JP5248556B2 - Catheter for uniform drug delivery - Google Patents

Description

The present invention relates generally to catheters, and more particularly to catheters for delivering fluid medication evenly throughout the infusion portion of the catheter.

Infusion catheters for delivering fluid medication into anatomical systems such as the human body are known in the art. Such catheters generally include a flexible hollow tube that is inserted into a region of the anatomy. The tube typically has one or more lumens along the axial direction through which fluid can flow. The proximal end of the catheter tube is connected to a fluid source from which fluid is introduced into the catheter tube. The fluid flows through one of the lumens by pressure applied at the proximal end of the tube. In each lumen, one or more outlet holes are generally provided along the injection portion near the distal end of the tube, through which fluid exits the tube. Such outlet holes are made by drilling holes in the side wall of the hollow tube.

Under certain treatment conditions, it may be advantageous to deliver the fluid medicament to multiple sites on the wound site. For example, wounds that require pain reliever drugs may involve multiple nerve endings rather than a single nerve trunk. One example of such a wound is a surgical incision. As previously mentioned, it is known to provide a plurality of outlet holes to allow fluid medicament to flow out of the catheter tube. The outlet holes can be provided along the catheter tube at various positions in the axial direction and the outer circumferential direction so as to adjust the position of the site where the drug is delivered. An example of a catheter having such a configuration is disclosed in US Pat. No. 5,800,407 by Eldor. In some cases, it may be desirable to deliver such agents at a low pressure to allow fluid to reach at a relatively low rate. For example, pain medications must be delivered gradually to reduce toxicity and other side effects. Further, in many cases, it is preferable to dispense fluid medication from the infusion portion of the catheter at a substantially uniform rate, so that the medication is evenly distributed throughout the wound area.

Unfortunately, prior art catheters with multiple exit holes, such as the catheter according to Eldall's teachings, have limitations, and when trying to deliver fluid medication at low pressure, the proximal end of the infusion portion of the catheter tube The fluid tends to flow out only from the outlet hole (s) closest to. The reason is that the fluid flowing in the tube flows out easily from the outlet hole having the least flow resistance. The longer the flow path through which the fluid flows in the lumen, the greater the flow resistance and pressure drop experienced by the fluid. The hole at the most proximal end has the least flow resistance and pressure drop. Thus, fluid tends to flow out of the catheter tube primarily through these outlet holes. As a result, the fluid medicament is delivered only to a small area of the wound area. Thus, it is the size of the holes, the total number of outlet holes, and the flow rate that affect the undesirable tendency of the fluid to flow only from the most proximal outlet holes. The larger the hole size or the number of holes, the easier the fluid will flow out of the most proximal hole. Conversely, as the flow rate increases, such behavior of the fluid is suppressed.

The undesirable tendency for fluid to exit only from the most proximal hole in the catheter may be overcome by increasing the fluid velocity or pressure to allow fluid to flow out of the more outlet holes in the catheter. In fact, if the flow rate or pressure is high enough, the fluid will flow out of all the outlet holes. However, it may be pharmaceutically desirable to deliver the drug at a relatively slow rate, i.e., low pressure. Also, even when fluid delivery by high pressure is acceptable or desirable, prior art catheters do not deliver fluid evenly along the infusion portion of the catheter. Rather, the flow velocity at the outlet hole near the proximal end of the liquid injection part tends to be larger than in the case of the outlet hole near the distal end. This is because the fluid passing through the hole near the proximal end experiences only a small flow resistance and pressure drop. Conversely, the fluid passing through the hole closer to the distal end experiences greater flow resistance and pressure drop, resulting in a lower fluid flow rate. The farther the hole is, the lower the fluid outflow rate. As a result, the entire wound portion can be unevenly distributed.

Another known type of infusion catheter is one in which a plurality of lumens are provided within a single catheter tube. By making a hole in the wall of the tube, each lumen is provided with one outlet hole. These outlet holes are opened at various axial positions along the injection part of the catheter tube. In this way, the fluid medicament can be delivered to several places in the wound part. Although this arrangement improves the fluid distribution, there are some problems. One problem is that the velocities of the fluid flowing out of the outlet are not equal because, for the same reason described above, the flow resistance increases as the outlet hole becomes distal. Another problem is that the number of lumens, and therefore the number of fluid outlet holes, is limited due to the small diameter of the catheter tube. As a result, fluid is only delivered to a limited number of points within the wound area. Yet another problem is that the proximal end of the lumen needs to be attached to a complex shaped manifold, which increases the cost of manufacturing the catheter.

An example of a catheter that can distribute fluid medication more evenly throughout the catheter infusion is shown in US Pat. No. 5,425,723 by Wang et al. One discloses an infusion catheter consisting of an outer tube, an inner tube disposed concentrically within the outer tube, and a central lumen within the inner tube. Since the diameter of the inner tube is smaller than that of the outer tube, a ring-shaped channel is formed between them. The outer tube is provided with a plurality of evenly spaced outlet holes to define a catheter injection portion. In use, the fluid flowing inside the central lumen exits through a side hole that is cleverly arranged inside the side wall of the inner tube. In particular, the spacing between adjacent side holes is reduced along the length of the inner tube so that more fluid will flow out of the more distal side holes. This fluid then flows longitudinally through the ring-shaped channel and then out through the outlet holes in the outer tube wall. In a ring-shaped channel, fluid can flow in either the distal or proximal direction, depending on where the closest outlet hole of the outer tube is. By using this configuration, the speed at which the fluid exits the catheter can be more evenly promoted.

Unfortunately, this one catheter is only effective when delivering fluid at relatively high pressures. When used for relatively low pressure fluid delivery, the catheter disclosed by One cannot distribute fluid evenly. Instead, there is a greater tendency for fluid to flow out of the side and outer tube side holes closest to the proximal end of the catheter infusion, since these holes have the least flow resistance. Even for high pressure fluid delivery, there are some limitations in this setting. One of the limitations is that the concentric tube design is relatively complex and difficult to manufacture. Each tube must be flexible enough to move freely within the dissection system, and in addition, the ring-shaped channel must always be open to allow the fluid to flow evenly. I must. Another limitation is that if there is a bent part in the injection part of the tube, the ring-shaped flow path may be disturbed. In the bent portion of the catheter, the ring-shaped flow path may be deformed or the inner tube and the outer tube may be in contact with each other. If this occurs, there will be a difference in fluid pressure across the longitudinal cross section of the ring-shaped channel, resulting in uneven delivery of fluid.

Therefore, it is a relatively simple and easy-to-manufacture design that is effective for delivering both high and low flow rate fluids and is capable of delivering fluid medication evenly across its infusion. There is a need for an improved infusion catheter that is capable. Furthermore, it has been found that a special type of catheter, such as a one catheter, can deliver fluid evenly only when the pressure and velocity of the fluid is high. However, this type of infusion catheter has a relatively simple and easy-to-manufacture design that can maintain equal fluid delivery despite bending or other physical deformations. is necessary.

[Summary of Invention]
Accordingly, it is a primary object and advantage of the present invention to provide an improved catheter that overcomes some or all of the limitations described above and delivers fluid medication to the wound portion of the anatomical region.

A catheter is provided for evenly delivering fluid medication within the anatomical region. One embodiment of the catheter consists of a stretched tube and a stretched outer tubular porous membrane that encloses the length of the stretched tube so that there is a ring-shaped space between the tubular membrane and the stretched tube. The tubular membrane is made of a highly porous material, and the average pore diameter is preferably in the range of about 0.1 micrometers to about 0.5 micrometers . One embodiment of the catheter has an average pore size that is particularly suitable for filtering out bacteria. The plurality of fluid outlet holes are provided in a part of the extending tube sealed in the tubular film. In use, fluid in the catheter flows through all of the outlet holes and into the ring-shaped space. The tubular membrane ensures that fluid is evenly delivered within the anatomical region.

In one embodiment of the present invention, a catheter is provided for delivering fluid evenly throughout the anatomical region, including an elongated tubular member made from a porous membrane. The membrane is sized to be inserted through the subcutaneous layer surrounding the anatomical region, eg, human skin. The membrane is such that fluid introduced under pressure to the open end of the tubular member passes through the side wall of the tubular member and flows out at a substantially uniform velocity over the length of the tubular member. It is configured. The present invention also provides a method for delivering fluid evenly throughout the anatomical region, including inserting an elongated tubular member into the anatomical region and an open end of the tubular member. Introducing a fluid under pressure.

In other embodiments of the invention, catheters and methods are provided for delivering fluid evenly throughout the anatomical region. The catheter includes a stretched support and a porous membrane that surrounds the support. The support is configured such that one or more lumens are formed between the support and the porous membrane. Alternatively, the support may be a tubular member having a plurality of holes therein. The method includes inserting the catheter into the anatomical region and introducing fluid under pressure at a proximal end of at least one of the lumens. Advantageously, the fluid enters the anatomical region through the membrane at a substantially uniform rate. The present invention further provides a method of manufacturing the catheter, the step of forming the stretched support, and the support is porous so that one or more lumens are formed between the support and the membrane. And surrounding with a membrane.

