CA1289833C

CA1289833C - Working well balloon angioscope and method

Info

Publication number: CA1289833C
Application number: CA000557357A
Authority: CA
Inventors: Robert A. Mackin
Original assignee: Individual
Current assignee: Individual
Priority date: 1987-01-28
Filing date: 1988-01-26
Publication date: 1991-10-01
Anticipated expiration: 2008-10-01
Also published as: EP0283661A2; EP0283661A3; JPH01221133A; US4784133A

Abstract

ABSTRACT

A transparent plastic collapsible balloon is attached to the distal end of a flexible bronchoscope or angioscope. The inflatable balloon has a cavity or "working well" at its distal end which communicates by means of a tube with the central channel of the angioscope. Separate channels of the angioscope allow inflation of the balloon after it has been introduced into a vein or artery and visualization of tissue against which the distal end of the balloon is pressed. A laser fiber, forceps, or other instrument can be passed through the central channel of the angioscope, and through an opening in the distal end of the balloon into the working well cavity to allow lasing or other procedures to be performed on tissue abutted by the balloon and isolated by the working well cavity, and to also allow direct visualization of such procedures.

Description

1 : :C~LI~l~

3 The lnvention rel~te~ to anqio8cope~ and pro~edures 4 us1ng angioscopes, and particularly to Pn ~ngloscope ¦ having on $ts distal end a tran~parent balloon having a distal cavity that communicates with a central channel of 71 the angioscope to allow passage of laser fibers, biopsy 81 forceps, or other instrument through the transparent 9¦ balloon and into the distal cavity.

11¦ Fiber optic cardioscopes and angioscopes have been 121 developed to allow visualization of $ntravascular or 13¦ intracardiac structures without performing a major 14¦ surgical procedure suc~ as a thoracotomy to accomplish 15¦ such visualization. In these devices, an inflatable 16¦ transparent balloon is attached to the distal end of the 17¦ cardioscope. After the instrument is inserted into a 18¦ blood vessel, the balloon is inflated and the instrument 19¦ is advanced through the vein or artery to the desired 20¦ location. The inflated balloon serves to displace blood, 21 ¦ and when the lumen is occluded or the balloon comes in 22¦ contact with the endothelium of a vessel or cardiac 23 ¦ structure, direct viewing can be accomplished. Originally 24 ¦ referred to as cardioscopes, fiber optic cardioscopes have 25 ¦ become smaller in diameter and have come to be referred to 26 ¦ as angioscopes to reflect their utility in intracardiac 27 l .: ~
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1 and lntr~va6cular vlewing. More recently, angio6copy haR

2 been of u6e for d1agnosis and therApy of systemlc, 3 coronary snd pulmonary 8y8tems. One pre~ently known 4 flexible fiber optic ang~oscope des~gn, which perhaps is the closest prlor art, includes an inflatable end-balloon 6 attached to the distal end of the flberoptic angioscope.
7 A hollow inflation channel, a light channel, and a viewing 81 channel communicate with the interior of the balloon.
9¦ Following insertion of the end balloon into a vessel, the 10¦ balloon is inflated with air or liquid. The balloon 11¦ serves to occlude a blood vessel or is abutted against an 12¦ intracardiac structure or the like, and visualization is 13¦ accomplished. Another design includes an inflatable 14¦ balloon positioned nea'r but not at the end of the angioscope and is referred to as a near-end-balloon 16¦ angioscope. After passage of the near-end-balloon 17¦ angioscope into a vessel, the balloon is inflated, which 18¦ retards blood flow. A solution such as saline is flushed 19¦ through a central channel of the catheter to clear blood from the area to be viewed. A third design of prior 21¦ angioscopes incorporates no balloon ln its basic 22¦ structure. Instead it is passed through a guiding 23 ¦ catheter, which itself may or may not have an inflatable 24 ¦ balloon, to the area to be viewed. Saline or other 25 ¦ solution is flushed to clear the area to be viewed through 26 ¦ the guiding catheter or a hollow channel in the 228 angioscope. As a practical matter, the end-balloon ~ 3 angioscope can be used only in diagnosis to allow accurate viewing of intravascular structures, etc., but doe~ not seem adaptable to therapeutic procedures, because biopsy forceps, laser fibers and the like cannot be physically pas~ed through the balloon wall without damaging the balloon.

