Blood control iv catheter with stationary septum activator.
Abstract
La solicitud describe un ensamble de catéter (100), que comprende un adaptador de catéter (120) que tiene una abertura próxima, un extremo distal, una trayectoria de fluido que se extiende entre éstos, un extremo distal del adaptador del catéter aloja un catéter (50); un septo (40) deslizablemente dispuesto dentro de la trayectoria del fluido (26), el septo divide la trayectoria del fluido en una cámara de fluido próxima (146) y una cámara de fluido distal (148); un accionador del septo (20) fijamente colocado dentro de la cámara de fluido distal y con una superficie de sonda configurada para sesgar el septo en una posición abierta cuando el septo se hace avanzar dentro de la trayectoria del fluido hacia el extremo distal del adaptador del catéter.

Term
7.4 yearsleft in the term
Expires 10 February 2034.
- Priority
- Filed
- Granted
- Today
- Expires
14 claims: 4 independent, 10 dependent
- 1REIVINDICACIONES Habiéndose descrito la invención como antecede, se reclama como propiedad lo contenido en las siguientes reivindicaciones:1. Un ensamble del catéter, caracterizado porque comprende: un adaptador de catéter que tiene una abertura próxima, un extremo distal, y una trayectoria del fluido que se extiende entre éstos, el extremo distal del adaptador de catéter aloja un catéter, en donde el adaptador de catéter incluye una porción ahusada, en donde una superficie interior de la porción ahusada se estrecha gradualmente hacia el extremo distal;un septo deslizablemente dispuesto dentro de la trayectoria del fluido, el septo tiene una sección transversal en forma de H que forma un receptáculo distal, un receptáculo próximo, y una membrana que separa el receptáculo distal del receptáculo próximo, en donde el receptáculo distal incluye un brazo superior y un brazo inferior;un accionador del septo colocado dentro del receptáculo distal, el accionador del septo tiene un lumen central que se extiende hacia el extremo próximo del adaptador de catéter, el accionador del septo tiene una sonda configurada para desviar el septo en una posición abierta al abrir una trayectoria a través de la membrana del septo p el fluido fluya a través del septo cuando se hace avanzar el septo dentro de la trayectoria de fluido hacia el extremo distal del adaptador de catéter de manera que la trayectoria de 5 fluido fluye a través del lumen central del accionador del septo y a través del septo cuando la sonda desvía el septo en la posición abierta, en donde un extremo distal del accionador del septo incluye una base, en donde la sonda se extiende de manera próxima desde la base del accionador del septo, en donde 10 un diámetro interior de una porción del lumen central que se extiende a través de la base es más grande que un diámetro interior de una porción de la trayectoria de fluido que se extiende a través de la sonda, en donde la base esta asegurada de manera fija a la porción ahusada del adaptador de catéter, 15 en donde el brazo superior y el brazo inferior están configurados para hacer contacto con la base para extenderse hacia afuera en respuesta a todo el septo que se desliza de manera distal dentro de la posición abierta;en donde insertar un dispositivo externo en la 20 abertura próxima del adaptador de catéter desliza todo el septo de manera distal dentro de la posición abierta y en donde remover el dispositivo externo permite que la membrana se cierre automáticamente para deslizar todo el septo de manera próxima dentro de una posición cerrada en donde los 25 brazos superior e inferior se extienden paralelos entre sí en la posición cerrada.
- 2El ensamble del catéter de conformidad con la reivindicación 1, caracterizado porque además comprende un material anti-patogénico aplicado al accionador del septo en 5 una superficie interconectada entre el accionador del septo y el septo.
- 3El ensamble del catéter de conformidad con la reivindicación 2, caracterizado porque el material antipatogénico comprende un lubricante. 10
- 4El ensamble del catéter de conformidad con la reivindicación 1, caracterizado porque al menos uno del adaptador de catéter, el septo, y el accionador del septo además comprende una superficie expuesta a la trayectoria del fluido.
- 5El ensamble del catéter de conformidad con la 15 reivindicación 4, caracterizado porque además comprende un material anti-patogénico aplicado a la superficie expuesta a la trayectoria del fluido.
- 6El ensamble del catéter de conformidad con la reivindicación 5, caracterizado porque el material anti20 patogénico comprende un lubricante.
- 7El ensamble del catéter de conformidad con la reivindicación 1, caracterizado porque además comprende un material anti-patogénico aplicado a una superficie exterior del septo en una superficie interconectada entre el septo y 25 una superficie interior del adaptador de catéter. TT Tk ir TF-% τ ................. « I il/1 IJ I I IVI 1 1 ΙΡβ* 8 ”Μ Ο A X » A A Λ. |J . .....P ^ΛΟ» INSTITUTO MEXICANO f·.........iiIsSIlii’I.Ji» DE LA ¡TiOPíhDAD ,ΐβΐΐΐΐχ/^ίτ'-t*
- 8El ensamble del catéter de conf~~..—___ reivindicación 7, caracterizado porque el material antipatogénico comprende un lubricante.
- 9El ensamble del catéter de conformidad con la 5 reivindicación 8, caracterizado porque el lubricante es un lubricante a base de Silicon.
- 10El ensamble del catéter de conformidad con la reivindicación 2, caracterizado porque el material antipatogénico es rígido o semi-rígido. 10
- 11El ensamble del catéter de conformidad con la reivindicación 7, caracterizado porque el material antipatogénico es rígido o semi-rígido.
- 12El ensamble del catéter de conformidad con la reivindicación 2, caracterizado porque además comprende un 15 identificador de color para indicar un tipo específico del material anti-patogénico.
- 13El ensamble del catéter de conformidad con la reivindicación 2, caracterizado porque el material antipatogénico se aplica al accionador del septo a un grosor 20 deseado que es proporcional a una duración de efectividad del material anti-patogénico en la superficie interconectada.
- 14El ensamble del catéter de conformidad con la reivindicación 2, caracterizado porque el material antipatogénico está en comunicación con una porción de la 25 trayectoria del fluido.
Independent claims14
137 paragraphs in 11 sections, as filed
(54) Title: INTRAVENOUS CATHETER (IV) FOR BLOOD CONTROL WITH STATIONARY SEPTO ACTIVATOR. (54) Title: BLOOD CONTROL IV CATHETER WITH STATIONARY SEPTUM ACTIVATOR.
