WO1998000059A1

WO1998000059A1 - Implantation and measuring system and method for repairing vesicular aberrations

Info

Publication number: WO1998000059A1
Application number: PCT/US1997/011666
Authority: WO
Inventors: Dilip Bobra
Original assignee: Dilip Bobra
Priority date: 1996-07-03
Filing date: 1997-07-02
Publication date: 1998-01-08
Also published as: AU3794297A

Abstract

An implantation and measuring system for ascertaining the extent of a vesicular aberration of a vessel of an animal and for effecting repair of the vesicular aberration, the system comprising an insert (25) having graduations (35) receivable into and through the vessel for placement proximate the vesicular aberration, the graduations (35) being detectable and viewable by an imaging means for allowing a user to ascertain the extent of the vesicular aberration, and a catheter (40) for introducing a repair apparatus suitably sized for placement proximate the vesicular aberration for effecting repair of the vesicular aberration.

Description

IMPLANTATION AND MEASURING SYSTEM AND METHOD FOR REPAIRING

VESICULAR ABERRATIONS

TECHNICAL FIELD

This invention relates to medical devices. More particularly, this invention relates to medical devices for repairing soft tissue. In a further and more specific aspect, the instant invention relates to an implantation apparatus and system for aiding the repair of vesicular aberrations.

BACKGROUND ART

The human cardiovascular system is a closed tubular system in which blood, propelled by a muscular heart, flows through vessels to and from all parts of the body. Two circuits, the pulmonary and the systemic, consist of arterial, capillary, and venous components.

Arteries transport blood to body tissues under high pressure, which is exerted by the pumping action of the heart. The heart forces blood into these elastic tubes, which recoil, sending blood on in pulsating waves. It is, therefore, imperative that the vessels possess strong, elastic walls to ensure fast, efficient blood flow to the tissues. From arteries, blood is gradually transported to arterioles, which are characterized as having thinner vessel walls and smaller lumens, or passageways, through which blood passes. From the arterioles, blood is supplied to capillaries for delivering blood to bodily tissues for nourishing the bodily tissues with oxygen. Capillaries eventually converge with small venules whose function it is to collect blood from capillary beds. As the venules continue to increase m size, they begin to exhibit the wall structure characteristic of arteries, though much thinner. Venules eventually lead to veins, which function to conduct blood from peripheral tissues to the heart. Veins tend to follow a course parallel to that of arteries, but are present in greater numbers. Arteries and veins are unfortunately prone to a variety of maladies which can inhibit the flow of blood ultimately causing substantial and serious bodily injury.

For instance, the coronary arteries, which originate in the aorta and supply blood to the muscular tissue of the heart, can be susceptible to atherosclerosis which is characterized by the narrowing of the artery from the deposition of atheromatous plaques containing cholesterol and lipids. The prior art has provided certain procedures for correcting atherosclerosis. If an artery is incompletely obstructed, medication can be used for clearing the obstruction. Another commonly used technique is to surgically bypass around the diseased portion with a vein segment if medication is not effective. Carbon dioxide endarectomy is also performed. In this operation, carbon dioxide is introduced directly into the obstructed coronary artery. The carbon dioxide tends to loosen the inner atheromatous core from the artery thereby restoring blood flow through the affected artery. In both procedures, a heart-lung machine s used to support the circulation. Although both of the above-mentioned procedures are exemplary, they are terribly expensive, and patient recovery can be considerable, further adding to the expense.

As a result, catheters have been developed with strong inflatable balloons constructed towards their end and along the line of the catheter. Commonly referred to as balloon angioplasty, the balloons can be inflated by compressed air at different controlled pressures. They are used for dilation of a partly obstructed coronary artery, with restoration of blood flow to the heart muscle, and of a severely obstructed heart valve. This procedure generally requires no anesthetic and, using specialized radiological imaging techniques, is sometimes done on an outpatient basis. Several coronary arteries may be dilated in this way, with flattening of the atheromatous material against and into the arterial wall.

