JP5502784B2 - Intravascular catheter - Google Patents

Description

  The present invention relates to an intravascular catheter, and more particularly, blood purification, administration of an infusion / medical solution, blood sampling, measurement of pulse pressure / blood flow, electrophysiological examination, or temporary, short-term extracorporeal method. The present invention relates to an intravascular catheter used for various medical diagnosis and treatment purposes such as cardiac pacing.

  Conventionally, a catheter for indwelling a central vein has been used for patients who require administration of an infusion / medical solution (see Non-Patent Document 1). Also, blood purification is required for diseases such as renal failure, diabetes, drug addiction, systemic inflammatory response syndrome (SIRS), acute respiratory stimulation syndrome (ARDS), multiple organ failure (MOF), hepatitis, pancreatitis, etc. For patients, a blood access catheter is used in which a catheter is placed in a blood vessel to remove blood (see Non-Patent Document 2). Furthermore, for patients who need to measure central venous pressure and blood flow, a catheter for pulse pressure measurement that is placed in a blood vessel and measures venous pressure, and thermodilution that measures blood flow such as cardiac output A catheter is used (see Non-Patent Document 3). In addition, short-term pacing catheters used as short-term extracorporeal electrodes for cardiac pacemakers have been developed and are widely used in today's clinical settings.

  The conventional catheters described above usually have a structure in which the lumen of one catheter is divided into a single layer or a plurality of layers depending on the purpose, and a drug solution, blood, etc. flow through each lumen, pulse pressure and An electrical signal flows as a sensor for measuring blood flow.

  Further, in the blood access catheter used in hemodialysis and the like, a coaxial type catheter in which a removable inner catheter is inserted into the lumen of the outer catheter as shown in FIG. 5 has been developed, and blood removal is performed with the outer catheter. In addition, it is widely used in clinical sites together with obturators (internal plugs) that are used by feeding blood with an inner catheter and inserted when not in use (see Non-Patent Document 4).

Edited by Japan Society for Parenteral and Enteral Nutrition: Guidelines for Parenteral and Enteral Nutrition for Comedies, 43, Nanedo (2000) Yuhei Hirasawa: Dialysis Therapy Manual (5th revised edition), 170, Japan Medical Center (1999) Sanae Tsuruta, Kazuko Harada: Postoperative treatment manual, 66, Terinsha (1991) Shigeru Miyagata, Ryuji Hongo, Akira Matsuzaki, Ryuzo Kato, Hiroshi Kobayashi, Tadashi Harada, Masayoshi Tsuchida: Invention of double lumen type UK catheter, Journal of Japan Dialysis Society 5 (4), 220 (1990)

  A single-layer catheter as described above is made for the purpose of single use and requires placement or replacement of the catheter depending on the purpose. As a result, frequent puncture to the patient is essential. It was. Even when a single catheter with multiple layers of lumens is used for multiple purposes, the lumen is blocked by blood or chemicals, or when blood is drawn from the side holes of the catheter, it sticks to the blood vessel wall. For example, if a trouble that cannot be performed such as being unable to be sucked occurs, for example, even if a lumen other than the target lumen can be used, the entire catheter must be replaced. In addition to enormous burdens, both mentally and mentally, it also caused a significant loss in the medical economy.

  In addition, frequent catheter replacement due to such troubles increases the risk of infection associated with the invasion of pathogenic bacteria and the possibility of blockage of the blood vessel itself, systemic inflammatory reaction syndrome, acute respiratory stimulation syndrome, multiple organ failure, It has been a particularly serious problem for patients with high immune risk such as leukemia, elderly patients with weak blood vessels, infants with small blood vessels, and undeveloped infants.

  Further, the above-described coaxial type catheter can be replaced even if the inner catheter cannot be used due to occlusion, as in the case of the catheter described above. However, when the outer catheter becomes occluded or has poor blood removal, The catheter itself had to be removed, i.e. the entire catheter had to be replaced.

