CN104507515A - Antimicrobial introducer and needle - Google Patents
Antimicrobial introducer and needle Download PDFInfo
- Publication number
- CN104507515A CN104507515A CN201380023150.8A CN201380023150A CN104507515A CN 104507515 A CN104507515 A CN 104507515A CN 201380023150 A CN201380023150 A CN 201380023150A CN 104507515 A CN104507515 A CN 104507515A
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- communicated
- vein
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- dilator
- antimicrobial
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Classifications
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/08—Materials for coatings
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- A61L31/086—Phosphorus-containing materials, e.g. apatite
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/08—Materials for coatings
- A61L31/10—Macromolecular materials
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- A—HUMAN NECESSITIES
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- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
-
- A—HUMAN NECESSITIES
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/16—Biologically active materials, e.g. therapeutic substances
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- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
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- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
- A61M25/06—Body-piercing guide needles or the like
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
- A61M5/14—Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M5/158—Needles for infusions; Accessories therefor, e.g. for inserting infusion needles, or for holding them on the body
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- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/404—Biocides, antimicrobial agents, antiseptic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M2025/0056—Catheters; Hollow probes characterised by structural features provided with an antibacterial agent, e.g. by coating, residing in the polymer matrix or releasing an agent out of a reservoir
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- A—HUMAN NECESSITIES
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- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
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- A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
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- A61M25/0662—Guide tubes
- A61M2025/0681—Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
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- A61M2205/00—General characteristics of the apparatus
- A61M2205/02—General characteristics of the apparatus characterised by a particular materials
- A61M2205/0205—Materials having antiseptic or antimicrobial properties, e.g. silver compounds, rubber with sterilising agent
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/02—General characteristics of the apparatus characterised by a particular materials
- A61M2205/0238—General characteristics of the apparatus characterised by a particular materials the material being a coating or protective layer
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M29/00—Dilators with or without means for introducing media, e.g. remedies
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
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- Heart & Thoracic Surgery (AREA)
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- Anesthesiology (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Biophysics (AREA)
- Pulmonology (AREA)
- Inorganic Chemistry (AREA)
- Molecular Biology (AREA)
- Media Introduction/Drainage Providing Device (AREA)
- Materials For Medical Uses (AREA)
- Apparatus For Disinfection Or Sterilisation (AREA)
Abstract
A device for threading a conduit into a communication with a vein or artery beneath the skin of a patient, during insertion of components such as a PICC line is provided. Surfaces of a hollow needle, dilator, and sheath included in kit, and which are anticipated to contact the skin of a patient during the procedure are provided with an antimicrobial surface area formed thereon. The surface area so positioned prevents bacteria and other pathogens from occupying the contacting surfaces and thereby being communicated into the tissue below the patient's skin.
Description
Background of invention
2. background technology
Ink vessel transfusing medical catheter, as PICC puts pipe, Chang Zuowei chemotherapy regimen, antibiotic therapy, prenatal nutrition, requires blood vessel and the intravenous passage carrying out the therapeutic scheme be communicated with outside patient body with other.This kind of medical catheter, through being usually used in long-time use, is 30 days, even more of a specified duration.In using, first PICC must be put pipe or other type medical catheter imports blood vessel or peripheral vein, as cephalic vein, basilic vein, or brachial veins.The medical catheter of fluid flow tube is housed once insert patient vessel's system through skin, just can pushes certain anchor point to towards heart direction.Generally, needle point is communicated with sinuatrial node on this anchor point.
Usually, inserting the process of medical catheter through skin and blood vessel perienchyma, is realized by multiple step.This process adopts plurality of medical parts, apparatus or instrument by medical professional.The normally used instrument for thrusting patient skin and tissue is called introducer.The target arterial of its end and patient vessel's system or vein are connected with tissue by introducer transdermal.After properly connecting introducer, once targeted vein of having good positioning, doctor axially can insert medical catheter through introducer.
In brief, this introducer comprises one and has the tearable sheath that dilator that end section is the elongate body of taper and have interior axis hole.Interior axis hole leans out from tearable sheath end to make a part for its tapered zone for receiving dilator.
