JP4906408B2 - Indwelling catheter - Google Patents

Description

  The present invention relates to an indwelling catheter used in the medical field. More specifically, the present invention relates to various medical treatments such as extracorporeal circulation for blood purification, administration of infusion / medical solution, blood sampling, measurement of pulse pressure / blood flow rate, etc. The present invention relates to an indwelling catheter used for the purpose of treatment.

  Conventionally, for patients who need long-term infusion / medical solution administration, central vein indwelling catheters and gastrointestinal feeding catheters are used (see Non-Patent Document 1), renal failure, diabetes, drug addiction, For patients who need blood purification for diseases such as systemic inflammatory response syndrome (SIRS), acute respiratory stimulation syndrome (ARDS), multiple organ failure (MOF), hepatitis, pancreatitis, etc. A blood access catheter is used to remove blood by indwelling (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.

  Most of the above-mentioned catheters are used as a means for some kind of access such as administration of drug solution, blood removal, measurement of in vivo information between the target blood vessels and body fluid tubes and organs inside and outside the body. Usually, one catheter is inserted from the outside of the body through the skin and subcutaneous tissue to the target site.

  In addition, in a catheter inserted from a skin puncture site, a path through which bacteria enter a blood vessel, a body fluid tube or an organ through a drug administered from the lumen of the catheter, or from the skin puncture site to the outer wall of the catheter It has become a problem that infection is caused by the route entering the subcutaneous tissue, blood vessels, body fluid tubes, and organs along the path. In particular, the frequency of the latter route is high, and there are many cases that cause serious infections despite frequent disinfection and strict management by medical workers, which is a serious social problem.

  For the purpose of preventing infection from the skin piercing part of the catheter, for example, a skin fixing tool containing an antibacterial agent for the catheter (see Patent Document 1), or a catheter coated with an antibacterial agent on the surface (Patent Document 2) Have been developed).

In addition, for the purpose of long-term indwelling of the catheter, a catheter that is made of polyester cotton is attached to a part of the catheter and brought into close contact with the subcutaneous tissue, and the catheter is expected to be fixed and prevent infection (Non-Patent Documents 4 and 5) ) Has also been developed and widely used in the medical field.
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 Procedure Manual, 66, Terinsha (1991) JP-A-2-234767 Japanese Patent No. 2665399 JP 2006-51406 A Broviac NW, Cole JJ, Scriber BH: “a silicone rubber right atrial catheter for prolonged parenteral alimentation”, Surgery, Gynecology & Obstetrics, 136, 602 (1973) Hickman RO, Buckner D, Clift RA: “A modified right atrial catheter for access to the venous system in marrow transplant recipients : Surgery, Gynecology & Obstetrics, 148: 871 (1979) Shigeru Miyagata, Ryuji Hongo, Akira Matsuzaki, Ryuzo Kato, Hiroshi Kobayashi, Tadashi Harada, Masayoshi Tsuchida: Design of Double-Luminous UK Catheter, Journal of Japanese Dialysis Society, 5 (4), 220 (1990)

  However, while the catheter skin fixing device containing the antibacterial agent is easy to handle, problems remain in that the antibacterial activity is sustained by the outflow of the antibacterial agent and the gap between the antibacterial agent and the skin cannot be completely closed. In addition, the catheter coated with the antibacterial agent has problems such as persistence due to the outflow of the antibacterial agent and allergies when placed in the living body.

  A catheter with a cuff attached is considered to be the safest because it blocks the bacteria that enter the body by the antibacterial force of the subcutaneous tissue inherent in the living body. When it is necessary to remove it when it is clogged or infected, it is necessary to surgically remove the entire subcutaneous tissue around the catheter, which places a heavy physical and mental burden on both medical personnel and patients. It was strong.

