CN101155611A - Adjustable infusion catheter - Google Patents

Abstract

An adjustable infusion catheter includes a flexible tube containing one or more axial lumens that allows fluid to flow from the proximal end of the catheter to the distal end. A syringe or infusion pump is the usual pressure source for fluid at the proximal end. A plurality of small-diameter holes are provided in a fenestrated area near the distal end of the tube to disperse fluid throughout a targeted region within the patient's body. The length of the fenestrated area of the catheter body is adjusted by a slidable sheath which can be positioned along the length of the fenestrated area so that its exposed length substantially matches the targeted region. The ends of the slidable sheath include a seal portion to prevent leakage around the ends of the sheath. Heat shrinkable plastic material can be used to form the sheath and the end seals.

Description

Adjustable infusion catheter

Technical field

What present invention relates in general to is field of infusion catheters.More particularly, the present invention relates to a kind of improved apparatus and method, be used for giving the target area of delivering to patient body with fluid, make diffuse fluid arrive whole target area medicine or other treatment.

Background technology

The infusion catheter that is used for conducting drugs to the patient body target area is being known in the art.These conduits generally include a flexible pipe that comprises one or more axial cavity, and axial cavity makes the fluid can be from the proximal flow of conduit to far-end.The fluid source of band such as syringe or infusion pump pressure is connected in catheter proximal end, provides fluid stream to the distal end of catheter that inserts patient body.The distal portion of conduit is provided with one or more portals, and portals to form fluid communication between the part that surrounds the conduit outside of fluidic axial cavity of delivery and patient body.As seen in the prior art, these portal and take various ways, for example, opening in the axial cavity end is cut hole or the seam of wearing chamber or pipe sidewall, the space between the circle of the spring of a pipe of coiled, perhaps, penetrate the crack mouth of the porous membrane that is configured as a pipe.

The conduit of even conveyance fluid on the Infusion Segment of whole stretching, extension.For some medical treatment, it is favourable that the liquid medicine that drips slowly or other treatment fluid are transported to whole stretching area as far as possible equably.For example, analgesic directly is infused into operation place, is commonly used to provide postoperative pain to handle.For long incision or be subjected to the operation process of the regional broad of art tissue (disturbed tissue) (several square inch or bigger), clinical research confirmation, when low speed (the general order of magnitude) infusion analgesic at 1～10cc/hr, when being subjected to instil on the art zone, can improve the alleviation of pain along the whole length of otch or whole.Only provide several infusion catheters that portal that desired wide fluid dispersion under these situations can't be provided.On spread length, increase a plurality of portalling simply, can cause most of fluid only to ooze in a few from these portal usually, therefore can't make other parts in enough fluid contact target zones, therefore can not meet clinical needs.The various infusion catheters that prior art provides, intention is providing uniform fluid to disperse on several inches of catheter length or longer whole stretch section.Several relevant prior-art devices are discussed below.

The Wundcath infusion catheter (authorizing the United States Patent (USP) the 6th, 676,643 and 6,689,110 of Brushey) that Micor makes provides a kind of catheter body that is made of flexible plastic pipe.Plastic tube proximal openings, far-end sealing have formed an one axial cavity, and wherein, near the stretch section along tape punching the pipe far-end forms a large amount of holes.Fine wire helical spring is positioned over intracavity and extends through the total length of catheter body.This helical spring contacts by each adjacent turn or almost contacts the circle that is close to and turns to.The fluid that major part flows in the conduit is advanced along the helical spring inboard of tinsel, permeates away between the circle circle, and the orifice flow in catheter body is to the outside.The seepage effect intention that helical spring causes distributes fluid more equably between all holes along the run of tape punching.And if do not have this helical spring words, most of fluid will go out from several orifice flows at first.

The Soaker conduit (authorizing the United States Patent (USP) the 6th, 626,885 of Massengale) that I-Flow sells provides a kind of catheter body that is made of flexible plastic pipe.Plastic tube proximal openings, far-end sealing have formed an one axial cavity, wherein, have formed a large amount of holes along stretch section near the pipe far-end.A microporous pipe of porous material being made the tubulose of both ends open and making is placed on the far-end that intracavity is positioned at conduit, and extends the run that surpasses tape punching slightly.The fluid that major part flows in the conduit is advanced along microporous pipe, oozes out from micropore, and the orifice flow in catheter body is to the outside.The seepage effect intention that microporous pipe causes distributes fluid more equably between all holes along the run of tape punching; And if do not have this microporous pipe, most of fluid will go out from several orifice flows at first.

The UniFlo conduit that Sorenson (Merit Medical) sells (authorizing people's such as Mottola United States Patent (USP) the 6th, 179,816 and 5,957,901) provides a kind of catheter body that is made of flexible plastic pipe.Plastic tube proximal openings, far-end sealing have formed an one axial cavity, wherein, have formed a large amount of holes along stretch section near the pipe far-end.With to use independent element to help the fluidic Wundcath of homodisperse in catheter body different with the Soaker conduit, the UniFlo conduit is controlled the dispersion of fluid along the run of tape punching by the size of control hole.For the suitable conduit of size (for example 20G diameter in 5 inches about 30 holes of long Duan Shangyou), the order of magnitude in the hole in the UniFlo conduit less than the order of magnitude in the hole in Wundcath and the Soaker conduit (0.001 inch to 0.01 inch magnitude on).The size in each single hole is little, has increased the flow resistance in each hole of flowing through, thereby the maximum flow rates in each hole that reduced to flow through, and forces fluid to flow more equably porose of institute along the run of tape punching; And if the hole is big, most of fluid will go out from several orifice flows at first.