In another embodiment of the invention, a catheter and method are provided for delivering fluid evenly throughout the anatomical region. This catheter includes an elongated tube having a plurality of outlet holes along its length, and a tubular porous membrane concentrically enclosed within the tube. A lumen is defined between the tube and the membrane. In this method, the catheter is inserted into the anatomical region and fluid is introduced under pressure into the proximal end of the lumen so that the fluid is successfully transferred to the membrane and outlet holes at a substantially uniform rate. And passing through the anatomical region. The present invention further provides a method of manufacturing this catheter, which includes the steps of forming a stretched tube, providing a plurality of outlet holes in the length direction of the tube, and forming a tubular porous membrane. And concentrically disposing the tubular porous membrane within the tube so that a lumen is formed by the tube and the membrane.

In yet another embodiment of the present invention, an apparatus and method are provided for delivering fluid evenly throughout the anatomical region. Preferably, the device is simple and easy to manufacture and includes a stretch catheter having a plurality of outlet holes in the lengthwise direction. The outlet hole may serve as an orifice that restricts flow. Alternatively, an orifice that restricts flow may be provided within the catheter or at a location proximal to the catheter. The outlet hole may be gradually increased in size along the length of the catheter, with the largest outlet hole being more distal than the smallest outlet hole. Alternatively, the holes may be laser drilled to approximately the same size. Preferably, fluid flowing under pressure within the catheter flows out of substantially all outlet holes at a substantially uniform rate. The method includes inserting a catheter into the anatomical region and introducing fluid under pressure to the proximal end of the catheter. This fluid passes through the exit holes and enters the anatomical region, but preferably flows out of substantially all of the exit holes at a substantially uniform rate. The present invention further provides a method of manufacturing the device, comprising forming a stretched catheter and gradually increasing the exit hole from the proximal end to the distal end along the length of the catheter. And providing a plurality of outlet holes along the length of the catheter.

In yet another embodiment of the present invention, a catheter and method for delivering a fluid medicament to an anatomical region is provided. The catheter consists of a tube, a “weeping” tubular coil spring attached to the distal end of the tube, and a stop that seals the distal end of the spring. A tube and spring each define a portion of the central lumen. The spring has adjacent coils in contact with each other, and fluid below the threshold dispensation pressure in the spring can flow radially between the coils and out of the lumen. It is prevented. This spring has the property of expanding when the fluid pressure exceeds the distribution threshold pressure, and flows in the radial direction between the coils so that the fluid flows out of the lumen. That is, “weeping” through the springs. Alternatively, fluid may be swept from the defective portion of the spring coil. The fluid is preferably distributed substantially evenly over the length of the spring part and over the entire circumference. In use, fluid is introduced into the open proximal end of the tube and allowed to flow through the portion of the spring to a pressure above the dispensing threshold pressure so that the fluid will sweep from the spring.

In yet another embodiment of the present invention, a catheter and method for delivering a fluid medicament to an anatomical region is provided. The catheter includes a tube sealed at the distal end and a “weeping” tubular coil spring concentrically housed within the tube, as described above. A plurality of outlet holes are provided in the side wall in the longitudinal direction of the tube to define a liquid injection portion of the tube. This spring is accommodated in the liquid injection part, and a space between the tube and the spring is a lumen part. In use, fluid is introduced by introducing the fluid into the open proximal end of the tube, flowing to the portion of the spring, the fluid being dispensed by weeping from the lumen through the spring to a pressure above the dispensing threshold pressure of the spring, and then the tube So that it flows out of the outlet hole.

In yet another embodiment of the present invention, a catheter is provided that includes an elongated tube and a solid flexible member located within the tube. The distal end of the tube is sealed, and a plurality of outlet holes are provided in the side wall of the tube. This outlet hole is along the length of the tube and defines the injection portion of the catheter. The tube is sized to be inserted into the anatomical region. The member is placed in a tube and is sized to create a ring-shaped space between the tube and the member. This member is made of a porous material. The catheter is preferably configured such that fluid introduced at the proximal end of the tube flows out of the outlet hole at a substantially uniform rate throughout the injection portion.

In yet another embodiment, the present invention provides a catheter that includes an elongated tube having a plurality of outlet slots in its sidewalls. This slot is provided in the length direction of the tube, and demarcates the injection part of the catheter. This exit slot is typically arranged to be parallel to the longitudinal axis of the tube. The tube is preferably configured so that the fluid flowing therein flows from substantially all slots at a substantially uniform rate. In some cases, the length of the slot is increased from the proximal portion to the distal portion of the injection portion.

In yet another embodiment, the present invention includes a catheter for delivering fluid to the anatomical region. The catheter includes an elongated tubular catheter body that defines a distally closed lumen. A portion of the catheter body has a plurality of openings extending in the side wall of the catheter body, thereby defining a liquid injection portion of the catheter. A tubular sheath composed of a porous material is disposed on the liquid injection part and extends at least the length of the liquid injection part. The tubular sheath and catheter body are configured such that fluid in the lumen must pass through the tubular sheath to exit the catheter. The pore size of the porous material is less than about 0.5 micrometers .

Yet another embodiment of the present invention includes a catheter for delivering fluid to the anatomical region. The catheter includes an elongated tubular catheter body having a side wall, the outer surface of the side wall defining a relatively uniform first diameter. The catheter body also includes a lumen. The distal portion of the catheter body allows fluid to pass from within the lumen to the exterior of the catheter body, thereby defining the infusion portion of the catheter. A tubular sheath composed of a porous material has a side wall, a first end, and a second end. The tubular sheath is disposed on the liquid injection part such that the liquid injection part is between the first end and the second end. The inner surface of the tubular sheath side wall defines a second diameter that forms a clearance space between the tubular sheath and the catheter body. The first and second ends of the tubular sheath are coupled to the outer surface of the catheter body to substantially seal the interstitial space.

In yet another embodiment, the present invention includes a catheter for delivering fluid to the anatomical region. The catheter includes an elongated proximal tube that defines a lumen. An elongated distal tube composed of bioabsorbable material defines a lumen that communicates with the lumen of the proximal tube. At least a portion of the distal tube communicates fluid from the lumen to the exterior of the distal tube, thereby defining the 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 overlapping portion of the proximal and distal tubes is at least about 0.02 inches, and more preferably is about 0.03 inches.

Yet another embodiment of the invention includes a catheter for delivering fluid to an anatomical region comprising an elongated proximal tube defining a lumen. The elongated distal tube has a closed end and is composed of a biocompatible material. The distal tube defines a lumen that communicates with the lumen of the proximal tube. At least a portion of the distal tube defines a porous sidewall that allows fluid within the lumen to pass through the portion of the distal tube.

A further aspect of the invention includes a method for delivering fluid throughout an anatomical region of a patient. The method includes inserting an elongated tubular member into the patient's incision, the tubular member having a proximal portion attached to the distal portion at a junction. The distal portion includes a bioabsorbable material. At least a portion of the distal sidewall defines a porous membrane that allows fluid within the tubular member to pass through the sidewall. The method further includes positioning the tubular member such that the junction is within the patient's body, closing the incision, and introducing fluid into the open proximal open end of the tubular member.

For purposes of summarizing the present invention and its advantages over the prior art, some of the objects and advantages of the present invention are listed above. Of course, it is to be understood that not all such objectives and advantages need be achieved in certain embodiments of the invention. Thus, for example, the present invention may be used in a manner that achieves or optimizes one or more of the advantages taught herein without achieving other objectives or advantages taught or suggested herein. It is well known to those skilled in the art that can be embodied or implemented.

All of these embodiments are intended to be included within the scope of the invention disclosed herein. These and other embodiments of the present invention will be readily apparent to those skilled in the art from the following detailed description of the preferred embodiments with reference to the accompanying drawings, but the present invention is disclosed. It is not limited to any particular preferred embodiment (s).

