CN1835715A - Vascular wound closure device - Google Patents
Vascular wound closure device Download PDFInfo
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- CN1835715A CN1835715A CN 200480023342 CN200480023342A CN1835715A CN 1835715 A CN1835715 A CN 1835715A CN 200480023342 CN200480023342 CN 200480023342 CN 200480023342 A CN200480023342 A CN 200480023342A CN 1835715 A CN1835715 A CN 1835715A
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Abstract
An apparatus (430) for closing a vascular wound includes an apparatus that can be threaded over a guidewire(458) into place at or adjacent the wound. The apparatus includes a chamber(520) that encloses a hemostatic material (270) therein. When the apparatus is positioned adjacent the wound as desired, the hemostatic material is deployed from the chamber. Blood contacts the hemostatic material, and blood clotting preferably is facilitated by a hemostatic agent within the material. Thus, the vascular puncture wound is sealed by blood clot formation.
Description
Related application
The application has required also to have required in the priority of the 60/547th, No. 154 U. S. application of submission on February 23rd, 2004 in the priority of the 60/495th, No. 424 U. S. application of submission on August 14th, 2003.Above-mentioned application is integrated with among the present invention by reference.
Background of invention
Technical field
The present invention relates generally to the system that promotes closure of openings in blood vessels.Especially, the present invention carries a kind of material near blood vessel.
Background technology
In many medical treatments, thereby opening carries out treatment, diagnosis or the rectification of certain form at this opening part organizationally.For example, in order to carry out balloon dilatation in the lumen of vessels, thereby must on tremulous pulse, cause opening to insert air bag.This opening needs sealing subsequently.
Balloon dilatation is applied in the treatment of peripheral blood vessel in the lumen of vessels, to strengthen or the blood flow of recovery in significantly narrow limb artery; It also is applied to treating coronary occlusion.In fact, coronary angioplasty can be used to the myocardial revascularization of coronary stricture and obstruction as the main feasible selection of bypass.Be different from bypass, angioplasty need not general anesthesia, opens the thoracic cavity, makes motive-lung machine or blood transfusion.Angioplasty not only has less intrusion and wound for the patient, and owing to need short hospital stays and short convalescent period, its price also is lower.
The operation of balloon dilatation at first is the femoral artery that the pin of hollow is inserted the patient by skin and surrounding tissue in the lumen of vessels.Make guide wire enter tremulous pulse, arrive the blood vessel that to treat or the obstructive position of valve along patient's vascular system then by the pin of hollow.Using X-ray developing technique to help guide wire passes vascular system and enters the approaching narrow location that will treat.Then, foley's tube is passed guide wire and make the sacculus of venting enter into the inside of narrow location.Then, air bag is expanded repeatedly up to narrow blood vessel is widened.Operation is extracted conduit and guide wire out after finishing in blood vessel and patient's body.
After the conduit that uses in angioplasty was removed, the wound that punctures on femoral artery must seal, and needed hemostasis at the arterypuncture place.Normally, nearly a few hours are attempted hemostasis near use ice bag of the zone wound and/or compressing.Yet when the patient moved, wound very likely can ftracture and bleed once again.Another possible complication is to develop into false aneurysm, and it has increased infection and rimose once again possibility.
Attempted to use the method for staple (staple), clip, collagen plugs and stitching to seal the wound of puncture.These methods and employed device thereof are relatively more inconvenient, and can only obtain limited success.
Other wound in patient's vascular system may also be difficult to locate, approaching and sealing.Therefore, a kind of apparatus and method of being convenient to locate and sealing this type of wound in patient's vascular system are useful.A kind ofly can locate sustainedly and stably, isolate with the device of sealing puncture wound and will eliminate common for a long time bleed relevant with this type of wound.
Summary of the invention
Therefore, need a kind of apparatus and method that are used for localization of blood vessel wound accurately and seal this wound in this area.
According to an embodiment, provide a kind of device that is used for the subcutaneous delivery material.This device comprises elongated carrier pipe, and it has chamber, and described chamber is set within it that portion holds material; Elongated propulsion members, it has distal portions, and described distal portions is set to extend through slidably at least a portion of described carrier pipe, thereby at least a portion of described material is released from described carrier pipe; And flexible locking member, it is set to and can assembles around described propulsion members at least in part, and when being subjected to compressing longitudinally usually, is suitable for expanding in a lateral direction.The locking member of described flexibility is positioned near the described propulsion members, make when described locking member is subjected to compressing longitudinally usually, described locking member lateral expansion to be engaging described propulsion members, thereby increases the friction between described propulsion members and the described locking member.
According to another embodiment, described propulsion members has at least one projection.The locking member of described flexibility is positioned near the described projection, makes when described locking member is subjected to vertically compressing, and described locking member lateral expansion to be engaging described propulsion members projection, thereby suppresses described propulsion members moving with respect to described locking member.
According to another embodiment, the invention describes a kind of assembly that is used for vascular wound closure.This assembly comprises carrier pipe, and it is set within it that portion holds hemostatic substance; Be set to the described far-end of described carrier pipe to be positioned the device of approaching described vascular wound; Propulsion members, it has distal portions, and described distal portions is set to pass through at least in part the described near-end assembling of described carrier pipe; And the scalable stopper, its surface around described propulsion members is provided with.The diameter of the part of described propulsion members is greater than the diameter of at least a portion of described carrier pipe.Described scalable stopper is set to the described surface engagement with described propulsion members, and selectively along the described proximal end surface of described propulsion members move or distally move, connect described device and described carrier pipe with adjustable ground.
For summarizing preferred embodiment and the beneficial effect that is better than prior art, some embodiment and beneficial effect have been described in preamble.Certainly can understand, there is no need in each specific embodiments, all to obtain whole above-mentioned beneficial effects.Thus, for example those skilled in the art can understand, can be according to can the obtaining or optimized or one group of beneficial effect of this paper instruction, and the mode that there is no need to obtain other target that might indicate or advise or effect is herein specialized or implement the present invention.
With reference to accompanying drawing, those skilled in the art can be readily appreciated that above to be discussed from the description of preferred embodiment hereinafter embodiment and other embodiment, the present invention is not limited to disclosed any embodiment preferred.
Brief description of drawings
Fig. 1 is for assembling the side view of the vascular closure devices of finishing and preparing to use;
Fig. 2 is the side view of the distal portions of device as shown in Figure 1;
Fig. 3 is the side view with propulsion members of feature of the present invention;
The device that Fig. 4 shows as shown in Figure 1 is advanced in patient's the blood vessel by guide wire;
Fig. 5 shows device as shown in Figure 4, the state that its retractor arms is opened and extraction tool is moving;
Fig. 6 shows device as shown in Figure 5, wherein, sthptic sponge is advanced to the position of contact blood vessel wall;
Fig. 7 shows device as shown in Figure 6, and its retractor arms is removed;
Fig. 8 shows device as shown in Figure 7, and its conduit and guide wire are removed;
Fig. 9 shows device as shown in Figure 8, and wherein, flowable binding agent is transported to sponge;
Figure 10 shows device as shown in Figure 8, and wherein, propulsion members takes out in patient's body;
Figure 11 shows the puncture wound that is closed after the treatment of an embodiment using described apparatus and method;
Figure 12 shows another embodiment of vascular wound closure device;
Figure 13 shows the side view of the conduit that uses according to embodiment as shown in figure 12;
Figure 14 shows the traction apparatus part of device as shown in figure 12, and its retractor arms is shown in an open position;
Figure 15 shows one of them the side plan view in as shown in Figure 14 the retractor arms;
Figure 16 shows conduit as shown in figure 13, and it is arranged in as shown in figure 15 the retractor arms;
Figure 17 shows the partial sectional view of another embodiment of vascular wound closure device;
Figure 18 shows the side view of the conduit of basis embodiment as shown in Figure 17;
Figure 19 shows the partial sectional view of the propulsion members of basis embodiment as shown in Figure 17;
Figure 20 shows the partial sectional view of the carrier pipe of basis embodiment as shown in Figure 17;
Figure 21 shows the sectional view of the carrier pipe as shown in figure 20 that obtains along line 21-21;
Figure 22 shows the tube wall part of carrier pipe as shown in figure 20, and this carrier pipe has snap close (detent catch) bonding part;
Figure 23 shows the device as shown in figure 12 between the operating period;
Figure 24 shows the tube wall part of another embodiment of carrier pipe, and this carrier pipe has the j-interlocking and closes part;
Figure 25 shows another embodiment of vascular wound closure device;
Figure 26 shows the partial cut away side views of the conduit of basis embodiment as shown in Figure 25;
Figure 27 shows the part sectioned view of the propulsion members of basis embodiment as shown in Figure 25;
Figure 28 shows the partial sectional view of the carrier pipe of basis embodiment as shown in Figure 25;
Figure 29 shows another embodiment of vascular wound closure device;
Figure 30 shows the partial sectional view of the conduit of basis embodiment as shown in Figure 29;
Figure 31 shows the partial sectional view of the propulsion members of basis embodiment as shown in Figure 29;
Figure 32 a shows the side view of the handle support that is used in combination with as shown in figure 31 propulsion members;
Figure 32 b shows the top view of the handle bracket shown in Figure 32 a;
Figure 33 shows the top view of the handle that is used in combination with as shown in figure 31 propulsion members;
Figure 34 shows the top view of the engagement member that is used in combination with as shown in figure 31 propulsion members;
Figure 35 shows the partial sectional view of the carrier pipe of basis embodiment as shown in Figure 29;
Figure 36 shows carrier pipe as shown in figure 35 in two;
Figure 37 is the side view of the vascular wound closure device of assembling fully with feature of embodiment as shown in figure 29;
Figure 38 shows device as shown in figure 37, and its conduit, propulsion members and carrier pipe do not engage each other;
Figure 39 shows device as shown in figure 37, and it is provided with hemorrhage;
Figure 40 is the side view of another embodiment of vascular wound closure device;
Figure 41 is the profile of device as shown in figure 40;
Figure 42 a is the enlarged drawing of the part of device as shown in figure 41;
Figure 42 b is the enlarged drawing of another part of device as shown in figure 41;
Figure 43 shows a part that is positioned near the device as shown in figure 41 of the position of vascular wound;
Figure 44 shows device delivery tube portion as shown in figure 41 in two;
Figure 45 shows the propulsion members of device as shown in figure 41;
The far-end that Figure 46 shows propulsion members as shown in figure 41 fits into the enlarged drawing in the near-end of carrier pipe as shown in figure 44;
Figure 47 shows the duct portion of device as shown in figure 41;
Figure 48 shows the enlarged drawing that as shown in figure 47 conduit is attached to the near-end of propulsion members as shown in figure 45;
Figure 49 is the axonometric chart of the collar (collar) part of device as shown in figure 41;
Figure 50 shows towards the part of the propulsive device as shown in figure 41 of tissue wounds;
Figure 51 shows device as shown in figure 50, and this device is positioned at the position of approaching wound and is provided with hemorrhage.
Detailed description of the preferred embodiments
The embodiment of this paper is specially adapted to seal those inaccessible and/or see vascular wounds.For this wound, thereby be difficult to directly and accurately repair wound on the blood vessel its sealing.In addition, also there is the defective that is associated with direct reparation blood vessel.For example, because the clinician can not see the injury, therefore be difficult to settle exactly closed dielectric such as stitching thread, staple or clip.The inaccurate placement of these closed dielectrics causes sealing insufficient probably, and the clinician might not aware puncture wound and remains open.In addition, the inaccurate placement of closed dielectric may cause the permanent damage that comprises fracture and additional puncture to blood vessel.In addition, enter in the blood flow if closed dielectric extends through wound, this medium can increase thrombotic probability, maybe may cause potential noxious substance to enter in the blood flow.Certainly, if inadvertently closed dielectric is discharged in the blood flow, may cause serious vascular occlusion complication.
With reference to Fig. 1, vascular wound packaged unit 30 comprises the far-end 34 with conduit 32 and the elongated conduit 32 of near-end 36.Distal openings 38 is passed the far-end 34 of conduit 32 and is formed, and along the longitudinal axis opening of conduit 32.Conduit 32 comprises the cone point 40 that is positioned at far-end 34.The elongate body 42 of conduit 32 is in the position near cone point 40.Preferably, main body 42 is at the diameter that has basically identical on its length direction.Inner chamber 44 in conduit 32 inside from distal openings 38 to near-end 36 longitudinal extensions.
