KR101164383B1 - Catheter for uniform delivery of medication - Google Patents

Abstract

The catheter 250, 272 of the present invention is provided for uniform distribution of the liquid therapeutic agent within the anatomical area. One embodiment of the catheter 272 forms a lumen 283 and has an elongated proximal tube 282 and a closed end 284 and includes an elongated distal tube 280. The distal tube 280 is made of a bio-absorbable material and forms a lumen 281 in communication with the lumen 283 of the proximal tube 282. Another embodiment of the catheter 250 includes an elongated tubular catheter body 254 that forms a lumen 268. The distal end 262 of the lumen is closed and a portion of the catheter body 254 includes a plurality of openings 266 to form the infusion of the catheter 250. The tubular sheath 252 is made of a porous material and is located above the injection portion. The tubular cover 252 extends at least the length of the infusion portion. The tubular cover 252 and catheter body 254 are configured such that the fluid in the lumen 268 exits the catheter 250 only through the tubular cover 252.

Description

Catheters for uniform transport of therapeutic agents {CATHETER FOR UNIFORM DELIVERY OF MEDICATION}

The present invention relates to a catheter. More specifically, the present invention relates to a catheter that uniformly delivers fluid medication to the infusion portion.

Infusion catheters for delivery of liquid therapeutics to anatomical systems such as the human body are well known in the art. Such catheters generally have a flexible hollow tube that is inserted into any part of the anatomy. Hollow tubes generally have one or more axial lumens through which fluid can flow. The proximal end of this catheter tube is connected to a source of fluid, from which fluid is introduced into the catheter tube. The fluid flows into one of the lumens under pressure provided at the proximal end. Each lumen commonly has one or more exit holes along the inlet of the distal end of the tube to allow fluid to exit the tube. These exit holes are created by drilling the side walls of the hollow tube.

For any medical condition, it is advantageous to deliver the liquid therapeutic agent to multiple sites within the wound area. For example, some wounds that require analgesics are connected to multiple nerve endings rather than one nerve stem. An example of such a wound is a surgical incision. As mentioned earlier, it is known that there are a number of exit holes through which the liquid therapeutic agent exits the catheter tube. The exit holes are located at various axial and circumferential positions along the catheter tube to adjust the position of the site where the drug is to be delivered. One example of a catheter of this type is described in Eldor, US Pat. No. 5,800,407. In addition, in some cases, it is desirable to deliver such therapeutic agents under low pressure so that the fluid is delivered at a relatively slow rate. For example, some analgesics should be delivered slowly to avoid toxicity and other side effects. In addition, in many cases, it is desirable to administer the liquid therapeutic agent at a substantially constant rate through the catheter infusion so that the therapeutic agent is evenly distributed throughout the wound area.

Unfortunately, conventional catheters with multiple outlet holes, such as the catheter disclosed by Elder, have a tendency for fluid to be discharged only through the exit hole (s) closest to the proximal end of the inlet of the catheter tube when transporting liquid therapy under low pressure. There are disadvantages. This is because the fluid flowing through the tube is more easily discharged through the exit hole providing the least flow resistance. The longer the flow path of the fluid in the lumen, the greater the flow resistance and pressure drop experienced by the fluid. The proximal outlet hole provides the smallest flow resistance and pressure drop. Therefore, the fluid tends to exit the catheter tube mainly through this exit hole. As a result, the liquid medication is delivered only to a small area within the wound area. The tendency for the fluid to flow undesirably only through the nearest exit hole depends on the size of the exit hole, the total number of exit holes and the flow rate. As the size or number of exit holes increases, the tendency for the fluid to exit only to the nearest exit hole increases. On the contrary, when the flow rate increases, such a tendency of the fluid decreases.

The tendency for fluid to flow undesirably only through the closest exit hole of the catheter can be solved in some cases by increasing the flow rate or hydraulic pressure, which causes the fluid to flow through more exit holes of the catheter. In fact, if the flow rate or hydraulic pressure is high enough, the fluid will flow through all exit holes. However, sometimes it is medically desirable to deliver the formulation at a relatively slow rate, ie at a low pressure. Also, even if it is acceptable or desirable to deliver the fluid at high pressure, previous catheters do not deliver the fluid evenly along the infusion. Rather, the flow rate through the exit hole closer to the distal end of the injection tends to be greater than the flow rate through the exit hole closer to the distal end. This is because the fluid passing through the closer outlet hole experiences less flow resistance and pressure drop. In contrast, the fluid flowing through the distant outlet holes experiences greater flow resistance and pressure drop, resulting in a lower flow rate. The farther the exit hole, the lower the discharge flow rate of the fluid. As a result, the formulation distribution is uneven throughout the wound area.

In another known type of infusion catheter, there are several lumens within the catheter tube. Each lumen has an exit hole made by drilling a hole in the wall of the tube. These exit holes are in different axial directions along the inlet of the catheter tube. In this way, the liquid therapeutic agent can be delivered to various sites within the wound area. This type has improved latex distribution, but there are some disadvantages. One of them is that, for the same reason as discussed above, the greater the flow resistance, the greater the flow resistance, so that the flow rate of the fluid passing through the outlet holes is not the same. Another disadvantage is that the number of lumens and the resulting number of fluid exit holes are limited because of the small diameter of the catheter tube. As a result, the fluid is delivered only to very limited locations within the wound area. Another disadvantage is that the proximal end of the lumens must be attached to one complex manifold, which increases the cost of manufacturing the catheter.

An example of a catheter that more uniformly administers a liquid therapeutic agent through the catheter infusion is disclosed in Wang, US Pat. No. 5,425,723. Wang discloses an injection catheter comprising one outer tube, one inner tube concentrically within the outer tube and a central lumen within the inner tube. The inner tube is smaller in diameter than the outer tube so that an annular passage is formed therebetween. The outer tube has a plurality of exit holes spaced at regular intervals, defining the inlet of the catheter. In use, the fluid flowing into the central lumen passes through side holes strategically located in the side walls of the inner tube. In particular, the spacing between adjacent side holes decreases along the length of the inner tube, leading to more fluid to escape through the farther side holes. The fluid then flows longitudinally through the annular passageway before exiting through the exit hole in the outer tube wall. In the annular passageway, the fluid may flow in either the distal end or the proximal end, depending on the location of the closest exit hole in the outer tube. This form allows fluid to exit the catheter at a more constant flow rate.

Unfortunately, Wang's catheter is only effective for delivering relatively high pressure fluids. When used to deliver fluids at relatively low pressures, Wang initiated catheter does not provide uniform administration of fluids. Instead, the fluid is likely to exit through the side holes of the inner and outer tubes closest to the proximal end of the catheter inlet. Because these holes provide the lowest flow resistance. Even with high pressure delivery, there are some limitations to this structure. One limitation is that the concentric tube structures are relatively complex and difficult to manufacture. Both tubes should be flexible enough to maneuver through the anatomy, while the annular passage should be open to allow the fluid to flow uniformly therein. Another limitation is that if there is a bend in the inlet of the tube, the annular passage can be interrupted. Flexure in the catheter deforms the annular passageway or allows the inner and outer tubes to contact. This results in a non-uniform hydraulic pressure in the longitudinal cross section of the annular passage, resulting in an uneven fluid transfer.

Accordingly, there is a need for an improved infusion catheter that uniformly delivers a liquid therapeutic agent along the infusion, which is both effective and relatively simple for both high and low flow rate delivery. In addition, it is recognized that certain classes of catheters, such as Wang's catheter, deliver fluid evenly only at high hydraulic pressures or high flow rates. However, there is a need for an injection catheter that belongs to this class but is relatively simple and easy to manufacture, and that can maintain uniform fluid delivery even when bent or otherwise physically modified.

Summary of the Invention

Accordingly, it is a major object and advantage of the present invention to address some or all of these limitations and to provide an improved catheter for delivering a liquid therapeutic agent to the wound area of the anatomical region.

The catheter is provided for uniform distribution of the liquid therapeutic agent within the anatomical area. One embodiment of the catheter consists of an elongated tube and an outer elongated tubular porous membrane surrounding the length of the longitudinal tube, with an annular space between the tubular membrane and the longitudinal tube. The tubular membrane consists of a high porous material and preferably has a range of average pore diameters between about 0.1 micron and 0.5 microns. One embodiment of the catheter has an average pore diameter that is particularly suitable for filtration of bacteria. A plurality of fluid exit holes are provided in the portion of the elongated tube enclosed in the tubular membrane. In operation, the fluid in the catheter flows through all exit holes into the annular space. The tubular membrane ensures that the fluid is distributed evenly within the anatomical region.

