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WO2011055308A1 - Dispositif médical - Google Patents

Dispositif médical Download PDF

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Publication number
WO2011055308A1
WO2011055308A1 PCT/IB2010/054974 IB2010054974W WO2011055308A1 WO 2011055308 A1 WO2011055308 A1 WO 2011055308A1 IB 2010054974 W IB2010054974 W IB 2010054974W WO 2011055308 A1 WO2011055308 A1 WO 2011055308A1
Authority
WO
WIPO (PCT)
Prior art keywords
inflatable
liquid
permeable element
medical device
permeable
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/IB2010/054974
Other languages
English (en)
Inventor
Amos Neheman
Gershon Goldenberg
Hanoch Kislev
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
REALVIEW MEDICAL Ltd
Original Assignee
REALVIEW MEDICAL Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by REALVIEW MEDICAL Ltd filed Critical REALVIEW MEDICAL Ltd
Publication of WO2011055308A1 publication Critical patent/WO2011055308A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • 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
    • A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A61M31/002—Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time
    • 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
    • A61M25/0017—Catheters; Hollow probes specially adapted for long-term hygiene care, e.g. urethral or indwelling catheters to prevent infections
    • 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
    • A61M25/01—Introducing, guiding, advancing, emplacing or holding catheters
    • A61M25/02—Holding devices, e.g. on the body
    • A61M25/04—Holding devices, e.g. on the body in the body, e.g. expansible
    • 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
    • A61M25/10—Balloon catheters
    • A61M25/1002—Balloon catheters characterised by balloon shape
    • 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
    • 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
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/105—Balloon catheters with special features or adapted for special applications having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes
    • 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
    • A61M25/10—Balloon catheters
    • A61M2025/1043—Balloon catheters with special features or adapted for special applications
    • A61M2025/1061—Balloon catheters with special features or adapted for special applications having separate inflations tubes, e.g. coaxial tubes or tubes otherwise arranged apart from the catheter tube
    • 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
    • A61M25/0097—Catheters; Hollow probes characterised by the hub

Definitions

  • Infections associated with medical implants represent a major healthcare problem. For example, 5% of patients admitted to an acute care facility develop a hospital acquired infection. Hospital acquired infections (nosocomial infections) are the 11th leading cause of death in the US and cost over $2 billion annually. Nosocomial infections directly cause 19,000 deaths per year in the US and contribute to over 58,000 others.
  • Urinary tract infection accounts for 28% of the nosocomial infections. A significant percentage of these infections are related to bacterial colonization of implanted medical implants such as Foley catheters. Once such medical implant becomes colonized by bacteria, it must frequently be replaced resulting in increased morbidity for the patient and increased cost to the healthcare system. Often the infected device serves as a source for a disseminated infection which can lead to significant morbidity or even death.
  • the medical device may include a liquid conduit; an inflatable and permeable element; wherein the liquid conduit has an inlet for receiving a liquid and an outlet for providing the liquid to the inflatable and permeable element; wherein the inflatable and permeable element, once inflated with the liquid, allows the liquid to flow through holes in the inflatable and permeable element to form a film of liquid that surrounds an external surface of the inflatable and permeable element; wherein the film of liquid reduces a formation of biofilm on the external surface of the inflatable and permeable element after the inflatable and permeable element may be inserted into a cavity of a person.
  • the inflatable and permeable element may facilitate a continuous flow of the liquid through the inflatable and permeable element.
  • the inflatable and permeable element may facilitate a continuous flow of the liquid through the inflatable and permeable element during a prolonged period that exceeds three days.
  • the inflatable and permeable element may facilitate a continuous flow of the liquid through the inflatable and permeable element during a prolonged period that exceeds a week.
  • the inflatable and permeable element may facilitate a continuous flow of the liquid through the inflatable and permeable element during a prolonged period that exceeds a month.
  • the inflatable and permeable element once inflated, may be arranged to act as a fixation element that prevents the inflatable and permeable element from exiting the cavity of the person.
  • the inflatable and permeable element once inflated may be arranged to act as a fixation element that fixes the inflatable and permeable element to the cavity of the person.
  • Thee inflatable and permeable element may include multiple holes that are spread across the inflatable and permeable element, wherein the multiple holes facilitate the formation of the film of liquid.
  • the medical device may include an outlet for draining body liquids from the cavity of the person.
  • the inflatable and permeable element may facilitate a continuous flow of the liquid through holes of the inflatable and permeable element; wherein the continuous flow of the liquid facilitates a renewal of the film of liquid after a portion of the film of liquid may be detached from the external surface of the inflatable and permeable element.
