CN1383385A - Inflatable medical device maintaining injectors for delivery to localized region - Google Patents

Inflatable medical device maintaining injectors for delivery to localized region Download PDF

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Publication number
CN1383385A
CN1383385A CN99816495A CN99816495A CN1383385A CN 1383385 A CN1383385 A CN 1383385A CN 99816495 A CN99816495 A CN 99816495A CN 99816495 A CN99816495 A CN 99816495A CN 1383385 A CN1383385 A CN 1383385A
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China
Prior art keywords
fluid
blood vessel
described device
described fluid
vessel wall
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Pending
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CN99816495A
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Chinese (zh)
Inventor
丹尼斯·M·比希尔
罗伯特·E·赖斯
彼得·巴拉斯
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InterVentional Technologies Inc
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InterVentional Technologies Inc
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Priority claimed from US09/232,392 external-priority patent/US6210392B1/en
Priority claimed from US09/232,156 external-priority patent/US6102904A/en
Application filed by InterVentional Technologies Inc filed Critical InterVentional Technologies Inc
Publication of CN1383385A publication Critical patent/CN1383385A/en
Pending legal-status Critical Current

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M29/00Dilators with or without means for introducing media, e.g. remedies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/104Balloon catheters used for angioplasty
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M25/1002Balloon catheters characterised by balloon shape
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/0043Catheters; Hollow probes characterised by structural features
    • A61M2025/0057Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/105Balloon 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/1086Balloon catheters with special features or adapted for special applications having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Hematology (AREA)
  • General Health & Medical Sciences (AREA)
  • Biophysics (AREA)
  • Child & Adolescent Psychology (AREA)
  • Pulmonology (AREA)
  • Vascular Medicine (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • Media Introduction/Drainage Providing Device (AREA)
  • External Artificial Organs (AREA)

Abstract

A method and device for injecting fluid into a treatment area of a vessel wall is provided herein. A first version of the device includes an inflatable balloon mounted on a catheter and a plurality of dispensers extending outwardly and moving with the balloon. At least one fluid passageway connects each injector in fluid communication with a fluid source. During use of the device, the balloon is first positioned in a vessel proximate the treatment area. Next, the balloon is inflated to embed the dispensers into the vessel wall. Subsequently, the fluid from the fluid source is introduced into the fluid passageway and through the dispensers into the treatment area. A second version of the device includes a plurality of flexible tubes mounted between a multi-lumen catheter and a grommet. A push-pull wire is connected to the grommet and passed through a lumen of the multi-lumen catheter. The dispensers are mounted on each of the flexible tubes.

Description

Maintain the used inflatable medical treatment device of injection head to the regional drug delivery of fixed point
Technical field
Relate generally to of the present invention is used for the treatment of the medical apparatus of patient's blood vessel.More particularly, the present invention relates to the medical apparatus in a kind of patient's of being inserted into the cardiovascular system, this device can be used for directly to the blood vessel wall injecting fluid.In addition, the invention still further relates to the method for a plurality of different treatment blood vessels.
Background technology
Narrow and/or pathological changes is patient vessel's a FAQs.The arteries urethroptasty is a kind of narrow a kind of operation in the human vas for the treatment of.In the tremulous pulse urethroptasty, have a medical catheter to one and in blood vessel, advance and be contiguous to stenosis up to air bag attached to the inflatable airbag on the catheter shaft.Follow the inflation air bag.This causes in the narrow kitchen range place compression precession astillen and expands whole blood vessel.
Yet angioplasty is used for the treatment of narrow success always in the blood vessel.And, thereby angioplasty can irritate the angiostenosis that blood vessel causes secondary.Its result has proposed multiple other device to use in conjunction with angioplasty.For example, a this device uses an air bag that a plurality of holes are leaned against on the blood vessel wall.Then (blood vessel) endothelium is treated from hole.
Unfortunately, this device is verified is not entirely satisfactory.Especially, install with this, majority, if not all, fluid all can not the penetration rate of blood tube wall and rushed in the blood flow.Because some fluidic toxicity, this operation jeopardizes patient's health.In addition, because fluid is flushed away, relatively invalid to the treatment of blood vessel.
In view of this, an object of the present invention is to provide a kind of apparatus and method, to be used for the treatment of secondary narrow, suppresses narrow generation and/or suppress because that operation wound causes in the blood vessel is narrow.Another object of the present invention provides a kind of device that is used for the treatment of blood vessel, has the mechanism of penetration rate of blood tube wall, and described mechanism and the mechanism of fluid being injected blood vessel wall are what to separate.Another purpose of the present invention provides and a kind ofly can optionally change the dynamics that is used for the penetration rate of blood tube wall and the device of the degree of depth.A further object of the present invention provides a kind of device for the treatment of blood vessel, and it is easy to use and is quite simple and production cost is not high.Of the present invention also have a purpose to provide a kind ofly to be used for the treatment of blood vessel and to the apparatus and method of patient's risk minimum.
Summary of the invention
The present invention is directed to the apparatus and method that satisfy these needs.This device is designed in a vasotropic area for treatment of fluid source and injects a kind of fluid.Described device comprises an expansion member and one or more allocation head.As following proposition, described expansion member optionally and exactly control is allotted the motion of head, and fluid source optionally provides pressure fluid source to allotting head.Thereby making the mechanism that allots a penetration rate of blood tube wall and mechanism to blood vessel wall side release fluids is what to separate.
Importantly, it is narrow that the present invention can be used for treating safely secondary, suppresses restenosis and/or suppress angiostenosis, simultaneously to patient's risk minimum.In addition, the present invention is that focus is specific and allow can be the only vasotropic exactly accurate zone of doctor send fluid.This is important, because many fluids may be deleterious to other zone of health.For example, some fluid may blinding.