According to one embodiment of the present invention, a catheter is provided that includes an elongated tubular member made of a porous membrane and that uniformly delivers fluid to an anatomical region. The membrane is sized to be inserted through the subcutaneous layer surrounding its anatomical area, such as human skin. The membrane is of a type such that, under a certain pressure, the fluid flowing into one open end of the tubular member can flow through the side wall of the tubular member at a sufficiently constant velocity along the tubular member. The present invention also provides a method for uniformly delivering fluid to an anatomical region, which inserts an elongated tubular member into the anatomical region and introduces the fluid to one open end of the tubular member under some pressure. Steps.

In another embodiment, the present invention provides a catheter and method for uniformly delivering fluid to an anatomical region. The catheter consists of one extended support and one porous membrane surrounding the support. The support is such that one or more lumens are formed between it and the membrane. Alternatively, the support may be a tubular member having a plurality of holes therein. The method consists of inserting the catheter described above into the anatomical area and introducing the fluid under pressure into the proximal end of the one or more lumens. Advantageously, the fluid enters the anatomical region through the membrane at a sufficiently constant rate. The present invention further provides a method of making the catheter comprising forming an extended support and wrapping the support with a porous membrane such that at least one lumen is formed between it and the membrane.

In another embodiment, the present invention provides a catheter and method for uniformly delivering fluid to an anatomical region. The catheter consists of an elongated tube that includes a plurality of exit holes along its length and a tubular porous membrane that resides concentrically within the tube. The tube and membrane define the lumen. The method consists of inserting the catheter into the anatomical region and introducing the fluid at a certain pressure into the proximal end of the lumen so that the fluid enters the anatomical region, preferably through the membrane and the exit hole, at a sufficiently constant velocity. It is. The present invention additionally forms one elongated tube, provides a plurality of outlet holes along the length of the tube, forms one tubular porous membrane and allows the tubular porous membrane to exist concentrically into the tube and It provides a method of making the catheter comprising the step of defining a membrane lumen.

In another embodiment, the present invention provides an apparatus and method for uniformly delivering fluid to an anatomical region. The instrument comprises one elongated catheter having a plurality of exit holes along its length, and is preferably simple and easy to manufacture. The exit hole may function as a flow-restricting orifice. Alternatively, the flow restriction orifice can be made anywhere in the catheter or near the catheter. The exit hole may gradually increase in size along the length of the catheter, such that the largest exit hole is distal than the smallest exit hole. Alternatively, the exit holes can be drilled with a laser and approximately the same size. Preferably, the fluid flowing into the catheter under any pressure will flow through virtually all exit holes at substantially the same speed. The method consists of inserting the catheter into the anatomical area and introducing fluid into the proximal end of the catheter under some pressure. The fluid flows through the exit hole and enters the anatomical region, preferably through all of the exit holes at sufficiently the same speed. The present invention further provides a plurality of exits along the length of the catheter in such a way as to form an extended catheter and allow the exit hole to gradually increase in size along its length from the proximal end to the distal end of the catheter. Provided is a method of making the device comprising providing a ball.

In another embodiment, the present invention provides a catheter and method for delivering a liquid therapeutic agent to an anatomical region. The catheter consists of a tube, a whipping tubular coil spring attached to the distal end of the tube and a stop to close the distal end of the spring. The tube and spring each define a portion of the central lumen. The spring has neighboring coils in contact with each other to prevent the fluid from escaping the lumen by radially flowing between the coils within the spring and below the threshold dispensation pressure. The spring has the property of increasing when the fluid pressure is greater than or equal to the threshold distribution pressure that allows fluid to be administered from its lumen radially through the coils, ie, "weep" through the spring. Alternatively, the fluid may whip through the defect of the spring coil. Preferably, the emulsion is distributed substantially uniformly throughout the length and circumference of the spring. In use, the fluid flows into one open proximal end of the tube and flows into the spring, allowing the fluid to whip through the spring by applying a pressure greater than or equal to the threshold dispense pressure.

In another embodiment, the present invention provides a catheter and method for delivering a liquid therapeutic agent to an anatomical region. The catheter consists of one tube with a distal end closed and one "weeping" tubular coil spring as described above, surrounded by the tube and concentrically therein. There are a number of exit holes in the side wall along the length of the tube to define the inlet of the tube. The spring is present in its infusion to allow the lumen to be confined within the tube and the spring. In use, fluid enters one proximal end of the tube, flows into the spring, and applies pressure above or equal to the threshold distribution pressure so that the fluid is whipped through the spring and then flows through the exit hole of the tube. To be dispensed from.

In another embodiment, the present invention provides a catheter composed of one elongated tube and a solid flexible member located within the tube. The tube has a closed distal end and a number of exit holes in the side wall of the tube. The exit holes extend along the length of the tube, defining the inlet of the catheter. The tube is sized to be inserted into the anatomical region. The member is located in the tube and the size is such that an annular space is formed between the tube and the member. The member is formed of a porous material. Preferably, the catheter is shaped such that the fluid entering the proximal end of the tube can flow through the exit hole at a substantially constant rate throughout the inlet.

In another embodiment, the present invention provides a catheter comprising one elongated tube having a plurality of exit slots in the side wall. The slots extend along the length of the tube, defining the catheter portion. The outlet slots are generally in a direction parallel to the longitudinal axis of the tube. Preferably, the tube is shaped such that the fluid flowing therein can flow through virtually all outlet slots at substantially the same speed. In an optional aspect, the slots increase in length from the proximal to the distal end of the infusion.

In another embodiment, the present invention includes a catheter for delivering fluid to an anatomical region. The catheter includes an elongated tubular catheter body that forms a distally-closed lumen. A portion of the catheter body includes a plurality of openings extending through the sidewall of the catheter body to form the infusion portion of the catheter. A tubular sheath constructed from a porous material is located above the infusion and extends at least the length of the infusion. The tubular sheath and catheter body are configured to allow fluid in the lumen to pass through the catheter through the tubular sheath. The pore size of the porous material is less than about 0.5 microns.

Another embodiment of the invention includes a catheter for delivering fluid to an anatomical region. The catheter includes an elongated tubular catheter body with sidewalls, the outer surface of the sidewall forming a relatively uniform first diameter. The catheter body also includes a lumen. The distal end of the catheter body allows fluid to flow from the interior of the lumen to the exterior of the catheter body, thereby forming an injection portion of the catheter. The tubular cover constructed from the porous material has a side wall, a first end and a second end. The tubular sheath is positioned above the injection portion and the injection portion is provided between the first end and the second end. The inner surface of the side wall of the tubular cover has a second diameter configured to form a gap space between the tubular cover and the catheter body. The first and second ends of the tubular sheath are bonded to the outer surface of the catheter body to substantially seal the gap.

In another embodiment, the present invention includes a catheter for delivering fluid to an anatomical region. The catheter is long and includes a proximal tube that forms the lumen. An elongated distal tube consisting of a bio-absorbable material forms a lumen in communication with the lumen of the proximal tube. At least a portion of the distal tube allows fluid to communicate with its exterior from within the lumen to form an infusion portion of the catheter. The proximal end of the distal tube and the distal end of the proximal tube overlap each other. The proximal end of the distal tube is bonded to the distal end of the proximal tube with a biocompatible adhesive to form a substantially fluid tight joint therebetween. The length of the overlap portion of the distal and proximal tubes is at least about 0.02 inches, more preferably 0.03 inches.

Yet another embodiment of the present invention includes a catheter that is long and includes a distal tube that forms the lumen for dispensing fluid into an anatomical region. The long distal tube has a closed end and consists of a bio-absorable material. The distal tube forms a lumen in communication with the lumen of the proximal tube. At least a portion of the distal tube includes a porous side that allows fluid in the lumen to pass through a portion of the distal tube.

Another aspect of the invention includes a method for delivering fluids throughout the anatomical region of a patient. The method inserts an elongated tubular member into the incision of the patient, the tubular member having a distal portion attached to the proximal portion at the junction. The distal portion comprises a bio-nonabsorbent material. At least a portion of the distal sidewall forms a porous membrane adapted to allow fluid in the tubular member to pass through the sidewall. The method further comprises positioning the tubular member such that the abutment is provided within the patient, closing the incision and injecting fluid into the open proximal end of the tubular member.

