood control intravenous catheter with antimicrobial properties is presented a medical device that includes a fluid path and a septum housed slidingly within the fluid path. the septum can be opened by a septum actuator disposed in a fixed position within the fluid path. in some instances, both the septum actuator and the septum have at least one surface exposed to the fluid path. an antipathogenic material can be applied to these surfaces.
公开号:BR112015003645B1
申请号:R112015003645-7
申请日:2013-08-21
公开日:2021-04-27
发明作者:Marty L. Stout；Jonathan Karl Burkholz；S. Ray Isaacso
申请人:Becton, Dickinson And Company；
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专利说明:

BACKGROUND OF THE INVENTION
[001] The present invention relates to systems and methods for coating various surfaces of medical devices with an antipathogenic material. In particular, the present invention relates to systems and methods for selectively applying antipathogenic material to internal surfaces to reduce or eliminate pathogenic colonization and growth within the medical device.
[002] A formidable challenge of modern medical treatment is the control of infection in the dispersion of pathogenic organisms. One area in which this challenge is constantly present is infusion therapy of different types. Infusion therapy is one of the most common medical procedures. Hospitalized patients, treated at home and other patients receive fluids, pharmaceuticals and blood products through a vascular access device inserted in the patient's vascular system. Infusion therapy can be used to treat an infection, apply anesthesia or analgesia, offer nutritional support, treat cancerous growths, maintain blood pressure and heart rate, or many other uses with clinical significance.
[003] Infusion therapy is facilitated by a vascular access device. The vascular access device can access the patient's peripheral or central vasculature. The vascular access device can be short (days), medium (weeks) or long (months or years). The vascular access device can be used for continuous infusion therapy or intermittent therapy.
[004] A common type of vascular access device is the plastic catheter, which inserts into a patient's vein. The length of the catheter can vary from a few centimeters for peripheral access to many centimeters for central access, and may include devices, such as peripherally inserted central catheters (PICC). The catheter can be inserted transcutaneously or it can be implanted under the patient's skin through surgery. The catheter, or any other vascular access device connected to it, can have a single lumen or several lumens for the simultaneous infusion of several fluids.
[005] A vascular access device can serve as a niche, resulting in a widespread BSI (bloodstream infection). This can be caused by failure to regularly level the device, by a non-sterile insertion technique, or by pathogens entering the fluid flow pathway through either end of the pathway following insertion of the catheter. When a vascular access device is contaminated, pathogens adhere to the vascular access device, colonize and form a biofilm. The biofilm is resistant to most biocidal agents and is a source of development of pathogens that can enter the patient's bloodstream and cause a BSI.
[006] An approach to prevent biofilm formation and patient infection is to provide an antipathogenic coating on various medical devices and components. However, some medical devices and components comprise materials or aspects that are incompatible with antipathogenic coatings. Thus, while methods exist to provide an antipathogenic coating on various medical devices and components, challenges remain. Consequently, it would be an advance in technique to expand or even replace current techniques with other techniques. Such techniques are revealed here. BRIEF SUMMARY OF THE INVENTION
[007] In order to overcome the limitations discussed above, the present invention relates to systems and methods for selectively coating surfaces of medical devices that come into contact with blood or other fluids as part of an infusion therapy.
[008] Some implementations of the present invention include a medical device containing a fluid pathway. A septum is housed by sliding into the fluid pathway. A septum actuator is disposed in a fixed position within the fluid path. In operation, the septum can be advanced towards the septum actuator, which can pierce the septum, opening the septum and allowing fluid to flow through it. In some instances, both the septum actuator and the septum have at least one surface exposed to the fluid path. An antipathogenic material can be applied to these surfaces.
[009] In some cases, the septum has a tubular shape and has a barrier member. The septum can thus form a proximal cavity. The barrier member may have a slit extending between a distal and proximal side of the barrier member. The barrier member can divide the septum into a proximal cavity and a distal cavity, and a part of the septum actuator can be arranged within the distal cavity.
[010] In some implementations, an antipathogenic material including a lubricating agent is applied to the probe part of the septum actuator to reduce the friction between the septum actuator and the septum during device activation. In other implementations, a rigid or semi-rigid antipathogenic material is applied to various surfaces of a base part of the septum actuator.
[011] Certain aspects of the present invention additionally include a color coding system, whereby the identity of the antipathogenic material is identified based on the color of the medical device.
[012] In other aspects of the present invention, a ventilation channel can be interposed to the septum and an internal surface of the infusion therapy device. The antipathogenic material can be applied to a surface of the ventilation duct. The antipathogenic material applied to the surface of the ventilation duct may be less than the thickness that would occlude the ventilation duct to allow ventilation through the duct.
[013] Some aspects of the present invention include a medical device having a compatible surface that includes at least one mechanical connection to facilitate the connection between the surface and an antipathogenic material. Other aspects of the invention include providing a chemical bond between a compatible surface of a medical device and an anti-pathogenic material by surface crosslinking.
[014] The present invention additionally includes various methods, techniques and materials for identifying and coating surfaces of medical devices that include non-critical dimensions. Thus, an antipathogenic material can be applied to various surfaces within a medical device to reduce or eliminate colonization and / or pathogenic growth within the medical device, thereby reducing the risk of pathogenic infection in patients. BRIEF DESCRIPTION OF THE VARIOUS VIEWS OF THE DRAWINGS
[015] In order for the manner in which the aforementioned characteristics and advantages of the invention are obtained, as well as other characteristics and advantages, to be easily understood, a more specific description of the invention briefly described above will be presented with reference to its specific embodiments, the which are illustrated in the attached drawings. These drawings illustrate only embodiments characteristic of the invention and, therefore, should not be considered in a way that limits the scope of the invention.
[016] Figure 1 is a cross-sectional view of a catheter assembly comprising a septum and a septum actuator prior to activation, the catheter assembly, the septum and the septum actuator having various surfaces with critical and non- criticisms according to a representative embodiment of the present invention.