On near-end 36, has connector part 46.Connector part 46 comprises the main inner chamber 48 and second inner chamber 50.Main inner chamber 48 extends and extends jointly with conduit cavity 44 along the y direction of conduit 32.Second inner chamber 50 stretches out from main inner chamber 48, but communicates with main inner chamber 48 and conduit cavity 44.Have proximal openings 52 in the proximal end of main inner chamber 48, as distal openings 38, it is the axis opening longitudinally.Second opening 54 is at second inner chamber, 50 inner openings.
The size of distal openings 38 and proximal openings 52 is set at and is suitable for holding guide wire 58 (guide wire that for example is used for angioplasty and other vascular surgery).Thus, guide wire 58 can pass conduit 32, and this conduit can advance on guide wire 58.
Form porose 60 at conduit 32 near the sidewall of the far-end 34 of conduit 32.Preferably, form at least two holes 60.All holes 60 are preferably located in apart from the position of the far-end 34 basic equidistances of conduit 32.Preferably, be formed with the bossing 62 of conduit 32 in the zone of wound hole 60, the far-end of this region adjacent most advanced and sophisticated 40 and main body 42.At bossing 62 places, the external diameter of conduit 32 is slightly larger than the external diameter of whole catheter main body 42.
Continuation is provided with vacuum or other suction source 64 with reference to Fig. 1, and communicates with second inner chamber 50 of catheter extension part 46 by managing 66.Therefore, can come evacuation by conduit cavity 44.Preferably, the size that will hold the distal openings 38 of guide wire 58 and proximal openings 52 is set at and can makes guide wire 58 basic occlusion of openings, thereby can come evacuation by hole 60.Between suction source 64 and conduit 32, observation panel 68 is set.Observation panel 68 is set to make the clinician to observe the material of extracting out by hole 60 and conduit cavity 44.Observation panel 68 will be discussed hereinafter in more detail.
See figures.1.and.2, traction apparatus 70 preferably is installed on conduit 32.Traction apparatus 70 comprises the relative elongated retractor arms 72 that vertically is arranged on the conduit 32.By clinician's manipulation, retractor body 74 can optionally open and close retractor arms 72.The elongated retractor arms 72 of traction apparatus 70 is placed on the conduit 32, thus the far-end 76 that makes retractor arms equate with the width of arterial wall at least near the distance of guide hole 60, preferably, be at least about 0.5 to 2 millimeter.
Be appreciated that device of the present invention can comprise those and the different structure of typical structure illustrated in figures 1 and 2.For example, can suitably use other conduit and retractor structures.For example, the 09/325th, No. 982 U. S. application of submitting on June 4th, 1999, the present the 6th, 287, the conduit that some that put down in writing in No. 322 United States Patent (USP)s is suitable for and the embodiment of traction apparatus, the full content of above-mentioned application is integrated with among the present invention by reference.
Referring again to Fig. 1, hemostatic member 80 is placed on the conduit 32 position near traction apparatus 70.As described in will going through hereinafter, this hemostatic member comprises the material of being made or contained hemorrhage by hemorrhage.Described hemorrhage can help blood clotting.In one embodiment, hemostatic member 80 comprises sponge or spongy material.In this manual, the term sponge represents to have the broad concept with the consistent purposes of its ordinary meaning, its expression but be not limited to partially porous at least infiltration and be suitable for some blood at least and flow into wherein material, and blood can permeate in this material.For example, sponge can comprise natural or the artificial sponge, weave or supatex fabric, fiber fluffy piece or analog.In addition, sponge can contain the material that can partially absorb blood when blood contacts with this material at least, maybe can contain the not material of absorbing blood.
Be the needs of this explanation, hemostatic member 80 is meant sponge 80.Yet, be appreciated that the use of term " sponge " is not limited to be used as the material ranges of hemostatic member.In fact, anyly can help or promote the material of blood clotting can be used as hemostatic member.
Run through this description, the term hemorrhage is widely used with its its ordinary meaning, and, its expression but be not limited to the reagent that promotes blood clotting.This reagent can adopt any dosage form, comprises liquid state, powder, granular or the like, and can comprise substrate or carrier or combine with substrate or carrier.Also used the term hemostatic substance in this description, its generalized concept as the ordinary meaning purposes uses.Its expression but be not limited to any material that promotes the blood clotting characteristic that has.Therefore, hemostatic substance can comprise the hemorrhage of independent use, perhaps is used in combination with substrate or carrier, and this substrate or carrier separate formation with hemorrhage.The term hemostatic substance comprises sthptic sponge.
Preferably, sponge 80 is extended around catheter main body 42, and is configured to along conduit 32 longitudinal sliding motions.Most preferably, conduit 32 extends through via hole 82 and passes sponge 80.When passing sponge 80, conduit 32 forms via hole 82.
Also be provided with propulsion members 84 at conduit 32 near sponge 80 places.With reference to Fig. 3, propulsion members 84 comprises main part 86 and proximal handle part 88 simultaneously.Pass main part 86 and be formed with elongated inner chamber 90.As shown in Figure 1, inner chamber 90 is preferably around conduit 32, thereby permission propulsion members 84 can slide with respect to conduit 32.Position at contiguous propulsion members 84 distal portions is formed with a plurality of holes 92 of passing main part 86.
About the Fig. 4 that will be described in detail hereinafter, vascular wound packaged unit 30 can make the clinician locate the veins beneath the skin wound " w " exactly, be transported to the wound near wound w and with sthptic sponge 80.Sthptic sponge 80 contains the hemorrhage that can help to promote the wound w sealing.
In order fully to use sthptic sponge 80, at first blood vessel packaged unit 30 is located exactly and near vascular wound w.Be appreciated that method and apparatus of the present invention can be used to seal various blood vessels and other wound.Fig. 1-11 and relevant discussion thereof have represented to use embodiment to seal the embodiment of the puncture wound on patient's femoral artery 94.
Specifically with reference to Fig. 1,2,4 and 5, in order accurately to locate and near the femoral artery puncture wound w, at first conduit 32 to be through on the guide wire 58, this guide wire passes puncture wound w in advance and inserts in patient's the femoral artery 94.Inner chamber 44 is connected to suction source 64, and parts 30 are pierced into patient's tissue 96 by guide wire 58, thereby make the distal tip 40 of conduit 32 extend through vascular puncture wound w.
In case parts 30 enter, suction source 64 is extracted body fluid out by hole 60.This body fluid passes through observation panel 68, thereby makes the clinician can differentiate the body fluid that is drawn out of.Observation panel 68 can have any suitable structure or position.For example, observation panel can comprise the transparent pipeline that is connected with conduit, have the part of the conduit of the syringe of substantially transparent of suction source and observation panel function or substantially transparent concurrently.Most preferably, conduit 32 is made by transparent material, thereby in case begin to extract out blood from conduit, the clinician can find at once.
As shown in Figure 4, when arterial wall 98 and intravasation 94 were passed in hole 60, blood " b " began by also importing by observation panel 68 in the 60 suction conduits 32 of hole.Therefore, when blood b when observation panel 68 is found, the clinician will know that hole 60 has just penetrated puncture wound w, and the far-end 76 of retractor arms 72 is positioned at outer wall 98 places near tremulous pulse 94, preferably, in about 2mm scope of arterial wall 98.So, with retractor arms 72 separately, as shown in Figure 5, thereby surrounding tissue 96 is extracted from wound w, around puncture wound w, form space 100.Conduit 32 still part places in the puncture wound w, thereby blocks wound effectively, and prevents that blood from flowing out by wound.Projection 62 makes the edge warpage of wound w, thereby has strengthened the seal at conduit 32 and puncture wound edge.
Continuation is with reference to Fig. 5, and can use extraction tool 102 to remove may be at the tissue fluid in the space 100 and other material, and near the tube wall 98 of the blood vessel 94 the cleaning puncture wound w.
Then with reference to Fig. 6, in case puncture wound w is accurately located, propulsion members 84 advances to far-end along conduit 32, contact thereby sponge 80 shifted onto with blood vessel wall 98, thus the encirclement puncture wound w.As indicated above and hereinafter go through like that, sponge 80 contains the hemorrhage that can help to quicken at wound location w the formation blood clotting, thus the help wound healing.
Preferably, sponge 80 to small part is coated with binding agent, thereby makes described sponge be bonded to blood vessel wall 98 to small part.As a kind of selection (or additionally), sponge is being advanced to before blood vessel wall contacts, mobile binding agent can be transported to the zone around the described puncture wound.Certainly, described sponge can be carried under the situation of not using binding agent.
Sponge 80 preferably is placed on the conduit 32, thereby makes it basically around conduit 32.Therefore, because the tip 40 of conduit places among the wound, when sponge placed with the approaching position of blood vessel wall 98, sponge 80 was basically around wound w.As shown in Figure 7, when sponge 80 places with the approaching position of wound w, traction apparatus 70 can be shifted out.After traction apparatus 70 is moved out of, on every side body tissue 96 collapse in sponge 80 and propulsion members 84 around.When body tissue 96 surrounded sponge 80 and binding agent curing, propulsion members 84 was fixed sponge 80 holding positions.
Then with reference to Fig. 8,, conduit 32 and guide wire 58 can also be shifted out in patient's body when propulsion members 84 during at assigned address.Once 32 that occupied, as to pass sponge 80 via hole 82 by conduit voluntarily avalanche thereon, thereby basically with its sealing.Vascular wound w no longer by conduit 32 fillings, can predict that the blood b in the blood vessel 94 will flow in the sponge 80, to small part immersion sponge 80.In the above-described embodiment,, be appreciated that in other embodiments that described conduit can be removed prior to described traction apparatus although traction apparatus 70 is removed prior to conduit 32.
In another embodiment, on propulsion members 84, can use extra pressure to stop the blood flow that passes blood vessel 94 to small part.With the method, the clinician can control the speed that wound w flows into the blood of sponge 80 of passing.Certainly, can use other method and apparatus temporarily to reduce or stop blood flow by blood vessel.
In a preferred embodiment, sponge 80 contains by the material that is dipped in the hemorrhage or alternate manner constitutes through the hemorrhage processing.Described reagent is specially adapted to help blood coagulation.Therefore, the blood that flows into described sponge runs into described reagent and rapid condensation, makes wound form the sealing of nature by blood clotting.Can use spongy hemorrhage, it can comprise such as Gelfoam
TM, Oxycell
TMAnd Avitene
TMProduct.Other can be a chitosan as the material of sponge.Can soak into these and other sponge of being suitable for reagent, described reagent comprises such as helping accelerate blood to form the thrombin (a kind of liquid coagulant) of grumeleuse, and the Hemadex that can obtain from Medafor company
TMThat other can conveniently use material is a kind of collagen Ultrafoam that is sold by C.R.Bard/Davol company
TMSponge.This Ultrafoam
TMSponge is by the Avitene that is a kind of natural coagulating agent
TMCollagen is made, and does not need to add thrombin.This has reduced preparation time, and has reduced the potential risk that the thrombin of beef reaction takes place the patient.Can also contain other medicines in the sponge.For example, antibiotic medicine, anti-infectives, healing auxiliary agent and analog thereof can be dipped among the sponge material.
In particularly preferred embodiments, hemorrhage comprises starch, but for example the microporosity polysaccharide microsphere body of bio-absorbable (for example, by (the Emergency Medical Products of emergency medical Products Co., Ltd of Wei Sikang star state Wo Jisha, Inc.of Waukesha, WI) TRAUMADEX of Xiao Shouing
TM).These microspheres have the duct of micro-replication.The orifice size of microsphere can promote to absorb water and blood in the ultra concentration of albumin, thrombin and other protein and cellular component.Microsphere also influences platelet function, and strengthens fibrin formation.In addition, it is believed that microsphere can quicken the enzyme ' s reaction speeding that condenses.When directly applying to just at bleeding wound by pressure, these particles play the effect of molecular sieve, with the liquid of extracting from blood.The controlled porosity of these particles can be repelled and surpass 25,000 daltonian platelet, erythrocyte and serum albumin, and they concentrate on the surface of particle subsequently.This molecular repulsion character makes on particle surface platelet, thrombin, fibrinogen and other protein that forms high concentration, thereby produces gelatification.The tight cell and the component of gel are quickened normal coagulation cascade.Tissue around the fibrin network that forms in this intensive protein-cellular matrix closely is bonded to.Gelation process began in the several seconds, though the grumeleuse that is produced is tough unusually, also usually along with microgranule breaks together.This microporosity polysaccharide microsphere body and other hemorrhage the applicant common pendent, submit on June 14th, 2004, " releasable multifunctional hemostatic agent (DeployableMultifunctional Hemostatic Agent) " by name the 10/868th, carried out more detailed discussion in No. 201 U. S. applications, the full content of this application is integrated with among the present invention by reference.