Although there are operative risks, such as emboli and tearing of the arterial wall, the results seem to be acceptable and the technique may be repeated, if necessary. The inherent limitation of this corrective technique is that it is not a permanent corrective measure. Thus, in order for it to be effective, it must be periodically repeated, which is undesirable and can lead to considerable expense.

Other maladies affecting the arteries for inhibiting the passage of blood consist of occlusive diseases and nonocclusive diseases. Common occlusive diseases are arteriosclerosis, arterial thrombosis, and arterial embolism. Common nonocclusive maladies are arteπovenous fistula, which is characterized as a penetrating injury resulting in an opening between an artery and its immediately adjacent vein, and aneurysms, which are characterized as the bulging of an arterial wall at a point of weakness. Aneurysms can result m pain and may occasion sudden death if they rupture. Like the corrective procedures described above in relation to the coronary arteries, they may similarly be used for correcting such occlusive diseases and arteriovenous fistula.

Like arteries, veins are similarly prone to occlusive and nonocclusive vesicular aberrations, such as blood clots and direct mechanical injury. Like the arteries, veins may similarly be repaired either medically, surgically, or perhaps with angioplasty if needed.

As a result of the inherent deficiencies described above in combination with balloon angioplasty, which is normally used for repairing occlusive maladies or vessel constrictive maladies, the prior art has recently provided a repair apparatus, or vesicular insert, that is introduced into the affected vessel for placement proximate a malodorous area. The insert, commonly referred to as a stent, is comprised of a mesh of shape retaining material operative for introduction into a vessel for distending the vessel outwardly for restoring the proper flow of blood through the vessel. The stent is normally permanently introduced into the affected vessel, and results have been exemplary for the restoration of blood flown.

However, the introduction of the stent into the affected vessel has proven troublesome. In particular, occlusive maladies and vessel constrictive maladies suitable for repair by the stent normally extend over a varying area or length of an affected vessel. Some of these maladies can be quite extensive in size, while others not so. Thus, stents having varying sizes are needed for vesicular maladies having varying sizes. In order to select an appropriately sized stent for effecting repair of a vesicular malady, one must guess the proper size and hope that it is suitably sized only after insertion within the affected vessel. If not properly sized, a variety of problems can and normally do occur. For instance, once a stent is introduced into a vessel, it is virtually impossible to remove it without actually cutting it away, thus necessitating more than one stent for effecting repair of the vessel. This adds to the expense and additional risk of the procedure which is undesirable. Accordingly, there is no convenient way of providing a user with the ability to easily select a properly sized stent the first time. DISCLOSURE OF THE INVENTION

Briefly, to achieve the desired objects of the instant invention in accordance with a preferred embodiment thereof, provided is an apparatus for ascertaining the extent of a vesicular aberration of a vessel of an animal such as a human being. The apparatus includes an insert having graduations receivable into and through the vessel for placement proximate the vesicular aberration. The graduations are detectable and viewable by an imaging means for allowing a user to ascertain the extent of the vesicular aberration. The apparatus may further include a catheter for introducing a repair apparatus through a bore of the insert suitably sized for placement proximate the vesicular aberration for effecting repair of the vesicular aberration. The repair apparatus may be provided as a stent.

Also provided is a system for ascertaining the extent of a vesicular aberration of a vessel of an animal. The system is comprised of a measuring apparatus receivable into and through the vessel for placement proximate the vesicular aberration, the measuring apparatus having graduations. The system further includes imaging means for viewing the graduations and the vesicular aberration for allowing a user to ascertain the extent of the vesicular aberration for the purpose of diagnosis.

Next provided is a method of ascertaining the extent of a vesicular aberration of a vessel of an animal, the method comprising the steps of providing a measuring apparatus, inserting the measuring apparatus into and through the vessel for placement proximate the vesicular aberration, and measuring the vesicular aberration with the use of an imaging means for projecting an image of the graduations and the vesicular aberration. Still further provided is a method of repairing a vesicular aberration of a vessel of an animal, the method comprising the steps of measuring the extent of the vesicular aberration, selecting a repair apparatus suitable for repairing the vesicular aberration, and implanting the repair apparatus proximate the vesicular aberration for effecting repair of the vesicular aberration.

