JP2004505713A - Devices and methods for magnetic anastomoses and ports in blood vessels - Google Patents

Abstract

Method and apparatus for forming a magnetic anastomosis between hollow bodies. End-to-side, side-to-side and end-to-end anastomoses between components can be generated with or without mechanical connections. The anastomosis component (542) has a variety of configurations and can be secured to the blood vessel in a variety of ways (eg, magnetically, mechanically or adhesively). Device for examining the position of another delivery device (550) and components on the loaded delivery device (772), as well as the seal between the vessel and the anastomosis component (774, 776) secured to the vessel (770, 730) is also provided.
[Selection] Figure 60B

Description

[0001]
(Cross-reference of related applications)
This application is a continuation-in-part of application serial number 09 / 638,805 (attorney docket number 015) filed on August 12, 2000. The application serial number 09 / 638,805 is a continuation-in-part application of the application serial number 09 / 562,599 (attorney docket number 018) filed on April 29, 2000. The present application further includes provisional application serial number 60 / 255,635 (attorney docket number 019) filed on December 13, 2000, and application serial number 09/851, filed on May 7, 2001. Claim the priority of No. 400 (Agent reference number 020). The entire disclosure of each of the above related patent applications is expressly incorporated herein by reference.
[0002]
(Background of the Invention)
(Field of Invention)
The present invention relates to forming an anastomosis between hollow structures and further forming a port leading to the interior or lumen of the hollow body. More particularly, the present invention relates to forming an anastomosis using magnetic force and forming a magnetic port in a vessel.
[0003]
(Description of related technology)
Despite significant advances that have been realized in cardiology and cardiovascular surgery, heart disease remains the leading cause of death worldwide. Coronary artery disease or atherosclerosis is one major cause of death in the United States today. As a result, those skilled in the cardiovascular field continue to seek new and improved methods of treating cardiovascular disease with varying success rates.
[0004]
Coronary artery disease is currently undergoing interventional treatment (eg, surgical procedures including percutaneous transluminal coronary angioplasty (PTCA), coronary stenting and adeletomy, and coronary artery bypass grafting (CABG)). Being treated. The purpose of these procedures is to reestablish or improve blood flow through the occluded (or partially occluded) coronary artery, for example, by enlarging the arterial blood flow lumen Or by creating a bypass that does not occlude blood. What treatment is typically used depends on the severity and location of the obstruction. CABG is typically performed when interventional treatment has not been successful, or for some reason or another, there are no options applicable to a given patient. If successful, these procedures restore flow within the treated lumen and blood flows to myocardial tissue that was not previously sufficiently perfused.
[0005]
According to another proposed procedure, the target vessel (eg, coronary artery) is in direct fluid communication with a ventricle containing blood (eg, the left ventricle). Blood flows from the ventricle to a conduit in fluid communication with the artery. As such, this procedure can be described as a ventricular bypass procedure. The advantage of this procedure is that there is no need to manipulate the aorta. This is done, for example, when a lateral interlocking clamp is used in a typical CABG procedure to form a close anastomosis between the bypass graft and the aorta.
[0006]
The most intriguing aspect of CABG (as well as many other procedures that need to form an anastomosis) is connecting the graft vessel to the target vessel in a fixed fluid tight manner. This has traditionally been done by hand using a suture that passes through two vascular tissues to form a handsewn connection. Due to the small coronary vessel diameter (typically 1-4 mm), forming these hand-stitched anastomoses is highly technical and time consuming. Problems in forming a sutured anastomosis are exacerbated when access to the target vessel is limited or limited compared to open chest CABG (eg, in minimally invasive or percutaneous procedures). That is. Many other medical procedures also require the attachment of hollow structures (by suturing or other methods) and therefore the same or similar considerations (eg, treatment of peripheral vascular disease or injury, and arteriovenous shunts) Formation).
[0007]
Many different anastomotic joining methods have been proposed in the art, but have not been fully implemented to be accepted at any significant level acceptable in the art. Exemplary problems experienced by some of these conjugates include damage to the graft or target vessel wall. This is due, for example, to tissue perforation, penetration or excessive compression, and cannot produce repeatable results. Moreover, it is somewhat confusing and difficult to achieve to create an anastomotic bond that creates and maintains a clear connection.
[0008]
Accordingly, there is a need in the art for a method and apparatus for forming a reliable anastomosis between hollow bodies in a relatively fast, easy and repeatable manner.
[0009]
(Summary of the Invention)
According to one embodiment, a method of securing a magnetic anastomosis component to a hollow body is provided, which comprises the following steps: an opening that can generate or be attracted by a magnetic field Providing an anastomotic component having a portion and a placement member capable of generating or attracted to a first arrangement within the lumen of the hollow body at a selected location Positioning and using a magnetic attraction between the anastomotic component and the placement member to position the component at a selected position. The anastomotic component is secured to the hollow body and the placement member is changed from the first configuration to the second configuration and then removed from the lumen of the hollow body.
[0010]
According to another embodiment, a method of securing a magnetic anastomosis to a blood vessel having a lumen has an opening adjacent to the blood vessel having a lumen and is capable of generating or attracted by a magnetic field. Installing an anastomotic component capable of providing, providing a plurality of separate attachment members each configured to engage the anastomosis component, and securing the anastomosis component to the blood vessel using the separate attachment members Including the steps of:
[0011]
According to another embodiment, a method is provided for adhesively fixing a magnetic anastomotic component to an end of a hollow body having a lumen. The method provides an anastomotic component having an opening adapted to be placed in communication with a lumen of a hollow body that can generate or be attracted by a magnetic field Applying adhesive to at least one of the anastomotic component and the hollow body adjacent to the end of the hollow body, and using the adhesive to secure the anastomotic component to the hollow body adjacent to the end of the hollow body Including the steps of:
[0012]
According to yet another embodiment, a method is provided for securing a magnetic anastomosis component to an end of a hollow body having a lumen. The method includes providing an anastomotic component including a first portion and a second portion, wherein at least one of the first portion and the second portion is capable of generating a magnetic field, or A step that can be attracted by a magnetic field, a step of positioning a first portion of the anastomosis component within the lumen of the hollow body, and a second portion of the anastomosis component at least partially around the outside of the hollow body. Positioning the portion and pressing the first and second portions against the tissue of the hollow body to secure the anastomotic component to the hollow body.
[0013]
According to yet another embodiment, a method is provided for checking a seal between an anastomotic component and a blood vessel to which the anastomotic component is secured. The method includes providing an anastomotic component having an opening that can generate or be attracted by a magnetic field, and attaching the anastomotic component to a blood vessel in fluid communication with the lumen of the blood vessel. And using a cover that can generate or be attracted by a magnetic field to shield the anastomotic component opening and maintain a seal between the cover and the anastomotic component And using magnetic attraction to prevent blood from exiting through the opening of the anastomotic component, thereby leaking blood may be due to leakage at the attachment between the anastomotic component and the hollow body Steps.
