JPS5850940A - Cathetel - Google Patents

Abstract

(57) [Summary] This bulletin contains application data before electronic filing, so abstract data is not recorded.

Description

DETAILED DESCRIPTION OF THE INVENTION The present invention relates to a catheter and a rounding method for attaching electrical conductors to a catheter body.

U.S. Patent No. t? ? JAJJ is used in the diagnosis of cardiovascular and pulmonary diseases. A flow management catheter is disclosed having multiple lumens suitable for use in the flow management process.

When this catheter is used for thermodilution measurements, cryogenic liquid is injected into the right atrium or superior vena cava (via the boat JO) and the resulting change in blood temperature is detected by the thermistor in the pulmonary artery. This change in blood temperature, detected by K (represented by the numbers JjT), is indicative of cardiac output. Three bores are required in this invention for the rounding to accomplish such an operation, namely one for guiding the gas for balloon expansion, the other for the cold A third lumen is for supporting a thermistor lead for transporting liquid for injection of liquid (or for monitoring right atrial pressure, drawing blood, or insufflating therapeutic media). .

If other possibilities are required, one or more bores can also be provided. In this way, this patent discloses a 40th lumen that extends completely through the catheter body so that when the catheter is in place and the balloon is Used to measure pulmonary arterial pressure when inflated or pulmonary capillary wedge pressure when the balloon is inflated.

Due to the possibility of multiple functions, it is important to obtain as much diagnostic information as possible during the course of the Chichill method, which is a very important objective for the cardiac catheterization method.
Such objectives have been achieved in the past by increasing the dimensions (outer diameter) of such catheters;
This has been achieved by reducing the cross-sectional area of each lumen, thus reducing the performance characteristics of the catheter. If the number of lumens is to be increased without changing the external dimensions of the catheter, the lumens must only be made smaller, which reduces the need for septa between the lumens. However, this requires a further reduction in the bore size.

Even when partitions or partitions bounding multiple bores are made as thin as possible, their thickness is still substantially equal to that for several bores within any given dimension. reduce the available space. pr, *to,
The external dimensions of such catheters, which must be able to pass through the vasculature without causing injury to the patient, must be kept as small as possible. Therefore, the e7 Tuns catheter <outer diameter is approximately 0.0, t
7 inches - 1,3 zvzrn) Fi, y) A large 1 French catheter (outer diameter 0.0 - 1 inch - 1, det! 1111) y) is also easy to operate and reduces the risk of possible side effects during use. It is considered to be even more desirable because it reduces Therefore, it is generally believed that in order to achieve multiple functions in optimally sized diagnostic catheters, it is necessary to compromise the performance potential of such catheters.

Other U.S. patents disclosing multi-lumen catheters include No. 4'14A & 00J.

, 2113 J, ti01, J7/0.
7t/, 44341? Koe, 3/! rLr92゜ao
4Isatz, zosaott, and 1,1859
It's No. 30.

The present invention is advantageous in part to conventional techniques that require that the electrical leads of a catheter must be isolated within a separate lumen to avoid contact with liquids and electrical shorts and attendant risks to the patient. This idea is due to this discovery that it is not true at all. 4IK, Applicant requires a flow-tubing gas communication passage, such as a balloon catheter, and also a proximal port for cryogenic liquids (or for blood sampling, or pressure measurements) and It has been discovered that in catheter constructions that require a distal diaster or other electrical element, one of the lumens, previously thought to be necessary, can be omitted entirely. Nine, since the space occupied by such a bore can be used to increase the cross-sectional area of other bores, it is also necessary for the purpose of bounding such bores. Since the space previously occupied by the septum is also available, the result is that catheters made in accordance with the present invention exhibit superior flow characteristics and It has other performance characteristics. In another aspect, the present invention allows the external dimensions of a catheter having multiple lumens to be substantially reduced without simultaneously reducing its performance characteristics.

The purpose is thus to omit the bulkheads that normally support electrical conductors and to pass those conductors through other bulkhead parts so that the conductors are nevertheless in contact with the liquid possible. This was achieved by increasing the length of Kg so that the distance is m from k.

In the structure disclosed herein, a lead wire or conductor extends through the gas conducting lumen from the proximal end of the catheter to an intermediate point where the lead wire or conductor extends through the gas conducting lumen. It passes through a longitudinal septum separating the bore from a second bore used for injection of medical fluids and other diagnostic functions. The conductor then extends through the second bore to a distal point where an electrical element, usually a resistor or other center, is placed.