Can use any suitable hemostasis substrate as support for the hemorrhage of preferred embodiment.But in particularly preferred embodiments, hemostasis substrate comprises chitosan.Chitosan obtains from chitin, and it is a kind of biopolymer that mainly obtains from shrimp and Carapax Eriocheir sinensis refuse.Chitosan is chitinous main derivant, and is the collective term that is applied to chitosan in each stage of deacetylation and depolymerisation.The chemical constitution of chitin and chitosan is similar to cellulose.Difference is, and is different with the bonded hydroxyl in C-2 place in each D-glucose monomer in the cellulose, and the C-2 place in chitinous each D-glucose monomer has acetylation amino (NHCOCH
3), and the C-2 place in each D-glucose monomer of chitosan has amino.
Cellulose
Chitin
Chitosan
Chitin and chitosan all are nontoxic, but chitosan is applied even more extensively in medical science and medicinal application than chitin.Chitosan shows good biocompatible, and can be by chitosanase, papain, cellulase and acid protease biodegrade.Chitosan shows antiinflammatory and analgesic effect, and can promote hemostasis and wound healing.Chitosan also is used as hemorrhage in surgical intervention and Wound protection.The haemostatic effect of chitosan is described in No. 373 United States Patent (USP)s the 4th, 394.
Can in the device of preferred embodiment, use single hemostasis substrate or have different shape and/or the combination of the hemostasis substrate of composition.Different matrix morphology may be preferred, for example, and fiber fluffy piece, hair (fleece), fabric, sheet, stitching thread or powder.Can adopt different substrates to form the homogeneous mixture of material, perhaps can from two or more differing formed substrate, prepare composite interstitial substance.A kind of preferred complex comprises chitosan and collagen.Other details that relates to chitosan and other suitable matrix has carried out more going through in applicant's common undecided application " releasable multifunctional hemostatic agent ".
Preferably, spongy material is soft and flexible, and meets the structure of blood vessel, wound and blood vessel surrounding space.Therefore, spongy material is particularly suitable for being applied to vascular puncture place small space on every side.In addition, after the instrument such as traction apparatus 70 was removed, the tissue 96 that sthptic sponge 80 is punctured around the wound w was fixed, and these tissue 96 avalanches are on sponge 80.
As shown in Figure 9, in order further to help sponge 80 fix in position are transported to the inner chamber 90 of the flowable binding agent 106 in the adhesive source 108 by propulsion members 84 on the sponge 80.The flow through far-end of opening of propulsion members 84 of binding agent 106, and pass hole 92 by propulsion members main part 86.Through solidifying, binding agent 106 is in the scope of sponge 80 and form confining bed on every side, thereby blood b is limited in the zone of sponge.This helps minimizing to bleed and further quickens to form blood clotting.In one embodiment, after binding agent solidified, it was impermeable basically, thereby blood is limited in the scope of expectation.Add binding agent 106 and also help more complete closed to pass the passage of sponge, this passage forms by taking out conduit 32.In addition, binding agent 106 helps sponge 80 is fixed on and puncture wound w and surrounding tissue 96 corresponding positions.
As discussed above, be advanced touch blood vessel wall before, sponge 80 can be soaked in binding agent, perhaps more preferably, on sponge 80, apply layer of adhesive.With the method, can control the adhesive distribution on the sponge.Use binding agent to apply the outer surface of described sponge by control ground, after binding agent solidified, this binding agent can be bonding with this sponge and vascular wound w peripheral region (comprising that blood vessel 94 is own), and also can form the border seal of described sponge.The barrier film that the coating of binding agent can be used as impermeability or differential permeability is limited in blood b in the sponge 80.Be appreciated that the coating that can use binding agent replaces or be additional to by propulsion members 84 applying on the extra binding agent 106.
Can on described sponge, use multiple flowable binding agent.For example, can use the sealant such as Tisseel fibrin tissue, it can obtain from Irving Baxter health care company (Baxter Healthcare Corp.).Other commercially available binding agent that is fit to comprises the Bioglue that obtains from Cryolife company
TMAnd the Floseal that obtains from rich Shen medical skill (FusionMedical Technologies)
TMVarious cyanoacrylate adhesives are commercially available at present, and can be applicable among the present invention.Certainly, anyly can seal described sponge or can delay at least that blood flow passes or the product that overflows this sponge all is acceptable.Be appreciated that also some binding agent need not angiosomes and/or outer wall are cleared up before being injected into.
The comfort level of hardening time and use changes according to the different of adhesive therefor.For example, some binding agent can in seconds be solidified into ductile gel form, and other may directly be solidified into hard form through several minutes.Selection can allow the clinician that sponge was advanced near the position of wound and the hardening time that contacts with arteries, and this sponge will begin to combine and sealed by binding agent basically with blood vessel wall at this moment.Be appreciated that and use any acceptable binding agent with any acceptable hardening time.According to this description, when a kind of binding agent adheres to surrounding tissue and can not flow naturally, can think that this binding agent has solidified.
In case after sponge 80 is accurately placed, propulsion members 84 can be taken out.As shown in figure 10, can help take out propulsion members 84 by release lever 110 being passed propulsion members inner chamber 90 and touching sponge 80.When propulsion members 84 is extracted out, fix sponge 80 by release lever 110 in patient's body.Therefore, when propulsion members 84 was extracted out, release lever 110 engaged with sponge 80, so that counter traction to be provided.With the method,, also propulsion members 84 can be taken out even exist between sponge 80 and the propulsion members 84 under some adherent situation.Below with reference to Figure 11,, can use of skin 112 sealings of any suitable closed dielectric (for example stitching thread 114) with the patient in case release lever 110 is drawn out of.Sthptic sponge is stayed original position.Under the help of sthptic sponge, the natural coagulation process of body will stop up and repair vascular wound w.Therefore, healing will do not have false aneurysm, do not discover or the situation of danger such as faulty wound closure under carry out.
In the embodiment that reference Fig. 1-9 discusses, described conduit comprises single lumen catheter.In another embodiment (not shown), slender conduit has first inner chamber, and it comprises the pipeline that extends to proximal openings and hold guide wire therein slidably from distal openings.Outer wall at described conduit is limited with second inner chamber, and it is total to the center around first inner chamber and with first inner chamber.The hole of passing described conduit outer wall is opened in second inner chamber.In addition, channel lumen communicates with described second inner chamber.In this embodiment, distal openings and the proximal openings of holding guide wire do not communicate with second inner chamber, and this second inner chamber communicates with suction source by channel lumen.Therefore, in this embodiment, body fluid is less than the embodiment of using single inner chamber by the probability that far-end and near-end guide wire opening are inhaled into conduit.Yet single lumen catheter manufacturing cost is lower, and compares with two lumen catheter and can have less diameter.
Introduce another embodiment of vascular wound closure device below with reference to Figure 12-16.Described device comprises traction apparatus 200 and slender conduit 250.
With reference to Figure 13, conduit 250 has near-end 250a and far-end 250b especially.The far-end that passes conduit forms distal openings, and it is along the longitudinal axis opening of described conduit.Be limited with inner chamber 250c in described catheter interior.Tip 256 at conduit 250 far-end 250b places is preferably taper.Near-end 250a is provided with connector part, and this connector part preferably includes the main inner chamber and second inner chamber.Described main inner chamber extends along the longitudinal axis of described conduit, and extends jointly with conduit cavity 250c.The duct wall that runs through near described far-end is formed with at least one telltale holes 258.Preferably, conduit 250 is normally straight, and its size is about 4-8F, more preferably about 6F.
The outer surface 252 of conduit 250 preferably has common cylindrical shape, and comprises bossing 254.In a preferred embodiment, bossing 254 limits connection between two separating part (not shown) of conduit 250.In the embodiment of this marginal data, bossing 254 is a cylindricality, and comprises length 254a.
Continuation is with reference to Figure 13, and propulsion members 260 is preferably movably around described catheter outer surface 252.Preferably propulsion members 260 is set to and on conduit 250, slides.Propulsion members 260 preferably has the diameter big inner chamber of its diameter than the bossing 254 of conduit 250, thereby propulsion members 260 can be slided on bossing 254.
Below with reference to Figure 14-16, traction apparatus 200 preferably is configured to be installed on the conduit 250.In the embodiment of graphic extension, traction apparatus 200 preferably has two retractor arms 202 that mutually link to each other movably, and each retractor arms has from near-end 206 to far-end 208 length 204.Retractor arms 202 preferably can open between position (seeing Figure 14) and the close stance (seeing Figure 12) mobile.As shown in figure 12, when at close stance, retractor arms 202 is preferably surrounded catheter segment 250 at least.Only show two retractor arms 202 although be appreciated that the embodiment of the traction apparatus 200 of graphic extension, traction apparatus 200 can have more than two retractor arms 202.
Continuation is with reference to Figure 14 and Figure 15, and preferably, each retractor arms 202 is limited with inner surface 210, and it is usually facing to the inner surface 210 of another retractor arms 202.Each inner surface 210 is limited with edge 212, and it preferably extends along the length 204 of arm 202.Inner surface 210 also preferably limits chamber or the groove 220 that extends between edge 212.Preferably, groove 220 extends the length of retractor arms 202.As shown in figure 12, when retractor arms 202 was in the closed position, preferably, the groove 220 on the retractor arms 202 was in conjunction with forming the path 221 that extends along the length on the arm 202 204.
With reference to Figure 14-15, groove 220 preferably includes the proximal part 222 at near-end 206 places that are positioned at retractor arms 202.In a preferred embodiment, when retractor arms 202 was in the closed position, proximal part 222 had common arc, and it is set to admit movably and contact and at least a portion conduit 250 remained on the fixed position basically.Proximal part 222 also has degree of depth 222a, and its length 204 common and retractor arms 202 is perpendicular.For example, can to have the radiuses approximately identical with the outer surface 252 of conduit 250 be the semicircular cross section of 222a to proximal part 222.But when retractor arms 202 during in the closed position, proximal part 222 can have Any shape, and it is set to contact basically with conduit 250.Most preferably, the size of proximal part 222 and being provided with basically and conduit 250 complementations, thus make traction apparatus 200 substantially closely control conduit 250 at proximal part 222.
Continuation is with reference to Figure 15 and 16, and groove 220 preferably includes the receiving portion 224 that is adjacent to proximal part 222.Receiving portion 224 preferably has common arcual shape, and has usually and the perpendicular degree of depth 224a of length 204 of arm 202, and it is greater than the degree of depth 222a of proximal part 222.Correspondingly, receiving portion 224 limits the edge 224b between receiving portion 224 and proximal part 222.Illustrated receiving portion 224 has the semicircular cross section, and its radius is 224a, greater than the radius 222a of proximal part 222.Most preferably, receiving portion 224 is complementary substantially with conduit bossing 254, thereby admits bossing 254 therein.
Groove 220 also preferably includes the contact portion 226 that is adjacent to receiving portion 224.Similar to proximal part 222, contact portion 226 is preferably complementary substantially with catheter outer surface 252, admits conduit 250 movably, and when receiving arm 202 when in the closed position, contact portion 226 contacts and control conduit 250 substantially.Contact portion 226 preferably has and the vertical substantially degree of depth 226a of the length 204 of retractor arms 202.In a preferred embodiment, degree of depth 216a is similar to the degree of depth 222a of proximal part 222.For example, the semicircular cross section radius of contact portion 226 is 226a, and the radius 222a of itself and proximal part 222 is roughly the same.The degree of depth 226a of contact portion 226 is also preferably less than the degree of depth 224a of receiving portion 224, thereby makes receiving portion 224 limit edge 224c between receiving portion 224 and contact portion 226.
Still with reference to Figure 15 and Figure 16, in the embodiment of graphic extension, proximal part 222 and contact portion 226 are separately all less than receiving portion 224.Most preferably, proximal part 222 and contact portion 226 are set to conduit bossing 254 and can not slip over any part among 222 and 226.Therefore, as shown in figure 16, when bossing 254 placed receiving portion 224, this bossing was under an embargo and slides to near-end or far-end.Thus, as shown in figure 12, when retractor arms 202 with closed catheter in wherein the time, whole conduit 250 vertically is locked in the relevant position of traction apparatus 200.
