US3837347A - Inflatable balloon-type pacing probe - Google Patents

Abstract

A catheter device having a tubular assembly with a forward probe portion including spaced proximal and distal members having electrodes secured thereto and being provided with inflatable means comprising a balloon member interconnecting said members; and fluid receiving means in communication with the probe portion for dilating said balloon member upon exposure to fluid introduced under pressure through the fluid-receiving means.

Description

finite tates i tet [19 Tower Sept. 24, 1974 INFLATABLE BALLOON-TYPE FACING 3.397.699 8/1968 K0111 1214/349 R PROBE 3,528,406 9/1970 Jcckc1clu1...... 128/2115 R 3,599,620 8/1971 Balin 1 128/3491) Inventor: Allen J- Tower, d g NJ. 3,674,014 7 1972 Tillandcr 128/2.05 R 3,680,544 8/1972 Shinnick eta1.. [28/419 P [73] Asslgnee' glfggg i g corporat'on 3,707,960 1/1973 Freed .1 128/2.06 E

[22] Filed: Apr. 20, 1972 Primary Examiner-William E. Kamm {21] pp NO 245 938 Attorney, Agent, or FirmLilling & Siegel 57 ABSTRACT [52] US. Cl. 128/404, 128/344, 128/349 B, t 1

128/419 P A catheter device having a tubular assembly with a [51] Int. Cl .2. A61n 1/04 forward probe portion including Spaced proximal and [58] Field of Search 128/4O4 419 P 340 B distal members having electrodes secured thereto and 128/340 D 340 E 205 R 6 E R being provided with inflatable means comprising a bal- M 6 R 349R loon member interconnecting said members; and fluid 1 receiving means in communication with the probe [56] References Cited portion for dilating said balloon member upon exposure to fluid introduced under pressure through the UNITED STATES PATENTS fluid receiving means. 3,087,492 4/1963 Garth 128/350 R 3,348,548 10 1967 Chardack 128/419 P 8 Claims, 4 Drawmg Flgllles INFLATABLE BALLOON-TYPE PACING PROBE This invention relates generally to insertion probes and/or catheters and, more specifically, to an inflatable balloon-type pacing probe capable of being moved within body cavities and/or blood vessels of persons and animals.

The medical professions have enjoyed considerable success over the years using devices such as catheters and probes, which are introduced or inserted into body channels and blood vessels. Catheters are most frequently employed within the urinary tract to withdraw urine from the bladder, for example, by passing the catheter through the urethra or passage through which urine is normally discharged. Probes, on the other hand, which are not provided with openings to receive body fluids, must also be capable of insertion into and movement within relatively small body cavities, such as blood vessels, without injuring vessel and organ tissues or causing discomfort to the patient or animal being treated.

While the present invention is principally directed to probes for use in pacing or regulating the heartbeats of a person or animal, it is contemplated and within the scope of this invention to provide medical personnel with insertion apparatus such as probes and the like equipped with structural safety features which minimize or eliminate tissue damage and discomfort.

Balloon-type insertion devices are well known to the art. In many instances a bag or balloon formed of rubber other stretchable material is provided on catheters, for example, to retain the catheter within a body channel by inflating the balloon once the device is properly located. The expanded bag or balloon contacts the tissue walls defining the body channel and further movement into or out of the channel is prevented. Such insertion devices known to the art, however, often cause considerable tissue damage and patient discomfort both when being inserted as well as when being inflated. Although such devices are fabricated of relatively flexible and resilient material, most of these flexibility and resilience characteristics are exhibited in transverse directions with respect to the relatively longitudinal axes of these normally elongated tubes. Thus, while the tube of a catheter will easily bend to conform to the contour of a body channel, there yet will be an uncushioned relatively longitudinal transfer of forces to the forward tip or end of this tube which are required to advance it upon insertion.