Liquids cannot enter the part of the lumen that contains the electrical conductors, because the port for infusion of drug solutions (or for fluid collection or atrial pressure measurement) is a leakage from a conductor which is being cut through the conductor, embedding the conductor at a point of traverse and preventing flow communication between a proximal portion of a second bore and a distal portion of the same bore; This is because they are isolated by the stop plug.

To carry out the method of the present invention, a lateral port is first formed at the neutralization midpoint of the outer wall of the catheter body, and the port is used for injection of medical fluids, blood sampling or pressure applications at a predetermined nine. placed in communication only with bores intended for transporting liquids. A suitable tool is then inserted through the port to create a parallel bore for the flow of liquid, intended to transport only the gas as intended for the inflation and deflation of the balloon. A separate bore also forms an opening in the septum. This aperture is preferably formed just at the distal end of the port F, and the procedure is to insert a tool through the port at an angle so that the tip of the tool touches the septum distally. It is carried out immediately by inserting it at a point that is biased towards the center, so it only weighs one shoe. At least 41 electrical conductors are then passed through the chichill body such that the proximal portion of the electrical conductor is aligned within the gas conducting bore over the proximal side of the aperture. The distal portion of the conductor passes through the other bore and extends over the distal side of the aperture, and the middle portion of the conductor passes through the aperture from one bore to the other. Extends. Finally, a leakproof bladder is introduced into the second bore through the port;
The portion of the liquid transport lumen just at the end of the port is closed and leaktight, and the opening in the septum is also preferably leaktight, while the gas conduction lumen is Leave it open.

In accordance with embodiment K disclosed herein, the leakage stop is applied to the 9-way portion of the conductor and the distal portion of the conductor, otherwise
Any portion exposed to fluid passing past Port F to the proximal end of the catheter body is shelved.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS The present invention will be described below with reference to FIG. 1-1 of the accompanying drawings showing embodiments thereof.

FIG. 1 shows a catheter 10 abrading the right side of a patient's heart i*m. Briefly, the parts of the heart 1llH and their actions are as follows.

The right atrium/J sends blood to the superior vena cava and inferior vena cava tS and l.
From the right ventricle II, blood flows to the lungs via the pulmonary valve I and the pulmonary artery I. Oxygenated blood returning from the lungs enters the left atrium/9 and then passes through the mitral valve -
It passes through the right ventricle and the right ventricle. Blood passes through the heart (1), the aortic valve (J), and then leaves via the aorta (1).

Catheter 10 is designed as a multi-purpose flow controlled catheter having a tubular body which is provided with a pressure responsive device in the form of a balloon at its distal end. . At its proximal end 1.::.
The catheter body 11 terminates in a fitting which connects the inner bore of the catheter to the connector tubes t, At and 30. Is the connector pipe Jf partially divided into a branch pipe J? a and Jfl), and in 17, as is known, all tubes, pipes, branch pipes, connecting tubes, syringes, pipes, etc. are attached to the ninth coupling element 3/
~38 are provided.

The structure described above is essentially a commonplace one. For 0gl use, the catheter body/I is soft and easy to dislodge from the antecubital, femoral, subclavian artery, or jugular vein. The balloon J6 is introduced into the vascular system from the region of the balloon J6, and in a deflated or partially inflated state is advanced into the middle of the right atrium lJ. The balloon is then inflated to its maximum recommended capacity, and blood flow through the heart R is rapidly routed through the catheter 10 tipped with the inflated balloon to the right atrium/J and pulmonary artery/1. (Figure 1). When catheter l# is thus positioned K
a. Balloon-1 is advanced through the pulmonary artery into what is commonly referred to as the pulmonary capillary wedge location, and a senna or other tube is inserted into the distal portion of the catheter body (just proximal to the balloon-1). Electrical element J! is placed inside the pulmonary artery/l and is sometimes referred to as a proximal boat (distal port at the tip of the distal catheter body), as opposed to a balloon. JA is right atrium/
Placed inside J. Many diagnostic procedures can be performed with the catheter 10 positioned in this manner, all of which are known (and are therefore only briefly described here). Bo) JA is the right atrium/
J can be used for taking pressure measurements, for injecting or insufflating solutions, or for taking blood samples, while end port 37 can also be used for sampling or insufflating. or for infusion or for measuring pulmonary artery and pulmonary capillary wedge pressures (depending on whether such constants are carried out by inflating or deflating the balloon a4). In thermodilution measurements, a sterile, cold solution is injected into the right atrium via port 31, and changes in blood coolness and temperature are detected by a thermistor 36, thus:
Allows calculation of cardiac output.

