JP2004528056A - Method and apparatus for forming a stoma in a blood vessel - Google Patents

Abstract

An entry tip that is retracted after the tip is inserted over the vessel wall (1700), an entry head (1604) that passes through the vessel wall, and a base that does not pass through the vessel wall (1602). A cutting tip is used on the base to cut the vessel wall. Upon completion of the cut, the entry head is retracted with respect to the blood vessel to remove the cut plug from the blood vessel.

Description

[Related application]
[0001]
This application is related to US Provisional Application 60 / 254,689 and PCT Publication and Applications WO 99/62415, WO 00/56226, WO 00/56228, WO 01/70091, WO 01/70118, WO 01/70119, PCT / IL01 / 00266, and PCT / IL01 / 00600.
【Technical field】
[0002]
The present invention relates to a punch and similar device for forming an opening in a blood vessel.
[Background Art]
[0003]
Holes are formed in blood vessels for a variety of reasons, the main ones being (a) inserting a tube into the vessel (and also removing the tube that later seals the hole) and (b) between the graft and the vessel. To form an anastomotic joint.
[0004]
PCT Publication WO 00/74579, the disclosure of which is hereby incorporated by reference, discloses that the outer tube is advanced and optionally rotated to cut into the blood vessel from the outside and then by barbs connecting to the hole former. A hole former is described in which movement of a cut in a blood vessel is prevented.
[0005]
U.S. Pat. A retractable retraction shear piercer is described that is retracted. This causes shearing in certain parts of the blood vessel as the cutting head is retracted toward and into the tube.
[Summary of the Invention]
[0006]
An object of some embodiments of the present invention relates to a method of forming a hole in a blood vessel using a cutting operation. Other embodiments provide alternative or additional advantages.
[0007]
In some embodiments of the present invention, the hole former includes an entry tip that is retracted after the tip is inserted over the vessel wall, and an entry head that passes through the vessel wall. A base that does not pass through the tube wall. A cutting edge is provided on the base to cut the vessel wall. Alternatively, the cutting operation is assisted by a rotation of the base, for example a full rotation and / or a pendulum-like rotation. Optionally, when some or all of the cutting is completed, the entry head is retracted into the vessel, thus removing the cut plug from the vessel. Optionally, the entry head includes a thickened portion to prevent the plug from slipping off the head. Optionally, the entry head is retracted relative to the base, for example, the entry head is operated by a spring. Alternatively or additionally, the retraction is made by retraction of the entire hole former and the overtube is advanced over the base to engage a hole formed in the vessel to prevent leakage.
[0008]
It should be noted that in some embodiments of the present invention, the hole former does not use any contra. Rather, if some contra is needed, it is provided by the target vessel itself. In these embodiments, the entry head is used to prevent the cutting edge from sliding sideways and / or to prevent the cut plug from falling into the blood vessel.
[0009]
Optionally, the entry head comprises a hollow lumen, optionally with threads, barbs, or other treatments for engaging tissue. In an exemplary embodiment of the invention, the lumen is integral with the solvent reservoir inside or outside the hole former. Alternatively or additionally, threads are formed on the outside of the entry head, for example, to assist entry.
[0010]
In an alternative embodiment of the invention, a cutting edge is used on the entry head, alternatively or additionally on the base. As an alternative or addition to the cutting operation, a shearing operation is performed by a base and a head that slide on each other. Alternatively or additionally, an anvil cutting operation is performed by placing tissue between the anvil and the cutting edge. In some, but not all embodiments of the invention, there is a relative rotation between the head and the base. In an exemplary embodiment of the invention, the head is retracted toward the base and the vessel is cut from inside the vessel.
[0011]
One aspect of some embodiments of the present invention relates to protecting a leaflet valve inside a multi-tool anastomotic delivery system. In an exemplary embodiment of the invention, a scaffold of the same delivery system is used for the transfer of the hole former and the transfer of the anastomotic connector (or other tools). While replacing the two tools, valves in the scaffold are used to prevent blood from blood vessels from leaking through the scaffold. In an exemplary embodiment of the invention, the hole former is covered by a cover (e.g., a silicon tube) while the hole former is covered by a cover (e.g., a silicon tube) to prevent the sharp part of the hole former from contacting the valve. Inserted beyond the valve. Alternatively, the cover is designed to be split, for example having perforations and / or having a rip code.
[0012]
One aspect of some embodiments of the present invention is a lumen using a tube with a sharp cutting edge and a means for engaging tissue, such as a one-way engagement such as barbs and / or internal threads. And a hole forming device. As the tube is advanced (and / or rotated) relative to the vessel wall or other tissue, the tissue is cut by the cutting edge and forced into the lumen where it engages. Optionally, the tube has external threads which assist in advancing in tissue, for example. Optionally, a central guide, such as a needle, is provided to stabilize the position of the tube relative to the target tissue. Optionally, the central guide is threaded. The guide may or may not be retractable with respect to the tube. In other exemplary embodiments, the guide advances forward of the cutting edge, is at about the same level as the plane defined by the cutting edge, or is retracted from this plane.
[0013]
One aspect of some embodiments of the present invention relates to a retracted retraction hole former, wherein the entry head includes a cutting edge and the head rotates so as to be retracted toward the base. Optionally, the base rotates. In an exemplary embodiment of the invention, the cutting edge fits the inner surface of the base. Alternatively, the cutting edge fits against the base.
[0014]
One aspect of some embodiments of the present invention is to provide a retraction in the distal end of the entry head for receiving a tissue plug removed from the vessel wall while forming a hole in the vessel wall. The present invention relates to a hole former provided. Optionally, the evacuation section is formed by a cutting edge of the entry head. Alternatively or additionally, a cutting edge is formed in the base of the hole former. The cutting edge (if there are two or one or both) can be of various designs, for example smooth, sawtooth and / or beveled. In an exemplary embodiment of the invention, the retraction is deep enough to accommodate a tissue plug created by one, two or more hole forming operations, even if the plug breaks. Having.
[0015]
In an exemplary embodiment of the invention, the retraction comprises a plug extraction means. In one example, a spring element, for example, a flexible silicone mass or a metal spring, is provided in the retraction and once the hole formation is completed and the hole former is removed from the vessel, the spring element causes the plug to be at least partially out of the hole. Is released. Alternatively or additionally, an axially retractable catch is used in the retraction section, which is retracted from the retraction section, for example manually or by a spring, when the entry head separates from the base. And / or remain in place.
[0016]
One aspect of some embodiments of the present invention relates to a hole former that combines anvil cutting and at least one knife cutting and shearing to form a hole in a blood vessel. In an exemplary embodiment of the invention, an anvil cut is performed to cut the adventitia of a blood vessel, and another cutting method is performed to cut the intima of the blood vessel. Different cutting methods may be performed using the same cutting edge or one or more cutting surfaces. In one example, the sloping portion of the entry head contacts the base to perform an anvil cutting operation, while the cutting edge formed on the entry head slides past the base to perform a knife cutting and / or shearing operation. Is performed. In another example, the cutting edge performs a knife cutting operation until it hits an inclined portion of the base, and also performs an anvil cutting operation.
[0017]
One aspect of some embodiments of the present invention relates to a rotary anvil cutting type hole former. Optionally, at least one of the anvil and the cutting head is actuated by a spring such that when the anvil and the head come into contact, one of them is retracted, thus preventing damage to the cut and / or It is reduced. In an exemplary embodiment of the invention, the entry head functions as a cut, and the base is an anvil and is operated by a spring. Optionally, the entry head is retracted and rotated by a screw. Optionally, when the head reaches the base, the head can rotate an infinite number of times. Optionally, when the head reaches the base, the threads are slid and the base is advanceable by a spring.
[0018]
One aspect of some embodiments of the present invention relates to an anvil punch for a resilient material, for example, on a base or entry head. Optionally, the cut of the hole former rotates relative to the anvil. Optionally, when the entry head is forcibly retracted, it pushes the resilient material sideways and retracts into a pre-existing aperture in the anvil.
[0019]
One aspect of some embodiments of the invention relates to setting parameters of the hole former. In an exemplary embodiment of the invention, D is the outside diameter of the cutting edge and d is the minimum diameter of the hole former between the entry head and the base. In an exemplary embodiment of the invention, the hole remover is set so that the diameter of the hole is the desired value. Generally, D is close to d, and the amount of tissue removed by the hole forming operation tends to be small, and the space for receiving the tissue plug during the hole forming operation is small. If D is sufficiently larger than d, larger holes can be formed, whose size approaches or exceeds D.
[0020]
An aspect of some embodiments of the present invention is that in an exemplary embodiment of the present invention relating to various designs of the entry tip and / or entry head, a plug that selectively functions as an anvil or retains a vessel vessel wall. The entry head, acting as a holder, is expandable, for example a spiral, deformable silicon or a plurality of radially extending (optionally interconnected) arms. Alternatively, the entry head functions as a cutter, for example, in a spiral configuration. Optionally, retraction of the entry tip causes expansion of the entry head.