In addition, preferably, groove 220 comprises cell part or the chamber 228 that is adjacent to contact portion 226.Chamber 228 preferably has arcuate shape basically, and has and the vertical substantially degree of depth 228a of the length 204 of retractor arms 202, and its value is greater than the degree of depth 226a of contact portion 226.For example, the radius 228a in the semicircular cross section that had of chamber 228 is greater than radius 226a.In addition, contact portion 226 is limited with edge 226b between contact portion 226 and chamber 228.But chamber 228 is set to the wherein part of holding conduit 250, and limits clearancen chamber 228b between conduit 250 and retractor arms 202.When retractor arms 202 was positioned at the closed position, empty chamber 228b expanded to the whole spaces around the conduit 250 substantially.Empty chamber 228b is set to wherein can accept and hold hemostatic substance 270, thereby hemostatic substance can partly be looped around around the outer wall 252 of conduit 250 at least.Further describing of hemostatic substance 270 sees below.
The distal portions 230 of groove be restricted to adjacent cavity 228 and have less than the degree of depth 228a of chamber 228 and with the vertical substantially degree of depth 230a of the length 204 of retractor arms 202.Distal portions 230 is preferably complementary substantially with catheter outer surface 252, thereby when retractor arms 202 is in the closed position, can contact substantially with conduit 250 and it be controlled.For example, distal portions 230 can have the semi-circular cross-section that radius is 230a.In a preferred embodiment, the radius 222a of the radius 226a of radius 230a and contact portion 226 and/or proximal part 222 is roughly the same.Preferably, level and smooth substantially transition portion 230b makes chamber portion 228 be connected with distal portions 230.
Referring again to Figure 12-16, in actual applications, hemostatic substance 270 preferably places around the outer surface 252 of the conduit 250 between bossing 254 and the guide hole 258.When arm 202 was shown in an open position, conduit 250 placed among the groove 220, thereby bossing 254 places among the receiving portion 224, and hemostatic substance 270 fills in the chamber 228.Preferably, conduit 250 and traction apparatus 200 are arranged to when it fits together, the far-end 208 and the distance between the telltale holes 258 of retractor arms 202 equate with the width of arterial wall at least.Preferably, described distance is at least about 0.5 to 2 millimeter.
When retractor arms 202 moves to the closed position, when bossing 254 was positioned among the receiving portion 224 simultaneously, conduit 250 relative traction apparatuss 200 vertically locked.Therefore, even apply longitudinal force one of therein, conduit 250 and container 200 also can move together.In application, the embodiment of discussing in conjunction with Fig. 1-4 in as mentioned is described, and device is sent in patient's body, makes conduit 250 enter in the wound w.When the observation panel (not shown) that is connected in conduit 250 is observed blood b, preferably retractor arms 202 is moved to open position.Then, push propulsion members 260 the far-end 250b of conduit 250 to, with contact and hemorrhage 270 is pushed into wound w contacts.
In the embodiment described in Figure 12-16, preferably, hemostatic substance 270 comprises having ductile fibrous substance.For example, preferably, described substrate comprises fluffy---fibrous cotton shape material, it can be treated to suitable shape and size, to adapt to specific shape of wound.Most preferably, hemostatic substance 270 comprises by chitin fiber preparation and has injected fluffy of microporosity polysaccharide microsphere body.Fluffy of above-mentioned hemostasis has been discussed in applicant's the undecided application " releasable multifunctional hemostatic agent " and microporosity polysaccharide microsphere body has been stored in the method for hemostasis on fluffy.Also can adopt other fibrous matrix and hemorrhage in other embodiments.
In other embodiments, hemostatic substance 270 can flood with the medicine relevant with the treatment wound of any amount.For example, antibiotic medicine, anti-infectives further can be injected or are stored on the substrate.
Can further understand, according to another embodiment, bossing 270 can have different shape.For example, bossing needn't extend around conduit 250, and can adopt a plurality of bossings.Preferably, the shape of the receiving portion of traction apparatus 200 and bossing complementation.In addition, the inner chamber of propulsive element 260 can have the cross sectional shape that matches with bossing, and can be non-circular in certain embodiments.
Below with reference to Figure 17-23, another embodiment medium vessels wound packaged unit 300 comprises the conduit 310 with near-end 312 and far-end 314 and is defined in therebetween inner chamber (not shown).Propulsion members 330 with near-end 332 and far-end 334 places on the conduit 310 slidably.Carrier pipe 350 with near-end 352 and far-end 354 places on the conduit 310 slidably and is positioned at the far-end of propulsion members 330.Preferably, use such as polyacrylic polymeric material and make packaged unit 300.Preferably, also available hypoallergenic material is made parts 300.
With reference to Figure 18, conduit 310 preferably includes the fixed position barrier structure 316 that is positioned at catheter surface 310a especially.Far-end 314 is preferably taper, and forms the hole of running through 318 near the side of the conduit 310 of far-end 314.In one embodiment, conduit 310 preferably includes second branched pipe 319 that is positioned at near-end 312 places, and has the second inner chamber (not shown) that is connected to conduit 310 inner chambers.Preferably, second branched pipe 319 is arranged to be connected to effectively the various devices that are used for vascular wound closure, as air extractor.For example, in one embodiment, can on second branched pipe 319, connect syringe, evacuation to pass through conduit 310.
Preferably, engagement member 320 is placed around conduit 310 movably, and be arranged to can with barrier structure 316 mechanical engagement.In the embodiment of graphic extension, the outer surface of barrier structure 316 is provided with screw thread, and the inner surface of engagement member 320 is provided with screw thread, makes each screw thread to engage, thereby makes engagement member 320 and conduit 310 not have mutual vertically moving when engaging.Thus, member 320 and conduit 310 are releasably interconnected.In another embodiment, the mechanical connection manner that can use other to be fit to.For example, can also use snap close mode or j-lock mode.
In this manual, term releasably connects the broad terms that its common implication is used in expression, its expression but be not limited to those can remove the member that its interconnective mode connects or is fixed together.For example, can use but be not limited to following manner makes member connect: screw thread, snap close mode, jointly constitute but knock-down bridge (conformed yet breakable bridge) for example, the cover plate (flashing from injection-molding) that forms by injection molding, binding agent etc.
Especially with reference to Figure 19, propulsion members 330 preferably includes substantially for the mid portion 336 of cylindricality, substantially for the transition portion 337 of taper and be the distal portions 338 of cylindricality substantially.The diameter of mid portion 336 is preferably more than the diameter of distal portions 338.Propulsion members 330 preferably is limited with passage 330a, and it extends to far-end 334 from near-end 332, and preferably is configured to and can passes wherein slidably by holding conduit 310.For example, passage 330a has ring shaped cross-section, and its diameter is greater than the diameter of catheter surface 310a.But, the big or small deficiency of passage 330a so that conduit barrier structure 316 pass through.Thus, propulsion members 330 can not be on conduit 310 moves to its near-end and crosses barrier structure 316.
332 places are provided with near-end engagement member 342 at near-end.In the diagram embodiment, on the outer surface of near-end engagement member 342, have screw thread, its size and setting are suitable for the engage threads with engagement member 320.As shown in figure 27, catheter abutment member 320 is set to both can engage with barrier structure 316, can engage with the near-end connecting elements 342 of propulsion members again, thus optionally that propeller 330 is vertically fixing with respect to conduit 310.
337 places are provided with distal engagement member 344 at contiguous transition portion.In the diagram embodiment, distal engagement member 344 comprises the basic hemispheric bossing that is.
Referring again to Figure 20-21, carrier pipe 350 preferably has body 350a and conical outer surface 350b thereof especially, and the top 357 that has at near-end 352 arrives the diameter 350c that reduces gradually between the far-end 354.The thickness of the wall 350e of carrier pipe 350 is " t ".Carrier wall 350e preferably is limited with the chamber 350d that extends to far-end 354 from near-end 352.Chamber 350d is preferably taper, and preferably therein conduit and wall between can hold hemostatic substance 270.The near-end 352 of carrier pipe 350 also preferably is set to hold at least the distal portions of propulsion members 330.The far-end 354 of carrier pipe 350 has distal openings, and it is set to admit conduit 310 from wherein extending through.
With reference to Figure 21, carrier pipe 350 preferably includes vulnerable area 356 especially.In diagrammatic embodiment, vulnerable area 356 comprises the part of the thickness " t " that has minimizing in the carrier pipe 350.The vulnerable area 356 that reduces thickness preferably near or extend to its far-end 354 at the near-end 352 of carrier pipe 350.Vulnerable area 356 defines the zone of on carrier pipe 350 preferential tear or distortion, makes that described carrier pipe will be out of shape near vulnerable area 356 or break when externally applied forces surpasses certain threshold level.In this diagram embodiment, carrier pipe 350 has two vulnerable areas 356, and it is included in the elongated portion of mutual thickness relative, that have minimizing " t " on the diametric(al).Preferably, the whole length of elongated vulnerable area 356 extension carrier pipes 350.
According to this description, the term vulnerable area is the broad terms of its common implication of expression, and expression but be not limited to when applying threshold force preferentially is broken, crooked, extension, expand or the scope or the zone of other distortion.In the embodiment of graphic extension, vulnerable area comprises relatively thin part.According to other embodiment, vulnerable area can be including, but not limited to its material by scratch, boring, through the part of physical or chemical treatment etc.In addition, vulnerable area can comprise may with the material of the identical or different resilient or easy deformation of the material of the remainder of member.
As shown in figure 21, in the diagram embodiment, carrier pipe 350 has two vulnerable areas 356.But be appreciated that carrier pipe 356 can have one or more vulnerable areas 356.
In one embodiment, carrier pipe 350 preferably includes the isolating start-up portion 358 that is positioned at near-end 352.Start-up portion 358 preferably is close to vulnerable area 356 or aims at vulnerable area 356.In the diagram embodiment, start-up portion 358 is and vulnerable area 356 aligned recesses 358.In other embodiments, start-up portion 358 can have other shape.
Referring again to Figure 20, carrier pipe 350 comprises near the handle 362 that is positioned at the near-end 352.Handle 362 preferably include two from conical outer surface 350b apart from vulnerable area the outward extending reverse support arm in position of 356 certain intervals.In the diagram embodiment, delivery tube handle 362 comprises mutually be two support arms of 90 ° usually relatively and with vulnerable area 356 on diametric(al).
Referring again to Figure 17, the assembling of vascular wound packaged unit 300 is performed such, promptly, the far-end 314 of conduit 310 slides and passes the passage 330a of propulsion members 330, thereby the near-end 332 that makes propulsion members 330 is preferably against barrier structure 316, and therefore the far-end 314 of conduit 310 stretched out from the far-end 334 of propulsion members 330.Engagement member 320 engages with barrier structure 316 and pusher member proximal engagement member 342, thereby makes propulsion members 330 vertically be fixed to conduit 310.
The near-end 352 of carrier pipe 350 slips over the far-end 314 of conduit 310, thereby makes conduit 310 pass opening 350d.When carrier pipe 350 near-ends when slipping over conduit 310, bonding part 360 engages with the distal engagement member 344 of propulsion members 330.Like this, conduit 310, propulsion members 330 and carrier pipe 350 mutual vertically fixing have been realized.Therefore, this propulsion members and carrier pipe can be used as one and common moving.The chamber 350d that hemostatic substance 270 can be added carrier pipe 350 before assembling process or among the assembling process.
Continuation is with reference to Figure 17, and when the device assembling, the far-end 314 of conduit 310 stretches out from the far-end 354 of carrier pipe 350, and guide hole 318 preferably equates with the width of arterial wall at least apart from the distance of far-end 354.Preferably, this distance is about 0.5 to 2 millimeter.
In order to use this device, with above combine the device that the described similar mode of Fig. 1-4 will make up and be advanced in the vascular wound " w ".The far-end 354 that is located in its carrier pipe 350 when this device preferably, unclamps engagement member 320 during basically near wound " w " from the barrier structure 316 of conduit 310 and the near-end engagement member 342 of propulsion members 330.Similarly, preferably the engagement member 360 of the carrier pipe 350 distal engagement member 344 from propulsion members 330 is unclamped.Correspondingly, propulsion members 330 and carrier pipe 350 no longer include vertically fixing each other.