BRIEF DESCRIPTION OF THE DRAWINGS

The foregoing and further and more specific objects and advantages of the instant invention will become readily apparent to those skilled in the art from the following detailed description of a preferred embodiment thereof taken in conjunction with the drawings m which:

Fig. 1 is a perspective v ew of an embodiment of an implantation and measuring apparatus for ascertaining the extent of a vesicular aberration and for introducing a repair element into a vessel;

Fig. 2 is the implantation and measuring apparatus of Fig. 1 shown as it would appear in use for introducing a stent into and through a vessel for repairing a vesicular malady;

Fig. 3 is a fragmented view of the implantation and measuring device of Fig. 1, further illustrating graduations formed therewith;

Fig. 4 is a perspective view of a monitor of a diagnostic imaging apparatus;

Fig. 5 is a perspective view of a scanner of the diagnostic imaging apparatus operative for emitting electromagnetic radiation for allowing a user to view the internal structure of an animal on the monitor of Fig. 7; F g. 6 is an enlarged view of a stent shown as it would appear carried upon an outer end of a catheter extending through an insert of the implantation and measuring device shown in Fig. 1; and

Fig. 7 is a view illustrating the implantation and measuring apparatus of Fig. 1 as it would appear inserted with the vessel of Fig. 2, and further illustrating how graduations carried by the implantation and measuring apparatus may be employed for ascertaining the extent of the vesicular malady. BEST MODES FOR CARRYING OUT THE INVENTION

Turning now to the drawings, in which like reference characters indicate corresponding elements throughout the several views, attention is first directed to Fig. 1 which illustrates an implantation and measuring apparatus being generally designated by the reference character 20. Apparatus 20 is comprised of an insert 25 herein defined as a hollow, flexible tube 26 for insertion into a body cavity, duct, or vessel of an animal such as a human being. Tube 26, having a substantially elongate configuration and being suitably constructed of a substantially flexible material suitable for insertion into an animal, includes a substantially cylindrical outer surface 27, an open outer end 28, and an open inner end 29 having a finger flange 30 coupled thereto that a user may grip during use. Tube 26 includes a substantially cylindrical inner surface (not shown) defining a bore 31 extending from second open end 29 to first open end 28. Tube 26 further includes a scale 34 defined by graduations 35 carried by and extending along substantially the entire length of tube 26 from second end 29 to first end 28. Although graduations 35 may be carried by other portions of insert 25 as suitably desired, graduations 35 are preferably formed upon substantially cylindrical outer surface 27 m equally spaced-apart and substantially linear alignment to coincide to a predetermined and preselected measuring scale for allowing a user to measure the extent or size of a particular object, the specific details of which will be herein specifically described as the detailed description ensues.

Bore 30 of insert 25 is operative for receiving catheter 40 therethrough. Like insert 25, catheter 40 includes a hollow, flexible tube 41 for insertion into a body cavity, duct, or vessel of an animal such as a human being. Tube 41, having a diameter less than the diameter of tube 26, a substantially elongate configuration and being suitably constructed of a substantially flexible material suitable for insertion into an animal, includes a substantially cylindrical outer surface 42, an open outer end 43 extendible through and beyond outer end 28 of insert 25, and an open inner end 44 having an attachment

45 coupled thereto. Attachment 45 is detachably engagable to other medical instrumentation as desired by a medical practitioner for carrying out certain and specific medical procedures, details of which will not be herein specifically addressed as they will be readily apparent to those having ordinary skill.

Apparatus 20 may be employed for carrying out a wide variety of specific medical procedures. However, with respect to the instant discussion, application of apparatus 20 will be discussed in combination with the repair of a diseased or damaged region of a vessel such as a an occlusive and non-occlusive vesicular malady. In particular, reference is directed to Fig. 2 illustrating a portion of a human leg 50 having a vessel 51 passing therethrough, which could be either an artery or a vein operative for communicating blood. Vessel 51 is further shown damaged or afflicted with a vesicular aberration illustrated generally as a bulge in vessel 51 being generally designated at 52. The outer ends 28 and 43 of apparatus 20 are shown having been inserted through an incision 53 formed through leg 50 and further nto and through vessel 51 for placement of outer ends 28 and 43 proximate vesicular aberration 52. The object of the procedure being described is to effect repair of vesicular aberration 52 through the placement of a stent 54 at the location of vesicular aberration 52.