[0021]
Alternatively or additionally, an anvil is provided such that it faces only a part of the circumference of the cutting edge.
[0022]
In an exemplary embodiment of the invention, the entry tip and head have a threaded tube, and the hole formation is performed by retracting the thread relative to the base.
[0023]
In an alternative embodiment of the invention, the entry head comprises a disc, which is inserted from its side and / or is deformed such that it enters the vessel vessel wall after entering the vessel. . The disk is then used in a hole forming operation, for example as an anvil.
[0024]
In the example of a threaded head and a disk-shaped head, the cutting operation may be, for example, a knife, a shear and / or an anvil, optionally utilizing the cutting edge of the entry head.
[0025]
In an exemplary embodiment of the invention, the entry tip takes the form of one, two or more sided knives. Alternatively, the entry tip takes the form of a screw. Alternatively or additionally, the entry head is in the form of one, two, three or more deep bivalve shells. Alternatively, the entry head is cross-shaped or polygonal in cross-section, rather than circular as in some other embodiments.
[0026]
In an alternative embodiment of the invention, one, two or more cutting spikes are formed as cutting edges of the entry head. The spike has a wide base and a narrow tip, with a cutting surface along its outer edge. In one example, two spikes are provided, together with the base, forming a bridge around the entire perimeter of the entry head.
[0027]
One aspect of some embodiments of the present invention relates to a needle-like hole former. In an exemplary embodiment of the invention, the base is in the form of a needle with a stoma, optionally with a beveled tip. The needle itself may, for example, be provided with a symmetrical or asymmetrical conical tip. The edges of the stoma are sharp. The tissue entry tip is provided to pass through the stoma and includes a transverse extension that is substantially identical in shape to the stoma. In use, the entry tip is inserted into the blood vessel such that the transverse extension also crosses the vessel wall. The entry tip is then retracted, retracting the vessel toward the base, such that the sharp cutting edge of the base and / or optionally the sharp surface of the transverse extension cuts the vessel wall.
[0028]
One aspect of some embodiments of the present invention relates to marking a piercing movement. In an exemplary embodiment of the invention, the hole former has a visible display indicating movement of the base relative to the entry head and the base and / or relative to other portions of the hole former. . In one example, a slot is formed in the base or in an extension of the base through which markings on the extension of the entry head are visible. Optionally, the hole former is used via a transfer system. In an exemplary embodiment of the invention, the transfer system includes a relative movement of another transferred tool, optionally with a similar progress indicator, such as a hole former and / or an anastomotic connector transfer tool. It has a window for watching movement. Optionally, a loud mechanical click is generated, alternatively or additionally, when the desired point is reached by progress.
[0029]
One aspect of some embodiments of the invention relates to a lateral cutter for a blood vessel. In an exemplary embodiment of the invention, the side cutter has an L-shaped element with a sharp tip. The tip is inserted into the blood vessel and the arm of the L-shaped element is parallel to the axial direction of the blood vessel. The L-shaped element is then retracted relative to the base, with a cutting action being performed by the selectively sharp inner edge of the L-shaped element and / or a shearing action being performed on the base. The base is optionally sharpened. The base may be on one side of the L-shaped element or may sandwich the L-shaped element. Optionally, the cutting arm of the L-shaped element is parallel to the base, alternatively the arm is tilted toward or away from the base.
[0030]
Hence, according to an exemplary embodiment of the present invention,
An entry head adapted to be inserted over the vessel wall,
A base part,
At least one cutting surface on at least one of the entry head and the base portion, the cutting surface being adapted to initially contact an intima of the blood vessel;
A shaft operatively connected to the cutting surface, the shaft being configured to rotate the cutting surface relative to the blood vessel;
The approach head and the base are carried in opposite directions to remove a tissue plug from a blood vessel;
A hole forming apparatus for forming an opening in a blood vessel is provided.
[0031]
In an exemplary embodiment of the invention, the cutting surface is on the entry head, and the shaft rotates the entry head. Alternatively or additionally, the cutting surface is on the base, and the shaft rotates the base.
[0032]
Alternatively or additionally, the plug is knife-cut by the cutting surface. Alternatively or additionally, the plug is formed by shearing between the entry head and the base. Alternatively or additionally, the plug is formed by an anvil cut between the entry head and the base.
[0033]
In an exemplary embodiment of the invention, the hole forming device is adapted to insert the entry head from outside the blood vessel.
[0034]
Alternatively or additionally, the hole forming device is adapted to insert the entry head from inside the blood vessel.
[0035]
Alternatively or additionally, the entry head is adapted to penetrate the vessel wall.
[0036]
Alternatively or additionally, the cutting edge has a tissue retraction to hold the plug.
[0037]
Also, according to an exemplary embodiment of the present invention,
An entry head adapted to be inserted over the vessel wall,
A base part,
At least one cutting surface on at least one of the entry head and the base portion, wherein there is a retreat portion for receiving a plug of the vessel wall;
A shaft operatively connected to the entry head and the base portion, the shaft being configured to carry the entry head and the base portion in opposite directions to remove a tissue plug from a blood vessel to the retraction portion. Have,
A hole forming apparatus for forming an opening in a blood vessel is provided.
[0038]
In an exemplary embodiment of the invention, said cutting surface is on said entry head. Optionally, the tissue retracting section is retracted into the base section.
[0039]
In an exemplary embodiment of the invention, said cutting surface is on said base.
[0040]
In an exemplary embodiment of the invention, the device has a resilient element at the tissue retraction and compressed by the plug. Alternatively or additionally, the device has a plug extractor mounted on the shaft and adapted to move axially with respect to the tissue retraction to remove the plug.
[0041]
Also, according to an exemplary embodiment of the present invention,
An entry head adapted to be inserted over the vessel wall,
A base part,
A cutting surface on at least one of the approach head and the base portion,
An anvil surface on at least one of the approach head and the base portion;
The entry head and the base portion are effectively connected to the entry head and the base portion, and the entry head and the base portion face each other in order to remove a plug from a blood vessel by a cutting operation by the cutting surface and an anvil cutting operation by the anvil surface. A shaft configured to carry;
A hole forming apparatus for forming an opening in a blood vessel is provided.
[0042]
In an exemplary embodiment of the present invention, the cutting operation is a shearing operation between the cutting surface and the base. Alternatively or additionally, the cutting operation is a knife cutting operation with a cutting surface.
[0043]
In an exemplary embodiment of the invention, the cutting surface is involved in an anvil cutting operation. Alternatively, the anvil surface does not contact the cutting surface.
[0044]
In an exemplary embodiment of the invention, at least one of the cutting surface and the anvil surface rotates.
[0045]
In an exemplary embodiment of the invention, the anvil cutting operation and the cutting operation are performed on different layers of a blood vessel. Optionally, said anvil cutting operation is performed on the adventitial layer of said blood vessel.
[0046]
In an exemplary embodiment of the invention, the anvil cutting operation moves the anvil in a shocking manner.
[0047]
Also, according to an exemplary embodiment of the present invention,
An entry head adapted to be inserted over the vessel wall,
A base part,
A cutting surface on at least one of the approach head and the base portion,
An anvil surface on at least one of the approach head and the base portion;
The approach head and the base are effectively connected to each other, and are configured to carry the approach head and the base in directions facing each other to perform an anvil operation between the cutting surface and the anvil surface. Having a shaft,
At least one of the anvil surface and the cutting surface rotates with respect to the blood vessel,
A hole forming apparatus for forming an opening in a blood vessel is provided. Optionally, said rotation is mechanically synchronized with said transport.
[0048]
Alternatively or additionally, the anvil includes an elastic backing that deforms when the cutting surface strikes the anvil surface. Alternatively or additionally, the anvil bounces off intermittently during rotation. Alternatively or additionally, said rotation is mechanically unlimited in number of rotations. Alternatively or additionally, the anvil surface is inclined. Optionally, the inclined anvil surface shifts in a direction different from the direction of rotation and the direction of conveyance in the direction facing each other when the cutting surface strikes.
[0049]
Also, according to an exemplary embodiment of the present invention,
An entry head adapted to be inserted over the vessel wall,
A base part,
A cutting surface on at least one of the approach head and the base portion,
An elastic anvil part having a surface on at least one of the approach head and the base part;
A shaft operatively connected to the entry head and the base portion and operable to carry the entry head and the base portion in opposite directions to perform an anvil motion between the cutting surface and the anvil surface; And having
A hole forming apparatus for forming an opening in a blood vessel is provided. Optionally, said anvil surface is elastic. Alternatively or additionally, the anvil portion is resiliently retractable.
[0050]
Also, according to an exemplary embodiment of the present invention,
Choose a vessel punch designed with an inner shaft of diameter d and a cutting edge of diameter D,
Selecting the ratio of d and D and the value of D to obtain the desired hole diameter to be drilled,
A method is provided for designing a hole forming device for forming an opening in a blood vessel. Optionally, the method comprises selecting a depth of the tissue retraction that affects the diameter of the punch design.