  On the other hand, many conventional catheters are inserted directly into blood vessels, body fluid tubes, and organs in the body, so that the lumen is blocked by blood or chemicals, or when the blood is sucked from the side hole of the catheter, it sticks to the blood vessel wall. If a problem occurs that prevents the patient from fulfilling the purpose, for example, the indwelling catheter must be replaced, which not only imposes a heavy physical and mental burden on both the healthcare professional and the patient. The medical economy was also a big loss.

  As a conventional technique, a coaxial type catheter has been developed that is used as a double lumen catheter for extracorporeal circulation, and an outer catheter and one inner catheter are coaxially formed in two layers (Non-patent Document 6). However, even if the inner catheter cannot be used due to troubles such as obstruction, it can be replaced, but if the outer catheter becomes obstructed or has poor blood removal, it will eventually be necessary to replace the entire catheter. there were.

  Also, in the catheter disclosed in Patent Document 3 as a multi-lumen access device, it has been proposed to insert a removable inner catheter into the lumen of an outer catheter having a plurality of lumens. In addition to this catheter, an outer catheter is inserted into a blood vessel, and in order to perform access such as blood removal using only the inner catheter, it is necessary to secure the flow rate of access, and inevitably the lumen of the catheter. The size, that is, the outer diameter of the inner catheter is increased, and the outer diameter of the outer catheter is inevitably increased in conjunction with this, and the indwelling blood vessel is restricted.

  The present invention relates to an indwelling catheter for accessing a blood vessel, a body fluid tube, or an organ from outside a human body through a skin piercing part, and it is easy to handle at the time of insertion and removal, and is an inner catheter for indwelling. An object of the present invention is to provide an indwelling catheter that is less susceptible to restrictions on the number and outer diameter and that can effectively prevent infection through the outer wall of the catheter.

  As a result of diligent studies to achieve the above object, the present inventors have shortened the length of the outer catheter to a length that stops in the subcutaneous tissue, so that the inside of the target body vessel, body fluid tube, or organ The tunnel opened in the subcutaneous tissue when the inner catheter is placed is closed naturally when the inner catheter is not used, and the original subcutaneous tissue infection prevention effect is exhibited even without using an antibacterial agent. The present invention has been found.

  That is, the present invention relates to an indwelling catheter that is placed from outside the body into a blood vessel, body fluid tube, or organ from outside the body through a skin piercing part and subcutaneous tissue, the indwelling catheter comprising an outer catheter and the outer catheter The inner catheter is inserted through the inner lumen of the inner catheter and detachably engages with the outer catheter, and when placed in the body, the inner catheter has a length that reaches the blood vessel, body fluid tube, or organ, The outer catheter is characterized by an indwelling catheter characterized in that the distal end of the outer catheter has a length that stops in the subcutaneous tissue. Preferably, the outer catheter has a single-layer or inner lumen. There are two or more layers, and preferably, the lumen of the inner catheter is a single layer or two or more layers, and preferably Toner catheter, which is the indwelling catheter which is composed of one or two or more.

  According to the present invention, a tunnel made of a subcutaneous tissue is in close contact with the surface of the catheter when the inner catheter is in place, and the anti-infection action of the subcutaneous tissue inherent in the living body is exerted, thereby allowing bacteria to enter from the outside of the body through the skin insertion part. Can be effectively blocked. When the inner catheter is removed, it closes naturally to prevent infection by antibacterial or anti-infective power in the living tissue, and when not needed, an obturator (inner plug) can be inserted to enclose the entire lumen. Therefore, the catheter can be placed for a long time.

  Furthermore, according to the present invention, since the outer catheter is not inserted into a blood vessel or the like in the body, there is no restriction on the outer diameter, and therefore, it is possible to selectively mount the inner catheter having a shape and number suitable for various purposes. When trouble such as occlusion occurs, a new inner catheter can be easily replaced, and as a result, it can be continuously placed over a long period of time.

  Hereinafter, the present invention will be described in detail.