  In the present invention, it is possible to selectively attach a shape and number of inner catheters suitable for various purposes to a single outer catheter placed in a blood vessel. It is an object of the present invention to provide a catheter for indwelling blood vessels in which a new inner catheter having a different number can be exchanged simply and in a necessary number, and can be indwelled continuously over a long period of time. In particular, the outer catheter can be used continuously until the end of its purpose, as long as there is no problem with itself, so it can be used for various purposes including central parenteral nutrition that is used over a long period of one month or one year. Useful for.

  As a result of intensive studies to achieve the above object, the present inventors have been able to detachably attach to the lumen of the outer catheter placed in the blood vessel and to place a plurality of inner catheters according to various purposes in combination. The present inventors have found that the above problems can be solved and have reached the present invention.

  That is, the present invention relates to an intravascular placement catheter comprising an outer catheter and an inner catheter that is inserted into the lumen of the outer catheter and is detachably fitted to the outer catheter. The gist of the present invention is a lumen catheter or an intravascular catheter characterized by comprising one or more multilayer lumen catheters, and preferably two or more single-layer lumen catheters or multilayers constituting an inner catheter The intravascular catheter as described above, wherein the lumen catheters are detachable separately.

  Further, a preferred embodiment of the present invention is the above-mentioned intravascular catheter having a therapeutic or diagnostic sensor function, in which a therapeutic or diagnostic sensor is mounted through the lumen of the inner catheter. The catheter for indwelling an intravascular vessel having a cardiac pacing function, to which an electrode for a cardiac pacemaker is attached through a lumen.

  According to the present invention, a single outer catheter placed in a blood vessel can be selectively mounted with a shape and number of inner catheters suitable for various purposes, and a new inner catheter can be used when trouble such as occlusion occurs. Can be easily replaced, and when not required, an obturator (inner plug) can be inserted to enclose the entire lumen. In addition, since a device having a means for removing or collecting a thrombus formed on the outer circumference or lumen of the catheter during placement can be inserted, the placement of the catheter over a long period of time is possible.

  In addition, periodic replacement of the inner catheter can be easily performed to prevent infection. Moreover, what provided the cuff in the outer catheter can be closely_contact | adhered with a subcutaneous tissue.

It is the schematic which shows an example which connects the inner catheter which consists of the outer catheter and two single layer lumen catheters in the catheter of this invention. (A) Schematic showing an example of the overall shape (B) Partial sectional view of the catheter A-A ′ It is the schematic which shows an example of sectional drawing which shows the connector part inner surface of the outer catheter in this invention. (A) Lateral view of connector part (B) Catheter B-B 'partial sectional view It is the schematic which shows an example which mounts | wears with the two inner catheters in the outer catheter in this invention. (A) Schematic showing an example of the overall shape (B) Partial sectional view of the catheter A-A ′ It is the schematic which shows an example of the connector part shape for mounting | wearing with the three inner catheters in the outer catheter in this invention. (A) Side view (B) Top view It is the schematic of the shape of the coaxial blood access catheter which is a prior art. (A) Schematic diagram showing overall shape (B) Cross section of catheter A-A ' It is the schematic which shows an example of the adapter part structure of the inner catheter in this invention. (A) Side view (B) Perspective view of side It is the schematic which shows an example of the attachment fitted to the connector part of an outer catheter in order to mount | wear with two inner catheters in this invention. (A) Viewed from the side of an attachment for mounting two inner catheters (B) Viewed from the top of an attachment for mounting two inner catheters It is the schematic which shows an example of the attachment fitted to the connector part of an outer catheter in order to mount | wear with the three inner catheters in this invention. (A) Viewed from the side of the attachment for mounting the three inner catheters (B) Viewed from the top of the attachment for mounting the three inner catheters It is the schematic which shows an example of the attachment fitted to the connector part of an outer catheter in order to mount | wear with the double-lumen-shaped inner catheter in this invention. (A) Schematic showing the overall shape (B) Schematic showing the structure of the attachment It is the schematic which shows an example of the structure of the screw type attachment 53 which can finely adjust the length of the inner catheter with which the outer catheter in this invention was mounted | worn. (A) Schematic showing the overall shape of the outer catheter and inner catheter mounted (B) Schematic showing the structure of the attachment It is the schematic which shows an example of the structure of the bellows type attachment 54 which can finely adjust the length of the inner catheter with which the outer catheter in this invention was mounted | worn. (A) Schematic showing the overall shape of the outer catheter and inner catheter mounted (B) Schematic showing the structure of the attachment It is the schematic which shows an example of the structure of the combination type attachment 55 which can finely adjust the length of the inner catheter with which the outer catheter in this invention was mounted | worn. (A) Schematic showing the overall shape of the outer catheter and inner catheter mounted (B) Schematic showing the structure of the attachment It is the schematic which shows an example of the structure of the clamping fixed attachment 56 which can finely adjust the length of the inner catheter with which the outer catheter in this invention was mounted | worn. (A) Schematic diagram showing the overall shape of the outer catheter and inner catheter mounted (B) Schematic diagram showing the structure of the attachment (C) Schematic diagram in which the lock ring 24 of the inner catheter is fitted to the attachment (D) Attachment Schematic showing the structure of the lumen of It is the schematic which shows an example of the obturator (inner plug) for mounting | wearing an outer catheter when not using the inner catheter in this invention, and preventing thrombus formation of a lumen | bore. It is the schematic which shows an example of the shape of the device for physically removing the thrombus formed in the lumen | bore of the outer catheter in this invention. It is the schematic of the catheter which attached the cuff to the outer catheter in order to make it closely_contact | adhere to the subcutaneous tissue in this invention. It is the schematic which shows an example of the outer catheter which can remove and replace the side injection part in this invention.