  • the medical device may include an outlet for draining a body liquid from the cavity of the person and draining the portion of the film of liquid that may be detached from the external surface of the inflatable and permeable element.
  • the medical device may include an inserting element conduit through which an inserting element may be inserted; wherein the inserting element assists in an insertion of the inflatable and permeable element into the cavity of the person.
  • the medical device may be a catheter.
  • the liquid conduit may form a space through which through which an inserting element may be inserted; wherein the inserting element assists in an insertion of the inflatable and permeable element into the cavity of the person.
  • the inflatable and permeable element may be made of silicone.
  • it can be a liquid silicone rubber such as Elastosil LR3003/30 A/B of Wacker Chemie AG.
  • the flow of liquid through the inflatable and permeable element can be few percent till almost hundred percent per month, two months, more than two months, a year, two years and the like. For example, a flow of liquid of about 10% in two years can be provided.
  • the inflatable and permeable element can have a volume of 20 cc but other volumes can be used, including few CCs, 10 CC, more than 20 CC.
  • the inflatable and permeable element may be made of a permeable hydroscopic material.
  • the thickness of a wall of the inflatable and permeable element may be about 200 microns.
  • the liquid conduit may include a valve that allows a flow of liquid to the inflatable and permeable element and prevents a flow of the liquid from the inflatable and permeable element towards the outlet of the conduit.
  • the inflatable and permeable element may have an elasticity coefficient of about 200%.
  • the liquid may include anti-bacterial components.
  • the liquid may include anti-adhesive components.
  • the medical device may include a sensor; wherein the inflatable and permeable element may at least partially surround the sensor.
  • the medical device may include a functional device; wherein the inflatable and permeable element at least partially surrounds the functional device.
  • the medical device may include a second inflatable and permeable element; wherein the second inflatable and permeable element may be arranged to anchor the medical device to a wall of the cavity of the person.
  • a method for implanting an inflatable and permeable element may include: inserting the inflatable and permeable element into a cavity of a person; filling the inflatable and permeable element with a liquid that flows to the inflatable and permeable element through a liquid conduit has an inlet for receiving a liquid and an outlet for providing the liquid to the inflatable and permeable element; wherein the inflatable and permeable element, once inflated with the liquid, allows the liquid to flow through holes in the inflatable and permeable element to form a film of liquid that surrounds an external surface of the inflatable and permeable element; and wherein the film of liquid reduces a formation of biofilm on the external surface of the inflatable and permeable element after the inflatable and permeable element is inserted into a cavity of a person.
  • a method for utilizing an inflatable and permeable element may include: flowing liquid through holes of the inflatable and permeable element that is located in a cavity of a person; wherein the flow of liquid forms a film of liquid that surrounds an external surface of the inflatable and permeable element; wherein the film of liquid reduces a formation of biofilm on the external surface of the inflatable and permeable element after the inflatable and permeable element is inserted into a cavity of a person; and performing a medical action while the inflatable and permeable element is located in the cavity of the person.
  • Figures 1-2 illustrate different views of a medical device, according to an embodiment of the invention.
  • Figures 3-4 illustrate cross sectional views of a medical device, according to an embodiment of the invention.
  • Figure 5 illustrates an inflatable and permeable element according to an embodiment of the invention
  • Figure 6 illustrates a cross section of an inflatable and permeable element according to an embodiment of the invention
  • Figures 7 and 8 illustrate views of a medical device, according to an embodiment of the invention.
  • Figure 9 illustrates a cross sectional view of a medical device, according to an embodiment of the invention.
  • Figure 10 illustrates a medical device and an inserting element that is spaced apart from the medical device, according to an embodiment of the invention
  • Figures 11 and 12 illustrate a medical device and an inserting element that is inserted in the medical device, according to an embodiment of the invention
  • Figure 13 is a cross sectional view of a medical device and an inserting element that is inserted in the medical device, according to an embodiment of the invention
  • Figure 14 is a cross sectional view of a front portion of a medical device and of an inserting element that is inserted in the medical device, according to an embodiment of the invention
  • Figure 15 shows a cross section of a bladder of a person and shows a medical device and an inserting element, before the medical device is inserted in the bladder, according to an embodiment of the invention
  • Figure 16 shows a cross section of a bladder of a person and shows a medical device and an inserting element, when the medical device and an inserting element is inserted in the bladder, according to an embodiment of the invention
  • Figure 17 shows a cross section of a bladder of a person and shows a medical device and a syringe, when the medical device is inserted in the bladder, according to an embodiment of the invention
  • Figure 18 shows a cross section of a bladder of a person and shows a medical device that has an inflatable and permeable element that is inflated within the bladder, according to an embodiment of the invention
  • Figure 19 shows a cross section of a bladder of a person and shows a medical device that drains the bladder, according to an embodiment of the invention
  • Figure 20 illustrates a method according to an embodiment of the invention
  • Figure 21 illustrates a method according to an embodiment of the invention
  • Figure 22 illustrates a medical device, according to an embodiment of the invention
  • Figures 23-24 illustrate cross sectional views of a medical device, according to an embodiment of the invention.