Another problem associated with conventional balloon-type insertion devices concerns itself with the inflation of the balloon. Here again, since conventional devices already described are formed with a balloon extending annularly around a continuous portion of the tubing near or adjacent its forward tip, the presence of a continuous length of tubing prevents substantial elongation or shortening of this tube when body tissue is contacted by either the forward tip of this tubing or the expanded balloon. Forces are thus transmitted directly to the tissue without being cushioned and, as is sometimes the case, tissue walls are damaged or even punctured or torn.

Accordingly, it is an object of the present invention to provide a balloon-type, flow-directed insertion device equipped with safety cushioning means for preventing tissue damage.

Another object of the present invention is to provide a novel balloon-type pacing probe for use in stimulating the hearts muscles.

Yet another object of this invention is to provide a segmented insertion device for use within elongated cavities wherein thesegments are joined by an inflatable balloon adapted to isolate forces from being transmitted between segments.

A further object of my invention is to provide a segmented balloon-type pacing probe for use within body blood vessels, and which is of a predetermined relatively small diameter with respect to the diameter of said blood vessels, such that the normal flow of blood is not restricted during its use.

Yet another object of the present invention is to provide a flow directed, balloon-type pacing probe for use in indicating and/or evaluating heart block Adams- Stokes seizures, marked bradycardia, ventricular tachy-arrhythmias and digitalis induced arrhythmias.

The present invention fulfills the aforementioned objects and overcomes limitations and disadvantages of prior art solutions to problems associated with this art. According to one aspect of the invention, an elongated, relatively flexible tubular assembly is formed with a hollow resilient insertion tube extending between forward and rearward ends thereof. The assembly is preferrably provided at its forward end with a multielectrode or multi-polar pacing probe capable of regulating the frequency of heartbeats in response to signals generated outside the body. This probe is introduced,

for example, into the right shoulder region of the patient via a 14 gauge cannula or cut-down. The hollow insertion tube is formed in two spaced segments of different lengths which are mechanically interconnected by an inflatable balloon which, in turn, extends annularly about the space between said segments. The longer or proximal tube segment carries a proximal electrode to which an electrical conductor is secured. The shorter or distal tube segment carries a distal electrode to which another electrical conductor is soldered and which is electrically insulated from the proximal electrode and its respective conductor. Both the proximal and distal electrodes serve to stimulate the heart in response to impulses carried to them from remote signal-generating apparatus via said conductors.

The invention will be more clearly understood from the following description of a specific embodiment of the invention, together with the accompanying drawings, wherein similar reference characters denote similar elements throughout the several views, and in which:

FIG. 1 is a fragmentary view of the entire probe assembly according to one embodiment of the invention;

FIG. 2 is an enlarged fragmentary view of the insertion balloon-type tipor probe portion of the invention shown in FIG. 1;

FIG. 3 is a cross-sectional elevational view of the insertion tip or probe portion of FIG. 2, illustrating the balloon in its inflated condition; and

FIG. 4 is an enlarged cross-sectional elevational view looking along line 4-4 of FIG. 3.

Referring now in more detail to the drawing, in FIG. 1 a balloon-type bi-polar pacing insertion assembly, generally designatednumeral 10, is shown to include elongatedhollow tubing 12 which extends between avalved adaptor assembly 14 and aprobe assembly 16.

Tubing 12, is a preferred embodiment of the invention, consists of a chemically and organically nonporous material such as Corolan which is manufactured by the Electro-Catheter Corporation of Rahway, New Jersey, and which is capable of being sterilized by heat or chemical action, and which further has a substantially smooth, low-friction surface so as to be capable of easy insertion into and through a body cavity, such as a vein. Other suitable materials may be substituted fortubing 12 and are contemplated by this invention, including, without limitation, radio opaque vinyl-type tubing which is visible by X-ray. Tubing 12 is relatively flexible to permit its passage through irregular body channels such as the veins leading to the heart.