(57) Summary
The application describes a catheter assembly (100), comprising a catheter adapter (120) having a proximal opening, a distal end, a fluid path extending therebetween, a distal end of the catheter adapter housing a catheter (fifty); a septum (40) slidably disposed within the fluid path (26), the septum divides the fluid path into a proximal fluid chamber (146) and a distal fluid chamber (148); a septum actuator (20) fixedly positioned within the distal fluid chamber and with a probe surface configured to bias the septum in an open position when the septum is advanced within the fluid path to the distal end of the adapter of the catheter.
(57) Abstract
The application discloses a catheter assembly (100), comprising a catheter adapter (120) having a proximal opening, a distal end, and a fluid pathway extending therebetween, a distal end of the catheter adapter housing a catheter (50); a septum (40) slidably disposed within the fluid pathway (26), the septum dividing the fluid pathway into a proximal fluid chamber (146) and a distal fluid chamber (148); a septum actuator (20) fixedly positioned within the distal fluid chamber and having a probe surface configured to bias the septum into an open position when the septum is advanced within the fluid pathway towards the distal end of the catheter adapter.
PATENT TITLE No. 359644
Headlines):
Home:
Denomination:
Classification:
BECTON, DiCKINSON AND COMPANY
Becton Orive, Mail Cede 110, Franklin Lakes, New Jersey, 07417-1880, USA
INTRAVENOUS CATHETER (IV) FOR BLOOD CONTROL WITH STATIONARY SEPTO ACTIVATOR,
Inventors)
A61M25 / 00; A61M25 / 06; A61M39 / 04;
A61M25 / 00; A61M25 / 0097; A61M39 / 162, A61M39 / 0693; A61M25 / 0606; A61M39 / 0606; A61M2039 / 064; Α61Μ2039 / Ό68 JONATHAN KARL BURKHOLZ: S. RAY ISAACSON: MARTY L. STOUT
CIP:
CPC:
A61M39 / 06; A61M39 / 26
<img file="MX359644B_D0001.tif" />
Number
MX / a / 2015/010181
International:
2014
Validity: Twenty years
Expiration Date Issue Date
The patent of reference
Pursuant to the date of pi
Who subscribes to this title (Official Journal of the Federation 01/25/2006, 05/06/2000, 06/01/2010, and 12 · fractions i and lili of the Regulation 07/28/2004 and 09/07/2007) ; articles 1 '3 "
Industrial Property (DOF 12/27/1999. Faculties in the Deputy General Directors, Departmental Coordinators and other subordinates of 07/29/2004, 08/04/2004 and 09/13/2007).
Lad Industry !.
(not extendable, counted to rights.
the Industrial Property Law
..... 999. 01/26/2004, 06/16/2005, s 1 ', 3 * fraction V subsection a), 4' amended on 07/01/2002, 07/15/2004, or Organic of the Mexican Institute of the 7 ); Τ ', 3 ° and 5' Clause a) of the Agreement that delegates Regional, Divisional Deputy Directors, (DOF 12/15/1999, amended on 02/04/2000,
The present office. it is signed with an advanced electronic signature (FIEL), based on the. articles 7 BIS 2 of the Industrial Property Law; 3rd of. its Regulations, and 1 section III, 2 section V, 26 BIS and 26 TER of! Agreement, which establishes the guidelines for the use of the Electronic Payment and Services Portal (PASE) of the Mexican Institute of Industrial Property, in the procedures indicated.
<img file="MX359644B_D0002.tif" />
DIVISIONAL DIRECTOR OF PATENTS NAHANNY CANAL REYES
[] Original string:
NAHANNY MARISOL CANAL REYES | 0000100QQQ0403252793 | Tax Administration Service | 1695 || MX / 2018/84477 | MX / a / 2015/010181 | Patent Title PCT | 1027 | RGZjPáe (s) | KAjisPEwrMr2iFLg39c
Digital stamp:
txtuXsE2GbS4w + 7wmitJvNT7p1X6 + e1dbTH / uyuppCI1oEZOFHOLorz2aDhgJ8Mdcr + 4D22BXpkOk46 * 79k26 + 7ltR MpA | 4 / dBSjN01 Jf¡el4KETNqWdXhhaEmmSSag9SL8oEeC6wOIQMXJerYKkvxyyAtCOSYOq7X54w / ZsMSAFWyghqxi a89xzS6Wyg4lk3gq0Fw¡11u9vxruMJ7IB5Ov6Dk0DuCg18A1AvWgy575Q / SewshLkl6p5HinfuRNruDXkeHDqsSUlfo4j CoZJvfvXiom4ulxVNWped4b2KNQJ8fzm8iqKizW3P6l4nMhDnwf5SfaGXXWRD2qAVXrtllWA ==
1, Pijieblo. Santa Marta Tepepan. Xochimflco. 16020. Ciudad tile México, (66) 63340 / '00 www.gob.mxíimpi
<img file="MX359644B_D0003.tif" />
INTRAVENOUS CATHETER (IV) FOR BLOOD CONTROL -___ ___________
FROM SEASONAL SEPT
FIELD OF THE INVENTION
The present invention relates to the intravenous catheter for blood (IV) control with an integrated stationary septum activator. Furthermore, the present invention relates to systems and methods for coating various surfaces of the IV catheter for blood control with antipathogenic material. Still further, the present invention relates to systems and methods for coating various interconnected surfaces between a catheter adapter, the stationary septum activator, and an IV blood catheter blood control septum with an antipathogenic lubricating material to reduce friction between these.
BACKGROUND OF THE INVENTION
Controlling the spread of infection in pathogenic organisms is a formidable challenge of modern medical treatment. One area where this challenge is constantly present is in infusion therapy of various kinds. Infusion therapy is one of the most common health care procedures. Hospitalized, domestic care, and other patients receive fluids, pharmaceuticals, and blood products via a vascular access device inserted into the patient's vascular system. Infusion therapy can be used to treat an infection, provides anesthesia or analgesia, provides nutritional support, treats cancerous growths, controls blood pressure and heart rate, or many other clinically significant uses.
Infusion therapy is facilitated by a vascular access device. The vascular access device can access the peripheral or central vasculature of the patient. The vascular access device can remain internally for short term (days), moderate term (weeks), or long term (from months to years). The vascular access device can be used for continuous infusion therapy or for intermittent therapy.