Below with reference to Figure 23, when the position that carrier pipe 350 is fixed on basically near wound w, preferably propulsion members 330 is advanced to the opening 350d of the carrier pipe 350 in distally subsequently.Because greater than the diameter of carrier pipe 350, therefore, when propulsion members 330 advanced, carrier pipe 350 broke along vulnerable area 356 diameter of propulsion members 330 basically.In one embodiment, the operator catches the handle 340 of propulsion members 330 and the handle 362 of carrier pipe 350, promotes propulsion members 330 is passed carrier pipe 350.
In case carrier pipe 350 breaks, and opening occurs, thereby hemostatic substance 270 is discharged from chamber.When propulsion members 330 advanced, its contact was also released hemostatic substance 270 carrier pipes 350 and is contacted wound " w ".Preferably, the part of breaking of carrier pipe 350 is taken out from wound location.
As described in conjunction with other embodiment hereinbefore, conduit 310 can be slided through the passage 330a of propulsion members 330 and extract out.In addition, can also use the release lever (not shown) that counter traction is provided, take out from wound location to help propulsion members 330.For example, the passage 330a that release lever can be passed propulsion members 330 slides and inserts, thereby hemostatic substance 270 is engaged with wound location.Because release lever provides counter traction, make that hemostatic substance 270 keeps original position when taking out propulsion members, therefore, the operator can take out propulsion members 330 under the situation that does not influence hemostatic substance 270.
In embodiment discussed above, before being advanced with respect to carrier pipe, propulsion members unclamps engagement member.Be appreciated that in other embodiments, engagement member can be adapted as to have only when the external force that applies above threshold value and could destroy engagement member, thereby dismountable engagement member is taken apart mutually.Therefore, when the operator applied external force and advances described propulsion members, the operator realized unclamping described engagement member simultaneously and propulsion members is advanced.
In another embodiment, the outer surface of the distal engagement member of propulsion members has screw thread, and the inner surface of the near-end engagement member of carrier pipe has screw thread.Thus, described propulsion members and described carrier pipe interfix with thread connecting mode.In this device, described propulsion members is screwed into propulsion members by rotation and advances with respect to described carrier pipe.This device permission operator regulates the distance between delivery tube and the catheter indicator holes.When described device is provided so that described carrier pipe near wound,, therefore, described propulsion members is advanced by continuing propulsion members is screwed into described carrier pipe because carrier pipe is fixed.Thus, propulsion members will enter and finally at vulnerable area carrier pipe be torn.Afterwards, use handle that propulsion members is further advanced.
In another embodiment, can use the engagement member of other type and structure.For example, can use various dismountable closing component structure such as J-lock or L-lock (seeing Figure 24).In addition, in another embodiment, described engagement member can also be a different structure.For example, described engagement member can be included in the binding agent between described propulsion members and the described conduit, and this binding agent is set to can rupture when applying threshold force.In another embodiment, described propulsion members and conduit through mild heat in conjunction with or otherwise combine.Thus, under the effect of threshold force, between described propulsion members and conduit in conjunction with destroyed.
Figure 25-28 has illustrated the embodiment that has with above with reference to another wound closure device 330 ' of the described embodiment similar features of Figure 17-23.As possible, use identical Reference numeral to represent similar elements, but the element in the present embodiment comprise title " ' ".
With reference to Figure 25, locking device 300 ' preferably includes releasably interconnective conduit 310 ', propulsion members 330 ' and carrier pipe 350 ' especially.In addition, device 300 ' preferably includes threaded engagement member 344 ', and it is surrounded on the propulsion members 330 ' slidably.
Especially with reference to Figure 26, conduit 310 ' preferably includes threadless barrier structure 316 ' below.In addition, the part that engagement member 320 ' preferably is set to this engagement member is slidably located on the barrier structure 316 ', thereby it can be entangled.Yet the proximal part of engagement member can not slip over barrier structure 316 ', and therefore, described barrier structure has limited the far-end displacement of described engagement member.
Below with reference to Figure 25 and Figure 27, the near-end 332 of propulsion members 330 ' is set to when propulsion members 330 ' places conduit 310 ' to go up slidably, and it is near barrier structure 316 '.The screw thread of engagement member 342 near-end outer surfaces preferably is set to when described member 320 ' is advanced on the near-end 332 of propulsion members 330 ', the screw thread mechanical engagement of described screw thread and engagement member 320 '.
Propulsion members 330 ' preferably includes the transition portion 337 ' near distal portions 338.Transition portion 337 ' preferably includes column-shaped projection part 337a ' and the basic tapering part 337b ' of being.Bossing 337a ' comprises no thread outer surface, and preferably be set to admit slidably engagement member 344 ' around the far-end on its outer surface, thereby make engagement member 344 ' entangle bossing 337a '.The near-end of engagement member 344 ' can not slip over bossing 337a ', and therefore, bossing 337a ' is limited in the mobile of far-end of combination member 344 ' on the propulsion members 330 '.
With reference to Figure 25 and 28, carrier pipe 350 ' is preferably incorporated in the bonding part 360 ' of its near-end 352.Bonding part 360 ' preferably includes the outer surface 360a ' with screw thread, its be set to can with engagement member 344 ' mechanical engagement.In a preferred embodiment, as mentioned before, carrier pipe 350 ' comprises vulnerable area 356 '.In another preferred embodiment, the main body 350a ' of carrier pipe 350 ' comprises isolating half part 350f, 350g, its be set to around " z " axle mutually near, and on engagement member 344 ' being screwed to bonding part 360 ' time, two and half parts are in the position that interfixes basically.In another preferred embodiment, carrier pipe 350 ' comprises the body 350a ' with two and half part 350f, 350g, and two and half parts are connected by vulnerable area 356 ' at the near-end 352 of carrier pipe 350 '.In another embodiment, described two and half parts connect by elastic component, and this member helped with two and half partial fixings together before discharging hemostatic substance.
Referring again to Figure 25, preferably, vascular closure devices 300 ' is assembled, makes conduit 310 ', propulsion members 330 ' and carrier pipe 350 ' releasably to engage by engagement member, thereby interfixes.For example, conduit 310 ' is inserted in the propulsion members 330 ' slidably abut against on the near-end 332 of propulsion members 330 ' up to barrier structure 316 '.Then, engagement member 320 ' is slipped over barrier structure 316 ' and stubborn being combined on the near-end engagement member 342 of propulsion members 330 '.Similarly, carrier pipe 350 ' is slipped over conduit 310 ' and propulsion members 330 ', near transition portion 337 ', wherein, carrier pipe 350 ' is preferably equipped with hemostatic substance 270 up to the near-end 352 of carrier pipe 350 '.Then, engagement member 344 ' is slipped over bossing 337a ', and be threaded with bonding part 360 '.
As previously discussed, in case described device is positioned at the position of contact wound, engagement member 344 ', 320 ' can be unclamped, thereby remove being connected between propulsion members 330 ' and conduit 310 ' and carrier pipe 350 '.The operator promotes propulsion members 330 ' and enters carrier pipe 350 ', so that the carrier pipe distortion, and promote hemostatic substance 270 near wound " w ".
In the embodiment of just having discussed, described carrier pipe is set to break when described propulsion members advances.In another embodiment, described carrier pipe does not break but is deformed to the material that is enough to make in the carrier pipe and therefrom discharges.For example, constitute by elastomeric material to the described carrier pipe of small part, thereby propulsion members can make described carrier pipe distortion and the material in this carrier pipe be released and near wound such as silicones.In addition, in an embodiment that is made of described carrier pipe elastomeric material, this carrier pipe need not to comprise vulnerable area.These principles also can be used in conjunction with other embodiment discussed in this article, comprise following embodiment.
Figure 29-37 illustrated have with above with reference to another vascular closure devices 300 of Figure 17-23 and the many similar features of the described embodiment of Figure 25-29 " embodiment.As possible, use identical Reference numeral to represent similar elements, but the element in the present embodiment comprise title " " ".It will be appreciated, of course, that similar element needn't adopt identical structure.
Especially with reference to Figure 29, locking device 300 " preferably include releasably interconnective conduit 310 ", propulsion members 330 " and carrier pipe 350 ".
Equally with reference to Figure 30, conduit 310 " preferably include threadless barrier structure 316 ", it is with respect to the catheter body projection.In addition, engagement member 320 " part that preferably is set to this engagement member is slidably located on barrier structure 316 " thereby on it is entangled.Yet, engagement member 320 " proximal part can not slip over barrier structure 316 ", therefore, described barrier structure has limited engagement member 320 " far-end displacement.
Below with reference to Figure 29 and 31, propulsion members 330 " preferably elongated, and place on the conduit 310 ' slidably.Propulsion members 330 " near-end 332 " be set to approach conduit 310 when propulsion members 330 ' slides " and on the time, it is near barrier structure 316 ".Near-end engagement member 342 " outer surface with screw thread preferably is set to when described combination member 320 " be advanced propulsion members 330 " and near-end 332 " when going up, described screw thread and engagement member 320 " the screw thread mechanical engagement.Like this, propulsion members 330 " and conduit 310 " releasably be bonded together, and near-end 332 " near barrier structure 316 ".
Near-end engagement member 342 " the outer surface with screw thread preferably be set to and have the handle 340 of screw thread " mechanical engagement.With reference to figure 32a, 32b and 33, illustrated handle 340 " comprise handle support 370 and handle arm 371.Handle support 370 comprises extends main body 365 and flange 367.Preferably, main body 365 has square or the rectangular opening 369 corresponding square or rectangular shapes in handle arm of being limited to 371, thereby under engagement state, handle support 370 and handle arm 371 are rotated together.Flange 367 also preferably has square or rectangular shape.Handle arm 371 preferably can be slided vertically with respect to handle supportive body 365, thereby and preferably at engagement member 320 " from near-end engagement member 342 " when separating, handle arm 371 can remove and pass the barrier structure 316 of conduit from handle support 370 ".Be appreciated that in other embodiment, can adopt any suitable device (for example ratchet (detent)) that arm handle 371 releasably is connected to support member 370.
Continuation is with reference to Figure 29 and 31, propulsion members 330 " preferably include and tip part 338 " contiguous scalable stopper 337 ".Scalable stopper 337 " preferably include columnar projections parts 337a " and common taper parts 337b ".Protruding part 337a " comprise threadless outer surface and threaded inner surface.Propulsion members 330 " the thread outer surface of distal engagement member 374 preferably be configured at scalable stopper 337 " be advanced propulsion members 330 " and distal portions 338 " when going up, itself and scalable stopper 337 " the screw thread mechanical engagement.
Continuation is with reference to Figure 34, engagement member 344 " proximal part preferably make the hole 368 that its size and structure are provided with like this; promptly; engagement member 344 " can not be at scalable stopper 337 " distally slip, but can be at central shaft part 372, handle support 370 and conduit barrier structure 316 " slip of near-end ground.In the illustrated embodiment, hole 368 common and handle support lugn 367 complementations.Therefore, when having taken out engagement member 320 " and handle 371 after, if necessary, also can take out engagement member 344 ".Taking out engagement member 344 " after, handle arm 371 can on handle support 370, be replaced.
Continuation is with reference to Figure 29 and Figure 35-36, carrier pipe 350 " comprise by isolating two halves or two sections 350f ", 350g " main body 350 that constitutes.Section 350f ", 350g " be individually formed, but be set to abut against each other along " z " axle, to form carrier pipe 350 ".Preferably, first section 350g " have the leader 380 that is set to be fixed in the depression 381, depression 381 is formed on second section 350f " interior so that described section is aimed at fully to form carrier pipe 350 ".
Each section 350f ", 350g " have and be set to recessed inner surface usually, thereby when assembling, pipe 350 " along conduit 310 " install concentrically.In the illustrated embodiment, when the pipe 350 " when being positioned at correct position, described inner surface is at conduit 310 " and inner surface between make chamber.Preferably, the distal portions of chamber is taper at least, thereby the diameter of chamber reduces smoothly towards its far-end.
Referring again to Figure 29, scalable stopper 337 " preferably with the carrier pipe 350 of assembling " top contact.By rotating scalable stopper 337 ", can be with it with respect to propulsion members 330 " near-end ground or distally propelling.When desire with conduit 310 ", propulsion members 330 " and carrier pipe 350 " when being bonded together; with propulsion members 330 " with carrier pipe 350 " engage before, at first with respect to propulsion members 330 " near-end ground or distally mobile scalable stopper 337 " can regulate carrier pipe 350 effectively " with respect to conduit 310 " the position.Therefore, another feature of the present embodiment is, by scalable stopper 337 " move, can be with respect to conduit 310 " in the hole regulate carrier pipe 350 " the position of far-end.This point is for coming with respect to conduit 310 according to particular blood vessel wall and/or clinician's preference " in the hole regulate carrier pipe 350 " the position need.For example, the clinician can regulate stopper 337 ", thus with carrier pipe 350 " far-end be arranged on apart from conduit 310 " the about 1mm in hole and the desired position between the 1cm.