Valved adaptor assembly 14, as shown in FIG. 1, consists of a Y-shaped plastic orrubber housing 18 formed with a leg orend 20 which receives and is secured airtightly to the rearward end oftubing 12, such as by potting or cementing. Another leg orend 22 ofhousing 18 holds two insulated electrical wires or conductors 24 and 26, which extend fromhousing end 22 at their most rearward ends to maleelectrical connector pins 28 and 30, respectively.Connector pins 28 and 30 are of a conventional type which will matingly engage electrical sockets (not shown) of remote apparatus, described in more detail below. Housing legs orends 20 and 22 serve as strain-reliefs in receivingtubing 12 and conductors 24 and 26 such that the possibility of breakage or fracture is minimized. Legs orends 20 and 22 further serve as air-tight junctions, thereby preventing the undesirable flow of air between the interior ofadaptor assembly housing 18 and the environment.

Larger leg orend 32 ofhousing 18 is formed with atapered opening 34 which is adapted to receive the forward end of a vented-type syringe, or air duct, designatedreference numeral 34 in FIG. 1. Thus, air or another pre-selected fluid may be introduced under pressure through opening 34, such as by moving the plunger of a vented syringe 36 forward within its barrel, and thereafter throughhollow tubing 12 towardprobe assembly 16. Vented syringe 36 is preferably a 2% cubic centimeter (cc) syringe formed with a hole through its barrel at a location corresponding to 1 %cc, thereby preventing the possibility of burstingballoon 70, described below. No more than 1 /2 cc of fluid is thus introduced.Adaptor assembly 14 is preferable equipped with a valve of a type known to the art, for preventing undesirable fluid or air flow through thehousing 18, as well as to enable personnel to control the fluid pressure withintubing 12.

Looking now atprobe assembly 16 in FIGS. 2 and 3, it is seen thatassembly 16 comprises two forward segments oftubing 12 which, for convenience, are designatedproximal tubing segment 38 anddistal tubing segment 40 in FIG. 3. The adjectives proximal and distal are hereinafter used merely to denote locations with respect to valvedadaptor assembly 14.Distal segment 40 is substantially shorter thanproximal segment 38 and is preferable formed by severing a predetermined length of tubing from the forward end oftubing 12.

Proximal tubing segment 38 terminates at aforward end 42 which defines anopening 44.Distal tubing segment 40 extends between itsrearward end 46 and a forward end 48, bothends defining openings 50 and 52, respectively.Forward end 42 and rearwardend 46 are spaced from one another a predetermined distance which, in a preferred embodiment of the invention, is three (3) millimeters. It is within the scope of this invention for this distance to vary, preferably between two (2) and five (5) millimeters, although my invention contemplates a spacing of from one (I) to ten (10 millimeters.

Probe assembly 16 further includes an annularproximal electrode 54 which is bonded to tubing segment 38 a small distance fromforward end 42. Proximal electrode '54 is formed of an electrically conductive metal, preferably platinum. Similarly, a cup-shapeddistal electrode 56 is bonded todistal tubing segment 40 such that the interior ofdistal electrode 56 annularly surrounds and encloses forward end 48 ofsegment 40.Distal electrode 56 is preferably made of platinum or other suitable electrically conductive material, and is formed with ahollow nose portion 58 which constitutes the forwardmost tip ofinsertion assembly 10. The outer surfaces ofnose portion 58 are smooth and frictionless, and are rounded to provide a blunt convex surface designed not to irritate, puncture or damage body tissue.

A predetermined quantity ofsolder 60 located within thehollow nose portion 58 ofdistal electrode 56 firmly, both mechanically and electrically, securesdistal electrode 56 to acentral cabe assembly 62 which, in turn, extends relatively longitudinally through the confines of tubing fromadaptor assembly 14 tosegments 38 and 40 and thereafter to solder 60. It is important here to emphasize the importance of the strong mechanical locking ofdistal electrode 56 to the remainder of theinsertion assembly 10 since, as it should be apparent, separation of the distal electrode and/ortubing segment 40 within the circulatory system of a patient could result in substantial injury, or possibly death. The firm bonding ofdistal electrode 56 totubing segment 40, coupled with the firm soldered bond ofdistal electrode 56 tocable assembly 62 effectively precludes this danger. The presence of an inflatable bag orballoon 70, shown in FIGS. 2 and 3 are described in more detail below, serves to yet further eliminate this danger of separation.