A plurality of other disclosed other catheter configurations of prior art document attempt to provide rationally dispersion of fluid flow uniformly along the Infusion Segment that stretches.Though the major part of these prior-art devices does not resemble so good (at least with the low relatively flow volume delivery fluid time) of device discussed above performance, perhaps manufacture obviously more expensive, but, here they to be comprised to come in, as realizing the example of fluid along the homodisperse further means of stretching, extension Infusion Segment of conduit.

The conduit of length-adjustable Infusion Segment is provided.At some medical treatment situation, use have the infusion catheter that stretches Infusion Segment with liquid medicine or other treatment FLUID TRANSPORTATION on extension region.For these medical treatment, hope can make the length of stretching, extension Infusion Segment and needs now be complementary.For example, when along incision length infusion analgesic when alleviating postoperative pain, wish the length of run that can the accommodation zone perforation, with the length coupling of otch, medicine just can be along the total length conveying of otch like this.Above-described Wundcath, Soaker and UniFlo conduit do not provide any mechanism to regulate this length, but provide according to two kinds or three kinds of patterns, and each pattern has different, fixed fenestrated catheter segment length.It is 2.5,5 or 10 inches fenestrated catheter segment that common available pattern provides length.Multiple other conduits that prior art provides design at thromboembolism or with infusion of drug limited section in the blood vessel usually, and the adjusting to Infusion Segment is provided really.Several related art devices are discussed below.

IV conduit (United States Patent (USP) the 4th, 968, the 306) design of people such as Huss instruction is used for flow rate with about 80cc/hr with the select segment of medicine venoclysis to blood vessel.The Huss device provides: the conduit of band guide line; Catheter body is formed by distal seal inside and outside elongated tubular together, and guide line is contained in the interior pipe, and forms an annular fluid passage between inner and outer pipe; A plurality of portalling on outer tube, between the zone of fluidic circular passage of delivery and catheter body outside, form fluid communication; Sliding sheath is contained on the catheter body, can slide along the length of catheter body, thereby can cover or open the optional part of fenestrated catheter segment.

Because several reasons, the Huss device for example is transported to operation place with anesthetis, to carry out the processing of postoperative pain for some medical applications and impracticable.The first, the Huss device does not provide guarantees that fluid is along the equally distributed means of fenestrated catheter segment.Under this high flow rate in 80cc/hr scope (purposes that Huss device meaning is fixed), not problem; But, be generally used for carrying anesthetis with the low flow rate in 1～10cc/hr scope of alleviating postoperative pain under, just be a problem.

The second, the Huss device does not provide the means that sliding sheath fully are sealed in catheter body.This device is described as has 0.059 inch sliding sheath inside dimension (ID) and 0.059 inch catheter body external dimensions (OD) usually.This " transition " cooperates (line-to-line fit) can provide enough sealings for the fluid infusion of the short pulse formula in 80cc/hr scope (purposes that Huss device meaning is fixed), yet, slow infusion for consecutive numbers hour or a couple of days just can not provide enough sealings.When considering normal manufacturing tolerance, can expect and have at least 0.001 inch, and the gap that more possible is up to 0.005 inch, and provide enough leakage paths to make the outlet that is covered cause tangible fluid flow, the fluid of these flows will drip to the outside from the sheath end.In order to guarantee good sealing, be necessary between sheath and catheter body, to provide and interfere or interference fit.But way is unpractical in the Huss design like this, because if by the interference engagement sizing, these parts can not assemble.

Because complexity that number of components is big, the desired tolerance of parts is tight and the subassembler plants, the Huss device manufactures quite expensive.It is acceptable that the manufacturing cost of Huss conduit is decided purposes for the thromboclastic meaning of the life-threatening vascular of disposal, at this moment can accept a conduit and sell hundreds of dollars or more expensive on market.Yet for carrying anesthetis to handle occasions such as postoperative pain, the manufacturing cost of Huss device is just unacceptable, and at this moment this device must be produced to have the cost competitiveness in 1～10 dollar scope.

At last, the Huss device comprises a tightly lasso that is positioned at the sheath proximal end.This lasso can twist and tighten up on catheter body, seals this near-end in case stopping leak leaks (noticing that needing this feature is that the design of sheath itself does not have the evidence that excellent sealing is not provided with respect to catheter body).Except cost increased, this ferrule design had also caused piece volumes big, had reduced the comfortable of patient and convenient.In handling the occasion of postoperative pain, conduit will be fixed on the patient skin and time of stay put a few hours or a couple of days, and during during this period of time, it is movable that the patient often wants.Lasso is fixed on that wearing and tearing and stimulation, the especially patient that may cause skin on the skin go round thereby when lasso and skin friction.The volume of lasso also can bring inconvenience, because any significant projection on the skin surface all can be hooked to above clothes, decoration, the sheet etc.

The disclosed conduit of people such as Zhan (United States Patent (USP) the 5th, 626,564) is similar to the Huss device, has same defective when assessing at the present invention.The disclosed device of people such as Quriel (United States Patent (USP) the 6th, 755,813) discloses a kind of similar device, also is to have some same deficiencies.

Conduit (United States Patent (USP) the 6th, 594,880,6,093,180 and 6,056, the 725) design of Elsberry instruction be used for for example treat cerebroma, Alzheimer disease or other neurological application scenarios with infusion of drug to substantive target.This catheter design is typically implanted in the patient body, uses the infusion pump of implanting to carry out long-term treatment.The conduit that the Elsberry device is provided has the antipriming pipe of end sealing, and this antipriming pipe remains on the opening of the second non-porous pipe.The material that forms second pipe expands when being heated or be exposed to certain special chemical substance, and gets back to original state when removing heat or chemical substance.When second tube swelling, user slidably antipriming pipe advances or goes out, thereby makes the length of exposing mate the size of substantive target; Then remove heat or chemical substance,, hold it on the position after the adjusting so second pipe tightens up on first pipe.Because several reasons, for carrying out the postoperative pain disposal and wait some medical applications such as anesthetis being transported to operation place, the Elsberry device is unpractical.