[017] Figure 2 is a cross-sectional view of the catheter assembly of Figure 1, with the septum and antipathogenic material removed, showing internal ventilation channels in accordance with a representative embodiment of the present invention.
[018] Figure 3 is a cross-sectional view of the catheter assembly of Figure 1, comprising a septum and a septum actuator after activation in accordance with a representative embodiment of the present invention.
[019] Figure 4 is a partial cross-sectional view of a catheter assembly comprising a septum and an alternative septum actuator according to a representative embodiment of the present invention.
[020] Figure 5 is a partial cross-sectional view of a catheter assembly comprising another septum and an alternative septum actuator according to a representative embodiment of the present invention.
[021] Figure 6 is a partial cross-sectional view of a catheter assembly further comprising another septum and an alternative septum actuator according to a representative embodiment of the present invention.
[022] Figure 7 is a cross-sectional view of an isolated septum according to a representative embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION
[023] The presently preferred embodiment of the present invention will be better understood with reference to the drawings, in which like reference numbers indicate like or similarly functional elements. It will be easily understood that the components of the present invention, as described and illustrated in general in the accompanying figures, can be organized and designed in a wide variety of different configurations. Therefore, the following more detailed description, as represented in the figures, should not be interpreted in such a way as to limit the scope of the invention as claimed, being merely representative of the presently preferred embodiments of the invention.
[024] The term “proximal” is used to indicate a part of a device that, during normal use, is closer to the user and further away from the patient. The term “distal” is used to indicate a part of a device that, during normal use, is further away from the user using the device and closer to the patient. The term "activation" of the valve or septum mechanism is used to indicate the opening or closing action of such a valve. For example, in some embodiments, a catheter assembly is provided containing a septum and a septum actuator, in which the catheter assembly undergoes activation when the septum actuator is advanced through the septum, thus providing a fluid pathway through the septum. septum.
[025] The term "critical dimension" is used to indicate at least one of a height, length, width, depth, diameter, thickness, angle, texture or other structural aspect of a device's surface that is essential to the operation of the device. For example, in some embodiments, a medical device may include a surface that is configured to interface with another device or component. As such, the surface can include a critical dimension that is configured to accommodate the optimal interaction between the surface of the medical device and the device or interface component. Thus, in some embodiments, a surface having a critical dimension must remain unmodified to preserve the intended and / or desired interaction of the surface when operating or using the medical device. Conversely, the term “non-critical dimension” is used to indicate at least one of a height, length, width, depth, diameter, thickness, angle, texture or other structural aspect of a medical device that it is not essential to the operation of the device.
[026] The term "chemical bond" is used to indicate an attraction between atoms that allows an anti-pathogenic material to be applied to a desired surface of a medical device. For example, in some cases, an antipathogenic material of the present invention is applied to the surface of a medical infusion therapy device by means of chemical bonding, where the atoms of the antipathogenic material and the atoms of the medical device are chemically attracted to each other. . The chemical bond can include any type of atomic bond, such as a covalent bond, an ionic bond, dipole-dipole interactions, London dispersion force, Van der Walls force and hydrogen bridge. A chemical bond can additionally be indicated by the terms "crosslinking" or "surface crosslinking" for some embodiments.
[027] The term "mechanical bond" is used to indicate a physical, non-chemical interaction between two or more materials. For example, in some cases, a surface of a medical device is altered to include a texture, a groove and / or a groove with an opening that retains an anti-pathogenic material by means of capillary force. In other embodiments, a mechanical connection comprises a structural aspect that provides a larger surface area for a surface of a medical device. In addition, in some embodiments, a mechanical bond comprises a hydrophilic or hydrophobic material or coating that is applied to a surface of a medical device to attract an anti-pathogenic material. A mechanical connection can additionally be indicated by the term "mechanical interlock" for some embodiments.
[028] The term “compatible surface” is used to indicate a surface of a medical device that includes a non-critical dimension, or a surface that includes a critical dimension that will not be adversely affected by the addition of an anti-pathogenic material or coating.
[029] The terms "rigid" or "semi-rigid" are used to indicate a physical property of an anti-pathogenic material, in which the material is deficient, or free from, or largely free from flexibility. Alternatively, these terms are used to indicate an inflexible or largely inflexible physical property of an anti-pathogenic material when applied or coated on a device's surface. In some cases, the term “semi-rigid” is understood to describe a physical property of an anti-pathogenic material that is rigid to some degree or in parts.
[030] The term "modified rheology" is used to indicate a physical property of an anti-pathogenic material, in which the viscosity of an anti-pathogenic material is modified to prevent excessive migration of the anti-pathogenic material once applied to a surface of a device. As such, the modified rheology of the antipathogenic material prevents or substantially prevents contact between the antipathogenic material and adjacent surfaces or components.
[031] The term “antipathogenic” is used to indicate a material, such as a coating material that acts against pathogens. Pathogens can include any organism or substance capable of causing a disease, such as bacteria, viruses, protozoa and fungi. Therefore, an "antipathogenic material", as contemplated here, includes any material that has properties to act against a pathogen.
[032] The present invention relates, in general, to systems and methods for applying antipathogenic materials to various surfaces of medical devices. In particular, the present invention relates to systems and methods for applying antipathogenic materials to surfaces of medical devices for infusion therapies, wherein the surface comprises part of a fluid pathway of the medical device. In some cases, an antipathogenic material is applied to a surface comprising a non-critical dimension. In some embodiments, an antipathogenic material is applied to one or more surfaces of a medical device prior to the assembly of the medical device. In other embodiments, an antipathogenic material is applied to the first part or component of a medical device and subsequently transferred to a second part or component of the medical device through controlled migration of the antipathogenic material. In other cases, an antipathogenic material is mixed with or incorporated into the material of the medical device during a device molding process. In addition, in some cases, an anti-pathogenic material is applied or incorporated into the material of a medical device so that the anti-pathogenic material is eluted from the material of the medical device to the immediate vicinity of the coated medical device.