Thus, there remains an unmet need for an improved angioscope structure and method that permit both intracardiac and intravascular visualization, and which al~o permits accurate lasing, biop~y, or other mechanical procedures to be accomplished on the viewed surface.
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1 SUMMARY OF THE INY~TTQN

3 Accord$ngly, it 16 ~n object of the lnvention to 4 provide ~ angioscopic structure ~nd technique for accomplishing direct visualization of abutted tissue, and 6 simultaneous performing of laser or other procedures on 7 the visualized area.

It is another object of the invention to provide an angioscopic structure and technique that avoids damage to 11 an inflated end-balloon structure by laser energy or 12 mechanical structure utilized to perform procedures on the 13 visualized area beyond the balloon.
14 r Briefly described, and in accordance with one 16 embodiment thereof, the invention provides an angioscope 17 including a transparent balloon, a flexible catheter 18 having a first channel and second and third channels 19 opening into the interior of the balloon, and a,tube extending between thè distal end of the first channel r and 21 extending through the transparent balloon, and opening 22 into a region beyond a distal portion of the transparent 23 balloon, an optical fiber passing through the second 24 channel from a light source to produce light that emanates from the distal end of the catheter, an optical fiber and 27 means for effectuating viewing of the region illuminated ., ' .

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~ 3 1 by ~he light source, and an apparatus pa~sing through the 2 flrst channel and the tube to the reglon beyond the d$stal 3 portion of the tran~parent balloon for lnteracting with 4 tissue or substance illuminated by ~he light ~ource. In the described embodiment of the invention, a ~working 61 well~ recess is provide in the di~tal surface portion of 71 the transparent balloon, the working well recess portion 81 f the balloon including a centered opening into which the 91 tube opens, so that the first channel provides a 10¦ continuous, open path from a proximal end of the 11 ¦ angioscope into the working well recess. After inserting 12¦ a distal end of the flexible catheter into a vein or ~3¦ artery, the balloon is inflated, either with a gas or a .41 transparent liquid, suc~h as saline solution, and light 15¦ conducted by the optical fiber through the second channel 16 illuminates the region beyond the distal surface of the ~7¦ transparent balloon. In one described embodiment of the 18¦ invention, the distal end portion of the inflated balloon ~9¦ is pressed against the wall of an intravascular^structure, 20¦ isolating the working well recess. Saline solution is 21¦ forced through the first channel and the tube into the 221 working well region to flush out blood therein, allowing 231 clear visualization (through the third channel) of the 241 intravascular wall tissue bounding the working well 25¦ recess. Various apparatus, such as a laser fiber, biopsy 26¦ forceps, or tubular means for conducting sufficiently cold 27 ¦ liquid to freeze the tissue or other substance adjacent to 28 ~ .

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1 the work~ng well recess, then may be passed through the 2 first channel ~nd the tube into the work~ng well region.
3 Ablation of the adj~cent tlssue or ~ubstance ln the 4 working well recess is thereby accomplished through the first channel and the tube while illumination is 6 accompli~hed through the second channel and through the ¦ wall of the transparent balloon and accurate visualization 8 is accomplisihed through the third channel and the wall of 9¦ the transparent balloon. In another embodi~ent of the 10¦ invention, accurate visualization of a procedure including 11¦ retrieving a foreign object by means of a biopsy forceps is achie ed.

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3 Fig. 1 16 ~ partial perspective view of ~ prior art 4 angioscope.

6 ¦ Fig. 2 i6 a partial perspective view of a complete 8 angioscope in accordance with the present invention.
9 ¦ Fig. 3 is an enlarged partial perspective view of 10 ¦ detail 3 of Fig. 2.
11 l 12 ¦ Fig. 4 is a section view along section line 4-4 of 13 ¦ Fig. 3-14 ¦
Fig. 5 is a partial cutaway section view useful in 16 explaining the use of the angioscope of the present 17 invention.