Elsberry matching requirements user will apply the heat or the chemical solvent of controlled quatity before regulating Infusion Segment length, keep adjusting position then and wait until thermal expansion effects or the disappearance of chemically expansible effect always.This way is unpractical under general surgical operation background, because: (a) controlled thermal source or special chemical solvent generally can't obtain in operating room, therefore need provide specially, increased cost, caused inconvenience, (b) clinician and operating room time all very short usually, relevant cost is very high, therefore, finishing the required increase time of regulating step is can be not cost-effective.

In addition, " zero tolerance " (i.e. " transition ") cooperation between the Elsberry device instruction antipriming pipe and second pipe, and antipriming pipe do not reach the near-end (originally can directly be fixed to catheter extension at this position antipriming pipe) of conduit, but only is held in place by contacting with second pipe.This way can provide fixing fully, and implantation catheter can reduce most external force for implantation catheter in brain involved meticulous location and operation.These external force can cause conduit to remove from its lay down location.But, carrying out under the occasion such as postoperative pain disposal anesthetis being transported to operation place, conduit during placing and taking off and during use (especially the patient is when motion) is exposed to tangible external force.Be used in the occasion of these types if having the conduit of Elsberry design, the lay down location accidental separation of antipriming pipe from conduit all may take place, require to undergo surgery subsequently to take out and stay the intravital part of patient in use or during taking off.

When selecting second tube material, the Elsberry device be limited in those be heated or obviously expand when being exposed to particular chemicals and after heat or chemical substance are removed the material of reinstatement.The Elsberry instruction says that potential material options is polyacrylonitrile, silicone elastomer or polyurethane.Be used for carrying out the composite behaviour that the conduit of occasions such as postoperative pain disposal requires relevant high tensile, high ductibility, antitorque knot, pliability and lubricating ability usually such as anesthetis being transported to operation place.(the most frequently used is 19～21G), and silicone will can't provide enough composite behaviours of this more relevant performance with polyacrylonitrile under the small size of the application scenario that is generally used for these types.Have some polyurethane can be used for conduit under these occasions, still, for these occasions required material property and the required chemical induction expansion character of adjustability, this material can not all obtain optimization.

Therefore, need a kind of infusion catheter, can be along the Infusion Segment conveyance fluid that stretches, can be along the total length homodisperse FLUID TRANSPORTATION of this Infusion Segment, make the user can easily regulate the length of this Infusion Segment in use, and this needs also are not met now.In order to provide wide adaptability to be used in surgical procedures widely, be furnished with at least 10～12 inches, when being approximately the suitable long Infusion Segment of suitable minor diameter of 19～21G, and with using together than the infusion system under the slow flow rates in 1～10cc/hr scope the time, this improved infusion catheter must be worked well.In addition, the manufacturing cost of this improved conduit necessarily can not be apparently higher than the manufacturing cost of the Wundcath that is spoken of, Soaker and the existing conduit of UniFlo formula.

Summary of the invention

The invention provides a kind of infusion catheter and using method thereof, portal, fluid can be dispersed on the whole target area by extending part setting along distal end of catheter.Stretch section can be regulated by the user, and can according to application scenario now require indicated like that with the fluid through part from short length adjustment to long length.A kind of governor motion so just is provided, has manufactured inexpensively, used easily, comfortable for the patient, convenient, and can disperse run with low flow rate, low fluid driving pressure dispersing fluid along fluid.

Conduit of the present invention is provided with elongated, flexible tubular catheter body, has the axial cavity that stretches to far-end from near-end.The distal portions of catheter body is perforated, and forms the fluid passage that extends through catheter body wall from the chamber, forms a plurality of paths that are used for fluid is discharged to from the catheter body the inside zone, catheter body outside.Outside sliding sheath is formed by flexible pipe, and internal diameter equals or be a bit larger tham the external diameter of catheter body.The end of sheath is necked to the external diameter that internal diameter is slightly smaller than catheter body, makes when sheath is contained on the catheter body, and but the sheath end of constriction forms not saturating fluid slidably sealing with respect to the outside of catheter body.The length of sheath is greater than the length of catheter body fenestrated section, but shorter than the part of the close fenestrated section of catheter body.When sheath covered the entire belt perforated portion to the far-end slip, all fluid passages all were covered, and the fluid of intracavity can not be discharged into the outside of conduit.When sheath slides and when opening part or all fenestrated section, fluid passage is opened to near-end, fluid can be from the chamber discharges through the path of respectively having opened.By regulating the position of sheath, the user can selectively opened fenestrated section needs part, to provide roughly and infusion length as the body region coupling of infusion target.

In a preferred embodiment, catheter body is formed of an extruded polymeric tube, and is formed with closed end at far-end, and fluid passage is formed by a series of micropores that pass tube wall.A plurality of micropores are provided with along the predetermined length (fenestrated section) of catheter body.Size and quantity to micropore are selected to guarantee that fluid is at entire belt perforated portion homodisperse.

In a preferred embodiment, sheath is formed by the heat-shrinkable polymeric tube of extruding.By use the heat that applies selectively in manufacture process, the short section of sheath near-end and far-end shrinks, so that fluid-tight sealing to be provided between sheath and catheter body.

In a further embodiment, the end of sheath can be formed by thicker circumferential end ring, to form sealing between the outer surface of sheath and tubular catheter body.In addition, can increase the lubricity of sheath material and/or catheter body,, but still provide necessary fluid-tight so that sheath can be better slide along catheter body.