In order to summarize the invention and its advantages over the prior art, certain objects and advantages of the invention have been described above. Of course, not all such objects or advantages are necessarily achieved in accordance with any particular embodiment of the present invention. Thus, for example, one of ordinary skill in the art will appreciate that one or more groups of advantages taught in the present invention may be practiced without necessarily fulfilling the other objects or advantages taught or suggested herein. It will be appreciated that it may be implemented or implemented in a manner that is utilized.

All these embodiments are intended to be within the scope of the invention described herein. These and other embodiments of the invention will be apparent to those skilled in the art from the following detailed description of the preferred embodiments in conjunction with the accompanying drawings. The invention is not limited to the particular preferred embodiment (s) described.

1 is a schematic side view of a catheter with features and advantages in accordance with a first embodiment of the present invention.
2 is a cross-sectional view of the catheter of FIG. 1 taken along line 2-2 of FIG.
3 is a cross-sectional view of the catheter of FIG. 1 taken along line 3-3 of FIG.
4 is a perspective view of the end of the catheter and the support beam of the catheter of FIG. 1, taken along line 4-4 of FIG.
5 is a side view of a catheter with features and advantages in accordance with a second embodiment of the present invention.
6 is a cross-sectional view of the catheter injection portion of FIG. 5 taken along line 6-6 of FIG.
7 is a cross-sectional view of a catheter with features and advantages in accordance with a third embodiment of the present invention.
8 is a side view of a catheter with features and advantages in accordance with a fourth embodiment of the present invention.
9 is a side view of a catheter with features and advantages in accordance with a fifth embodiment of the present invention.
FIG. 10A is a cross-sectional view of the catheter of FIG. 9 illustrating an unextended state of the spring. FIG.
FIG. 10B is a cross-sectional view of the catheter of FIG. 9 showing the extended state of the spring. FIG.
11 is a cross-sectional view of a catheter with features and advantages in accordance with a sixth embodiment of the present invention.
12 is a side view of a catheter with features and advantages in accordance with a sixth embodiment of the present invention.
13 is a longitudinal cross-sectional view of a catheter with features and advantages in accordance with a seventh embodiment of the present invention.
14-16 are longitudinal cross-sectional views of a catheter similar to the catheter of FIG. 13 showing an alternative attachment between an inner porous member and a tube.
FIG. 17 is a cross-sectional view of the catheter according to FIGS. 13 to 16, wherein the inner porous member shares a center with the outer tube.
FIG. 18 is a cross-sectional view of the catheter according to FIGS. 13 to 16, wherein the inner porous member does not share a center with the outer tube.
19 is a schematic view of the catheter of the present invention, used in connection with an air removal filter.
20 is a side view of a catheter with features and advantages in accordance with an eighth embodiment of the present invention.
21 is a side view of a catheter with features and advantages in accordance with a ninth embodiment of the present invention.
22 is a schematic of the use of the catheter of the present invention to treat blood clotting.
23 is a side view of a catheter with features and effects in accordance with a tenth embodiment of the present invention including a tubular porous membrane or cover;
FIG. 23A is a cross-sectional view of the catheter of FIG. 23 along lines 23A-23A. FIG.
FIG. 24 is a cross-sectional view of the catheter of FIG. 23 along lines 24-24. FIG.
25 is a schematic view of a catheter with features and effects, in accordance with an eleventh embodiment of the present invention, wherein at least a portion of the catheter is comprised of a bio-absorbable material.
FIG. 26 is an enlarged view of the junction between the non-porous and bio-absorbable portion of the catheter of FIG. 25;
FIG. 26A is a sectional view of the junction of FIG. 26 along line 26A-26A. FIG.
FIG. 27 is an enlarged view of the distal end of the catheter of FIG. 25.

1-4 illustrate an infusion catheter 20 in accordance with one embodiment of the present invention. The catheter 20 preferably includes a flexible support 22 (FIGS. 2-4), a nonporous membrane 24, and a porous membrane 26. The membranes 24, 26 are wrapped around the support 22 to form a plurality of axial lumens between the inner surface of the membrane 24 and the membrane 26 and the surface of the support 22. It is described in great detail. The nonporous membrane 24 defines a non-infusion section 28 of the catheter 20, and preferably supports 22 from the proximal end to the point 30 of the support as shown in FIG. 1. To cover. Similarly, the porous membrane 26 defines the injection portion 32 of the catheter 20 and preferably covers from the point 30 to the end of the support 22. Alternatively, catheter 20 may be formed without nonporous membrane 24. In this form, the porous membrane 26 covers the entire length of the support 22 such that the entire length of the support 22 corresponds to the injection portion of the catheter 20. The injection portion can have any desired length desired. The proximal end of the catheter 20 is attached to a supply 34 containing an emulsion 36, such as a liquid therapeutic. The distal end of the catheter 20 includes a cap 48 (FIG. 4), which defines the end point of the axial lumen within the catheter.

In use, the catheter 20 is inserted into an anatomical system, such as a human body, to transport the flowable medication directly to the wounded area within the anatomical system. In particular, catheter 20 delivers medication throughout the generally linear segment of the wound, corresponding to the injection portion of catheter 20. Thus, the catheter is preferably inserted such that the infusion portion 32 is located within the wound site. Using known methods, the surgeon or nurse may insert the catheter 20 with the aid of an axial guide wire 46 located within the axial guide wire lumen 44 of the catheter. Once the catheter is in the desired position, the guide wire 46 is simply pulled through the proximal end of the catheter 20. Alternatively, catheter 20 may be provided without a guide wire or a guide wire lumen.

2 and 3 show a preferred form of the support 22. The surface of the support 22 includes an interruption, such as a plurality of ribs 40, as shown in the figure. By constructing an interruption, when the membrane 24 and the membrane 26 surround the support 22, the membrane forms part of the walls of several axial lumens 38, and thus the axial lumen Latex 36 may flow. In a preferred form, the plurality of ribs 40 extend radially from the common axial central portion 42 of the support 22. Rib 40 extends along any length of support 22, preferably along its entire length. In the case of the non-injection portion 28, as shown in FIG. 2, the nonporous membrane 24 preferably tightly surrounds the outer rim of the rib 40. As a result, an axial lumen 38 is formed between the inner surface of the nonporous membrane 24 and the outer surface of the support 22. Similarly, in the case of injection 32, as shown in FIG. 3, the porous membrane 26 preferably tightly surrounds the outer rim of the rib 40 so that the inner surface of the porous membrane 26 and the support ( An axial lumen 38 is formed between the outer surface 22 of 22.

In an alternative embodiment of the catheter 20, the porous membrane 26 may wrap around the entire length of the support 20, resulting in replacement for the nonporous membrane 24. In this embodiment, the overall length of the support 22 corresponds to the injection section 32. According to another alternative embodiment of the invention, the support 22 only extends in the inlet 32 and a tube extending from the fluid supply 34 to the proximal end of the support 22 may be provided. . In this embodiment, the tube replaces the nonporous membrane 24 and the portion of the support 22 that extends within the non-injection 28 in the preferred embodiment. In other words, the tube defines the non-injection 28.

In a preferred embodiment, the number of ribs 40 is equal to the number of axial lumens 38. Although two ribs 40 and axial lumens are shown in FIGS. 2 and 3, the objective of providing several lumens within the catheter 20 is appropriately taken into account while maintaining flexibility and, if necessary, fluid independence of the lumen. Optionally, a suitable number of ribs 40 and lumen 38 can be provided. Here, the words "liquid independence" and "liquid separation" used when describing a plurality of axial lumens simply mean that the lumens are not in fluid communication with each other. Preferably, membranes 24 and 26 are bonded along the outer rim of the ribs using any suitable adhesive, such as a medicament grade adhesive or epoxy. This prevents the membranes 24 and 26 from slipping which may occur when the catheter is inserted or removed into the anatomy. More preferably the membrane is glued along the entire length of each outer rim of the rib 40. As an alternative, the membrane surrounds the support and may not be attached to the support by foreign material. The membrane and the support can be fixed to each other by other means known to those skilled in the art. This maintains fluid independence of the lumen 38. If desired, an axial guide wire lumen 44 may be provided in the axial center portion 42 of the support 22. Guide wire lumen 44, as described above and as readily understood by one of ordinary skill in the art, guide wire 46 that may be used to assist in inserting catheter 20 into the anatomy. Adapt to accept.