19 Fig. 6 is a partial perspective cutaway view illustrating utilizàtion of the angioscope of the present 21 invention to retrieve a foreign article.

23 Fig. 7 is a partial section view useful in explaining 24 the procedure of Fig. 6.

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1 ~ig. 8 1~ a part~al perspectlve cutaway view 2 lllustratlng utiliz~tion of the ~ngloscope of the present 4 ¦ Inventlo to perform a blopsy on an intr~c^rdiac tumor.

Pig. 9 ls a partial perspective view of another 61 embodSme t of the angiosco,oe of the present invention.

8 ¦ Fig. lO is a section view along section line lO-lO of 10~ Fig. 9.
11¦ Fig. ll is a partial perspective view of the 12¦ angioscope in Fig. 3 illustrating introduction of a laser 13~ fiber into the working well cavity thereof.

15¦ Fig. 12 is a section view of an alternate embodiment 16 of the angioscope of the present invention.

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'' ' ' 1 ~ESCRIPTION O~ THE TNVE~TION

3 Referring now to Fig. l, reference numernl l 4 designates the end-balloon angio~cope prevlously referred 5 I to. The inflatable clear plastic balloon lB is attached 6 ¦ by sutures or other means 2 to a flexible angioscope 71 catheter lA. Various channels are provided in catheter 8 lA. For example, an inflation port 3A, a viewing port 3B, 9 and a light channel 3C are provided. This device perhaps 10¦ represents the closest prior art to the present invention.

12¦ In accordance with the present invention, the distal 13¦ end of a fiber optic angioscope of the present invention 14¦ is shown in Figs. 3 and 4. Catheter 6 represents the 1~¦ ~flexible fiber optic extension~ of the body 15 of 16¦ angioscope 5. An eye piece 25 enables the physician to t71 view a passage or cavity into which the distal end of 18¦ angioscope 15 is introduced, and is attached to the ~91 proximal end of the body 15 of angioscope 5. An 20¦ angulation knob 16 controls the axial orientation of the 21¦ distal tip of catheter 6 relative to body 15 of the 22¦ angioscope. A laser fiber 23 or other instrument can be 23 ¦ passed through a biopsy channel ll of the catheter 6 to 24 ¦ allow lasing, biopsy, or other procedure to be performed 25 ¦ on tissue or other matter near or at the distal end of 26 ¦ cathete 6. Such laser fiber or Inrtrument can be ,, ~ 10 i ' ,~ ~ ' ;. , R3~
1 lntroduced into the channel 11 before or ~fter the 2 catheter 6 16 introduced lnto the vein, artery ~r other 3 cav~ty. If thl~ 16 done, after the catheter ls lntroduced 4 lnto the body, a clear chamber can be provided at the proximal end of the catheter, into which chamber blood can 61 be drawn through which the instrument can be passed, to 7 ensure that no air bubbles are forced by the instrument 8 throuqh channel 11 into the body.

~ol Reference numeral 19 designates a source of 11¦ transparent gas or liquid which is forced through tube 20 12¦ and channel 13 to inflate balloon 7. Air could be used as 13¦ a gas, and saline solution could be utilized as a liquid.
14¦ Fig. 11 shows the end 49 of a laser fiber 24.
~51 16¦ In Pig. 2, light source 17 is connected by optical 17¦ fiber 18 to angioscope 5 and extends through channel 12 of 18¦ catheter 6 to provide illumination at the distal end of t91 catheter 6. Channel 14 permits viewing of the r-egion 20¦ beyond the distal end of catheter 6.
2tl 22¦ In accordance with the present invention, inflatable 23 ¦ balloon 7 is attached by sutures 8 or the like to the 241 distal end of catheter 6. A recess 8, referred to herein 25 ¦ as a working well~, has a central opening therein. The 227a ~ portion f balloon 7 forming that hole is attecheo by 2a 1 1l . ~ :
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1 sultable bonding m~terlal to a rlgid plast~c ~leeve 9 2 h~vlng pa~6age 10 therethrou~h that opens lnto both 3 working well B and central pa~sage or "blopsy channel~ 11 4 ln catheter 6. The proximal end of tube 9 is threaded into a corresponding threaded area 21 at the distal 6 portion of passage 11 ~n catheter 6.