In first scheme of the present invention, described expansion member comprises an air bag, and air bag can expand into dilated second configuration from first configuration of a contraction.Allot head radially from air bag stretch out and and air bag between first configuration and second configuration, move together.Allot that head preferably penetrates the blood vessel endothelium layer at area for treatment place and in air bag release fluids optionally during in second configuration.With this configuration, allot a degree of depth that penetrates into blood vessel wall and be subjected to accurately controlling with the dynamics that is used for the penetration rate of blood tube wall.This allows the present invention send out fluid to the appropriate area of blood vessel wall and makes damage minimum to blood vessel wall simultaneously.In addition, described air bag can be used for blood vessel dilating side by side.
At least one fluid passage connects and allots the fluid source that a fluid is communicated with.For example, described fluid passage can comprise a flexible tubular sleeve, and described sleeve pipe comprises and at least a portion of closed airbag outer surface basically.Fluid source comprises a fluid pump with fluid passage in fluid communication, and being used for optionally provides the pressure fluid supply from fluid source to allotting head.
Each allots head can be a piped basically projection, has an attachment end and recessed a section of being used for recessed blood vessel wall.Attachment end comprises a substrate that is directly installed on the tubular sleeve.In some embodiment that the present invention proposes, recessed section is defined by the edge of opening of allotting head.In other enforcement, each allots head can comprise a porous section and a hole, and this hole connects an allocation wall that defines the female section.
Depend on fluid and desirable treatment, fluid can penetrate area for treatment with the allocation head basically and discharge simultaneously, and also can penetrate at the allocation head has a time delay between area for treatment and the release fluids.
The alternative plan of expansion member comprises a multi-cavity catheter, breather, a plurality of flexible pipe and one or more allocation head that is fixed on the described flexible pipe that breather is connected to conduit.Breather can move and flexible pipe is reorientated near blood vessel wall with respect to conduit.
The present invention still is a kind of area for treatment and send fluidic method to area for treatment from fluid source of being used to expand.Described method is included in and advances expansion member in the blood vessel, expanded expansion member in blood vessel, and optionally from allotting head release fluids to area for treatment.The expansion of expansion member causes that each opening of allotting head penetrates area for treatment.In addition, the expansion of expansion structure can also cause that blood vessel expands simultaneously.
The present invention still is the invigorate blood circulation method of tube wall of a kind of treatment.This method comprises the following steps: to provide fluid, advances expansion member in blood vessel, expansion member is moved to one second configuration, thereby allot at least one part of recessed section contact blood vessel wall of head, and at least one part of recessed blood vessel wall and optionally from recessed section to the blood vessel wall release fluids.
Can be with being enough to cause that the speed of the local enlargement of blood vessel wall is forced into fluid from each allocation head in blood vessel wall.This allows fluid be distributed in the blood vessel wall with the fluid that distributes in blood vessel wall.Preferably, in this implemented, the allocation head was properly spaced out and swells to produce a plurality of isolated parts, and these enlargements are one after the other basically around blood vessel wall perimeter distribution fluid.
Type of fluid can be different to adapt to patient's specific needs.More specifically, described fluid can be designed for treatment secondary narrow disease in other words, narrow again by making the influence of performing the operation in blood vessel last time minimize inhibition, and/or suppresses endovascular narrow.For example, in order to suppress restenosis, fluid can contain and is suppressed on certain pathological conditions smooth muscle cell at the anti-proliferative agent of blood vessel internal breeding.The fluid of optionally killing quick somatoblast can be used to suppress the hypertrophy of smooth tissue growth.Suitable fluid can comprise anti-proliferative agent, such as methotrexate, meticortelone, amycin, albumen synthesis inhibitory factor, toxic fragment such as pseudomonas, endotoxin (PE) or ricin A (RA) toxin, and radiosiotope, such as iridium 111, yttrium 90, cadmium 67, technetium 99, thallium 205 and phosphorus 32 radiopharmaceuticals.The present invention who is proposed is suitable for sending dangerous fluid to blood vessel wall safely uniquely, and the Fluid Volume that pours blood flow is minimized.
Flexible ground for example, can send with device of the present invention and irritate blood vessel side shoot circulation fluid.This produces new collateral blood vessels when narrow and provides prophylactic treatment for the patient by developing at original blood vessel.The fluid that comprises a kind of tremulous pulse generation factor inhibitors can be used for this purpose.
Pour the into Fluid Volume of blood flow in order to reduce.Part fluid can be with the pH value precipitation near blood vessel.Typically the pH of blood vessel is about 7.Be less than about 6 or be higher than the fluid of 8pH value thereby can use.After fluid dispense was advanced blood vessel wall, fluidic pH value was near 7 and segment fluid flow precipitation.In this embodiment, described fluid can comprise a kind of precipitant, a kind of active component that is attached to or is included in the precipitant, and a kind of carrier components that carries precipitant and active component.Precipitant is deposited in the blood vessel wall, and carrier part is rushed in the blood flow.Because active component is attached to or is included in the precipitant, so active component is retained in the blood vessel.This amount that fluidic active component is rushed in the blood flow is minimized.For this embodiment, for example fluidic active component can comprise above generalized anti-proliferative agent.Precipitant and active component in addition for example can comprise radioactive nucleus or radiation medicine precipitation, such as gold colloid, i.e. and gold 198 and gold 199 and/or inorganic precipitant.