Continuation is with reference to Figure 37-39, vascular closure devices 300 " preferably assembled so that conduit 310 ", propulsion members 330 " and carrier pipe 350 " releasably engage by engagement member, thereby relative to each other fixing.For example, conduit 310 " insert propulsion members 330 slidably " in, up to barrier structure 316 " against propulsion members 330 " near-end 332 ".Engagement member 320 then " at barrier structure 316 " go up to slide, and be threaded into propulsion members 330 " near-end engagement member 342 " on.Preferably, around propulsion members 330 " far-end near conduit 310 " twine hemostatic substance 270, carrier pipe 350 " be set at conduit 310 " on, thereby hemostatic substance is closed in the chamber.Carrier pipe 350 " be set at conduit 310 " and propulsion members 330 " on the part, thereby carrier pipe 350 " near-end 352 " against scalable stopper 337 ".Then, engagement member 344 " at bossing 337a " go up and slide, and with bonding part 360 " threads engage.Before with propeller and pipe joint, the clinician can be by advancing or the scalable stopper 337 of pulling back " come the position of adjustable pipe with respect to conduit.Preferably, carrier pipe 350 " be arranged on conduit 310 " on, thereby carrier pipe 350 " far-end and the distance of guide hole at about 1mm between the 1cm.
As mentioned above, in case when Zu Zhuan device is positioned at the position of contiguous wound " w " fully, engagement member 344 ", 320 " throw off, thereby propulsion members 330 " from conduit 310 " and carrier pipe 350 " disengagement, as shown in figure 38.Handle 340 " preferably taken out at once, thus engagement member 344 " can on handle support 370, take off.Handle 340 " preferably be replaced, and scalable stopper 337 " preferably move near central shaft part 372, thereby it can freely slide, and can not limit propulsion members 330 " with respect to carrier pipe 350 " propelling.
Shown in Figure 39 is the most clear, when the clinician with propulsion members 330 " advance carrier pipe 350 " and in the time, propulsion members 330 " far-end engage with hemostatic substance 270, and advance towards wound " w ".When the operator with propulsion members 330 " advance carrier pipe 350 " and in the time, propulsion members 330 " distal portions 338 " preferably the cone-shaped inner surface with the carrier pipe chamber contact, thereby at least in part with carrier pipe 350 " section 350f ", 350g " separate.Make hemostatic substance 270 from chamber, discharge like this and arrive near wound or the wound the blood vessel.
According to an embodiment, described device preferably is set to when assembling during this device, stopper 337 " only be pushed into one or several screw thread of pusher member distal engagement member 374.Like this, in order to discharge hemostatic substance 270 rather than at first to retract stopper 337 ", the clinician can turn handle simply with respect to stopper 337 " advance propeller.Very fast stopper 337 " will get loose from engagement member 374, and on central shaft part 372, be free to slide, thereby allow the clinician to advance propulsion members 330 apace and easily ".
In the above-described embodiment, carrier pipe the section 350f ", 350g " be set to when propulsion members 330 " separated from one another when being pushed into.In certain embodiments, carry pipeline section to separate fully, in other embodiments, can have only carrier pipe 350 " a part separate.Described section preferably is set to propulsion members 330 " propelling and carrier pipe 350 " engage, thereby described pipe in material can therefrom send.
With reference to Figure 40,41 and 42a-b, vascular wound packaged unit 430 comprises the elongated conduit 432 with far-end 434 and near-end 436.Distal openings 438 is formed the far-end 434 that passes conduit 432, and open along the longitudinal axis of conduit 432.Conduit 432 comprises cone point 4440 at far-end 434.The elongate body 42 of conduit 432 is set near cone point 4440.Main body 42 is preferably to be had along the uniform basically diameter of its length.Inner chamber 444 in conduit 432 inside from distal openings 438 to near-end 436 longitudinal extensions.
Connector part 446 is arranged on the near-end 436.Connector part 446 comprises the main inner chamber 448 and second inner chamber 450.Main inner chamber 448 extends along the longitudinal axis of conduit 432, and extends jointly with conduit cavity 444.Second inner chamber 450 stretches out from main inner chamber 448, but is communicated with main inner chamber 448 and conduit cavity 444.Proximal openings 452 is arranged on the near-end of main inner chamber 448, and open along the longitudinal axis similarly with distal openings 438.Second opening 454 is open in second inner chamber 450.
The size of distal openings 438 and proximal openings 452 is set at and is suitable for holding guide wire 458, for example is used for the guide wire of angioplasty and other vascular surgery.Thus, guide wire 458 can pass conduit 432, and this conduit can advance on guide wire 458.
On near the sidewall of the conduit 432 of distal end of catheter, form porose 460.In another embodiment, form two holes at least.All holes are preferably located in the basic position that equates of far-end distance apart from conduit.
Continuation is provided with vacuum or other suction source 464 with reference to Figure 40,41 and 42a-b, and is communicated with second inner chamber 450 of catheter extension part 446 by pipe 466.Thereby can pass through conduit cavity 44 evacuation.Preferably, the size that will hold the distal openings 438 of guide wire 458 and proximal openings 452 is set at and can makes guide wire 458 abundant occlusion of openings, thereby can pass through hole 460 evacuation.Configuration observation panel 468 between suction source 464 and conduit 432.Observation panel 468 is set to make the clinician to observe the material of extracting out by hole and conduit cavity 44.
With reference to Figure 43, shown vascular wound packaged unit 430 can accurately be set to adjacent with the veins beneath the skin wound " w " with wound closure equally.With reference to Figure 40-43 and 50, in order accurately to locate and near the femoral artery puncture wound w, at first conduit 432 to be through on the guide wire 458, this guide wire passes the femoral artery 94 that puncture wound w is inserted the patient in advance.Inner chamber 444 is connected suction source 464, and parts 430 are pierced into patient's tissue 96 by guide wire 458, thereby make the distal tip 440 of conduit 432 extend through vascular puncture wound w.
In case parts 430 enter, suction source 464 is extracted body fluid out by hole 460.Body fluid passes through observation panel 468, thereby makes the clinician can differentiate the body fluid that is drawn out of.Observation panel 468 can have any suitable structure or position.For example, observation panel can comprise the transparent pipe that is connected with conduit, have the part of the conduit of the syringe of substantially transparent of suction source and observation panel function or substantially transparent concurrently.Most preferably, conduit 432 is made by transparent material, thereby Once you begin extracts blood out from conduit, and the clinician can find at once.
As shown in figure 43, when arterial wall 98 intravasations 94 were passed in hole 460, blood " b " began by importing in the 460 suction conduits 432 of hole and by observation panel 468.Therefore, when when observation panel 468 is observed blood b, the clinician will know that hole 460 has penetrated puncture wound w, and the far-end 502 of carrier pipe 490 is positioned at outer wall 98 places near tremulous pulse 94, preferably, and in arterial wall 98 about 1cm scopes.
Continuation is with reference to Figure 44, carrier pipe 490 normally elongated and comprise first and second members 492,494 that form separately, described member is engaged with each other to form carrier pipe 490.Each pipe component 492,494 has far-end 502, near-end 504, outer surface 506 and inner surface 508.The guide pillar 510 that is formed on one of pipe component 492,494 is installed in the guiding depression 512 that is formed in another member, thus alignment tube member 492,494.After connecting as illustrated in fig. 4 and aiming at, pipe component 492,494 forms carrier pipes 490.As shown in the figure, the near-end 504 of carrier pipe 490 is preferably on its outer surface 506 and has screw thread.Handle portion 514 is arranged on the far-end of near-end 504, and carrier pipe 490 502 is tapered from handle 514 towards far-end usually.
In a preferred embodiment, hemostatic substance 270 comprises the hydrophilic fibers hair.In this manual, the term hair uses as the generalized concept of ordinary meaning purposes, and refer to (and unrestricted) non-woven or woven form of fabric or fluffy or balled form.Should be appreciated that described fiber hair can be treated to or be covered as any suitable form, to strengthen its hydrophilic and/or hemostatic.In a preferred embodiment, fiber shells polysaccharide hair is treated to and has deposited hemorrhage thereon.More preferably, on described hair, deposited microporosity polysaccharide microsphere body.
Continuation is with reference to Figure 45, and propulsion members 500 comprises elongate body 530, and has far-end 528 and near-end 532.Inner chamber 534 longitudinally forms by propulsion members 500, and its gravel size decision be set to can be slidably holding conduit 432 within it.Preferably, propulsion members 500 has enough rigidity, thus can its near-end 532 or near it is held and pushes away forward, engage and promote the hemostatic substance 270 in the carrier pipe 490 successively, and can be exceedingly not bonding or crooked.The distal portions 528 of propulsion members 500 is set to be installed in the proximal part 504 of carrier pipe 490.Yet the distal portions 528 of propulsion members 500 preferably has at least than the part big diameter of carrier pipe 490 near its far-end 502.Like this, when propulsion members 500 was advanced with respect to carrier pipe 490, propulsion members 500 engaged with the inner surface 508 of pipe component 492,494, and promotes it separately, thereby hemostatic substance 270 is discharged from carrier pipe 490.
In the illustrated embodiment, propulsion members 500 has screw thread along its far-end 532.Form annular ring 540 at far-end 528 at a distance of the position of " d " with propulsion members 500.Annular ring 540 is from the radially outward outstanding very little distance of the outer surface of propulsion members 500.Because annular ring 540 is only from the outstanding very little distance in the surface of propulsion members 500, so it can not influence the slip of propulsion members in the near-end 504 of carrier pipe 490.
In the illustrated embodiment, propulsion members 500 has the inner chamber 534 that the diameter that is about 4mm and diameter are about 2mm.Annular ring 540 is about 0.1mm to 0.25mm from the outward extending distance of outer surface, more preferably, is about 0.15mm.
Still with reference to Figure 46, the enlarged drawing when its distal portions 528 that shows propulsion members 500 is installed on the carrier pipe 490 preferably, is provided with a pair of elastic annular locking member 544 around propulsion members 500.Locking member 544 preferably is set to each the side direct neighbor with annular ring 540, and it is of a size of and can engages with the near-end 504 of carrier pipe 490, thereby can not slip into carrier pipe 490 or slide on carrier pipe 490.Preferably, elasticity locking member 544 is installed around propulsion members 500, thereby it can slide along propulsion members 500, even can slide on annular ring 540.
Female thread tightening cover 546 is set to can be screwed on the near-end 504 of carrier pipe 490.Tightening cover 546 has proximal end wall 548, and proximal end wall 548 has the hole 549 of break-through.Hole 549 is of a size of and can holds propulsion members main body 530 and slip thereon.As shown in the figure, the both sides of locking member 544 adjacent rings circles 544 and being arranged on the propulsion members main body 530, propulsion members 500 is inserted in the carrier pipe 490, engages with the near-end 504 of carrier pipe 490 up to locking member 544.Then, on propulsion members 500, advance and cover 546, and cover 546 and be screwed on the carrier pipe 490.Because lid 546 is tightened, therefore cover 546 proximal end wall 548 and engage with locking member 544, locking member 544 is vertically compressed between the near-end 504 of proximal end wall 548 that covers and carrier pipe then.Because its elasticity, when locking member 544 is vertically compressed, its lateral expansion, thus annular ring 544 places and near and propulsion members 500 fluid-tight engagement.
In the illustrated embodiment, locking member 544 and annular ring 540 fluid-tight engagement, thus it can not slide on circle.Because locking member 544 is arranged on the both sides of circle 540, can prevent that therefore propulsion members 500 from sliding on near-end or distal direction with respect to pipe 490.Yet, unclamping from compressive state in case cover 546 loosening and locking members 544, annular ring 540 can slide by locking member 544, and propulsion members 500 can correspondingly slide.
In the illustrated embodiment, tightening cover 546 and carrier pipe 490 have screw thread.Should be appreciated that, can use other fixture, for example J-lock or ratchet.