8 In accordance with the present invention, flexible 9 catheter 6 can be introduced in a conventional fashion through a intravascular path, into an intravascular 11 structure or cavity. The balloon is inflated after the ~2 distal end of catheter 6 has been introduced into the 13 intravascular structure or cavity. In Fig. 5, reference 14 numeral 26 represents the interior of (for example) a chamber of the heart. Reference numeral 28 designates the 16 endocardium. The distal end of working well balloon 7 is 17 pressed against the surface of endocardium 28, deforming 18 and/or flattening the balloon, as indicated by reference 19 numerals 29. The flattening of the distal end ~àlloon portion surrounding the working well 8 serves to displace 21 blood from the adjacent lining or endocardium of the heart 22 26 and also serves to isolate the working well area 8 from 23 the surrounding blood pool. Saline or other solution then 24 can be delivered through channel 11 to flush the remaining blood from the working well region 8, making it possible 26 for the physician to easily view the surface of ~ ..
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1 endocardium 28 through catheter 6 ~nd clear plastic 2 balloon 7.

My initial experiment~ were performed uslng a working well balloon 7 formed of transparent polyurethane material 6 wh~ch was formed by dipping a preshaped glass rod and ball 7 into polyurethane, withdrawing it, and allowing the 8 polyurethane to dry thereon. The glass then was broken 9 free and cleared from the polyurethane. A small opening was made in the recessed working well 8 and a rubber 11 sleeve 9 was secured thereto. The polyurethane balloon 12 was attached to the end of a 4 millimeter Olympus flexible 13 pediatric bronchoscope. A quartz fiber with its sheath 14 was then passed throug~ a one-way valve into and through the biopsy channel ll of the bronchoscope and through the 16 rubber sleeve 9 into the working well 8.

18 This device was used in my laser atrial septostomy 19 experiments on two mongrel dogs. An internal jugular vein was~used to gain vascular access. An incision large 21 enough to acco~nodate the working well balloon angioscope 22 catheter 6 was made into the vein wall, and the distal end 23 of the angioscope 5 was inserted. The catheter 6 then was 24 advanced to the superior vena cava and the balloon was inflated to a volume of approximately 2 cubic centimeters.
26 The catheter 6 then was advanced to the interatrial -' ' .
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1 septum, which then w~ visu~lized through the vlewlng port 2 14 ~nd the distal tr~nsparent working well wall of balloon 3 7.
5 ¦ Nd:YAG laser light at a 40 watt level was delivered 6 over a 2-3 ~econd lnterval to the atrial septum via the 71 quartz laser fiber. Although difficulties were 81 encountered, including a failure of the material in the 9¦ working well 8 and collapsing of the balloon 7, which 10¦ precluded further visualization, laser charring of the 11¦ visualized tissue was observed during the delivery of 21 laser energy. I expect that if cold saline solution had '31 been used instead of air to cool the quartz fiber during .41 the delivery of the laser energy, the above problem would ~51 have been avoided. Saline cooled quartz fiber systems are 16¦ commercially available, and implementation thereof in the 17 ¦ angioscope 5 should present no great difficulty. Another 18¦ problem observed was that the polyurethane did not ~9¦ collapse satisfactorily because rather sharp ed-ges were 20 ¦ created where the polyurethane collapsed on itself.
21 ¦ Transparent latex or other material may be more suitable.