[0014]
According to yet another embodiment, a method is provided for confirming the proper orientation of a magnetic anastomosis component. The method includes providing a delivery device that supports at least one anastomotic component having an opening, the anastomotic component being capable of generating a magnetic field and magnetized according to a selected polarity and adjacent to the anastomotic component. Providing a fixture including at least one portion movable to a position to be used, and using the fixture to determine whether the anastomosis component is properly oriented to the delivery device. Include.
[0015]
According to another embodiment, a first part comprising an opening adapted to be placed in communication with a lumen of a hollow body, and attached to the first part and attached to an end of the hollow body A magnetic anastomotic component having a second portion including an expandable tubular body configured to be provided. The first portion and the second portion are generally arranged laterally to each other, at least one of which can generate or be attracted by the magnetic field.
[0016]
According to another embodiment, a magnetic anastomosis component is provided, which has a tubular body and a plurality of separate attachment members. Each of the plurality of separate attachment members can be selectively engaged with the tubular body to secure the tubular body to the hollow body. At least one of the tubular body and the attachment member can generate a magnetic field or be attracted by the magnetic field.
[0017]
According to yet another embodiment, an apparatus is provided for checking a seal between an anastomotic component and a fixed hollow body. The device includes an expandable structure comprising a surface that is substantially impermeable to fluid and a material that can generate or be attracted by a magnetic field. The expandable structure can be magnetically attached to a magnetic anastomosis component or a ferromagnetic anastomosis component secured to a hollow body by placing a non-fluidic surface over the component to block flow. The expandable structure is expanded to break the magnetic attraction between the magnetic material and the component.
[0018]
Other features, aspects, benefits and advantages of the present invention will be understood from the detailed description of exemplary embodiments thereof, taken together with the following drawings.
[0019]
(Detailed description of preferred embodiments)
1-5 are several exemplary embodiments of an anastomotic fixation component constructed in accordance with the present invention for use in forming an anastomosis between a first hollow body and a second hollow body. Indicates. FIG. 1 shows a stationary component 10 having an annular body that is an object and an opening 12. In general, the stationary component 10 is plate-like and annular in the same plane and has a constant (or substantially constant) thickness and a constant (or substantially constant) width near its periphery. . The fixation component 10 is made and configured in such a size that it is placed adjacent to the opening of the first hollow body made for anastomosis to the second hollow body. The second fixation component is disposed adjacent to the opening of the second hollow body for forming an anastomotic connection.
[0020]
FIG. 2 shows an elliptical anastomosis fixation component 14 having an opening 16. Generally, the fixed component 14 is plate-shaped and the opening 16 is configured to provide a fixed component 14 having an end 18 that is larger than the side 20. FIG. 3 shows a racetrack-shaped fixed component 22 having an opening 24. With respect to the stationary component 14, the opening 24 provides a stationary component 22 having an end 26 that is larger than the side 28. FIG. 4 shows a fixed component 30 having an opening 32, two ends 34, 36 and two sides 38. Generally, the stationary component 30 has a racetrack-like configuration, but the end 36 is larger than the end 34, which provides a component 30 having an asymmetric configuration. In other words, the opening 32 is different from the opening 12 of the fixed component 10, the opening 16 of the fixed component 14, and the opening 24 of the fixed component 22 shown in FIGS. Not placed in. The end 36 also provides a tapered leading edge for easier introduction by a hollow body such as a blood vessel.
[0021]
It will be appreciated that the specific shape and specific size of the stationary component can be varied from the exemplary configurations shown in FIGS. For example, the thickness or width of the stationary component can be varied along with all or part of the body of the stationary component. The anastomotic component of the present invention is not necessarily plate-shaped but is preferably plate-shaped. That is, the first dimension D1 of the anastomosis component is smaller than the second dimension D2 of the anastomosis component (FIG. 1). Typically, the smaller dimension of the anastomotic component corresponds to the larger dimension, while the larger dimension of the anastomotic component corresponds to the width or length (ie diameter in the case of FIG. 1). By minimizing the thickness of the fixed component, one or more components are placed inside the lumen of a relatively small hollow body (eg, coronary artery), reducing the amount of foreign matter in the bloodstream and reducing flow impedance. Minimize.
[0022]
It should be noted that the fixation component shown in FIGS. 1-4 is flat, but may instead be bent or arcuate, or include a combination of flat and bent portions. Alternatively, in the exemplary and preferred configurations, the shape of each stationary component corresponds to the opening of each component. That is, the stationary component and its opening preferably have a complementary configuration (eg, elliptical component, elliptical opening). Nevertheless, the fixation component may have a non-complementary shaped opening. Finally, each exemplary securing component includes only one opening, and one or more openings can be used if desired.
[0023]
According to another embodiment of the present invention, the anastomotic fixation component is formed of or capable of generating a magnetic field that acts to hold the component in a desired positional relationship, or that material is embedded in the anastomosis component . The magnetic field causes the stationary component to maintain the first hollow body and the second hollow body in the desired location so as to be in high liquid tight communication. The anastomosis component preferably has magnetic properties and may include a permanent magnet material or permanent magnet assembly, a ferroelectric material or ferroelectric assembly, a ferrimagnetic material or ferrimagnetic assembly, or an electromagnetic material or assembly.
[0024]
Each of the fixed components shown in FIGS. 1-4 is formed from substantially any suitable magnetic field generating material so that a magnetic force can be generated over the entire area of the component. FIG. 5 shows an alternative embodiment, in which a fixed component 40 having an opening 42 and a racetrack-like configuration similar to the fixed component 22 of FIG. Stipulate. In particular, the stationary component 40 includes a magnetic field generating member 44 disposed in another region, and in the exemplary embodiment, the magnetic field generating member 44 is present at the end of the component. Thus, the remaining region 46 can be formed from a different material. It will be appreciated that the magnetic field generating member 44 may be disposed in alternative (or additional) regions of the stationary component 40. An exemplary reason for providing a fixation component 40 having a region 46 is to allow the use of a hard magnetic material for the member 44, for example through a small incision or port, trocar, catheter, cannula, etc. It is further possible to partially or completely collapse the component by folding region 46 for delivery.
[0025]
Suitable materials that can be used to form a magnetic field-generating anastomotic fixation component include NdFeB (neodymium iron boron), SmCo (samarium cobalt) and Alnico (aluminum nickel cobalt). Currently, NdFeB is preferred for magnetic properties. The magnitude of the force applied depends on the material used, the size of the magnet and the number of magnets. Furthermore, different applications require different force ranges. For example, when treating small diameter vessels, it is desirable to minimize that force as much as possible while still achieving fluid tightness and a secure attachment. As an example, when anastomosing coronary vessels, it is preferable to use an anastomotic component that generates a magnetic force in the region of less than 0.25 lbs (more preferably, less than about 0.15).