  • Figure 25 illustrates a cross section of an inflatable and permeable element and of a catheter body and illustrates a camera and a cable according to an embodiment of the invention
  • Figure 26 illustrates a medical device, according to an embodiment of the invention
  • Figures 27-28 illustrate cross sectional views of a medical device, according to an embodiment of the invention.
  • Figure 29 illustrates a medical device, according to an embodiment of the invention.
  • Figures 30-31 illustrate cross sectional views of a medical device, according to an embodiment of the invention.
  • Figure 32 illustrates a cross section of an inflatable and permeable element and of a catheter body and illustrates a camera and a cable according to an embodiment of the invention
  • Figure 33 illustrates a medical device according to an embodiment of the invention.
  • Figures 34 and 35 illustrate a cross section of the medical device along two imaginary planes, according to an embodiment of the invention.
  • permeation (which may be a continuous permeation, but not necessarily so) of certain organic liquid compositions through an inflatable and permeable element.
  • the inflatable and permeable element acts as an enclosure and may enclose a functional device such as a sensor, a video camera, an ultrasound transceiver and the like.
  • the inflatable and permeable element may be a balloon, may be an enclosure, an envelope and the like.
  • the inflatable and permeable element may include (or be made of) a porous polymer membrane.
  • the inflatable and permeable element is provided with liquid and can allow the liquid to pass through and provide a protective layer (film) that may reduce a growth of biofilm (or other forms of undesirable biological contamination) on inflatable and permeable element or on a functional device that may be at least partially surrounded by the inflatable and permeable element.
  • the inflatable and permeable element can contact body fluids (and can even be immersed in the body fluids) and the flow of liquid through the inflatable and permeable element can prevent or reduce the growth of biofilm once the inflatable and permeable element contacts the body fluids.
  • the continuous permeation of the liquid can minimize the accumulation of protein from the body fluid on an external surface of the inflatable and permeable element and can interfere with the bacteria adhesion process on the external surface of the inflatable and permeable element.
  • the protein layer is considered a pre-condition which promotes bacterial attachment onto surface in continuous contact within the body fluid. Thus, preventing a growth of the protein layer, slowing down the growth of the protein layer, and removal of the protein layer can reduce and even prevent the bacterial attachment.
  • the medical device can move in relation to the cavity of the person and can even contact the wall of the cavity.
  • This movement and especially a contact inducing movement can cause biofilm and/or protein that started to develop on (or to be attached to) an external surface of the inflatable and permeable element to be removed from the inflatable and permeable element.
  • a portion of a liquid film formed on the external surface of the inflatable and permeable element can be detached from the inflatable and permeable element due to such movement (and/or contact) but it replaced be replaced by new film portion that is formed from liquid that diffuses (or otherwise propagates) through the inflatable and permeable element.
  • the inflatable and permeable element can be used to drain the cavity of the person from body fluids.
  • detached matter such as detached biofilm, detached proteins and even detached liquid
  • detached liquid can also be drained.
  • the drainage may cause the cavity to collapse or otherwise increase the frequency (and/or duration and) of contact between a wall of the cavity and the inflatable and permeable element, can increase a duration of contact between the inflatable and permeable element and. This can increase the regeneration of new film portions that are cleaner than previously detached portions of the film.
  • the inflatable and permeable element has a wall that can be made of a hydrophobic and permeable material that can operate as a membrane that can be wetted by the liquid (such as a liquid organic composition) and permit its diffusion through wall.
  • the wall can prevent body liquids (such as water) from diffusing into the inflatable and permeable element.
  • body liquid droplets may not be formed within a liquid conduit (such as an inflation lumen) of the medical device.
  • the inflatable and permeable element may provide sufficient control on biofilm growth adjacent to and also inside the inflatable and permeable element. Thus, the possibility of subject's cavity bacterial contamination is minimized.
  • the liquid the passes through the inflatable and permeable element can include anti-bacterial materials (can form an antibacterial composition), which is effective against biofilm growth adjacent to the organic liquid - body liquid interface.
  • the biofilm growth can be related to the generation of small two phase regions embedded within the film of liquid (such as an oil layer) formed on the external surface of the inflatable and permeable element.
  • Various substances such as proteins that are present in the body liquid can diffuse into said two phase regions.