In a preferred embodiment, the near-end of catheter body is connected to AN connector, for example Tuohy-Borst adapter or Luer lock connector, and this correspondence being connected of far-end and fluid source.

These and other advantage of the present invention, feature and purpose can be easier to understand behind detailed description of having been done below having seen and the accompanying drawing.

Description of drawings

In conjunction with the accompanying drawings, can more easily understand the present invention.In the accompanying drawings:

Fig. 1 is the sketch map according to adjustable infusion catheter of the present invention, expression be that conduit is connected on the infusion pump, and on the whole length at surgical wound place, carry liquid medicine;

Fig. 2 is the sketch map of another embodiment of adjustable infusion catheter, comprises the catheter body of two branch roads, is used for carrying out infusion simultaneously in two independent infusion site;

Shown in Fig. 3 is that sheath is regulated the sketch map that slides along catheter body with sheath, and wherein, the entire belt perforated portion is exposing;

Fig. 4 is the sketch map that the expression sheath covers only about half of fenestrated section;

Fig. 5 is the sketch map that the entire belt perforated portion of expression conduit is covered by sheath;

Fig. 6 describes liquid medicine flows out conduit when sheath is positioned to expose the entire belt perforated portion sketch map;

Fig. 7 is the sketch map that the expression sheath covers the adjustable infusion catheter of part fenestrated section;

Fig. 8 is that the entire belt perforated portion of expression adjustable infusion catheter is covered and does not have mobile sketch map;

Fig. 9 is the amplification view of adjustable distal end of catheter, and this far-end has the micropore of the perforation of forming;

Figure 10 is an amplification view of replacing the catheter body far-end, and wherein, a coil is arranged in axial cavity, and macropore has formed perforation;

Figure 11 is the amplification view of adjustable another embodiment of conduit, and wherein, an antipriming pipe is positioned at axial cavity, and macropore has formed perforation;

Figure 12 is the amplification view of adjustable another embodiment of conduit, and wherein, the catheter body far-end is formed by porous material;

Figure 13 is the amplification view of adjustable another embodiment of conduit, expression be that the end of catheter body forms sphere, shift out from the end of conduit to prevent sheath;

Figure 14 is the amplification view of the perforated portion near-end of adjustable conduit, and this near-end has a raised-diameter segment around the catheter body periphery, is used for preventing that sheath from coming off from the far-end of conduit;

Figure 15 is the amplification view of adjustable catheter body, and this catheter body has scale mark, is placed on the intravital degree of depth of patient with the position and the conduit of visual means indication sheath on catheter body;

Figure 16～Figure 19 is that expression is transported to the sketch map of the method for patient's body region of interest within to liquid medicine with conduit, and wherein, sheath is positioned to make the fenestrated section coupling target infusion site of conduit, and conduit is through a guide member reeve target infusion site then;

What the sketch map of Figure 20～Figure 21 was represented is, injects conduit with fluid, then conduit is connected to infusion pump, is used for liquid medicine is carried along the whole length of target infusion site.

The specific embodiment

More specifically with reference to accompanying drawing, what Fig. 1 described is according to adjustable infusion catheter of the present invention just in use, liquid medicine is transported to patient's surgical wound position 800 now.Adjustable pipe guide 600 comprises flexible tubular conduit 602, is used for liquid medicine is transported to target infusion site 800 from infusion device 700.The pattern that infusion device 700 shown in Figure 1 adopts is disposable Beeline infusion pump, by the McKinleyMedical LLLP sale of Wheat Ridge company.But a variety of devices can be used for a flow of liquid supplying duct, comprise syringe, gravity supply type infusion bag or bottle, perhaps in fact any machinery or electronics infusion system that is widely used in medical practice.In Fig. 1, target infusion site 800 is depicted as operative incision.But conduit 600 of the present invention can be used for any infusion site as target in patient's body, comprises special body structure, as nerve tract, organ, perhaps diseased tissue area and body cavity are as intraarticular space, abdominal part or chest space, internal blood vessel, perhaps surgery location.

What Fig. 2 represented is an alternative embodiment of the present invention, and a kind of pair of adjustable pipe guide 610 of branch road contains two branch roads 604,606, is used for respectively to two positions, 810,820 infusions.Each branch road is all adjustable separately, allows the user that two different infusion site of size are mated.As shown in Figure 2, the branch road 604 below the conduit is adjusted to the littler otch 810 of coupling, and top branch road 606 is adjusted to the longer otch 820 of coupling.

Fig. 3～Fig. 5 is illustrated to be the adjusting of infusion catheter.The critical piece of adjustable infusion catheter is catheter body 100, sheath 200 and proximal connector 300.Catheter body 100 is one section flexible pipe material, and saving distal portions along one of pipe material has perforation 165.The near-end of catheter body 100 is connected in fluid-tight fashion to proximal connector 300, forms from proximal connector along the endoporus of catheter body and through the 165 outside fluid passages of boring a hole.Sheath 200 is flexible pipe material of a segment length, is formed by suitable plastic such as hot shortness's polymer.The size of sheath 200 will decide to become: during " expansion " state before being in pyrocondensation, the internal diameter of sheath is contained in the external diameter outside of catheter body 100, leaves some minimum clearance at least, slides on catheter body to allow sheath.The size of sheath 200 also will decide to become: when being in " recovery " state after the pyrocondensation, above-mentioned internal diameter be reduced to size at least minimally less than the external diameter of catheter body 100, to guarantee the interference fit between sheath and the catheter body, allow sheath to slide like this, also between sheath and catheter body, formed fluid-tight sealing 167 along catheter body length.The length of sheath 200 preferably is specified to the length that minimally at least is longer than the catheter body fenestrated section, and like this, when needs, sheath can be adjusted to and block the entire belt perforated portion.A kind of substitute mode is that sheath can be shorter than fenestrated section.In this case, at least a portion fenestrated section always is not covered always, and is therefore open to produce fluid stream.