A common vascular access device comprises a plastic catheter that is inserted into a patient's vein. The length of the catheter can range from a few centimeters or peripheral access, to many centimeters for central access, and can include devices such as peripherally inserted central catheters (PICCs). The catheter can be inserted transcutaneously or can be surgically implanted below the patient's skin. The catheter, or any other vascular access device attached to it, may have a single lumen or multiple lumens for the infusion of many fluids simultaneously.
A common vascular access device comprises a blood control sepro that controls the flow of blood and other fluids through the vascular access device. In some instances the vascular access device further includes a septum actuator that slidably houses within the vascular access device. The septum actuator can be advanced through the blood control septum to allow blood or other fluids to skirt the septum. Generally, the septum actuator is retained within the vascular access device by providing a channel or other feature where the septum actuator is capable of sliding. These features require precise machining to obtain the critical dimensions required to facilitate proper sliding movement of the septum actuator within the vascular access device.
A vascular access device can serve as a nest of infection, resulting in BSI (disseminated blood stream infection). This can be caused by failure to rinse the device, a non-sterile insertion technique, or by pathogens entering the fluid flow path at either end of the path after catheter insertion. When a vascular access device becomes contaminated, pathogens adhere to the vascular access device, colonize, and form a biofilm. The biofilm is resistant to '>
i ·> ii »'S is most biocidal agents and provides a replenishment stream for pathogens to enter the patient's bloodstream and cause BSI.
One method of preventing biofilm formation and infection of the patient is to provide an anti-pathogenic coating on various medical devices and components. However, some medical devices and components comprise materials and features that are incompatible with anti-pathogenic coatings. Thus, although there are methods to control blood flow through a vascular access device, and to provide an anti-pathogenic coating, there are still challenges. Accordingly, it would be an improvement in the technique to augment or even replace the current techniques with other techniques. Such techniques are described herein.
BRIEF DESCRIPTION OF THE INVENTION
In order to overcome the limitations explained above, the present invention relates to systems and methods for selectively coating non-dimensionally critical surfaces of medical devices that have contact with blood or other fluids as part of an infusion therapy.
Some implementations of the present invention include a medical device for infusion therapy, such as a catheter assembly, with a septum for control '>
i ·> ii »'S of blood that slides within a fluid path of a catheter adapter. The blood control septum is configured to slide into the catheter adapter in both distal and proximal directions. The catheter adapter further includes a septum actuator that is secured to an interior surface of the catheter adapter in a fixed position. The septum actuator comprises a probe portion that is concentric or axially positioned within the fluid path of the catheter adapter in a position that is close to the septum for blood control. As the septum for blood control slides in the distal direction, the probe portion of the septum actuator is advanced through the septum for blood control to provide a path through the septum. After release of the septum for blood control, the septum slides in the proximal direction such that the probe portion of the septum actuator is removed from the septum for blood control. That is, the path through the septum for blood control is closed to prevent further fluid flow through the fluid path of the catheter adapter.
In some instances, the septum actuator comprises a molded feature of the inner surface of the catheter adapter. In other instances, the septum actuator comprises a separate unit that engages so
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In some instances, an antipathogenic material is applied to various surfaces of the catheter assembly to prevent colonization of pathogens within the fluid path of the device. In other instances, the anti-pathogenic material further comprises a lubricating agent to reduce friction between the various components of the catheter assembly.
Some surfaces of the catheter assemblies of the present invention may include a non-critical dimension, where an anti-pathogenic material is applied to the surface.
In some instances, an anti-pathogenic material is applied to
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In some instances, a medical device for infusion therapy is provided with a septum actuator that includes a probe portion configured to advance through a septum of the device after actuation of the septum actuator. In some implementations, an anti-pathogenic material including a lubricating agent is applied to the probe portion of the septum actuator to reduce friction between the septum actuator and the septum during device activation. In other implementations, a rigid or semi-rigid anti-pathogenic material is applied to various surfaces of a base portion of the septum actuator.
Certain aspects of the present invention further include a color coding system, whereby the identity of the anti-pathogenic material is identified based on the color of the medical device.
Some aspects of the present invention include a medical device with a compatible surface that includes at least one mechanical bond through which the bond between the surface and an anti-pathogenic material is facilitated. 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 entanglement.
The present invention further includes various methods, techniques, and materials for identifying and coating medical device surfaces that include non-critical dimensions. In this way, an anti-pathogenic material can be applied to various surfaces within a medical device to reduce or eliminate pathogenic colonization and / or growth within the medical device thereby reducing the risk of pathogenic infection in patients.
BRIEF DESCRIPTION OF THE FIGURES
In order to easily understand how the above-described advantages and other features of the invention are obtained, a more particular description of the invention will be made briefly described above with reference to its specific embodiments that are illustrated in the attached figures. These figures describe only typical embodiments of the invention and are therefore not to be considered as limiting the scope of the invention.
Figure 1 is a cross-sectional side view of a catheter assembly comprising a stationary septum actuator, integrated for activation in accordance with a representative embodiment of the present invention.
Figure 2 is a cross-sectional side view of a catheter assembly comprising a septum actuator that is fixedly coupled to the catheter adapter via an annular groove in accordance with a representative embodiment of the present invention.
Figure 3 is a cross-sectional side view of the catheter assembly of Figure 1 after activation according to a representative embodiment of the present invention.
Figure 4 is a cross-sectional side view of a catheter assembly comprising a septum actuator having a distal end comprising a wedge that is configured to fixedly engage a base portion of the catheter within the distal end of the catheter adapter, The septum actuator further comprises a probe extending distally from the wedge and positioned adjacent to the septum for blood control of the catheter assembly in accordance with a representative embodiment of the present invention.
Figure 5 is an enlarged cross-sectional view of the catheter assembly of Figure 4 according to a representative embodiment of the present invention.
Figure 6 is a cross-sectional side view of the catheter assembly of Figure 4 after activation via a Luer adapter in accordance with a representative embodiment of the present invention.
Figure 7 is a cross-sectional side view of a '> t ·> i ι »' S septum for blood control with non-lubricating, lubricious anti-pauogenic material applied to various surfaces with critical and non-critical dimensions according to a representative embodiment of the present invention.