  • these regions e.g., tiny air bubbles, tiny water droplets in oil
  • the flow of liquid, the chemical structure of the liquid, and additionally or alternatively, the replacement of liquid film portion by another film portion may prevent or otherwise reduce the growth of a biofilm.
  • Using such an inflatable and permeable element with a liquid that may be an organic liquid composition that does not dissolve in water or other body liquids, can enable a relatively high and constant concentrations of said anti-bacterial agent within an organic liquid layer (film) formed on the external surface of the inflatable and permeable element.
  • a liquid that may be an organic liquid composition that does not dissolve in water or other body liquids
  • one or more anti-bacterial agents of the liquid can effectively control biofilm growth on the organic liquid/ body liquid interface.
  • Such an anti-bacterial agent can be a composition which may kill, impede differentiation, reduces toxic effects, prevent bacterial adhesion to the external surface of the inflatable and permeable element, or induces apoptosis in micro-organisms.
  • An antibacterial agent may be (but is not limited to) an antibiotic, a biocide, a bacteriocine, an antimicrobial enzyme, an anti-adhesion composition, a peptide and a phage.
  • the anti-bacterial agent may be integrated into the wall of the inflatable and permeable element.
  • the integrated anti-bacterial agent can be operable to minimize bacteria attachment onto the wall of the inflatable and permeable element.
  • the said composition is in the form of nanoparticles which accumulate pure water around them.
  • said the liquid includes specific molecules which prevent bacteria attachment on body lumens
  • the medical device can include a functional device or be arranged to at least partially support such a functional device.
  • the functional device is functional in the sense that executed a function (such as a medical operation) during at least a portion of the period in which the inflatable and permeable element is within the cavity of the person.
  • Non-limiting examples of a functional device may include an image recorder, ultrasound transceiver, and another type of sensor.
  • the functional device (or at least a portion thereof) can be coated or otherwise surrounded by a wall of the inflatable and permeable element.
  • the medical device can include multiple inflatable and permeable elements.
  • one inflatable and permeable element may be used to protect a functional device, while another inflatable and permeable element can be used to anchor the catheter to the cavity (for example- to the bladder), as in Foley catheter.
  • the first inflatable and permeable element can include one or more conduits (such as lumens), electrical cables etc.
  • at least one inflatable and permeable element may be in the shape of near-spherical, toroid, cylinder etc. it is noted that according to such an embodiment of the invention, the lumens of both sections may be inter-connected so as to enable organic liquid filling through a single port.
  • the functional device of the medical device can be an imaging device.
  • the suggested medical device can include or can at least partially surround an image sensor and provide biofilm control for extended periods within the patient body.
  • a wall of the inflatable and permeable element be placed on the imaging sensor or at least may be placed on an imaging window or an imaging area of the image sensor and thus may prevent or reduce the growth of biofilm.
  • the inflatable and permeable element may minimize visibility interference for the image recording device.
  • a continuous liquid permeation through the wall of the inflatable and permeable element may enable sufficient quality imaging of cell, tissue or organ designed to be viewed by the said image recording device.
  • the medical device also referred to as a medical implant
  • said functional device is an image recording device that can image the interior wall of the bladder.
  • the image recording device is designed to record multiple images of the bladder internal surface.
  • the inflatable and permeable element enables detection of findings on the bladder internal surface by said image recording device throughout its stay (which may be prolonged) within the bladder.
  • the medical device is a medical implant.
  • the medical implant can be implantable within subject's body cavity. It is noted that the medical implant may include means for actively controlling, preventing, or limiting growth of biofilm on its surface.
  • the following description relates mainly to a medical device that is a catheter that is aimed to drain a bladder of a person.
  • the inflatable and permeable element is a fixation balloon that is used to fix the catheter to the bladder and is inflated with liquid that may flow through the inflatable and permeable element can prevent (or reduce) biofilm growth on the inflatable and permeable element.
  • FIGS 1-4 and 7-9 illustrate a medical device such as catheter 200, according to an embodiment of the invention. It is however noted that the medical device 200 is not limited to the examples offered in the drawings, and that this drawings are offered by way of example only, and not intending to limit the scope of the invention in any way.
  • the catheter 200 may include various components such as some or all of the following components: catheter body 210, an outlet such as opening 220, an inflatable and permeable such as fixation element 250, a drainage conduit such as drainage lumen 230, a liquid conduit such as an inflation lumen 240.
  • the drainage lumen 230 is used for draining of body fluids from catheter body 210.
  • the body fluids enter the catheter body via the opening 220 and can flow through a conduit such as drainage lumen 230 till it flows out of the catheter 200.
  • the drainage lumen 230 can also act as an insertion device conduit through which an insertion device 280 can propagate.