Form the material of catheter body 100 preferably flexible, have suitable biocompatibility, can save cost and can utilize extruding, the manufacturing of terminal shaping standard catheter production technologies such as (tipforming) for long-term body contact tissue.Suitable material includes but not limited to nylon, polyether block amide, polyurethane, polyimides, PVC, PEP and PTFE.

The material that forms sheath 200 is preferably flexible, the hot shortness, have suitable biocompatibility, can save cost and also can utilize standard pipe material production technology manufacturings such as extruding for long-term body contact tissue.Suitable material includes but not limited to polyester, PTFE, FEP and polyolefin.

In a preferred embodiment, proximal connector 300 is cloudy type luer lock connectors.The material that forms proximal connector 300 preferably will be transported to systemic fluid subsequently for contact to have suitable biocompatibility, can save cost and can use injection molding and standard production technology manufacturings such as solvent or binding agent combination.Suitable material includes but not limited to acrylic resin, Merlon, ABS, PVC, polyethylene and polypropylene.Proximal connector can permanently be attached to catheter body, for example is bonded to the cloudy type luer lock connector of catheter body, perhaps is detachably connected to catheter body, for example the Tuohy-Borst adapter.

By catching sheath and along the pulling of the direction of hope, the user can regulate the position of sheath 200 along catheter body 100.When the slip sheath, also to control catheter body or proximal connector so that tension force to be provided, but omit this point among the figure, to observe apparatus of the present invention better.When sheath distad slided, the fenestrated section 165 of catheter body was local or all cover by sheath.The degree that covers depends on the axial location of sheath.In Fig. 3, the represented device that goes out is the proximally-located of sheath 200 along catheter body 100, and the entire belt perforated portion of catheter body is exposed.In Fig. 4, sheath 200 distad slided along catheter body 100, made sheath 200 cover a part of fenestrated section 165 of catheter body.On this position, sheath 200 stops that therefore, fluid can only flow out from the part that do not cover of fenestrated section from the flowing of the perforation 165 that is covered.In Fig. 5, sheath 200 slides further, and the far-end that makes sheath is very near the far-end of catheter body 100 and cover the entire belt perforated portion 165 of catheter body.On this position, sheath is blocks flow fully, because all perforation all have been covered.

Fig. 6～Fig. 8 has described the fenestrated section 165 of catheter body 100 in more detail, and shows the final pattern of the fluid stream that comes out from device when sheath is adjusted to the same position that Fig. 3,4,5 describes respectively.Device shown in Figure 6 is the proximal part that sheath 200 slides into catheter body 100, and the entire belt perforated portion 165 of catheter body is exposed.In this position, the fluid that is transported to conduit from infusion device through proximal connector 300 oozes catheter body along entire belt perforated portion 165.Device shown in Figure 7 is that sheath 200 distad slides, and has covered a part of fenestrated section 165, and has not covered the remainder of fenestrated section.In this position, the fluid that is transported to conduit can not flow out in the perforation through being covered, and these perforation are blocked by sheath, and therefore, fluid can only ooze catheter body along the part that fenestrated section is not covered.Device shown in Figure 8 is that sheath 200 is further far away sliding, has covered entire belt perforated portion 165.In this position, block fluid fully and flow out from conduit.

Referring now to Fig. 9,, the cutaway view by the distal end of catheter part illustrates in greater detail the preferred embodiment of the present invention.The form that catheter body 100 is taked is a closed-end tube 122, has formed axial cavity 120 in the inside of outer tubular wall 140.The perforation 160 that penetrating tubular wall 140 and axial cavity 120 are provided with has formed the fluid passage of the infusion site area of outside from proximal connector 300 to distal end of catheter.In the preferred embodiment, each perforation size of 160 is controlled and is very little, even the fluid that is transported to conduit from infusion device also can be flowed out through all perforation that are not covered when this fluid provides with quite low flow rate and low infusion pressure.The fluid flow rate of any single perforation 160 of flowing through is proportional to the size and the inside and outside differential pressure of opening.If single perforation 160 is too big, so, most or all fluids will flow out from the position in nearest perforation.By setting the size of perforation enough for a short time, a spot of perforation can not hold all fluid stream, and therefore, fluid will distribute between all perforation that do not cover more equably.

Must select two kinds of afoul needs below balance to bore a hole 160 actual size and position: provide uniform flux distribute (this requires the hole dimension minimum) in the entire belt punch block; The flow restriction that causes of guaranteeing to bore a hole can not cause the speed that transports fluid into infusion site obviously to reduce (this requires the hole dimension maximum) clinically.In this preferred embodiment, each bores a hole 160 size in 0.0002 inch to 0.005 inch scope, and the optimal perforation size depends on the thickness of catheter body wall 140, set the number of holes (desired extent of the number of holes that is not covered when comprising common purposes), fluid flow through the hope flow rate range of conduit and the fluid pressure that infusion device 700 produces.In order to improve fluidic concordance, the size and the spacing of each perforation can change on entire belt punch block or fenestrated section 165.For example, the distal portions of perforated portion can have more, bigger perforation 161,, perhaps is used for when having only quite a spot of perforation that enough low flow restriction is provided when far-end is not covered to the fluid crushing that far-end flows and causes with the balance fluid.

Though illustrated embodiment comprises the circular distal 122 of a sealing at the catheter body far-end,, smooth, the open terminal configuration of replacements such as end terminal or have a little perforation 124 in the end also is acceptable.The embodiment that does not seal for end is because tubular sheath can not be blocked the end of catheter body far-end, so sheath can not be used for stoping fully infusion.