As shown in FIG. 4, the catheter 20 preferably includes an end or cap 48 secured to the distal end of the support 22. The end portion 48 may be integrally formed with the support 22 or adhesively bonded thereto. Preferably, as shown, the proximal end of the end 48 is circular and has a diameter such that the outer surface of the proximal end of the end 48 aligns with the outer rim of the rib 40 of the support 22. To have. Porous membrane 26 wraps around the proximal end of end 48. The membrane 26 is preferably adhered to the end 48 such that the fluid 36 in the lumen 38 does not leave the catheter 20 without passing through the membrane 26. End 48 prevents axial fluid flow through distal end of catheter 20. However, if desired, the end 48 may optionally be formed of a porous material to allow any axial dosing from the end of the catheter 20. The distal end of the tip 48 is preferably domed as shown so that the catheter 20 can be more easily inserted into the anatomical region.

The support 22 may be formed of a variety of materials with due regard to flexibility, light weight, strength, smoothness, and non-responsiveness to the anatomical system, ie safety. Suitable materials for the support 22 include nylon, polyamide, Teflon and other materials known to those skilled in the art. The porous membrane 26 is preferably a sponge or foam material or hollow fiber. Membrane 26 may be formed from a variety of suitable materials, with due regard for purposes that are flexible and nonreactive to anatomical systems. The membrane 26 preferably has a porosity resulting in a substantially even distribution of the fluid along the surface area of the inlet portion 32 of the catheter 20, with an average pore size small enough to allow bacteria to pass through the membrane wall. Try to restrict the flow. Suitable materials for the membrane 26 are polyethylene, polysulfone, polyether sulfone, polypropylene, polyvinylidene difluoride, polycarbonate, nylon or high density polyethylene. The material is advantageously biocompatible. Porous membrane 26 may filter bacteria from the liquid therapeutic agent as it flows through the membrane 26. It is known that even the smallest bacteria cannot pass pores smaller than 0.23 microns. Thus, the average pore size or pore diameter of the porous membrane 26 is less than 0.23 microns to prevent bacteria from passing through the membrane 26. The average pore size or pore diameter of the membrane 26 is preferably about 0.1 to 1.2 microns, more preferably 0.3 to 1 micron and even more preferably about 0.8 micron.

As described above, the proximal end of the catheter 20 may be connected to the chemical liquid supply 34. The catheter 20 is formed such that each axial lumen 38 is fluidly independent. In other words, the lumens 38 are not in fluid communication with each other. The catheter 20 is connected to a single chemical liquid supply 34 so that the fluid 36 can flow in each lumen 38. Alternatively, the catheter 20 may be connected to a plurality of separate chemical liquid supplies such that several different fluids may flow independently in the lumen 38. According to this configuration, each lumen 38 is connected to a separate latex supply such that the total number of other fluids that can be transported to the anatomy system can be the number of lumens 38. Alternatively, the fluid lumen does not need to be fluidly independent. For example, the membrane 26 may not adhere to the support along the entire length of the support 22, with the fluid 36 moving between the lumens 38.

The catheter 20 delivers the fluid directly to the portion of the anatomy adjacent to the infusion 32. The latex 36 from the latex source 34 is introduced into the axial lumen 38 at the proximal end of the catheter 20. The latex 36 initially flows into the non-injection portion 28. When the fluid 36 reaches the inlet 32, it seeps into the porous membrane 26. As more of the fluid 36 enters the infusion 32, the fluid diffuses longitudinally in the walls of the membrane 26 until the entire membrane 26 and the injection 32 are saturated with the fluid. . At this time, the fluid 36 begins to pass through the membrane 26, thereby exiting the catheter 20 and entering the anatomy. Furthermore, due to the nature of the porous membrane 26, the fluid 36 advantageously passes through the entire surface area of the porous membrane 26 at a substantially uniform rate. Thus, the fluid is transported at substantially the same rate throughout the generally linear segment of the wound or site of the anatomy. Furthermore, the above advantages are obtained for low and high pressure emulsion transportation.

5 and 6 illustrate a catheter 50 in accordance with an alternative embodiment of the present invention. According to this embodiment, the catheter 50 includes an elongated outer tube 52 and an inner elongated tubular porous membrane 54. The tubular membrane 54 is preferably concentric in the outer tube 52. More preferably, the tube 52 tightly surrounds and supports the tubular membrane 54 such that the inner size of the tube 52 and the outer size of the membrane 54 are relatively tight. A plurality of fluid outlet holes 56 are provided in the tube 52, preferably over the entire circumference of the tube. The portion of the tube 52 including the exit hole defines the injection portion of the catheter 50. The tubular membrane 54 only needs to be provided along the length of the infusion but can be longer. Optionally an axial outlet hole may be provided in the distal end 58 of the tube 52. In addition, as will be appreciated by those skilled in the art, a guide wire and / or guide wire lumen may be provided to assist in the insertion of the catheter 50 into the anatomy.

The tube 52 may be formed of various suitable materials, such as nylon, polyimide, Teflon, and other materials known to those skilled in the art, with due regard to the non-responsiveness, flexibility, light weight, strength, smoothness, and safety to the anatomical system. . In a preferred form, the tube 52 is preferably a 20 gauge catheter tube with an inner diameter and an outer diameter of 0.019 inches and 0.031 inches, respectively. The exit hole 56 of the tube 52 is preferably about 0.015 inch in diameter and provided to be axially identical along the tube 52. The exit hole 56 is preferably positioned such that all holes have an angle of about 120 degrees with respect to the longitudinal axis of the tube 52 from the angular position of the preceding hole. The longitudinal separation between adjacent outlet holes 56 is preferably in the range of about 0.125 to 0.25 inches, more preferably about 3/16 inches. In addition, the injection portion can optionally have a desired length. This shape results in uniform transport of the fluid throughout the generally linear segment of the wound site. Of course, the exit holes 56 may be provided in any number of relative arrangements.

Tubular porous membrane 54 is preferably a sponge or foam material or hollow fiber. Tubular membrane 54 may have an average pore size or pore diameter of 0.23 microns or less to filter bacteria. The pore diameter is preferably in the range of 0.1 to 1.2 microns, more preferably 0.3 to 1 micron, even more preferably about 0.8 micron. Tubular membrane 54 may be formed from any suitable material, taking into account the purpose of non-responsiveness to the anatomical system, maintaining flexibility, fitting well within the size constraints of tube 52, and It has a porosity which results in a substantially uniform distribution of the fluid through all outlet holes 56 in 52. Suitable materials for the membrane 54 are polyethylene, polysulfone, polyethersulfone, polypropylene, polyvinylidenedifluoride, polycarbonate, nylon, or high density polyethylene. Preferred inner and outer diameters of the tubular membrane 54 are 0.010 inches and 0.018 inches, respectively. If a guide wire 46 is provided, the guide wire may be stainless steel with a diameter of about 0.005 inches. Tube 52 may be secured to membrane 54 by epoxy or other means known to those skilled in the art. Alternatively, the membrane 54 may be in contact with the tube 52 by an interference fit and may not use other materials to secure the membrane 54 in the tube 52.

In use, the catheter 50 supplies fluid to an area of the anatomical system adjacent to the infusion of the catheter 50. While the fluid flows into the inlet, the fluid first permeates into the tubular porous membrane 54. As more fluid enters the infusion, the fluid diffuses longitudinally inside the wall of tubular member 54. Once the member 54 and tubular space therein are saturated, the fluid passes through the member 54 and leaves the catheter 50 by flow through the outlet hole 56 of the tube 52. Furthermore, advantageously, the fluid will pass through the membrane substantially uniformly throughout the surface area of the member 54, resulting in a substantially uniform flow through substantially all of the exit holes 56. Thus, the fluid is supplied at substantially the same rate throughout the wounded area of the anatomy. Furthermore, the above advantages are obtained for low and high pressure emulsion feeds.

7 shows a catheter 70 according to another embodiment of the present invention. The catheter 70 includes a tube 72 having a plurality of outlet holes 76 on the side wall of the tube and a tubular porous member 74 concentrically surrounding the tube 72. The catheter 70 acts in a similar manner to the catheter 50 described above in connection with FIGS. 5 and 6. In use, the liquid therapeutic agent begins to be absorbed into the porous membrane 74 through the exit hole 76. The emulsion diffuses longitudinally inside the membrane walls until the membrane is saturated. Afterwards, the fluid just leaves the wall and enters the anatomy. Advantageously, the emulsion is distributed to the anatomy system at a substantially uniform rate throughout the surface area of the membrane 74. As in the previous embodiment, the high pressure and low pressure fluid feeds benefit from this.