Hereinafter, the present invention will be described in detail.

  The greatest feature of the present invention is that an inner catheter composed of two or more single-layer lumen catheters or one or two or more multilayer lumen catheters is detachably fitted to the outer catheter.

  As the outer catheter used in the present invention, those known as outer catheters in conventional coaxial type catheters can be similarly used.

In the present invention, various methods can be employed as means for fitting the inner catheter and the outer catheter in a detachable manner as follows.
a) A method in which an adapter portion through which a plurality of inner catheters are passed and fixed is fitted into a connector portion of an outer catheter, and a fitting portion is screwed with a lock ring portion. b) Each inner catheter is passed through and fixed. The adapter part is fitted into an integrated connection part formed corresponding to each inner catheter in the connector part of the outer catheter and screwed with a lock ring. The connection part in c) b) is connected to the outer catheter via the attachment. Method of screwing to the connector part d) Method of screwing an elastic rubber attachment having a tapered inner hole into which the Y tube part of the inner catheter can be inserted into the connector part of the outer catheter and pushing the inner catheter into the inner hole. This will be described with reference to the drawings.

  FIG. 1 shows an overall view of a blood vessel indwelling catheter of the present invention detachably fitted by the method a). FIG. 1 shows a state in which the adapter part of the inner catheter is removed from the connector part of the outer catheter for convenience of explaining the fitting method. The inner catheter 2 penetrates and is fixed to the adapter part 23, and the lower part of the adapter part 23 is a male luer taper 25 (see FIG. 6). The inner cavity has a luer taper structure 26 as shown in FIG. 2A so that the connector part 11 of the outer catheter 1 can be fitted and connected to the adapter part 23 to which the inner catheter 2 is fixed.

  A screw part 19 is formed in the connection part 20 at the upper part of the connector part 11 of the outer catheter 1, and the adapter member 23 can be detachably fitted to the connector part 11 by being screwed by the lock ring part 24. .

  The configuration other than the above in the vascular indwelling catheter of the present invention can be the same as the conventional vascular indwelling catheter (see FIG. 5). That is, the outer catheter is provided with a side injection portion 14 that can be used as a blood removal or blood supply lumen, and a thread hook portion 13 for fixing the catheter and the skin with a suture thread. The tube connected to the proximal tube of the inner catheter 2 and the side injection portion 14 of the outer catheter 1 is provided with a hub 15 for connecting to a line such as an extracorporeal circulation circuit, a syringe, etc. A clamp 16 is provided for blocking.

