DE2252478A1 - PROBE INSERTABLE INTO BODY CAVES - Google Patents

Description

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ELECTRO-CATI-IETER CORPORATION, Rahway, New Jersey 07065 / USA

Insertable probe into body cavities

The invention relates to a probe which can be introduced into body cavities, in particular for use in conjunction with a Cardiac pacemaker, which is arranged at the front end of a hose line and has an inflatable element, which can be acted upon by a pressure medium via the hose line. The invention addresses itself quite generally with probes and / or catheters of this type, but especially with those that are used in connection with a pacemaker Find use and have an inflatable element that is inside the body cavities and / or blood vessels can be moved by humans and animals.

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Probes of the type described above have been used widely in medical applications as catheters and cardiac probes for years Technology found. They are inserted into body cavities or blood vessels, with catheters mostly used for treatment of the urinary tract is used to remove urine from the urinary bladder, for example. The catheter is passed through the urethra. There are also probes that have no openings for absorbing body fluids but must be moved in and within relatively small body cavities, e.g. in blood vessels. This must be done without damaging or destroying the blood vessel or organic tissue and without the treated human or animal are caused by the masses of inconvenience.

Probes with balloon-like inflatable elements which can be introduced into body cavities are known in the art. In many cases For example, a bag or balloon made of rubber or other stretchable material is molded onto catheters, around the catheter in place in the vessel or body cavity and hold in place by inflating the balloon when properly positioned. The inflated balloon rests against it the inner walls of the body cavity or the blood vessel, thus touching the body tissue and preventing further movement the catheter or the probe into the vessel.

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However, probes of this known type often cause considerable Damage to the tissue and bring pain and discomfort to the treated patient in particular, when they are inserted and then inflated. Although these probes are made of a relatively flexible and resilient Material exist, the flexibility and resilience affects mainly transverse to the longitudinal axis the normally elongated or tubular shaped probes. It follows that although the hose a catheter can be bent easily to fit the contour a body cavity or a vessel, but the possibility remains that in the longitudinal direction Forces acting on the front end of the probe, which are necessary for the movement of the probe after insertion, are relative are transmitted undamped «,

Another problem with the known balloon-like inflatable Probes consists, lies in the inflation of the balloon itself. Because with these known the balloon itself extends annularly around a continuous section of the hose line at or near its front end, means this means that this continuous hose line is a noticeable lengthening or shortening when it hits the anterior probe tip or the expanded balloon on body tissue. Thus' the pushing forces undamped "transferred directly to the body tissue, so that

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In some cases the tissue is damaged and even torn or pierced.

The object of the present invention is therefore to propose a probe of the type explained at the beginning in which any Impairment of the body tissue with which the probe comes into contact is avoided. This probe should in particular be suitable for stimulating the heart muscle in conjunction with a pacemaker.

According to the invention, this object is achieved in that the probe consists of a front and a rear probe part, which are connected to one another by means of the inflatable element are connected.

The probe according to the invention is thus divided into sections, which are connected to each other by an inflatable balloon that holds the two sections against each other in the It is isolated that no noticeable forces are transmitted between them when the probe is inserted into elongated body cavities is inserted. The probe has a certain, relatively small diameter in relation to the diameter of the blood vessel into which it is to be inserted, so that normal blood circulation during its use is not prevented. The probe according to the invention should in particular Are used for indication and / or training

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Evaluation of cardiac block phenomena, the Adams-Stokes symptom complex, pronounced bradycardia as well as absolute and digitalis-induced arrhythmia.

The present invention solves the object set above and also meets the requirements explained further. In a particularly expedient embodiment, an elongated, relatively flexible hose line is provided, which preferably has a multiple electrode "or at its front end multi-pole pacemaker probe, which regulates the heart rate depending on the outside of the Body generated signals is used. This probe, for example inserted into a patient's right shoulder region through a 14-gauge cannula or incision. The hollow one Probe part is in two parts, where ^ as mentioned, the two parts are arranged at a distance from one another and are different Have lengths. Both parts of the probe are mechanically connected to one another by an inflatable balloon, the encloses the space between the two probe parts in a ring shape. The longer or rear part of the probe carries a Electrode that is connected to an electrical conductor. In the same way, there is one on the front probe part Arranged electrode with which another electrical conductor is connected by soldering. The electrical conductor is opposite the rear electrode and the leading

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renden conductor electrically insulated. Both electrodes are used to stimulate the Merz depending on impulses, which are fed in from a device via the electrical conductors.

Further advantages and features of the present invention emerge from the following description of a preferred one Embodiment based on the accompanying drawings as well as from further subclaims.