8 shows a catheter 60 according to another embodiment of the present invention. The catheter 60 is more suitable for supplying fluid at relatively high flow rates to regions of the anatomical system. The catheter 60 includes a tube 62 having a plurality of outlet holes 64 in increasing sizes. In particular, the more distal exit holes have a larger diameter than the more proximal exit holes. The position of the exit hole 64 on the tube 62 defines the length of the inlet of the catheter 60. The injection portion can optionally have a desired length. The proximal end of the catheter 60 is connected to the fluid supply and a guide wire and / or guide wire lumen may also be provided to assist insertion of the catheter 60 into the anatomy.

As described above, for high or low pressure fluid supply, the exit hole closer to the distal end of the catheter tube generally has increased flow resistance compared to the exit hole closer to the proximal end of the tube. In addition, the fluid flowing through the more distal exit holes will experience a greater pressure drop. As a result, the flow rate of the fluid through the hole in the proximal side is usually higher, which results in non-uniform fluid transport. In contrast, catheter 60 advantageously provides a substantially uniform fluid supply through substantially all outlet holes 64, under relatively high flow rate conditions. This is because the larger size of the more distal holes compensates for increased flow resistance and pressure drop. In other words, because the more distal holes are larger than the more proximal holes, the flow rate through the more distal holes is larger than when they have the same size as the more proximal holes. Advantageously, the exit hole 64 has a gradually increasing size, resulting in a substantially uniform fluid supply. In addition, the exit holes 64 can be sized such that they combine to form a flow-resistant orifice, as described below in connection with the embodiment of FIG. 12.

Compared to the catheter of the prior art, the catheter 60 advantageously has a simple and easy manufacturing process. It is all necessary to drill a plurality of exit holes 64 in the tube 62. Furthermore, the catheter 60 can support greater bending compared to prior art catheter while maintaining its operability. In contrast to prior art catheter such as Wang catheter, even if the tube 62 is somewhat bent, it will still supply fluid relatively uniformly. This is because the tube 62 has a single lumen with a relatively large cross section. If the tube 62 is somewhat curved, the fluid flow in the lumen is less likely to experience a containment condition and subsequent pressure drop that could result in a non-uniform fluid supply.

The tube 62 of the catheter 60 may be formed from any of a variety of materials, with due regard to nonresponsiveness, flexibility, light weight, strength, smoothness, and safety to the anatomical system. Suitable materials include nylon, polyimide, teflon and other materials known to those skilled in the art. The infusion can have any length desired, but preferably has a length of 0.5 to 20 inches, more preferably a length of about 10 inches. The diameter of the exit hole 64 is preferably in the range from about 0.0002 inches on the proximal side of the inlet to 0.01 inches on the more distal side of the inlet. The largest, ie distal, exit hole is preferably about 0.25 inches from the distal end of tube 62. In a more preferred form, the axial separation between adjacent exit holes 64 is in the range of about 0.125 to 0.25 inches, more preferably about 3/16 inches. Optionally, the exit hole 64 may be provided with adjacent holes at an angle of about 120 degrees, as in the embodiment of FIG. 5. Of course, if too many exit holes 64 are provided, the tube 62 may become undesirably weak.

9, 10A and 10B illustrate a catheter 80 according to another embodiment of the present invention. The catheter 80 includes a tube 82, a "weeping" tubular coil spring 84, and a stop 86. The proximal end of the spring 84 is attached to the distal end of the tube 82 such that the tube and the spring each define a portion of the central lumen. A dome-shaped stop 86 is preferably attached to and closes the distal end of the spring 84. The portion of the spring 84 at the distal end of the tube 82 constitutes the injection portion of the catheter 80. As shown in FIG. 10A, in the non-extended state, the spring 84 has adjacent coils in contact with one another so that fluid flows radially between the coils and out of the lumen within the spring and under threshold dispension pressure. Is prevented. The spring 84, as shown in FIG. 10B, has a particular feature that extends longitudinally when the fluid pressure is greater than the threshold distribution pressure of the spring, thereby causing the fluid to whip out of the lumen, ie between the coils outwards. Enables to be supplied radially by leaking. As an alternative, the spring extends radially without stretching, allowing the fluid to whip through the coil of the spring. Furthermore, as will be appreciated by one of ordinary skill in the art, the spring can extend longitudinally and radially to allow the wetting of the fluid. Advantageously, the fluid between the spring coils is distributed substantially uniformly throughout the length and circumference of the spring portion, ie the infusion portion, which is the end of the tube 82. The catheter 80 can be used for fluid supply at high or low flow rates.

In use, the catheter 80 is inserted into the anatomical region and the spring 84 is the region where the liquid therapeutic agent is to be supplied. The spring is initially unextended as shown in FIG. 10A. The fluid is introduced into the proximal end of the tube 82 of the catheter 80 and flows through the spring 84 to the stop 86. As the fluid is continuously introduced into the proximal end of the tube 82, fluid accumulates inside the spring 84. When the spring 84 is filled with fluid, the fluid pressure increases faster. The fluid imparts a force acting radially outward on the spring coil. As pressure builds up, the outward force is greater. Once the fluid pressure reaches the threshold distribution pressure, the outward force causes the spring coil to disengage slightly, causing the spring to extend longitudinally, as shown in FIG. 10B. Alternatively, as described above, the coil may be radially separated. The fluid then flows through a separate coil and is dispensed from the catheter 80. Furthermore, the distribution is advantageously uniform throughout the infusion portion of the catheter 80. Since the fluid is continuously introduced into the tube 82, the spring 84 is maintained in an extended state to continuously distribute the fluid to a desired portion of the human body. If the fluid introduction is temporarily stopped, the fluid pressure in the spring 84 may drop below the threshold distribution pressure. In this case, the spring contracts and the coils once again adjoin so that the fluid is no longer dispensed.

Several spring shapes can achieve the object of the present invention. Suitable spring shapes are readily available 316L or 402L. In a preferred form, the spring 84 has 200 coils per inch along its length. In this form, the spring can advantageously withstand a high degree of bending without leaking fluid from the inside, and only extreme bending will separate adjacent coils. Thus, the spring 84 can be bent significantly within the anatomical region without causing the fluid to leak, thus dispensing the fluid only in one part of the human body. The spring 84 may have any length required to determine the length of the infusion of the catheter 80. The spring can be formed from various materials with due regard to strength, flexibility and safety. Preferred material is stainless steel. In a preferred form, the inner and outer diameters of the spring are about 0.02 inches and 0.03 inches, respectively, and the spring wire has a diameter of about 0.005 inches. The proximal end of the spring 84 is preferably enclosed concentrically within the distal end of the tube 82. The spring may adhere to the inner wall of the tube 82 using, for example, a UV adhesive, potting material, or other adhesive material. Alternatively, the spring may be soldered in the tube 82 or tightly fitted into the proximal plug and tightly fitted into the tube 82.

Tubes 82 and stops 86 may be formed from any of a variety of materials, with due regard to flexibility, light weight, strength, smoothness, and safety. Suitable materials include nylon, polyimide, teflon and other materials known to those skilled in the art.

11 shows a catheter 90 in accordance with another embodiment of the present invention. The catheter 90 includes an end-closed tube 92 and a "weeping" tubular coil spring 94 concentrically enclosed within the tube 92 to define the lumen within the tube and the spring. A plurality of exit holes 96 are provided in the side wall of the tube along the length of the tube 92. The length of the tube 92, including the exit hole 96, defines the injection portion of the catheter 90. The exit hole 96 is preferably provided over the entire wall of the injection section. The infusion can have any length desired. In a preferred form, the axial spacing between adjacent holes 96 is in the range of about 0.125 to 0.25 inches, more preferably about 3/16 inches. Adjacent holes 96 are preferably located at an angle of about 120 degrees apart. The spring 94 is preferably enclosed within the injection portion of the catheter and has a similar shape to the spring 84 of the embodiment of FIGS. 9, 10A and 10B. The spring 94 is preferably longer than the injection portion and is positioned such that all outlet holes 96 are adjacent to the spring 94. In this form, the fluid will not escape the lumen without flow between the spring coils. Preferably a stop is attached to the tube to close the distal end of the tube. Alternatively, the tube 92 may have a blocked distal end. The catheter 90 can be used for fluid transport at high or low flow rates.