[033] In general, an antipathogenic material according to the present invention can include any material that has antipathogenic properties that can be applied to the surface of a medical device, such as an infusion therapy device. For example, in some embodiments, an antipathogenic material may include an antimicrobial composition, as taught in US Patent Applications No. 12 / 397,760, 11 / 829,010, 12 / 476,997, 12 / 490,235 and 12 / 831,880, each of which is incorporated here by reference in its entirety. In some embodiments, an antipathogenic material may additionally include an anti-infective or antimicrobial lubricant, as taught in US Patent Applications No. 12 / 436,404 and 12 / 561,863, each of which is incorporated herein in its entirety. In addition, in some embodiments, an antipathogenic material is incorporated into the material of a medical device, or a component thereof, such as a septum actuator.
[034] Some embodiments of the present invention comprise a medical device or component containing at least one surface that defines a part of a fluid pathway through the medical device, such as an infusion therapy device (for example, a catheter set or Luer adapter). The surface of the medical device is coated with an antipathogenic material to prevent colonization of pathogens on the coated surface.
[035] The application of an anti-pathogenic material to the surface of a medical device results in the addition of a layer or “cap” of anti-pathogenic material to the surface. This layer of antipathogenic material has a dimension (i.e., thickness) that can affect a relationship between the coated surface and an interface of the adjacent component of the medical device. For example, in some embodiments, a medical device may include an opening with a diameter for compatiblely receiving a second medical device, such as by a friction, pressure, mechanical or clamping fit. As such, the diameter of the opening includes critical dimensions to ensure proper fit between the opening and the second medical device. In this example, the addition of an antipathogenic material to the surface of the opening will adjust the diameter of the opening, thereby adversely affecting the ability of the opening to receive the second medical device.
[036] Therefore, in some embodiments of the present invention, it is undesirable to modify or coat a surface of a medical device or component where the surface includes a critical dimension that will be adversely affected by the addition of the antipathogenic material. Thus, some embodiments of the present invention comprise a method for coating a medical device with an anti-pathogenic material, wherein the method includes a first step of identifying the surfaces of the medical device that include non-critical dimensions. The method may additionally include a step by which surfaces containing non-critical dimensions are then coated with an anti-pathogenic material. Some methods of the present invention may additionally include steps to identify and isolate surfaces of the medical device that have critical dimensions, before coating the remaining surfaces with an antipathogenic material.
[037] In the additional examples of the teachings of the present invention, a catheter assembly device 10 is illustrated in Figures 1 to 3. The catheter assembly device 10 shows a non-limiting example of a medical device containing various surfaces that can be coated with an anti-pathogenic material. Thus, the catheter assembly device 10 provides a representative embodiment to demonstrate and discuss the methodologies of the present invention regarding the selection and coating of surfaces with an antipathogenic material.
[038] Referring now to Figure 1, a cross-sectional view of a catheter assembly 10 is illustrated. Catheter assembly 10 generally includes a catheter 12 coupled to a distal end 22 of a catheter adapter 20. Catheter 12 and catheter adapter 20 are integrally coupled so that an inner lumen 26 of catheter adapter 20 is in communication of fluid with a lumen 14 of catheter 12. Catheter 12 generally comprises a biocompatible material with torsional pressures of sufficient stiffness associated with insertion of the catheter into a patient. In some embodiments, catheter 12 comprises a metallic material, such as titanium, stainless steel, nickel, molybdenum, surgical steel and alloys thereof. In other embodiments, catheter 12 comprises a rigid polymeric material, such as vinyl or silicon.
[039] The catheter set 10 can additionally include aspects for use with an “over the needle” type catheter set. For example, a flexible or semi-flexible polymer catheter can be used in combination with a rigid introductory needle to allow insertion of the catheter into a patient's vasculature. Surgically implanted catheters can also be used.
[040] Once inserted into a patient, catheter 12 and catheter adapter 20 provide a fluid conduit to facilitate the delivery of a fluid and / or the recovery of a fluid to or from a patient, as required by a procedure infusion desired. Thus, in some embodiments, catheter material 12 and catheter adapter 20 are selected to be compatible with biofluids and drugs commonly used in infusion procedures. Additionally, in some embodiments, a portion of catheter 12 and / or catheter adapter 20 is configured for use in conjunction with an intravenous tubing section (not shown) to additionally facilitate the delivery of a fluid or the removal of a fluid from or for a patient.
[041] The various embodiments of the present invention can be adapted for use with any medical device or accessory containing a lumen in which a septum is placed. For example, in some embodiments, a female Luer adapter coupled to a section of intravenous tubing may comprise a septum and a septum actuator in accordance with the present teachings. In other embodiments, one or more ends of a Y-port adapter may comprise a septum and a septum actuator in accordance with the teachings of the present invention.
[042] In some embodiments, a proximal end 24 of the catheter adapter 20 includes a flange 28. The flange 28 provides a positive surface that can be configured to allow coupling an intravenous tubing or Luer adapter to the catheter assembly 10. In some embodiments, flange 28 additionally includes a set of threads for receiving a Luer adapter via a threaded connection.
[043] In some embodiments, a septum 40 can be slidably housed with the inner lumen 26 of the catheter adapter 20. The septum 40 generally comprises a flexible or semi-flexible polymer plug with an outer diameter that is configured to fit fit within the inner lumen 26. In some embodiments, the septum 40 is shaped like a tube with one or more internal cavities. In some embodiments, the barrier surface 42 is disposed between a distal end and a proximal end of the septum 40 and can divide the interior of the septum 40 into a proximal cavity 44 and a distal cavity 48. In other embodiments, the barrier surface 42 can be arranged at or near the distal or proximal end of the septum 40. A slit 46 can be formed in the barrier surface 42 to selectively open fluid communication between the proximal cavity 44 and the distal cavity 48. As illustrated, some embodiments of the septum have a substantially "H" shaped cross section. When positioned inside the catheter adapter 20, the barrier surface 42 divides the inner lumen 26 of the catheter adapter 20 into a proximal fluid chamber 30 and a distal fluid chamber 32. Thus, the presence of septum 40 can control or threshold the passage of fluid between the proximal and distal fluid chambers 30 and 32. As illustrated, the septum 40 can be retained in place within the inner lumen 26 through contact with one or more internal surfaces of the inner lumen, through contact with antipathogenic material and / or by contact with probe 54 of the septum actuator 50.