[0051]
Also, according to an exemplary embodiment of the present invention,
A base part,
A deformable approach head having a portion made of an elastic material, wherein the head is adapted to be inserted beyond a blood vessel, and a diameter after the approach is larger than a diameter during the approach. One that is transformed into
It is operatively connected to the entry head and the base portion and acts to transport the entry head and the base portion in opposite directions to remove a plug of tissue between the entry head and the base portion. Having a shaft,
A deformable hole former is provided.
[0052]
Optionally, the former includes a retracted entry tip which is adapted to deform the head when retracted.
[0053]
Also, according to an exemplary embodiment of the present invention,
A base part,
A deformable entry head comprising a radially expanding spiral, a deforming disk, and at least one of a plurality of radially extending arms, such that the head is inserted across a blood vessel. It has become so that the diameter after intrusion becomes larger than the diameter during intrusion,
It is operatively connected to the entry head and the base portion and acts to transport the entry head and the base portion in opposite directions to remove a plug of tissue between the entry head and the base portion. Having a shaft,
A deformable hole former is provided. Optionally, the disk continues to be oriented axially during the approach.
[0054]
Also, according to an exemplary embodiment of the present invention,
A threaded entry head adapted to be inserted beyond the vessel wall,
A base part,
A shaft operatively connected to the entry head and the base portion and operative to transport the entry head and the base portion in opposite directions such that a cutting operation is performed by the threads.
A hole forming apparatus for forming an opening in a blood vessel is provided. Optionally, said thread is a cutting edge. Alternatively or additionally, when the threads and the base are transported, the threads cooperate with the base to perform a shearing action. Alternatively or additionally, the threads cooperate with the base to perform an anvil cutting operation.
[0055]
Also, according to an exemplary embodiment of the present invention,
A needle with a small hole inclined at its tip,
A puller having a radially extending extension that fits through the stoma and is adapted to engage the vessel wall of the blood vessel toward the needle. Have,
A hole forming apparatus for forming an opening in a blood vessel is provided. Optionally, said angled stoma has a sharp cutting edge.
[0056]
Also, according to an exemplary embodiment of the present invention,
Two elements that cooperate to remove vascular tissue when moved in a direction facing each other;
Handle and
A visible indicator incorporated into the handle to indicate a relative degree of movement of the element.
A hole forming apparatus for forming an opening in a blood vessel is provided.
[0057]
Also, according to an exemplary embodiment of the present invention,
An L-shaped spike with a sharp shear at the end of the arm,
At least one base surface substantially parallel to the arm and adapted to shear against the arm.
An incision former is provided.
[0058]
Optionally, said incision former has at least two substantially parallel base surfaces. Alternatively or additionally, the base surface is not parallel to the arm.
[0059]
Also, according to an exemplary embodiment of the present invention,
An entry head with a sharp tip adapted to be inserted over the vessel wall;
A base with an inner lumen,
At least one cutting surface on the base portion, wherein the device cuts across the blood vessel without drawing the blood vessel toward the cutting surface;
A shaft mechanically connecting the approach head and the base portion,
There is a tissue holding shaft portion between the base portion of the shaft and the approach head, the approach head preventing tissue penetrated by the shaft portion from sliding down on the approach head,
The shaft has a first mechanically defined and axially locked retraction position such that the entry head is at least partially covered within the inner lumen by the base portion; and A second mechanically defined retracted position such that the shaft portion is axially locked with respect to the shaft portion, wherein the shaft portion is exposed between the base portion and the entry head.
A hole forming apparatus for forming an opening in a blood vessel is provided. Optionally, movement of said shaft between said positions is not mechanically coupled to rotation of said base. Alternatively or additionally, the approach head is conical. Alternatively or additionally, the approach head has at least one protrusion extending radially greater than the smallest diameter of the shaft portion. Optionally, said at least one protrusion is a barb cut from said shaft. Optionally, the barbs are resilient and flexible so that when the entry head is inserted into the vessel, it is sufficiently pushed by the shaft portion by the vessel wall of the vessel.
[0060]
Optionally, the entry head has a retractable entry tip. Alternatively or additionally, the entry head is rotationally locked with respect to the base.
[0061]
In an exemplary embodiment of the invention, at the first retracted position, the entry head is retracted completely into the lumen. Alternatively or additionally, the shaft portion is at least 150% of the width of the blood vessel for which the device is designed.
[0062]
In an exemplary embodiment of the invention, the device is adapted to form a stoma from outside a blood vessel.
[0063]
Optionally, the shaft, when released, moves from the first retracted position to the second retracted position by a spring. Alternatively or additionally, movement of said shaft relative to said base is restricted between said two positions. Alternatively or additionally, the shaft has only two retracted positions. Alternatively or additionally, the shaft is rigid.
[0064]
In an exemplary embodiment of the invention, the inner lumen has a clearance relative to the entry head such that vascular tissue is not cut between the entry head and the inner lumen. Alternatively or additionally, the entry head is adapted not to pull back on the vessel wall during cutting and is so arranged. Optionally, the entry head has a lumen in the direction of the tube wall.
[0065]
In an exemplary embodiment of the invention, said device comprises external power means for moving said shaft between said positions. Optionally, the device has a drug supply coupled to an opening proximate to the entry head and the base.
[0066]
Also, according to an exemplary embodiment of the present invention,
An entry head having a sharp tip adapted to be inserted over a vessel wall, wherein the tip has a lumen in the direction of the vessel wall;
A base with an inner lumen,
At least one cutting surface on the base portion and adapted to cut over the blood vessel;
A shaft mechanically connecting the approach head and the base portion, and fixing an axial position of the approach head with respect to the base,
A hole forming apparatus for forming an opening in a blood vessel is provided. Optionally, said lumen elutes the drug. Alternatively or additionally, the lumen is adapted to engage tissue. Alternatively or additionally, the lumen allows tissue to move in one direction relative to the lumen.
[0067]
Also, according to an exemplary embodiment of the present invention,
An entry head with a sharp tip adapted to be inserted through the vessel wall,
A base with an inner lumen,
At least one cutting surface on the base portion, the cutting surface being adapted to cut through the blood vessel such that the device does not draw the blood vessel toward the cutting surface;
A shaft mechanically connecting the approach head and the base portion, and fixing an axial position of the approach head with respect to the base,
A hole forming apparatus for forming an opening in a blood vessel is provided. Optionally, said inner lumen is adapted to engage said tissue. Alternatively or additionally, the diameter of the entry head does not vary.
[0068]
Also, according to an exemplary embodiment of the present invention,
Covering at least one sharp edge of said tool with a cover,
Insert the tool over the valve,
Removing the cover,
A method is provided for inserting a tool into a scaffold with an internal valve. Optionally, said removing is breaking up.
[0069]
Also, according to an exemplary embodiment of the present invention,
A base portion having an inner lumen, wherein the inner lumen is adapted to engage tissue of the blood vessel;
And at least one cutting surface adapted to cut through the blood vessel, on the base portion.
A hole forming apparatus for forming an opening in a blood vessel is provided. Optionally, threads are formed inside the inner lumen. Alternatively or additionally, the device has a transverse stabilizer that fixes an axial position with respect to the cutting surface.
[0070]
Also, according to an exemplary embodiment of the present invention,
Means for forming a stoma in the blood vessel;
Dissolving means for supplying a drug at the position of the small hole,
A hole forming apparatus for forming an opening in a blood vessel is provided. Optionally, said forming means comprises cutting means. Alternatively or additionally, said forming means comprises shearing means. Alternatively or additionally, said forming means comprises anvil cutting means.
[0071]
Also, according to an exemplary embodiment of the present invention,
Insert the entry head into the vessel wall,
A cutting base is advanced toward the blood vessel so as not to apply a contra force to the blood vessel via the entry head;
A method for forming a stoma in a blood vessel is provided. Optionally, advancing is advancing using a rotary motion.
[0072]
Non-limiting embodiments of the present invention will be described with reference to the following description of exemplary embodiments, which is taken in conjunction with the drawings. The drawings are not generally drawn to scale, and any measurements are merely exemplary in nature and are not necessarily limiting. In the drawings, identical structures, elements, or features that appear in one or more drawings are preferably assigned the same or similar reference numerals in all of the drawings in which they appear.
BEST MODE FOR CARRYING OUT THE INVENTION
[0073]
End-to-side anastomosis typically requires an opening made in a "side" vessel, typically the target vessel. When an incision is made in the lateral vessel, the target vessel is torn and / or deformed by widening the incision to create the oval or circular opening typically required for an anastomotic connection. sell. Alternative methods include drilling or cutting holes in blood vessels (eg, using the methods described in the Background of the Invention). However, we believe that such perforations may result in one or more tears around the hole. For example, a hole with a diameter of 2.5 mm in the aorta usually breaks, and when an anastomosis is performed, the hole can widen and leak. In some cases, the size of the aortic hole that affects the occurrence of tears is indicated, but when performing an anastomosis with a larger diameter, the smallest hole size is needed to prevent aortic deformation. Would be needed.