Figure 8 is a cross-sectional view of a septum actuator with a distal end comprising a wedge that is configured to fixedly engage a base portion of a catheter within a distal end of a catheter adapter, the septum actuator further it comprises a probe that extends distally from the wedge so as to be positioned adjacent to the septum for blood control of a catheter assembly, The septum actuator has lubricating and non-lubricating material applied to various surfaces with critical and non-critical dimensions in accordance with a representative embodiment of the present invention.
DETAILED DESCRIPTION OF THE INVENTION The presently preferred embodiments of the present invention will be better understood by reference to the figures, where similar reference numbers indicate identical or functionally similar elements. It will be readily understood that the components of the present invention, as generally described and illustrated in the figures herein, could be arranged and designed in a wide variety of different configurations. Thus, the following more detailed description, as represented in the figures, is not intended to limit the scope of the invention as claimed, but is merely representative of the presently preferred embodiments of the invention.
The term proximal is used to denote a portion of a device that, during normal use, is closer to the user and further from the patient. The term distal is used to denote a portion of a device that, during normal use, is further away from the user operating the device and closer to the patient. The term activation of the valve or septum mechanism is used to denote the action of opening or closing such a valve. For example, in some embodiments, a catheter assembly is provided with a septum and a septum actuator, wherein the catheter assembly receives activation when the septum actuator is advanced through the septum, thereby providing a path of the fluid through the septum.
The term critical dimension is used to denote at least one of a height, length, width, depth, diameter, thickness, angle, texture, or other structural feature of a surface of a medical device that is critical to device operation. For example, in some embodiments, a medical device may include a surface that is configured to interact with another device or component. That is, the surface may include a critical dimension that is configured to accommodate the optimal interaction between the surface of the medical device and the interconnecting device or component. Thus, in some embodiments, a surface having a critical dimension must remain unchanged to preserve the intended and / or desired interaction of the surface in operation or use of the medical device. Conversely, the term noncritical dimension is used to denote at least one of a height, length, width, depth, diameter, thickness, angle, texture, or other structural feature of a medical device that is not critical for device operation.
The terms chemical bonding or chemical bonding are used to denote 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 instances an anti-pathogenic material of the present invention is applied to the surface of a medical device for infusion therapy via chemical bonding, where the atoms of the anti-pathogenic material and the atoms of the medical device are chemically attracted. each. The chemical bond can include any type of atomic bond such as a covalent bond, an ionic bond, dipole-dipole interactions, London scattering force, Van der Waals force, and hydrogen bonding. A chemical bond may further be denoted in terms of entanglement or surface entanglement for some embodiments.
The terms mechanical bond or mechanical bond are used to denote a physical, not chemical, interaction between two or more materials. For example, in some instances a surface of a medical device is altered to include a texture, a groove, and / or a crest with an egg that controls an anti-pathogenic material via capillary force. In other embodiments, a mechanical linkage comprises a structural feature that provides an increased surface area to an area of a medical device. Furthermore, 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 bond can also be denoted by the term mechanical interlocking in some modalities.
The term "compatible surface" is used to denote 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.
The terms rigid or semi-rigid are used to denote a physical property of an antipathogenic material, where the material is deficient in, or lacking, or for the most part lacks flexibility. Alternatively, these terms are used to denote an uncompromising or largely inflexible physical property of an antipathogenic material when applying or coating a surface of a device. In some instances, the term semi-rigid is understood to describe a physical property of an antipathogenic material that is rigid to some degree or in some parts.
The term modified rheology is used to denote a physical property of an anti-pathogenic material, where the viscosity of an anti-pathogenic material is modified to prevent excessive migration of the anti-pathogenic material once it is applied to a surface of a device. That is, the modified rheology of the anti-pathogenic material prevents or substantially prevents contact between the anti-pathogenic material and the adjacent surfaces or components.
The term anti-pathogenic is used to denote a material, such as a coating material, that acts against pathogens. Pathogens can include any organism or substance capable of causing disease, such as bacteria, viruses, protozoa, and fungi. Accordingly, an anti-pathogenic material as contemplated herein includes any material that has properties to act against a pathogen.
The present invention relates to an intravenous (IV) catheter for blood control with an integrated, stationary septum activator. Furthermore, the present invention relates to systems and methods for coating various surfaces of the IV catheter for blood control with an anti-pathogenic material. Furthermore still, the present invention relates to systems and methods for coating various interconnected surfaces between a catheter adapter, the stationary septum activator, and an IV catheter blood control septum for blood control with antipathogenic lubricating material to reduce friction between these.
In some instances, an anti-pathogenic material is applied to a surface that comprises a non-critical dimension. In some embodiments, an anti-pathogenic material is applied to one or more surfaces of a medical device before assembling the medical device. In other embodiments, an anti-pathogenic material is applied to a first portion or component of a medical device and subsequently transferred to a second portion or component of the medical device through controlled migration of the antipathogenic material. In other instances, an anti-pathogenic material is intermixed with, or incorporated within the material of the medical device during a device molding process. Furthermore, in some instances an antipathogenic material is applied to or incorporated into the material of a medical device such that the anti-pathogenic material is eluted out of the material of the medical device within
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For example, in some embodiments, an IV catheter assembly for blood control is provided with lubricating and non-lubricating antipathogenic materials applied to the surfaces of the catheter assembly that have critical and non-critical dimensions, as taught in US Patent Application. Serial No. 13 / 471,716, which is incorporated herein in its entirety.
In general, an anti-pathogenic material according to the present invention can include any material with anti-pathogenic properties that can be applied to the surface of a medical device. For example, in some embodiments an anti-pathogenic material can include an antimicrobial composition, as taught in US Patent Applications Nos. serial 12 / 397,760, 11 / 829,010, 12 / 476,997, 12 / 490,235, and 12 / 831,880, each of which is incorporated herein by reference, in its entirety. In some embodiments, an anti-pathogenic material may further include an anti-infective or antimicrobial lubricant, as taught in US Patent Applications Serial Nos. 2 / 436,404 and 12 / 561,863, each of which is incorporated in the present in its entirety. Furthermore, in some embodiments an anti-pathogenic material is incorporated into the material of a medical device, or not its components, such as a septum actuator.