For correctly inserting and locating medical catheter end, directly by drug conveying to the vascular system of patient, first tourniquet or similar device is needed to be arranged at above the targeted insertion site of patient's arm or lower limb, to compress blood flow, thus make vein dilatation, be convenient to medical professional and choose objective vein or a tremulous pulse.
Have good positioning after vein or tremulous pulse, by guid needle, be usually called Sai Dingge pin, be installed on the front portion of syringe and insert target blood, unclamping tourniquet subsequently.After extracting syringe, user seals or presses syringe needle tail end with thumb, prevents losing blood or suck air and causes thromboembolism.
Adopt a flexible guide wires, seal wire end is axially inserted along Sai Dingge pin internal channel, till only visible guidewire proximal.Seal wire is pushed ahead, sends to targeted vein through needle stand.After seal wire is in place, i.e. removable syringe needle.
Then, the introducer of band sheath and dilator is communicated to targeted vein through guidewire proximal.Usually, doctor can cut epidermis with safe operating knife so that the propelling of dilator.Introducer probes in patient body after specific length along seal wire, dilator can be removed from sheath.
Next step, insert sheath until it is correctly positioned targeted vein by the end of medical catheter, drawn except by tearable sheath subsequently and tear to pieces immediately, so just can realize adjusting the location of medical catheter end from pipeline.
Obviously, in this process, in order to successfully locate medical catheter, the action at insertion point place needs elaborately planned and precise manipulation in a large number.These operations, refer to insertion in protective layer of skin and subcutaneous tissue, remove syringe needle, then insert through same channels, remove introducer.Although the method for promising these assemblies sterilization in modern medicine, and can leave in sterile bag by them, they still probably carry surperficial pathogenic bacterium and infectant as antibacterial, virus etc., and by its muscle below skin introducing insertion point and vein.Introducer is carried out in sheath, and through skin barrier, subcutaneous tissue menses tube wall target approach blood vessel, in the process, its distal outer surface provides topical carrier for this infectant.
This pollution can introduce even several pathogenic bacterium of one or infectant, even comprise virus, antibacterial, fungus parasite, and makes these pathogenic bacterium or infectant through the skin barrier it being had to barrier effect, enters patient body subendothelial tissue or quiet, tremulous pulse.Such as common bacterial dermatosis pathogenic bacterium, comprise staphylococcus aureus and Hemolytic streptococcus, all easily survive on patient skin, in air and on the surface of various medical facilities.Herpes simplex is the common pathogen of another kind of viral dermatosis, is easy to enter in patient body through piercing process.
Although modern medicine has been attempted to adopt the similar means such as heating, illumination, steam to strengthen bactericidal effect, but the propagation of pathogenic bacterium or infectant has the trend strengthened gradually, its can on patient skin amount reproduction, or be transferred to medical apparatus and instruments from patient skin in the process that medical catheter inserts, and in the tissue being entrained into patient and vascular system.
Therefore, need a kind ofly strengthen the protection of patient and can prevent pathogenic bacterium and infectant from entering method in its body, in order to meet the demand that existing syringe needle and introducer fail to meet for a long time.Have the device of the barrier propterty of this enhancing, should provide the method for improvement on the basis of conventional antimicrobial technology, the method can pierce through in patient skin process at medical apparatus and instruments, stops this infectant to enter subcutaneous tissue and vascular system.This device should arrange antimicrobial surface characteristic at the outer surface of the introducer combinationally used and syringe needle, stops or suppress the breeding of pathogenic bacterium with this, and wherein, these pathogenic bacterium bring virulence factor into subcutaneous tissue by contacting with outer surfaces.
The previous embodiment of correlation technique and any restriction are intended to illustrate and do not have an exclusiveness, and do not represent describing herein and any restriction of claimed invention.By the following explanation of reading comprehension also by reference to the accompanying drawings, be there is various obvious limitation by those skilled in the art in discovery correlation technique.
1. technical field
The US provisional patent that the application is 61/607512 for the patent application serial numbers that on March 6th, 2012 submits to requires priority, and quoting in full of this United States Patent (USP) is combined in this.