  Further, as shown in FIG. 17, the outer catheter of the present invention removes the clamp tube portion 12, the clamp 16 and the hub 15 portion of the side injection portion where trouble such as damage is likely to occur so that it can be used repeatedly for a long period of time. An exchangeable structure can also be taken. In this case, the outer catheter 1 includes a thread hook portion 13, a clamp tube portion 12, and a connector portion 11.

  In the present invention, the number, length, and number of lumens of the inner catheter are selected according to the purpose. For example, when used as a catheter for central parenteral nutrition, an infusion solution is administered to the inner catheter. On the other hand, when used for extracorporeal circulation such as blood purification, two inner catheters 2 (21 and 22) having different lengths for blood removal are connected as shown in FIG. It can be circulated.

  Further, in the present invention, the inner catheter 2 may be equipped with various sensors such as pulse pressure and blood flow volume through the lumen and electrodes for cardiac pacing. It can also be used for applications and diagnostics. Examples of the sensor include a metal wire that is embedded in the lumen of the catheter and senses an electrical signal or the like.

  Taking a thermodilution catheter as an example, when measuring blood flow, the temperature is measured by the temperature dilution of blood when ice-cold physiological saline is flowed from the proximal side of the catheter and the temperature is measured by a sensor on the distal end side. To do. Regarding pressure measurement, there is also a method in which air is injected into a balloon provided at the distal end of the catheter and the pressure applied to the balloon is measured by a pressure sensor on the proximal side.

  The cardiac pacing electrodes are provided at two locations on the distal end and proximal side of the catheter, and the electrodes are paced by connecting to an external pacemaker generator outside the body.

  As for the shape of the clamp 16, a pinch type that closes the tube by pressing with a finger, or a slit type that closes the tube by sliding the slit into a plate-like one that has a slit that gradually decreases in width is available. However, the shape is not limited as long as it has a function of closing the tube.

  In addition, as shown in FIG. 2B, it is preferable to adopt a backflow prevention valve structure 18 that suppresses blood leakage as much as possible when the inner catheter 2 or obturator 3 is attached. Can also be used. The structure of the backflow prevention valve may be, for example, a layer having a thickness of elastic rubber with slits, but the material and structure are not particularly limited as long as the structure does not leak liquid such as blood.

  The material of the catheter of the present invention may be any material that is safe and elastic when placed in the body, particularly in blood vessels, such as polyurethane, silicone, polyvinyl chloride, polybutadiene, polyamide, ethylene-vinyl acetate copolymer, and the like. Preferably, a polyurethane having a property of maintaining hardness outside the body and having flexibility in the body is preferable.

  The outer catheter 1 of the present invention has a cuff 52 having a function of closely contacting the subcutaneous tissue 8 as shown in FIG. 16 at one place in the catheter portion between the skin 7 insertion portion and the blood vessel 9 insertion portion, or Two or more places may be attached.

  Examples of the shape of the cuff include a cotton-like fiber, a sponge-like material, and a partially raised catheter, and the material is a synthetic polymer compound such as polyester, nylon, acrylic, or cotton, silk And natural polymer compounds such as chitin.

  As another fitting method in the present invention, as in b) above, an adapter portion in which the inner catheter is penetrated and fixed for each one is formed in the connector portion of the outer catheter corresponding to each inner catheter. It is possible to adopt a method of fitting into the connected connection part 20 and screwing with a lock ring. Specifically, it is shown in FIG. 3 and FIG. FIG. 3 shows a case where there are two inner catheters, and FIG. 4 shows a case where there are three inner catheters. The connecting portion 20 is formed on the upper portion of the connector portion 11 of the outer catheter 1 so as to correspond to each of the inner catheters 2 and is integrated with the connector portion 11. A screw 19 is formed at the mouth of the connecting portion 20 so that the lock ring 24 is screwed. In the intravascular indwelling catheter shown in FIG. 3 or FIG. 4, when removing the inner catheter 2 for cleaning or replacement, it is possible to remove the lock ring 24 of the target inner catheter.