[044] In some embodiments, the catheter assembly 10 additionally comprises a septum actuator 50. The septum actuator 50 is generally fixedly positioned within the distal fluid chamber 32 and has a part that is positioned adjacent to the septum 40. In some cases, the septum actuator 50 comprises a base 52 that is coupled to the catheter adapter 20. For example, as illustrated, base 52 can be inserted at least partially into the proximal end of catheter 12. In this configuration, base 52 it acts as a wedge by forming a pressure fit between the catheter 12 and the catheter adapter 20 to retain, at least partially, the catheter 12 and the base 52 in place. In another example, the base 52 can be coupled directly to the catheter adapter 20 by means of a fixation device, adhesive, joining technique or molding. As illustrated, the septum actuator 50 may have a tubular configuration with a hollow interior that forms a lumen 56 in fluid communication with the lumen 14 of catheter 12. As further illustrated, the septum actuator 50 additionally comprises a probe 54 which is positioned adjacent to the barrier surface 42 of the septum 40 before activation of the catheter assembly 10. Probe 54 may include protrusions or other mechanisms to prevent proximal movement of the septum 40 after activation of the septum.
[045] In some embodiments, the septum actuator 50 may comprise several aspects to facilitate the use of the septum actuator 50 within the catheter assembly 10. For example, the septum actuator 50 may include various vents 16 and other structural aspects for controlling the flow of fluid through and around the septum actuator 50, as taught in US Patent Applications Nos. 12 / 703,336 and 12 / 703,406, each of which is incorporated herein for reference purposes in its entirety.
[046] In some embodiments, the septum 40 is slidably housed within the catheter adapter 20, so that the septum 40 comprises a component independent of the catheter assembly 10. As such, the septum 40 is capable of being advanced in a distal direction, in which the septum actuator 50 pierces the slit 46, opening a fluid path through the septum 40. This process is illustrated in Figure 3 and described in more detail with reference to that figure.
[047] In some embodiments, the septum 40 and / or the septum actuator 50 may be coated with an antipathogenic material before being inserted into the catheter adapter 20. In some cases, the septum 40 and / or the septum actuator 50 it is coated with a rigid or semi-rigid antipathogenic material so that the fluid surrounding these structures comes into contact with the antipathogenic material. In other cases, the septum 40 and / or the septum actuator 50 is coated with a fluid or viscous antipathogenic material so that the antipathogenic material is transferred to the surfaces of the catheter assembly 10 that come in contact with the antipathogenic material. Furthermore, in some cases, the septum material 40 and / or the septum actuator 50 comprise an antipathogenic material or agent. For example, the material of the septum actuator 50 may include an antipathogenic material that is incorporated or mixed with the material of the septum actuator 50 during a manufacturing process. In some cases, the antipathogenic material is able to be eluted from the septum 40 or the septum actuator 50 to the surrounding areas within the catheter adapter 20. For example, a fluid passing through the catheter adapter 20 can be treated with the material antipathogenic effect of the septum actuator or by direct contact with the antipathogenic material or by contact with the antipathogenic material that was eluted from the material of the septum actuator 50.
[048] In some embodiments, a septum 40 and septum actuator 50 are provided within a fluid pathway of catheter assembly 10, so that all fluid passing through catheter assembly 10 comes into contact with septum 40 and the septum actuator 50, or pass in proximity to these structures through their immediate surroundings. Thus, some embodiments of the present invention provide antipathogenic treatment of a fluid within the catheter assembly 10 by providing a septum 40 and / or a septum actuator 50 having an external or exposed surface that is coated with antipathogenic material. In addition, some embodiments of the present invention prevent bacterial colonization within a fluid pathway of the catheter assembly 10 by providing a septum 40 and / or a septum actuator 50 having an antipathogenic coating material coated thereon. In some cases, an antipathogenic material is applied to various surfaces of the septum 40 and / or the septum actuator 50 that comprise non-critical dimensions. In other cases, an antipathogenic material is applied to various surfaces of the septum 40 and / or the septum actuator 50 that comprise critical and non-critical dimensions. Furthermore, in some cases, an antipathogenic material is applied to all surfaces of the septum 40 and / or the septum actuator 50 that may come in contact with a fluid flowing through a fluid path of the catheter assembly 10.
[049] As previously discussed, several surfaces of the ponent catheter assembly 0 comprise critical dimensions that can be adversely affected by the addition of an antipathogenic coating or material. For example, parts of the base 52 of the septum actuator 50 may comprise critical dimensions configured to securely couple the septum actuator 50 to the catheter adapter 20. Therefore, in some embodiments, it is undesirable to apply an antipathogenic material to these parts of the base 52 Similarly, in some embodiments, it is undesirable to apply an antipathogenic material to the outer surface of the septum 40, where the diameter of the outer surface of the septum 40 comprises a critical dimension configured to form an interface with the groove 16. Furthermore, it can be undesirable to apply an antipathogenic material to others of such structures, interfaces and aspects of the catheter assembly that comprise critical dimensions.
[050] The catheter adapter 20 additionally comprises several surfaces that can be coated with an antipathogenic material, where the surfaces include non-critical dimensions. For example, in some embodiments, the inner surface of the distal fluid chamber 32 comprises a non-critical dimension and is, therefore, coated with an anti-pathogenic material. Similarly, various internal and external surfaces of probe 54 of the septum actuator 50 comprise non-critical dimensions and are therefore coated with antipathogenic material. Certain surfaces of the proximal fluid chamber 30 additionally include non-critical dimensions and can therefore be coated with an anti-pathogenic material, as illustrated. In particular, the surfaces arranged near the septum 40 comprise non-critical dimensions.