Cable assembly 62 preferably comprises a Teflon coated, brass platedelectrical conductor 64, such as copper (Teflon is a registered trademark of the E. I. du- Pont de Nemours, Inc. of Wilmington, Delaware).Assembly 62 is relatively flexible and easily bends such that forces applied directly to thenose portion 58 ofdistal electrode 56 will result in a lessening of the distance between tubing segment ends 42 and 46. Aconductive wire 68 extends throughproximal tubing segment 38 ofelongated tubing 12 to and through anaperture 66 formed through the wall ofproximal tubing segment 38, and thereafter to and in mechanical and electrical contact withproximal electrode 54, such as by soldering or brazing.Conductor 64 andwire 68 are electrically insulated from one another by virtue of the presence of the Teflon coating around the length ofconductor 64.Conductor 64 andwire 68 are mechanically and electrically connected withinadaptor assembly 14 to conductors 24 and 26, respectively, and thus, also to connector pins 28 and 30, respectively. It is contemplated by and within the scope of the present invention to substitute a single conductor or wire in the place ofconductors 64 and 24; and similarly, to substitute a single conductor or wire in the place ofwire 68 and conductor 26.

An inflatable bag orballoon 70 is shown relaxed in FIG. 2 and inflated in FIGS. 3 and 4.Balloon 70, in a preferred embodiment of this invention, comprises a latex tube which extends annularly over and in firm airtight, bonded contact with the outer surfaces of bothforward end 42 oftubing segment 38 and rearward end 46 oftubing segment 40. Bonding of the inner extremities ofballoon 70 totubing segments 38 and 40 may be accomplished by cementing, heat-induced welding or fusion, or other suitable conventional means.Balloon 70 may be fabricated from suitable stretchable materials other than latex, which are inert and which are capable of being sterilized by heat or chemical action.

It should now be apparentthatfluid, preferably air, introduced under predetermined pressures intoelongated tubing 12 by syringe 36, for example, will causeballoon 70 to gradually stretch or expand both radially outwardly to a diameter approximately one-quarter to one-half the diameter of the blood vessel within which it is situated, as well as longitudinally from the relaxed position shown in FIG. 2 to that shown in FIG. 3. The longitudinal expansion ofballoon 70, in turn, causesdistal electrode 56 to be biased away fromproximal electrode 54, such that the spacing or distance between ends 42 and 46 oftubing segments 38 and 40 is increased. Upon deflation ofballoon 70,segment 40 will once again return to its original spacing fromsegment 38.

In use, theprobe assembly 16 ofinsertion assembly 10 is caused to enter a blood vessel through a placement or percutaneous needle inserted through an incision made in the skin of a patient, and probeassembly 16 together with portions oftubing 12 are manipulated through the blood vessel toward the heart. This is accomplished with theballoon 70 completely relaxed and without the presence of pressures greater than atmospheric pressure withintubing 12. Either by noting the length oftubing 12 inserted, or by monitoring of the location ofprobe assembly 16 in a conventional manner known to the medical arts, a relatively precise positioning of the proximal and distal electrodes is accomplished. Once positioned within the superiorvena cava balloon 70 is inflated in the manner heretofore described and the inflated probe assembly is advanced to the right ventricle of the heart, whereupon the balloon is deflated and the probe assembly is stabilized in the apex of the ventricle. The position of the probe can be verified by X-ray of the patients chest, or fluoroscopy.

Connector pins 28 and 30 can be mechanically and electrically connected to an electrocardiograph apparatus, so that monitoring of the position of the distal electrode has been enabled, and thereafter connected to an impulse generator, such as a Pacemaker, a registered trademark of the Electro-Catheter Corporation of Rahway, New Jersey. Electrical impulses generated by the Pacemaker are carried to proximal anddistal electrodes 54 and 56, thereby stimulating the rhythmic contractions within the heart commonly known as heartbeats.