It shows:

FIG. 1 shows a partial view of an entire probe arrangement according to the present invention;

FIG. 2 shows an enlarged illustration of the balloon-like probe tip of the probe according to FIG. 1;

FIG. 3 shows a section through the probe tip according to FIG. 2, showing the balloon in the inflated state shows, and

FIG. 4 shows an enlarged cross section, seen in the direction of the arrows 4-4 in FIG.

According to the illustration in FIG. 1, a 2-pole probe arrangement, designated as a whole by 10, with a balloon, which is shown in FIG Connection with a pacemaker for the heart is used, a hose line 12, which between a with

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BADORIQfNAL

Valve provided adapter 14 and the actual probe 16 is located. In a preferred embodiment, there is Hose line 12 made of a chemically and organically non-porous material, for example Corolan (trademark), manufactured by Electro-Catheter Corporation of Rahway, New Jersey. This material can by means of Can be sterilized by heat or chemical action and also has a largely smooth friction arine Surface so that it can be easily inserted into and through body cavities, e.g. veins. It can, however other suitable materials for the hose line 12 can also be used. This includes, for example, a radiation-proof Vinyl that becomes visible on X-rays. The hose line 12 is relatively flexible to allow passage through irregularly shaped body cavities, E.g. to enable veins leading to the heart.

The adapter 14 provided with a valve according to FIG. 1 consists from a Y-shaped plastic or rubber housing 18 with a leg 20 which receives the end of the hose line 12 and is glued or cemented to it airtight. Another leg 22 of the housing 16 holds two insulated electrical conductors 24, 26 extending from leg 22 extend out to conventional plugs 28 and 30. These Plugs can be placed in corresponding, not shown, book _ a device to be explained below.

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BATH ORIGINAL

-S-

2252A78

be faltering. The legs 20 and 22 of the housing are used to relieve stress when receiving the hose line 12 and the conductor 24, 26, so that the risk of breakage is reduced to a minimum. They also serve as airtight connections and thus prevent the inadmissible penetration of air from the environment into the interior of the housing 18 of the adapter.

The larger leg 32 of the housing 18 has a tapering opening ~ $ k which serves to receive the front end of a ventilated injection syringe or an air channel, which is designated by 36 in FIG. In this way, air or some other selected medium can be introduced under pressure through the opening 3 ^, for example by actuating the plunger of the injection syringe 36 in the cylinder, and passed through the hose line 12 to the probe 16. The vented injection syringe 36 is preferably a 2 1/2 cm tip which has an opening in the cylinder at a location corresponding to a content of 1 1/2 cm, in order to prevent the balloon 70, which will be explained below, from bursting . This means that no more medium than 11/2 car can be supplied.

The adapter 14 is preferably equipped with a check valve to prevent an undesired flow of medium or air through the housing 18 and to prevent it to the doctor

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allow the medium pressure in the hose line 12 to monitor. · ■

As shown in FIGS. 2 and 3, the probe 16 has two front sections of the hose line 12 which, for the sake of simplicity, are referred to as the proximal section 38 and the distal section 40 (FIG. 3). In this context, the designations "proximal" and "distal" only serve to define the position in relation to the adapter 14 provided with a valve Hose line 12. received. The proximal portion 38 terminates at the front end 42, which includes an opening 44. The distal portion 40 extends between the rear end 46 and the front end 48, both of which have openings 50 or ₀ 52, and a certain distance from one another comply _s in a preferred embodiment 3 is now. It goes without saying that it is within the scope of the invention to change this distance between 1 and 10 mm, preferably between 2 and 5 mm. ■ "■

The probe 16 also has an annular proximal electrode 54, which with the proximal portion 38 in one small distance from · 'whose end 42 is connected «, The pro-

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ORKWNAL INSPECTED

ximal electrode 54 consists of electrically conductive material, preferably made of platinum. Similarly, a cup-like distal electrode 56 is associated with the distal portion 46 of the tubing connected so that the interior of the distal electrode 56 is the front end 48 of the section 40 includes all around. The distal electrode 56 is also preferably made of platinum or some other material electrically conductive material and has a hollow pointed portion 58 which is the foremost tip of the entire Probe assembly 10 forms. The outer surfaces of the tip part 58 are smooth and low-friction and rounded to to form a blunt convex surface that is as little irritating, pressing or damaging the body tissue as possible.