1 is a schematic side view of a catheter having features and advantages according to a first embodiment of the present invention. FIG. FIG. 2 is a cutaway view of the catheter of FIG. 1 taken along line 2-2 of FIG. FIG. 3 is a cutaway view of the catheter of FIG. 1 taken along line 3-3 of FIG. FIG. 4 is a perspective view taken through line 4-4 of FIG. 1 and a perspective view of the distal end and support beam of the catheter of FIG. FIG. 6 is a side view of a catheter having features and advantages according to a second embodiment of the present invention. FIG. 6 is a cross-sectional view of the liquid injection part of the catheter of FIG. 5 taken along line 6-6 of FIG. FIG. 6 is a cross-sectional view of a catheter having features and advantages according to a third embodiment of the present invention. FIG. 10 is a side view of a catheter having features and advantages according to a fourth embodiment of the present invention. FIG. 7 is a side view of a catheter having features and advantages according to a fifth embodiment of the present invention. FIG. 10 is a cross-sectional view of the catheter of FIG. 9 with the spring unstretched. FIG. 10 is a cross-sectional view of the catheter of FIG. 9 with the spring in an extended state. FIG. 7 is a cross-sectional view of a catheter having features and advantages according to a sixth embodiment of the present invention. FIG. 9 is a side view of a catheter having features and advantages according to a sixth embodiment of the present invention. FIG. 10 is a longitudinal cross-sectional view of a catheter having features and advantages according to a seventh embodiment of the present invention. FIG. 14 is a longitudinal cross-sectional view of a catheter similar to FIG. 13, with a different attachment between the inner porous member and the tube. FIG. 14 is a longitudinal cross-sectional view of a catheter similar to FIG. 13, with a different attachment between the inner porous member and the tube. FIG. 14 is a longitudinal cross-sectional view of a catheter similar to FIG. 13, with a different attachment between the inner porous member and the tube. FIG. 17 is a transverse cross-sectional view of the catheter of FIGS. 13-16, with the inner porous member concentric with the outer tube. FIG. 17 is a lateral cross-sectional view of the catheter of FIGS. 13-16, wherein the inner porous member is not concentric with the outer tube. 1 is a schematic view of a catheter of the present invention being used in combination with a degassing filter. FIG. 10 is a side view of a catheter having features and advantages according to an eighth embodiment of the present invention. FIG. 10 is a side view of a catheter having features and advantages according to a ninth embodiment of the present invention. FIG. 2 is a schematic diagram using a catheter of the present invention to treat a clot. FIG. 10 is a side view of a catheter having features and advantages according to a tenth embodiment of the present invention, including a tubular porous membrane or sheath. FIG. 24 is a cross-sectional view of the catheter of FIG. 23 taken along the line 23A-23A of FIG. FIG. 24 is a cross-sectional view of the catheter of FIG. 23 taken along the line 24-24 of FIG. FIG. 22 is a schematic side view of a catheter having features and advantages according to an eleventh embodiment of the present invention, wherein at least a portion of the catheter is constructed from a bioabsorbable material. FIG. 26 is an enlarged side view of a joint portion between the nonporous portion and the bioabsorbable portion of the catheter of FIG. 25. FIG. 27 is a cross-sectional view of the joint of FIG. 26 taken along the line 26A-26A of FIG. FIG. 26 is an enlarged side view of the distal end of the catheter of FIG. 25.

Detailed Description of Preferred Embodiments
An injection catheter 20 according to an embodiment of the present invention is shown in FIGS. The catheter 20 preferably includes a flexible support 22 (FIGS. 2-4), a non-porous membrane 24, and a porous membrane 26. Membranes 24 and 26 surround support 22 and form a plurality of axial lumens between the inner surfaces of membranes 24 and 26 and the surface of support 22. This will be described in more detail below. The non-porous membrane 24 defines the non-injected portion 28 of the catheter 20 and preferably covers the support 22 from the proximal end to the point 30 (FIG. 1). Similarly, the liquid injection part 32 of the catheter 20 is determined by the porous membrane 26 and preferably covers the support 22 from the point 30 to the distal end of the support 22. Alternatively, the catheter 20 can be configured without the nonporous membrane 24. In this structure, since the porous membrane 26 covers all parts of the support 22, it becomes a liquid injection part of the catheter 20 over the entire length of the support 22. There is no restriction on the length of the liquid injection part. The proximal end of the catheter 20 can be connected to a fluid supply 34 containing a fluid 36 such as a liquid medicament. At the distal end of the catheter 20 is a cap 48 (FIG. 4) that defines the end of the axial partial lumen inside the catheter 20.

In use, the catheter 20 is inserted into an anatomical system, such as the human body, to deliver fluid medication directly to a wound portion within the anatomical system. More specifically, the catheter 20 is designed to deliver the drug to the entire linear portion in the wound portion, corresponding to the liquid injection portion 32 of the catheter 20. Therefore, this catheter is preferably inserted so that the liquid injection part 32 is located inside the wound part. Using known methods, a doctor or nurse can insert the catheter 20 using an axial guidewire 46 that passes through the axial guidewire lumen 44 of the catheter 20. Once the catheter is in place, the guidewire 46 can be easily withdrawn from the proximal end of the catheter 20. Alternatively, a catheter 20 that does not use a guidewire or guidewire lumen can be made.

2 and 3 show a support 22 having a preferred shape. As shown in the figure, a plurality of obstacles such as ribs 40 are provided on the surface of the support 22. The obstruction is configured such that when the membranes 24 and 26 cover the support 22, the walls of the plurality of axial lumens 38 are formed by the membrane, through which fluid 36 can flow. A structure in which the plurality of ribs 40 protrude radially from the common central shaft portion 42 of the support 22 is preferable. The rib 40 preferably extends in the length direction of the support 22 and extends over the entire length thereof. In the non-injection portion 28 shown in FIG. 2, it is preferable that the non-porous membrane 24 firmly covers the outer end of the rib 40. Thereby, an axial lumen 38 is formed between the inner surface of the non-porous membrane 24 and the outer surface of the support 22. Similarly, in the liquid injection part 32 as shown in FIG. 3, it is preferable that the porous membrane 26 firmly covers around the outer end of the rib 40, thereby the axial lumen 38. Is formed between the inner surface of the porous membrane 26 and the outer surface of the support 22.

In another embodiment of the catheter 20, instead of using a non-porous membrane 24, the entire length of the support 20 can be covered by a porous membrane 26. In this embodiment, the entire length of the support 22 corresponds to the liquid injection part 32. In another embodiment, the support 22 may be installed only inside the liquid injection part 32, and a tube may be used from the fluid supply source 34 to the proximal end of the support 22. In this embodiment, the tube replaces the support 22 that extends to the non-porous membrane 24 and in the preferred embodiment to the non-injection 28. In other words, the tube defines the non-injection portion 28.

In a preferred configuration, a shape where the number of ribs 40 matches the number of axial lumens 38 is desirable. 2 and 3, five ribs 40 and axial lumens 38 are shown, but the number of ribs 40 and lumens 38 is not limited, and there can be multiple lumens in the catheter 20; Appropriate considerations should be taken to maintain the flexibility and, if desired, to achieve the goal of fluid independent in the lumen. As used herein, terms such as “fluid independence” and “fluid separation” mean that the lumens do not pass fluids to each other when used with multiple axial lumens. It ’s just that. The membranes 24 and 26 are preferably adhered along the outer edges of the ribs 40, in which case any suitable adhesive may be used, such as a medical adhesive or epoxy. By doing so, it is possible to prevent the membranes 24 and 26 from slipping when the catheter is inserted or removed from the anatomical structure. More preferably, the outer end of each rib 40 is bonded to the membrane over its entire length. As an alternative method, the membrane covers the periphery of the support, but may be a method that does not fix the support to the support using foreign matter. In addition, the membrane and the support may be fixed to each other using other methods known to those skilled in the art. Thereby, liquid independence in lumen 38 is maintained. If desired, an axial guidewire lumen 44 may be provided in the central shaft portion 42 of the support 22. The guidewire lumen 44 is used to pass the guidewire 46, which is used as an aid to insert the catheter 20 into the anatomy. This has been described above and is well known to those skilled in the art.

As shown in FIG. 4, the catheter 20 is preferably provided with a distal end or cap 48 for securing the distal end of the support 22. The end portion 48 can be molded as one piece with the support 22 or it can be attached thereto with an adhesive. As shown in the figure, the proximal end of the distal end 48 is preferably disk-shaped and is diametric so that the outer surface of the proximal end of the distal end 48 meets the outer end of the rib 40 of the support 22. A porous membrane 26 covers around the proximal end of the end 48. Preferably, the membrane 26 adheres to the distal end 48 and prevents fluid 36 in the lumen 38 from exiting the catheter 20 without passing through the wall of the membrane 26. A distal end 48 is the distal end of the catheter 20 and stops the axial flow of fluid. However, if desired, the end 48 can optionally be made of a porous material so that some fluid is released axially from the distal end of the catheter 20. The distal end of the distal end 48 is preferably dome-shaped as shown in the figure, which allows the catheter 20 to be easily inserted into the anatomical region.