[051] In general, antipathogenic material can be applied to any internal or external surface of a medical device, or to a component of a medical device, where the surface comprises or is exposed to a fluid pathway through the medical device. The surface can additionally include a critical or non-critical dimension. In this way, pathogens within a fluid passing through the medical device are prevented from colonizing within the medical device. In some embodiments, the thickness of the anti-pathogenic material is proportional to a duration of the effectiveness of the anti-pathogenic material on the coated surface. Thus, the duration of the coating's effectiveness can be increased by increasing the thickness of the antipathogenic material applied to the surface. The duration of effectiveness can be further modified by modifying the physical properties of the antipathogenic material to increase or decrease the rate at which antipathogenic agents are able to elute out of the coating material.
[052] As illustrated, in some embodiments, a rigid or semi-rigid antipathogenic material 60 is selected, which is configured to allow long-term elution of the antipathogenic agents contained within the material 60. As such, it is desirable to provide the material antipathogenic to much of the fluid-path surface area of the catheter assembly 10. In other embodiments, a viscous, fluid antipathogenic material 62 is selected, which additionally comprises a lubricating agent. For example, in some embodiments, an antipathogenic material 62 is provided, which additionally includes a silicon lubricating agent, such as MED-460 (manufactured by NuSil Technology, LLC). The inclusion of a lubricating agent reduces the friction between the interface components of the catheter assembly 10. For example, as further illustrated, the antipathogenic material 62 is applied to the probe part 54 of the septum actuator 50, thus reducing the friction between the septum actuator 50 and septum 40. In another example, antipathogenic material 62 is applied to the outer diameter of septum 40, thereby reducing the friction between septum 40 and catheter adapter 20 and allowing septum 40 to slide into the lumen internal 26. In some embodiments, the antipathogenic material 62 additionally provides a fluid-tight seal between the septum 40 and the outer surface of the probe 54. In addition, in some embodiments, the antipathogenic material 62 provides a fluid-tight seal for the crack 46 of septum 40 prior to activation or provides a fluid tight seal to slot 46 after removal of probe 54 from septum 40. Furthermore, in some embodiments, an antipathogenic material 62 is provided between the septum 40 and the catheter adapter 20.
[053] Antipathogenic material 62 can be applied to parts of probe 54 and / or septum 40 before assembly of catheter assembly 10. In some embodiments, antipathogenic material 62 is able to flow or migrate when placed in contact with others. surfaces. Therefore, in some embodiments, excess antipathogenic material 62 from probe 54 is applied to septum 40 after assembly of catheter assembly 10, as illustrated. In other embodiments, the antipathogenic material 62 comprises a modified rheology to prevent or control excessive migration of the antipathogenic material 62 within the catheter adapter 20. For example, the antipathogenic material 62 may additionally include rheological modifiers to increase the viscosity of the material, such as like silica, talc or clay.
[054] The process for coating or applying the anti-pathogenic material to compatible surfaces of the catheter assembly 10 can be carried out by immersing the desired parts or components of the device in their respective coating material 60 and / or 62. Alternatively, anti-pathogenic materials can be sprayed on the desired surfaces. In some embodiments, surfaces that have critical dimensions are masked or otherwise protected before applying the antipathogenic material to the remaining surfaces. Compatible surfaces can additionally include a mechanical aspect to encourage mechanical bonding between the coating material and the compatible surface.
[055] For example, a compatible surface can be designed to include a physical aspect that increases the mechanical bonding of the coating material, such as a texture, a groove, a groove or some other aspect that increases the surface area of the compatible surface. . In some embodiments, a mechanical connection is facilitated by a mechanical interlock comprising an opening that retains the antipathogenic material by capillary force or by forces of surface tension. In other embodiments, a mechanical interlock comprises a hydrophilic or hydrophobic material or coating that is applied to the compatible surface to attract the antipathogenic material.
[056] In addition, in some embodiments, the antipathogenic material is chemically bonded to the compatible surface of the catheter or medical device assembly by a chemical bond, such as surface crosslinking. For example, in some embodiments, a compatible surface of a device comprises a polymeric material that is capable of forming chemical bonds with at least one component of an antipathogenic material. Non-limiting examples of polymeric materials that can be used to achieve surface crosslinking include polycarbonate, polyester and polyurethane. In some cases, an antipathogenic material is applied to a compatible surface of a device and then cured to obtain the surface crosslink between the pathogenic material and the surface of the device.
[057] Referring also to Figure 1, for some infusion therapy techniques, the air flow between the distal and proximal chambers 32 and 30 may be desirable. For example, for embodiments comprising a septum 40 containing a fluid tight slot 46, the passage of air from the distal chamber 32 to the proximal chamber 30 can be restricted before opening or activating the septum 40 with the septum activator 50, as discussed earlier. Thus, when catheter 12 of catheter assembly 10 is inserted into a patient's vascular system, positive pressure develops within the distal chamber 32, thereby preventing a desired return of the patient's blood to catheter adapter 20. An observable return it is generally desirable to confirm the precise placement of the catheter tip into the patient's vein. Thus, some embodiments include aspects or elements to allow airflow between the distal chamber 32 and the proximal chamber 30, without requiring activation of the septum 40 with the septum activator 50. As such, some embodiments of the present invention provide a return observable, as generally desired for infusion procedures.
[058] For example, in some embodiments, a plurality of air ventilation channels 16 are interposed with the septum 40 and the internal surface of the catheter adapter 20. Such air ventilation channels 16 can extend further ahead of the distal end septum 40 beyond the proximal end of septum 40 when septum 40 is in a pre-actuated position, as illustrated. Air ventilation channels 16 can relieve positive pressure within the distal chamber 32 by providing access for air to bypass the septum 40 to the proximal chamber 30. In some embodiments, air ventilation channels 16 are constructed by removing parts from the inner surface of the catheter adapter, resulting in a plurality of generally parallel grooves. In some embodiments, the air vents 16 are sized and shaped to allow air flow, but to restrict the flow of fluid through the air vents 16. In other embodiments, the air vents 16 are sized and shaped to allow airflow and fluid flow, but to restrict fluid flow to less than or equal to a predetermined flow rate. Figure 2 shows the catheter set 10 of Figure 1, with the septum 40 and the antipathogenic material removed to allow a clearer view of the air ventilation channels 16.
[059] In some embodiments, an antipathogenic material is applied to one or more surfaces of the ventilation channel 16, the antipathogenic material applied to the surface of the ventilation channel 16 having a thickness less than that which would occlude the ventilation channel 16.