  As another fitting method in the present invention, as in the above c), there is a method in which the connecting portion in b) is directly screwed to the connector portion 11 of the outer catheter via the attachment. Specifically, FIG. 7 and FIG. 8 show the case where FIG. 7 shows two inner catheters and FIG. 8 shows the case where three inner catheters are used. In this aspect, the connecting portion 20 formed corresponding to each inner catheter 2 is integrated with the attachment, and the inner lumen of this attachment is threaded and screwed to the mouth portion of the outer catheter connector portion. The

  Furthermore, as another fitting method in the present invention, as shown in the above d), an elastic rubber attachment having a tapered inner hole into which the Y tube portion of the inner catheter can be inserted is screwed to the connector portion of the outer catheter. And a method of pushing the inner catheter into the inner hole. Specifically, it is shown in FIG. In FIG. 9, the attachment 6 having a structure that substantially matches the shape of the Y tube portion 51 of the general double lumen catheter 5 can be connected to the connector portion 11 of the outer catheter. By matching the shape of the elastic rubber layer 27 which is a part of the fitting portion of the attachment 6 with the shape of the Y tube portion 51 of each catheter to be mounted, catheters having various shapes can be used as the outer catheter 1 of the present invention. It becomes possible to connect to.

  In the present invention, by devising an attachment for connecting the outer catheter 1 and the inner catheter 2, the length of the inner catheter can be finely adjusted while being connected to the outer catheter 1.

  As an example of this, FIG. 10 shows an attachment main body portion as a screw structure 53, and the lock ring 24 portion fitted to this is rotated to adjust the length fitted to the outer catheter 1. In addition, there is a method of adjusting the length of the attachment by rotating the lock ring portion 24 of the adapter portion 23 of the inner catheter 2.

  Fine adjustment of the length of the inner catheter is performed for the purpose of changing the tip of the catheter to a position where it does not contact the blood vessel wall. The length of fine adjustment is preferably within 5 cm, but in the range of 1 to 2 cm. More preferably, it performs a function.

  Another method for finely adjusting the length of the inner catheter may be a combination of a plurality of detachable attachments 55 as shown in FIG. 12 in addition to the bellows attachment 54 as shown in FIG. An attachment 56 that adjusts and fixes the length while tightening the lock ring as shown in FIG. 13 may be used. The range of fine adjustment of the length is as described above.

  As a method for finely adjusting the length of the inner catheter, in addition to the above attachment, the structure of the attachment may be integrated with the connector portion of the outer catheter 1.

  In the indwelling catheter of the present invention, an obturator (inner plug) as shown in FIG. 14 is used to prevent the inner catheter 2 from being clogged with a thrombus formed in the outer catheter lumen. 3 can also be attached.

  The obturator 3 may have a structure of a rod-shaped obturator main body 31 having a thickness for closing the lumen of the outer catheter and an adapter 23 for being attached to the outer catheter 1. The structure of the adapter 23 may be basically the same as that of the inner catheter 2.

  On the other hand, it is possible to fill the lumen of the outer catheter 1 with an anticoagulant such as heparin without using the obturator 3, but in the unlikely event that a thrombus is formed, FIG. It is also possible to physically remove or collect the thrombus by wearing the device 4 for removing or collecting the thrombus as shown.

  As an example of the structure of the device for removing or collecting the thrombus, there is a loop-shaped wire portion 41 for grasping a target object such as a thrombus. The shape of the wire portion 41 has a structure capable of removing or collecting the thrombus. Anything is acceptable as long as it is a thing. In addition, there is an operation part 42 for actually inserting and removing the wire part 41 from the catheter, and an adapter part 23 for fitting the connector part 11 of the outer catheter. The structure of the adapter portion 23 may be basically the same as that of the inner catheter 2.

  Further, the structure of the device 4 for removing or collecting the thrombus may be a method for removing or collecting the thrombus by suction force in addition to the wire shape.

The catheter for intravascular placement of the present invention may be subjected to antithrombotic treatment in order to prevent blood clots from being formed by contact with blood during placement.

  For antithrombotic treatment, a method of immobilizing plasminogen activator such as urokinase on the catheter surface of the base material by chemical bonding method (for details, refer to Japanese Patent No. 1406830), anticoagulation factor such as heparin on the catheter surface Various methods such as a coating method have been developed, but are not limited to specific methods.

  The range of the antithrombotic treatment may be the outer surface, the inner surface, or both of the catheter as long as it is a portion that contacts blood.