23 ¦ Despite the problems encountered in the initial 24 experiments, atrial septoscopy by means of laser energy 25 ¦ using an optic angioscope described above appears to be ?6 practical and advantageous to existing methods of atrial 27 I septostomy.
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2 Ot~er potential appl~cations of the working well balloon angioscope of the present lnvention lnclude 4 identification of intraYascular or intracardiac foreign bodies which require extractlon. Figs. 6 and 7 illustrate 61 this application, wherein a pair of biopsy forceps 33 or 71 the like are introduced beyond the working well 8 of the 8 balloon 7, which allows accurate visualization of the 9¦ foreign object 34. (Object 34 might be a broken off ~ol portion of an endocardial pacemaker lead, catheter, or 11¦ other object.) 13¦ Another potential application of the working well '41 balloon angioscope is ~the direct visualization of biopsy '51 sites of the myocardium or of a cardiac tumor. Fig. 8 16 ¦ illustrates this application, wherein a cardiac tumor 45 : 17 ¦ of heart 44 is being visualized via catheter 6 and working 18 ¦ well balloon 7. Biopsy forceps such as 33 in Figs. 6 and 19 ~ 7 could be utilized to remove a bit of tissue f~rom the visualized site.

22 Another possible application of the working well 23 balloon angioscope is in studies of cardiac arrythmias, I
24 wherein a number of thin flexible conductors 47 are embedded in the walls of the balloon 7, as shown in Fig.
26 9. These conductors 47 pass through a cable in the 28 . 15 ., ,"

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~, 1 c~theter 6 and terminate upon conductive electrodes ~8 2 located on the outer balloon surface ~round the perlmeter 3 of work1ng well 8, as 6hown ln ~i9B. 8 and lO. m e electrodes 48 could be utilized to map the endocardium and 5¦ ascertain the anatomic sites of micro-reentrant and/or 61 ectopic foci. Direct correlation between observed tissue 71 configuration and rhythm disturbance could thereby be 81 achieved. After identification of the the effects 91 arrythmogenic foc~s, ablation or potential destruction by 'I freezing or heatinq or by means of electrical, mecha~ical, 111 chemical or laser energy could be accomplished. As 12¦ another alternative, some of the electrodes such as 48 in ~3¦ Fig. 9 could be positioned on various other portions of 14¦ the balloon than on its left or distal end portion. This 15¦ may be advantageous for recording and mapping of 16¦ electrical activity within the heart. ~he electrodes need 17¦ not actually touch the endocardium, as the electrical 18¦ signals in the endocardium are transmitted through the ~9¦ blood. ~

21¦ The above-described working well balloon angioscope 22¦ also may have application in the study of the effects 231 arrythmogenic and antiarrythmogenic substances, which 241 could be instilled or injected through the biopsy channel 2sl ll into the working well region 8 after the distal end of 226~ the balloon is abutted against the endocardium, thereby .. . . . .
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, . , 1 1BO1atin9 the are~ which would be contacted by the 2 ~rrythmogenlc or antlarrythmogenlc sub6tance6. Dlrect 3 visuallzation of the ~lte under 6tudy can conflrm that the working well area has not moved from the intended ~ite 5¦ being studied.

71 Other potential applications of the working well 81 balloon angioscope in conjunction with use of laser fibers 9 introduced through the biopsy channel 11 include ablation ~ol of accessory ~i.e., anomalous) pathways, the ~¦ atrioventricular node, the ~is bundle, ectopic foci, 12¦ hypertrophic (i.e., two thick) myocardium, mural thrombi 13¦ (i.e., intracardiac clots), ~yxomas (tumors) and treatment ~41 of calcified, noncalcified, and congenital valvular .51 stenosis.
16¦
'71 An alternate embodiment of the invention is shown in 18 ¦ Fig. 12, wherein the threaded left-hand end of the rigid 19 ¦ tube 9 is threaded into a threaded hole 55 at the end of a 20 ¦ passage 54 through an inner catheter 53 that is slidable 21 ¦ within the central channel 11 of outer catheter 6. (The 22 ¦ other channels 12, 13, and 14 shown in Fig. 3 also are 23 included in the outer catheter 6 or the inner catheter 53, 24 depending upon the amount of room available and other considerations.) The embodiment of the invention shown in 26 Fig. 12 allows the inner catheter 53 to be moved relative a 17 -. . ~

to the outer catheter 6 in the direction of arrows 56.
This provides the user with control over the depth of the working well 8, which in some cases might be advantageous.