A predetermined amount of solder 60 within the tip portion 58 of the distal electrode 56 both mechanically connects as well as electrically this electrode with a central supply line 62, which extends through the hose line extends from adapter 14 to sections 38 and 40 and to solder joint 60. It is important that the distal electrode 56 receives a firm mechanical connection with the remaining part of the probe assembly 10, as a Separation of this electrode and / or section 40 in the circulatory system of a patient leads to considerable difficulties, possibly even death. The fixed connection of the distal electrode 56 with the hose

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section 40 by means of the fixed soldering point on the supply line 62 eliminates this danger. Also the arrangement of the inflatable balloon 70 (FIGS. 2 and 3), which follows will be explained in detail below, assists in eliminating this risk of separation. '.

The feed line 62 consists essentially and preferably made of a Teflon-coated, brass-coated, electric Conductor 64, for example made of copper. It is relatively flexible and easy to bend, so that forces are immediate on the tip portion 58, the distal electrode 56, to decrease the distance between the ends 42 and 46 of the hose sections. A lead wire 68 extends through the proximal tube section 38 to and through an opening 66 through that in the wall of the proximal tube ab ™. section 38 is formed. Subsequent to this opening, the lead wire 68 forms mechanical and electrical ones Contact with the proximal electrode 54, what for example is achieved by soldering or welding. The conductor 64 and the wire 68 are electrically against each other " insulated by the Teflon coating over the entire length of the conductor 64. They are mechanical and electrical with connected to conductors 24 and 26 in adapter 14 and are thus also connected to plugs 28 and 30. Instead of of the two conductors 64 and 24 could also be a single

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ger ladder must be present. The same applies to the two conductors 68 and 26.

In the drawings, a balloon 70 is also shown, the in Figure 2 in unloaded and in Figures 3 and 4 in inflated State can be seen. The balloon 70 consists in a preferred embodiment of a latex tube that ring-shaped and in a firm, airtight adhesive connection with the outer surfaces of the front end 42 of the section 38 and the rear end 46 of section 40 surrounds these ends. The connection of the inner ends of the balloon 70 with the "hose sections 38 and 40 can be glued, Be welded or melted down or produced by some other suitable measure. The balloon 70 can also consist of suitable stretchable materials other than latex that are inert and subject to heat or chemicals can be sterilized.

From the above it follows that by introducing a flowing medium, preferably air, under a predetermined pressure in the hose line 12 from the injection syringe 36, the balloon 70 is gradually stretched is and both radially and in the longitudinal direction from the relaxed design shown in Figure 2 to the in Figure 3 expands. Radially, it has a diameter of approximately a quarter to a half

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the diameter of the blood vessel in which it is located is. The longitudinal expansion of the balloon TO in turn causes the distal electrode 56 to separate from the proximal electrode 54 is pushed away, so that the distance between the ends 42 and 46 of the hose sections 38 and 40 increases again. After releasing the balloon 70 ', however, moves section 40 back towards its original distance from section 38.

In use, the probe 16 becomes the entire assembly 10 through an insert or percutaneous needle inserted into a The patient's skin incision is inserted into a Blood vessel inserted, then the probe 16 together with the parts of the hose line 12 located in the blood vessel through the blood vessel in the direction manipulated to the heart 12 there is no overpressure above atmospheric pressure. Either by determining the length of the hose line inserted or by monitoring the position of the probe 16 in a relatively precise positioning of the proximal and distal electrodes can be established in a conventional manner. Once the balloon 70 has arrived in the upper hollow artery, it is expanded in the manner described above and pushed the expanded probe into the right ventricle. The balloon is then relieved and the

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SAD ORIGINAL

Probe stabilized in the apex of the chamber. The location of the probe can be determined by means of X-rays or by fluoroscopy be verified.

The plug contacts 28, 30 are then connected mechanically and electrically to an electrocardiograph, so that it is possible to monitor the position of the distal electrode, and finally the connection is made to a pulse generator, for example a so-called "pacemaker". Through this pacemaker generated electrical pulses reach the proximal and distal electrodes 54 and 56, respectively, and thereby stimulate the rhythmic contractions of the heart, commonly known as heartbeats.

During the insertion of the probe, the tip part can with body tissue in on the way towards the heart Come into contact, as the path prescribed by the blood vessel is very irregular. This contact with body tissue will hinder further advancement of the probe and result in both tissue displacement and Lead generation of forces at the probe tip. As a result of this, the distal tube section 40 becomes in the direction of moved onto the proximal tube section 38. The result of this relative movement between the two sections given safety precaution prevents the passage

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poking out of body tissue and based mainly on the existence of the distance between the two sections as well as the resilient compressibility of the relaxed balloon 70. In this way, the forces occurring in the proximal tube section 38, which are required to move the probe forward, not transferred directly to the body tissue, but rather captured by the cushioning effect of the compressible balloon 70.