The present invention relates to a kind of for providing introducer and the syringe needle of Ink vessel transfusing passage for patient.More particularly, the present invention relates to a kind ofly has the introducer of antimicrobial coating and Sai Dingge pin to combinationally use, and wherein, this coating can block surface bacteria and be transmitted to insertion point.
In the process that needle pierces skin inserts tremulous pulse or vein, the tissue at insertion point place, the tissue of adjacent place or vascular system are easy to infect.In the process piercing through skin barrier, be present in the infectant in patient skin outer surface, conventional needles, as antibacterial, virus, fungus and other infectant, by with pin and/or introducer outer surface and the contact with skin, be easy to invade insertion point.This can cause inflammation and destroy puncture tissue cellularity around.If the infectant that syringe needle or introducer carry enters the vascular system of patient, also can cause distal site and infect.The defect that the present invention is directed to above-mentioned syringe needle and introducer provides a kind of solution, by arranging the antimicrobial coating of the factor that prevents infections on the surface of the introducer combinationally used and syringe needle and contact skin, infectant such as antibacterial, virus etc. is hindered to enter the muscle of below insertion point.
Summary of the invention
The device of disclosure and description provides a kind of assembly herein, by using this assembly, preventing pathogenic bacterium and infectant from invading patient body through injection site, solving existing technological deficiency.Device disclosed herein, is provided with antimicrobial surface characteristic, for stoping or suppressing this infectant in the breeding of this outside of deivce face and/or survival, achieves above-mentioned target.
In at least one preferred model of disclosed device, arrange antimicrobial surface region in medical treatment device appearance, this device by pipeline, as medical catheter, is connected to target blood or other target area through patient skin.The antibacterial surface performance of this device kills the antimicrobial surface that infectant or pathogenic bacterium maybe can be suppressed to breed or coating provides by a kind of, and this infectant or pathogenic bacterium enter this device by the air of patient skin or application site.During via skin access device, be arranged at coating on device or material need cover certain length, be enough to make this device in the process inserted through skin, some is placed in outside patient's epidermis the face coat of itself and contact skin all the time.This coating or material are overlying on the surface of introducer (as tearable introducer) and Sai Dingge pin and contact skin.In a first preferred model of the present invention, preferably, on the outer surface that antibacterial surface zone-coating is overlying on syringe needle and introducer and/or inner surface, its length starts until pass skin incision and expose certain distance outside epidermis from this device end.In this way, when this device is entered in patient body by skin, pathogenic bacterium are as antibacterial, virus or other is present in epidermis or subcutaneous infectant will only directly contact with the surf zone with antimicrobial coating.
In the model, this device can adopt conventional method well known in the art as after the sterilizations such as heating, steam, chemical treatment or illumination sterilization technology further, seals up for safekeeping with aseptic packaging.During use, this device is taken out from packaging, is supplied to user of service in conventional manner.
But, also can imagine other pattern, in this mode, by certain means for this assembly arranges antibacterial part or antimicrobial surface region, thus for the pre-packaged of existing or stock and the syringe needle of sterilization and introducer arrange antimicrobial coating surf zone.Such as, the anti-biotic material existed with gas form with liquid or vapor phase deposition, was convenient to user before inserting in patient body by existing syringe needle and introducer, it is directly arranged on this syringe needle and introducer.This anti-biotic material can paste, oily or similar form be contained in the spray bottle that can be atomized, and is that existing syringe needle and introducer arrange this antimicrobial coating, thus makes existing syringe needle and introducer have the advantage of this coating for user.This model of the present invention, continues the existing sterile needle and the introducer that use stock, and allows user to arrange antimicrobial coating to it before being applied to patient, for provides the art new practical type because allowing user.
In other preferred model, by dipping or the surf zone otherwise anti-biotic material and performance thereof being arranged at syringe needle and introducer, thus be provided with antibacterial region for it.In addition, it must be noted that, this anti-biotic material can be any applicable expection object and have the material of anti-microbial property.But experiment proves, particularly preferably is, when insertion process completes, the coating formed by one or more anti-biotic materials or the length of surf zone, start at until this face coat exposes epidermis certain distance is advisable from the device end inserting skin at first.