[0026]
Figures 6-8 show the first and second hollow bodies made for anastomosing in three different ways. FIG. 6 shows a first hollow body 50 having an opening 52 that is connected to the opening 54 of the second hollow body 56 and adapted to form an end-to-side anastomosis. Is done. A complete anastomosis connects the tubes of each hollow body, and the opening 52 is formed in the wall of the first hollow body 50, for example by incising or piercing the wall of the hollow body. The part 54 is defined by the end of the second hollow body 56. FIG. 7 shows a first hollow body 58 having an opening 60 adapted to be connected to the opening 62 of the second hollow body 64, thereby bringing the lumens into communication. Form a side-to-side anastomosis. The openings 60, 62 are formed in the walls of the cavities 58, 64, for example as described above with respect to the openings 52. FIG. 8 shows a first hollow body 66 having an opening 68 coupled to the opening 70 of the second hollow body 72 and adapted to form an end-to-end anastomosis. Each opening 68, 70 is defined by the end of a respective hollow body 66, 72.
[0027]
The incision or other opening in the hollow body is preferably sized to cooperate with the magnetic anastomosis component used. For example, a gauge (not shown) can be placed along the tube and used as a guide to form an incision with the correct length. Multiple gauges (eg, each multiple gauge includes a small rod with a handle to facilitate placement of the rod along the tube wall) are supplied to use different anastomotic elements and anastomotic tubes The
[0028]
FIGS. 9 and 9A show a first hollow body 74 supplied to a first anastomosis fixation component 78 and a second hollow body 76 supplied to a second anastomosis fixation component 80, wherein the first anastomosis fixation component 78 and the second anastomosis fixation component 80 are used to create an exemplary end-to-side anastomosis according to one embodiment of the present invention. As best shown in FIG. 9A, the securing component 78 includes two members 78A, 78B disposed oppositely on the surface of the wall of the first hollow body 74. The fixed component 80 includes two members 80 </ b> A and 80 </ b> B disposed on the opposing surfaces of the abduction end of the second hollow body 76. The members forming each anchoring component 76, 78 can be held in a desired and preferably fixed relative position by magnetic force. Magnetic force is also used to hold the position of the two fixed components. The fixation components 78, 80 are moved together from the position of FIG. 9A to create a high fluid tight anastomosis.
[0029]
10A-10D illustrate a further end-side anastomosis formed according to another embodiment of the present invention. FIG. 10A shows a first stationary component 82 coupled to the first hollow body 84 and a second stationary component 86 coupled to the second hollow body 88. The stationary components 82, 86 have a laminated structure that includes one layer of material capable of generating a magnetic field disposed between two outer layers of different materials. To generate the magnetic field, the component may include, for example, a permanent magnet material or permanent magnet assembly, a ferroelectric material or ferroelectric assembly, a ferrimagnetic material or ferrimagnetic assembly, or an electromagnetic material or electromagnetic assembly. Some exemplary materials that can be used include metals, polymers, ceramics, and the like.
[0030]
One example of an embodiment of the present invention includes a stationary component having an intermediate layer of permanent magnet material (eg, NdFeB) and two outer layers of ferroelectric material (eg, 300 or 400 series stainless steel). The outer layer can be attached to the intermediate layer by suitable adhesion or magnetic force. One particular example of a fixed component constructed in accordance with this embodiment includes a 0.008 "thick inner magnetic layer and a 0.001" thick outer stainless steel layer. It will be appreciated that in this aspect of the invention, other materials or other assemblies may be used.
[0031]
The advantage of the layered configuration is that the outer layer provides the strength and necessary integration required for the assembly (typically the more easily brittle magnets that are more easily friable), even though the magnetic layer is very thin, The point that allows the thickness to be reduced. In the above example, the stainless steel layer is very thin, but is capable of absorbing additional loads (eg, tension generated during movement of the hollow body or adjacent tissue). Of course, the specific overall dimensions of the fixed component and the dimensions of the individual layers (or layers when a multilayer structure is used) depend on the application (for example, for the fixed component 22 shown in FIG. Preferably less than 0.040 ", more preferably less than 0.020" (eg about 0.015 "or such as at most 0.008").
[0032]
The ability to form very thin fixation components allows the formation of an anastomosis between relatively small hollow bodies (eg, coronary vessels). Furthermore, an anastomosis can be formed between blood carrying hollow bodies. A blood-carrying hollow body has one or more stationary components placed in the blood flow path while minimizing foreign objects that are exposed to blood.
[0033]
FIG. 10B shows a first fixed component 90 coupled to the first hollow body 94 and a second fixed component 92 disposed in the second hollow body 96. The first securing component 90 includes a single member 98 that is disposed within the lumen of the first hollow body 94 relative to the interior surface of the wall of the first hollow body 94 adjacent to the opening. Substantially member 98 has a coating and preferably completely surrounds its outer surface. In some applications, it may be desirable to apply an appropriate coating or appropriate surface treatment to all or some anastomotic fixation components. For example, the first hollow body 94 represents a blood vessel such as a coronary artery or a peripheral artery, and the fixation component 90 is exposed to the blood flow pathway. Thus, depending on the material used to form the member 98, the surface of the member 98 can be coated, or the surface of the member 98 can be treated to promote better thrombogenicity. And / or it may be desirable or necessary to improve flow through the anastomosis site. Some exemplary materials that can be used to coat or process an anastomotic fixation component constructed in accordance with the present invention are gold, platinum, titanium, nitride, parylene, silicone, urethane, epoxy, Teflon (R) and polypropylene are included.
[0034]
FIG. 10C shows that the first fixed component 102 and the second fixed component 104 are connected to the first hollow body 106 and the second hollow body 108, respectively. As described above, each component 102, 104 includes a single member formed from a magnetic material, a ferromagnetic material, and an electromagnetic material. Instead of ablating one end of the hollow bodies 106, 108, in this embodiment, a portion 110 configured to attach the end of the first hollow body 106 is provided to the first stationary component 102. . Portion 110 can take a variety of forms, such as a DACRON® suture ring or bioadhesive. It can be appreciated that the portions for attaching the hollow body may be located in different regions of the second different fixation component 104 shown in FIG. 10C.
FIG. 10D shows an embodiment of the invention similar to the embodiment of FIG. 10C with a first stationary component 112 coupled to the first hollow body 116 and a second component 114 coupled to the second hollow body 118. Indicates. In this embodiment, the means for attaching the first component 112 to the first hollow body 116 includes an expandable member 120 (eg, a stent) disposed within the lumen of the first hollow body. The member 120 pushes the end of the first hollow body 116 against the first fixed component 112 and attaches the component in a highly airtight liquid manner. The embodiment of FIGS. 10C and 10D is only two of various ways, and the fixation component can be coupled to a hollow body with abduction of the tissue of the hollow body.