[060] Referring now to Figure 3, catheter set 10 is illustrated after activation with a Luer 70 adapter. Catheter set 10 is activated as septum 40 is advanced distally, thereby making probe 54 pierce through slit 46 of septum 40. In some embodiments, septum 40 is advanced distally as the Luer 70 adapter is inserted into opening 56 of the catheter adapter. In some embodiments, opening 27 (illustrated in Figure 2) comprises an inner wall surface diameter and angle that is configured to receive probe 72 of the Luer 70 adapter in a friction or tight fit. Therefore, in some embodiments, it is undesirable to apply an anti-pathogenic material to the opening 27, where an anti-pathogenic coating would adversely affect the fitting of the probe 72 within the opening 27.
[061] Alternatively, in some embodiments, opening 27 may be coated with an antipathogenic material 60 that is viscous but fluid enough to be displaced by probe 72 after coupling the Luer adapter 70 to the proximal end 24. In these embodiments, the antipathogenic material can act as a sealant between probe 72 and aperture 27, where probe 72 removes the necessary excess amount of antipathogenic material to leave a small amount of antipathogenic material between the interface surface of aperture 27 and probe 72 .
[062] In some embodiments, an antipathogenic material 62 is configured to be transferred to the interface surface within the catheter assembly 10 after activation. For example, in some embodiments, antipathogenic material in probe 54 of the septum actuator 50 is transferred to septum 50 and into the septum slit 46 as probe 54 pierces through slit 46. In addition, antipathogenic material 60 in the septum 40 is transferred to the inner surfaces of the inner lumen 26 as septum 40 is advanced distally into the catheter adapter 20. Thus, the antipathogenic material 60 can be applied to various surfaces of the catheter assembly 10 in anticipation of the additional delivery of the antipathogenic material after activation of the catheter set 10. In other embodiments, the antipathogenic material 60 comprises a rigid or semi-rigid material that is not transferred during activation of the catheter set 10.
[063] In some embodiments, various other aspects and / or structural surfaces of the catheter assembly 10 may include critical dimensions to which it is undesirable to apply an antipathogenic material. For example, in some infusion therapy techniques, it is desirable to allow a controlled flow of fluid through the septum 40 before activation of the septum 40. Thus, in some embodiments, the slit 46 may additionally comprise an escape orifice having a diameter of opening calculated to allow the controlled flow of liquid or air between the proximal and distal fluid chambers 30 and 32. Since this leakage port may include critical dimensions, it may be undesirable to block or reduce the calculated opening diameter by adding a antipathogenic material.
[064] Referring now to Figure 4, a septum 40 is illustrated within a catheter adapter 20 containing structural aspects to maintain the position of septum 40 within the lumen 26 of catheter adapter 20 and thereby prevent it to move out of the opening 27 at the proximal end 24 of the catheter adapter 20. For example, in some embodiments, the septum 40 comprises one or more fins 82 that can be met with a proximal limiter 80 of the catheter adapter 20 for prevent further proximal movement of the septum 40. The fins 82 may comprise any protuberance, hook, hitch or other suitable structure configured to form a barrier surface, such as the illustrated flat proximal surface of the fins 82. The proximal limiter 80 may include a protrusion extending from the inner surface of the catheter adapter 20. The proximal limiter 80 may extend radially partially or completely around a portion of the lumen in suit 26. In some embodiments, to accommodate one or more fins 56, the septum 40 and the inner lumen 26 are formed and sized to provide an opening between the septum 40 and the inner lumen 26 in which the fins 56 and the proximal limiter 80 reside. As discussed earlier, various surfaces of the catheter adapter 20 can be coated with an antipathogenic material 60 and / or 62. This may include coating parts of the fins 82, the proximal limiter 80 and parts of the catheter adapter 20 in proximity to the proximal limiter 80 and fins 82.
[065] As further illustrated in Figure 4, in some embodiments, the septum actuator 50 does not include burrs (for example, burrs 58 in Figures 1 to 3). Instead, the septum 40 can be retained in an activated position (illustrated in Figure 3) by forces between the septum 40 and the septum actuator 50. In other embodiments, the septum 40 can return to a pre-activated location (shown in Figure 1) after removing the inserted device (for example, the Luer 70 adapter in Figure 3).
[066] Referring now to Figure 5, an alternative configuration is illustrated to maintain the position of the septum 40 within the lumen 26 of the catheter adapter 20 and prevent it from moving out of the opening 27 at the proximal end 24 of the adapter of catheter 20. As illustrated, septum 40 includes fins 40, similar to those of septum 40 in Figure 4. However, the proximal limiter 80 in Figure 4 is replaced by channels 90 or grooves, which are configured to retain a fin 40 in the while allowing the septum 40 to slide proximally during septum activation. Thus, the channels 90 can be long enough to accommodate the movement of the septum 40 from a pre-activation location (for example, illustrated in Figure 1) to an activation location (for example, illustrated in Figure 3). In some embodiments, various surfaces of the fins 20 and / or channels 90 may be coated with an antipathogenic material 60 and / or 62.
[067] Referring now to Figure 6, an alternative septum configuration is illustrated to provide greater structural support to the septum 40 during septum activation. As illustrated, septum 40 can include a reinforced part 100 at its proximal end 102. Reinforced part 100 can help prevent septal collapse during activation of the septum. In general, the reinforced part 100 can include a side wall 104 having an increased thickness along the remaining side walls 106 of the septum 40. The reinforced part 100 can include a thickness between about 25% and 150% thicker than the walls remaining sides 106 of the septum 40. As shown in Figure 6, the reinforced part 100 can protrude out of the septum 40. Figure 7 shows an embodiment of a septum 40 having a reinforced part 110 which protrudes inward.
[068] Figure 7 further illustrates an example of a septum 40 having a barrier member 42 disposed at a proximal end 112 of septum 40. In this configuration, septum 40 does not include a distal cavity (for example, the distal cavity 48 of the Figures 1 and 3 to 6). Instead, in such embodiments, septum 40 is retained next to probe 54 of septum activator 40 instead of residing within the distal cavity of the septum.
[069] The present invention can be realized in other specific forms without deviating from its structures, methods or other essential characteristics as described in general terms in the present document and claimed hereinafter. The described embodiments should be considered, from all points of view, only as illustrative and non-restrictive. Therefore, the scope of the invention is indicated by the appended claims, rather than by the preceding description. Any changes that fall within the meaning and equivalence range of the claims must be considered within the scope of the claims.