Some embodiments of the present invention comprise a medical device or component with at least one surface defining a portion of a fluid path through the medical device. The surface of the medical device is coated with an anti-pathogenic material to prevent colonization of pathogens on the coated surface.
Applying an anti-pathogenic material to the surface of a medical device results in the addition of a layer or cover of anti-pathogenic material to the surface. This layer of anti-pathogenic material has a dimension (i.e. thickness) that can affect a relationship between the coated surface and an interconnected or adjacent component of the medical device. For example, in some embodiments, a medical device may include an opening with a diameter to compatibly receive a second medical device, such as by friction, pressure, mechanical adaptation, or interference. That is, 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 anti-pathogenic 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.
Accordingly, in some embodiments of the present invention it is undesirable to modify or cure 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 of coating a medical device with an anti-pathogenic material, wherein the method includes a first step of identifying surfaces of the medical device that include non-critical dimensions. The method may further include a step whereby surfaces with non-critical dimensions are then coated with an anti-pathogenic material. Some methods of the present invention may further include steps to identify and isolate critical dimension medical device surfaces, prior to coating other surfaces with an anti-pathogenic material.
Referring now to Figure 1, a blood control catheter assembly 10 is shown. In general, the blood control catheter assembly 10 comprises a catheter adapter 20 with a proximal end 22, a distal end 24 and a trajectory of the fluid 26 extending between them. In some instances, proximal end 22 comprises a feature for coupling an external device to catheter adapter 20. For example, in some embodiments, proximal end 22 comprises a group of threads to receive a compatible Luer adapter.
Catheter adapter 20 generally has a tubular shape. An inner surface 28 tapers toward the distal end 24, with a gradually reduced diameter. The catheter adapter 20 is preferably made of a transparent or semi-transparent material so as to show the interior, allowing the interior movement to be verified. Suitable materials for catheter adapter 20 include, but are not limited to, thermoplastic polymer resins such as polycarbonate, polystyrene, polypropylene, and the like.
Catheter assembly 10 further comprises a catheter 50. A base portion 52 of catheter 50 is inserted into a distal end opening 24 and secured via a press-fit wedge 60. In some embodiments, it is preferred that a liner be provided. lubricant to the outer surface of catheter 50 to reduce resistance caused by insertion through the skin or into a blood vessel. Suitable materials for catheter 50 include, but are not limited to, thermoplastic resins such as fluorinated ethylene propylene (FEP), polytetrafluoroethylene (PTFE), polyurethane, and the like. In some embodiments, catheter 4 is formed from a thermoplastic hydrophilic polyurethane that softens upon exposure to physiological conditions present in the patient's body.
The catheter assembly 10 may further include features for use with a non-needle assembly. For example, a flexible or semi-flexible polymeric catheter can be used in combination with a rigid introducer needle to allow insertion of the catheter into a patient's vasculature. Surgically implanted catheters can also be used.
Once inserted into a patient, catheter 50 and catheter adapter 20 provide a fluid conduit to facilitate fluid delivery to and / or recovery of fluid from a patient, as required for a desired infusion procedure. Thus, in some embodiments, the material of catheter 50 and catheter adapter 20 is selected to be compatible with biofluids and drugs commonly used in infusion procedures. Additionally, in some embodiments, a portion of catheter 50 and / or catheter adapter 20 is configured to be used in conjunction with a section of intravenous line (not shown) to further facilitate delivery of fluid to or removal of fluid from a patient. .
The catheter adapter 20 further comprises a septum driver 30. The septum driver 30 is securely secured within the fluid path 26 and positioned such that a blood control septum 40 can slide in a distal direction. 14 into fluid path 26 and skew into an open position »· r via septum actuator 30. In some instances, the septum actuator comprises an internal molded feature of catheter adapter 20. For example, septum actuator 2 0 may include a base 34 that fuses to or forms as part of interior surface 28. Alternatively, the actuator The septum 20 may comprise a separate unit having a base 34 which is fixedly secured within an annular groove 2 9 of the inner surface 28, as shown in Figure 2.
With continued reference to Figures 1 and 2, septum actuator 20 further comprises a probe portion 32 extending proximally from base 34. Probe portion 3 is generally axially centered within fluid path 26. A distance between probe portion 32 and base 34 is selected to allow free forward or distal movement of septum 40 over the actuator of septum 30. In some instances, the distance between probe portion 32 and base 34 is selected to limit forward movement of septum 40 within fluid path 26, thereby preventing excessive penetration of probe portion 32 through from opening 42 of septum
40.
The septum actuator 30 is generally tubular and comprises a lumen 36 that is in fluid communication with the fluid path 26. In some instances, the blood control septum 40 comprises a front receptacle and a rear receptacle 46, wherein the front and rear receptacles are separated by a membrane 48 comprising an opening 42. The front receptacle 44 generally comprises an inside diameter and length that is configured to receive and house the probe portion 32 of the septum actuator 30. Accordingly, when the opening 42 of the septum 40 is biased in an open position, fluid can flow freely between lumen 36, fluid path 26 and catheter 50.
Prior to activation of septum 40, probe portion 32 is placed within front receptacle 44 in a position that is close to membrane 48. Opening 42 of septum 40 is biased in an open position as septum 40 slides into of the fluid path 26 in the distal direction 14 on the probe portion 32. In some instances, septum 40 is advanced in distal direction 14 as an external device 12 is inserted into fluid path 26 at proximal end 22, as shown in Figure 3.
With continued reference to Figure 3, septum 4 0 slides and repositions distally within fluid path 26 as external device 12 is inserted into proximal end 22 of catheter adapter 20. A contact surface 13 of external device 12 is inserted into proximal end 22 to contact the proximal end 49 surface of septum 40. As the contact surface 13 is advanced within fluid path 26, septum 40 slides in distal direction 14 thereby advancing septum 40 over probe portion 32 of septum actuator 30. The portion of Probe 32 biases opening 42 in an open position, thereby providing fluid communication between catheter 50, lumen 36, front receptacle 46, fluid path 26, and external device 12. After removal of external device 12, the elastic properties of septum 40 result in a self-closing of opening 42 thereby causing septum 40 to slide in the proximal direction 16 to its initial starting position.