In addition, fluidic active component can be designed to one slowly, the time discharges prescription, thereby active component is discharged into blood vessel on the time period that prolongs.In other words, active component can be degraded on a period of time lentamente little by little fluidic active component is discharged in the blood vessel wall.Can use a kind of biodegradable polymer that a kind of sustained release prescription to active component is provided.
Flexible ground, described fluid can comprise a kind of bonding agent that is fixed in the fluidic active component.Bonding agent in conjunction with, adhere to or be linked at least one part of blood vessel wall.Bonding agent can comprise an aglucon in conjunction with the smooth muscle cell composition of part such as collagen of blood vessel wall or blood vessel wall.This assurance fluid active component piece falls to being retained in the blood vessel wall and makes the amount that is punched into the fluidic active component in the blood flow minimized.The example that is attached to the aglucon of blood vessel wall composition comprises that pdgf receptor, colloidality molecule include, but are not limited to integral protein family on the activated platelet and some molecule of receptor, such as thrombin receptor.Flexible ground for example can use the phosphorus three tooth peptides that are attached on the collagen.In yet another embodiment, bonding agent can have direct affinity to form ion, covalent bonds or the Robert Van de Walle gravitation to blood vessel or its some composition.
In yet another embodiment, fluid can be used for gene therapy on blood vessel wall.For example, fluid can comprise changes virus, adenovirus vector or carries the related carrier (AAV) of adenovirus that suitable DNA payload is carried out suitable gene conversion.The present invention can use the specific vascular treatment point of gene alteration and not influence the fluid of health remainder.
And, use device of the present invention, the allocation head can extend.This feature makes device of the present invention to send fluid from blood vessel, enters organ or specific tissue regions then through blood vessel wall.
Recognize that importantly device according to the present invention utilizes that a kind of to make the latter of mechanism that allots a penetration rate of blood tube wall and the mechanism of release fluids intravasation wall be what to separate.And described device can change the power that is used for the penetration rate of blood tube wall and blood vessel dilating wall simultaneously.And the fluid of the uniqueness that the present invention proposes makes the Fluid Volume of rushing in the blood flow minimum and be retained in amount maximum in the blood vessel wall.In addition, the present invention also is particularly useful in a radiosiotope and directly is injected in the blood vessel wall.
Brief description
Read this description with reference to accompanying drawing and can understand novelty of the present invention and the present invention itself in its structure and two schemes of its work better.In the accompanying drawing:
Fig. 1 is that an intra-arterial the patient has been placed the patient's of the device with feature of the present invention perspective view;
Fig. 2 is the perspective view with device of feature of the present invention;
Fig. 3 A is placed on the cross-sectional view that the device shown in Figure 2 in patient's the tremulous pulse is got along the 3-3 line among Fig. 2;
Fig. 3 B is the amplification sectional elevation of the allocation head in a tremulous pulse and a plurality of patient's of the being placed on tremulous pulse.
Fig. 4 A is the perspective view with allocation first embodiment of feature of the present invention;
Fig. 4 B is the perspective view with allocation second embodiment of feature of the present invention;
Fig. 4 C is the side view with allocation the 3rd embodiment of feature of the present invention;
Fig. 4 D is the side view with allocation the 4th embodiment of feature of the present invention;
Fig. 5 A is a plurality of perspective views of allotting an enforcement of head with feature of the present invention;
Fig. 5 B is a plurality of perspective views of allotting another enforcement of head with feature of the present invention;
Fig. 6 is the perspective view of another enforcement with device of feature of the present invention;
Fig. 7 is the sectional elevation of getting along the 7-7 line of Fig. 6;
Fig. 8 is the perspective view of another enforcement with device of feature of the present invention;
Fig. 9 is the sectional elevation of device shown in Figure 8, and the configuration of the withdrawal of getting along 9-9 line among Fig. 8 is shown.
Figure 10 is the sectional elevation of device shown in Figure 8, is depicted as the expansible configuration of getting along 9-9 line among Fig. 8.
Figure 11 is the sectional elevation in device shown in Figure 8 patient's when placing the blood vessel;
Figure 12 A is the part of blood vessel and the longitudinal section of allotting penetration rate of blood tube wall device before;
Figure 12 B is the part of blood vessel and the longitudinal section of allotting a penetration rate of blood tube wall device part afterwards;
Figure 12 C is the axial sectional elevation of blood vessel and device, and the allocation head of penetration rate of blood tube wall is shown;
Figure 12 D illustrates the longitudinal section that fluid injects blood vessel wall after the blood vessel wall into;
Figure 12 E illustrates the axial cutaway view to the allocation head of blood vessel wall injection;
Figure 12 G is the axial sectional elevation of blood vessel and device, and the fluid that is distributed in the blood vessel wall is shown;
Figure 13 A is the longitudinal section of blood vessel and device, illustrates to contain radioisotopic fluid and send in blood vessel wall;
Figure 13 B is the part longitudinal section of blood vessel and device, illustrate contain radioisotopic fluid and in blood vessel wall, send after;
Figure 14 A is the longitudinal section of blood vessel and device, the fluid that contains precipitant is shown sends in blood vessel wall;
Figure 14 B is the part of blood vessel and the longitudinal section of device, after the fluid that contains precipitant is shown sends in blood vessel wall;
Figure 15 A is the longitudinal section of blood vessel and device, the fluid that has bonding agent is shown sends in blood vessel wall;
Figure 15 B is the part of blood vessel and the longitudinal section of device, and the part that bonding agent is attached to blood vessel wall is shown;
Figure 16 A is the longitudinal section of blood vessel, the cytogene of blood vessel is shown and has the part of the device of feature of the present invention;
Figure 16 B is the longitudinal section of blood vessel, illustrates with device and inject the fluid that comprises viral gene in blood vessel wall; With
Figure 16 C is the longitudinal section of the part of blood vessel, and viral gene attack cells gene and displacement cytogene are shown.