[0074]
Blood vessels are composed of several layers. The outermost layer is a tough fibrous layer called the outer membrane. The innermost layer is called the intima. The present inventors have discovered that as cutting progresses from outside to inside, the adventitia catches the cut and deforms it before the intima is cut. In addition, we may perform different determined cutting methods on different layers of the blood vessel.
[0075]
When a portion (plug portion) is cut off on the vessel wall, it is usually desirable to prevent the plug from falling into the bloodstream. In addition, it is desired that the plug does not fall off during or after hole formation.
[0076]
One or more of the above problems are solved by embodiments of the present invention.
[0077]
FIG. 1A illustrates a hole former 100 according to an exemplary embodiment of the present invention, which has a base tube 102 and an entry head 104 inserted into the vessel wall of a blood vessel 106. As shown, the blood vessel 106 has an intima layer 108 and an adventitia layer 110. As exemplarily shown in FIG. 2, the tip of the approach head 104 may be a retractable approach tip.
[0078]
In an exemplary embodiment of the invention, the entry head 104 has a cutting edge 114 that is retracted toward the vessel and cuts into the vessel when it is retracted. Optionally, the cutting edge 114 is formed as a rim of a cup 116 having a wall surface 112. The cup 116 desirably functions to place a plug of tissue cut from the blood vessel 106 by the cutting edge 114.
[0079]
In the embodiment of FIG. 1A, the base tube 102 has an anvil surface 118 that strikes the cutting edge 114 when the entry head 104 is fully retracted. In an exemplary embodiment of the present invention, when retracted, the cutting edge 114 causes knife cutting until it is near the anvil 118 where an anvil cutting operation suitable for cutting the adventitia 110 occurs. Perform the operation.
[0080]
FIG. 1B shows an alternative hole former 130 in which the knife cutting operation and the anvil operation are performed in different ways. Since the outer diameter of the wall 112 is smaller than the inner diameter of the base tube 102, the cup 116 can be retracted into the bore 138 of the tube 102. If the clearance between the cutting edge 114 and the bore 138 is small enough, a shearing action will take place between the entry head 104 and the base tube 102. Optionally, the cutting edge 114 is sharp enough to perform a knife cutting operation.
[0081]
In an exemplary embodiment of the invention, anvil cutting occurs between the cutting edge 142 of the base tube 102 and an anvil 140 that is optionally inclined with respect to the entry head 134.
[0082]
Optionally, one or both of the entry head 104 and the base tube 102 rotate in the same or opposite directions. Instead of a complete rotation, a pendulum-like rotation may be performed.
[0083]
As the entry head is retracted into base tube 102, one or both of head 104 and tube 102 may move. Optionally, this movement is interrupted, as described below, to allow a shocking anvil cutting operation.
[0084]
The connection between forward and rotational movement is optional. In one example, this connection is achieved by a thread linking the forward movement to the rotational movement. Instead of rotating during retraction, rotation occurs after retraction (eg, when the edge begins to pinch the vessel wall). Optionally, rotation and retraction are controlled separately, for example, controlling rotation with one and controlling retraction with another.
[0085]
2A-2E show cross-sectional views of an exemplary hole former 200, similar to the embodiment of FIG. 1B, according to an exemplary embodiment of the present invention.
[0086]
FIG.2A illustrates an optional retraction retract entry tip 202 that is retracted by retracting a shaft 208 mounted after the entry is completed, wherein the sharp tip is It does not damage the walls of blood vessels that are far away from the blood vessels. Optionally, retraction of the distal end unlocks a retraction mechanism that retracts the entry head into the base section manually or automatically (e.g., using a spring or motor). Also shown is the shaft 206 used to retract the entry head 104. The illustrated former 200 is attached to a transfer system 210, which is optionally a separate transfer system.
[0087]
FIG. 2B shows the handle portion of the former 200, which is, for example, a rotating handle 212. As the entry tip 202 enters the blood vessel, the slot 210 is used to retract the tip. The threads 214 are used, for example, to control retraction and rotation of the entry head 104 while using the hole former 200.
[0088]
FIG. 2C shows a central portion of the former 200, including a clip 220 for locking the former 200 to the phase system 210. FIG.
[0089]
FIG. 2D shows a portion of the former 200 in which the base tube 102 connects with the rest of the former 200. As described below, an optional volume 222 is provided for placing a resilient element (eg, silicon or spring) connecting the base tube 102 and the former 200.
[0090]
FIG. 2E illustrates exemplary dimensions of a system 200 used in the human aorta.
[0091]
It should be noted that, in an exemplary embodiment of the invention, once the plug is removed from the vessel wall, it is advanced toward the hole in which the base tube 102 is formed, for example, to prevent blood leakage. It is.
[0092]
FIG. 3 illustrates various dimensions of the approach head 304 that may be relevant in an exemplary embodiment of the invention. The diameter d is the outer diameter of the shaft 308 used to retract the head 304. The diameter D is the outer diameter of the circle drawn by the cutting edge 314. The depth W is the depth of the tissue retreat area 316 where the plug is placed. The inventors have determined that the size of the tissue plug removed from the targeted blood vessel depends on the geometry of the tissue retraction. Therefore, if W is very small, many tissue plugs will be limited. Similarly, if D is close to d, there will be less room for the tissue plug. Optionally, the use of cutting edge 314 rather than a rounded end reduces the chance of tissue slipping over and thus cutting edge 314 cuts into tissue and Hold it in position. Optionally, the shape of the evacuation area is designed to affect the shape of certain plugs. For example, if the evacuation section is full before the cutting is completed, the diameter of the plug decreases. The direction of decrease in the thickness direction of the plug may depend on the cutting direction and / or the orientation of the retraction part. For example, if a tissue retraction and / or a cutting edge is formed on the tube 102, a decrease occurs in the direction toward the blood vessel. In addition, a knife cut is performed to ensure that the early cut tissue has a known diameter, while shearing ensures that the later cut tissue is based on the allowable volume of the retraction area. Done for. By making a cut from both sides of the blood vessel toward the middle, an hourglass-like shape is used, and a limited volume of tissue retraction area is used between the two cutting surfaces.
[0093]
Various ratios of rotational movement to axial movement may be used. This is, for example, 1/1, ie 1 mm forward per revolution. In one example, at least 10 or at least 30 rotations occur during the formation of the hole. In other examples, one or less rotations occur.
[0094]
If W is large enough, the tissue plug removed from the body will fit in the retraction 316, making it more difficult to use the hole forming system. In particular, when performing a smooth cutting operation, W becomes large, and it becomes almost impossible to access the tissue plug from outside. In an exemplary embodiment of the invention, a mechanism is provided to assist in plug removal.
[0095]
FIG. 4A shows the entry head 400 provided with a tissue extractor 420 for extracting a tissue plug from the tissue retraction unit 416. In an exemplary embodiment of the invention, extractor 420 includes one or more radial extensions (or edges) 422 that extend inside retraction 416. As the entry head 104 advances, the tissue plug catches the extension 422 and is withdrawn from the retraction 416. An optional elastic element 424, such as a spring or soft rubber, is used to push the extractor 420 toward the base 102. In an alternative embodiment, the extractor is free to move.
[0096]
FIG. 4B shows an alternative mechanism 400 in which a resilient element 442, such as a spring or silicone plug, is used in the tissue retraction area. During the hole forming operation, the elastic element is compressed by the plug and rebounds at the end of the operation to push out the plug.
[0097]
In some embodiments of the present invention, as shown by way of example in FIG. 1A, the cutting edge contacts a non-moving element and is not damaged thereby. FIG. 5 illustrates a base retraction mechanism 500 that allows the both 102 to be elastically retractable, according to an embodiment of the present invention. Thus, for example, when the cutting edge hits, the base 102 is pushed back to the cutting edge instead of crushing the cutting edge. A potential advantage of such resilient contact is that manufacturing tolerances when designing the threads that couple the axial and rotational movements of the entry head 104 can be relaxed.
[0098]
In an exemplary embodiment of the invention, mechanism 500 has a resilient element 502, such as a piece of silicone rubber or a spring (or base 102 is resilient), allowing for axial movement of base 102. And
[0099]
A further potential advantage of such elastics is that the entry head 104 continues to rotate after contacting the base 102. A further potential advantage is that the entry head hits the base 102 and then jumps over the threads, resulting in abrupt movement of the head 104 relative to the base 102, which assists in cutting the adventitia.
[0100]
FIG. 6 illustrates an alternative hole former 600 according to an embodiment of the present invention. In this embodiment, the former 600 has an entry head 604 with an optional retraction entry tip (not shown). The slicing operation is selectively performed between the upper end edge of the approach head 604 and the inner diameter of the base 602. Alternatively or additionally, the knife cutting operation is performed by the inner diameter of the entry head and / or the leading edge 610 of the base 602. One or both of the head 604 and the base 602 rotate. Optionally, the head 604 is retracted using a screw drive operating within the handle 606. Alternatively, head 604 (and similar heads in other embodiments described herein) is retracted using a spring-loaded mechanism.