  The indwelling catheter of the present invention is composed of an outer catheter and an inner catheter. When the inner catheter is inserted into the lumen of the outer catheter and placed in the body, it reaches the blood vessel, body fluid tube or organ in the body. It is necessary to have a length that can be reached and to be detachably engaged with the outer catheter. The outer catheter is preferably used in combination with an inner catheter composed of one or more multilayer lumen catheters of two or more layers, but may be one or more inner catheters of a single layer lumen.

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 an indwelling catheter of the present invention detachably fitted by the method a). FIG. 1 shows a state in which the adapter portion 23 of the inner catheter 2 is removed from the connector portion 12 of the outer catheter 1 for convenience of explaining the fitting method. While the distal end side of the inner catheter 2 is indwelled in the blood vessel 8, the distal end 20 of the outer catheter 1 ends up to the inside of the subcutaneous tissue 7, and the inner catheter 2 extended from the distal end 20 of the outer catheter is a blood vessel insertion portion 9. Until then, the tunnel 10 in the subcutaneous tissue 7 is inserted. The inner catheter 2 penetrates and is fixed to the adapter portion 23, and the lower portion of the adapter portion 23 has a male luer taper shape 25. The inner cavity has a Luer taper structure 26 as shown in FIG. 3A so that the connector part 12 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 portion 19 is formed on the upper portion of the connector portion 12 of the outer catheter 1, and the adapter portion 23 can be detachably fitted to the connector portion 12 by being screwed with a lock ring portion 24.

  The outer catheter used in the present invention is shorter in length compared to what is known as an outer catheter in a conventional coaxial type catheter. That is, the outer catheter in the indwelling catheter of the present invention has such a length that the distal end of the outer catheter stops in the subcutaneous tissue when placed in the body. Usually, the thickness of the subcutaneous tissue varies depending on the physique, gender, and age, but it is in the range of about 16-37 mm, and the average is 20 mm (Miyako Takahashi et al .: “Investigation of injection site by CT photograph analysis—intramuscular muscle” Injection-", Journal of the Japan Academy of Nursing Science, 8 (3), 128 (1988)), and insert the subcutaneous tissue between the skin insertion site of the catheter placed for normal purpose and the target blood vessel or organ The length is 10 to 20 mm, and when inserting a long distance between subcutaneous tissues for the purpose of long-term indwelling, although it varies depending on the indwelling site, it is considered to be 20 to 300 mm and an average of 50 to 100 mm.

  Therefore, the specific length of the outer catheter in the present invention is preferably designed so that the length from the skin insertion portion to the distal end portion of the catheter is 10 to 300 mm, more preferably 20 to 200 mm, Most preferably, it is 50-100 mm.

  FIG. 2 is a schematic view showing a state of the outer catheter 1 when the inner catheter 2 is removed from the catheter in FIG. The distal end 20 of the outer catheter from which the inner catheter 2 has been removed is in the subcutaneous tissue 7, and the tunnel 10 to the blood vessel insertion portion 9 can be almost completely closed by the expansion and contraction of the subcutaneous tissue itself. Further, the blood vessel insertion portion 9 into which the inner catheter 2 has been inserted can be naturally occluded by the expansion and contraction of the blood vessel wall.

  The other configuration of the indwelling catheter of the present invention can be the same as the conventional vascular indwelling catheter shown in FIG. That is, the outer catheter includes a side injection portion 29 that can be used as a blood removal or blood supply lumen, and a thread hooking portion 14 for fixing the catheter and the skin with a suture thread. Further, the proximal tube of the inner catheter 2 and the tube connected to the side injection portion 29 of the outer catheter 1 are 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.

  In the present invention, the number, length, and number of lumens of the inner catheter 2 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 2. On the other hand, when used for extracorporeal circulation such as blood purification, as shown in FIG. 1, an inner catheter 2 having two lumens for blood removal can be connected to circulate blood.