It should be understood that the electrical element jj need not defeat the form of the thermistor - this element 3! may be an electrode for detecting (or stimulating, if necessary) the electrical activity of the heart, as shown in detail in US Pat. However, unlike the structure disclosed in this patent in which two lumens extend through the catheter body,
The catheter of the present invention can perform the same function with only two lumens.

As shown in FIG. 1, the catheter body has three branched partitions or septa.

By this, the body // has three parallel inner holes #/.

It is divided into Sanco and SanJ.

The inner hole 41/ is a through hole communicating with the connector tube λ1 and extending all the paths in the terminal boat JIIt.

This bore l/ is shown in the light of the function already mentioned as cooperating with this terminal port 'J7. If such a function is deemed unnecessary, the through-bore reference 1 may be omitted, or the space occupied by this bore may be replaced by the inner bore 4IJ and the bow J.
1 or to reduce the external cross-sectional dimensions of the catheter body// to provide a lumen intended to serve some other purpose. You should understand that it is okay to do so.

The inner hole 1 communicates with the connector tube 1t and transports gas to the balloon chamber #in order to inflate and deflate the balloon 11,
Further, one gas selected as a passage for transporting gas from the balloon-type aS is carbon dioxide. & Therefore, if the balloon J1 were to be destroyed, it would be because of the relatively slow diffusion rate in its blood. However, it is conceivable that other gases may be used, or even recommended under the 41Iys filth bowl.
Furthermore, although balloon λ1 is shown as ff1Hc] and is described in detail herein for illustrative purposes, it should be understood that other types of pressure-responsive φ stages may be substituted. be.

For example, the pressure responsive means may take the form of a diaphragm equipped with a pressure transducer for measuring blood pressure at or near the tip of the catheter, in which case the lumen may be Serves as a gas-containing passageway to vent the opposite side of the diaphragm to the atmosphere.

If the pressure-responsive element consists of a balloon, the gas enters the balloon chamber 4I or from the balloon chamber #1 via a transverse boat aS formed in the wall of the catheter body 11, and Leaving (FIG. 3), the balloon roller can be secured in place in any suitable manner. For more information on this point, see U.S. Patent No. J, ? ? Methods and structures for mounting balloons are well known in the art and form part of the present invention, see 9 A. As such, a more detailed explanation is believed to be unnecessary here. However, if the balloon is in Figures J and C (
It is shown in its fully deflated state (in solid lines) and in its fully expanded state in FIGS. 1 and 2 (in phantom lines).

The inner bore aS directs liquid to the proximal port 36 (or bow)
This is the inner hole for transportation from Jl. As shown, J4 is so named because it is located at a substantial distance from the tip and distal port of the catheter. 1 as shown in
Port J& is actually placed in the dovetail intermediate position. Thus, in a typical catheter having an overall body length of about /10 m, the distance between the proximal lumen and the distal tip is typically is in the range of about 1 to 1 m, this distance being selected so that port 3 is aligned in the right atrium or cephalic vein when the catheter is positioned as shown in FIG. 1111. Ru.

The electrical element Jj is placed close to the balloon 1 inside the bore 9J. The electrical element 3j, which is in the form of a thermistor as shown more clearly in FIG. embedded within. Although any suitable embedding medium may be used, particularly effective tabular results are shown in New Chassis N,L.

(5hamicals K by “Biothane”)
obtained by polyurethane casting materials reprinted under the name J.

The conductors at for the electrical elements jjK extend from the base through the bore aS to an adjacent point, preferably just at its distal end. At that point, the conductor +@at extends laterally through an aperture 4It in the septum Il 0 separating the lumen 1J from the lumen. The conductor at then passes through the inner hole #- in the direction of the base.
It extends through the connector tube (J), the branch (Jet) and the fitting (J3). As is known, the coupling 7J can be connected to a thermodilution cardiac output computer, or if 4, element J! If it takes the form of an electrode rather than a sensor, it can be connected to other supplementary electronic equipment.

A sealant plug S0 is placed on the distal side of the boat J1 in the borehole 4I to prevent leakage of liquid from entering the distal end of the borehole 4I. The conductor AT is closed in the vicinity of the boat 36 so that it cannot pass between J4 and IIJ, and the conductor AT is closed so as not to be exposed to the liquid passing through the boat J4. Performs many functions.

If the catheter body // is formed from polyvinyl chloride, then a sealant plug made of vinyl chloride may be found to be effective, however.
It should be appreciated that any material can be selected for the catheter body and sealant plug.