In some embodiments, probe portion 32 comprises a tapered outer surface to facilitate closure of opening 42 and retraction of septum 40 in the proximal direction 16 after removal of external device 12. In other embodiments, inner surface 28 Catheter adapter 20 comprises one or more surface features to restrict or limit distal movement of septum 40. For example, in some embodiments the inner surface 28 comprises a reduced diameter 543 that compresses the outer surface of septum 40 as septum 40 is advanced in the distal direction 14. After removal of external device 12, compressive forces help to septum 40 to slide in the proximal direction ± o to xenumrr its initial position
Referring now to Figure 4, a blood control catheter assembly 100 is shown. In some embodiments, catheter assembly 100 comprises a septum actuator 130 having a probe portion 132 and catheter wedge 134 interconnected via a lumen 136. Catheter wedge 134 is inserted into catheter base 52 to secure catheter 50 at distal end 24 of catheter adapter 20. Probe portion 132 extends outwardly from catheter wedge 134 toward proximal end 122 of catheter adapter 120. In some embodiments, probe portion 132 is approximately axially centered within fluid channel 26 of catheter adapter 120. Lumen 136 of septum actuator 130 interconnects probe portion 132 and wedge of catheter 134 and provides seamless communication between them. The distance between probe portion 132 and wedge of catheter 134 is generally selected to allow septum 40 to slide in distal direction 14 a sufficient distance to advance probe portion 132 through opening 42 of the membrane 48, thereby providing fluid communication between catheter 50, lumen 136, posterior chamber 46, and fluid path 26.
In some instances, the distance between probe portion 132 and catheter wedge 134 is cut off to prevent over insertion of probe portion 132 through opening 42. For example, the distance between probe portion 132 and wedge of catheter 134 may be selected to obtain contact between a distal end of septum 40 and the interior wall surface 128 of catheter adapter 120 when maximum desired penetration is obtained. of probe portion 132 through opening 42.
In some embodiments, septum 40 comprises an outer diameter that is slightly larger than a reduced diameter 154 of inner surface 128. Septum 40 forms a fluid-tight seal with an inner surface 128 at reduced diameter 154. That is, septum 40 divides fluid path 26 into proximal fluid chamber 146 and distal fluid chamber 148. In some instances, it is undesirable for fluid to leak into distal fluid chamber 148. Accordingly, wedge of catheter 134 forms a fluid tight seal with base 52 of catheter 50. In addition, an outer diameter of the portion Probe 132 is slightly larger than an inside diameter of front receptacle 44. That is, a fluid tight seal is provided between probe portion 132 and septum 40 in rear receptacle 44.
Referring now to Figure 5, an enlarged view of the iuu catheter assembly is shown. In some embodiments, catheter assembly 100 is first assembled by inserting catheter 50 into catheter adapter 120 such that base 52 of catheter 50 is positioned at distal end 24. Catheter 50 is secured to catheter adapter 120 inserting the wedge of catheter 134 of septum actuator 130 into base 52. Catheter wedge 134 is configured to secure catheter 50 to catheter adapter 130 by inserting into catheter 50 and compressing base 52 between catheter wedge 134 and the distal end · 24. This compression is adequate to provide a seal fluid tight between catheter 50 and septum actuator 130, thus preventing fluid leakage into distal fluid chamber 148. This fluid tight seal provides fluid communication between catheter 50 and lumen 136 of septum actuator 130.
After catheter 50 and septum actuator 130 are secured, septum 40 is inserted into catheter adapter 120 at proximal end 122. Septum 40 slides into catheter adapter 120 such that probe portion 132 of septum actuator 13 0 is inserted into front receptacle 44. In some embodiments, septum 40 is positioned within fluid path 26 such that membrane 48 is spliced with probe portion 132.
After further movement of septum 4U in distal direction 14, probe portion 132 is advanced through opening 42 of membrane 48, thereby providing fluid communication between lumen 136 of septum actuator 130 and rear receptacle 46 of septum 40, as shown in Figure 6. For example, an external device 12, such as a Luer adapter, can be inserted into proximal end 122 to contact and advance septum 40 in the distal direction 14. In some embodiments, probe portion 132 comprises an outer surface Beveled 138 which contacts membrane 48 and forms a fluid tight seal with upper and lower tabs of membrane 48. That is, liquid is prevented from leaking between membrane 48 and beveled outer surface 138.
In some embodiments, a blood control catheter assembly of the present invention comprises one or more surfaces that can be coated with an antipathogenic material. An anti-pathogenic material can be provided to prevent colonization of pathogens in various components of the catheter assembly. Additionally, an antipathogenic material comprising a lubricant can be applied to various components of the catheter assembly to reduce friction between interconnected surfaces and prevent colonization of pathogens at the interface.
In some instances, an anti-pathogenic material is first applied to interior surfaces 28/128 before assembling the catheter assembly. In this way, the anti-pathogenic material is transferred from the inner surface 28/128 to various other components during assembly and use. In other instances, an anti-pathogenic material is applied to the various components of the catheter assembly before being inserted into the catheter adapter. In this way, the anti-pathogenic material is transferred from the various components to the catheter adapter during assembly and use.
In some embodiments, the inner surface 28/128 is coated with a rigid or semi-rigid anti-pathogenic material such that the fluid flows through the fluid path 26 is contacted with the antipathogenic material. That is, bacterial colonization on the coated surfaces is prevented. The stiff or semi-stiff properties of the anti-pathogenic material prevent easy removal of the surface coating. In this way, the surface remains coated for the duration of the effectiveness of the anti-pathogenic material. In some instances, the stiff or semi-stiff properties of the anti-pathogenic material allow a surface to be coated without interfering with a critical dimension of the surface, as taught in US Patent Application Serial No. 13 / 471,716.
In other embodiments, the inner 28 / izb surface is coated with a viscous or fluid anti-pathogenic material comprising a lubricating agent, such as Silicon oil. In some instances, the lubricating coating is provided on the interconnected surfaces between septum 40 and inner surface 28/128. The septum 40 may comprise a material that exhibits high friction when moved against a polymeric surface, such as the inner surface 28/128. For example, septum 40 may comprise a Silicon material that exhibits tacky characteristics when septum 40 is moved within fluid chamber 26 of catheter adapter 120. Thus, in some embodiments, it is advantageous to place an anti-lubricant material. pathogenic between the interconnected surfaces of septum 40 and catheter adapter 120 to facilitate sliding movement of septum 40 within catheter adapter 120. Accordingly, an anti-pathogenic coating material of the present invention may include a lubricant to obtain this benefit.