Stent 54, shown more completely in Fig. 6, is well known to those having ordinary skill for repairing specific vesicular aberrations, and is generally comprised of a framework 60. Framework 60 includes a mesh 61 of shape retaining material comprising a plurality of filaments 62 coupled together in meshing engagement, filaments 62 being constructed of shape retaining stainless steel, or other shape retaining substance suitable for introduction into the human body. Framework

60 further includes a first open end 63, a second open end

64, and has a substantially tubular shape. Stent 54, is typical, and those having ordinary skill will readily understand that stent 54 is movable between a normal expanded configuration and a collapsed configuration, details of which are not shown in the drawings and will not be herein further discussed m great detail except to the extent necessary to provide a full and clear disclosure of the instant invention as herein specifically described.

Stent 54 is operative for repairing specific vesicular aberrations affecting blood vessels within either the arterial or venous components of the circulatory system. In particular, the flow of blood through the arterial or venous components of the circulatory system of living organisms such as humans and certain other animal species, can be impeded as a result of occlusive disorders, or nonocclusive disorders. Occlusive disorders, as previously discussed, are characterized as blockages or obstructions formed or deposited within a blood vessel. Nonocclusive disorders can include aneurysms and arteπovesicular fistula resulting from penetrating injury caused by a bullet or a sharp object. With placement of stent 54 within a vessel proximate the diseased or damaged region, repair may be effected.

Thus, a method of placing or introducing stent 54 proximate vessel 51 for effecting repair of a damaged or diseased portion of vessel 51 can be seen with reference back to Fig. 2. In Fig. 2, extending through insert 25 and further extending beyond outer end 28 is seen catheter 40 having stent 54 carried thereon. The positioning of stent 54 in vessel 54 would normally be carried out by first inserting outer end 28 of insert 25 into vessel 54 for placement proximate vesicular aberration 52. Next, as can be easily seen m Fig. 6, stent 54 would be placed upon portions of catheter 40 proximate outer end 43 and then plunged through bore 31 of insert 25, outer end 43 of catheter 40 being further plunged or extended beyond outer end 28 of insert 25 for introduction of stent into vessel 51 proximate vesicular aberration 52 needing repair, clearly shown in Fig. 2.

For placement, stent 54 is removed from catheter 40 and catheter 40 then pulled back through insert 25. When catheter 40 is removed, stent 54 assumes the normal expanded configuration as a result of the shape memory inherent with filaments 62. As stent 54 assumes the normal expanded configuration, filaments 62 impinge against the inner surface of vessel 51 thereby effecting repair of vesicular aberration 52. Such a technique will be readily understood by those having ordinary skill. It will further be appreciated by those having ordinary skill that stent 54 may be selectively housed about a balloon of a conventional balloon catheter and secured within a vessel by inflating the balloon, the balloon then deflated for removal from the vessel .