The support 22 can be made of various materials, and appropriate considerations may be made for purposes such as flexibility, light weight, strength, smoothness, non-responsiveness to the anatomical system, that is, safety. Suitable materials for the support 22 include nylon, polyamide, Teflon® and other materials known to those skilled in the art. For the porous membrane 26, a sponge-like material, a foam-like material, a hollow fiber or the like is preferable. Membrane 26 can be made of any suitable material, but appropriate considerations may be made for the purposes of flexibility and non-responsiveness to the anatomical system. The membrane 26 has a pore size such that fluid is almost evenly discharged over the entire surface of the liquid injection portion 32 of the catheter 20, but the average pore is small enough that bacteria cannot pass through the membrane wall surface. A size is preferred. Suitable materials for the membrane 26 are polyethylene, polysulfone, polyethersulfone, polypropylene, polyvinylidene difluoride, polycarbonate, nylon or high density polyethylene. Suitably, these materials are biocompatible. This porous membrane 26 can filter out unwanted bacteria as the fluid drug passes through the membrane 26. As is known, any small bacterium cannot pass pores smaller than 0.23 micrometers . Therefore, the average pore size or pore diameter of the porous membrane 26 can be made less than 0.23 micrometers so that bacteria do not pass through the membrane 26. The average pore size or pore diameter of the porous membrane 26 is preferably in the range of about 0.1 to 1.2 micrometers , more preferably in the range of about 0.3 to 1 micrometer , and even more preferably about 0.00. 8 micrometers .

As described above, the proximal end of the catheter 20 can be connected to a fluid source 34. The catheter 20 can be configured such that each of the axial lumens 38 is fluidly independent. In other words, the lumens 38 do not fluidly mix with each other. It is also possible to connect the catheter 20 to a single fluid source 34, in which case fluid 36 will flow to all lumens 38. Alternatively, the catheter 20 can be connected to multiple separate fluid sources, in which case several different fluids flow through the lumen 38 separately. With this configuration, each lumen 38 can be connected to a separate fluid source so that the total number of different fluids that can be delivered to the anatomy is the same as the number of lumens 38. It will be. Alternatively, these fluid lumens need not be fluidly independent. For example, the membrane 26 may not be secured to the support 22 over the entire length of the support 22, in which case the fluid 36 can move between the lumens 38.

In use, the catheter 20 allows fluid to be delivered directly to the area of the anatomy adjacent to the injection portion 32. A fluid 36 from a fluid source 34 is pumped through the proximal end of the catheter 20 and into an axial lumen 38. The fluid 36 initially flows through the non-injection portion 28. When the fluid 36 arrives at the liquid injection part 32 for the first time, it penetrates into the porous membrane 26. When more fluid 36 enters the liquid injection part 32, it diffuses in the vertical direction in the wall of the film 26, and the entire film 26 and liquid injection part 32 are saturated with the fluid. At this point, fluid 36 begins to pass through membrane 26 and exits catheter 20 and enters the anatomy. Further, due to the properties of the membrane 26, it is preferred that the fluid 36 pass through the entire surface of the porous membrane 26 at a substantially uniform rate. This will deliver fluid at a substantially uniform rate across the generally linear site of the wound portion of the anatomical structure. Furthermore, this advantage remains the same whether the fluid is delivered at low pressure or high pressure.

5 and 6 show a catheter 50 according to another embodiment of the present invention. In this embodiment, the catheter 50 includes a stretched outer tube 52 and an inner stretched tubular porous membrane 54. The tubular membrane 54 is preferably enclosed concentrically inside the outer tube 52. It is more preferable that the tube 52 firmly surrounds and supports the tubular membrane 54 and that the inner surface of the tube 52 and the outer surface of the membrane 54 are relatively firmly attached. Preferably, a plurality of outlet holes 56 are provided in the tube 52 and span the entire outer periphery. A portion of the tube 52 where the outlet hole 56 exists defines a liquid injection portion of the catheter 50. The tube-shaped film 54 may be longer than the length of the liquid injection part, but may be longer. In some cases, the distal end 58 of the tube 52 may also be provided with an axial outlet hole. A guide wire and / or guide wire lumen may also be provided to assist in inserting the catheter 50 into the anatomy, as is well known to those skilled in the art.

The tube 52 can be made of any suitable material, such as nylon, polyimide, Teflon, or other materials known to those skilled in the art, and is non-reactive, flexible, lightweight, strength, Appropriate consideration should be given to purposes such as smoothness and safety. As a preferred configuration, the tube 52 is preferably a 20 gauge catheter tube having an inner diameter and an outer diameter of 0.019 inches and 0.031 inches, respectively. The outlet holes 56 in the tube 52 are preferably about 0.015 inches in diameter and spaced equally along the length of the tube 52. The holes 56 are preferably arranged so that each hole is displaced from the adjacent hole by an angle of about 120 degrees with respect to the longitudinal axis of the tube 52. The axial spacing of adjacent outlet holes 56 is preferably in the range of about 0.125 to 0.25 inches, more preferably about 3/16 inches. Moreover, there is no restriction | limiting in the length of a liquid injection part. With this configuration, fluid can be delivered widely and evenly throughout the normally linear portion of the wound portion. As a matter of course, the outlet holes 56 may be arranged in various other arrangement methods.

The tubular porous membrane 54 is preferably a sponge-like material, a foamed material, or a hollow fiber. The average pore size or pore diameter of the tubular membrane 54 can be less than 0.23 micrometers for filtering bacteria. Pore diameter is preferably in the range of about 0.1 to 1.2 micrometers, more preferably from about 0.3 to 1 micrometer, and even more preferably about 0.8 micrometers. The tubular membrane 54 can be molded from any suitable material, but is non-responsive to the anatomical system, remains flexible, is within the size limits of the tube 52, and all of the outlet apertures 56 of the tube 52. Appropriate considerations may be taken for such purposes as having a pore size that allows fluid to flow out of the fluid almost uniformly. Examples of suitable materials for the membrane 54 include polyethylene, polysulfone, polyethersulfone, polypropylene, polyvinylidene difluoride, polycarbonate, nylon, or high density polyethylene. The inner and outer diameters of the tubular membrane 54 are preferably 0.010 inches and 0.018 inches, respectively. If guide wire 46 is used, the guide wire may be a stainless steel wire having a diameter of about 0.005 inches. Tube 52 may be secured to membrane 54 using epoxy or methods known to those skilled in the art. As an alternative method, the membrane 54 may be closely attached to the tube 52 by an interference fit, and no other material may be used to secure the membrane 54 to the tube 52.

In use, the catheter 50 causes fluid to be delivered to the area of the dissection system adjacent to the injection portion of the catheter 50. When the fluid flows into the liquid injection part, it penetrates into the tubular porous membrane 54. When a larger amount of fluid enters the liquid injection part, the fluid diffuses in the vertical direction in the wall of the tubular film 54. When the membrane 54 and the tube space therein are saturated, fluid passes through the membrane 54 and out of the catheter 50 through the outlet hole 56 of the tube 52. In addition, preferably, the fluid passes through the membrane substantially evenly across the surface of the membrane 54, resulting in a substantially uniform flow from substantially all of the outlet holes 56. In this way, fluid is delivered at a substantially uniform rate throughout the wound portion of the anatomical structure. Moreover, this advantage does not change whether the fluid is delivered at low pressure or high pressure.

FIG. 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 membrane 74 that concentrically encloses the tube 72. Catheter 70 functions similarly to catheter 50 described above in connection with FIGS. In use, the fluid drug passes through the outlet hole 76 and begins to penetrate into the porous membrane 74. The fluid diffuses longitudinally through the membrane walls and saturates the membrane. The fluid then leaves the membrane wall and enters the anatomy. Preferably, fluid is injected into the anatomy at a substantially uniform rate across the surface of the membrane 74. Similar to the previous embodiment, this advantage remains the same whether the fluid is delivered at low pressure or high pressure.

FIG. 8 shows a catheter 60 according to another embodiment of the present invention. The catheter 60 is suitable for delivering fluid at a relatively high rate to areas within the dissection system. In the catheter 60, the tube 62 has a plurality of outlet holes 64, and the size of the outlet holes 64 gradually increases. More specifically, the more distal the hole is than the proximal outlet hole, the larger the hole diameter. The length of the liquid injection part of the catheter 60 is determined by the position of the outlet hole 64 of the tube 62. There is no restriction on the length of the liquid injection part. The proximal end of catheter 60 is connected to a fluid source. A guidewire and / or guidewire lumen may be provided to assist in inserting the catheter 60 into the anatomy.

As described above, whether the fluid is delivered at low pressure or high pressure, the outlet hole near the distal end of the catheter tube has a flow resistance compared to the outlet hole near the proximal end of the tube. Get higher. Also, the fluid flowing from the more distal holes experiences a greater pressure drop. As a result, fluid velocity is usually greater in the more proximal holes, which results in uneven fluid delivery. In contrast, the catheter 60 advantageously allows fluid to be delivered approximately evenly from almost all outlet holes 64 even under relatively high flow rate conditions. The reason is that the diameter of the more distal hole is increased to offset the effects of increased flow resistance and pressure drop. In other words, the more distal hole is larger than the more proximal hole, so the more distal hole is larger than would occur if it were the same size as the more proximal hole. It is because it becomes a flow velocity. If the diameter of the hole 64 is gradually increased, the fluid delivery is preferably substantially uniform. Further, as described below in connection with the embodiment of FIG. 12, the size of the outlet holes 64 can be adjusted so that they combine to form a flow rate limiting orifice.