From the foregoing, it can be seen that the catheter of the present invention requires one less lumen than a conventional catheter to accomplish the same monitoring or diagnostic function, and that the omission of one lumen is an improvement. Allowing dimensional adjustments to result in rounded performance characteristics, smaller external dimensions, or both.

It is believed that this is clearly the case. For example, a J lumen catheter of the present invention of French dimensions may be substantially
It has been found to have performance characteristics (flow capacity and frequency response) K that approximate the performance characteristics (flow capacity and frequency response) of a large (external diameter) 1 French size conventional lumen catheter.

The conductors for the electrical elements are insulated, but this insulation is primarily intended to prevent the conductors from coming into electrical contact with each other. This is because the plug SO effectively prevents the liquid from entering the inner hole IJ or touching the conductor Km. If so, it will be protected against contact with blood that may enter the bore 121 via the III-strength tube S, since the blood entering the bore will be directed at the intersection. This is because the inner hole is condensed and sealed long before reaching at.

Several steps in making the catheter are shown in Figures 7-D. After the proximal boat number 3 is formed into the catheter body // at a position midway along its length,
An open-loop forming tool jj is inserted through the bow) JA at a forwardly directed angle and in contact with the septum 〇 (Fig.
The heat-weldable material may be melted upon contact, thereby creating the opening 4Ay, but other cutting,
Alternatively, it is believed that it is obvious that drilling techniques can be used to form this opening (as in Boat 36).
The boat 34 is small, and the boat 34 acts as a docking boat during the construction process, and the opening 41It is designed so that the boat J
I! is formed on the distal side of 4! be noticed.

After the aperture t is formed, any desired number of electrical conductors aX are drawn into position (FIG. 1). When this stage is completed and running, each □ conductor 41g is arranged in the inner hole eJ, on the side of the base of the opening, and has a portion close to the base, and a middle portion that is open. Japanese ginseng! and the distal portion is aligned over the distal side of the aperture ay in the bore IJ. 1iF-plug material is introduced into the inner hole J through the nozzle s1, in this case %,
□Use boat 3 as an approach opening (see diagram).

After hardening, the sealant finally forms a plug IO, which is connected to the bow of the conductor 4It), ? 4 and seal the aperture AT and inner hole D just at the distal end to the boat 34 near the base. Preferably, the trailing surface of the plug I0 is arranged such that the trailing surface of the plug I0 is arranged as shown in FIG. AK to assist in directing the flow of certain liquids (such as those discharged from fitting 34 and connector tube 30); It has a 3-shaped outline to help with orientation. In the case of pressure measurement, the fittings J and (Hiro) 3 can be connected to any one of a number of pressure measuring devices, rather than a syringe.
6.fi! ,
In the illustrated embodiment, the sealant plug 8jO is formed in situ and introduced by the nozzle 11 in the form of a 9 fluid into the bore. 10 If desired, the plug S-O is introduced preformed into the bore 11 12
You can also do that. Such a pre-formed plug 139 may be provided with a recess or channel and may accommodate a portion that makes direct contact 15 with the internal opening ay of the bore J of the conductor 14, thereby 16 Optionally, within the limits of one direction of the port col, 17 may be used to permit the placement of an aperture, preformed or not, '9! I*1 plug expansion,
When secured in a predetermined position inside bore 2, the guide 2 and the gas flow path are passed into or out of the proximal portion of bore 4IJ, covering J4. The pericarp performs many functions, including insulating it from fluids.

While the present invention has been described in nine details for purposes of illustration, it will be appreciated by those skilled in the art that many of these details may be changed without departing from the spirit of the invention. I want people to understand that I can do it.

[Brief explanation of the drawing]

FIG. 1 is a schematic cross-sectional view showing a catheter embodying the present invention in a state in which the catheter is positioned in a state where the catheter is used; FIG. 2 is a front view of the catheter; Figure 2 is an enlarged longitudinal sectional view of the distal end of the catheter;
The reference figure is the cross-sectional view taken along the dashed line in Figure 2, 1Nzl.
fa is an enlarged cross-sectional view taken along line j-j in Fig. 2, #l4
illi2 is an enlarged cross-sectional view according to 4-4gK in Fig. 2,
Figure 2 is a schematic diagram showing the sequence of steps in carrying out the method of the invention. 10・Working catheter; ll・Fist catheter body; J4・
・Balloon; JI... Electrical element; J11 boat; -o1 m apart; &/, $J. Reference J...inner hole; reference g--@port; duct...open hole; dat...conductor; dat...opening; IQ...plug 01j...
·tool.