  The catheter for intravascular placement of the present invention is coated with an antibacterial agent or antibiotic on the entire surface or a part of the base catheter in order to prevent infection with bacteria, fungi, viruses, etc. during the catheter placement. (For example, refer to Japanese Patent Laid-Open No. 2001-276210) or those in which an antibacterial agent is directly kneaded with a base material (for example, refer to Japanese Patent Laid-Open No. 8-157541).

  The catheter for indwelling according to the present invention has been subjected to a lubrication treatment such as coating the surface of a base material with a hydrophilic polymer compound in order to facilitate insertion into a subcutaneous tissue or blood vessel (for example, a special treatment). Kaihei 10-248919). Many methods have been developed for the lubricity treatment, and any method may be selected. The range of the lubrication treatment may be any part as long as it is a part that comes into contact with the human body or a part that comes into contact with a tool or the like for placing the catheter.

1 Outer catheter 2 Inner catheter 3 Obturator (inner plug)
4 Device for removing or collecting thrombus 5 Double lumen type catheter 6 Attachment 7 Skin 8 Subcutaneous tissue 9 Blood vessel 11 Connector part 12 Clamp tube part 13 Thread hook part 14 Hub 16 Clamp 18 Backflow prevention valve 19 Screw part 20 Connecting portion 21 Inner catheter 22 with shorter length Inner catheter 23 with longer length Adapter portion 24 Lock ring portion 25 Male luer taper portion 26 Female luer taper portion 27 Elastic rubber 28 Tip of inner catheter 29 Inside lock ring Screw shape 31 Bar-shaped obturator main body 41 Loop wire 42 Operation part 43 Sheath part 44 Extension part 51 Y pipe part 52 Cuff 53 Screw type attachment 54 capable of fine adjustment of length 54 Bellows capable of fine adjustment of length Type attachment 55 Fine adjustment of length is possible Combination attachment 56 Tightening fixed attachment 61 capable of fine adjustment of the length 61 Screw structure 62 of the attachment body Stretchable bellows attachment 63 of the attachment body 63 Multiple combination attachments 64 Groove screw structure 65 of the attachment body Inner catheter Lock ring 66 for tightening Groove

Claims (9)

In an indwelling catheter comprising an outer catheter and an inner catheter that is inserted into the lumen of the outer catheter and is detachably fitted to the outer catheter.
The inner catheter 2 or more monolayers lumen catheter or consists multilayered lumen catheter,
The inner catheter is provided with an adapter portion through which the inner catheter is fixed,
The outer catheter includes one connector portion that is detachably connected to the adapter portion,
Two or more single-layer lumen catheters or multi-layer lumen catheters constituting the inner catheter are each fixed to the adapter part,
The connector portion is provided at a proximal end portion of the outer catheter, and includes a plurality of connection portions to which the adapter portions are detachably connected.   The intravascular catheter according to claim 1, wherein the adapter portion and the connector portion are fixed by screw tightening.   The intravascular indwelling catheter according to claim 1 or 2, wherein an axial distance between the adapter part and the connector part can be finely adjusted.   The catheter for indwelling blood vessels according to claim 1 or 2, wherein a screw type attachment capable of fine adjustment of a length is provided between the adapter part and the connector part.   The intravascular placement catheter according to claim 1 or 2, wherein a bellows type attachment capable of fine adjustment of a length is provided between the adapter part and the connector part.   The intravascular catheter according to claim 1 or 2, wherein a plurality of detachable attachments capable of fine adjustment of the length are provided between the adapter part and the connector part.   The intravascular indwelling catheter according to claim 1 or 2, wherein a fastening and fixing attachment capable of fine adjustment of a length is provided between the adapter part and the connector part.   The intravascular catheter according to any one of claims 1 to 7, having a therapeutic or diagnostic sensor function, wherein a therapeutic or diagnostic sensor is mounted through a lumen of the inner catheter. The catheter for indwelling an intravascular vessel according to any one of claims 1 to 7, having a cardiac pacemaker function, wherein an electrode for a cardiac pacemaker is attached through a lumen of the inner catheter.