[0035]
FIG. 11A is a cross-sectional view of the end-to-side anastomosis produced by the first and second components 122, 124 disposed adjacent to the openings of the first and second hollow bodies 126, 128. is there. Fixed components 122 and 124 are plate-like (as described above) and are generally flat. FIG. 11B shows first and second fixation components 130, 132 configured in accordance with an exemplary embodiment of the present invention, which are the openings of the first and second hollow bodies 126, 128. Is placed adjacent to. The stationary components 130, 132 are plate-like, but are generally not flat but arcuate or bent. As will be appreciated, the curvature of the fixation components 130, 132 results in a more flattened-out shape of the first hollow body 126 when used with the flat fixation components 122, 124. Compared to the case, it maintains a substantially circular configuration.
[0036]
The arcuate locking components 130, 132 preferably have complementary radii or substantially complementary radii to provide a uniform distribution of force and good sealing. However, the stationary components of the present invention have different degrees of curvature, and each curvature is constant or varies across the body of the component. Alternatively, the illustrated fixed components 130, 132 extend approximately 120 °, and other configurations extending from 0 ° to 360 ° can be used at 180 °, for example, if desired. Finally, FIG. 11A shows a pair of flat components and FIG. 11B shows a pair of arcuate components, but each pair of anchoring components used to generate the anastomosis will change the degree. It may have a different configuration.
[0037]
FIGS. 12 and 13 illustrate another embodiment of the present invention, in which first and second hollow bodies 134, 136 are respectively fed to the fixation component to create an end-to-side anastomosis. The embodiment of FIG. 12 uses first and second anchoring components 138, 140 that are positioned adjacent to openings in the hollow bodies 134, 136, respectively. As described above, each fixation component 134, 136 includes a single member that may include one or more materials and one or more layers. As mentioned above, the securing component is secured by adhesive or other means and maintains position by magnetic force. As shown in FIGS. 14A and 14B, the fixation components 138, 140 are located through openings formed in the walls of the hollow bodies 134, 136 and are disposed in the respective lumens L1, L2. Once 138, 140 are joined, a high fluid tight anastomosis is formed that connects the first hollow body 134 and the second hollow body 136. If the hollow bodies 134, 136 are blood (or other liquid) carrying structures, the anastomosis brings these hollow bodies into fluid communication and provides a high liquid tightness.
[0038]
The embodiment of FIG. 13 uses a first fixed component 142 and a second fixed component 144. The openings of the hollow bodies 134 and 136 are adjacent to each other so that the first fixing component 142 and the second fixing component 144 are partially disposed in the lumens of the hollow bodies 134 and 136, respectively. It is located in the state. Each hollow body opening may be a surgical incision or a perforated hole. Each stationary component 142, 144 includes a pair of members. Each member may include one or more materials and one or more layers. One member of each of the first and second fixation components 142, 144 is located within the lumen of the hollow body, while the other member of the fixation component is external to the hollow body by the tissue between the members. Is located.
[0039]
Figures 15 and 16 show a further embodiment of the invention. In this embodiment, the first hollow body 146 and the second hollow body 148 are provided in the first anastomosis fixing component and the second anastomosis fixing component, respectively, and the end-to-end anastomosis is performed. Form. FIG. 15 shows that the first fixed component 150 and the second fixed component 152 are positioned in a state where the openings of the hollow bodies 146 and 148 are adjacent to each other. Each opening is defined by the end of the hollow body and extends into the lumen of the hollow body.
[0040]
Each stationary component 150, 152 includes one member that may be configured as described above. The end of each hollow body 146, 148 is turned up outside the component through an opening defined therein by each fixed component. As a result, the first fixed component 150 and the second fixed component 152 are joined end to end, and the turned ends of the hollow bodies 146 and 148 are brought into sealing contact. When the hollow body is a real blood vessel, the intimal surface of the blood vessel comes into contact with such an anastomosis.
[0041]
The embodiment of FIG. 16 includes a first fixed component 154 and a second fixed component 156, each positioned with the openings of the hollow bodies 146, 148 facing each other. Each of the fixed components 154 and 156 includes a pair of members configured as described above. The first fixed component 154 has one member 154A located around the exterior of the first hollow body 146 (with the end turned up) and an opening defined by the end of the hollow body 146. And the other member 154B located. The members 154A and 154B are fixed at appropriate positions by magnetic force. The second fixed component 156 has the same or similar configuration and includes members 156A, 156B located adjacent to the ends of the second hollow pair 148. In the embodiment of FIGS. 15-16, the anchoring component is not disposed within the lumen of any hollow body and is therefore contained within or moves through the hollow body or There is no exposure to other substances.
[0042]
Another embodiment of the present invention is described with reference to FIGS. FIG. 17A shows a hollow body 160 having an opening 162 and an anastomotic fixation component 164 located adjacent to the opening. The stationary component 164 is located in the lumen L of the hollow body 160 and has an opening 166. The opening 166 is aligned with the opening 162 in the wall of the hollow body 160 as shown. For example, if the fixation component is passed through an incision in the wall, the tissue defining the opening 162 may be able to move beyond the opening 166 of the fixation component 164 shown in FIG. 17B. In such a case, as indicated by reference numeral 168 in FIG. 17B, the effective area of the securing component 164 available to communicate with the second hollow body to which the hollow body 160 is anastomosed (not shown). Decrease.
[0043]
18A-18B illustrate a hollow body 160 having the opening 162 of FIGS. 17A-17B, but a stationary component 170 constructed in accordance with another embodiment of the present invention is located adjacent to the opening 162. The stationary component 170 has an opening 162 and a feature that leaves the opening 162 free to flow. Fixed component 170 has a flange 174 and an extension 176 coupled to (or integrally formed with) the flange. As can be seen, the extension 174 may move or splatter after the tissue defining the opening 162 of the hollow body 160 or the tissue adjacent to the opening 162 has delivered fluid, or the anchoring component 170. Prevents the flow cross-sectional area from decreasing.
[0044]
19A-19C illustrate a hollow body 180 that may represent, for example, a patient's coronary artery or peripheral artery. The lumen of this hollow body is narrowed by S. In FIG. 19A, a fixation component is coupled to an opening in the wall of the artery and a site is formed to create an end-to-side or side-to-side anastomosis. The anastomosis fixing component 170 is provided with a hollow body 180. In FIG. 19B, another configuration of the anastomosis fixation component 182 that includes a flange 184 and a discontinuous or segmented extension 186 that passes through, or partially passes through, the opening in the wall of the hollow body. A hollow body 180 is provided. FIG. 19C shows a fixation component 188 having a multi-part configuration that includes a flange 190 and a separate extension 192 that is received at the opening of the hollow body 180. It should be understood that these configurations are just a few of the various configurations that can be employed in implementing this aspect of the invention.