Compared to prior art catheters, the catheter 60 has the advantage of being simple and easy to manufacture. All that is required is to drill a plurality of outlet holes 64 in the tube 62. Furthermore, the catheter 60 can withstand greater bending than prior art catheters and the operability is not compromised. In contrast to prior art catheters, such as the one catheter, it is still possible to deliver fluid relatively evenly even if the tube 62 is bent to some extent. This is because the tube 62 has a single lumen with a relatively large cross section. Even if the tube 62 is bent to some extent, it is unlikely that the flow of fluid in the lumen will be disturbed, resulting in a change in pressure that causes non-uniform fluid injection.

The tube 62 of the catheter 60 can be made of a variety of materials, with appropriate consideration for purposes such as non-responsiveness, flexibility, light weight, strength, smoothness, and safety to the anatomical system. Suitable materials include nylon, polyimide, Teflon (registered trademark) and other materials known to those skilled in the art. Although there is no restriction | limiting in the length of a liquid injection part, It is preferable that it is about 0.5-20 inches in length, and if it is about 10 inches or more in length, it is more preferable. The diameter of the outlet hole 64 preferably ranges from about 0.0002 inches at the proximal end of the infusion section to about 0.01 inches at its distal end. The largest or most distal outlet hole 64 is preferably about 0.25 inches from the distal end of the tube 62. The axial spacing between adjacent holes 64 is preferably in the range of about 0.125 to 0.25 inches, more preferably about 3/16 inches. Similar to the embodiment in FIG. 5, the holes 64 may be provided so that adjacent holes are arranged at an angle of about 120 degrees. As a matter of course, if too many outlet holes 64 are provided, the strength of the tube 62 decreases, which is not preferable.

9, 10A, and 10B show 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 hit stop 86. The proximal end of the spring 84 is fitted to the distal end of the tube 82 so that each of the tube and spring defines a central lumen location. A domed stop 86 is preferably attached and sealed to the distal end of the spring 84. The portion of the spring 84 that is distal to the tube 82 is the liquid injection portion of the catheter 80. In the unstretched state, as shown in FIG. 10A, the spring 84 has adjacent coils that are in contact with each other, so that fluid within the spring that is below the dispensing threshold pressure is in the coil. It does not happen to move radially between them and exit the lumen. As shown in FIG. 10B, the spring 84 has the property of extending in the length direction, so that when the fluid pressure rises above the dispensing threshold pressure, “weeping”, that is, out of between the coils. Leaks radially into the fluid, causing fluid to flow out of the lumen. Alternatively, the spring may not be stretched, but may expand radially to sweep fluid from between the spring coils. Further, it is possible for the spring to extend both in the length direction and in the radial direction to cause weeping, which is well known to those skilled in the art. Preferably, the fluid between the coils of the spring flows substantially evenly throughout its length and circumference in the portion of the spring distal to the tube 82, i.e., the injection portion. The catheter 80 can be used regardless of whether the fluid is delivered at low pressure or high pressure.

In use, the catheter 80 is inserted into the anatomical region so that the spring 84 is at the site where the fluid medicament is to be delivered. This spring is initially unstretched as shown in FIG. 10A. Fluid is introduced from the proximal end of the tube 82 of the catheter 80 and fed into the spring 84 so that the fluid reaches the stop 86. As fluid continues to be introduced into the proximal end of tube 82, fluid accumulates in spring 84. When the spring 84 is full of fluid, the fluid pressure rises faster. The fluid loads the spring coil in the radially outward direction. As the pressure increases, the outward force increases. When the fluid pressure rises to the dispersion threshold pressure, the outward force causes the spring coil to slightly disengage, causing the spring to stretch lengthwise as shown in FIG. 10B. Alternatively, as described above, the coils may be separated in the radial direction. As such, fluid flows through the separated coils and is released from the catheter 80. In addition, this release has the advantage that it is uniform throughout the injection portion of the catheter 80. If fluid is continuously introduced into the tube 82, the spring 84 remains open and fluid is continuously released to the desired area within the anatomy. When the introduction of the fluid is temporarily stopped, the pressure of the fluid in the spring 84 falls below the dispersion threshold pressure. When this happens, the springs contract and the coils are connected again, and no fluid is released.

Various types of springs can be used to achieve the objects of the present invention. Suitable spring types are 316L or 402L, which are readily available. In a preferred configuration, the spring 84 is approximately 200 coils per inch along its length. According to this configuration, even if the spring is subjected to a considerable bending, fluid does not leak from the inside, and the adjacent coils are separated only when the spring is bent extremely greatly. Thus, within the anatomical region, the spring 84 can be bent to a large extent without leaking fluid and can be released only to one site of the anatomical structure. The length of the spring 84 can be freely changed, thereby defining the length of the injection portion of the catheter 80. This spring can be made from a variety of materials, with appropriate consideration for strength, flexibility, and safety purposes. A preferred material is stainless steel. In a preferred configuration, the inner and outer diameters of the spring are about 0.02 inches and 0.03 inches, respectively, and the spring wire thickness is about 0.005 inches in diameter. The proximal end of spring 84 is preferably inserted concentrically into the distal end of tube 82. This spring can also be adhered to the inner wall of the tube 82, for example UV adhesive, potting material or other adhesive material can be used. Alternatively, the spring can be soldered into the tube 82, or a proximal plug can be attached and secured in the tube 82.

The tube 82 and the stopper 86 can be made of various materials, but appropriate considerations may be made for purposes such as flexibility, light weight, strength, smoothness, and safety. Suitable materials include nylon, polyimide, Teflon (registered trademark) and other materials known to those skilled in the art.

FIG. 11 illustrates a catheter 90 according to another embodiment of the present invention. The catheter 90 is comprised of a tube 92 with a sealed distal end and a “weeping” tubular coil spring 94, which is concentrically enclosed within the tube 92, and the tube and A lumen is defined within the spring. A plurality of outlet holes 96 are provided in the length direction and side wall of the tube 92. The length of such an exit hole 96 in the tube 92 defines the injection portion of the catheter 90. This outlet hole 96 is preferably arranged over the entire wall of the liquid injection part. There is no restriction on the length of the liquid injection part. In a preferred configuration, the axial spacing between adjacent holes 96 is preferably in the range of about 0.125 to 0.25 inches, more preferably about 3/16 inches. Adjacent holes 96 are preferably disposed at an angle of about 120 degrees. The spring 94 is preferably enclosed in the injection part of the catheter, and is configured in the same manner as the spring 84 in the embodiment of FIGS. 9, 10A and 10B. The spring 94 is preferably longer than the liquid injection part, and it is preferable that all the outlet holes 96 be in a position facing the spring 94. According to this configuration, fluid does not flow out of the lumen except between the spring coils. It is preferable to attach a hit stop to the tube and seal its distal end. Alternatively, the tube 92 may be shaped so that the distal end is sealed. The catheter 90 can be used whether fluid is delivered at low pressure or high pressure.

In use, the catheter 90 is inserted into the anatomical region so that the injection portion is at the site where the fluid medicament is to be delivered. Fluid is introduced from the proximal end of the tube 92 of the catheter 90 and fed into the spring 94 to allow the fluid to reach the sealed distal end of the tube 92. As fluid continues to be introduced into the proximal end of tube 92, fluid accumulates inside spring 94. When the fluid is full in the spring 94, the pressure of the fluid increases and fluid weeping occurs through the spring coil as described above in connection with the embodiment of FIGS. 9, 10A and 10B. Further, the fluid passes through the spring coil and flows out almost uniformly over the entire length and outer circumferential direction of the spring 94. Next, the fluid exits from the tube 92 through the outlet hole 96 of the liquid injection part. The size of the exit holes should preferably be equal so that the fluid flows out of the exit holes at a substantially uniform velocity and is usually evenly distributed throughout the desired area of the anatomy. can get. If fluid is continuously introduced into the catheter 90, the spring 94 remains open and fluid is continuously released from the catheter. When the introduction of the fluid is temporarily stopped, the pressure of the fluid in the spring 94 falls below the dispersion threshold pressure. When this happens, the springs contract and the coils are connected again, and no fluid is released.

In a preferred configuration, the spring 94 and tube 92 are in contact throughout the length of the spring so that fluid weeping from the spring is forced out of the hole 96 in the injection section. One end of the spring 94 is preferably fixed to the inner wall of the tube 92, and the other end of the spring is preferably displaced as the spring expands and contracts. The spring can be adhered to the tube 92 using, for example, a UV adhesive, potting material, or other adhesive material. As another method, one end of the spring may be soldered to the inner wall of the tube 92. The tube 92 may be made using any suitable material. It is preferable to keep the inner wall of the tube 92 smooth so that the spring can expand and contract more freely.