Described material can be one or more in one group of anti-biotic material, and this group anti-biotic material comprises the mixture of the polysiloxanes of nitrofural coating, the mixture of silver or silver ion or Nano silver grain solid solution and sticky polymers coating, the mixture of copper or copper-bearing materials solid solution and sticky polymers coating, chlorhexidine and hydroxyapatite coating or contains in the materials such as chlorhexidine polylactide coating.This group anti-biotic material also comprises the surface after a kind of anodized, and this surface comprises polymer containing chlorhexidine and calcium phosphate coating, viral inhibitors, fungistat and known antibacterial.
For above description, before at least one preferred embodiment of specific explanations invention disclosed herein, should be appreciated that the present invention is not limited to form at the CONSTRUCTED SPECIFICATION hereafter described or represent in accompanying drawing explanation and assembly in force.Invention described herein also can be applicable to other embodiment, and apparent various method for those skilled in the art also can be utilized to implement and realize.Meanwhile, also should be appreciated that wording and term are only used to be described as used herein, and be not considered to be limitation of the present invention.
Same, it will be understood by those skilled in the art that, the concept of institute of the present invention foundation is easy to be used the basis as other structure of design, method and system, thus formed and to be a kind ofly communicated with somewhere in its body through patient skin and from skin incisions, to lean out the device come, and can be used for the multiple objects implementing device disclosed herein.Therefore, importantly, under the precursor not deviating from the spirit and scope of the present invention, claim of the present invention should be considered as comprising these similar structure and methods.
Adopt time in claims for describing various inventive point and embodiment " comprising " one word refer to take over what content including but not limited to institute after " comprising ".Therefore, the use of " comprising " represents that listed elements is for necessity or enforceable, but other element is selectable.This phrase " by ... composition " refer to comprise and be limited to thereafter take over what content.Therefore, this phrase " by ... composition " represents that institute column element is necessary or enforceable, and there is not other element.This phrase " substantially by ... composition " refers to any key element listed after comprising phrase, and is not limited to not disturb or to the activity of institute of the present invention column element or act on other helpful elements.Therefore, phrase " substantially by ... composition " represents that institute column element is necessary or enforceable, but whether other element can according to affecting the activity of listed elements or be used for selecting.
An object of the present invention is, provide a kind of device, this device enters certain target site in its body through the cortex of patient and subcutaneous tissue and forms a passage, and the outer surface of this device and inner surface or the contact layer of one of them arrange anti-microbial property.The Sai Dingge pin such as adopted in medical catheter in implantable intravascular and introducer.
Another object of the present invention is, provides a kind of antimicrobial coating that can be applicable to existing apparatus.
Above-mentioned and other characteristics of objects of the present invention and advantage and the advantage for currently available technology, to become apparent in the following description, and by this explanation and following illustrate in fully disclosed in improve one's methods and realize, but it should not be considered as limitation of the present invention.
Accompanying drawing explanation
Fig. 1 is a schematic diagram of introducer of the present invention, and wherein, decompose and illustrate dilator and sheath assembly, the mid portion of introducer main body is in use wrapped up by sheath and leans out from sheath end, wherein, this introducer arranges antimicrobial coating.
The schematic diagram of a kind of composition model that Fig. 2 applies for introducer, wherein, dilator is coaxially connected with sheath, and introducer body terminal section leans out from sheath.
Fig. 3 is a schematic diagram of Sai Dingge pin, wherein, the outer surface of axial passage and needle main body arranges antimicrobial coating.
Fig. 4 is a kind of using forestland of described device, and wherein, introducer and syringe needle are loaded in aseptic packaging.
Fig. 5 is the another kind of using forestland of described device, wherein, provides a kind of spray bottle or other suitable device, is convenient to user and arranges antimicrobial coating with volatility adhesive carrier form on existing apparatus.