Shown in embodiment used the annular ring 540 that is arranged on the propulsion members 500.Yet, should be appreciated that, also can use the structure of utilizing similar principles.For example, the projection of any kind be can use, protuberance, a series of protuberance, nail or other projection of giving prominence to comprised from the surface of propulsion members 500.In addition, shown in the present embodiment, can be only on a zone that is positioned at apart from the far-end predetermined length of propulsion members, projection be set, perhaps in other embodiment, can be arranged at all places or even be provided with continuously, thereby make setting and fixed position immobilization and the optimization of propulsion members with respect to carrier pipe along propulsion members.In addition, in other embodiment, the surface of propulsion members can be treated to and produce rough surface rather than a series of protuberances etc., for example by hanging down the grit paper polishing or making it produce recess.In this case, projection is considered to extend from the lowermost portion of recess, groove etc.When locking member 544 is vertically compressed, locking member with lateral expansion and with at least a portion fluid-tight engagement of described recess and projection, thereby propulsion members 500 is fixing in place with respect to carrier pipe 490.Like this, projection is considered to when lid when being tightened, and locking member can realize that grasp is with fixing any configuration of surface of propulsion members by this projection.
In the illustrated embodiment, locking member 544 comprises elastic ring.Should be appreciated that in other embodiment, locking member can have different shapes, and can only extend around the part of propulsion members.In addition, though shown embodiment shows two locking members 544 on the side in the both sides that are arranged on annular ring 540, but be appreciated that, other embodiment can only be used and be set to a locking member releasably engaging with annular ring or other bulge-structure, perhaps more than two locking member.In another embodiment, use one or more locking members, but do not formed projection on the surface of propulsion members.In this embodiment, when lid was tightened, locking member was closely promoted against propulsion members, with the frictional force between increase locking member and the propulsion members, thereby prevented the motion of propulsion members with respect to carrier pipe.
Continuation is with reference to Figure 47, and conduit 432 preferably includes the barrier structure 550 that extends radially outwardly from catheter surface.In the illustrated embodiment, barrier structure 550 comprises annular ring, yet can reckon with, can use the projection of any kind.Still with reference to Figure 48, engagement member 552 is preferably around conduit 432 and is provided with movably, and is set to near-end 532 mechanical engagement with propulsion members 500.In the illustrated embodiment, engagement member 552 has screw thread on the surface within it, to engage with the near-end with screw thread 532 of propulsion members 500.When engagement member 552 and propulsion members 500 engaged, conduit barrier structure 550 was locked between the proximal end wall 554 of the near-end 532 of propulsion members 500 and engagement member 552.Like this, conduit 432 is installed in the position suitable with respect to propulsion members 500 alternatively.As mentioned above, propulsion members 500 is installed in the position suitable with respect to carrier pipe 490 alternatively.Like this, when tightening cover 546 and engagement member 552 engaged as described above, conduit 432, propulsion members 500 and carrier pipe 490 all were positioned at relative to each other fixed position.
In another embodiment, conduit 432 comprises projection, annular ring for example, and be provided with one or more locking members, thus when engagement member 552 engages, releasably propulsion members 500 is fixed to conduit 432.
Continuation wherein shows the collar 560 with reference to Figure 49.The shown collar 560 preferably is made for the ring of disconnection by polymer.Like this, the collar 560 has elasticity and can circumferential expansion.
Still with reference to Figure 40-43,50 and 51, the collar 560 preferably is set to install around carrier pipe 590.The diameter of the non-strictness of the collar 560 is at least less than the most diameter of the tapering part of carrier pipe 490.Therefore, the collar 560 circumferential expansion are to be installed on the carrier pipe 490.This circumferential expansion is subjected to the resistance of the collar 560, thereby the collar 560 applies inside power on carrier pipe 490.By organizing propulsion tube, it is quite little that the overall diameter of carrier pipe 490 is manufactured to ground for easily.As a result, the width of the wall of pipe component 492,494 is preferably suitable little.In certain embodiments, the pipe component with thin-walled is easier to bending.The inside power that the collar 560 is applied helps pipe component 492,494 is kept together, thereby closely installs around conduit 432, and hemostatic substance 270 is contained in the chamber 522.
In the illustrated embodiment, the collar 560 is set to and can slides on carrier pipe 490.Preferably, the collar 560 and carrier pipe 490 all have slick composition surface.Should be appreciated that, can use other suitable surface texture.Continue with reference to 43,50 and 51,, on guide wire 458, described device is advanced and the wound w position adjacent in order correctly to place vascular closure devices 430.Figure 50 shows and passes bodily tissue 96 towards the partly propulsive parts 430 of puncture wound w.When propulsion plant 430, the collar 560 and patient's skin engagement, as shown in figure 50.When further propulsion plant, the collar 560 continues the skin engagement with the patient, and carrier pipe 490 slides to far-end with respect to the collar 560, as shown in figure 43.When pipe slided with respect to the collar 560, the collar was along with the diameter expansion of taper carrier pipe 490, and the collar applies peripheral force continuously, closed to help holding tube.Can anticipate, also help holding tube to close around the bodily tissue 96 of the part of the carrier pipe 490 of the collar 560 far-ends.
When device 430 is positioned near wound w or the wound w desired location, as shown in figure 43, engagement member 552 and lid 546 separately, thereby propulsion members 500 can advance with respect to carrier pipe 490 and conduit 432.Especially with reference to Figure 51, when advancing propulsion members 500, the far-end 528 of propulsion members 500 engages with the inner surface 508 of pipe component 492,494, thereby makes pipe component 492,494 separate and release hemostatic substances 270 in the carrier pipe chamber 522.In the embodiment shown in Figure 51, pipe component the 492, the 494th, flexible, thus it will be outwardly-bent under the effect that comes from propulsive propulsion members 500.
As mentioned above, in one embodiment, hemostatic substance 270 comprises hydrophilic fibers chitosan hair.Because described hair is hydrophilic, so it is attached on the blood vessel 98 around wound, and be attached on around bodily tissue 96 on.In addition, because hair 270 is fibrous, and, therefore there is not fibrous material to pass through wound intravasation 94 because when described material was released, conduit 432 blocked wound w effectively.In addition, when conduit 432 when wound w is removed, hair collapses easily before by conduit in the occupied space.Described hair possess hydrophilic property, and fully around wound w, thus help the quick-acting haemostatic powder of wound relatively.
In certain embodiments, locking device 430 is assembled, thereby the distance of 490 far-end 502 equals or be a bit larger tham the width of blood vessel wall 98 from guide hole 460 to carrier pipe.Like this, carrier pipe 490 is set to and the wound w direct neighbor.Continuation is with reference to Figure 43 and 51, and in the illustrated embodiment, the distance of 490 far-end 502 is greater than the width of blood vessel wall 98 from guide hole 460 to carrier pipe, but less than about 1.5cm.More preferably, this distance is about 1cm or littler.Like this, when guide hole 460 intravasations 94 and clinician saw that blood enters observation panel 468, carrier pipe 490 is placed as certain intervals near blood vessel wall 98 but with it.In the illustrated embodiment, this is a security feature, can not enter or damage wound location w with the far-end 502 that guarantees carrier pipe member 492,494.After discharging hemostatic substance 270, propulsion members 500 promotes described material and with blood vessel wall 98 with wound w contacts or very approaching with it on conduit 432.According to another embodiment, carrier pipe 490 separates with blood vessel wall 98 and is at least the triple approximately distance of blood vessel wall thickness.
Continuation is with reference to Figure 51, when pipe component 492,494 shown in release after when expanding, the resistance that exists pipe component 492,494 to move to far-end, thus further guarantee safety.In addition, though the collar 560 can on carrier pipe 490, slide, its for carrier pipe 490 with respect to the collar 560 further to the mobile resistance that provides of far-end.
Be used for stock size of passing the conduit of femoral artery of the present invention and be about 6F or littler.In the embodiment shown in Figure 40-51, conduit 432 is preferably dimensioned to be about 6.5F.Because the conduit 432 of locking device has than the used bigger diameter of conduit before the clinician wound closure, thus conduit 432 enough greatly with the edge of wound fluid-tight engagement, and block wound effectively.Conduit 432 helps to prevent that with respect to this closely cooperating of wound w hemostatic substance 270 from passing through and intravasation 94 between conduit and edge of wound.The conduit that is appreciated that different size also can be used for the present invention, and as locking device.Locking device conduit 432 preferably has than conduit used in the process between sealing and the bigger diameter of other surgical technique and tools.Preferably, conduit 432 has the diameter of about 0-1F, more preferably is about 0.5F, greater than the conduit that uses before.
According to another embodiment, comprise typographic(al) mark or other labelling on the carrier pipe 490.In use, the clinician notices the degree of depth of perforation in initial vascular puncture.Then, in the blood vessel closed process, the labelling on the carrier pipe 490 is as clinician's reference, can determine the degree of depth of pipe and with respect to the position of vascular wound.Be appreciated that this labelling can be printed on the carrier pipe or can or reduce part and physically form in the rising of pipe.
According to another embodiment, the vascular wound closure device with above index map 12-23,25-28,29-37 or feature that 40-51 describes is placed in the workbox of clinician's use.In the present embodiment, described device constitutes (as other plastics of medical grade) by material disposable but that be fit to, and is combined and is assembled into each member and releasably connects each other, and is provided with hemostatic substance in the carrier pipe.Though described device can be pre-assembled, the clinician also can be by unclamping pipe and propulsion members, adjusting, will manage then and propulsion members engages the position of adjustable pipe with respect to conduit again.Described device is disinfectant and preferably is placed in (not shown) in sealing, the disinfectant container that this container is set to and can opens, for example operating room or catheterization lab in the disinfectant environment.
Although invention has been described in conjunction with some embodiment preferred and embodiment, but will be understood by those skilled in the art that embodiment that the present invention can exceed special announcement expand to other interchangeable embodiment and/or application of the present invention with and conspicuous modification and equivalent.In addition, although described and described a plurality of variations in detail,, according to content disclosed herein, other embodiment is clearly for those skilled in the art.Can also predict that can carry out various combinations and sub-combinations thereof to concrete feature of embodiment of the present invention and content, it all within the scope of the invention.Correspondingly, be appreciated that and the various features and the content of disclosed embodiment can be made up mutually or replace to form the change pattern of disclosed invention.Therefore, above-mentioned its purpose of concrete disclosed embodiment does not limit the scope of the invention, and can only determine scope of the present invention by the reasonable understanding to claim.
Claims
(according to the modification of the 19th of treaty)
1. device that is used for the subcutaneous delivery material, described device comprises:
Elongated carrier pipe, it has chamber, and described chamber is set within it that portion holds material;
Elongated propulsion members, it has distal portions, described distal portions is set to extend through slidably at least a portion of described carrier pipe, thereby at least a portion of described material is released from described carrier pipe, and described propulsion members has at least one projection;
Flexible locking member, it is set to and can assembles around described propulsion members at least in part, and when being subjected to compressing longitudinally usually, is suitable for expanding in a lateral direction;
Wherein, the locking member of described flexibility is positioned near the described propulsion members projection, make when described locking member is subjected to compressing longitudinally usually, described locking member lateral expansion is to engage described propulsion members projection, thereby increase the friction between described propulsion members and the described locking member, so that restrain described propulsion members moving with respect to described locking member.
2. device as claimed in claim 1, wherein, the locking member of described flexibility is set to engage with the near-end of described carrier pipe.
3. device as claimed in claim 2 further comprises tightening cover, and it is configured to the selectively locking member of the described flexibility of compression between the described near-end of described lid and described carrier pipe.
4. device as claimed in claim 3, wherein, described tightening cover can selectively engage with described carrier pipe.
5. device as claimed in claim 1, wherein, described locking member is annular substantially.
6. device as claimed in claim 1, wherein, described projection comprises from the outstanding annular ring in the surface of described propulsion members.
7. device as claimed in claim 1, wherein, described projection comprises that at least one is from the outstanding protuberance in the surface of described propulsion members.
8. device as claimed in claim 1, wherein, the surface of described propulsion members comprises the recess that forms within it, and described projection is outstanding from described recess.
9. device as claimed in claim 1, wherein, described projection stretches out between about 0.05-0.3mm.
10. device as claimed in claim 1, wherein, described projection stretches out between about 0.1-0.2mm.
11. device as claimed in claim 1, wherein, described material comprises hemostatic substance.
12. device as claimed in claim 11, wherein, described material is hydrophilic.
13. device as claimed in claim 12, wherein, described material is fibrous.