[0045]
The anastomotic fixation component of the present invention can be delivered and placed in a variety of ways. 20A-20B and 21A-21B somewhat illustrate an exemplary delivery device 200 in which a first portion 202 is operably coupled to a second portion 204. The first portion 202 is fixed to the shaft 206, while the second portion 204 is fixed to the shaft 208. The shaft 208 passes through the slot 210 in the portion 202. The first portion 202 defines a support ledge 212 and the second portion 204 defines a support ledge 214 as well. FIG. 20A shows the device 200 in the first part holding the anastomotic fixation component of the present invention. This portion is shown in FIG. 21A, where ledges 212, 214 support a stationary component 216 having an opening 218 therein. An opening 218 in the stationary component 216 surrounds a boss 220 that extends upward from the ledge. The boss 220 is preferably used to facilitate alignment of the stationary components on the support ledges 212, 214. When used in an application having an opening formed in the side wall of a hollow body, it is used to limit the surrounding tissue during placement.
[0046]
20B and 21B show the device 200 after moving from the position of FIGS. 20A and 21A to a second position. This movement is accomplished by moving the shaft 208 in the direction of the arrow to slide the second position 204 relative to the first position 202. This moves the support ledge 214 in the opening 218 of the anastomosis fixation component 216 (FIG. 21B). This movement allows the user to separate the device 200 from the fixed component 216 once the support ledge is positioned at the desired position. As shown, depending on the relative size and shape of each component, the device 200 may need to be moved back and forth relative to the stationary component 216 or manipulated to separate them.
[0047]
The delivery device 200 shown is only one possible device suitable for use in placing the anastomotic fixation component of the present invention and may be modified or replaced with a different delivery device or delivery system. It is understood that it is good. For example, the delivery device 200 may be modified such that both support ledges 212, 214 move relative to the boss 220 (if used) to remove the fixation component without full contact. Any suitable material (s) can be used to construct the delivery device 200. It will be appreciated that magnetic or ferromagnetic materials can be used to interact magnetically with the stationary component. This magnetic interaction may be desirable to facilitate component delivery. The delivery device can also be composed of a non-magnetic material such as titanium, a polymer, or a ferromagnetic material.
[0048]
For purposes of illustration, the formation of the anastomosis using the delivery device 200, the first fixation component of the present invention, and the second fixation component will be described with reference to FIGS. FIG. 22A shows a delivery device 200 having a first anchoring component 222 with two members 222A, 222B. The member 222A is supported by the ledges 212, 214 of the device 200 and the other member 222B is held on the ledge (eg, by a magnetic force on the device 200). The member 222A is inserted into the opening in the wall of the blood vessel V having the stenosis S. Member 222A may be shaped to be easily inserted into a vascular lumen or may be processed to facilitate insertion. For example, the tip of the member 222A may be formed as shown in the embodiment of FIG.
[0049]
22B shows one member 222A of the fixation component 222 positioned against the inner surface of the vessel wall and the other member 222B moving to the vessel wall. FIG. 22C shows members 222A and 222B in place with delivery device 200 remaining. 22D shows how the device 200 is removed through the first fixation component 222, and FIG. 22E leaves the fixation component 222 in the vessel wall and forms what can be characterized as a magnetic port P. Show. The stationary component (s) may be subjected to a surface treatment such as coating, roughened or treated surface, or mechanical protrusions to facilitate engagement with the walls of the hollow body.
[0050]
The fixation component 222 shown defines a magnetic port P and generates a magnetic field that can be used to couple another blood vessel to that port. In FIG. 22F, the graft vessel G provided on the second anchoring component 224 (which itself includes two members) holds the first anchoring component 222 and the second anchoring component 224 in the desired relative position. It is anastomosed to the port P by the magnetic force. The present invention also fixes the relative distance between the first fixation component and the second fixation component so that, for example, forced or forcedly pressed tissue is magnetically It can be realized using means that keeps the components from leaving apart due to the application. Such means may include a protrusion that extends directly between the components and serves as a stop, or an intermediate element that couples to the components and restricts them from further movement. It is understood that forming a magnetic port according to the present invention can also be used for applications other than blood vessels and for applications that do not require anastomoses to another blood vessel, for example, to access a body part of a patient. To do.
[0051]
Some exemplary applications of the present invention are described with reference to FIGS. 23-23A, 24-24A, and 25-25A. FIG. 23 is an anterior view of a human heart having a graft vessel G. FIG. The graft vessel G has one end 230 attached to the aorta, such as by a sutured anastomosis, and another end 232 adjusted to anastomos the closed LAD. One fixation component 234 is coupled to the end 232 of the graft G by any of the methods described above. The other fixed component 236 is coupled to the LAD adjacent to its internal opening. Fixed components 234, 236 (at least a portion of) may be formed from a material capable of generating a magnetic field and attached as shown in FIG. 23A. With such a configuration, the graft G is in fluid communication with the lumen of the LAD. The graft G may also be attached to the aorta by an anastomosis system constructed in accordance with the present invention.
[0052]
FIG. 24 shows another exemplary application of the present invention applied to the heart shown in FIG. The ventricular coronary shunt S has one end 237 disposed in the myocardium in fluid communication with the left ventricle LV. A short S is provided in the fixed component 238 adjacent to its other end, while the LAD is provided in the fixed component 236 of FIG. The short S is adapted to be coupled to the LAD via a side-to-side anastomosis, so that the anchoring component 238 is located within the opening in the side wall of the short (the short end of the short is 240 Tied in). FIG. 24A shows the completed anastomosis with fixation components 236, 238 coupled and held in place via a magnetic field generated in accordance with the teachings of the present invention.
[0053]
Figures 25-25A illustrate yet another embodiment of the many different applications of the present invention, namely the formation of an AV short. FIG. 25 shows a patient's arm with many blood vessels inside. An artery 242 is shown positioned relatively proximal to the vein 244. AV shorts are often formed between arteries and veins to provide a site for repeated access to the patient's vasculature, for example to treat a dialysis patient. The short itself is typically formed from a synthetic implant material and may have much better resistance to repeated needle sticks than a human vein. The AV short 246 is formed between the artery 242 and the vein 244 by forming a side-to-side anastomosis using the first fixation component 248 and the second fixation component 250. The short 246 is preferably formed from ePTFE, DACRON® or other suitable synthetic implant material.