  Furthermore, in the present invention, the inner catheter 2 may be equipped with various sensors such as pulse pressure and blood flow through the lumen and electrodes for cardiac pacing, and such an indwelling catheter is used for therapeutic purposes. It can also be used for diagnostic purposes. 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.

  FIG. 4 is a schematic diagram illustrating an example of a method for placing the inner catheter 2 in a blood vessel. In order to insert the inner catheter 2 into the blood vessel 8, for example, a puncture needle covered with an outer cannula is inserted from the outer catheter 1, the vessel wall is punctured and the cannula is placed, and then only the puncture needle is removed. Then, the guide wire 27 is placed in the cannula. The inner catheter 2 can be placed in the blood vessel by advancing the inner catheter 2 along the guide wire 27.

  As for the shape of the clamp 16 in the catheter for indwelling according to the present invention, a pinch type in which the tube is closed by pressing with a finger, or a plate-like one is provided with a slit whose width gradually decreases, and the tube is formed by sliding the slit. There is a slit type shape that closes the tube, but the shape is not limited as long as it has a function of closing the tube.

  As shown in FIG. 3B, the connecting portion 12 of the outer catheter 1 adopts a backflow prevention valve structure 18 that suppresses blood from leaking out of the body as much as possible when the inner catheter 2 or obturator 3 is attached. It is preferable, but it can be used without it. 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 for the indwelling catheter of the present invention may be any material that is elastic and safe to be placed in the body, particularly in blood vessels. For example, polyurethane, silicone, polyvinyl chloride, polybutadiene, polyamide, ethylene-vinyl acetate copolymer Examples thereof include polyurethane, but polyurethanes having a property of maintaining hardness and flexibility in the body are preferred outside the body.

  The outer catheter 1 in the indwelling catheter of the present invention has a cuff 17 having a function of closely contacting the subcutaneous tissue 8 as shown in FIG. 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.

  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 2 can be finely adjusted while being connected to the outer catheter 1.

  As an example of this, FIG. 7 shows an attachment main body portion as a screw structure 31 and a lock ring 24 portion fitted to this is rotated to adjust the length to be 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.

  The fine adjustment of the length of the inner catheter 2 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 is in the range of 1 to 2 cm. It is more preferable to fulfill the function.

  Another method for finely adjusting the length of the inner catheter may be a combination of a plurality of detachable attachments 33 as shown in FIG. 9 in addition to the bellows attachment 32 as shown in FIG. An attachment 34 that adjusts and fixes the length while tightening a lock ring as shown in FIG. 10 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 2, the structure of the attachment may be integrated with the connector portion 12 of the outer catheter 1 in addition to the above attachment.

  In the indwelling catheter of the present invention, an obturator (internal plug) 3 as shown in FIG. 5 is used to prevent a clot from being formed and blocked in the lumen of the outer catheter when the inner catheter 2 is not used. Can also be installed.

  The obturator 3 may have a structure of a rod-shaped obturator body 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.

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

  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 indwelling of the present invention is coated with an antibacterial agent or antibiotics on the whole 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 a material 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, see Japanese Patent Application Laid-Open No. Hei. 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.