权利要求:
Claims (13)
[0001]
1. A catheter assembly (10), comprising: a catheter adapter (20) having a lumen (26); a catheter (12) coupled to a distal end (22) of the catheter adapter (20), the catheter (12) including a lumen (14) in fluid communication with the lumen (26) of the catheter adapter (20); FEATURED by the fact that the catheter assembly (10) still comprises: a septum (40) slidably housed within the lumen (26), the septum (40) including a barrier surface (42) that divides the lumen (26 ) in a proximal cavity (44) and a distal cavity (48); a septum actuator (50) disposed in a fixed position within the distal cavity (48), the septum actuator (50) extending proximally into the distal cavity (48), the septum actuator (50) having a probe ( 54) having an outer surface and an inner surface, the inner surface forming a lumen (56) in fluid communication with the lumen (26) of the catheter adapter (20) and the lumen (14) of the catheter (12); and an antipathogenic material applied to the inner surface and the outer surface of the septum actuator (50), where the antipathogenic material is applied to an outer diameter of the septum (40) configured to fit within the lumen (26), thereby reducing friction between the septum (40) and the catheter adapter (20) and allowing the septum (40) to slide proximally into the lumen (26) during activation of the septum.
[0002]
2. Catheter assembly (10) according to claim 1, CHARACTERIZED by the fact that at least one surface of the catheter adapter (20) and the septum actuator (50) is coated with the antipathogenic material.
[0003]
3. Catheter assembly (10), according to claim 1, CHARACTERIZED by the fact that the antipathogenic material comprises a lubricant.
[0004]
4. Catheter set (10), according to claim 1, CHARACTERIZED by the fact that the antipathogenic material is rigid or semi-rigid.
[0005]
5. Catheter assembly (10), according to claim 1, CHARACTERIZED by the fact that the antipathogenic material comprises an identification color to indicate a specific type of antipathogenic material.
[0006]
6. Catheter assembly (10), according to claim 1, CHARACTERIZED by the fact that it still comprises: a ventilation channel (16) interposed between the septum (40) and an internal surface of the catheter adapter (20); and the antipathogenic material being applied to a surface of the ventilation duct (16), the antipathogenic material applied to the surface of the ventilation duct (16) having a thickness less than that which would occlude the ventilation duct (16).
[0007]
7. Catheter assembly (10) according to claim 1, CHARACTERIZED by the fact that the septum (40) is configured to move in a distal direction when a separate device is inserted into a proximal opening of the catheter adapter ( 20); wherein the septum actuator (50) has a probe (54) and a base (52), the probe (54) being positioned adjacent to the septum (40), the base (52) being attached to the catheter adapter (20) .
[0008]
8. Catheter assembly (10), according to claim 1, CHARACTERIZED by the fact that the antipathogenic material is not applied to the base parts (52) configured to securely couple the septum actuator (50) to the catheter adapter ( 20).
[0009]
9. Catheter assembly (10), according to claim 1, CHARACTERIZED by the fact that the antipathogenic material comprises a first antipathogenic lubricant and a second rigid or semi-rigid antipathogenic material.
[0010]
10. Catheter assembly (10), according to claim 1, CHARACTERIZED by the fact that the catheter adapter (20) comprises an internal surface that forms the lumen (26), the antipathogenic material being applied to the internal wall of the adapter catheter (20).
[0011]
11. Catheter assembly (10), according to claim 1, CHARACTERIZED by the fact that the antipathogenic material is applied to at least part of the internal and external surfaces by at least one of a mechanical and a chemical bond.
[0012]
12. Catheter assembly (10) according to claim 10, CHARACTERIZED by the fact that the septum actuator (50) has burrs (58) at a proximal end.
[0013]
13. Catheter assembly (10), according to claim 1, CHARACTERIZED by the fact that the septum (40) has an H-shaped cross section, the antipathogenic material being applied to one or more internal surfaces of the septum (40 ).