FIG. 12 shows a catheter 100 according to another embodiment of the present invention. The catheter 100 is constituted by a tube 102 with a distal end having a plurality of outlet holes 104 on the side wall of the tube 102. The portion of the tube 102 where the outlet hole 104 exists defines the injection portion of the catheter 100. The exit hole is sized so that the total opening area of the exit hole 104 is smaller than any cross-sectional or orifice area that limits the flow rate present elsewhere in the catheter. . Therefore, these outlet holes 104 serve as a flow rate limiting device for the catheter 100. In use, this catheter has the advantage of discharging fluid from substantially all outlet holes 104. Fluid introduced from the proximal end of the tube 102 passes through the tube and reaches its sealed distal end. At this point, fluid accumulates inside the infusion portion of the catheter. Because the hole 104 is small, fluid cannot substantially flow out of the hole. In it, the injection part of the catheter is filled with fluid. As fluid is continuously introduced from the proximal end of tube 102, the pressure of the fluid begins to rise. At some point, sufficient pressure is reached for fluid to flow out of the outlet hole 104. In addition, fluid exits from substantially all outlet holes 104.

Preferred in this configuration is that the outlet holes 104 are all the same size, thereby allowing fluid to flow out of substantially all of the holes at a substantially uniform rate. The holes 104 are preferably opened using a laser, whereby a very fine hole diameter can be obtained. The diameter of the outlet hole 104 is preferably about 0.0002 inches, or about 5 micrometers . The tube 102 can be provided with a number of outlet holes 104. In order to deliver fluid more evenly throughout the anatomical region, it is desirable to provide a hole over the entire outer periphery of the injection portion of the catheter 100. The axial spacing between adjacent holes 104 is preferably in the range of about 0.125 to 0.25 inch, but more preferably about 3/16 inch. The catheter 100 can be used regardless of whether the fluid is delivered at low pressure or high pressure. The tube 102 can be made from a variety of materials known to those skilled in the art, as described above.

FIG. 13 shows a catheter 200 according to another embodiment of the present invention. The catheter 200 includes a tube 202 with a sealed distal end having a plurality of outlet holes 204 along the injection portion of the catheter, as in the embodiment described above. The hole 204 is preferably provided over the entire outer periphery of the tube 202. An extending member 206 made of a porous material is enclosed in the tube 202. The member 206 is generally cylindrical and is preferably solid. This member 206 is preferably disposed in the tube 204 so that a ring-shaped space 208 is formed between the outer surface of the member 206 and the inner surface of the tube 202. The member 206 is preferably present starting at the distal end 210 of the tube 202 and going back to the proximal point of the catheter infusion. As another method, the member 206 may exist only in the liquid injection part. The member 206 is generally preferably concentric with the tube 202, but the advantages of the present invention can be enjoyed even when designed non-concentric. Member 206 is preferably made from a flexible material to facilitate placement of catheter 200 within the patient's body.

In use, fluid medication flowing through the tube 202 saturates the porous member 206 and flows into the ring-shaped region 208. When member 206 reaches saturation, fluid in member 206 flows into region 208 and exits catheter 200 through outlet hole 204. Preferably, the fluid pressure is uniform everywhere in the ring-shaped region 208 so that the fluid flows substantially uniformly from all the holes 204. This ring-shaped region 208 has several advantages. One advantage is that it works to optimally equalize the flow through the outlet holes 204. The member 206 can also be made from a porous material that tends to expand when saturated with liquid. In such a case, the member 206 preferably expands into the ring-shaped region 208, but preferably does not compress the tube 202. Thereby, the inner surface of the tube 202 becomes a high-pressure region, and the possibility of causing the drug to flow out unevenly inside the wound site is suppressed. Alternatively, the member 206 may expand to contact the tube 202 and still achieve the objectives of the present invention.

Member 206 is made of a porous material, the average pore size in the range of 0.1 to 50 micrometers, more preferably about 0.45 micrometers. The radial width W of the ring-shaped region 208 is preferably in the range of 0 to about 0.005 micrometers , more preferably about 0.003 micrometers . The member 206 can be made of various materials, but appropriate considerations may be made for purposes such as porosity, flexibility, strength, and durability. A preferred material is Mentek.

Member 206 can be secured within tube 202 through the use of an adhesive. In one embodiment, as shown in FIG. 13, adhesive is applied to the distal end of member 206 to form a joint 212 with the inner surface of the distal end of tube 202. Preferably, the adhesive is applied at or near the proximal end of the injection portion of the catheter 200. Further, the adhesive can be applied to any longitudinal position on the circumference of the member 206, thereby forming a ring-shaped joint with the inner surface of the tube 202. For example, in the embodiment of FIG. 13, the ring-shaped coupling portion 214 is provided in the immediate vicinity of the liquid injection portion of the catheter 200. Other configurations are possible. For example, FIG. 14 shows an embodiment in which an adhesive is applied to the distal end of member 206 to form a coupling portion 216 and a ring-shaped coupling portion 218 at approximately the center of the injection portion. FIG. 15 illustrates an embodiment in which adhesive is applied only to the distal end of member 206 to form a bond 220. FIG. 16 shows an embodiment in which an adhesive is applied only to the center of the liquid injection part to form a ring-shaped coupling part 222. Those skilled in the art will appreciate from the teachings herein that the adhesive can be applied in any of a variety of configurations. Accordingly, adhesive at the distal end of the catheter (ie, 212, 216, and 220 in FIGS. 13, 14, and 15, respectively) is not required.

In this best embodiment of the invention, preferably two connections are included, one in the most proximal hole of the catheter and one in the most distal hole of the catheter. Each joint is formed by an adhesive described below.

The ring-shaped joint 214 can be formed by injecting liquid form adhesive from one of the outlet holes 204 when the member 206 is in the tube 202. The adhesive having a generally high viscosity tends to flow around the outer periphery of the member 206 instead of flowing into the main body of the member 206. Accordingly, as will be appreciated by those skilled in the art, the adhesive forms a ring-like joint with the tube 202. The adhesive also closes the outlet hole 204 to be injected. Any of a variety of adhesives are acceptable, but the preferred adhesive is Loctite.

As described above, the member 206 is preferably concentric with the tube 202. FIG. 17 shows a cross section of the catheter 200, where the member 206 is concentrically enclosed within the tube 202. Alternatively, member 206 may be positioned adjacent to tube 202 as shown in FIG. The configuration of FIG. 18 may be easier to manufacture than the configuration of FIG. 17 because the member 206 need not be centered within the tube 202.

Those skilled in the art will appreciate from the teachings herein that the member 206 may have any desired length and may extend along any desired length of the infusion portion of the catheter 200. . For example, member 206 need not extend to the distal end of tube 202. Further, the proximal end of the member 206 may be distal or proximal to the proximal end of the infusion part.

When using any of the catheters of the above embodiments, the catheter initially has air inside the catheter tube. For example, the catheter 200 shown in FIG. 13 can have air inside the porous material of the member 206. By introducing the liquid medicine into the catheter, air is forced out of the outlet hole. However, this will take several hours. If the catheter is inserted into the patient while air is inside and the liquid medication is introduced into the catheter, the patient's wound site will receive little or no liquid medication until air is removed from the catheter tube. Therefore, it is preferred to ensure that air exits the catheter prior to use by pouring the liquid drug into the catheter and then inserting the catheter into the patient. Still referring to FIG. 19, an air filter 224 known in the art can be inserted into the catheter tube proximal to the infusion portion 226 of the catheter 200. The filter 224 prevents unwanted air from entering the liquid injection part 226 of the catheter 200.

20 and 21 show a catheter tube having an elongated exit hole or slot. These catheter tubes can be used in place of the catheter tubes shown and described above. FIG. 20 shows a tube 230 having an exit hole or slot 232 extending in the longitudinal direction of the tube 230. The slot 232 is preferably provided on the entire circumference of the tube 230 along the injection part of the catheter. Compared to smaller exit holes, the elongated slot 232 tends to increase the flow rate of fluid exiting the catheter by lowering the flow impedance created in the fluid. As will be readily appreciated by those skilled in the art, the slot 232 can preferably be oriented in the longitudinal direction of the catheter body so as not to degrade the structural integrity of the catheter 200.

FIG. 21 shows a tube 234 having an exit hole or slot 236, the length of which exit hole or slot 236 increases along the length of the tube in the distal direction. In the illustrated embodiment, the slot closer to the proximal end of the injection portion of tube 234 is shorter in length than the slot closer to the distal end of the injection portion. As in the embodiment of FIG. 8, the catheter tube 234 can deliver fluid from almost all outlet slots 236 substantially evenly under conditions of relatively high flow rates. The reason is that by increasing the diameter of the more distant slot, the effects of increased flow resistance and pressure drop are offset. In other words, the more distal slot is larger than the more proximal slot, so the more distal slot is the same size as the more proximal slot. This is because the flow rate is large. Preferably, the length of the slot 236 becomes progressively longer, so that fluid delivery is preferably substantially uniform. Further, as in the embodiment of FIG. 20, the elongated slot has a generally higher outlet flow velocity.