Describe in detail
At first, referring to Fig. 1, illustrate that a kind of to be used for according to the present invention being placed in patient 2 the upper body be blood vessel 11 to the device 10 that a kind of fluid 13 injects pipe 11 walls of invigorating blood circulation.But install 10 tremulous pulse and the veins that can be used for patient's 12 whole bodies.Importantly as described, this device can substantially symmetrically directly be injected into the periphery of fluid 13 around blood vessel 11 in the blood vessel 11.
With reference to Fig. 2, first scheme with device 10 of feature of the present invention comprises a multi-cavity catheter 14, expansion member mounted thereto 15, a tubular sleeve 18 and a plurality of allocation 20.
Shown in Fig. 2 and Fig. 3 A, expansion member 15 has an inflatable air bag 16.Air bag 16 is inflation and contraction between first configuration of obviously withdrawing and the second obvious expansible configuration at least.Air bag 16 obviously dwindles when first configuration.At the second configuration air bag 16 can be any stage that is inflated to complete inflation from part, and this depends on the size of blood vessel 11.Air bag 16 and tubular sleeve 18 can be used the several materials manufacturing, comprise polyethylene terephthaldehyde ester (PET).
In addition, Fig. 2 illustrates the suitable part that tubular sleeve 18 holds air bag, and a plurality of allocation 20 is installed on the tubular sleeve 18, and certainly, shown allocation 20 is exemplary.
Fig. 3 A provides air bag 16, tubular sleeve 18 and allots proving absolutely of a respective outer side edges between 20, can see among the figure that the far-end of tubular sleeve 18 is attached directly on the outer surface 25 of air bag 16.Fig. 3 A also illustrates near-end 24 near-end ground that piped sleeve pipe 18 held and encapsulated air bag 16 basically and tubular sleeve 18 is shown and stretches out and cross air bag 16 on conduit 14 from air bag 16.Piped sleeve pipe 18 cooperates with the outer surface 25 of air bag 16 to define a part of fluid passage 26.Near-end 24 can be connected to the exocoel 27 (not showing among Fig. 3 A) of conduit 14 to finish fluid passage 26.
The far-end 28 that Fig. 3 A also illustrates air bag 16 is fixed on the conduit 14, and the near-end of air bag 16 attached on the conduit 14 to produce a expanding cavity 32 in air bag 16 inside.Air bag interface 34 can allow fluid enter expanding cavity.Be purpose of the present invention, the airbag chamber (not shown) that air bag interface 34 can connecting duct 14 is in fluid communication with it.Fig. 3 A also illustrates conduit 14 and is formed with an inner chamber 36, and inner chamber 36 sizes are done to such an extent that can hold a guide line 38 through wherein.
Blood vessel 11 comprises a plurality of layers.For the ease of this discussion, some layer, as endodermis 35a, basement membrane layer 35b, lamella 325c and intermediate layer 35d, and theca externa 35e is illustrated among Fig. 3 B.Basement membrane layer 35b, lamella 35c, intermediate layer 35d are thought of as internal layer.Importantly be to allot 20 length by control and accurately control and allot a penetration depth of 20 for device of the present invention.Thereby device 10 can send to fluid 13 destination layer of desirable blood vessel 11.For example, shown in Fig. 3 B, allot 20 and penetrate endodermis 35a, basal layer 35b and lamella 35c and exactly fluid 13 is distributed to intermediate layer 35d, be i.e. destination layer in this example.Flexible ground for example, can send to fluid 13 among the lamella 35c with short allocation 20.In addition, device 10 of the present invention can be used for blood vessel dilating 11 simultaneously.
Referring now to Fig. 4 A,, each is allotted 20 and comprises a substrate 40 and the tubulose projection 42 that an attachment end 44 and a recessed section 46 are arranged.And as can be seen, the attachment end 44 of tubulose projection 42 is linked on the substrate 40 and is an ingredient of substrate 40.Preferably, allot 20 by the nickel manufacturing tubulose projection 42 by going out to form from substrate 40 punching out.In the embodiment shown in Fig. 4 A, recessed section 46 is defined by an opening facing to substrate 40.Tubulose projection 42 is defined one and is passed allocation 20 fluid groove path 48 that extend.It all is annular basically that shown in Fig. 4 A each allots 20.
Fig. 4 B illustrates and allots another enforcement of 20.Each tubulose projection 42 that is shown among Fig. 4 B is conical basically.Similarly, the nickel manufacturing is preferably used in the allocation shown in Fig. 4 B 20, and forms and have the fluid groove path 48 that extends through syringe 20.
Fig. 4 C and 4E illustrate another and allot a variant embodiment of 20.Tubulose projection 42 is conical basically among this embodiment shown in Fig. 4 C to 4E, and still, in Fig. 4 C, recessed section 42 is defined by a hole of extending by the side of tubulose projection 42.Some is recessed into section 46 and is defined by a pair of hole of extending through a side of each tubulose projection 42 similarly in Fig. 4 D.This feature is suppressed at and clogs recessed section 46 when inserting in the blood vessel 11.In Fig. 4 E, tubulose projection 42 is by microporous material manufacture.Thereby microporous material defines each and allots 20 recessed section 46.Basically, in this embodiment, fluid 13 is forced into through microporous tubulose projection 42.
Fig. 5 A is illustrated on the identical substrate 50 and forms a plurality of allocations 20.In more detail, Fig. 5 A illustrates a microscler substrate 50, has formed from this substrate and has allotted 20.In all important schemes, the allocation shown in Fig. 5 A 20 is structurally identical with the above allocation of being discussed with reference to Fig. 4 A 20.Onlyly be not both them and collectively be installed on the identical substrate 50.