It is the schematic which shows an example in which the outer catheter in the catheter for indwelling of this invention and the inner catheter which has two lumens are combined, and it is indwelled in the blood vessel through the subcutaneous tissue. (A) Schematic diagram showing an example of the overall shape (B) Cross-sectional view of the catheter A-A 'portion (C) Cross-sectional view of the tunnel portion B-B' of the subcutaneous tissue through which the inner catheter is inserted Example of outer catheter with inner catheter removed in the present invention (A) Schematic diagram of outer catheter placed in subcutaneous tissue (B) Cross-sectional view of catheter AA ′ (C) Tunnel B- of subcutaneous tissue Cross section of B 'part Example of sectional view showing inner surface of connector part of outer catheter in the present invention (A) Perspective view from the lateral direction of the connector part (B) Sectional view of the catheter B-B 'portion Schematic showing an example of a method for indwelling an inner catheter in a blood vessel via a guide wire (A) An example showing a method for inserting an inner catheter into an outer catheter in the catheter for indwelling of the present invention and placing it in a blood vessel (B) ) Cross section of catheter A-A ' Schematic diagram showing an example of mounting an obturator (inner plug) on an outer catheter when the inner catheter is not used in the present invention (A) Schematic diagram of an outer catheter with an obturator mounted (B) Catheter AA ′ part Sectional view (C) Sectional view of the tunnel BB 'part of the subcutaneous tissue Schematic diagram of the shape of a conventional blood access catheter as a prior art (A) Schematic diagram showing the overall shape (B) Cross-sectional view of the catheter A-A 'portion Schematic showing an example of the structure of the screw attachment 31 that can finely adjust the length of the inner catheter attached to the outer catheter in the present invention (A) Schematic showing the overall shape of the outer catheter and the inner catheter attached ( B) Schematic showing the structure of the attachment Schematic showing an example of the structure of the bellows type attachment 32 that can finely adjust the length of the inner catheter attached to the outer catheter in the present invention (A) Schematic showing the overall shape of the outer catheter and the inner catheter attached ( B) Schematic showing the structure of the attachment Schematic which shows an example of the structure of the combination attachment 33 which can finely adjust the length of the inner catheter with which the outer catheter in this invention was mounted | worn (A) The schematic which shows the whole shape which mounted | worn with the outer catheter and the inner catheter ( B) Schematic showing the structure of the attachment Schematic diagram showing an example of the structure of a clamp-fixed attachment 34 that can finely adjust the length of the inner catheter mounted on the outer catheter in the present invention (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) Schematic diagram showing the structure of the lumen of the attachment

Explanation of symbols

1 Outer catheter 2 Inner catheter 3 Obturator (inner plug)
4 Outer catheter of conventional coaxial type catheter 5 Inner catheter of conventional coaxial type catheter 6 Skin 7 Subcutaneous tissue 8 Blood vessel 9 Blood vessel insertion part 10 Tunnel 11 Skin insertion part 12 Connector part 13 Clamp tube part 14 Thread hook part 15 Hub 16 Clamp 17 Cuff 18 Backflow prevention valve 19 Screw portion 20 Outer catheter distal end portion 21 Inner catheter distal end portion 22 Inner catheter side hole 23 Adapter portion 24 Lock ring portion 25 Male luer taper portion 26 Female luer taper portion 27 Guide wire 28 Obturator (inner plug) tip 29 Side injection part 31 Screw attachment 32 capable of fine adjustment of length 32 Bellows attachment 33 capable of fine adjustment of length Combination attachment 34 capable of fine adjustment of length Fine adjustment of length Possible clamping retractable attachments 41 attachment screw structure 42 attachment body telescopic bellows type attachment 43 more combinations lock ring 46 groove for fastening the grooved screw structure 45 inner catheter of Formula attachments 44 attachment body of the body

Claims (4)

An indwelling catheter for indwelling into a blood vessel, a body fluid tube or an organ from outside the body through a skin piercing part and a subcutaneous tissue,
The indwelling catheter is composed of an outer catheter that can be used as a double lumen , and an inner catheter that is inserted through the lumen of the outer catheter and removably engages with the outer catheter.
When placed in the body, the inner catheter has a length that reaches a blood vessel, a body fluid tube, or an organ, and the outer catheter is provided with a thread hook portion that is larger than the outer diameter of the outer catheter. An indwelling catheter characterized in that the length from the hanging portion to the distal end of the outer catheter is smaller than the thickness of the subcutaneous tissue .   The indwelling catheter according to claim 1, wherein the lumen of the outer catheter is a single layer or two or more layers.   The indwelling catheter according to claim 1 or 2, wherein the lumen of the inner catheter is a single layer or two or more layers.   The indwelling catheter according to any one of claims 1 to 3, wherein the inner catheter is composed of one or more inner catheters.