Preferred embodiment of the present invention explanation
Existing quoted figures 1 to 5, wherein similar assembly identifies with Similar reference numerals.Fig. 1 is a device introducer 12 of the present invention, comprises dilator 14 and the sheath 22 that can coaxially be connected with it.This device forms an initial channel through patient skin and subcutaneous tissue.Multiple assemblies of device disclosed herein can be made up of metal, common plastics or the polymeric material being applicable to this task, wherein, and the politef (PTFE) that this polymeric material is such as conventional at present.But, it should be noted that these assemblies can be made up of for any material forming antimicrobial surface of the present invention applicable combination in order to eliminate contact disclosed in this invention or the pathogenic bacterium of adjoining within the scope of patient muscle or epidermis and infectant.
Dilator 14 comprises near-end 16, and wherein, there is a locking nut 17 one end of this dilator, ends at the end 18 of a substantially tapered dilator body 20.Dilator body 20 has a mid portion " I ", and this part is 16 end sections " d " extending to dilator body 20 proximally.Dilator 14 also comprises an inside axial passage 15 surrounded by interior side-wall surface of this elongate body 20, proximally 16 is axially communicated to end 18.Axial passage 15 allows introducer 12 translation or push ahead in above-mentioned pre-aligned seal wire (not shown).
Visible in addition, the elongate body 20 of dilator 14 has antimicrobial surface region 21, and this antimicrobial surface region 21 can be arranged on end section " d ", and this end section " d " leans out with during sheath 22 axial engagement at this dilator 14, as shown in Figure 2.Or this antimicrobial surface 12 can be arranged at through or contact the appearance of all contact surfaces of cortex, or is arranged at rapidly on patient's cortex during insertion or any position that may contact or adjoin this cortex.
Reiterate, should note, dilator body 20 also can be made up of the solid solution of known polymer or plastic material, this polymer or plastic material soak in anti-biotic material as herein described, the polymer formed after solidifying or plastic material solid solution form sheath 22 and/or dilator body 20, as a kind of method of long-term conveying antibacterial.
But, in the preferred pattern of another kind, the inner surface of axial passage 15 and the part or all of outer surface of dilator body 20 can apply or arrange the antimicrobial surface region 21 with anti-microbial property additionally by dipping, plated film or other any mode that can arrange antimicrobial surface region 21 on surfaces externally and internally.In addition, if needed, also can comprise on locking nut 17 at near-end 16 antimicrobial surface region 21 is set.The whole inner surface of axial passage 15 should be antimicrobial surface.Further, during insertion, according to the insertion depth of dilator body 20, antimicrobial surface region 21 should be set at the surf zone of abundance, be covered with any region making contact or adjoin skin or tissue.
It should be noted that any conventional means by this known arranges this antimicrobial surface region 21 on all surface.This conventional means comprises: the vacuum chamber coating, the plasma film coating that adopt for metal and some plasthetics; And adopt anti-biotic material or reagent to be combined with polymeric material, flood on the top layer of destination object and solidify formation antimicrobial polymerizable material solid solution; Or other means anti-biotic material and adhesive carrier being mixed to form antimicrobial surface region 21 known in the art.
One or more these anti-biotic materials, carry out mixing with the material of constituent components itself, or mix with carrier such as polymeric material (as polyurethane or polyurethane-acrylate etc.) etc.This anti-biotic material forms viscous skin, in use through solidifying, is impregnated in solid solution, and is transported to module outer surface.When this polymer and anti-biotic material solidify formation solid solution, this polymeric material should have excellent viscosity and the resistance to elevated temperatures higher than Fahrenheit 250 degree.This can make this device can bear high pressure or other high-temperature sterilization process.
Such as; employing concentration is the silver nitrate of the produced silver ion of 15-25%; and with polymeric material as polyurethane or polyurethane-acrylate are combined; solid solution coating is formed on all surfaces of protection that needs after solidifying; produce a kind of excellent silver ion solid solution antimicrobial surface region 21, its silver produced or silver nitrate distribute equably in formed polymer material layer.
Like this, silver ion is constantly transported to on skin or contact tissue or the surf zone of device that adjoins by the surf zone 21 formed.Within a very long time, contact with skin or muscle and expose insertion point certain distance Anywhere on the surf zone 21 that formed or apply, the silver ion carried can be used as the antibacterial eliminating antibacterial, virus and other infectant.