In use, the catheter 90 is inserted into the anatomical area such that the infusion portion is placed at the portion where the liquid therapeutic agent is desired to be delivered. The fluid is introduced into the proximal end of the tube 92 of the catheter 90 and flows through the spring 94 to reach the blocked distal end of the tube 92. As the fluid is continuously introduced into the proximal end of the tube 92, the fluid accumulates in the spring 94. Finally, the spring 94 is filled with fluid, and the fluid pressure rises, causing fluid to leak through the spring coils as described above in connection with the embodiment of FIGS. 9, 10A, and 10B. Further, the fluid flows through the spring coil substantially uniformly throughout the length and circumference of the spring 94. Subsequently, the fluid leaves the tube 92 by flowing through the outlet hole 96 of the injection portion. The exit holes are preferably of the same size, allowing the fluid to flow through the exit holes at substantially the same speed, which advantageously results in a generally uniform distribution of the fluid throughout the required area of the human body. As the fluid is continuously introduced into the catheter 90, the spring 94 remains extended to dispense the fluid continuously from the catheter. If the fluid introduction is temporarily stopped, the fluid pressure in the spring 94 may drop below the threshold distribution pressure. In this case, the spring can retract so that the coil is once again adjacent and the fluid is no longer dispensed.

In a preferred embodiment, the spring 94 and the tube 92 are in contact along the entire length of the spring, allowing the fluid leaking through the spring to flow through the hole 96 in the inlet. Preferably one end of the spring 94 is attached to the inner wall of the tube 92 such that the other end of the spring is displaced as the spring is extended. The spring may be attached to the tube 92 using, for example, UV adhesive, potting material, or other adhesive material. Alternatively, one end of the spring may solder to the inner wall of the tube 92. Tube 92 may be made from any suitable material. The inner wall of the tube 92 is preferably smooth so that the spring can be freely elongated and retracted.

12 illustrates a catheter 100 in accordance with another embodiment of the present invention. The catheter 100 consists of a tube 102 with a closed end that has a plurality of outlet holes 104 in the inner wall of the tube 102. The portion with the exit hole 104 of the tube 102 defines the injection portion of the catheter 100. The exit hole 104 size allows the combined area of the opening to be smaller than any other flow-limited cross section or area of the orifice of the catheter. Thus, the exit hole 104 is the flow-limiter of the catheter 100. In use, the catheter advantageously dispenses the fluid through substantially all of the exit holes 104. The fluid introduced into the proximal end of the tube 102 flows through the tube to reach the blocked distal end of the tube. At this point, the fluid accumulates in the injection section of the catheter. The fluid does not substantially flow through the outlet hole 104 because of the small size of the outlet hole 104. Finally, the injection portion of the catheter is filled with fluid. As the fluid is continuously introduced into the proximal end of the tube 102, fluid pressure begins to form. At this point, the pressure is high enough to push the fluid through the exit hole 104. Further, the fluid flows through substantially all the exit holes 104.

In this preferred embodiment, the outlet holes are all the same size so that the fluid is dispensed at substantially the same speed through substantially all of the holes. The exit hole 104 is preferably drilled with a laser to achieve a very small pore diameter. The preferred diameter of the exit hole 104 is about 0.0002 inches or about 5 microns. Numerous exit holes 104 are provided in the tube 102. The holes are advantageously supplied through the entire circumference of the injection portion of the catheter 100 to transport the fluid more evenly throughout the anatomical region. The preferred axial spacing between adjacent exit holes 104 is in the range of about 0.125 to 0.25 inches, more preferably about 3/16 inches. The catheter 100 may be used for fluid transport at high or low flow rates. Tube 102 is known to those skilled in the art and can be formed from the various materials discussed above.

13 illustrates a catheter 200 according to another embodiment of the present invention. The catheter 200 includes a tube 202 having a plurality of outlet holes 204 in the tube along the inlet of the catheter, as in the embodiment described above. The hole 204 is preferably provided over the circumference of the tube 202. An elongated member 206 made of porous material is surrounded by the tube 202. Preferably, member 206 is generally cylindrical in shape and solid. Preferably the member 206 is located inside the tube 204 such that an annular space 208 is formed between the outer surface of the member 206 and the inner surface of the tube 202. Preferably, the member 206 extends backward from the distal end 210 of the tube 202 to the proximal point of the injection region of the catheter. As an alternative, member 206 may continue only to a portion of the infusion. The member 206 preferably shares the center with the tube 202 in general, but can achieve the object of the present invention even in the case of eccentricity. Preferably, member 206 is made of a flexible material to assist in positioning catheter 200 in the patient's body.

In use, the liquid therapeutic agent that flows into the tube 202 saturates the porous member 206 and flows into the annular region 208. Once the member 206 is saturated, the fluid in the member 206 flows to the region 208 and flows out of the catheter 200 through the exit hole 204. Advantageously, since the fluid pressure is uniform throughout the annular region 208, the fluid flows substantially uniformly through all the holes 204. The annular region 208 has several advantages. One advantage is that this tends to optimize the uniformity of flow through the exit hole 204. In addition, the member 206 tends to expand when formed from the porous material and saturated with the chemical liquid. In this case, the member 206 is an annular region 208, which can preferably expand without pressing the tube 202. This limits the likelihood of the occurrence of a high pressure region on the inner surface of the tube 202, which can cause a non-uniform outlet flow of the therapeutic agent at the wound site. As an alternative, member 206 may expand and contact tube 202 and still achieve the object of the present invention.

Member 206 is preferably formed of a porous material having an average pore size in the range of 0.1-1.50 microns, more preferably about 0.45 microns. The radial width W of the annular region 208 is preferably in the range of 0 to about 0.005 microns, more preferably about 0.003 microns. The member 206 may be made of various materials with proper consideration of porosity, flexibility, strength, and durability. Preferred material is Mentek.

Member 206 may be secured in tube 202 by the use of an adhesive. In one embodiment, as shown in FIG. 13, the adhesive is applied to the distal end of the member 206 to form a bond on the inner surface of the distal end 202 of the tube. Preferably, the adhesive is applied at or near the proximal end of the infusion of the catheter 200. In addition, the adhesive may be applied to the circumference of the member 206 at any position in the longitudinal direction of the member 206 to form an annular bond with the inner surface of the tube 202. For example, in the embodiment of FIG. 13, annular bond 214 is provided immediately proximal to the infusion of catheter 200. Another form is possible. For example, FIG. 14 shows an embodiment where an adhesive is applied to the distal end of the member 206 to make the bond 216 and to form a ring-shaped bond 218 in the general center of the infusion. 15 shows an embodiment of applying bond to distal end of member 206 to form bond 220. 16 shows that the adhesive is applied only to the center of the infusion to form a ring-shaped bond 222. Those skilled in the art will understand from the disclosure herein that the adhesive can be applied in various forms. Thus, for example, adhesive at the distal end of the catheter (ie 212, 216 and 220 in FIGS. 13, 14 and 15) is not necessary.

The present best form of the invention is preferably one in which two bonds are included, one in the most proximal pores and one in the most proximal pores. Each bond is made of an adhesive as described below.

The annular bond 214 can be formed by pouring a liquid adhesive through one of the exit holes 204 when the member 206 is in the tube 202. The adhesive is generally high viscosity and tends to flow along the circumference rather than to the body of the member. The adhesive thus forms an annular bond with the tube 202, which will be understood by those skilled in the art. The adhesive also fills the exit hole 204 in which it is poured. Various adhesives are acceptable, but the preferred adhesive is Loctite.

As mentioned above, the member 206 preferably shares a center with the tube 202. FIG. 17 shows a cross section of the catheter 200 concentrically surrounded by a member 206 within the tube 202. Alternatively, as shown in FIG. 18, member 206 may be positioned adjacent to tube 202. The form of FIG. 18 is easier to make than that of FIG. 17 because the member 206 need not be centered within the tube 202.

Those skilled in the art will understand from the disclosure herein that the member 206 can be of any length desired and can extend along any desired length of the infusion portion of the catheter. For example, member 206 need not extend to the distal end of tube 202. Furthermore, the proximal end of the member 206 may be distal or proximal with respect to the proximal end of the infusion.

If any catheter of this embodiment is used, the catheter first has air inside the catheter tube. For example, the catheter 200 shown in FIG. 13 may have air inside the porous material of the member 206. The introduction of a catheter's liquid therapeutic agent causes air to flow out of the exit hole. But this takes several hours. If the catheter is inserted into the patient with air and the liquid medication is introduced into the catheter, the wound site of the patient receives little medication until the air is removed from the catheter tube. Therefore, it is desirable to have a liquid therapeutic agent flow through the catheter prior to inserting the catheter into the patient to ensure that air is removed from the catheter before the catheter is used. Furthermore, as shown in FIG. 19, an air filter 224 having a tubular proximal injection portion 226 of the catheter 200 as known may be inserted into the catheter. Filter 224 prevents undesired air from entering the inlet of catheter 200.