Similarly, Fig. 5 B is illustrated on the same substrate 50 and forms a plurality of allocations 20.Allocation shown in Fig. 5 B 20 is structurally identical with the above allocation of being discussed with reference to Fig. 4 B 20.Only difference still is that they collectively are installed on the identical substrate 50.
Look back now Fig. 3 A, allot 20 and be installed on the piped sleeve pipe 18, thereby each corresponding fluid groove path 48 of 20 allotted aligns with the hole 52 in the tubular sleeve 18.Do like this is that fluid in order to be based upon between specific allocation 20 and the transfusing chamber 26 is communicated with.In fact, can be preferably when constructing device 10 at first handle assembly 10 be installed on the tubular sleeve 18, this can carry out in known mode in the field, such as by engaging, pierces through tubular sleeve 18 and carries out through allotting 20 then.
When air bag 16 inflations, extend 18 from 0.005 to 0.02 inches of the allocation of the present invention 20 inclined to one side open pipe shape sleeve pipes.Yet those skilled in the art will appreciate that this is apart from only giving an example.
In of the present invention another shown in Figure 6 implemented, the element of device 10 comprised and forms the conduit 14 of multi-cavity and hold guide line 38; Air bag 16; With the tubulose tank circuit 64 on a plurality of allocations 20 and a plurality of outer surface 25 that is installed in air bag.Each piped tank circuit 64 have one than the little diameter of air bag 16 and place the longitudinal axis 65 of substantially parallel air bag 16.
Fig. 6 further illustrates and is installed on each tubulose tank circuit 64 is to allot 20, is placed on the surface of the tubulose tank circuit 64 when air bag 16 inflations thereby allot 20, allots 20 an outwards motion radially.But, note, illustrate and allot 20 purposes for example just, should be appreciated that any allocation about above enforcement discussion 20 or allot a combination of 20 and can use.
Referring now to Fig. 7,, the section of device 10 is shown specifically the tubulose tank circuit 64.More specifically, the far-end 66 of the tubulose tank circuit 64 is sealed into and produces one allotting 20 parts that are connected to the fluid passage 26 of fluid source 60.Referring to Fig. 6 and Fig. 7, as can be seen, the near-end 68 of the tubulose tank circuit 64 is communicated with exocoel 27 fluids of conduit, and this exocoel is communicated with fluid pump 58 and fluid source 60 fluids.
Referring to Fig. 7, illustrate and allot 20 and be installed on the surface of the tubulose tank circuit 64.Further know clearly as Fig. 7 and to show, the substrate 40 of each allocation 20 is installed on the tubulose tank circuit 64 in 70 tops, corresponding hole.Be appreciated that for last figure any amount of tubulose tank circuit 64 can be installed on the outer surface of air bag 16.Can further understand, any amount of allocation 20 can be installed on the one tubulose tank circuit 64.
Fig. 8 illustrates the alternative plan of expansion member 25, and this expansion member comprises a multi-cavity catheter 80 and a breather 82.Multi-cavity catheter 80 is all distally placed around the longitudinal axis of identical breather 82 with breather 82, thereby and the far-end of multi-cavity catheter 80 separately.
The device that uses some type along longitudinal axis translation the breather 82 that moves.For example, referring to Fig. 8, a push-pull wire 84 is shown is connected on the breather 82.Push-pull wire 84 is passed a chamber of multi-cavity catheter 80 and push-pull wire 84 can be moved along the longitudinal axis to translation.The translational motion of push-pull wire 84 causes that breather 82 stands similar translational displacement.In many cases, can wish that device 10 of the present invention uses together in conjunction with guide line 38.In this case, push-pull wire 84 can form inner chamber, and guide line 38 can pass described inner chamber.
At this alternative plan, pipe 86 a plurality of hollows, flexible is attached to all between trachea 82 and the multi-cavity catheter 80, and each flexible pipe 86 comprises a far-end 88, a near-end 90 and a center 92.The near-end 90 of each pipe 86 is connected to multi-cavity catheter 80.The far-end 88 of each pipe 86 is connected on the breather 82.Preferably, pipe 86 radially distributes in as shown in Figure 8 mode basically around multi-cavity catheter 80 and breather 82.
Referring now to Fig. 9-11,, can see that each flexible pipe 86 is formed with a cavity 94.Flexible conduit 80 is passed in the chamber 94 of flexible pipe 86, allows fluid enter flexible pipe 86 by multi-cavity catheter 80.The chamber 94 of each flexible pipe 86 allows different fluid 13 feed in each flexible pipe 86 by multi-cavity catheter 80 dividually.Flexible ground, the chamber 94 of each flexible pipe 86 can be attached to one in one or a plurality of common chamber of multi-cavity catheter 80 inside.
Fig. 9 and 10 also illustrates a plurality of allocations 20 central area 90 attached to each pipe 86.Each flexible pipe 86 is formed with a plurality of holes 96, and a plurality of holes 96 allot 20 corresponding to each.On the function, each hole 96 is allotted 20 to each and is connected to chamber 94, allows the fluid pump 58 can be from fluid source 60 to chamber 94 pumping fluids 13, is used for discharging through allotting 20.