During the insertion of the probe,nose portion 58 may come into contact with body tissue on its journey towards the heart, clue to the irregular path defined by the blood vessel. This contact with body tissue will impede the progress of the probe and will both result in displacement of the tissue, and will create forces on the probe tip or nose. The result will be movement ofdistal tubing segment 40 andproximal tubing segment 38 towards one another. This safety feature of relative movement as between these segments prevents the puncturing of body tissue and is facilitated by both the presence of the space between the segments, as well as the resilient compressibility of therelaxed balloon 70.

Thus, forces existing inproximal tubing segment 38 necessary to advance the probe will not be transmitted directly to body tissue, but will be absorbed by the cushioning effect of thecollapsible balloon 70.

Yet another novel safety feature of this invention resides in the characteristics exhibited byprobe assembly 16 once it has been properly positioned and it is desired to inflateballoon 70. Upon inflation of balloon in the manner described, should the outer walls of the balloon gradually contact and come to bear against the inner body tissue walls defining the cavity within which the probe assembly has been positioned, increases in pressure withintubing 12 will result in corresponding increases in bearing forces against this wall tissue as a result of the balloons attempts to expand under this pressure. The present invention prevents these bearing forces from becoming dangerously excessive by permitting elongation ofballoon 70 when restrained by body tissue from expanding outwardly or transversely from the axis oftubing 12, and by permitting a separation oftubing segments 38 and 40 from one another by virtue of their resilient interconnection withballoon 70. It is also significant that onceballoon 70 has been inflated, movement of either ofsegments 38 or 40 will not be carried directly to the body tissue, but will result in a flexing of the resilient pressurized balloon.

Both in the case just described whereballoon 70 is relaxed, as well as in the case where the balloon is being inflated,probe assembly 16 and its elements exhibit a greater flexibility and resilience than heretofore made possible in the art. Greater angular displacements ofdistal electrode 56 from its normal longitudinal axis are possible with this electrode than are possible with known, more rigid continuous tubings. Furthermore, FIG. 3 clearly illustrates the fact that less angular and shear stresses will be present at the points of securement ofballoon 70 totubing segments 38 and 40 than in prior art-type balloon devices, due to the break or gap between these segments. The ability ofsegments 38 and 40 to move away from one another greatly relieves any stress concentrations at the points at which the annular balloon joins these segments.

While the invention has been described for a single pole or bi-polar pacing probe for use in persons, it is contemplated that the safety features of the invention have considerable advantageous use in veterinary medicine. A single pole device may be employed wherein a second electrode is positioned on the patients skin. It is also contemplated and within the scope of this invention that a balloon-type probe strucure of the type described may be used in non-pacing medical applications, such as the curing of an embolemia within a person or animal, by utilizing theinflatable balloon 70 to remove a clot from the circulatory system.

The embodiment of the invention particularly disclosed is presented merely as an example of the invention. Other embodiments, forms and modifications of the invention coming within the properscope of the appended claims will, of course, readily suggest themselves to those skilled in the art.

What is claimed is:

l. A pacing and sensing catheter device for use within body cavities, comprising: an elongated tubular assembly formed at a forward end thereof with a probe portion adapted to be inserted into and moved within said body cavities, said tubular assembly being further formed at a rearward end thereof with means communicative with said forward end for receiving a fluid; said probe portion including spaced proximal and distal members and proximal and distal electrodes secured to said proximal and distal members, respectively; a first conductor electrically connected to said proximal electrode, a second conductor electrically connected to said distal electrode, and said first and second conductors being electrically insulated from each other; inflatable means formed of an elastic material secured to and interconnecting each of said spaced proximal and distal members; and said inflatable means, comprising a balloon member adapted to be inflated upon fluid introduced under pressure through said fluid receiving means, whereby the forward end of said probe portion is resiliently mounted for inhibiting the transfer of forces between said proximal and distal members.

2. The device according to claim 1, wherein said first and second electrical conductors are elongated and extend in spaced relationship within said tubular assembly.

3. The device according to claim 2 for use with remote heartbeat pacing apparatus, further comprising first and second electrical connectors secured to said first and second conductors, respectively, for electrically interconnecting said proximal and distal electrodes with said remote apparatus.