Still referring to Fig. 9, also arrive Figure 13 referring to Figure 10 simultaneously, all these figure show the same detail of sheath.The far-end of sheath is represented according to sectional view.The form that sheath 200 is taked is an open-ended tube, and the tubular wall of being made by heat-shrinkable materials 240 forms.Most of sheath 200 is " expansion " form, is formed with to have the annulus 242 of minimum clearance at least between sheath wall 240 and catheter body wall 140.Far-end at sheath heats in manufacture process, becomes constriction or sealing 220 so that the end seal part 167 of sheath wall 240 is dwindled.As discussed above, " recovery " state of sheath pipe material provides the diameter of these 220 the insides, necking section after the pyrocondensation, and this diameter is less than the external diameter of catheter body 140.But, because catheter body is in place under sheath,, but be forced to the diameter state that stretches slightly of keeping so necking section 220 can not arrive the diameter state of abundant recovery, wherein, constriction sheath ID coupling catheter body OD.This state has been brought up the internal diameter of necking section 220 and crush seal or the interference fit between the catheter body external diameter, and because incomplete diameter recovers the sealing force of generation around catheter body, and in material contracting with heat, produced residual stress.This interference fit of necking section has formed saturating fluid but the sealing 167 that can slide, makes the sheath to slide into any desired location along conduit, keeps the fluid-tight sealing between sheath and the conduit simultaneously.Also can form the constriction end (in the enlarging section shown in Fig. 9～13, cannot see, but in Figure 14, can see) of equivalence at the near-end of sheath, make sheath two ends all with saturating fluid but the form that can slide seal around the periphery of catheter body.

In these preferred embodiments, the interference fit that necking section 220 and catheter body are 100 or seal 167 in 0.0005 inch to 0.005 inch scope, best interference size depend on the maximum fluid pressure potential difference that coefficient of friction between elasticity, catheter body and the sheath after the modulus of size (for example wall thickness and total diameter), catheter body and sheath material of catheter body and sheath and yield strength, the pyrocondensation of sheath material and infusion device 700 produce.

Referring now to Figure 10.In an illustrated alternative embodiment, perforation 160 is made of large-sized hole.Such as discussed above, perforation becomes senior general makes the perforation nearest from the position of most or all fluids flow out, and prevents uniform distribution on the entire portion that fluid flow is not covered in the punch block.Yet this embodiment provides a kind of replacement method that guarantees that uniform flux distributes by comprise Inside coil 123 in catheter body.Inside coil 123 by tinsel or other filament windings at interval closely multi-turn form.The very little role in interval between the circle circle is, restriction flows out to the maximum stream flow of adjacent perforated from the axial cavity 120 of coil the inside through any pipe nipple coil, thus, can both guarantee consistent flow distribution for each perforation that is not covered.Inside coil 123 can extend in the total length of catheter body the inside, also can be that length is shorter, only extends in the inside of the fenestrated area of catheter body.

Now referring to Figure 11.In another alternative embodiment shown in the figure, perforation 160 is made of the bigger hole of size.In this specific embodiments,, provide the assurance flow distribution uniform another kind of replacement means by in catheter body, comprising internal perforated pipe 124.Internal perforated pipe 124 is formed by poromerics such as expanded PTFE or polysulfones, and pore size is in 0.1 to 10 micron scope.Yet, be easy to replace with other suitable materials.The size role that micropore is very little is, restriction flows out to the maximum stream flow of adjacent perforated 160 from the axial cavity 120 of antipriming pipe the inside through any pipe nipple antipriming pipe, thus, can both guarantee consistent flow distribution for each perforation that is not covered.Internal perforated pipe 124 can extend in the total length of catheter body the inside, also can be that length is shorter, only extends in the inside of the fenestrated section 165 of catheter body.

Now referring to Figure 12.In another alternative embodiment shown in the figure, fenestrated section 165 is made of the porous tube section 145 that is contained in catheter body 100 far-ends.Porous tube section 145 is formed by poromerics such as expanded PTFE or polysulfones, and pore size is in 0.1 to 10 micron scope.Yet, be easy to replace with other suitable materials.The size role that micropore is very little is that restriction through the effusive flow of any pipe nipple antipriming pipe, thus, is guaranteed the part uniform distribution that be not covered of flow along porous tube section from axial cavity 120.Porous tube section 145 can extend through the total length of catheter body, wherein, a complementary non-porous epitheca part 200 of catheter body wall 140 covers antipriming pipe that part near tape punching zone 165, makes complementary non-porous outer wall 200 prevent that fluid from flowing out through porous tube section those parts near fenestrated section.Interchangeable mode is that 145 of porous tube sections form described fenestrated section 165, are connected to non-porous section of catheter body wall 140 in the proximal end of fenestrated area.

Shown in Figure 13 is the cutaway view of distal end of catheter, expresses the further details of this preferred embodiment.The distal tip 178 of shown catheter body 100, the structure 180 that has a spherical or enlarged-diameter in the end.The purpose of this structure is to prevent the end slippage of sheath 200 from catheter body 100.This structure has improved the user friendly of this device, because if the special assembly tool that in manufacture process, does not use, so, in case sheath wants slippage will be difficult to sheath back is set on the catheter body.

In addition, the end 166 of sheath 200 can have the circumferential end part 168 of thickening, is used for forming fluid-tight.The internal diameter of the end sections 168 of thickening is less than the external diameter of pipe 100.This still allows sheath 200 to slide along the surface of pipe 100.Whether shrink the end 166 of sheath sealing 200, can use thickened end part 168.