Another security precaution, according to the invention is based on the properties of the probe, once properly positioned and the balloon 70 inflated shall be. After the balloon 70 has been inflated in the manner explained above, its outer walls should gradually come into contact with the inner tissue walls of the body cavity in which the probe is located and lean on them. At the same time, however, the pressure in the hose line 12 rises, which leads to a corresponding increase the supporting forces against these tissue walls, because the balloon wants to expand due to the pressure. the The present invention prevents these support forces from assuming dangerous proportions by extending them of the balloons 70 when it passes through body tissue is hindered in any way in the outward expansion, i.e. transversely to the axis of the hose line 12,

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and by continuing to separate the hose sections 38 and 40 from each other due to their resilient connection by means of the balloon 70 allowed. Is significant thus for the invention that once the balloon 70 is inflated, a movement of one of the sections 38 or 40 is not transferred directly to the body tissue, but to a deformation of the resiliently pressurized Balloons leads. In both cases, i.e. in the case that the balloon 70 is relaxed as well as in the case that it is inflated, the probe 16 or its individual parts develop greater flexibility and flexibility, than this was previously possible. Ss are larger angular displacements the distal electrode 56 from its normal position than in the previously known rigid continuous ■ Hose lines possible. In addition, it clearly emerges from FIG. 3 that at the attachment points of the balloon 70 lower torsional and shear stresses occur at the hose sections 38 and 40 than in the known ones Balloon formations, which can also be attributed to the interruption or gap between the two sections is. The ability of the two tube sections 38 and 40 to move away from each other results in another Relief of stress concentrations at the points where the annular balloon connects these sections connects.

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It goes without saying that, despite the above explanation, a one or two-pole probe for use with a Pacemakers in persons; this probe with its described safety properties also has a special one Can be used advantageously in veterinary medicine., A single-pole version is used in the form that a second electrode is attached to the patient's skin. Furthermore, it is within the scope of the invention that the balloon-like probe structure can also be used in medical applications in which a Pacemaker is used, for example in the healing of an embolism in a person or in a Animal. In this case, the inflatable balloon 70 is used to clear an obstruction in the circulatory system.

The essence of the probe according to the invention therefore consists in that it has a relatively flexible holding part (balloon) that can be inflated or expanded by means of pressure means, which lies between the two spaced apart electrodes of the probe.

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Claims (11)

Patent (protection) claims { 1. I in body cavities insertable probe, in particular for use in connection with a pacemaker, which is arranged at the front end of a hose line and has an inflatable element that can be acted upon by a pressure medium via the hose line, characterized in that the probe consists of a front (40) and a rear (38) probe part, which are connected to one another by means of the inflatable element (70). 2. Probe according to claim 1, characterized in that the inflatable element consists of an elastic material Balloon (70) attached to the front and rear probe parts (40, 38). 3. Probe according to claim 1 or 2, characterized in that at least on the front probe part (40) one Electrode (56) is provided for stimulating and regulating the heart rate. 4. Probe according to one or more of claims 1 to 3, characterized in that on both probe tails 309844/0785 (38, 40) electrodes (54, 56) are provided,. 5. Probe according to claim 3 or 4, characterized in that that through the hose line (12) to the electrodes (54, 56) there are electrically isolated lines (62, 63) extend. 6. Probe according to claim 5, characterized _in that the electrodes (54, 56) are connected to a cardiac pacemaker via the lines (62, 68). 7. Probe according to one or more of claims 1 to 6, characterized in that with the hose line (12) an adapter (14) provided with a valve is connected to the end of a pressure medium line records. 8. Probe according to one or more of claims 1 to 7, characterized in that the front and rear probe valve (40, 38) consist of sections of the hose line (12) that the rear probe part (38) has a greater length than the front Probe part (40) and is connected to the interior of the inflatable element (70) via an opening (44), and that the mutually facing ends (42 _} 46) of the rear and front probe parts (38, 40.) are in a variable distance. 309844/0785 stand from each other. 9. Probe according to claim 8, characterized in that the inflatable element (70) is fastened between annular surfaces located on the probe parts (38, 40). 10. Probe according to one or more of claims 3 "to 9» characterized in that the electrodes (54, 56) are designed as platinum sleeves which are firmly connected to the outer surfaces of the probe parts (38, 40), wherein the rear probe part (38) has an opening (66) through which the leading to the electrode (54) Conductor (68) is passed through, and the electrode (56) assigned to the front, probe part (40) is cup-like formed on the outer surface of the probe part (40) attached and with the conductor (62) extending through both probe parts (38, 40) from the inside is firmly soldered here. 11. Probe according to one or more of claims 1 to 10, characterized in that with the hose line (12) a ventilated syringe is connected, by means of which a predetermined pressure in the inflatable Element can be generated. 30984 4/07 8 5