[0101]
Various marking systems for indicating the extent of hole formation, for example, as illustrated in FIG. 6, are also useful. One exemplary system has a stoma (or transparent portion 620) in the handle 606 and a second stoma 622 formed in the base 602. One or more visual markings on shaft 614 that are coupled to entry head 604 are visible through a stoma or transparent section to indicate the relative position of entry head 604 and base 602.
[0102]
Another exemplary pointing system has a transparent dome 612 through which the extension of bar 610, which is adapted to extend when the entry head is retracted, is visible.
[0103]
In another exemplary system, a lead that can connect a battery (not shown) to a power light 630, such as an LED, is short-circuited and a reference 624 indicates contact on shaft 614. . This allows the position to be indicated better than when using mechanical means. Alternatively or additionally, a mechanically (or electrically) generated sound, such as a click sound, sounds when retraction of head 604 is completed. Different sounds may be generated during retraction and after the head 604 contacts the base 602. Alternatively or additionally, a variable resistor may be used to indicate progress on a memory or other suitable scale display.
[0104]
7A-7I illustrate various entry tips and entry head designs, according to exemplary embodiments of the present invention. The entry tip is optionally retracted within each of the figures shown.
[0105]
FIG.7A shows an approach head 700 having a head body 704 having one side, two sides, three sides, or more sides being a bivalve shell-like concave surface, and a conical approach tip 702. It is.
[0106]
FIG. 7B shows an entry head 710 having a head body 714 that is asymmetric and sharp along one of its edges 716 and has a corresponding knife-shaped entry tip 712.
[0107]
FIG. 7C shows an approach head 720 having a conical head body 724 and an approach tip 722 recessed in a bivalve shell shape.
[0108]
FIG. 7D shows an entry head 730 having a conical head body 734 and an entry tip 732 with a knife-shaped side.
[0109]
FIG. 7E shows the entry head 740 such that the bivalve portion of the head body 744 and the bivalve portion of the entry tip 742 coincide.
[0110]
FIG.7F illustrates an entry head 750 where the head body 754 is a truncated cone with a longer, sharpened tip 752, for example, whose length is two or three times the diameter. .
[0111]
FIG. 7G illustrates an entry head 760 in which the head body 764 is a rounded bulb with a standard entry tip 762.
[0112]
FIG. 7H shows an entry head 770 with a threaded entry tip 762 such that the head body 774 optionally rotates as it advances.
[0113]
FIG. 7I shows the entry head 780 such that the head body 784 and the associated entry tip 782 form a cross-section knife.
[0114]
Still other variations are contemplated as well. For example, one or both of the cutting edges on the entry head may be inclined with respect to the axis or radius of the system (eg, such that the radius is not constant). For example, embodiments that perform inner edge cutting or outer edge cutting are provided with such tilted elements. Other components having different inclination angles may be used.
[0115]
8A and 8B illustrate an extended approach head 800, according to an exemplary embodiment of the present invention. Head 800 has an entry end 802 attached to shaft 810. A plurality of arms 804 extend radially from the shaft 810 at an oblique angle. Optionally, the arm is in a slot 808 in the shaft 810. In an exemplary embodiment of the invention, the arms pop out after shaft 810 exits constrained outer base tube 812 and crosses the interface of the wall of vessel 106. In an exemplary embodiment of the invention, the distal end of arm 804 is a rounded tip. FIG. 8B is a top view of FIG. 8A. Optionally, arm 804 is a sliver formed from the body of shaft 810.
[0116]
In use, the shaft 802 is retracted with respect to the base portion 812. The cutting operation is performed by the cutting edge of the tube 812. Alternatively or additionally, tip 806 functions as an anvil, a portion of which biases tissue toward cutting edge 814. Optionally, shaft 802 and / or base 812 rotate.
[0117]
9A and 9B illustrate an alternative extended approach head 904, according to an exemplary embodiment of the present invention. The hole forming system 900 includes a base tube 902 having a cutting edge 912, and an expansion head that has a small diameter when inserted into the blood vessel 106 (FIG.9A) and a large diameter when forming a hole (FIG.9B). . In an exemplary embodiment of the invention, the head 904 has an elastic and / or expandable element 908, such as silicon or other fluid or semi-fluid, that deforms and expands and extends (or expands). A disk portion 916 is formed. In an exemplary embodiment of the invention, the entry tip 906 of the head 904 (and optionally its associated base 914) or the entire head 904 is retracted relative to the base 910 of the head 904, and As a result, the silicon element 908 is compressed axially and extends radially. Alternatively. The element 908 may expand or deform due to the advancement of a rod sent to the element from the direction of the tube 902.
[0118]
In an exemplary embodiment of the invention, extension 916 functions to bias the vessel wall of blood vessel 106 toward base 902. Alternatively or additionally, it functions as an anvil to the cutting edge 912. Optionally, silicon element 908 has one or more hard patches on its surface. In an exemplary embodiment of the invention, such a rigid patch can be used for an anvil cutting operation, but is not required. Alternatively or additionally, the extension 916 fits the inner surface of the base tube 902 to allow for a shearing action. Alternatively or additionally, expansion of element 908 extends one or more sharp spikes or cutting edges (not shown) in the direction of base 102. Optionally, extension 916 is sloped at a point of cutting edge 912, which is provided for a tilted anvil cutting operation. Optionally, the resiliency of the element 908 is set such that when the cutting edge 912 abuts / approaches the extension 916, the extension allows the edge 912 to slide relative to the extension.
[0119]
It should be noted that even soft anvils and scissors can be subjected to free cutting operations. In addition, the elasticity of the silicon is adjustable (at the time of manufacture) to set the maximum stiffness at which the silicon is deformable.
[0120]
10A and 10B illustrate a hole former 1000 with an enlarged approach head 1004, according to an exemplary embodiment of the present invention.
[0121]
In an exemplary embodiment of the invention, head 1004 has a thin sheet 1008 that is tightly wound about an axis, as shown in cross section 1006. FIG. 10B shows the former 1000 after placement, wherein the head 1004 has a released conical shape. This cross section is shown as reference 1012. A shaft 1010 is optionally welded to the side or tip of the head 1004. Alternatively, sheet 1008 has been carved from shaft 1010.
[0122]
As the head 1004 expands, the head 1004 is retracted toward the base tube 1002 and depends, inter alia, on the relative geometry of the head 1004 and the base 1002 as described herein, e.g., knife, shear And / or performing a cutting operation such as an anvil cutting operation.
[0123]
11A and 11B illustrate a hole former with an anvil 1104 of varying geometry, according to an exemplary embodiment of the present invention. The hole former 1100 includes an entry tip 1114 attached to a shaft 1110, and a base tube 1102. An auxiliary cutting disk 1104 optionally having a small hole 1106 is attached to the shaft 1110. In an exemplary embodiment of the invention, an overtube 1112 (or other similar regulating element) holds the disc 1104, e.g., such that the disc is held between the extension 1108 of the tube 1112 and the shaft 1110. Keep it deformed. Optionally, another portion of the disk 1104 is held against the entry tip 1114 by the second extension 1116.
[0124]
In FIG. 11B, the entry tip 1114 and the disc 1104 are inserted over the vessel wall, and the tube 1112 is retracted so that the disc 1104 is free and its plane is perpendicular to the shaft 1110. At this point, the disc 1104 can be used as a base for an anvil or shear, particularly depending on the relative geometry of the disc 1104 and the base 1102. Optionally, the disk 1104 includes one or more spikes or cutting edges 1118, which can be used for cutting. Optionally, the geometry of the eyelet 1106 of the disk 1110 is adapted to match the cross-section of the shaft 1110 to prevent rotation.
[0125]
In an exemplary embodiment of the invention, the disks 1104 are arranged in the direction of the cut formed by the entry tip 1114. Alternatively or additionally, disc 1104 has sharp edges to assist in forming a cut.
[0126]
Optionally, the disk 1104 is tilted by deformation, and its transverse dimension is small. Alternatively or additionally, disk 1104 is always tilted. Alternatively or additionally, disc 1104 remains deformed by tension acting between one portion held by entry tip 1114 and the other portion retained by overtube 1112.
[0127]
Alternatively or additionally, disc 1104 is plastically deformed, for example, by advancement of overtube 1112 to make disc 1104 flat. Alternatively or additionally, disk 1104 is stabilized in two states, the state of FIG. 11A and the state of FIG. 11B.
[0128]
In this and other embodiments, various shape changing mechanisms may be used, such as, for example, the shape changing mechanisms described above, and deformations based on elasticity, superelasticity, and shape memory.
[0129]
FIG. 12 illustrates a resilient anvil hole former 1200 according to an exemplary embodiment of the present invention. The former 1200 has an entry head 1204, for example as described above, which comprises a wall 1206 with a cutting edge 1208. There is also a base 1202, but unlike some embodiments described above, the base 1202 has a resilient front end. In one embodiment, the cutting edge 1208 can enter the front end 1210. In another embodiment, the cutting edge 1208 compresses the end 1210 and then slides within the hollow shaft 1214 defined by the selectively deformed base 1202. Optionally, the degree of elasticity is selected to assist in cutting the adventitia.