Claims (1)

Claims: 1. a catheter body formed of a deflectable material and having an elongated tubular wall and having a proximal end and a distal end; 1. a catheter body having a proximal end and a distal end thereof; Part 1lIII! a pressure responsive means attached to the catheter body; , a second lumen parallel to the lumen and separated from it by a longitudinal septum h D , further comprising a second lumen h D within the lumen of the catheter body; a boat communicating with the 20th inner hole and located intermediate between the distal end and the end near the proximal end; and at least one electrical conductor extending through the opening and into the boat of the second bore at the distal end of the opening; leakage of fluid at the ninth lumen, preventing liquid above the distal end of the boat from entering the distal end of the boat in the second lumen and from entering the tenth lumen through the opening; The catheter consists of a sealant plug means providing a barrier free from mold. The catheter of claim 1, wherein the electrical lead is connected distally to an electrical element affixed to the catheter body at the distal end of the boat. 3. The catheter of claim 1, wherein the electrical element is an electrical sensor. The said opening is adjacent to the said boat.
said sealant plug means to prevent contact between said electrical conductor and fluid flowing through said boat;
2. A catheter according to claim 1, wherein a portion of said electrical conductor is recessed. 1. The catheter according to claim 5, wherein the opening is smaller than the boat. the aperture is located at the end of the boat, and the sealant plug means leaktight the aperture and embed a portion of the conductor extending through the aperture; A catheter according to claim 1. The boat is connected to the distal end of the catheter body.
j-J! 8. The catheter of claim 7, wherein the catheter is separated by a distance within the range of a.菰 The pressure responsive means is an inflatable balloon a, ti
8. A catheter according to any one of claims 1 to 7, wherein the first lumen communicates with the balloon through an aperture in the wall of the catheter body. It has a proximal end and a distal end and has a number of parallel bores therein, the glass bores being adapted to contain gas and having a longitudinal direction. A method for installing an electrical conductor into a catheter body which is separated from a second lumen for conducting fluid by a septum, wherein a transverse boat is inserted into the outer wall of said catheter body at a point midway through its length. It has a stage of forming
The boat communicates only with the striped 20 boreholes and defines a tight hole for the inflow and outflow of liquid thereto; introducing a tool to form an opening for interconnecting the rattan and the second inner hole;
1. at least one electrical conductor is arranged in the bore with the proximal portion of the conductor in the first bore above the proximal side of the aperture; A distal end portion is arranged in the second bore over a distal side of the aperture, and an intermediate portion of the conductive wire passes through the aperture and extends from one bore to the other bore. and then sealing the aperture and the second lumen with a sealant plug introduced through the boat distally and into the second lumen to prevent leakage. the liquid then passes through the second lumen between the boat and the proximal end of the catheter body without contacting the lead. A method characterized by allowing flow. 10. The method of claim 1, wherein the aperture is formed in the bulkhead just at the distal end of the boat. the sealant plug is formed of a flowable material capable of changing to a hardened state and is introduced in a flowable state into the second bore, and the sealant plug material is formed of a flowable material capable of changing to a hardened state; 11. The method of claim 10, wherein a portion is embedded within said second bore just at the distal end of said boat. 71 having a proximal end and a distal end and having a number of bores therein, the first of said bores being adapted to contain gas and bounded by a longitudinal partition. In a method for installing an electrical conductor within a catheter body that is separated from a second lumen for conducting
forming a horizontal opening in the outer wall of the catheter body that communicates only with the second inner hole; and forming a side opening large in the outer wall of the catheter body that communicates only with the second inner hole; introducing a tool through the aperture to form an aperture communicating with the aperture, and then inserting at least one electrical conductor into the bore so that a proximal portion of the electrical conductor is located within the aperture. (10) arranged in the inner bore on the proximal side of the aperture, a distal portion of the electrical conductor is arranged in the second inner bore, and a middle portion of the electrical conductor is arranged in the aperture; positioning to grind from one inner hole to another through the hole, and then closing said opening to prevent leakage. The aperture is introduced from a portion of the second inner hole through the horizontal hole and into the second inner hole and separated by a sealant. How to do it. /J wherein said sealant plug is formed of a flowable material capable of changing to a hardened state and introduced in flowable form into said second bore, wherein said sealant plug material: The method according to claim 1, wherein a portion of the electrical conductor is embedded inside the second inner hole and inside the opening.