The surf zone 21 formed or other anti-biotic material comprised in one group of anti-biotic material, or be made up of it completely.This group anti-biotic material comprise the polysiloxanes of nitrofural coating, the copper in curable polymer coating or copper-bearing materials, chlorhexidine and hydroxyapatite compo, in an anodized surface, contain the polylactide coating of chlorhexidine, the polymer containing chlorhexidine and calcium phosphate coating.
As shown in Figure 2, sheath 22 and dilator 14 axial engagement, wherein, sheath 22 has near-end 24, it has a locking nut 17 and handle 31.Proximally 24 extend an elongated cylindrical sheath main body 28, and this main body is communicated to open end 26, and the end section " d " of dilator body 20 is leaning out with self-putting down end 26 during sheath 22 axial engagement.
Sheath 22 also comprises an axial passage 25, and this axial passage 25 is surrounded by the inner passage wall surface being communicated with the opening part of near-end 24 and the cylindrical sheath main body 28 of end 26.The axial passage 25 of sheath 22 is intended to the mid portion " I " of reception dilator body 20 and engages at this, to make the end section " d " of the end 18 of dilator body 20 lean out from the end 26 of sheath main body 22, as shown in Figure 2.
In addition, a preferred object of the present invention is to provide above-mentioned antimicrobial surface region 21.By adopting anti-biotic material, or adopt polymer to make into sheath main body 28 and dilator body 20 with anti-biotic material solid solution, sheath main body 28 and the whole of end section " d " or skin and muscle can be contacted during insertion and expose on the abundant region of epidermis, form antimicrobial surface region 21, with reduce or effectively remove in insertion process operate introducer 12 time insertion point each contact surface on infectant as virus, antibacterial etc.
In addition, the near-end 24 of sheath, locking nut 17 and handle 31 also can be made up of plastic cement or polymeric material or coated with containing the coating of this anti-biotic material or thin film.In addition, preferably, to apply, the mode such as plated film, dipping or embedding, coated with one or more anti-biotic materials as herein described on the outer surface of whole internal channel wall forming axial passage 25, from forming antimicrobial surface region 21.Need point out, " painting " one the use of word be for convenience, be intended to comprise to apply, any mode of plated film, bonding or impregnating arrange described antimicrobial surface region 21.So, be all provided with antibiotic substance or attribute at contact skin and flesh or all regions of adjoining with it, stop or reduce to greatest extent the intrusion of infected particle and pathogenic bacterium.
In one group of surf zone, at least one or more surf zone should cover antimicrobial surface region 21 to make be about to contact skin or protected with the region contacting skin component touch.This group surf zone comprises the medial wall of the inner surface of tube axial 33, the outer surface of needle main body 36, the conduit wall of axial passage 25, the outer surface of sheath main body 28, the end section " d " of dilator body 20 and axial passage 15.
These regions also should comprise mid portion " I " and the handle 31 of dilator body 20 outside, because may touch skin, muscle maybe may touch the assembly being about to during insertion touch skin or muscle.Certainly, the surface of the whole surface of dilator body 20, the surface of sheath main body 28 and syringe needle all should cover antimicrobial surface to realize maximum protection.
As illustrated in figure 3 of the drawings, Sai Dingge pin 30 has the sharp tips 34 of needle main body 36, needle stand 39 and the needle main body 36 being with near-end 32.Needle main body 36 can be made up of metal, and, preferably, antimicrobial surface region 21 is set at the outer surface of needle main body 38 and whole or most of regions of the inner surface that surrounds the tube axial 33 navigating within needle main body 36.Should note, can adopt containing the polymer of anti-biotic material, plastic cement, thin film or gas-phase depositing materials etc., forming antimicrobial surface region 21 on the inside and outside surface of elongated needle head main body 38 described herein, be also surperficial arrange the method for anti-microbial property to arrange this surf zone 21 by other.In most case, if do not assessed the cost, preferably, this antimicrobial surface region 21 should cover the whole outer surface of needle main body 38 and navigate within the inner surface of tube axial 33 of needle main body 38, because their probably always contacts or be about to contact the assembly contacted with patient skin or subdermal muscle.