[0130]
FIG. 13 illustrates a hole former 1300 with a threaded entry head 104, according to an exemplary embodiment of the present invention. Head 1304 has a shaft 1310 with threads 1308 thereon. Optionally, there is a retractable entry tip 1306. In use, the shaft 1310 is inserted into the vessel wall and then rotated to advance the shaft by the thread. As some or all of the threads pass through the wall, the entry head 1304 is retracted toward the base 1302 and cuts tissue. In one example, there is a cutting edge 1312 on the thread 1308. Alternatively or additionally, a shearing operation is performed between the side of the thread and the base 1302.
[0131]
14A and 14B are perpendicular side views of a needle-shaped hole former 1400, according to an exemplary embodiment of the present invention. A hollow-tipped needle 1402 is formed, with a slanted eyelet 1408 with a sharp cutting edge 1410. In use, the entry tip 1404 extends beyond the wall of the blood vessel and is then retracted toward the needle. In an exemplary embodiment of the invention, the tip 1404 includes an extension 1406, such as an elastically extending extension that extends as the entry tip passes through the tissue from the needle. Optionally, extension 1406 functions as a knife. Alternatively or additionally, the distal end of extension 1406 is first inserted into the target blood vessel and then rotated, for example, as illustrated in FIG.
[0132]
15A and 15B illustrate two variations of an incision maker according to an embodiment of the present invention. FIG. 15A shows an incision former 1500. There are two movable parts, a base surface 1510 connected to the first handle 1514 and an L-shaped spike 1504 connected to the second handle 1512. Other designs of handles may be used. The two parts are optionally connected using a spring 1516. In use, the tip 1506 of the arm 1509 of the spike 1504 is inserted into a blood vessel, for example, a coronary artery. The incision-forming device 1500 then assumes that the arm enters the blood vessel and the axis of the blood vessel (this direction is the desired cutting direction. Is also possible). The arm 1509 is then retracted toward the surface 1510, and the vessel wall is cut by shearing. Optionally, the inside surface of arm 1509 is sharpened and functions as a knife.
[0133]
FIG.15B shows an alternative embodiment for an incision former according to an embodiment of the present invention, which has two base surfaces 1560, one on each side of the spike 1554 ( Only one side is shown). The spike tip 1556 of the arm 1559 and, optionally, the cutting edge 1558 of the arm 1559 perform the functions described above.
[0134]
Optionally, the surfaces 1560 and arms 1559, which are optionally substantially parallel, are not parallel, but extend, for example (as shown), or face each other.
[0135]
16A and 16B illustrate a hole forming system 1600 according to an alternative embodiment of the present invention. FIG. 16A shows the former 1600 in a scaffold 1616, and FIG. 16B shows an enlarged view of the tip 1618 of the former 1600. Referring first to FIG. 16B, the former tip 1618 has a sharp entry head 1604 adapted to be inserted into a blood vessel, and the shaft portion 1609 of the entry head 1604 barbs into the vessel vessel wall. Optionally, the head 1604 includes a roughened surface, barbs, threads, tissue retraction (e.g., 116 in FIG. 1), or a large diameter portion 1608, as described in more detail below, wherein the tissue is the shaft of the head. Prevents dropping from 1609. In an exemplary embodiment of the invention, the tilted extension cuts from a straight shaft into multiple positions (e.g., two or three) on the shaft, for example, as shown in FIG. 18 below. It is formed by radially pulling or curling the cut.
[0136]
The target blood vessel is cut by a cutting surface 1610 formed on a base 1602 such as a tube. As described above, the cutting surface may be smooth, rasp, saw, and / or wavy, and may provide different finishes to different portions of the surface. Optionally, the cutting surface 1610 may be a surface that is inclined with respect to the shaft 1609 or may not be in a plane. The base 1602 is optionally connected to the shaft 1614 of the former 1600 via a ramp 1612 that is used to assist in advancing the sleeve 1615 of the scaffold 1616 within the stoma formed in the blood vessel. ing.
[0137]
Optionally, the entry head 1604 is locked to the base 1602 during cutting, preventing its axial movement and, optionally, rotational movement.
[0138]
In an exemplary embodiment of the invention, when the hole is cut by surface 1610, entry head 1604 is retracted, drawing the lumen-cut tissue plug into base 1602. Optionally, the retraction operation is performed manually. Alternatively, the retraction operation is performed by a spring. Alternatively, other power sources may be used for other retraction, such as aerodynamics, such as compressed air, which is deployed in many hospital rooms. In another example, an electric motor or solenoid is used to retract the entry head 1604. The retraction movement may be entirely axial or involve a rotational direction. In some embodiments of the present invention, the entry head 1604 is freely rotatable relative to the base 1602, while in other embodiments, it is fixed so as not to move in the rotational direction. Base 1602 may or may not rotate relative to scaffold 1616.
[0139]
In an exemplary embodiment of the invention, a peg 1620 is provided in a channel 1621 with two evacuation spots, the position of the peg 1620 extending the head 1604 as shown in FIG.16A. And the position 1622 where the head 1604 is retracted. Optionally, a safety release switch 1626 is provided to lock head 1604 to prevent axial movement of head 1604 relative to base 1602 and / or to lock hole former 1600 to transfer scaffold 1661. .
[0140]
The use of different tools being transported together in a typical scaffold 1616 is not critical to the practice of the present invention. However, some types of such scaffolds have internal leaflet valves through which the tool advances. In some cases, surface 1610 and / or head 1604 may damage the valve as the hole former advances through the scaffold. In an exemplary embodiment of the invention, a protective cover 1630 is used. In an exemplary embodiment of the invention, the cover is a tube, e.g., a silicone tube or a heat shrink tube, from the sharp edge of the former 1600 (or other tool), e.g., the surface 1610 or the tip of the head 1604. Isolate the valve. After insertion, the cover 1630 is split or pulled out (eg, if one end is sealed). Optionally, cover 1630 includes perforations 1634, rip codes and / or pull tabs to assist removal after it has been inserted into scaffold 1616.
[0141]
17A through 17E illustrate the use of a hole former 1600, according to an exemplary embodiment of the present invention.
[0142]
In FIG. 17A, the entry head 1604 is advanced toward a blood vessel such as the aorta 1700.
[0143]
In FIG. 17B, the entry head 1604 has advanced into the vessel 1700, the shaft 1609 has penetrated the vessel 1700, and the entry head 1604 has not engaged the vessel 1700 in any way. In some embodiments, however, the entry head 1604 includes barbs that engage the blood vessel 1700 or remain within the vessel wall. Such engagement allows the tissue of the blood vessel to be stretched prior to cutting, possibly providing a smaller or larger diameter and / or conical ostium than the diameter of base 1602. This size and shape may depend on whether the head 1604 is retracted prior to the start and / or completion of the cut. Optionally, the entry head 1604 has a sharp tip (eg, that of FIG. 4A) that retracts.
[0144]
In FIG. 17C, a cut is made, for example, by rotating and / or advancing the base 1602 relative to the blood vessel 1700, and the cutting surface 1610 is cut into the blood vessel 1700. Depending on the use of the former 1600, the entire transfer system may rotate / advance, or only the base 1610 and / or sub-components of the system 1600 may rotate / advance.
[0145]
In FIG. 17D, the cut has been completed, the base 1610 has engaged the blood vessel 1700, and the tissue plug 1702 is at the shaft 1609. Some or all of the plugs 1702 may be configured to fit inside the base 1602. Optionally, a tissue evacuation section (not shown) may be on the entry head 1604.
[0146]
The entry head 1604 is retracted while retracting the plug 1702, and becomes the lumen formed in the base 1602. The entry head 1604 optionally has sufficient clearance to the inner diameter of the lumen. Alternatively, the clearance is small and the base 1602 and the entry head 1604 create a shearing action therebetween (eg, a loose strand is cut off). Optionally, the entry head 1604 is retracted prior to the completion of the cut, but in the illustrated embodiment, it has not been retracted so far. Alternatively, the entry head 1604 is retracted while the base 1602 is advanced, eg, to ensure that the distal side of the vessel is not damaged. However, optionally, the entry head 1604 is retracted in a manner that ensures that the entry head 1604 does not apply tension or excessive tension to the vessel 1700 or affect the stoma cut shape. In one example, the entry head is retracted such that the distance between the entry head 1604 and the base 1602 is greater than the thickness of the plug 1702, or at least its uncut thickness.
[0147]
If the vessel 1700 is filled with blood under a certain pressure, the entry head 1604 may be distal to the vessel 1700, especially if the length of the shaft 1609 and the entry head 1604 is sufficiently smaller than the diameter of the vessel 1700. It should be noted that there is little harm to the sides of the Alternatively, a retraction retract entry tip is used. Preferably, surface 1610 is advanced under a small pressure, such as its own weight, to prevent deformation of the blood vessel. Alternatively, blood vessel 1700 retains its shape on the side perpendicular to the direction of entry by pressure (by fingers or tools).