20 and 21 illustrate a catheter with elongated exit holes or slots. The catheter can be used in place of the catheter shown and described above. 20 shows a tube 230 having a longitudinally extending outlet hole or slot of the tube 230. The slot 232 is preferably provided along the inlet of the catheter, throughout the circumference of the tube 230. Compared to the small exit hole, the elongated slot 232 tends to decrease the flow impedance experienced by the fluid, thereby increasing the flow rate of the fluid leaving the catheter. Preferably the slot 232 can be oriented longitudinally on the catheter body so as not to compromise the structural integrity of the catheter 200, which can be readily understood by those skilled in the art.

21 shows a tube 234 with outlet holes or slots 236 that increase in length along the length of the tube in the distal direction. In the illustrated embodiment, the closer to the proximal end of the infusion of the tube 234, the shorter the length than the slot close to the distal end of the infusion. As shown in the embodiment of FIG. 8, catheter tube 234 advantageously provides a substantially uniform fluid supply through substantially all outlet slots 236 under relatively high flow rate conditions. This is because the more distal slots compensate for the flow resistance and pressure drop that the larger size increases. In other words, because the more distal slot is larger than the proximal slot, the flow rate through the more distal slot is greater than if it were the same size as the proximal slot. Advantageously, slot 236 is provided in a progressively increasing length, which results in a substantially uniform fluid supply. Further, extended slots generally result in higher escape flow rates as shown in the embodiment of FIG. 20.

In this embodiment of the catheter, an independent guide wire lumen may be provided within or adjacent to the disclosed lumen, as will be appreciated by those skilled in the art.

The catheter of the present invention can be used for various medical purposes. With reference to FIG. 22, in an exemplary application, catheter 20 (reference numeral 20 is used to distinguish the catheter, any of the above described catheter may be used) is a blood vessel within the vein or artery 242. It is inserted into coagulation 240. Preferably the infusion portion of the catheter is in blood coagulation 240. Preferably the liquid therapeutic agent is introduced into the proximal end of the catheter tube. Advantageously, the medicament of the catheter 20 exits through the entire infusion at the same flow rate to dissolve the blood coagulation 240.

23 and 24 show another preferred embodiment of the catheter 250. As shown in FIG. 23, the catheter 250 preferably consists of a long catheter body or tube 254 and a long outer elongated tubular porous membrane or tube sheath 252. . The elongated tube 254 preferably has a central lumen 268 in communication with an emulsion supply similar to the emulsion supply 34 of FIG. 1.

The tubular membrane 252 covers the length 255 of the long tube 254 and is located at a distance 253 (proximal) close to the distal end 262 of the long tube 254. It is preferable that it is done. In one embodiment, the length 255 is about 2.40 inches and the distance 253 is about 0.10 inches. In another embodiment, the length 255 is about 2.50 inches. In another embodiment, the length 255 is about 5.00 inches. In yet another additional embodiment, the length 255 and distance 253 may be modified to suit the catheter 250 generally through specific anatomical considerations.

As shown in FIG. 23A, the tubular membrane 252 surrounds a portion of the elongated tube 254 so that an annular clearance 270 is formed between the outer surface of the tube 254 and the inner surface of the tubular membrane 252. It is preferable. In a preferred embodiment, the tube 254 is concentric with the tubular membrane 252. In a preferred embodiment, the space 270 has a radial dimension of about 0.007 inches or less. In another embodiment, the space 270 may have a radial dimension between 0.002 and 0.007 inches. However, in some arrangements, the space 270 may be minimized or the inner surface of the tubular membrane 252 may be in contact with the outer surface of the tube 254.

A portion of the tube 254 enclosed within the tubular membrane 252 is provided with a plurality of fluid outlet holes 266. The outlet hole 266 is preferably located over the entire circumference of the tube 254 periphery. A portion of the tube 254 including the exit hole 266 forms an injection portion of the catheter 250. The tubular membrane 252 is preferably provided along only the length 255 of the infusion portion. However, in other arrangements, the tubular membrane may be made longer than the injection portion. In another embodiment, a guide wire and / or a guide wire lumen may be additionally provided at the infusion of the catheter 250, as will be apparent to those skilled in the art.

The tube 253 is made of nylon, polyimide, polytetrafluoroethylene (petf), and other materials known to those skilled in the art in consideration of the non-responsiveness, flexibility, light weight, strength, and smoothness of the anatomical system. Likewise, it can be formed of various suitable materials. In a preferred form, the tube 254 is a 20 gauge catheter tube, preferably 0.019 inches and 0.031 inches inside and outside diameter, respectively.

The exit hole 266 of the tube 254 is preferably about 0.015 inches in diameter, and is provided to be equally axially along the tube 254. The exit hole 266 is preferably positioned such that all holes have an angle of about 120 degrees with respect to the longitudinal axis of the tube 254 from the angular position of the preceding hole. The longitudinal separation between adjacent exit holes 266 preferably ranges from about 0.125 to 0.25 inches, more preferably about 3/16 inches. The outlet hole 266 may be provided in various other arrangements. However, it is preferred that the injection portion be kept enclosed in tubular membrane 252 as described above. 23 and 24 provide precise and uniform distribution of the fluid through approximately linear segments of the wound site.

The tubular membrane 252 is made of a highly porous material. In another embodiment, it is a sponge or foam material or hollow fiber. The tubular membrane may have an average pore size or pore diameter of about 0.23 microns or less to filter bacteria. The pore diameter is preferably in the range of about 0.1 to 0.5 microns, more preferably in the range of about 0.2 to 0.45 microns. The tubular membrane 242 can be formed from any suitable material, taking into account the purpose of non-responsiveness to the anatomical system, maintaining flexibility and within the size constraints (limiting conditions) of the tubular membrane 252. It fits well and has a porosity that allows for a substantially uniform distribution of the fluid through all exit holes of the tubular membrane 252. Some suitable materials for the membrane 252 are polyethylene, polysulfone, polyethersulfone, polypropylene, polyvinylidenedifluoride, polycarbonate, nylon, high density polyethylene or polytetrafluoroethylene. Preferably the tubular membrane 252 is the tube 254 is 19 gauge, preferably 0.042 inches and 0.045 inches in and inner diameter, respectively.

As shown in FIG. 24, the tubular membrane 252 is preferably secured to the tube 254 by distal and proximal tubular portions or collars 264, 265. The tubular portions 264, 265 include a tubing tube attached to the end of the tube 254 and the tubular membrane 252. The tubes 264, 265 may also use adhesives such as Loctite, Epoxy or other means known to those skilled in the art to be used to secure the tubular membrane 252 to the tube 254. For example, the tubular membrane 252 may be secured to the tube 254 by thermal or chemical bonding without the use of tubular portions 264 and 265.

In use, the catheter 250 delivers fluid to an area of the anatomical system approximately adjacent the tubular membrane 252 of the catheter 250. As the fluid flows through the central lumen 268 to the inlet, the fluid first flows through the exit hole 266 into the space 270. The fluid in the space 270 is then sucked into the tubular porous membrane 252. When the wall of the tubular membrane 252 is saturated, the fluid passes through the tubular membrane 252 and exits to the catheter 250. The fluid also effectively passes substantially uniformly through the tubular membrane over the surface area of the tubular membrane 252 and substantially uniformly along the length 255 of the tubular membrane 252. The fluid is therefore distributed in substantially the same proportions over the anatomical wound. This effect is also achieved in both low and high pressure emulsion distributions.

25-27 show an injection catheter of another embodiment, indicated by reference numeral 272. Preferably, the catheter 272 includes a non-porous tubular section or tube 282 connected to the distal bio-nonabsorbable portion, ie the porous tubular portion 280. The porous tubular portion 280 has an interior lumen 281, and the non-porous tube 282 has an internal lumen 283. The non-porous tube 282 forms a non-infusing section 274 of the catheter 272 and joints or joints from the fluid supply 283 as shown in FIG. 25. Preferably extends to 278. Similarly, the porous tubular portion 280 preferably forms an injection portion 276 of the catheter 272 and extends from the junction 278 to the distal end 284. Preferably the distal end 284 is formed by a tip 284a that forms the distal end of the lumen 281 within the porous tubular portion 280.