Fig. 9 and Figure 10 also illustrate the present invention and can move between the expansible configuration (being shown among Figure 10) of the configuration (being shown among Fig. 9) of first contraction and second.In more detail, can see that breather 82 and multi-cavity catheter 80 are separated by one first distance 98.First overall width that device 10 shown in Fig. 9 also has a usefulness 100 to indicate.As a comparison, can see that breather 82 shown in Figure 10 and multi-cavity catheter 80 are separated by second spacing distance 102 less than first spacing distance 98 shown in Fig. 9.Device 10 shown in Figure 10 also has second overall width 104 greater than first overall width 100 shown in Fig. 9.
Configuration that shown in Fig. 9 first shrinks and the difference between the second expansible configuration shown in Figure 10 are finished along the translational motion of the longitudinal axis by breather 82.In more detail, cause breather 82 when multi-cavity catheter moves in push-pull wire 84, each flexible pipe 86 leaves the Y-direction outside sweep.In this way, push-pull wire 84 can be used for the mobile breather 82 in translation ground to cause that pipe 86 is alternately crooked and to stretch, respectively as Figure 10 and shown in Figure 9.In some cases, preferably make flexible pipe 86 by elastomeric material, this material pipe 86 be offset to be bend otherwise be straight configuration.
Referring to Figure 12 A-12F, fluid 13 can allot 20 to be enough to the causing speed of local swelling in the blood vessel 11 wall walls to be forced into the wall of blood vessel 11 from each.This can send in the wall of blood vessel 11 and around the circumferential distribution of blood vessel 11 fluid 13.Preferably, shown in Figure 12 A and 12F, allot 20 spaced apart producing a plurality of isolated office cloth swelling 106, swelling one after the other fluid 13 basically around the periphery dispensing of the wall of blood vessel 11.Produce the fluidic viscosity that local swelling 106 needed speed depend on use.Typically, the fluid 13 between about 400 milliliters to 700 milliliters sent between about five and 45 seconds is enough to produce desirable local swelling.But, will be appreciated that amount that this paper proposes and time are only for example.Time range and the amount that needs to produce desirable local swelling change according to several factors, such as the viscosity of fluid 13.
Producing a plurality of isolated local swellings 106 needed intervals also changes according to the fluid 13 that uses.It is believed that and allot 20 circumferential distance 108 that should separate between about 1 millimeter to 6 millimeters that roughly interval 70 degree are to 140 degree.In addition, the fore-and-aft distance 110 of distributor mechanism 20 between should spaced apart about 0.5 millimeter to 3 millimeters.
The composition that injects the fluid 13 of blood vessel 11 depends on the treatment carried out and patient 12 body constitution.More specifically, fluid 13 can design in treatment secondary narrow or disease, and is narrow again and/or suppress narrow in the blood vessel 11 by making the influence of performing the operation in blood vessel last time minimize inhibition.For example, in order to suppress restenosis, fluid 13 can contain and suppress the interior outgrowth anti-proliferative agent of smooth muscle cell growth of blood vessel under certain pathological conditions.The fluid that is fit to can comprise anti-proliferative agent, such as: methotrexate, meticortelone, amycin, albumen synthesis inhibitory factor, toxic fragment such as pseudomonas, endotoxin (PE) or ricin A (RA) toxin, and radiosiotope, such as iridium 111, yttrium 90, cadmium 67, technetium 99, thallium 205 and phosphorus 32 radiopharmaceuticals.It is believed that the present invention who is proposed is suitable for sending hazardous fluids to blood vessel wall safely uniquely, the Fluid Volume that pours blood flow is minimized.
Flexible ground for example, can send with device of the present invention and irritate blood vessel side shoot circulation fluid.This feature makes it possible to develop into when narrow at original blood vessel provides prophylactic treatment by producing new collateral blood vessels for the patient.The fluid that comprises a kind of tremulous pulse generation factor inhibitors can be used in this purpose.
Figure 13 A and 13B illustrate the fluid 13 that comprises radiosiotope 112, and it can reduce and suppress the growth of the tissue and/or the cell of blood vessel 11.Because radiosiotope 112 be directly be injected into blood vessel 11 and inject symmetrically around the periphery of blood vessel 11, can use the low-energy relatively radiosiotope 112 that the short relatively half-life is arranged.These low-energy relatively radiosiotope should cause minimum damage to patient 12.The device 10 that this paper proposes is suitable for an area for treatment transmission radiosiotope 112 to blood vessel wall 11 safely uniquely, makes the amount minimum of the radiosiotope 112 that is punched in the blood flow simultaneously.In addition, can be encapsulated in radiosiotope 112 in the appropriate carriers, such as epichitosamine modification lipid, described lipid can absorb in the smooth muscle cell of lamella 35c into apace.
The radiological dose that sends in the blood vessel 11 can change to adapt to patient's needs.It is believed that now the dosage that tissue absorbs will be used to suppress restenosis between about 8 to 40 Curie.Be injected into the type of the fluid 13 and the fluid 13 of the accurate amount in the blood vessel 13, can change according to the amount that is punched into the fluid 13 in the blood flow and/or according to life-span of fluid 13.
Referring to Figure 14 A and 14B, minimized for the amount that makes the fluid 13 that pours in the blood flow, a part of fluid 13 can precipitate about the blood vessel pH value greatly.Typically the pH of blood vessel is about 7.Be lower than about 6 or be higher than the fluid 13 of 8pH value thereby can use.After blood vessel wall 11 was advanced in fluid 13 distribution, fluidic pH value was near 7 and segment fluid flow 13 precipitations.In this implemented, fluid 13 can comprise a precipitant 114, a kind of active component 115 that is attached to or is included in the precipitant 114, and a carrier components 117 that is carrying precipitant 114 and active component 115.Active component 15 is intended to treat the part of patient 12 fluid 13.In this example, precipitant 114 is precipitable in blood vessel wall 11, and carrier part 117 pours in the blood flow.