[0054]
It should be understood that the applications of FIGS. 23-23A, 24-24A, and 25-25A illustrate some of the many different uses of the present invention. Other applications of the present invention include, for example, neurology, urology, and gastrointestinal procedures. As a further example, the present invention can be used to form an anastomosis with an existing CABG graft. This existing CABG graft is partially or fully closed for an extended period of time, for example, by placing an anastomotic fixation component on the graft distal to the closure. In sum, it should be understood that the present invention can be modified to some degree different from the preferred embodiments shown and described in detail herein.
[0055]
As noted above, it will be appreciated that the present invention can be used in many different procedures. Such procedures include, for example, femoral-femoral bypass, femoral-popliteal bypass, femoral-tibial bypass, iliac-femoral bypass, axillary-femoral bypass, clavicle-femoral bypass, aorta-both There are bimodal bypass, aorto-iliac bypass, aorta-deep femoral bypass and external-thigh bypass. In essence, the present invention relates to anastomoses with many different blood vessels including, but not limited to, renal arteries, mesenteric vessels, inferior mesenteric arteries, eroneal anatomy, radial arteries and tibial arteries. Can be used to generate
[0056]
Another embodiment of the invention is described with reference to FIGS. A device for forming a port in a blood vessel (or forming an anastomotic joint) is collectively shown at reference numeral 252 in FIG. 26A. Device 252 includes a member (eg, permanent magnet 254) capable of generating a magnetic field. The permanent magnet 254 preferably has an opening 256 that is adapted to communicate with a blood vessel lumen or other hollow body. In this embodiment, the magnet 254 is housed in a housing that includes two elements configured to adhere to each other to house the magnet. One housing element 258 (as shown in FIG. 26A) is generally dish-shaped with a rim 260 and the other housing element 262 is generally lid-shaped.
[0057]
FIG. 26B shows the magnetic member 254 disposed within the element 258 and the element 262 located on the assembly. FIG. 26C shows the element 262 affixed to the element 254, thus affixing to form a housing and providing a sealed enclosure that includes the magnetic member 254. This enclosure preferably forms a sealed environment that protects member 254 from external elements (eg, blood or various bodily fluids) when device 252 is implanted within a patient. The housing elements 258, 262 shown can be attached by any suitable means. For example, if the housings are made of metal, the housing elements may be joined using laser welding. Other attachment means include adhesives, fasteners and the like.
[0058]
The housing containing the magnetic member can of course be formed from a single piece of suitable material, such as a metal blank, or more than two pieces of material joined as described above. . FIG. 26D is a cross-sectional view of the device 252 shown in FIG. 26C. This cross-sectional view shows the internal structure of the apparatus, with the lid-type element 262 fixed on the rim 260 of the dish-type element. FIG. 27A shows another configuration in which the member 254 is housed in a housing defined by a spool-shaped element 264 and a pair of lid-shaped elements 266 secured to the element 264, for example, as described above. Indicates. FIG. 27B shows yet another configuration in which member 254 is housed within a housing defined by engaging channel-shaped elements 268, 270. These channel-shaped elements 268, 270 are secured together to form an enclosure for member 254. The housing that houses the magnetic member is preferably formed from a material suitable for a good conductor with magnetic flux. Exemplary materials are as described above with reference to FIGS. 26A-26C and are discussed below in conjunction with FIGS.
[0059]
FIG. 26C also shows a schematic diagram (in phantom lines) of the means for indicating the polarity of the magnetic member 254. The exemplary indicator 272 may indicate the polarity of the magnetic field generated by the member 254 using any suitable form of writing, color, etc. For example, indicator 272 may simply include the printed letter “N” or “S”. This feature allows the user to confirm the proper orientation of the device 252 relative to another device, so that the devices attract each other (or repel each other if desired). Is guaranteed). Other possible ways to ensure proper orientation are pre-installing the component (s) at a selected location on the delivery device or automatically directing the component to the selected location Including providing a mechanism to attach. It may also be desirable to be able to remove and reinstall components from the delivery device if the orientation is incorrect.
[0060]
28-31, another embodiment of the present invention will be described. This embodiment includes a method and apparatus for increasing the magnetic force between two components. FIG. 28 shows a first component 274 and a second component 276 adapted to be coupled to a target vessel via magnetic force. The first component 274 and the second component 276 each include members 278, 280 capable of generating a magnetic field and mechanisms 282, 284 that increase the magnetic force between the components. That is, when equipped with mechanisms 282, 284 and placed proximally, components 274, 276 generate a stronger magnetic force than when placed proximally without that mechanism.
[0061]
FIG. 29 shows components 274, 276 located on opposing surfaces of the wall W of the target vessel TV and coupled on this opposing surface by magnetic force. As shown, the component has an opening, such as each opening 286, 288 in components 274, 276, to form a port in communication with vessel lumen L, partially occluded at O. Can do. These openings are preferably aligned with complementary openings in mechanisms 282, 284 to form a port extending into the lumen. Mechanisms 282, 284 enhance the magnetic field between components 274, 276, which more securely attaches the assembly to vessel wall W when the mechanism is omitted.
[0062]
With reference to FIGS. 30 and 31, the concepts underlying this aspect of the invention will be described with respect to the particular embodiment of FIGS. FIG. 30 is relatively proximal and can be viewed as a first member 278 and a second member 280 (a pair of permanent bar magnets) with the magnetic member poles oriented so that the components attract each other. ). FIG. 30 also schematically shows the magnetic field generated by the magnetic members 278,280. The magnetic field F1 provided between the members 278, 280 is basically uniform considering the relatively large surface area between the members and the small separation gap. The number of lines between members 278, 280 approximately indicates the strength of magnetic field F1.
[0063]
As shown in the drawing, the magnetic field F2 formed at the ends of the members 278 and 280 surrounds the periphery, and thereby the magnetic field F2 is dissipated or weakened. Magnetic field F2 significantly increases the magnetic force between members 278, 280 due to location and field F2 being relatively weak (because magnetic field F2 is weaker than magnetic field F1 and includes spaced magnetic flux lines). It is not possible. In other words, the magnetic flux density of magnetic field F1 or magnetic induction B (which is a measure of the strength of the magnetic field) is greater than the magnetic flux density of magnetic field F2. The present invention provides a means for increasing the magnetic force between two components utilizing the magnetic field F2. Note that for clarity, FIG. 30 omits a portion of the magnetic field extending inward toward the center of each component.
[0064]
FIG. 31 shows members 278, 280 in substantial proximity along the mechanisms 282, 284. FIG. The magnetic field F1 formed between the members 278 and 280 is basically uniform as described above with reference to FIG. However, as can be appreciated, the mechanisms 282, 284 change the location of the magnetic field F2 and the magnetic flux density. In particular, rather than surrounding the periphery as in FIG. 30, the magnetic field F2 is focused by mechanisms 282, 284 between the components 274, 276. Thus, the magnetic flux density increases, thereby increasing the magnetic force between the components.