As will be appreciated by those skilled in the art for all of the above embodiments of the catheter, an independent guidewire lumen may be provided within or adjacent to the disclosed lumen (s).

The catheter of the present invention can be used for various medical applications. Referring to FIG. 22, in one exemplary application, a catheter 20 (reference number 20 is used to identify the catheter, but any of the catheters described above) may be placed inside a vein or artery 242. It is inserted into the clot 240. Preferably, the infusion part of the catheter is in the clot 240. The liquid drug is preferably introduced at the proximal end of the catheter tube. It is advantageous that the liquid drug exits the catheter 20 and dissolves the clot 240, preferably at a substantially uniform rate.

23 and 24 show another preferred embodiment of the catheter 250. FIG. As shown in FIG. 23, the catheter 250 preferably comprises a tube, ie, an elongated tubular catheter body 254, and an elongated outer tubular porous membrane, ie, a tubular sheath 252. The elongated tubular catheter body 254 has a central lumen 268, which is preferably in fluid communication with a fluid source similar to the fluid source 34 of FIG. As shown, the central lumen 268 has a sole lumen of stretching the tubular catheter body (or stretched tube) 254.

Preferably, the tubular sheath 252 covers a length 255 of the elongated tubular catheter body 254 and is disposed proximally a distance 253 at the distal end 262 of the elongated tubular catheter body 254. In one embodiment, length 255 is about 2.40 inches and distance 253 is about 0.10 inches. In another embodiment, the length 255 is about 2.50 inches. In yet another embodiment, the length 255 is about 5.00 inches. In other embodiments, the length 255 and the distance 253 can be varied so that the catheter 250 generally conforms to the particular anatomy intended.

As shown in FIG. 23A, the tubular sheath 252 is filled with a portion of the stretched tubular catheter body 254, a ring-shaped clearance space between the outer surface and the inner surface of the tubular sheath 252 of the stretched tubular catheter body 254 270 is formed. In one preferred embodiment, the elongated tubular catheter body 254 is substantially concentric with the tubular sheath 252. In one preferred configuration, the space 270 has a radial dimension of less than about 0.007 inches. In another configuration, the space 270 may have a radial dimension of about 0.002 to about 0.007 inches. However, depending on the configuration, the space 270 may be minimal or, unlike the claimed invention, the inner surface of the tubular sheath 252 may be in contact with the outer surface of the elongated tubular catheter body 254. Also good.

A plurality of fluid outlet holes 266 are provided in a portion of the elongated tubular catheter body 254 enclosed within the tubular sheath 252. Preferably, an opening ( exit hole ) 266 is disposed over the entire circumference of the enclosed portion of the elongated tubular catheter body 254. The portion of the stretched tubular catheter body 254 where the opening 266 exists defines a liquid injection portion of the catheter 250. Desirably, the tubular sheath 252 is provided only along the length 255 of the liquid injection part. However, in an alternative arrangement, the tubular sheath can be longer than the injection portion. In other embodiments, 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 250 into the anatomy.

The stretched tubular catheter body 254 can be made from any of a wide variety of materials such as nylon, polyimide, ptfe (PTFE), and other materials known to those skilled in the art, and is non-responsive to the dissection system. Appropriate considerations may be made for flexibility, light weight, strength, smoothness, and safety purposes. A preferred configuration is that the elongated tubular catheter body 254 is a 20 gauge catheter tube having an inner diameter and an outer diameter of about 0.019 inches and about 0.031 inches, respectively.

The outlet hole or opening 266 of the elongated tubular catheter body 254 is preferably about 0.015 inches in diameter and is provided at an axial position at equal intervals along the infusion portion of the elongated tubular catheter body 254. . Opening 266 is arranged such that all pores with respect to the longitudinal axis of the stretched tubular catheter body 254 is offset at an angle from the angular position of about 120 degrees in front of the hole. The axial spacing between adjacent openings 266 is preferably in the range of about 0.125 to 0.25 inches, more preferably about 3/16 inches. Of course, the opening 266 may be provided in any of a variety of alternative configurations. Furthermore, there is no limitation on the length of the liquid injection part of the stretched tubular catheter body 254. However, as described above, it is preferable that the liquid injection part remains sealed inside the tubular sheath 252. The embodiment shown in FIGS. 23 and 24 delivers fluid widely and evenly throughout the normally linear portion of the wound portion.

The tubular sheath 252 is preferably made of a highly porous material. In other embodiments, the tubular sheath 252 may be made from a sponge-like material, a foam-like material, or hollow fibers. Tubular sheath 252 can have an average pore size or pore size of less than about 0.23 micrometers to filter out bacteria. The pore size is preferably in the range of about 0.1 micrometers to about 0.5 micrometers, more preferably in the range of about 0.2 to 0.45 micrometers. Tubular sheath 252 can be formed from any of a variety of suitable materials and is non-responsive to the anatomical system, remains flexible, fits within the size limits of tubular sheath 252, and Appropriate considerations may be made for the purpose of having a porosity (pore size) that allows fluid to be distributed substantially uniformly from all of the pores of the tubular sheath 252. Some suitable materials for the tubular sheath 252 are polyethylene, polysulfone, polyethersulfone, polypropylene, polyvinylidene difluoride, polycarbonate, nylon, high density polyethylene, or polytetrafluoroethylene. Preferably, the tubular sheath 252 is a 19 gauge tube having an inner diameter and an outer diameter of about 0.038 inches and about 0.042 inches to 0.045 inches, respectively.

As shown in FIG. 24, the tubular sheath 252 is preferably secured to the elongated tubular catheter body 254 by distal and proximal tubular portions, ie, collars 264, 265. As shown in the figure, the collars 264 and 265 include inclined portions in which the diameter changes between the outer surface of the elongated tubular catheter body 254 and the tubular sheath 252 and the diameter gradually changes. Preferably, the collars 264, 265 include a shrink tube that is secured to the elongated tubular catheter body 254 and the end of the tubular sheath 252. The collars 264, 265 may also be useful in securing the tubular sheath 252 to the elongated tubular catheter body 254 using an adhesive such as Loctice, epoxy, or other means known to those skilled in the art. Alternatively, the tubular sheath 252 may be secured to the elongated tubular catheter body 254 using other suitable methods. Although not the claimed invention, for example, the tubular sheath 252 may be fixed to the stretched tubular catheter body 254 by thermal bonding or chemical bonding without using the collars 264 and 265.

In use, the catheter 250 delivers fluid to a region of the dissection system generally adjacent to the tubular sheath 252 of the catheter 250. When the fluid flows through the central lumen 268 and into the injection portion, it first flows into the space 270 through the opening 266. The fluid in the space 270 then permeates into the porous tubular sheath 252. When the wall of the tubular sheath 252 is saturated, fluid exits the catheter 250 through the tubular sheath 252. Moreover, the fluid advantageously passes through the entire surface area of the tubular sheath 252 substantially uniformly, as a result, substantially uniform fluid along the length 255 of the tubular sheath 252 flows out. Thus, fluid is delivered at approximately the same rate throughout the wound area of the anatomy. Furthermore, this advantage is obtained for both low pressure fluid delivery and high pressure fluid delivery.

FIGS. 25-27 illustrate another embodiment of an infusion catheter indicated generally by the reference numeral 272. Preferably, the catheter 272 comprises a non-porous tubular portion or tube 282 that is connected to a distal bioabsorbable porous tubular portion 280. The porous tubular portion 280 has an inner lumen 281 and the non-porous tube 282 has an inner lumen 283. The non-porous tube 282 defines a non-injection portion 274 of the catheter 272 and preferably extends from a fluid source 283 to a junction, or joint 278 as shown in FIG. Similarly, the porous tubular portion 280 defines an infusion portion 276 of the catheter 272 and preferably extends from the junction 278 to the distal end 284. Preferably, the distal end 284 is defined by a tip 284 a that defines the distal end of the lumen 281 within the porous tubular portion 280.

As shown in FIGS. 26 and 26A, preferably, the junction 278 can be inserted at the distal end 285 of the tube 282 into the proximal end 287 of the lumen 281 inside the tubular portion 280. Preferably, a suitable type of medical adhesive is applied between the overlapping surfaces of the tube 282 and the tubular portion 280 to hold the tubes 280, 282 together. The adhesive is intended to be a biocompatible variety such as a medical “glue” used to close the wound. As shown in FIG. 26A, the proximal end 287 of the tubular portion 280 overlaps the distal end 285 by a distance 286. The distance 286 is preferably at least about 0.02 inches. More preferably, the distance 286 is at least about 0.03 inches, but in other embodiments, the distance 286 can be varied to achieve the desired level of bond strength. The above overlap distance is preferred because a fixed joint can be provided between the tube 282 and the tubular portion 280. Preferably, however, the overlap distance does not exceed about 0.25 inches so that the overlapping portion does not compromise the overall flexibility of the catheter 272.