[0148]
In FIG. 17E, the entire hole former has been advanced, and the sleeve 1615 has entered the wall of the blood vessel 1700, at which time the hole forming mechanism may be removed. Here, an anastomotic delivery system may be provided through the scaffold 1616 and its valve.
[0149]
In an exemplary embodiment of the invention, the length of shaft 1609 is greater than the wall thickness of blood vessel 1700, for example, 150%, 200% or 300% of its thickness. In the case of the aorta this corresponds, for example, to a length of 4-6 mm. Alternatively, the shaft is shorter than the diameter of the blood vessel. Optionally, shafts of different lengths are used for different patients and / or vessel sizes. Alternatively, a screw or other mechanism is used to adjust the length of shaft 1606, for example, by controlling the retracted position of peg 1620. The diameter of the entry head 1604 is selected such that this diameter prevents the plug 1702 from sliding, but clearance is maintained for the base 1602. The relationship between the diameter of the shaft 1609 and the cutting surface 1610 is optionally defined in FIG.
[0150]
FIG. 18 illustrates a hole former 1800, according to an alternative embodiment of the present invention. The former 1800 is connected via a cone 1812 to a base 1802 with an inner lumen having a cutting edge 1810 and a surface 1828. The entry head 1804 has a needle-like shaft 1809 having one or more barbs 1820 cut out of a recess formed from the body. Other methods of forming or attaching such barbs may be used as well. Optionally, shaft 1809 has a needle-like tip 1824, with an optional inner lumen having an inner surface 1826.
[0151]
In an exemplary embodiment of the invention, barbs 1820 are resilient such that when head 1804 is inserted into blood vessel 1700, barbs 1820 are bent back into recesses 1822 to reduce resistance during insertion. When the insertion is completed, it rebounds and returns.
[0152]
Optionally, surface 1826 and / or surface 1828 are provided with threads, barbs or other treatment members on the inside for better engagement with the tissue plug. Alternatively, the inner diameter of the lumen varies, for example, non-monotonically or monotonically (such as away from blood vessels).
[0153]
Hollow tips, such as those used in FIG. 18, may be used, for example, when continuously or with appropriate control, for example, by solvent administration (e.g., to prevent coagulation for recovery of cut tissue and / or assisting cutting). ) Is also used for other applications. Alternatively or additionally, such a lumen creates a vacuum, which provides a better connection between the former 1800 and the blood vessel 1700. Alternatively or additionally, a vacuum is created between the entry head 1804 (if any) and the base 1802, for example, through a lumen in the base 1802. Alternatively, solvent dosing is performed by other methods, such as, for example, where the entry head 1804 is sponge-like, or is supplied from a base 1802, for example, through its lumen or wall.
[0154]
In an alternative embodiment of the present invention, no entry head is provided and the threads inside the surface 1828 of the base 1802 selectively prevent the tissue plug 1702 from falling off. However, alternatively, an axial stabilizer such as approach head 1804 and shaft 1809 may be utilized. In one example, a wire is utilized. Alternatively, an axial helical shaft 1809 is utilized. This inner ballast may or may not have a fixed axial position relative to the base 1802. Even if not fixed, the range of movement is fixed and / or the number of stable positions is limited. In an exemplary embodiment of the invention, the ballast protrudes fully (e.g., 1-5 mm for the aorta) or slightly (e.g., 1 mm), or is coplanar, or retracts with respect to a surface defined by surface 1810. Retracted, optionally, so fixed. Optionally, the stabilizer is not strong enough (or does not sufficiently engage vessel 1700), which is used to bias vessel 1700 against base 1802.
[0155]
The above focuses on devices used outside blood vessels. However, they can also be used inside blood vessels.
[0156]
In an exemplary embodiment of the invention, the design is selectively modified to correspond to one or more of the following elements.
(a) which layer of the blood vessel is more accurately cut,
(b) what kind of cutting action is performed on each layer of the blood vessel,
(c) treatment of the tissue plug (if any) outside the vessel or inside the delivery system and / or the desired cut shape
[0157]
In the example of drilling from the inside to the outside of the present invention, the tissue retracting portion is located on the base, and the cutting edge extends forward. In another example, the tissue retract is on the entry head but the base advances toward the retract.
[0158]
In addition, stoma formation systems are used in multiple sizes, for example, two, three, or more sizes.
[0159]
It should be noted that elements described as tubes do not have to be tubes. In one example, the perforated base can be replaced by a slotted solid rod, which supports a shaft for retracting the entry head. The shaft need not be mounted in the center of the approach head.
[0160]
It should also be noted that the hole former can produce a plug that is not completely removed, for example a qualification or triangular flap.
[0161]
In an exemplary embodiment of the invention, the above device is a PCT application and publication WO 99/62415, WO 00/56226, WO 00/56228, WO 01/41623, WO 01/41624, WO 01/41624, incorporated herein by reference. Used in combination with the anastomosis tools described in PCT / IL01 / 00267, PCT / IL01 / 00069, PCT / IL01 / 00074, and PCT / IL01 / 00266. However, they may be used as stand-alone devices or as part of surgical kits and / or anastomotic connectors used for other applications.
[0162]
Change the order of the steps, the exact material used in the device, which vessels are `` lateral '' and which vessels (or grafts) are `` distal '' in the end-to-side anastomosis of the vessels, etc. It should be understood that the method and apparatus can take many forms variations. Further, in mechanical embodiments, the positions of the various elements can be interchanged without exceeding the disclosure, for example, using fixed elements instead of movable elements in parts that need to move relatively. . In addition, both methods and apparatus describe diversity in various features. It should be understood that different features can be combined in different ways. In particular, not all features described above in a particular form are required for all similar exemplary forms of the invention. Further, combinations of the above features from different forms are also considered to be within the scope of some exemplary forms of the invention. In addition, according to other exemplary aspects of the invention, some of the described features of the invention are adapted for use in the devices of the prior application. The particular geometry used to describe the invention should not limit the invention to the broadest interpretation of the invention being only these shapes, for example, even if a circular lumen is shown. In another form, an oval lumen may be used.
[0163]
Surgical kits comprising a set of medical devices suitable for performing one or a few anastomotic connections and / or for forming one or a small number of stomas are also within the scope of the present invention. The above measurements are only exemplary measurements in a particular case, the actual measurements will depend on the application. The terms "comprising,""including,""including,""including," or similar terms in the claims mean "including but not limited to."
[0164]
It will be understood by those skilled in the art that the present invention is not limited by what has been described thus far. Rather, the scope of the present invention is limited only by the claims.
[Brief description of the drawings]
[0165]
FIG. 1A illustrates a hole former with an outer cutting edge, according to an exemplary embodiment of the present invention.
FIG. 1B illustrates a hole former with an inner cutting edge, according to an exemplary embodiment of the present invention.
FIG. 2A is a cross-sectional view of an exemplary hole former, according to an exemplary embodiment of the present invention.
FIG. 2B is a cross-sectional view of an exemplary hole former, according to an exemplary embodiment of the present invention.
FIG. 2C is a cross-sectional view of an exemplary hole former, according to an exemplary embodiment of the present invention.
FIG. 2D is a cross-sectional view of an exemplary hole former, according to an exemplary embodiment of the present invention.
FIG. 2E is a cross-sectional view of an exemplary hole former, according to an exemplary embodiment of the present invention.
FIG. 3 illustrates various dimensions of a relevant entry head, according to an exemplary embodiment of the present invention.
FIG. 4A illustrates a plug removal mechanism, according to an exemplary embodiment of the present invention.
FIG. 4B illustrates a plug removal mechanism, according to an exemplary embodiment of the present invention.
FIG. 5 illustrates a base retraction mechanism, according to an exemplary embodiment of the present invention.
FIG. 6 illustrates an alternative hole former, according to an exemplary embodiment of the present invention.
FIG. 7A illustrates various entry tip and entry head designs, according to an exemplary embodiment of the present invention.
FIG. 7B illustrates various entry tips and entry head designs, according to an exemplary embodiment of the present invention.
FIG. 7C illustrates various entry tips and entry head designs, according to an exemplary embodiment of the present invention.
FIG. 7D illustrates various entry tip and entry head designs, according to an exemplary embodiment of the present invention.
FIG. 7E illustrates various entry tips and entry head designs, according to an exemplary embodiment of the present invention.
FIG. 7F illustrates various entry tips and entry head designs, according to an exemplary embodiment of the present invention.
FIG. 7G illustrates various entry tip and entry head designs, according to an exemplary embodiment of the present invention.
FIG. 7H illustrates various entry tips and entry head designs according to an exemplary embodiment of the present invention.
FIG. 7I illustrates various entry tip and entry head designs, according to an exemplary embodiment of the present invention.
FIG. 8A illustrates an extended approach head, according to an exemplary embodiment of the present invention.
FIG. 8B illustrates an extended approach head, according to an exemplary embodiment of the present invention.