  • the insertion device 280 can assist in the insertion of the medical device into a cavity of a person.
  • a front end of the insertion device can precede the front end of the (non-inflated) fixation balloon 250.
  • the inflation lumen 240 has an inlet and an outlet.
  • the outlet of the inflation lumen allows liquid that is inserted in the inflation lumen 240 to enter the fixation element 250.
  • the inlet of the inflation lumen 240 allows the liquid to enter the inflation lumen 240.
  • the liquid can be injected in the inflation lumen 240 by a syringe (such as syringe 290 of figure 18).
  • the inflation lumen 240 can include a valve (denoted 242 in figures 4 and 9) that allow a flow of liquid from the fixation element 250 and prevent the fixation lumen 250 from being drained from liquid. It is noted that such a valve can be connected to the inlet of the inflation lumen 240, to the outlet of the inflation lumen 240 or between the inlet and outlet of the inflation lumen 240. It is noted that multiple valves can also be provided.
  • the fixation balloon 250 can be used for fixation of the catheter 200 with respect to the body of the person after being inserted into the cavity of that person.
  • the valve 242 can be opened (tilted to open the inflation lumen 240) by the syringe itself or by the force applied by the liquid that is injected into the inflation lumen 240.
  • the anti-bacterial composition may include nano-particles operable for biofilm control. It is noted that according to an embodiment of the invention, the envelope of the medical implant may be operable for limiting the transport of those nano-particles into liquids within said subject's body cavity.
  • medical implants as herein disclosed may be used in various body parts of the subject.
  • the medical implant may at least partially dwell from the bladder of the subject.
  • Figures 5 and 6 illustrate an inflatable and permeable element such as a fixation balloon 250 can have an elastic and permeable wall 266 that can be inflated to provide an inner space 264 in which the liquid can be stored.
  • the liquid diffuses through the elastic and permeable wall 266 and forms a thin film (layer) of liquid 269 that prevents or reduced the formation of biofilm on the external surface 268 of the elastic and permeable wall 266.
  • the diffusion is illustrated (in figure 5) by arrows 222.
  • the holes through which the liquid diffuses are illustrated by dashed arrows 371.
  • Dashed arrows 221 of figure 5 illustrate the provision of liquid from the liquid conduit 240 to inner space 264.
  • Arrows 111 illustrate the drainage of body fluids into the outlet and the drainage lumen 230.
  • the liquid can be an organic liquid composition that may include an antibacterial agent that is dissolved or suspended within the organic liquid composition. It may diffuse through the elastic and permeable wall 266 (that may act as a hydrophobic membrane) and sweep with it promoting substances 135 which attach on droplets (also referred to as two phase regions or bio-growth regions 140) that are adjacent to the external surface of the elastic and permeable wall 266.
  • an antibacterial agent that is dissolved or suspended within the organic liquid composition. It may diffuse through the elastic and permeable wall 266 (that may act as a hydrophobic membrane) and sweep with it promoting substances 135 which attach on droplets (also referred to as two phase regions or bio-growth regions 140) that are adjacent to the external surface of the elastic and permeable wall 266.
  • said promoting substances 135 promote the conditions for the accumulation of anti-bacterial agent 120 on said two phase regions 140 which in turn prevents or control bacterial growth on the two phase regions 140.
  • a functional device (not shown) can be at least partially included in the inner space 264.
  • the elastic and permeable wall 266 or at least a portion of the elastic and permeable wall 266 can be transparent or at least partially transparent and thus may be used to cover a sensing area of an imaging device.
  • the invention may be used for enclosing a functional device that may include: (a) an electronic image recording device; (b) an optical imaging assembly suitable for imaging cell, tissue or organ within said cavity, onto said image recording device; (c) a lighting source; (d) an electric power source; and (e) a communication module, operative to transmit at least portions of the captured images to an external recorder.
  • the biofilm growth rate on the external wall surface is sufficiently low to ensure proper imaging of said cell, tissue or organ onto said image recording device during its intended operational period.
  • the organic liquid composition may not be limited to the envelope itself, and that permeation of the organic liquid composition may lead to permeation of liquid to other compartments of the medical device implant in which external surfaces of the functional device may be included, such as the wall 270 that leads to the fixation balloon.
  • Figures 15-19 illustrate a medical device, an insertion element and a bladder of a person during an insertion process of the medical device and during a drainage period, according to various embodiments of the invention.
  • the insertion process may start with inserting the inserting element 280 into (or through) a drainage lumen 230 that acts as an insertion element conduit.
  • a distal portion 281 of the insertion element 280 may be placed in front of a first end 251 of fixation balloon 250 and in front of a first end 211 of the catheter body 210.