类似技术:

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BR112015003645B1|2021-04-27|CATHETER SET WITH SEPTUM AND SEPTUM ACTUATOR

AU2017218966B2|2018-07-05|Blood control IV catheter with antimicrobial properties

ES2794911T3|2020-11-19|IV Catheter for Blood Monitoring with Stationary Septum Activator

BRPI0922354B1|2020-09-15|ANTIMICROBIAL LUBRICATING COMPOSITIONS

BR112015019137B1|2021-11-16|CATHETER SET

同族专利:

公开号 | 公开日

AU2013305749A1|2015-03-19|

MX353140B|2017-12-20|

BR112015003645A2|2017-07-04|

MX2015001893A|2015-05-15|

CN203494034U|2014-03-26|

JP2015526199A|2015-09-10|

CA2881451A1|2014-02-27|

AU2013305749B2|2017-06-15|

US9579486B2|2017-02-28|

US20140058336A1|2014-02-27|

EP2887987A1|2015-07-01|

CA2881451C|2019-12-17|

JP6492007B2|2019-03-27|

WO2014031774A1|2014-02-27|

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法律状态:
2018-11-21| B06F| Objections, documents and/or translations needed after an examination request according [chapter 6.6 patent gazette]|

2019-11-12| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

2021-03-23| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

2021-04-27| B16A| Patent or certificate of addition of invention granted|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 21/08/2013, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

申请号 | 申请日 | 专利标题

US13/591,897|2012-08-22|

US13/591,897|US9579486B2|2012-08-22|2012-08-22|Blood control IV catheter with antimicrobial properties|

PCT/US2013/056034|WO2014031774A1|2012-08-22|2013-08-21|Blood control iv catheter with antimicrobial properties|

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