Thus, an angioscope has been provided with a uniquely designed working well balloon which should have a number of important applicationR in the study and treatment of cardiovascular diseases.

The tube or sleeve 9 can be integral with the balloon, as long as it is sufficiently stiff that the pressure of the inflation gas or liquid does not collapse the channel through the tube or sleeve 9 , '' ' '

Claims

1. An angioscope comprising in combination:

(a) a flexible catheter having first, second and third channels therein and a proximal end and a distal end;

(b) an inflatable transparent balloon having a first opening and a second opening located opposite to the first opening;

(c) first means for producing a seal between the portion of the transparent balloon around its first opening and the distal end of the catheter;

(d) a tube having a first end connected in communication with a distal end portion of the first channel and having a second end extending through the second opening of the balloon, the second and third channels opening into the interior of the transparent balloon;

(e) second means for producing a seal between the portion of the transparent balloon around its second opening and the second end of the tube;

(f) third means passing through the second channel for producing light that emanates from the distal end of the catheter;

(g) fourth means passing through the third channel for effectuating viewing of the illuminated region from the proximal end of the catheter; and (h) fifth means passing through the first channel beyond the second end of the tube for interacting with tissue or substance illuminated through the wall of the transparent balloon by the third means and viewed through the fourth means and the wall of the transparent balloon.

2. The angioscope of Claim 1 including a working well recess in the surface of a distal portion of the transparent balloon, the second opening being centered in the working well recess.

3. The angioscope of Claim 2 including a fourth channel in the catheter opening into the transparent balloon and means for inflating the transparent balloon by passing fluid through the fourth channel.

4. The angioscope of Claim 2 wherein the fifth means includes a laser fiber extending through the first channel and extending to the second end of the tube, whereby the visualized tissue or substance can be ablated by a laser beam from the laser fiber.

5. The angioscope of Claim 2 wherein the fifth means includes a biopsy forceps instrument with jaws extending beyond the second end of the tube, whereby a sample of the visualized tissue or substance can be removed.

6. The angioscope of Claim 2 wherein the first end of the tube is threaded into the distal end portion of the first channel.

7. The angioscope of Claim 2 including a flexible inner catheter slidably disposed in the first channel, the inner catheter having a distal end, a fourth channel extending through the inner catheter, the first end of the tube being connected in communication with the distal end of the fourth channel, whereby the depth of the working well recess of the transparent balloon can be controlled by sliding the inner catheter in the first channel.

8. The angioscope of Claim 2 including a plurality of electrodes disposed on the outer surface of the transparent balloon, and a plurality of flexible conductors disposed along the surface of the transparent balloon, each flexible conductor extending along the catheter and being connected to a respective electrode, whereby electrical signals can by transmitted to and/or received from tissue or blood contacting the electrodes.

9. An angioscope comprising in combination:

(a) an inflatable transparent balloon;

(b) a flexible catheter having first and second channels therein extending from a proximal end to a distal end thereof, the second channel opening into the interior of the balloon, a proximal portion of the balloon being sealed to a distal end of the flexible catheter;

(c) tubular means for extending from the distal end of the flexible catheter through the balloon to extend the first channel through the balloon so that the extended first channel opens into a region beyond the balloon, a distal end portion of the balloon being sealed to a distal end portion of the tubular means;

(d) means passing through the catheter outside of the first channel for producing light that emanates from a distal end of the flexible catheter;

(e) means passing through the catheter outside of the first channel for effectuating viewing of the region illuminated by the light producing means; and (f) means passing through the first channel beyond the distal end portion of the tubular means for interacting with tissue or substance beyond the balloon illuminated by the light producing means and viewed through the viewing means.