As shown in FIGS. 26 and 26A, the junction 278 is distal end 285 of the tube 282 inserted into the proximla end 287 of the lumen 281 within the tubular portion 280. It is preferable that it consists of. Preferably an appropriate type of medical adhesive is provided between the tube 282 and the overlapping surface of the tubular portion 280 to hold the two tubes 280, 282 together. A variety of biocompatible adhesives, such as medical "glues" used to seal the wound, can be considered. As shown in FIG. 26A, the proximal end 287 of the tubular portion 280 overlaps the distal end 285 at a distance 286. Preferably, the distance 286 is at least about 0.02 inches. More preferably, the distance 286 is at least about 0.03 inches, and in other embodiments the distance 286 may be varied to achieve the required level of bond strength. The overlap distance described above is desirable because it can provide a secure bond between the tube 282 and the tubular portion 280. However, the overlap distance preferably does not exceed about 0.25 inches so that the overlap does not inhibit the overall flexibility of the catheter 272.

The tube 282 is made of nylon, polyimide, polytetrafluoroethylene (petf) and other materials known to those skilled in the art in consideration of the non-responsiveness, flexibility, light weight, strength, smoothness and safety of the anatomical system. Likewise, it can be formed of various suitable materials. In a preferred embodiment, it is desirable to have an outer diameter of about 0.035 inches or more and consists of a 20 gauge catheter tube.

The tubular portion 280 has an outer diameter of about 0.042 inches and allows the distal tip 285 of the tube 282 to fit properly within the proximal tip 287 of the lumen 281 as shown in FIG. 26A. It is desirable to have an inner diameter of the size. In a preferred embodiment, the tubular portion 280 is comprised of a highly porous material having an average pore size or pore diameter of about 0.23 microns or less to filter bacteria. The pore diameter is preferably in the range of about 0.1 micron to about 0.5 micron, more preferably in the range of about 0.2 to 0.45 micron.

As used herein, the porous material or porous membrane is preferably made of a material or member configured to pass with at least a small amount of resistance in the area through which the substance passes. The porous material or membrane is adjusted to achieve or enhance the property of fluid to pass through a torturous, non-linear route to slow the rate of passage of the material through the material, or inherent property). In addition, the porous material or member has a size of a pore diameter adjacent to the size of a single molecule of the material or the size of a unitary grouping of molecules, so that the diffusion rate of the material may be slowed down. A large number of molecules or unit molecular groups pass through either pore. Generally, the porous material or member is a flow of material that is not the result of micro-pass through the material itself and as a result of a direct pass formed through the material or membrane by elaborate processing such as, for example, laser drilling. Can achieve the required adjustment. Features between such a porous material or membrane and a member having a plurality of holes manually formed therethrough will be apparent to those skilled in the art.

  In another embodiment, the tubular portion 280 may be made of a non-porous material provided with a plurality of exit holes as described above. It can be seen that these exit holes can be employed in the tubular portion 280 according to any of the embodiments described above. The tubular portion 280 may also have any desired length. In one embodiment, the tubular portion 280 has a length of about 5 inches, and the tubular portion 280 and the non-porous tube 282 have an integrated length of about 20 inches. The configuration of tubular portion 280 provides uniform delivery of fluid along the length of tubular portion 280 and is therefore particularly useful for delivering fluid, such as therapeutic fluid, to long wounds such as incisions.

In addition to porosity, the material constituting the tubular portion 280 is preferably a bioabsorbable material as described above. In one embodiment, the material constituting the tubular portion 280 may be decomposed into the patient body in the range of about 5 to 7 days after insertion. During this period, the patient's body treats the bioabsorbable material such that the strength of the junction 278 is reduced. This weakening of the junction 278 facilitates the separation of the non-porous tube 282 from the tubular portion 280, and then the wound without disturbing the provision of the remainder (non-absorbing portion) of the porous tubular portion 280 in the wound. It facilitates the removal of the tube 282 from the side.

The catheter 272 is particularly suitable for use in connection with pain management or an intravenous system (ie, an infusion pump). During surgery, the physician or other practitioner places the catheter 272 at the wound site of the patient's body. The tubular portion 280 is preferably inserted into the wound site such that the entire tubular portion 280 and the distal end 285 of the tube 282 can enclose the patient's body. In addition, the patient is surrounded between about 0.1 to 0.4 inches of the distal end of the non-bioabsorbable tube 282. More preferably, the patient is surrounded between about 0.1 to 0.5 inches of the distal end of the non-bioabsorbable tube 282. The tubular portion 280 may be sutured to the surrounding tissue of the wound to tack the catheter 272 in place. This allows the catheter 272 to be accurately positioned at the wound site. Preferably, any enclosure used to secure the catheter 272 in place may be made of a bio-absorbable material. As a result, both tubular portions 280 and sutures can be absorbed by the body.

When the catheter 272 is properly attached to the patient, the proximal end of the tube 282 may be connected to the venous system or fluid supply. The catheter 272 has the advantage of delivering latex or other medication to the patient for 5-7 days or longer, depending on the original wound site in question. During this time, the tubular portion 280 may be absorbed into the body of the patient. When the tubular portion 280 is sufficiently absorbed, the junction 278 weakens and the nonporous tube 282 is pulled out of the wound. As the junction 278 weakens, the tube 282 is pulled to separate the distal end 285 of the tube 282 from the proximal end of the tubular 280. Thus, when the tube 282 is removed, the tubular portion 280 remains at the wound and is absorbed by the body of the patient. Leaving the tubular portion 280 at the wound site can appropriately reduce the amount of trauma to the surrounding tissue that may be caused by removal and use of a general catheter or pain management system.

As will be readily appreciated by those skilled in the art, any of the catheter embodiments described herein may be used in a variety of applications, which include peripheral nerve block, intrathecal infusion, epidermal infusion, and intravascular infusion, intravenous As well as infusions and intra-articular injections, etc., and can be used to treat pain in the wound site.

In addition, all catheters disclosed herein may be integral with the fluid line from the injection pump as opposed to being an independent catheter designed to be connected to or attached to the injection pump.

While the present invention has been disclosed in the context of certain preferred embodiments and examples, those skilled in the art will appreciate that other alternative embodiments and / or use of the present invention and obvious improvements and their equivalents may depart from the superficially disclosed embodiments of the present invention. I can understand that it comes to. Thus, the boundaries of the invention disclosed herein are not limited to the particular embodiments described above, but should be defined by interpreting the claims that follow.

Claims (8)

A catheter for delivering fluid to an anatomical area,
Elongated proximal tube forming the lumen;
Long distal tube consisting of a bio-absorbable material and forming a lumen in communication with the lumen of the proximal tube
Including,
A portion or the entirety of the side wall of the distal tube causes the fluid from the lumen to communicate with the exterior of the distal tube, thereby extending the length of the side wall of the distal tube between the closed distal end of the distal tube and the proximal tube. Forming an injection portion of the catheter extending along;
The proximal end of the distal tube and the distal end of the proximal tube overlap to form an overlap of the catheter having a wall thickness equal to the combined wall thickness of the distal tube portion and the proximal tube portion adjacent to the overlap portion to reinforce the catheter. And a proximal end of the distal tube is bonded to the distal end of the proximal tube with a biocompatible adhesive to form an fluid tight junction therebetween, the length of the overlap of the proximal tube and the distal tube being at least 0.02 inches
Catheter. The method of claim 1,
The overlap portion is at least 0.03 inches
Catheter. The method of claim 1,
The distal end of the lumen of the distal tube is closed with a tip
Catheter. The method of claim 1,
The bio-absorbable material is positioned within the patient and configured to dissolve sufficiently within 5 to 7 days such that the proximal tube is removable from the distal tube.
Catheter. The method of claim 1,
The injection portion of the catheter includes a plurality of other holes extending through the sidewall of the distal tube
Catheter. The method of claim 1,
The proximal tube has an outer diameter of 0.035 inches,
The distal tube has an outer diameter of 0.042 inches
Catheter. The method of claim 1,
The distal tube is configured to remain structurally intact without dissolving during the useful life of the catheter, and the distal tube dissolves after the end of its useful life so that the proximal tube can be removed from the distal tube and the distal tube A tube is configured to be left in the anatomical area to dissolve;
The useful life is a period of time during which the catheter can pass fluid from the lumen of the proximal tube to the lumen of the distal tube and through the infusion of the distal tube to the anatomical region.
Catheter. The method of claim 1,
The injection portion includes a porous sidewall portion that allows fluid in the lumen to saturate the porous sidewall portion and pass through the porous sidewall portion at any point along the length of the porous sidewall portion.
Catheter.

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