14. device as claimed in claim 13, wherein, described material comprises the chitosan hair.
15. device as claimed in claim 14, wherein, described material comprises chitosan hair and starch.
16. device as claimed in claim 12, wherein, described material comprises chitosan.
17. device as claimed in claim 1, wherein, described carrier pipe comprises a plurality of elongated pipe components, and described pipe component is set to and can moves between closed position engaged and open position.
18. device as claimed in claim 17, wherein, described pipe component is flexible, and further comprises the collar of the flexibility that is provided with around described pipe component, and the described collar is subjected to bias voltage, so that described pipe component is remained on described closed position.
19. device as claimed in claim 17, wherein, the described collar can slide on described carrier pipe.
20. device as claimed in claim 17 further comprises elongated conduit, and described carrier pipe chamber is set to admit the described conduit that passes its extension, can also hold material therein.
21. device as claimed in claim 20, wherein, described conduit comprises the sidewall that passes described conduit and the hole that forms, and described carrier pipe is placed on the described conduit, makes the far-end of described pipe near described side opening.
22. device as claimed in claim 21, wherein, between the about 5-1.5mm of the described far-end described conduit side opening of distance of described carrier pipe.
23. device as claimed in claim 21, wherein, it is three times of described blood vessel wall thickness at least that the described far-end of described carrier pipe is set to its distance to described side opening.
24. a system that is used for the subcutaneous delivery material, described system comprises:
Elongated carrier pipe, it has chamber, and described chamber is set within it that portion holds material, and the distal portions of described carrier pipe has the diameter littler than the proximal part of described carrier pipe;
Elongated propulsion members, it has distal portions, described distal portions is set to extend through slidably at least a portion of described carrier pipe, thereby at least a portion of described material is released from described carrier pipe, the diameter of the part of described propulsion members is less than the diameter of the described proximal part of described carrier pipe, but diameter greater than the described distal portions of described carrier pipe, make when described propulsion members is mobile with respect to described delivery tube ground, described propulsion members engages with the inner surface of the described distal portions of described carrier pipe, and makes described carrier pipe distortion;
Flexible locking member, it is set to and can assembles around described propulsion members at least in part, and when being subjected to compressing longitudinally usually, is suitable for expanding in a lateral direction;
Wherein, the locking member of described flexibility is positioned near the described propulsion members, make that when described locking member is subjected to compressing longitudinally usually described locking member lateral expansion to be engaging described propulsion members, thereby increase the friction between described propulsion members and the described locking member.
25. system as claimed in claim 24, wherein, described carrier pipe comprises a plurality of sections that link together.
26. system as claimed in claim 25, wherein, the distal direction of the described carrier pipe of described interior face of described carrier pipe is tapered.
27. system as claimed in claim 26, wherein, described propulsion members distally advances with respect to described pipe, and the far-end of described propulsion members engages with tapered described carrier pipe inner surface, thereby opens described pipe at least in part.
28. system as claimed in claim 25 further comprises the flexible collar, described cover is provided with around the described conveying pipeline section far-end of the described near-end of described carrier pipe, and wherein, the described collar is subjected to bias voltage, links together to keep described pipeline section.
29. system as claimed in claim 28, wherein, the described collar can slide on described carrier pipe.
30. system as claimed in claim 25, wherein, the described far-end of described propulsion members be set to from the described near-end of the section of described carrier pipe to the distance of described far-end about 2/3 to 3/4 the position contact with described section.
31. system as claimed in claim 24, wherein, described propulsion members has at least one projection, and the locking member of described flexibility is positioned near the described projection, make when described locking member is subjected to vertically compressing, described locking member lateral expansion to be engaging described propulsion members projection, thereby suppresses described propulsion members moving with respect to described locking member.
32. system as claimed in claim 31, wherein, the locking member of described flexibility is set to engage with the near-end of described carrier pipe.
33. system as claimed in claim 32 further comprises tightening cover, it is configured to the selectively locking member of the described flexibility of compression between the described near-end of described lid and described carrier pipe.
34. system as claimed in claim 33, wherein, described tightening cover can selectively engage with described carrier pipe.
Claims (32)
1. device that is used for the subcutaneous delivery material, described device comprises:
Elongated carrier pipe, it has chamber, and described chamber is set within it that portion holds material;
Elongated propulsion members, it has distal portions, and described distal portions is set to extend through slidably at least a portion of described carrier pipe, thereby at least a portion of described material is released from described carrier pipe;
Flexible locking member, it is set to and can assembles around described propulsion members at least in part, and when being subjected to compressing longitudinally usually, is suitable for expanding in a lateral direction;
Wherein, the locking member of described flexibility is positioned near the described propulsion members, make that when described locking member is subjected to compressing longitudinally usually described locking member lateral expansion to be engaging described propulsion members, thereby increase the friction between described propulsion members and the described locking member.
2. device as claimed in claim 1, wherein, described propulsion members has at least one projection, and the locking member of described flexibility is positioned near the described projection, make when described locking member is subjected to vertically compressing, described locking member lateral expansion to be engaging described propulsion members projection, thereby suppresses described propulsion members moving with respect to described locking member.
3. device as claimed in claim 2, wherein, the locking member of described flexibility is set to engage with the near-end of described carrier pipe.
4. device as claimed in claim 3 further comprises tightening cover, and it is configured to the selectively locking member of the described flexibility of compression between the described near-end of described lid and described carrier pipe.
5. device as claimed in claim 4, wherein, described tightening cover can selectively engage with described carrier pipe.
6. device as claimed in claim 2, wherein, described locking member is annular substantially.
7. device as claimed in claim 2, wherein, described projection comprises from the outstanding annular ring in the surface of described propulsion members.
8. device as claimed in claim 2, wherein, described projection comprises that at least one is from the outstanding protuberance in the surface of described propulsion members.
9. device as claimed in claim 2, wherein, the surface of described propulsion members comprises the recess that forms within it, and described projection is outstanding from described recess.
10. device as claimed in claim 2, wherein, described projection stretches out between about 0.05-0.3mm.
11. device as claimed in claim 2, wherein, described projection stretches out between about 0.1-0.2mm.
12. device as claimed in claim 2, wherein, described material comprises hemostatic substance.
13. device as claimed in claim 12, wherein, described material is hydrophilic.
14. device as claimed in claim 13, wherein, described material is fibrous.
15. device as claimed in claim 14, wherein, described material comprises the chitosan hair.
16. device as claimed in claim 15, wherein, described material comprises chitosan hair and starch.
17. device as claimed in claim 13, wherein, described material comprises chitosan.
18. device as claimed in claim 2, wherein, described carrier pipe comprises a plurality of elongated pipe components, and described pipe component is set to and can moves between closed position engaged and open position.
19. device as claimed in claim 18, wherein, described pipe component is flexible, and further comprises the collar of the flexibility that is provided with around described pipe component, and the described collar is biased, so that described pipe component is remained on described closed position.
20. device as claimed in claim 18, wherein, the described collar can slide on described carrier pipe.
21. device as claimed in claim 18 further comprises elongated conduit, and described carrier pipe chamber is set to admit the described conduit that passes its extension, can also hold material therein.
22. device as claimed in claim 21, wherein, described conduit comprises the sidewall that passes described conduit and the hole that forms, and described carrier pipe is placed on the described conduit, makes the far-end of described pipe near described side opening.
23. device as claimed in claim 22, wherein, between the about 5-1.5mm of the described far-end described conduit side opening of distance of described carrier pipe.
24. device as claimed in claim 22, wherein, it is three times of described blood vessel wall thickness at least that the described far-end of described carrier pipe is set to its distance to described side opening.
25. an assembly that is used for vascular wound closure, described assembly comprises:
Carrier pipe, it is set within it that portion holds hemostatic substance, and described carrier pipe has near-end and far-end;
Be set to the described far-end of described carrier pipe to be positioned the device of approaching described vascular wound;
Propulsion members, it has distal portions, and described distal portions is set to assemble at least in part the described near-end by described carrier pipe, and the diameter of the part of described propulsion members is greater than the diameter of at least a portion of described carrier pipe; And
The scalable stopper, its surface around described propulsion members is provided with, described scalable stopper is set to the described surface engagement with described propulsion members, and selectively along the described proximal end surface of described propulsion members move or distally move, connect described device and described carrier pipe with adjustable ground.
26. assembly as claimed in claim 25, wherein, described propulsion members comprises unthreaded portion and threaded portion is arranged, described scalable stopper is positioned at first of described propulsion members with connected mode screw position, and described scalable stopper is positioned at second unthreaded portion of described propulsion members in disconnected mode.
27. assembly as claimed in claim 25, wherein, described carrier pipe comprises a plurality of sections that link together.
28. assembly as claimed in claim 25, wherein, described carrier pipe surrounds out chamber, and at least a portion of described chamber has towards the tapered inner surface of the distal direction of described chamber.
29. assembly as claimed in claim 28, wherein, when described propulsion members distally advanced with respect to described pipe, the far-end of described propulsion members engaged with tapered described chamber inner surface, thereby opens described pipe at least in part.
30. assembly as claimed in claim 29, wherein, the described far-end of described propulsion members be set to enter described carrier pipe the section about 2/3 to 3/4 between the position contact with described section.
31. assembly as claimed in claim 25, wherein, described propulsion members further comprises detachable handle.
32. assembly as claimed in claim 31, wherein, the described distal engagement member of described propulsion members comprises and is set to the deep thread that can described propulsion members be engaged with carrier pipe.
Applications Claiming Priority (3)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US49542403P | 2003-08-14 | 2003-08-14 | |
| US60/495,424 | 2003-08-14 | ||
| US60/547,154 | 2004-02-23 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| CN1835715A true CN1835715A (en) | 2006-09-20 |
| CN100374083C CN100374083C (en) | 2008-03-12 |
Family
ID=37003240
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CNB200480023342XA Expired - Fee Related CN100374083C (en) | 2003-08-14 | 2004-08-16 | Vascular wound closure device |
Country Status (2)
| Country | Link |
|---|---|
| CN (1) | CN100374083C (en) |
| CA (1) | CA2801969C (en) |
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106102661A (en) * | 2014-03-26 | 2016-11-09 | 奥林巴斯株式会社 | Stent delivery system |
| CN107669302A (en) * | 2017-11-03 | 2018-02-09 | 韩宗霖 | A kind of closure apparatus for vascular operation |
| CN112774023A (en) * | 2014-07-04 | 2021-05-11 | 阿比奥梅德欧洲股份有限公司 | Sheath for sealing a passageway to a blood vessel |
Family Cites Families (4)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| US4738658A (en) * | 1986-09-19 | 1988-04-19 | Aries Medical Incorporated | Tapered hemostatic device for use in conjunction with a catheter for alleviating blood leakage and method for using same |
| US6056768A (en) * | 1992-01-07 | 2000-05-02 | Cates; Christopher U. | Blood vessel sealing system |
| AU2001273401A1 (en) * | 2000-07-14 | 2002-01-30 | Sub-Q Inc. | Sheath-mounted arterial plug delivery device |
| CN2436105Y (en) * | 2000-08-31 | 2001-06-27 | 蒲忠杰 | MIniature wound closure apparatus |
-
2004
- 2004-08-16 CN CNB200480023342XA patent/CN100374083C/en not_active Expired - Fee Related
- 2004-08-16 CA CA2801969A patent/CA2801969C/en not_active Expired - Fee Related
Cited By (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN106102661A (en) * | 2014-03-26 | 2016-11-09 | 奥林巴斯株式会社 | Stent delivery system |
| CN112774023A (en) * | 2014-07-04 | 2021-05-11 | 阿比奥梅德欧洲股份有限公司 | Sheath for sealing a passageway to a blood vessel |
| CN107669302A (en) * | 2017-11-03 | 2018-02-09 | 韩宗霖 | A kind of closure apparatus for vascular operation |
Also Published As
| Publication number | Publication date |
|---|---|
| CA2801969A1 (en) | 2005-02-24 |
| CN100374083C (en) | 2008-03-12 |
| CA2801969C (en) | 2015-02-24 |
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| CI02 | Correction of invention patent application |
Correction item: Priority Correct: 2004.02.23 US 60/547,154 False: Lack of priority second Number: 38 Page: The title page Volume: 22 |
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| COR | Change of bibliographic data |
Free format text: CORRECT: PRIORITY; FROM: MISSING THE SECOND ARTICLE OF PRIORITY TO: 2004.2.23 US 60/547,154 |
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