[0065]
The particular manner of increasing the magnetic force can be different from that shown. The example mechanisms 282, 284 are configured to alter the configuration of the magnetic members 278, 280 to increase the magnetic flux density and thus increase the magnetic force generated thereby. Mechanisms 282, 284 are separate elements coupled to members 278, 280. However, the means for increasing the magnetic force may include portions incorporated into the magnetic member, layers or coatings applied to the member, and the like. In addition, a preferred mechanism is an extension of the magnetic member that effectively channels the magnetic field F2 and focuses the magnetic flux between the components 274, 276 (more particularly between the opposing ends of the mechanisms 282, 284). It is a channel type forming part. However, it is understood that mechanisms having other configurations may be used to implement this aspect of the invention.
[0066]
The mechanisms 282, 284 have a higher permeability than air, focus the magnetic flux, and increase the magnetic flux density and magnetic force. That is, the mechanism provides a path with the least resistance compared to air, so that magnetic flux flows in the mechanism rather than air. This actually forms a magnetic circuit that captures a significant amount of the magnetic field F2. Otherwise, the magnetic field F2 does not contribute to the magnetic force between the two components. One benefit of this aspect of the invention is that it allows a thin magnetic member to be used for the component without sacrificing (or even increasing) the strength of the magnetic field. . In some applications, such as creating an anastomosis over small blood vessels, it is possible to minimize the amount of foreign material placed in or against the vascular tissue (eg, thrombogeneity). Usually preferred)
[0067]
The material used to form the mechanism for increasing the magnetic force preferably has a high permeability μ and focuses a desired amount of magnetic flux in one or more desired areas. The mechanism is preferably formed from a ferromagnetic material having a μ greater than that of air. More preferably, the material has a μ greater than 1.0, more preferably significantly greater than 1.0 or as large as possible. Exemplary ranges of values for μ include from about 1.0 to about 250,000, and from about 1.0 to about 1000. Ferromagnetic materials are preferably used to form the bundle focusing mechanism, although other materials may be used instead. For example, ferrimagnetic materials, paramagnetic materials, or diamagnetic materials may be used (the results achieved by these materials may be inferior to those obtained with ferromagnetic materials).
Depending on the size, material, and separation gap of each component having magnetic properties, the test is about 5% to about 75% higher than that obtained without the bundle focusing mechanism when using the bundle focusing mechanism of the present invention. It is possible to generate However, more preferred is a bundle focusing mechanism that increases the magnetic force from about 20% to about 75%. The exact amount of magnetic force used in practicing the present invention depends on various factors such as the size of the blood vessel, the magnetic force limitation before necrosis, etc., for example, when securing a component to the blood vessel.
[0068]
The benefits provided by this feature of the present invention include the ability to form a tight attachment to tissue via magnetic force, the ability to change the configuration of components and customize the amount or location of bundle focusing, as well as magnetic components It is clear that it includes the ability to maintain sufficient magnetic force to form an anastomosis while reducing the size of the anastomosis.
[0069]
FIGS. 32A and 32B show an anastomosis component 286 in the form of an electromagnetic assembly that includes a core 288 having an opening 290. The coil 292 has a lead 294 that is wound around the sidewall of the core 288 and continues to a power source such as a battery 296 (FIG. 32B). FIG. 32B shows the component 286 after it has been placed in the protective housing 298 by suitable means, such as a coating or structural enclosure as described above. The housing 296 is preferably formed from a biocompatible material that is strong and resistant to leakage.
[0070]
FIG. 33 shows an electromagnetic component 300 for use in closing an opening (eg, an opening in tissue such as ASD, VSD, PDA, etc.). As can be appreciated, the component 300 includes a housing 302 with at least one occlusion surface 304 adapted to seal a tissue or anastomosis component.
[0071]
FIG. 34A is an example of a component 286 coupled to the anastomosis component 286A disposed on the opposing surface of the target vessel TV with lumen L. FIG. Immediately above component 286, graft vessel G is shown (in phantom). Graft vessel G includes an anastomosis component AC that is oriented to magnetically attract (or be attracted to) the electromagnetic assembly of component 286. FIG. 34B shows the occlusion surface 304 of the component 300 used to temporarily or permanently occlude the magnetic port P communicating with the lumen L of the target vessel TV.
[0072]
The present invention may be implemented using magnetic force generation means, mechanical force generation means, or any other force generation means that secures a component to tissue or another component. FIG. 35A shows two anastomotic components 304, 306 that include a first magnetic member 308 and a second magnetic member 310 enclosed in housings 312, 314. The first component 304 has a sleeve portion 316 (in FIG. 35A, which is an extension of the housing 314) having an end 318 that projects beyond the second component 306. The end 318 of the second component 306 relative to the housing 314 may be crimped or otherwise manipulated using any suitable means, such as the instrument schematically represented in FIG. 35A. May be. As shown in FIG. 35B, the instrument is moved in the direction of the arrow to crimp the end 318 and mechanically couple the stationary components 304, 306 together. As a result, this embodiment couples components by both magnetic and mechanical forces.
[0073]
FIGS. 36A-39C illustrate another embodiment in the form of a component 320 to be coupled to tissue by a mechanical attachment portion 322. FIG. Component 320 includes a base 324 and a member 326 for creating a magnetic field. Opening 328 extends through component 320 and is placed in communication with a target vessel, such as, for example, a coronary artery or a peripheral artery. 36A and 36B and FIGS. 37A-37C show the component 320 in a compact profile, ie, a crimped configuration for delivery. The exemplary attachment 322 engages the tissue of the target vessel wall, thereby providing a plurality of arms 330 adapted to sandwich the vessel wall between the end 332 of the arm 330 and the base 324. Including. Component 320 may include separate members, as in the illustrated embodiment, or may include an integrated structure with a magnetic portion or an integrated structure without a magnetic portion.
[0074]
FIGS. 38A and 38B and FIGS. 39A-39C illustrate the component 320 in a raised profile, ie, a deployed configuration, corresponding to the position at which the tissue engages. FIG. 39B shows (in phantom) the tissue T engaged by the extended arm 332. However, these figures show an optional feature of this embodiment, namely a biocompatible layer G adapted to be placed in contact with tissue. Examples for use in layers that can be formed from any suitable material include sealing the opening of a blood vessel and facilitating tissue growth at that site. This embodiment of the invention uses mechanical forces to couple the component to the tissue, but forms a magnetic port that can be anastomosed (via member 326) to another component having the same or different configuration. Rather than presenting a magnetic port for docking a blood vessel, it is understood that the component 320 can present another structure for attaching the graft, such as a stent, staple or fastener, adhesive, and the like.