Referring now to Figure 7, in some embodiments an anti-pathogenic material 80 is applied to various surfaces of septum 40 prior to assembling the catheter assembly 10. For example, a rigid anti-pathogenic material 82 may be preferred for use in surfaces of septum 40 that are in direct contact with fluids flowing through catheter assembly 10. In some instances, a rigid anti-pathogenic material 82 can be applied to rear receptacle 46, where rear receptacle 46 is in direct contact with the fluid during use of the catheter assembly
10. Rigid anti-pathogenic material 82 is generally more resistant to wear, and therefore can be applied to surfaces that are susceptible to wear, such as surfaces that are in direct contact with the fluid. Rigid anti-pathogenic material 82 can also comprise a thin layer that is applied to surfaces that have a critical dimension. For example, rear receptacle 46 may have a diameter that is critical to facilitate proper flow dynamics of fluid through septum 40. Alternatively, rear receptacle 46 may have a diameter that is critical to receiving a portion of an external device .
Septum 40 may further comprise a lubricious antipathogenic material 84 that is applied to various surfaces of septum 40 to reduce friction between septum 40 and a surface of another device or component of the catheter assembly. For example, in some embodiments a lubricious antipathogenic material 84 is applied to an outer surface 90 of septum 40 to reduce friction between septum 40 and the inner surface of the catheter adapter. In addition, a lubricious anti-pathogenic material 84 can be applied to an interior surface of the front receptacle to reduce friction between septum 40 and probe portion 132 of septum actuator 130. In addition to reducing friction, the lubricious anti-pathogenic material 84 provides anti-pathogenic properties to septum 40 to prevent colonization of pathogens.
In some embodiments, the fluid nature of the lubricious anti-pathogenic material 84 allows transfer of the lubricious anti-pathogenic material 84 from septum 40 to other surfaces in contact with septum 40. For example, in some embodiments the anti-pathogenic material 84 deposited in front receptacle 44 is transferred to septum actuator 13 0 as the septum actuator is placed within front receptacle 44. Additionally, since the septum actuator is advanced through opening 42 of septum 40, the lubricious anti-pathogenic material 84 can be transferred to additional surfaces of the septum actuator. Still further, the lubricious anti-pathogenic material 84 on the outer surface 90 of septum 40 can be transferred to the inner surface of the catheter adapter as septum 40 slides distally and proximally into fluid channel 26 of the catheter adapter. In some instances, the lubricious anti-pathogenic material 84 is further transferred to various surfaces of the external device 12 as the external device 12 is inserted into the catheter adapter to
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>
advance septum 40 in the aistai ± <t direction. A transfer of the anti-pathogenic material 84 to the external device 12 can reduce friction between the external device 12 and the catheter adapter. Transfer of anti-pathogenic material 84 to external device 12 can further prevent colonization of pathogens in external device 12 and generally within the fluid path 26. Rigid anti-pathogenic materials 82 and lubricants 84 may further be transferred to the septum actuator of catheter assembly 10, according to the methods explained above.
Referring now to Figure 7, in some embodiments the rigid anti-pathogenic materials 82 and lubricants 84 are applied to various surfaces of the septum actuator 130 prior to assembly of the catheter assembly. For example, in some instances a rigid anti-pathogenic material 82 is applied to the inner surface of the septum actuator 130, so as to be in contact with the fluid flowing through the lumen 136. Furthermore, a lubricious antipathogenic material 84 is applied to probe portion 132 of septum actuator 130. Lubricious anti-pathogenic material 84 reduces friction between probe portion 132 and front receptacle 44 as septum 40 slides in the direction distal 14 within the catheter adapter. The lubricious anti-pathogenic material 84 further reduces friction between probe portion 130 and membrane 4b to cluster the easy insertion of probe portion 130 through opening 42 of membrane 48. Rigid anti-pathogenic materials and Lubricants 82 and 84 can also be applied to septum actuator 30 of catheter assembly 10, in accordance with the methods explained herein.
In some embodiments, the fluid nature of the lubricious anti-pathogenic material 84 allows transfer of the lubricious anti-pathogenic material 84 from the septum actuator 130 to other surfaces in contact with the septum actuator 130. For example, in some embodiments the anti-pathogenic material 84 deposited or coating the probe portion 132 of the septum actuator 130 is transferred to the front receptacle 44 as the septum actuator 130 is inserted into the front receptacle 44 during assembly. Additionally, since the septum actuator is advanced through opening 42 of septum 40, the lubricious antipathogenic material 84 can be transferred to additional surfaces of septum 40, such as membrane 48 and opening 42. In some instances, the material lubricious anti-pathogenic 84 is transferred from probe portion 132 to opening 42, thus further providing fluid tight seals to opening 42.
In some instances, the lubricating 84 and rigid 82 antipathogenic materials are applied to both the septum and the septum actuator prior to exsamnaging of the catheter. In other instances, excess lubricious anti-pathogenic material 84 is applied to the septum and the septum actuator with the intention of transferring the excess anti-pathogenic material to various surfaces of the catheter assembly when the various components of the catheter assembly are assembled .
In general, the anti-pathogenic materials of the present invention can be applied to any internal or external surface of a medical device, or a component of a medical device, where the surface comprises or is exposed to a path of fluid through the device doctor. The surface may further include a critical or non-critical dimension. Pathogens within a fluid that pass through the medical device in this way are prevented from colonizing within the medical device. In some embodiments, the thickness of the anti-pathogenic material is proportional to the duration of effectiveness of the anti-pathogenic material on the coated surface. In this way, the duration of the effectiveness of the coating can be increased by increasing the thickness of the anti-pathogenic material applied to the surface. The duration of effectiveness can also be modified by modifying the physical properties of the anti-pathogenic material to increase or decrease the degree to which anti-pathogenic agents are capable of '>
i ·> ii »'S elute out of the coating material.