  • the inserting of the inserting element 280 may be carried out during manufacturing, or in another stage prior to the medical operation of implanting the medical implant.
  • the process may continue with an insertion of the medical device 200 into its target location in the body of the subject (e.g. a bladder). This is illustrated in figure 16.
  • the distal end of the inserting device 280 has a smaller cross section than the first edge of the catheter and precedes the latter edge thus is eases the insertion of the catheter into the bladder.
  • a liquid can be provided to the catheter from a syringe (or other vessel or connecting tube).
  • the fluid may pass through the body of the catheter (and especially via one or more liquid conduits) and inflate the fixation balloon 250.
  • Figure 17 shows the syringe 290 and also shows the catheter without the insertion element 280. While figure 17 illustrates the fixation balloon in a non-inflated state, figure 18 illustrates the fixation balloon in an inflated state.
  • the catheter While the catheter is inserted into the bladder it can drain body fluids such as urine.
  • the liquid forms a film that prevents or reduced biofilm growth on the external surface of the fixation balloon.
  • the catheter 200 drains the body fluids to a collection bag 320.
  • the collection bag 320 receives fluids from a drainage pipe 330 that is inserted in the drainage lumen 230.
  • Figure 20 illustrates a method 400 according to an embodiment of the invention.
  • the method may starts by stage 410 of inserting the inflatable and permeable element into a cavity of a person.
  • Stage 410 is followed by stage 420 of filling the inflatable and permeable element with a liquid that flows to the inflatable and permeable element through a liquid conduit has an inlet for receiving a liquid and an outlet for providing the liquid to the inflatable and permeable element.
  • the inflatable and permeable element once inflated with the liquid, may allow the liquid to flow through holes in the inflatable and permeable element to form a film of liquid that surrounds an external surface of the inflatable and permeable element. Once inflates the pressure within the inflatable and permeable element may exceed the pressure within the cavity of the person. This pressure difference may induce the liquid to exit the inflatable and permeable element, for example by diffusion.
  • the film of liquid may reduce a formation of biofilm on the external surface of the inflatable and permeable element after the inflatable and permeable element is inserted into a cavity of a person.
  • Stage 420 may be repeated multiple times, thus increasing the period during which the medical device can be maintained in the cavity of the person.
  • the repletion can be triggered by a lapse of time, by a fullness level of the liquid in the inflatable and permeable element, by a required pressure in the inflatable and permeable element, and the like.
  • Figure 21 illustrates a method 500 according to an embodiment of the invention.
  • Method 500 includes stages 505, 510, 520 and 530.
  • Stage 510 includes flowing liquid through holes of the inflatable and permeable element that is located in a cavity of a person; the flow of liquid forms a film of liquid that surrounds an external surface of the inflatable and permeable element; the film of liquid reduces a formation of biofilm on the external surface of the inflatable and permeable element after the inflatable and permeable element is inserted into a cavity of a person
  • Stage 520 includes performing a medical action while the inflatable and permeable element is located in the cavity of the person.
  • Stage 510 may include flowing the liquid in a continuous manner through the inflatable and permeable element.
  • Stage 510 may include flowing the liquid in a continuous manner through the inflatable and permeable element during a prolonged period that exceeds three days.
  • Stage 510 may include flowing the liquid in a continuous manner through the inflatable and permeable element during a prolonged period that exceeds a week.
  • Stage 510 may include flowing the liquid in a continuous manner through the inflatable and permeable element during a prolonged period that exceeds a month.
  • Stage 510 may include (or can be followed by anchoring, to a wall of the cavity of the person) by a medical device that includes the inflatable and permeable element.
  • the anchoring can be executed by a second inflatable and permeable element.
  • Method 500 may include stage 530 preventing the inflatable and permeable to exit the cavity of the person.
  • Stage 530 may include fixing the inflatable and permeable element to a wall of the cavity of the person.
  • Stage 510 can include flowing the liquid through holes (such as microscopic holes) that are spread across the inflatable and permeable element.
  • Stage 520 may include draining a body liquid from the cavity of the person.
  • Stage 510 of flowing a liquid can result in renewing of the film of liquid after a portion of the film of liquid is detached from the external surface of the inflatable and permeable element.
  • Stage 520 may also include draining liquid that was detached from the film of liquid that is detached from the external surface of the inflatable and permeable element.
  • Stage 510 and 520 may be preceded by stage 505 of inserting the medical device in the cavity of the person.
  • the inserting may be preceded by inserting an inserting element through a conduit of the medical device. This conduit may also be used for drainage of body liquids from the cavity of the person. It is noted that the inserting element may assist in an insertion of the inflatable and permeable element into the cavity of the person.