Fig. 4 is a kind of using forestland of device 10, and wherein, syringe needle 30 and introducer 12 are contained in the common aseptic packaging in this area 40.Packaging 40 has a tearable angle 42, facilitates user to open packaging and takes out syringe needle 30 and introducer 12.But, should notice that syringe needle 30 and introducer 12 have independently surf zone separately, also can carry out disinfection in addition and separate packaging.
Fig. 5 also show the another kind of pattern of disclosed device, provides a kind of means for user arranges antimicrobial coating on existing unprotect device, wherein said unprotect device such as introducer 100 and syringe needle 200.Now, this anti-biotic material is contained in spray bottle 44 or other container, this container ejection solidified carrier mixture, as polyethylene or other polymeric material, be exposed to air or with another kind of firming agent in conjunction with time can solidify.
Anti-biotic material 46 arrange in pairs or groups with polymer or other solidified carrier and is used, person easy to use to spray, to brush, atomizing spraying or similar fashion, at the curable solid solution that a certain region overlay is made up of as silver nitrate polymeric material and antibacterial.Silver ion can be delivered to by institute's preparating mixture 46 at device 100 by this solid solution, on the antimicrobial surface region 21 that the unprotect of 200 is formed on the surface.But, it should be noted that and also can imagine other pattern, provide anti-biotic material, so that user applies on specified device with liquid, gas, cream, oil or similar form.
Show herein and describe whole basic feature of the present invention and characteristic.Specific embodiments of the invention by reference above, are intended to announce amendment scope of the present invention, various change and alternative.But in some cases, when not deviating from spirit of the present invention and interest field, some characteristic of the present invention can not use with other characteristic simultaneously.Should also be clear that when do not deviate from the present invention protection spirit or scope, those skilled in the art can carry out various substitute, modifications and variations.Therefore, all similar amendments, change and substituting is stated within the scope that claim protects all under the invention.
Claims (10)
1. insert pipeline and make itself and patient's venae subcutaneae or tremulous pulse carry out the device be communicated with, it is characterized in that, comprising:
Be provided with the hollow needle of elongated needle head main body, the outer surface of described needle main body extends to sharp tips cusp from head end, described needle main body has inner surface, and the tube axial that described inner surface surrounds is communicated to described extreme apex from described head end, provides the passage that seal wire is walked;
Be arranged on the dilator of described needle main body outside, have an elongated dilator body, described dilator body proximally extends to end, and is provided with outer surface between described near-end and end;
Described dilator body has one from described proximal extension to the mid portion of end section, and described end section is from described end towards described near-end; Described dilator body has axial passage, is surrounded by described medial wall, and described axial passage extends between described proximal openings and described distal opening;
With the sheath of described dilator axial engagement;
Described sheath has an elongated sheath main body, its outer surface extends to corresponding tail end from head end, and is provided with axial passage, and is surrounded by conduit wall, when described axial passage is in described link position, be positioned coaxially at the mid portion of the outer surface of described dilator body;
Be formed at the antimicrobial surface region on the one or more surf zones in one group of surf zone, described one group of surf zone comprises the inner surface of described axial duct, the outer surface of described needle main body, the conduit wall of described axial passage, the outer surface of described sheath main body, the end section of described dilator body, the medial wall of described axial passage; And
In described catheterization procedure, described antimicrobial surface region suppresses or stops pathogenic bacterium to be attached to described surf zone, and in the subcutaneous propagation of described patient.
2. make itself and vein or tremulous pulse carry out the device be communicated with according to the insertion pipeline described in claim 1, it is characterized in that, also comprise:
The described antimicrobial surface region be made up of one or more materials in one group of anti-biotic material, the solid solution that the solid solution that this group anti-biotic material comprises the polysiloxanes of nitrofural coating, the polymer coating of viscosity is combined to form with silver or silver ion or Nano silver grain, sticky polymers coating and copper or copper-bearing materials are combined to form, chlorhexidine is in conjunction with hydroxyapatite coating or contain chlorhexidine polylactide coating.