4. The device according to claim 3, wherein said proximal and distal members comprise spaced segments of said elongated tubular assembly, said proximal member being substantially longer than said distal member and being formed with a forward end which defines an opening communicative with interior walls of said balloon member, said distal member extending between forward and rearward ends thereof which define foward and rearward openings, respectively, the forward end of said proximal member and the rearward end of said distal member being disposed in variably juxtaposed relationship with respect to one another.

5. The device according toclaim 4, wherein said balloon member is secured to and extends between outer annular surfaces of said proximal and distal members adjacent the juxtaposed ends thereof.

6. The device according to claim 5, wherein said proximal electrode comprises an annular platinum sleeve secured to the outer surface of said proximal member, said proximal member being formed with an aperture through which said first electrical conductor extends to said proximal electrode, said distal electrode comprising a cup-shaped platinum member surrounding the forward end of said distal member and being secured to the outer annular surface of said distal member, said second electrical conductor extending from within said proximal member through the rearward and forward ends of said distal member, and being electrically connected to said cup-shaped distal electrode by a soldered deposit disposed within and in electrical contact with the inner portion of said cup-shaped distal electrode.

7. The device according to claim 1, wherein said fluid receiving means comprises an adaptor formed with an opening which is adapted to matingly accept an end of a fluid bearing conduit.

8. The device according to claim 7, further including a vented syringe adapted to be sealingly connected to said fluid bearing conduit for pressurizing said balloon member to a pre-determined value.

Claims (8)

1. A pacing and sensing catheter device for use within body cavities, comprising: an elongated tubular assembly formed at a forward end thereof with a probe portion adapted to be inserted into and moved within said body cavities, said tubular assembly being further formed at a rearward end thereof with means communicative with said forward end for receiving a fluid; said probe portion including spaced proximal and distal members and proximal and distal electrodes secured to said proximal and distal members, respectively; a first conductor electrically connected to said proximal electrode, a second conductor electrically connected to said distal electrode, and said first and second conductors being electrically insulated from each other; inflatable means formed of an elastic material secured to and interconnecting each of said spaced proximal and distal members; and said inflatable means, comprising a balloon member adapted to be inflated upon fluid introduced under pressure through said fluid receiving means, whereby the forward end of said probe portion is resiliently mounted for inhibiting the transfer of forces between said proximal and distal members.

2. The device according to claim 1, wherein said first and second electrical conductors are elongated and extend in spaced relationship within said tubular assembly.

3. The device according to claim 2 for use with remote heartbeat pacing apparatus, further comprising first and second electrical connectors secured to said first and second conductors, respectively, for electrically interconnecting said proximal and distal electrodes with said remote apparatus.

4. The device according to claim 3, wherein said proximal and distal members comprise spaced segments of said elongated tubular assembly, said proximal member being substantially longer than said distal member and being formed with a forward end which defines an opening communicative with interior walls of said balloon member, said distal member extending between forward and rearward ends thereof which define foward and rearward openings, respectively, the forward end of said proximal member and the rearward end of said distal member being disposed in variably juxtaposed relationship with respect to one another.

5. The device according to claim 4, wherein said balloon member is secured to and extends between outer annular surfaces of said proximal and distal members adjacent the juxtaposed ends thereof.

6. The device according to claim 5, wherein said proximal electrode comprises an annular platinum sleeve secured to the outer surface of said proximal member, said proximal member being formed with an aperture through which said first electrical conductor extends to said proximal electrode, said distal electrode comprising a cup-shaped platinum member surrounding the forward end of said distal member and being secured to the outer annular surface of said distal member, said second electrical conductor extending from within said proximal member through the rearward and forward ends of said distal member, and being electrically connected to said cup-shaped distal electrode by a soldered deposit disposed within and in electrical contact with the inner portion of said cup-shaped distal electrode.

7. The device according to claim 1, wherein said fluid receiving means comprises an adaptor formed with an opening which is adapted to matingly accept an end of a fluid bearing conduit.

8. The device according to claim 7, further including a vented syringe adapted to be sealingly connected to said fluid bearing conduit for pressurizing said balloon member to a pre-determined value.

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