Because active component 115 is attached to or is included in the precipitant 114, therefore guaranteed active component 115 a large amount of in the fluid 13 be retained in the blood vessel and amount that the active component 115 of fluid 13 is rushed in the blood flow minimized.In this implemented, for example the active component 115 of fluid 13 can comprise above generalized anti-proliferative agent.Precipitant 114 and active component 115 in addition for example can comprise radioactive nucleus or radiation medicine precipitant, such as the colloid of gold, i.e. and gold 198 and gold 199 and/or inorganic precipitant.
In addition, the active component 115 of fluid 13 can be designed to one and discharge prescription slowly, in time, thereby active component 115 is discharged into blood vessel wall 11 on the time period that prolongs.In other words, active component 115 can be degraded lentamente on a period of time and is discharged in the blood vessel wall 11 with the active component 115 fluid 13 little by little.Can use a kind of biodegradable polymer to provide writes out a prescription to the sustained release of active component 115.
Flexible ground can comprise a kind of bonding agent 116, active component 115 and carrier components 117 referring to Figure 15 A and the described fluid 13 of 15B.Bonding agent 116 is fixed in the active component 115 of fluid 13.Bonding agent 116 is applicable to combination, adheres to or be linked at least one part of blood vessel wall 11.For example bonding agent 116 can comprise an aglucon in conjunction with the smooth muscle cell composition of part such as collagen of blood vessel wall 11 or blood vessel wall.Because bonding agent 16 is fixed in the active component 115, guarantee being retained in the blood vessel wall 11 in a large number and making the amount of active component 115 of the fluid 13 that is punched in the blood flow minimized of active component 115 of fluid 13.The example that is attached to the aglucon of blood vessel wall composition comprises that pdgf receptor, colloidality molecule include, but are not limited to integral protein family on the activated platelet and receptor such as thrombin receptor.Another kind aglucon is sold with the Ceretec trade (brand) name by the Amersham company that is positioned at Illinois state Arlington Heights.Flexible ground for example can use the phosphorus three tooth peptides that are attached on the collagen.In another flexible enforcement, bonding agent 116 can have direct affinity to form ion, covalent bonds or the Robert Van de Walle gravitation to blood vessel or its some composition.
Flexible ground, shown in Figure 16 A-16C, fluid 13 can be used for blood vessel wall 11 is carried out gene therapy.In this implemented, fluid 13 can comprise the suitable viral vector 118 that is applicable to a cytogene 122 in infection cell 120, modification, inhibition or the reinforcement cell 120.For example fluid 13 can comprise changes virus, adenovirus vector or carries the related carrier (AAV) of adenovirus that suitable DNA payload is carried out suitable gene conversion.Flexible ground for example, can be used for gene therapy to naked DNA or polycation.Blood vessel 11 area for treatment 54 that fluid 13 usefulness gene alterations of the present invention are specific and do not influence the health remainder.
Another fluid 13 that can be used in the present invention comprises antibody, such as acceptor site monoclonal antibody, toxic agents, such as saponin, genetic stew such as DNA, cell material such as endotheliocyte and/or medicine such as heparin.Example provided by the invention only is the example that can be used for fluid 13 of the present invention.Those skilled in the art will appreciate that can develop other medicine and technological improvement.In addition, those skilled in the art will find out that the present invention can be used to suppress restenosis application in addition.For example, with the allocation 20 of lengthening, device 10 of the present invention can send fluid 13 to certain organs from blood vessel, enter organ or specific tissue regions then through blood vessel wall.Application operating
An example of the air bag 16 schemes running of expansion member 15 can be found out with reference to Fig. 1-3 best.At first guide line 38 is inserted in patient 12 the blood vessel 11.Doing like this is to set up the mechanical passage of an intravascular 11 to area for treatment 54, and fluid 13 is discharged at regional 54 places.
Then, on guide line 38, move to area for treatment 54 attached to the air bag on the conduit 14 16.Air bag is in its first configuration in the process that blood vessel 11 moves.In case when air bag 16 correctly is placed near the area for treatment 54, starts an inflator 56 and arrives its second configuration with inflation air bag 16.As shown in Figure 2, inflator 56 is connected to nearly (external) end of device 10.
Look back Fig. 3, as can be seen, along with air bag 16 inflations, expansible air bag 16 is oppressed tubular sleeves 18 and is caused that tubular sleeve 18 similarly expands.Area for treatment 54 is moved and embedded to the allocation 20 that then is installed on the tubular sleeve 18 radially from conduit 14.Further, can use air bag 16 blood vessel dilating 11 simultaneously.
After allotting 20 an embedding area for treatment 54, start the fluid pump 58 shown in Fig. 2 fluid 13 is pumped into fluid passage 26 from fluid source 60.Importantly, this pumping action causes that also any fluid wildcard that has pumped into fluid passage 26 sends out 20 and discharge and enter in the tissue of area for treatment 54.
Flexible ground can start fluid pump 58 before an allocation intravasation, and can stop fluid 13 to flow in diverter 20 embedding area for treatment 54 with valve 63.After allotting 20 a penetration to treat zone 54, can open valve 62, thereby inject simultaneously with allocation 20 an embedding area for treatment 54 basically.Flexible ground can take place after this time delay by waiting for the injection to about 20 second flow bodies 13 at least one approximately second.Further, one or more fluids 13 can be discharged in the blood vessel wall 11 at different time durations.
After fluid 13 was sent treatment region 54 in 80 minutes from fluid source, can loosen air bag 16 to its first configuration by reversing inflator 56.This action causes that air bag 16 shrinks and withdraws from from treatment region 54 allotting 20.Whole device 10 can be withdrawn from from patient 12 on guide line 38.