3. make itself and vein or tremulous pulse carry out the device be communicated with according to the insertion pipeline described in claim 1, it is characterized in that, also comprise:
Be the silver nitrate solution of 15-25% to be combined the sticky polymers coating that formed and to form described antimicrobial surface region with polymeric material by concentration.
4., according to the device described in claim 3, wherein said polymeric material comprises polyurethane or polyurethane-acrylate.
5. make itself and vein or tremulous pulse carry out the device be communicated with according to the insertion pipeline described in claim 1, it is characterized in that, also comprise:
The head end of described sheath is provided with handle, and at least one part of described handle has described antimicrobial surface region.
6. make itself and vein or tremulous pulse carry out the device be communicated with according to the insertion pipeline described in claim 2, it is characterized in that, also comprise:
One end of described sheath is provided with handle, and at least one part of described handle has described antimicrobial surface region.
7. make itself and vein or tremulous pulse carry out the device be communicated with according to the insertion pipeline described in claim 3, it is characterized in that, also comprise:
One end of described sheath is provided with handle, and at least one part of described handle has described antimicrobial surface region.
8. make itself and vein or tremulous pulse carry out the device be communicated with according to the insertion pipeline described in claim 1, it is characterized in that, also comprise:
Described antimicrobial surface has the performance of at least high temperature resistant Fahrenheit 250 degree, and described heat-resisting quantity can make described device accept high-temperature sterilization treatment.
9. make itself and vein or tremulous pulse carry out the device be communicated with according to the insertion pipeline described in claim 2, it is characterized in that, also comprise:
Described antimicrobial surface has the performance of at least high temperature resistant Fahrenheit 250 degree, and described heat-resisting quantity can make described device accept high-temperature sterilization treatment.
10. make itself and vein or tremulous pulse carry out the device be communicated with according to the insertion pipeline described in claim 3, it is characterized in that, also comprise:
Described antimicrobial surface has the performance of at least high temperature resistant Fahrenheit 250 degree, and described heat-resisting quantity can make described device accept high-temperature sterilization treatment.
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| PCT/US2013/029430 WO2013134421A1 (en) | 2012-03-06 | 2013-03-06 | Antimicrobial introducer and needle |
| US13/787,494 US20140257186A1 (en) | 2013-03-06 | 2013-03-06 | Antimicrobial introducer and needle |
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| JP (1) | JP2015510791A (en) |
| CN (1) | CN104507515A (en) |
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| CN107837099A (en) * | 2016-09-18 | 2018-03-27 | 成都测迪森生物科技有限公司 | A kind of push type hair planting apparatus |
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| US9332921B2 (en) | 2013-05-31 | 2016-05-10 | Innovatech, Llc | Anti-microbial electromyography needle |
| US9675793B2 (en) | 2014-04-23 | 2017-06-13 | Becton, Dickinson And Company | Catheter tubing with extraluminal antimicrobial coating |
| US10376686B2 (en) | 2014-04-23 | 2019-08-13 | Becton, Dickinson And Company | Antimicrobial caps for medical connectors |
| US9789279B2 (en) * | 2014-04-23 | 2017-10-17 | Becton, Dickinson And Company | Antimicrobial obturator for use with vascular access devices |
| US10232088B2 (en) | 2014-07-08 | 2019-03-19 | Becton, Dickinson And Company | Antimicrobial coating forming kink resistant feature on a vascular access device |
| US10493244B2 (en) | 2015-10-28 | 2019-12-03 | Becton, Dickinson And Company | Extension tubing strain relief |
| JP2021528163A (en) * | 2018-06-20 | 2021-10-21 | シー・アール・バード・インコーポレーテッドＣ Ｒ Ｂａｒｄ Ｉｎｃｏｒｐｏｒａｔｅｄ | Deployment tools and methods |
| CN116265037A (en) * | 2021-12-16 | 2023-06-20 | 巴德阿克塞斯系统股份有限公司 | Antimicrobial medical device, intravascular catheter assembly, and catheter introducer assembly |
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Also Published As
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| JP2015510791A (en) | 2015-04-13 |
| WO2013134421A1 (en) | 2013-09-12 |
| BR112014021904B1 (en) | 2021-06-08 |
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Application publication date: 20150408 |