FIG. 9A illustrates an alternative extended approach head, according to an exemplary embodiment of the present invention.
FIG. 9B illustrates an alternative extended approach head, according to an exemplary embodiment of the present invention.
FIG. 10A illustrates another alternative enlarged approach head, according to an exemplary embodiment of the present invention.
FIG. 10B illustrates another alternative enlarged approach head, according to an exemplary embodiment of the present invention.
FIG. 11A illustrates an anvil of varying geometry, according to an exemplary embodiment of the present invention.
FIG. 11B illustrates an anvil of varying geometry, according to an exemplary embodiment of the present invention.
FIG. 12 illustrates an elastic anvil hole former according to an exemplary embodiment of the present invention.
FIG. 13 illustrates a screw-type entry head, according to an exemplary embodiment of the present invention.
FIG. 14A illustrates a needle hole former, according to an exemplary embodiment of the present invention.
FIG. 14B illustrates a needle-shaped hole former, according to an exemplary embodiment of the present invention.
FIG. 15A illustrates two variations of an incision former, according to an exemplary embodiment of the present invention.
FIG. 15B illustrates two variations of an incision maker according to an exemplary embodiment of the present invention.
FIG. 16A illustrates a hole former according to an alternative embodiment of the present invention.
FIG. 16B illustrates a hole former according to an alternative embodiment of the present invention.
FIG. 17A illustrates the use of the hole former of FIG. 16 according to an exemplary embodiment of the present invention.
FIG. 17B illustrates the use of the hole former of FIG. 16, according to an exemplary embodiment of the present invention.
FIG. 17C illustrates the use of the hole former of FIG. 16, according to an exemplary embodiment of the present invention.
FIG. 17D illustrates the use of the hole former of FIG. 16, according to an exemplary embodiment of the present invention.
FIG. 17E illustrates the use of the hole former of FIG. 16, according to an exemplary embodiment of the present invention.
FIG. 18 illustrates a tip of a hole former, according to an alternative embodiment of the present invention.
[Explanation of symbols]
[0166]
100 hole former
102 base tube
104 approach head
110 Outer membrane
112 wall
114 Cutting Edge
116 cups
118 Anvil surface
130 hole former
134 Approach Head
138 bore
140 Anvil
200 hole former
202 Entry tip
208 shaft
210 Transport System
212 Rotating handle
214 thread
220 clips
304 approach head
314 Cutting Edge
316 Evacuation unit
416 Evacuation unit
420 tissue extractor
424 elastic element
500 Base retracting mechanism
502 elastic element
600 hole former
602 base
604 approach head
606 handle
610 bar
612 Dome
614 shaft
624 Reference section
700, 710, 720, 730 approach head
750, 760, 770, 780 approach head
800 extended approach head
802 entry end
804 arm
806 Tip
808 slots
810 shaft
812 Base part
814 Cutting edge
900 hole forming system
902 base tube
908 Silicon element
912 Cutting Edge
914 base
916 Extension
1000 hole former
1002 base tube
1004 Enlarged approach head
1008 sheet
1010 shaft
1100 Hole former
1102 Base tube
1104 disk
1106 Small hole
1110 shaft
1112 Overtube
1114 Entry tip
1200 hole former
1202 base
1204 approach head
1300 Hole former
1304 approach head
1308 thread
1310 shaft
1400 Needle type hole former
1402 needle
1404 Approach tip
1406 Extension
1500 Incision part forming device
1504 Spike
1509 arm
1510 Base surface
1516 Spring
1554 Spike
1558 Cutting edge
1559 arm
1560 Base surface
1600 hole forming system
1602 Base part
1604 Approach head
1609 shaft
1610 Cutting surface
1612 Inclined part
1615 sleeve
1616 Scaffold
1618 Entry tip
1620 pegs
1630 cover
1634 perforation
1700 Aorta
1702 Plug
1800 Hole former
1802 Base part
1804 Entry head
1810 Cutting edge
1812 cone
1820 thorn
1824 needle tip

Claims (38)

An entry head with a sharp tip adapted to be inserted over the vessel wall;
A base with an inner lumen,
At least one cutting surface on the base portion, wherein the device cuts across the blood vessel without drawing the blood vessel toward the cutting surface;
A shaft mechanically connecting the approach head and the base portion,
There is a tissue holding shaft portion between the base portion of the shaft and the approach head, the approach head preventing tissue penetrated by the shaft portion from sliding down on the approach head,
The shaft has a first mechanically defined and axially locked retraction position such that the entry head is at least partially covered within the inner lumen by the base portion; and A second mechanically defined retracted position such that the shaft portion is axially locked with respect to the shaft portion, wherein the shaft portion is exposed between the base portion and the entry head.
A hole forming apparatus for forming an opening in a blood vessel. The apparatus of claim 1, wherein moving the shaft between the positions is not mechanically coupled to rotation of the base. The device of claim 1, wherein the entry head is conical. The apparatus of claim 1, wherein the approach head has at least one protrusion extending radially greater than the smallest diameter portion of the shaft portion. The apparatus of claim 4, wherein the at least one protrusion is a barb cut from the shaft. 6. The barb of claim 5, wherein the barbs are resilient and flexible so that when the entry head is inserted into the vessel, the barbs are sufficiently pushed by the shaft portion by the vessel wall of the vessel. An apparatus according to claim 1. The apparatus of claim 4, wherein the entry head has a retractable entry tip. The apparatus of claim 1, wherein the entry head is rotationally locked with respect to the base. The apparatus of claim 1, wherein the entry head is retracted completely into the lumen at the first retracted position. The device of claim 1, wherein the shaft portion is at least 150% of the width of the vessel in device design. The device of claim 1, wherein the device is adapted to form a stoma from the outside of a blood vessel. The apparatus of claim 1, wherein the shaft, when released, is moved from the first retracted position to the second retracted position by a spring. The apparatus of claim 1, wherein movement of the shaft relative to the base is limited between the two positions. The apparatus according to claim 1, wherein the shaft has only two retracted positions. The device of claim 1, wherein the shaft is rigid. The device of claim 1, wherein the inner lumen has a clearance relative to the entry head so that vascular tissue is not cut between the entry head and the inner lumen. The device of claim 1, wherein the entry head is adapted to prevent retraction of the vessel wall during a cut and is so arranged. The device of claim 1, wherein there is a lumen in the direction of the tube wall of the entry head. The apparatus of claim 1, further comprising external power means for moving the shaft between the positions. The device of claim 1, comprising a drug supply coupled to an opening proximate to the entry head and the base. An entry head having a sharp tip adapted to be inserted over a vessel wall, wherein the tip has a lumen in the direction of the vessel wall;
A base with an inner lumen,
At least one cutting surface on the base portion and adapted to cut over the blood vessel;
A shaft mechanically connecting the approach head and the base portion, and fixing an axial position of the approach head with respect to the base,
A hole forming apparatus for forming an opening in a blood vessel. 22. The device of claim 21, wherein the lumen elutes a drug. 22. The device of claim 21, wherein the lumen is adapted to engage tissue. 22. The device of claim 21, wherein the lumen allows tissue to move in one direction relative to the lumen. An entry head with a sharp tip adapted to be inserted through the vessel wall,
A base with an inner lumen,
At least one cutting surface on the base portion, the cutting surface being adapted to cut through the blood vessel such that the device does not draw the blood vessel toward the cutting surface;
A shaft mechanically connecting the approach head and the base portion, and fixing an axial position of the approach head with respect to the base,
A hole forming apparatus for forming an opening in a blood vessel. 26. The device of claim 25, wherein the inner lumen is adapted to engage the tissue. 26. The apparatus of claim 25, wherein the diameter of the entry head does not vary. Cover at least one sharp edge of the tool with a cover,
Insert the tool over the valve,
Removing the cover,
A method of inserting a tool into a scaffold with a valve on the inside, the method comprising: 29. The method of claim 28, wherein said removing is dividing. A base portion having an inner lumen, wherein the inner lumen is adapted to engage tissue of the blood vessel;
And at least one cutting surface adapted to cut through the blood vessel, on the base portion.
A hole forming apparatus for forming an opening in a blood vessel. 31. The device of claim 30, wherein a thread is formed inside the inner lumen. 31. The apparatus of claim 30, further comprising a transverse stabilizer that secures an axial position with respect to the cutting surface. Means for forming a stoma in the blood vessel;
Dissolving means for supplying a drug at the position of the small hole,
A hole forming apparatus for forming an opening in a blood vessel. The apparatus of claim 33, wherein said forming means comprises cutting means. 35. The apparatus of claim 33, wherein said forming means comprises shearing means. 34. The apparatus of claim 33, wherein said forming means comprises anvil cutting means. Insert the entry head into the vessel wall,
A cutting base is advanced toward the blood vessel so as not to apply a contra force to the blood vessel via the entry head;
A method of forming a stoma in a blood vessel. 38. The method of claim 37, wherein advancing comprises advancing using a rotational motion.

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