  • Stage 520 can include sensing at least one parameter of the person by a sensor that is at least partially surrounded by the inflatable and permeable element.
  • the medical device includes an indicator such as a PH indicator, a pressure sensor, or a color sensor etc., for indicating a state (e.g. amount, permeation) of the organic liquid composition.
  • an indicator such as a PH indicator, a pressure sensor, or a color sensor etc., for indicating a state (e.g. amount, permeation) of the organic liquid composition.
  • Figures 22, 23, 26, 27, 29 and 30 illustrate various views of medical device 210, according to an embodiment of the invention.
  • Figure 24, 25, 28, 31 and 32 illustrate portions of the medical device 201 including a functional device such as a camera 700 according to various embodiments of the invention.
  • the camera 700 and a lens 701 may be surrounded by the inflatable and permeable element 250 or by a wall (or envelope or any other surrounding element) that is made of the same material as the inflatable and permeable element 250.
  • the inflatable and permeable element 250 has a first portion 253 that may act as a fixation element and a second portion 251 that encloses the camera 700 and the lens 701. Both portions 251 and 253 allow a liquid to flow (from a space 252) and through holes in the inflatable and permeable element 250 to form a film of liquid that surrounds an external surface of the inflatable and permeable element 250.
  • the liquid can be transparent or at least partially transparent and the same applies to the second portion 251 that encloses the camera 700 (or at least encloses the lens 701).
  • the camera 700 is illustrates as being connected to wires 702 that in turn are included in a cable 703. It is noted that the camera 700 can be wireless.
  • the camera 702 is illustrates as being placed before the first portion 253 but is may be parallel or even may follow the first portion 253.
  • the camera 700 can be inserted through the drainage lumen 230 before the insertion to the cavity of the person, during the insertion or after the insertion, but this is not necessarily so.
  • the camera 700 can be placed before the drainage lumen 230 (for example can be connected (directly or indirectly) to the front end of the body 210 of the medical device even before the medical device is inserted to a cavity of a person.
  • the camera 700 and the first portion 251 can act as an insertion device.
  • the walls of the inflatable and permeable element 250 and the camera 700 can form an inner space 252 in which the liquid can flow.
  • the second portion 251 that encloses the camera 700 can be inflatable but may be non-inflatable. In this sense only a portion of the inflatable and permeable element 250 should be inflatable.
  • the liquid conduit can include structural elements and, additionally or alternatively, can include multiple outlets.
  • the liquid conduit was illustrated as being an inflation lumen 240 having an annular cross section - the liquid would flow through a space defined by two co-axial cylinders. It is noted that the liquid conduit can have other shapes.
  • the structural elements can be made of the same material of the inflatable and permeable element but this is not necessarily so. The structural elements may allow a diffusion of liquid between liquid lumens but this is not necessarily so.
  • Figure 33 illustrates a medical device 3333 according to an embodiment of the invention.
  • Figures 34 and 35 illustrate a cross section of the medical device 3333 along two imaginary planes (D-D and H-H) illustrated in figure 33, according to an embodiment of the invention.
  • the medical device 3333 has multiple liquid lumens 252(1) - 252(5) that are spaced apart from each other from each other.
  • the liquid lumens can be spaced apart by one or more supporting elements that may increase the structural strength of the liquid conduit in comparison to the dual co-axial inflation lumen 240 of the previous figures.
  • the multiple liquid lumens 252(1) - 252(2) may be arranged in a zone that has an annular cross section and surrounds the drainage lumen 230. Some of the multiple lumens may have a curved cross section but other shapes and arrangements can be provided. The different liquid lumens can differ by shape, by size, or may have the same shape or size or both.
  • Figures 34 and 35 illustrates a circular liquid lumen 252(5) that is positioned at the top of the annular shaped zone and four liquid lumens 252(1) - 252(4) that have a curved cross section and are spaced in a symmetrical manner.
  • the openings of the liquid lumens 252(1) - 252(5) are located within the inflatable and permeable element 250.

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Hematology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Anesthesiology (AREA)
  • Biophysics (AREA)
  • Pulmonology (AREA)
  • Chemical & Material Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • Child & Adolescent Psychology (AREA)
  • Epidemiology (AREA)
  • Urology & Nephrology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

L'invention porte sur un dispositif médical pouvant comprendre un conduit de liquide, un élément gonflable et perméable, le conduit de liquide possédant une entrée destinée à recevoir un liquide et une sortie destinée à acheminer le liquide vers l'élément gonflable et perméable, l'élément gonflable et perméable, une fois gonflé par le liquide, permettant au liquide de s'écouler par des trous dans l'élément gonflable et perméable pour former un film liquide entourant la surface extérieure de l'élément gonflable et perméable et le film liquide se réduisant à la formation d'un biofilm sur la surface extérieure de l'élément gonflable et perméable après que l'élément gonflable et perméable ait été inséré dans une cavité chez une personne.