The tube 282 can be made from any of a variety of suitable biocompatible materials such as nylon, polyimide, ptfe (PTFE), and other materials known to those skilled in the art, Appropriate considerations may be made for the purposes of flexibility, light weight, strength, smoothness, and safety. In one preferred embodiment, tube 282 preferably comprises a 20 gauge catheter tube and preferably does not exceed about 0.035 inches in outer diameter.

Preferably, the tubular portion 280 has an outer diameter of about 0.042 inches, and the inner diameter is such that the distal end 285 of the tube 282 fits within the proximal end 287 of the lumen 281 as shown in FIG. 26A. It is the size that fits. In one preferred embodiment, the tubular portion 280 is comprised of a highly porous material having an average pore size or pore diameter of less than about 0.23 micrometers to filter out bacteria. More preferably, the pore diameter is in the range of about 0.1 micrometers to about 0.5 micrometers , more preferably in the range of about 0.2 to 0.45 micrometers .

As used herein, a porous material, or porous membrane, desirably refers to a material or member configured to pass a substance with at least a slight resistance in the region through which the substance passes. The porous material or membrane is preferably made of a material with inherent properties or obtains properties that slow or pass the material through the material through a tortuous or non-linear path, or such It is operated to enhance various characteristics. Alternatively, a porous material or member can be used to reduce the diffusion rate of a substance by having a pore size close enough to a single molecular size or unit group of molecules to form a large number of molecules or molecular groups. Can be prevented from passing through any one pore at the same time. Typically, a porous material or membrane is not desired as a result of having a microchannel in the material itself, rather than as a result of the formation of a separate channel in the material or membrane by an operational process such as laser drilling. Achieve adjustments. The difference between a porous material or membrane and a member having a plurality of holes formed manually will be readily understood by 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 outlet holes, as described herein. It should be understood that these outlet holes can be used in the tubular portion 280 according to any of the embodiments described above. Further, the tubular portion 280 can have any desired length. In one embodiment, tubular portion 280 is about 5 inches in length, and tubular portion 280 and non-porous tube 282 are about 20 inches when combined in length. Such a structure of the tubular portion 280 ensures that fluid is evenly delivered along the length of the tubular portion 280, and thus the drug is delivered to a length of wound areas such as an incision. Are particularly useful for delivering fluids such as

The material comprising the tubular portion 280 is desirably bioabsorbable in addition to being porous, as outlined above. In one embodiment, the material comprising the tubular portion 280 can be dissolved in the patient's body for a period ranging from about 5 days to about 7 days after insertion. During this period, the patient's body may process the bioabsorbable material such that the strength of the joint 278 is reduced. This weakening of the joint 278 removes the non-porous tube 282 from the tubular portion 280 and subsequently does not interfere with the placement of the remaining portion (non-absorbable portion) of the porous tubular portion 280 within the wound. It becomes easier to remove the tube 282 from the wound site.

The catheter 272 is particularly suitable for use with pain management or intravenous systems (ie, infusion pumps). In use, a physician or other practitioner places the catheter 272 within a wound site on the patient's body. The tubular portion 280 is preferably inserted into the wound site to such an extent that the entire tubular portion 280 and a portion of the distal end 285 of the tube 282 are enclosed within the patient's body. Preferably, about 0.1 to 0.4 inches of the distal end of the non-bioabsorbable tube 282 is encapsulated within the patient's body. More preferably, about 0.1 to 0.5 inches of the distal end of the non-bioabsorbable tube 282 is encapsulated within the patient's body. Tubular portion 280 can be sutured to the surrounding tissue within the wound to “clamp” catheter 272 in place. This facilitates the precise placement of the catheter 272 within the wound site. Preferably, any suture used to hold the catheter 272 in place is similarly constructed from a bioabsorbable material. As a result, both the tubular portion 280 and the sutured portion are absorbed into the body.

Once the catheter 272 is properly attached to the patient, the proximal end of the tube 282 can be connected to an intravenous system or other fluid supply device. The catheter 272 may advantageously deliver fluid or other medication to the patient in 5-7 days or more depending on the nature of the particular wound site of the subject. During this period, the tubular portion 280 is absorbed into the patient's body. When the tubular portion 280 is fully absorbed, the joint 278 weakens and the non-porous tube 282 is withdrawn from the wound site. Since the joint 278 is weakened, the distal end 285 of the tube 282 is disengaged from the proximal end 287 of the tubular portion 280 by withdrawing the tube 282. Thus, when the tube 282 is removed, the tubular portion 280 remains at the wound site and is absorbed into the patient's body. It should be appreciated that leaving the tubular portion 280 at the wound site advantageously reduces the amount of trauma to the surrounding tissue that would otherwise result from the use and removal of conventional catheters or pain management systems. .

As will be readily appreciated by those skilled in the art, any of the catheter embodiments described herein can be used for a variety of applications, for example, peripheral nerve blocks, intraspinal fluids , Epithelial injection, intravascular injection, intraarterial injection, intraarticular injection, and pain relief at the wound site, but are not limited thereto.

In addition, any of the catheters disclosed herein can be integrated with the fluid line exiting the infusion pump as opposed to being an independent catheter intended to be connected or secured to the infusion pump. It is.

Although the invention has been disclosed in accordance with certain preferred embodiments and examples, the invention is not limited to the specifically disclosed embodiments, other alternative embodiments and / or uses of the invention, and obvious modifications and It is well understood by those skilled in the art to include equivalents thereof. Accordingly, as we intend, the scope of the invention disclosed herein should not be limited to the specific disclosed embodiments described herein, but the claims that follow are interpreted fairly. Should only be determined by doing.

Claims (12)

An elongated tubular catheter body defining a unique lumen on the inner surface, the distal end of the lumen being closed and having a plurality of openings in the side wall of the catheter body defining a fluid injection portion of the catheter An elongated tubular catheter body;
A porous sheath made of a porous material through which a fluid can flow through a microchannel, and disposed so as to cover the liquid injection part and having a tubular sheath extending at least the length of the liquid injection part,
The catheter body and the tubular sheath are configured so that fluid in the lumen exits the lumen through any one of the plurality of openings, and is between the catheter body and the tubular sheath. Flowing into the radial gap space and then leaving the catheter only through the tubular sheath;
The tubular sheath has a distal first collar and a proximal second fixed to an outer surface of the catheter body so as to define the gap space between the catheter body and the tubular sheath. A catheter for delivering fluid to the anatomical region attached to the collar of the tube.   The gap space has a radial dimension of 0.002 inches (0.0508 mm) or more and 0.007 inches (0.1778 mm) or less, and the pore size of the porous material is less than 0.5 μm. The catheter according to claim 1.   The catheter of claim 1, wherein a distal end of the tubular sheath is coupled to the catheter body at a distance from a distal end of the catheter.   The catheter according to claim 3, wherein the distance is 0.1 inch (2.54 mm).   The catheter according to any one of claims 1 to 4, wherein the tubular sheath has an outer diameter of 0.045 inches (1.143 mm) or less.   The catheter according to any one of claims 1 to 4, wherein the tubular sheath has a length of 2 to 3 inches (50.8 to 76.2 mm).   The catheter of claim 6, wherein the length of the tubular sheath is 2.4 inches (60.96 mm).   The catheter according to any one of claims 1 to 7, wherein each of the first end and the second end of the tubular sheath is coupled to the outer surface of the catheter body by a shrink tube member. The catheter according to any one of claims 1 to 8 , wherein the porous material includes a hollow fiber material. Having a side wall, the outer surface of the side wall defining a uniform first diameter, comprising a single lumen defined by the inner surface of the side wall and closed at a distal end, at a distal portion from within the lumen An elongated tubular catheter body in which a fluid injection portion of the catheter that allows fluid to pass outside the catheter body is defined;
A tubular sheath composed of a porous material that allows fluid to flow through a microchannel,
The tubular sheath has a side wall, a distal first end, and a proximal second end, and the liquid injection portion is located between the first end and the second end. And the inner surface of the side wall of the tubular sheath defines a second diameter, the first diameter and the second diameter are defined by the tubular sheath and the catheter. A radial clearance space is formed between the tubular sheath and the first end and the second end of the tubular sheath through which the fluid in the lumen passes through the tubular sheath. Exiting the catheter body by a first collar and a second collar, respectively, to substantially seal the gap space, and after the fluid has passed through the catheter body, Before leaving the catheter, Without passing through the member, it passes through the clearance space and the tubular sheath, a catheter for delivering fluid to anatomical regions. The catheter according to claim 10 , wherein the gap space has a radial dimension of 0.002 inches (0.0508 mm) or more and 0.007 inches (0.1778 mm) or less. The catheter of claim 10 , wherein the collar includes a portion of a shrink tube.

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