In order to properly repair a diseased or damaged portion of an affected vessel, it is necessary to ascertain the extent of the diseased or damaged portion so that an appropriately sized stent 54 may be selected for effecting repair. Graduations 35, which can be seen more fully in combination with Fig. 3, are employed for this purpose of measuring the extent of the vesicular aberration so that a properly sized stent 54 may be selected. In particular, graduations 35 are provided to be detectable when inside and concealed by vessel 51 by means of a suitable imaging device. Although other means may be used, graduations 35, employed in combination with a suitable imaging device, are the preferred means of measuring vesicular aberrations. Additionally, although stent 54 has been herein disclosed as a repair apparatus for repairing a specific variety of vesicular aberration, it will be readily understood that apparatus 20 may be used in combination with other repair devices currently used to aid in the repair of diseased or damaged portions of vessels. Reference is now directed to Figs. 4 and 5, which illustrate how a vesicular aberration can be measured prior to selection and subsequent implantation of a repair device for effecting repair of a diseased or damaged portion of a vessel. In particular, similar to the illustration of Fig. 2, Fig. 5 illustrates insert 25 and catheter 40 of apparatus 20 inserted within incision 53 formed through human leg 50 and vessel 51, and further inserted into and through portions of a vessel 51 (not shown in Fig. 5) . A scanner 72 of a diagnostic imaging apparatus generally designated 73 is also shown in Fig. 5. Like conventional diagnostic imaging devices, diagnostic imaging apparatus 73 incorporates the use of electromagnetic radiation to produce images of internal structures of an animal for the purpose of accurate diagnosis. It will be readily understood by those having ordinary skill that diagnostic imaging is roughly equivalent to radiology, the branch of medicine that uses radiation to diagnose and treat diseases.

With respect to the instant discussion, scanner 73 is placed proximate leg 71 and emits electromagnetic radiation into leg 71 providing an image of internal structures of leg 71, and apparatus 20, on a screen 75 of a conventional monitor 74 which is part of the diagnostic imaging apparatus 73. The image, generally designated at 76, provided on screen 75 of monitor 74 can be seen as showing outer ends 28 and 43 of insert 25 and catheter 40, respectively, of apparatus 20 inserted within vessel 51 proximate vesicular aberration 52. Graduations 35, detectable by scanner 72 and also shown in image 76 projected on monitor 74, are viewable on monitor 74 for measuring the extent or size of vesicular aberration 52 affecting vessel 51. In particular, Fig. 7 illustrates a more detailed view of vesicular aberration 52 affecting vessel 51 as it might appear on screen 75 of monitor 74 with insert 25 of apparatus 20 placed therethrough. With insert 25 placed through vesicular aberration 52, graduations 35 may be positioned and viewed for measuring the length or extent of vesicular aberration 52 so that an appropriately sizeα stent 54 or other selecteα repair apparatus may be selected and then inserteα for placement proximate the vesicular aberration for effecting repair.

It will be readily understood that a highly efficient apparatus, system, and method has been disclosed for providing a medical practitioner with the means for easily and inexpensively ascertaining the extent of a diseased or damaged portion of an affected vessel m order to facilitate quick and efficient repair of the diseased or damaged portion with an appropriately sized repair apparatus. It will be readily understood by those having ordinary skill that although the instant invention has been herein discussed with application to vesicular maladies, the invention may be used in combination with other medical procedures if desired. Additionally, graduations 35 need only be carried by insert 25 so that they may be detectable by diagnostic imaging apparatus 73. Various changes and modifications to the embodiment herein chosen for purposes of illustration will readily occur to those skilled in the art. To the extent that such modifications and variations do not depart from the spirit of the invention, they are intended to be included within the scope thereof which is assessed only by a fair interpretation of the following claims. Having fully described the invention in such clear and concise terms as to enable those skilled in the art to understand and practice the same, the invention claimed is :

Claims

1. What is claimed is an apparatus for ascertaining the extent of a vesicular aberration of a vessel of an animal, said measuring apparatus comprising:

an insert receivable into and through said vessel for placement proximate said vesicular aberration; and

a scale, carried by said insert, detectable and viewable by an imaging means for allowing a user to ascertain the extent of said vesicular aberration.

2. The apparatus of claim 1, wherein said insert includes an outer end receivable into and through said vessel, and an inner end having a finger flange coupled thereto .

3. The apparatus of claim 2, wherein said insert is elongate and substantially flexible.

4. The apparatus of claim 3, wherein said insert is substantially tubular having a generally cylindrical outer surface .

5. The apparatus of claim 4, wherein said graduations are carried proximate said generally cylindrical outer surface.

6. The apparatus of claim 5, wherein said scale includes graduations equally spaced-apart and substantially linearly aligned along substantially the entire length of said insert from said inner end to said outer end.