Embodiment shown in Fig. 6 and 7 uses a plurality of discrete, piped tank circuits 64.Use this embodiment, can or keep fluids to be communicated with, or keep the fluid isolation between each tubulose tank circuit 64 with each tubulose tank circuit 64.For example, fluid between each tank circuit 64 is communicated with can be by each tubulose tank circuit 64 of fluid ground connection together in the exocoel 27 of conduit 14, thus from same fluid pump 58 to each the tubulose tank circuit 64 accommodating fluid 13.Flexible ground by establish an accordingly and independently exocoel 27 and set up its own being connected to corresponding fluid with independent fluid pump 58 to each tubulose tank circuit 64, can keep isolation between each tubulose tank circuit 64.Therefore, might inject various fluid 13 simultaneously by using a plurality of tubulose tank circuits 64 that respectively are connected to fluid pump 58 separately.
With concrete device 10 fluid 13 is injected into area for treatment 54 and illustrates in detail and disclose by this description, may obtain target of the present invention and advantage fully, be to be understood that the preferred embodiment of the present invention that this just is mentioned to.Do not plan structure shown in this article or design details had and be different from the restriction that defines in the appended claims.

Claims (23)

1. device that is used for the treatment of blood vessel wall, described device contains:
A fluid source comprises a kind of fluid;
An expansion member, described member moves between the configuration of a contraction and an expansible configuration;
Allot head for one, described allocation head and expansion member move between collapsed configuration and expanded configuration together; With
A fluid passage is communicated with fluid source with an allocation fluid.
2. the described device of claim 1 is characterized in that, described fluid suppresses the hypertrophy of smooth tissue growth in the blood vessel.
3. the described device of claim 1 is characterized in that, described fluid comprises a kind of radiosiotope.
4. the described device of claim 1 is characterized in that, described fluid irritates the generation of collateral blood vessels.
5. the described device of claim 1 is characterized in that, described fluid comprises technetium 99.
6. the described device of claim 1 is characterized in that, described fluid comprises phosphorus 32.
7. the described device of claim 1 is characterized in that, described fluid is used for gene therapy.
8. the described device of claim 1 is characterized in that, described fluid comprises gold colloid.
9. the described device of claim 1 is characterized in that, described fluid precipitates about the pH value of blood vessel greatly at least in part.
10. the described device of claim 1 is characterized in that, described fluid has the fluid pH value that is different from the blood vessel pH value, and to the described fluid of small part greatly about the pH value of blood vessel precipitation, thereby fluid during near blood vessel pH described fluid be deposited in the blood vessel wall.
11. the described device of claim 1 is characterized in that, described fluid comprises a kind of radiation medicine precipitant.
12. the described device of claim 1 is characterized in that described fluid comprises a kind of inorganic precipitant.
13. the described device of claim 1 is characterized in that described fluid has the pH value that is not higher than about 6pH value.
14. the described device of claim 1 is characterized in that described fluid has the pH value that is not less than about 8pH value.
15. the described device of claim 1 is characterized in that, described fluid comprises a kind of bonding agent that is attached at least a portion of blood vessel wall.
16. the described device of claim 15 is characterized in that, described fluid comprises a kind of aglucon of at least a portion in conjunction with blood vessel wall.
17. the described device of claim 15 is characterized in that, described fluid comprises a kind of aglucon that is attached to collagen.
18. the described device of claim 15 is characterized in that, described fluid has a kind of active component that is fixed to bonding agent.
19. the described device of claim 18 is characterized in that, described fluid has a kind of outgrowth active component that suppresses smooth tissue growth in the wall.
20. the described device of claim 18 is characterized in that, described fluid has a kind of a kind of radioisotopic active component that comprises.
21. the described device of claim 1 is characterized in that, described fluid source forces described fluid to be enough to producing the speed of swelling from allotting an intravasation wall in blood vessel wall.
22. the described device of claim 1 is characterized in that, comprises a plurality of isolated allocation heads, a described allocation spaced apart fluid that makes is sent around the circumference of blood vessel wall basically.
23. the described device of claim 22 is characterized in that, described fluid source forces described fluid to be enough to producing the speed of at least one local swelling from a plurality of isolated allocations intravasation wall in blood vessel wall.
CN99816495A 1999-01-15 1999-12-06 Inflatable medical device maintaining injectors for delivery to localized region Pending CN1383385A (en)

Applications Claiming Priority (4)

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US09/232,156 1999-01-15
US09/232,392 1999-01-15
US09/232,392 US6210392B1 (en) 1999-01-15 1999-01-15 Method for treating a wall of a blood vessel
US09/232,156 US6102904A (en) 1995-07-10 1999-01-15 Device for injecting fluid into a wall of a blood vessel

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CN101045175B (en) * 2006-03-29 2012-07-04 微创医疗器械(上海)有限公司 Double-layered balloon catheter
CN101489623B (en) * 2006-07-24 2013-07-10 Med-El电气医疗器械有限公司 Implantable neuro-stimulation electrode with drug elution material
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CN104436421A (en) * 2014-11-28 2015-03-25 刘宗军 Medicine injectable balloon

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KR20020000860A (en) 2002-01-05
IL144164A0 (en) 2002-05-23
CA2359503A1 (en) 2000-07-20
CA2359503C (en) 2008-05-13
HK1048958A1 (en) 2003-04-25
WO2000041761A1 (en) 2000-07-20
EP1165176A1 (en) 2002-01-02
EP1165176A4 (en) 2006-12-13
JP2003532439A (en) 2003-11-05
AU1337600A (en) 2000-08-01

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