PCT/IB2010/054974 2009-11-05 2010-11-03 Dispositif médical Ceased WO2011055308A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US25823809P 2009-11-05 2009-11-05
US61/258,238 2009-11-05

Publications (1)

Publication Number Publication Date
WO2011055308A1 true WO2011055308A1 (fr) 2011-05-12

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WO (1) WO2011055308A1 (fr)

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102011110778A1 (de) * 2011-07-21 2013-01-24 Ullrich Otto Katheter, insbesondere Verweilkatheter, zur Behandlung von Funktionsstörungen und/oder Erkrankungen der Blase und/oder der Prostata
ITMI20122062A1 (it) * 2012-12-03 2014-06-04 Cryoservice & Medical Devices S R L Catetere con guaina a dissipazione controllata di liquido
JP2014236951A (ja) * 2013-06-05 2014-12-18 根鎬 李 感染防止構造の小児用尿道挿入用カテーテル
US20200230366A1 (en) * 2019-01-18 2020-07-23 Becton, Dickinson And Company Intravenous therapy system having a needle hub and catheter hub
JP2021104332A (ja) * 2019-12-26 2021-07-26 ニューラヴィ・リミテッド 血管内カテーテル

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US5417657A (en) * 1993-10-06 1995-05-23 Hauer; Carolyn No-sepsis urinary drainage catheter
US20060178571A1 (en) * 2001-06-01 2006-08-10 Diametrics Medical Limited Apparatus and method for determining organ perfusion
US20080027416A1 (en) * 2006-07-25 2008-01-31 Hamel Kory P Catheter with Light Source
US20080058864A1 (en) * 2003-06-04 2008-03-06 Accessclosure, Inc. Occlusion member and tensioner apparatus and methods of their use for sealing a vascular puncture

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US5417657A (en) * 1993-10-06 1995-05-23 Hauer; Carolyn No-sepsis urinary drainage catheter
US20060178571A1 (en) * 2001-06-01 2006-08-10 Diametrics Medical Limited Apparatus and method for determining organ perfusion
US20080058864A1 (en) * 2003-06-04 2008-03-06 Accessclosure, Inc. Occlusion member and tensioner apparatus and methods of their use for sealing a vascular puncture
US20080027416A1 (en) * 2006-07-25 2008-01-31 Hamel Kory P Catheter with Light Source

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
DE102011110778A1 (de) * 2011-07-21 2013-01-24 Ullrich Otto Katheter, insbesondere Verweilkatheter, zur Behandlung von Funktionsstörungen und/oder Erkrankungen der Blase und/oder der Prostata
DE102011110778B4 (de) * 2011-07-21 2016-03-17 Ullrich Otto Katheter, insbesondere Verweilkatheter, zur Behandlung von Funktionsstörungen und/oder Erkrankungen der Blase und/oder der Prostata
ITMI20122062A1 (it) * 2012-12-03 2014-06-04 Cryoservice & Medical Devices S R L Catetere con guaina a dissipazione controllata di liquido
JP2014236951A (ja) * 2013-06-05 2014-12-18 根鎬 李 感染防止構造の小児用尿道挿入用カテーテル
US20200230366A1 (en) * 2019-01-18 2020-07-23 Becton, Dickinson And Company Intravenous therapy system having a needle hub and catheter hub
WO2020150472A1 (fr) * 2019-01-18 2020-07-23 Becton, Dickinson And Company Système de thérapie par intraveineuse comportant une embase d'aiguille et une embase de cathéter
KR20210118423A (ko) * 2019-01-18 2021-09-30 백톤 디킨슨 앤드 컴퍼니 바늘 허브 및 카테터 허브를 갖는 정맥내 치료 시스템
US11850381B2 (en) 2019-01-18 2023-12-26 Becton, Dickinson And Company Intravenous therapy system having a needle hub and catheter hub
AU2020208428B2 (en) * 2019-01-18 2025-01-30 Becton, Dickinson And Company Intravenous therapy system having a needle hub and catheter hub
KR102844065B1 (ko) * 2019-01-18 2025-08-12 백톤 디킨슨 앤드 컴퍼니 바늘 허브 및 카테터 허브를 갖는 정맥내 치료 시스템
JP2021104332A (ja) * 2019-12-26 2021-07-26 ニューラヴィ・リミテッド 血管内カテーテル
JP7648031B2 (ja) 2019-12-26 2025-03-18 ニューラヴィ・リミテッド 血管内カテーテル

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