In some embodiments, rigid or semi-rigid anti-pathogenic material 82 is selected, which is configured to allow long-term elution of the antipathogenic agents contained within material 82. That is, it is desirable to provide the anti-pathogenic material to much of the surface area of the fluid path of the catheter assembly. In other embodiments, a fluid, viscous anti-pathogenic material 84 is selected, which further comprises a lubricating agent. For example, in some embodiments a lubricious anti-pathogenic material 84 is provided, which further includes a Silicon lubricating agent, such as MED-460 (manufactured by NuSil Technology, LLC). The inclusion of a lubricating agent reduces friction between the interconnected components of the catheter assembly. In some embodiments, the lubricious anti-pathogenic material 84 further provides a fluid tight seal between the various components of the catheter assembly.
In some embodiments, the lubricious anti-pathogenic material 84 comprises a modified rheology to prevent or control excessive migration of the lubricious anti-pathogenic material within the catheter assembly. For example, the lubricious anti-pathogenic material 84 may further include rheology modifiers to increase the viscosity of the material, such as silica, talc or clay.
The process for coating or applying anti-pathogenic agents to compatible surfaces of the catheter assembly can be obtained by dipping the desired portions or components of the device into their respective coating material 82 and / or 64. Alternatively, the anti-pathogenic materials can be sprayed on the desired surfaces. In some embodiments, surfaces that have critical dimensions are masked or otherwise protected prior to application of the antipathogenic material to the other surfaces. Compatible surfaces may further include a mechanical feature to stimulate the mechanical bond between the coating material and the compatible surface.
For example, a compatible surface may be designed to include a physical feature that increases the mechanical bonding of the coating material, such as a texture, a groove, a ridge, or some other feature that increases the surface area of the compatible surface. In some embodiments, a mechanical bond is facilitated by a mechanical interlock that comprises an empty space that controls the anti-pathogenic material by means of capillary force or surface tension forces. In other embodiments, a mechanical interlock comprises a hydrophilic or hydrophobic material or coating that is applied to the compatible surface to attract the anti-pathogenic material.
In addition, in some embodiments the antipathogenic material is chemically attached to the compatible surface of the catheter or medical device assembly by a chemical bond, such as surface entanglement. 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 anti-pathogenic material. Non-limiting examples of polymeric materials that can be used to obtain surface entanglement include polycarbonate, polyester, and polyurethane. In some instances, an anti-pathogenic material is applied to a compatible surface of a device and then cured to obtain surface entanglement between the anti-pathogenic material and the surface of the device.
The present invention may be modernized in other specific ways without departing from its structures, methods, or other essential features as fully described herein and claimed below. The described modalities will be considered in all aspects only as illustrative, and not restrictive. The scope of the invention, therefore, is indicated by the appended claims, rather than by the foregoing description. All changes that fall within the meaning and equivalency ranges of the claims are encompassed within their scope.
The various embodiments of the present invention can be adapted for use with any medical device or accessory with a lumen where a septum sits. For example, in some embodiments, a female Luer adapter attached to a section of the intravenous line may comprise a septum and a septum actuator in accordance with the teachings herein. In other embodiments, one or more ends of a port adapter can comprise a septum and a septum actuator in accordance with the teachings of the present invention.
It is noted that in relation to this date, the best method known by the applicant to put the aforementioned invention into practice is the one that is clear from the present description of the invention.
Contents11
11 sheets
Sheet 1 Sheet 2 Sheet 3 Sheet 4 Sheet 5 Sheet 6 Sheet 7 Sheet 8 Sheet 9 Sheet 10 Sheet 11
28 members in 10 offices
Priority claims9
| Document | Office | Kind | Date |
|---|---|---|---|
| 13766550 | United States of America | – | |
| 201313766550 | United States of America | A | |
| 201313766550 | United States of America | A | |
| 2014015620 | United States of America | W | |
| 2014015620 | United States of America | W | |
| 13766550 | – | – | – |
| PCTUS2014015620 | – | – | – |
| US201313766550 | – | – | – |
| WO2014US15620 | – | – | – |
Members28
| Document | Office | Kind | |
|---|---|---|---|
| US2014228775A1 | United States of America | A1 | |
| CA2900361A1 | Canada | A1 | |
| WO2014126866A1 | World Intellectual Property Organization (WIPO) | A1 | |
| AU2014216479A1 | Australia | A1 | |
| MX2015010181A | Mexico | A | |
| EP2956200A1 | European Patent Office (EPO) | A1 | |
| CN204972644U | China | U | |
| JP2016506855A | Japan | A | |
| BR112015019137A2 | Brazil | A2 | |
| US9750928B2 | United States of America | B2 | |
| US2017368326A1 | United States of America | A1 | |
| AU2014216479B2 | Australia | B2 | |
| AU2018202408A1 | Australia | A1 | |
| MX359644BThis record | Mexico | B | |
| EP2956200B1 | European Patent Office (EPO) | B1 | |
| EP3431130A1 | European Patent Office (EPO) | A1 | |
| ES2707952T3 | Spain | T3 | |
| AU2018202408B2 | Australia | B2 | |
| JP6618804B2 | Japan | B2 | |
| JP2020028729A | Japan | A | |
| EP3431130B1 | European Patent Office (EPO) | B1 | |
| CA2900361C | Canada | C | |
| ES2794911T3 | Spain | T3 | |
| JP6942169B2 | Japan | B2 | |
| BR112015019137B1 | Brazil | B1 | |
| US11357962B2 | United States of America | B2 | |
| US2022265986A1 | United States of America | A1 | |
| US12178985B2 | United States of America | B2 |
1 legal event, as the office reported them to INPADOC
Events
| Event | Code | |
|---|---|---|
| Grant or registrationFG | FG |
Numbers
- Publication
- 359644
- Publication, DOCDB
- 359644
- Publication, EPODOC
- MX359644
- Application
- 2015010181
- Application, DOCDB
- 2015010181
- Application, EPODOC
- MX20150010181
Titles
- Spanish
- CATÉTER INTRAVENOSO (IV) PARA CONTROL SANGUINEO CON ACTIVADOR DE SEPTO ESTACIONARIO.
Classification
- CPC, 7
- A61M39/162
- A61M25/0097
- A61M25/0606
- A61M2039/064
- A61M39/0606
- A61M39/0693
- A61M2039/068
- IPC, 5
- A61M25 00
- A61M25 06
- A61M39 04
- A61M39 06
- A61M39 26