What Figure 14 described is an alternative embodiment that prevents the structure of sheath slippage catheter body far-end.According to this form, the lasso of enlarged-diameter or section 185 be arranged on catheter body top, sheath below, near the near-end of fenestrated section 165.The necking section 220 of sheath near-end slides into always and leans against raised-diameter segment 185.Raised-diameter segment 185 is as the backstop that prevents that sheath from further sliding.The position of raised-diameter segment 185 is arranged in sheath distal and blocked sheath before the catheter body far-end comes off.Raised-diameter segment 185 is preferably formed by a short section pipe material, with binding agent or solvent bonding or pyrocondensation or other thermal technology on catheter body in conjunction with in place.Interchangeable mode is, utilizes RF to be shaped or the technologies such as extrusion technique of variable-diameter, raised-diameter segment 185 directly can be made in the catheter body wall 140.

Figure 15 shows a kind of preferred embodiment of conduit, and wherein, visual indicator mark or scale 190 are included on the catheter body.Sheath is not shown among Figure 15, can be more clearly visible indicator mark 190 like this.The position of indicator mark 190 is provided with the user is in when cannot see in patient's body at the far-end of conduit, determines the position (being how long the part that fenestrated section is not covered has) of sheath and the apparent position of catheter tip.Indicator mark 190 is preferably by being formed directly on the outer surface of catheter body wall 140 with methods such as ink printing or laser markings.

The using method of the adjustable infusion catheter that Figure 16 represents to Figure 21.What Figure 16 described is that the user slides into desired location to sheath 200 along catheter body 100, makes the length of the length approximate match infusion site 800 (being drawn as open otch for the purpose of illustration) of the expose portion of fenestrated section 165.Figure 17 represents be guide member 900 by the user pass patient skin inject after the otch situation.Guide member 900 is depicted as strippable sheath 902 on sharp pin or stylet 901.What Figure 18 showed guide member peels off the still appropriate location in otch of sheath part 902, and pin/stylet part 901 is taken away, and conduit injects otch through sheath.Figure 19 described when sheath 902 from the patient extract out and during peel-away catheter conduit be retained in original place the otch.What Figure 20 described is that pipe guide 600 is in the appropriate location in the incision site 800, and catheter body is fixed on the patient skin with adhesive tape 612, and the user pours into being full of 608 pairs of conduits of fluidic syringe.Can see that fluid oozes from the expose portion of fenestrated section 165, on whole otch, provide quite consistent fluid to disperse.The whole infusion system that Figure 21 describes in being to use, wherein, infusion device 700 is connected to pipe guide 600, and fluid is carried along infusion site 800.

In these preferred embodiments, the material of catheter body and sheath is all formed by the lower material of coefficient of friction, perhaps all scribbles lubricant coating.This aspect of the present invention allows to form bigger interference fit between constriction sheath end and catheter body, and better sealing so just is provided, and can more keep not saturating fluid under the high pressure, and no longer need unreasonable high power that sheath is slided along catheter body.Low-friction material or lubricant coating have also reduced conduit and have adhered to bodily tissue or be implanted in probability on the intravital thing of patient, have reduced thus when treatment finishes conduit to be taken away needed strength (therefore having reduced the probability of the related conduit fragmentation that the takes place when user pulls at conduit very much) from patient body.

Sheath is preferably formed by colored or opaque material 169, contrasts by force with color or transparent formation with catheter body.User friendly has been improved by just can easily determine the position of sheath at a glance in this aspect of the present invention.

Conduit of the present invention can be made according to the size of wide range.The preferred size of conduit depends on the clinical application that this conduit will use.The length of fenestrated section can depend on the body position as target from changing to greater than 1 foot less than 1 inch.For the surgical procedures at wide region provides adaptability widely,, be about 10～15 inches long of fenestrated section, and sheath is longer than fenestrated section slightly with the preferred size of infusion of pain to the operation position.With infusion of pain to the preferred catheter body size range of operation in the position between 15G and 24G, what the clinician the most generally liked adopting is that 18G is to the size between the 21G.The length that the length of catheter body must equal sheath at least adds the length of fenestrated section, makes all perforation required spaces that can not be covered so that whole sheath to be provided near the fenestrated section location.The length of catheter body also will be enough to reach for infusion device position easily from infusion site, but long to since in a large number the pipe material that relax hinder patient's convenience.Can ambulant situation during infusion for the patient, the length in 18～60 inches scopes is normally suitable, and for most of occasions, 24～36 inches scope is enough used.

Above disclosed content a plurality of embodiment of the present invention has been proposed, these embodiment describe in detail in conjunction with the accompanying drawings.Those skilled in the art can understand, can make various changes, modification, other structure arrangements and other embodiment under instruction of the present invention, and can not exceed the scope of the invention that claim limits.

Claims (15)

1. an adjustable infusion catheter is used for medicine or treatment fluid are distributed in the intravital whole target area of patient, and described conduit comprises:

A. elongated flexible pipe has outer surface and external diameter, and described pipe also comprises near-end and relative closed distal end; Described pipe includes one or more and allows fluid from the described proximal flow of the described pipe axial cavity to described far-end, and the described far-end of described pipe is arranged and is used for injecting described target area in patient's body;

B. the medicine of low pressure, low discharge or treatment fluid source are attached to the near-end of described flexible pipe;

C. fenestrated area, be positioned near the described far-end of described pipe, the outer surface that is used to make described fluid cross described pipe from described chamber is distributed to the intravital described target area of patient, described fenestrated area is along the surperficial definite length extended of described pipe, and the length of described fenestrated area is greater than the intravital described target area of patient;

D. elongated flexible sheath, its internal diameter equals or is a bit larger tham the external diameter of described pipe, allow the described outer surface slip location of described sheath along described pipe, to cover and to seal the described fenestrated area of predetermined length, thereby stay the described fenestrated area of the exposure of a segment length, be used for described fluid is distributed in patient's body on the corresponding described target area.