7. The apparatus of claim 1, wherein said imaging means includes a diagnostic imaging apparatus for detecting and projecting an image of the interior of said animal, including said scale, for the purpose of acute diagnosis .

8. What is claimed is a system for ascertaining the extent of a vesicular aberration of a vessel of an animal, said system comprising:

a measuring apparatus receivable into and through said vessel for placement proximate said vesicular aberration;

a scale carried by said measuring apparatus;

imaging means for viewing said scale and said vesicular aberration for allowing a user to ascertain the extent of said vesicular aberration.

9. The system of claim 8, wherein said measuring device includes an insert having an outer end receivable into and through said vessel, and an inner end having a finger flange coupled thereto.

10. The system of claim 9, wherein said insert is elongate and substantially flexible.

11. The system of claim 10, wherein said insert is substantially tubular having a generally cylindrical outer surface .

12. The system of claim 11, wherein said scale is carried proximate said generally cylindrical outer surface.

13. The system of claim 12, wherein said scale includes graduations equally spaced-apart and substantially linearly aligned along substantially the entire length of said insert from said inner end to said outer end.

14. The system of claim 8, wherein said imaging means includes a diagnostic imaging apparatus for detecting and projecting an image of the interior of said animal, including said scale, for the purpose of acute diagnosis.

15. What is claimed is a method of ascertaining the extent of a vesicular aberration of a vessel of an animal, said method comprising the steps of:

providing a measuring apparatus;

inserting said measuring apparatus into and through said vessel for placement proximate said vesicular aberration; and

measuring said vesicular aberration.

16. The method of claim 15, wherein said step of providing a measuring apparatus further includes the steps of:

providing a substantially tubular flexible insert having a generally cylindrical outer surface, an outer end for receipt into and through said vessel, and an inner end having a finger flange coupled thereto; and

providing a scale along substantially the entire length of said insert extending from said inner end to said outer end.

17. The method of claim 16, wherein said step of providing said scale further includes the steps of providing graduations in spaced-apart and substantially linearly aligned orientation proximate said substantially cylindrical outer surface of said insert.

18. The method of claim 16, wherein said step of measuring said vesicular aberration includes the steps of viewing said scale residing within said vessel.

19. The method of claim 18, wherein said step of viewing said scale further includes the step of:

providing a diagnostic imaging apparatus for detecting and providing an image of the interior of said animal, including said graduations and said vesicular aberration, for the purpose of acute diagnosis .

20. What is claimed is a method of repairing a vesicular aberration of a vessel of an animal, said method comprising the steps of:

measuring the extent of said vesicular aberration;

selecting a repair apparatus suitable for repairing said vesicular aberration; and

implanting said repair apparatus proximate said vesicular aberration for effecting repair of said vesicular aberration.

21. The method of claim 20, wherein said step measuring said vesicular aberration includes the steps of:

providing a substantially tubular flexible insert having a generally cylindrical outer surface, an outer end, and an inner end having a finger flange coupled thereto;

providing a scale along substantially the entire length of said insert extending from said inner end to said outer end;

inserting said insert into and through said vessel for placement proximate said vesicular aberration; and

viewing said scale and said vesicular aberration for ascertaining the extent of said vesicular aberration.

22. The method of claim 21, wherein said step of inserting said insert into and through said vessel further includes the steps of: incising said vessel; and

inserting said outer end of said insert through the incision and into and through said vessel for placement of said outer end and said scale proximate said vesicular aberration.

23. The method of claim 22, wherein said step of viewing said scale and said vesicular aberration further includes the step of:

providing a diagnostic imaging apparatus for detecting and providing an image of the interior of said animal, including said scale and said vesicular aberration, for the purpose of acute diagnosis.

24. The method of claim 23, wherein said step of implanting said repair apparatus further includes the steps of:

providing a catheter having said repair apparatus carried by an outer end thereof;

plunging said outer end of said catheter through a bore of said insert and into said vessel;

placing said repair element proximate said vesicular aberration for effecting repair of said vesicular aberration; and

removing said catheter from said insert.