2. adjustable infusion catheter as claimed in claim 1, wherein, described sheath is formed by opaque material, makes the position with respect to described fenestrated area of described sheath to determine in visual mode.

3. adjustable infusion catheter as claimed in claim 1 wherein, forms a spherical part at the described far-end of described pipe, prevents that so that a backstop to be provided described sheath is moved the end that surpasses described pipe.

4. adjustable infusion catheter as claimed in claim 1, wherein, longitudinal axis along described pipe is marked with scale, makes the described near-end of the described sheath that is associated with described scale can confirm the position of described sheath with respect to described fenestrated area, thereby determines the length of exposure of described fenestrated area.

5. adjustable infusion catheter as claimed in claim 1, wherein, described pipe and/or described sheath have the lubricant coating of low friction, and described lubricant coating makes described sheath be easy to slide along the surface of described pipe, and described sheath can be positioned with respect to described fenestrated area by adjustable ground.

6. adjustable infusion catheter as claimed in claim 1, wherein, the material that is used for forming described pipe and/or described sheath has low-friction coefficient, and this makes described sheath be easy to slide along the surface of described pipe, thereby described sheath can be positioned with respect to described fenestrated area by adjustable ground.

7. adjustable infusion catheter as claimed in claim 1, wherein, the length of described sheath is greater than the length of the described fenestrated area of described pipe.

8. adjustable infusion catheter as claimed in claim 1, wherein, each end of described sheath all comprises fluid-tight, be used for the end of described sheath is sealed with respect to described pipe, and still allow described sheath to locate slidably to regulate the length of exposure of described fenestrated area along the surface of described pipe.

9. adjustable infusion catheter as claimed in claim 8, wherein, described sheath is formed by heat-shrinkable materials, the circumferential end zone of described sheath is heated to reduce the internal diameter of described sheath, thereby the described outer surface with respect to described pipe forms fluid-tight, and thus, described fluid can not leak from described sheath.

10. adjustable infusion catheter as claimed in claim 8, wherein, described fluid-tight is the circumferential hoop that is formed at each place, end of described sheath, wherein, the internal diameter of described end loops is less than the external diameter of described pipe, thereby form slidably fluid-tight, prevent to leak between described sheath and the described pipe.

11. adjustable infusion catheter as claimed in claim 8, wherein, near the described near-end of described pipe, be formed with the circumferential lasso of enlarged-diameter, the length of described sheath is equal to or less than the length of the described far-end from described lasso to described pipe of described pipe, the sealing that is positioned on the described near-end of described sheath contacts slidably with described lasso, is moved the described far-end that surpasses described pipe with the described far-end that prevents described sheath.

12. a method of making adjustable infusion catheter, described adjustable infusion catheter are used for medicine or treatment fluid are distributed in the intravital target area of patient, described method comprises following step:

A. obtain the elongated flexible pipe material of predetermined length, described pipe material has inner axial cavity, near-end and far-end, and has external diameter and outer surface;

B. on the zone of the close described far-end of described pipe, form the hole, form elongated fenestrated area;

C. form tubular sheath, described sheath has equaling or is a bit larger tham the internal diameter of the described external diameter of described pipe, and described sheath can be located on the described outer surface of described pipe slidably;

Described sheath is located on described pipe slidably;

E. at each place, end of described sheath, between the described outer surface of described sheath and described pipe, form fluid-tight sealing, between described sheath and described pipe in case the fluid stopping body leaks;

F. slided on the described fenestrated area of described pipe in the end of described sheath and be positioned to the most described far-end of close described pipe, stay and the corresponding one section predetermined exposure length in patient's target area, be used for described fluid is evenly distributed on the whole described target area.

13. method as claimed in claim 12, wherein, described sheath is formed by heat-shrinkable materials, and the circumferential district of each end of described sheath is heated, thereby the end that makes described sheath is shunk and is enclosed within tightly on the described outer surface of described pipe, to form described fluid-tight sealing.

14. method as claimed in claim 12 wherein, is formed on the hole of described fenestrated area, along with near the described far-end of described pipe, its diameter becomes greatly slightly, makes the described predetermined exposure length uniform distribution of described fluid along described fenestrated area.

15. an adjustable infusion catheter is used for medicine or treatment fluid are evenly distributed on the intravital whole target area of patient, described conduit comprises:

A. elongated flexible pipe has outer surface and external diameter, and described pipe also comprises near-end and relative closed distal end;

B. described pipe comprises one or more axial cavity, make fluid from the described proximal flow of described pipe to described far-end, the described far-end of described pipe is arranged to be used to inject the intravital described target area of patient;

C. the described near-end of described pipe is connected to the medicine or the treatment fluid source of low pressure, low discharge;

D. elongated fenestrated area, be formed near the described far-end of described pipe, the described outer surface that is used for described fluid is crossed from described chamber described pipe is distributed in the intravital described target area of patient, described fenestrated area is along the surperficial definite length extended of described pipe, and the length of described fenestrated area is greater than the intravital described target area of patient;

E. elongated flexible sheath, its internal diameter equals or is a bit larger tham the described external diameter of described pipe, described sheath can be slided along the surface of described pipe locate, to cover and to seal the described fenestrated area of predetermined length, thereby stay the length of one section exposure, be used for the fluid that on corresponding target area, distributes;

F. described sheath is formed by heat-shrinkable materials, and the circumferential end district of described sheath is heated reducing the internal diameter of described sheath, thereby forms the fluid-tight with respect to the described outer surface of described pipe, and still heat allows described sheath to carry out slidable adjustment with respect to described pipe.

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