[0075]
40A-40C illustrate an exemplary use of the apparatus shown in FIGS. 36A-39C. A delivery device 334 is shown schematically, which preferably includes a tip 336 configured to incise and expand tissue. A tip 336 can be mounted on the shaft 338. The tip 336 has a groove for fitting the end 332 (FIG. 40A) of the arm 330, and holds the end 332 in a compressed configuration. The delivery device 334 also has an end 340 for contacting the magnetic member 326 of the component 320 to prevent movement of the arm 330 relative to the delivery device.
[0076]
FIG. 40A shows the device 334 after the tip 336 cuts the tissue of the vessel wall W and the component is properly positioned on the wall surface. FIG. 40B shows the device 334 after the shaft 338 has been moved away to release the end 332 of the component arm 330 and allow the end 332 to extend into contact with the tissue T. FIG. Next, as shown in FIG. 40C, the delivery device 334 with the shaft 338 is removed proximally from the opening 328 of the component 320.
[0077]
It will be understood that this embodiment of the invention can, of course, take many configurations other than those specifically illustrated herein. For example, instead of providing the individual arms 330 that engage with the tissue T, a continuous surface or a semi-continuous surface may be used, or the surface may be flat or uneven.
[0078]
41A-41C illustrate a delivery device configured in accordance with yet another embodiment of the present invention. The delivery device 342 includes a support portion 344 and a holding portion or mechanism 346 that holds a stationary component SC on the device. The exemplary retaining portion 346 is supported by a shaft 348 and engages a flange 350 formed on (or attached to) the stationary component SC around the opening 352. The flanged fixed component SC is preferably magnetic and can be configured as described above with respect to the above-described embodiments (eg, FIGS. 19A-19C). FIG. 41A shows the delivery device 342 in the first position, and the retaining portion 346 is in the first position and holds the fixation component SC. Note that the device 342 may be used to deliver a fixed component or components without flanges.
[0079]
FIG. 41B shows the delivery device 342 after the retention portion 346 has been moved from the first position and the fixation component 342 has been released. In this embodiment, the retaining portion is rotated 90 ° from the first position, but may perform different movements to release and engage the stationary component. FIG. 41C shows the delivery device 342 after the delivery device 342 has been pulled proximally out of the opening 352 in the fixation component 342. FIG. 41C also shows a particular configuration of the support portion 344 of the device 342. A step 354 is formed to fit the opening 352 of the stationary component 342. The step 354 helps in aligning the fixation component and also assists in delivery to the tissue surface.
[0080]
42A-42C illustrate a delivery device 356 configured in accordance with yet another embodiment of the present invention. Device 356 includes a body 358. The body 358 functions to some extent as a support for the first component 360 and the second component 362. The first holding portion or mechanism 364 is movable relative to the body 358 and engages the first component 360 to hold the first component 360 in place prior to and during delivery. . The second holding portion or mechanism 366 is also movable and engages the second component 362 and holds the second component 362 in place. As described below, the shaft 368 supports the first retaining portion 364 and the body 358 has a notch 370 that facilitates the introduction of components into the vessel lumen.
[0081]
FIG. 42B shows the device 356 after moving the second retaining portion 366 toward the first component 360 to drive the second component 362 to its desired position (eg, facing the vessel wall). The state of is shown. FIG. 42C shows the device 356 after the first retaining portion 364 has been moved distally relative to the device body 358. Portion 364 is V-shaped, and this movement releases contact between portion 364 and first component 360, thereby releasing portion 364 from the device. These two components 360, 362 are maintained in place by magnetism.
[0082]
43A-43C illustrate a delivery device 356 used in coupling the first component 360 and the second component 362 to the vessel wall W. As shown in FIG. 43A, the notch 370 can be used to guide the first component 360 through the incision in the wall W. Here, it should be noted that the offset structure for facilitating the introduction work of the leading end portion of the component can be obtained according to another aspect of the present embodiment. As can be seen from FIG. 43A, this feature allows the longer component 360 to be introduced into the shorter incision. The term offset means extending the body 358 (ie, the delivery end of the device 356) laterally in one direction to make the device configuration asymmetric. For example, in the illustrated embodiment, the body 358 extends to one side to define a notch 370 but does not extend in the opposite lateral direction. Viewed another way, the delivery end of device 356 has an offset relative to the longitudinal axis of the device.
[0083]
FIG. 43B shows the first component 360 passing through the incision and lowering the second component 362 to a position that achieves the desired amount of magnetic traction. FIG. 43C shows that these two components are in such a position, so that the openings of these components are aligned substantially in line with the incision in the wall W. FIG.
[0084]
As described above with reference to FIG. 5, the present invention can be implemented using flexible components capable of generating a magnetic field. FIG. 44 illustrates another embodiment that includes a component 374. This component 374 is in the form of a foldable sheet and is in a folded state. This component 374 is used, for example, when delivering the component percutaneously. 45A-45B illustrate the direction in which a component 376 constructed in accordance with another embodiment expands and collapses, respectively. FIGS. 46A-46B each show a magnet 382 partially disposed on components 378, 380, according to yet another embodiment, such that these components are at least partially folded.
[0085]
FIG. 46C shows the component 384 constructed according to another embodiment being expanded. Frame 386 supports web or body 388 and has the ability to facilitate delivery because it generates a magnetic field and is foldable. A web 388 can be used to close the opening. FIG. 46D shows a collapsible component 390, which can be used to form a magnetic port or anastomosis. Component 390 preferably comprises a magnetic core covered by a superelastic or shape memory memory housing and has an end 392. This end 392 allows delivery of the component 390 in a linear and inconspicuous configuration. FIG. 46E shows an exemplary catheter C that retains the orientation of the component 390 in an inconspicuous manner.
[0086]
47A-47C illustrate yet another embodiment of the present invention. This embodiment provides a device 394 for closing an opening in tissue (eg, any of the cardiovascular defects described above). The device 394 can be used for other purposes. In FIG. 47A, a sheath or catheter 396 houses a pair of magnetic components 398, 400 on the shaft 402. The structure of these components 398 and 400 may be any structure as long as it is described above, and is configured to be attracted to each other on the opening to be closed in the tissue body. FIG. 47B shows the device 394 after relative movement has occurred in the sheath 396 and the components 398,400. Component 398 is delivered from sheath 396 and is in a fully expanded state, while component 400 is partially delivered from the sheath and is in an expanded state. FIG. 47C shows the device 394 comprising the component 398 being expanded from the axis 402. Shaft 402 and component 398 have magnetic joining means and / or mechanical coupling means (this is indicated by reference numeral 404). By such means, the component 398 is firmly held during the delivery period, after which the component 398 is delivered (preferably via remote actuation) after delivery of the component 398 to the target site.
[0087]
48A-48C illustrate an exemplary application of the embodiment shown in FIGS. 47A-47C. In this application, the device 394 is used to close the ventricular septal defect VSD in the septum S between the right ventricle RV and the left ventricle LV. FIG. 48 shows the device 394 being percutaneously introduced into the right ventricle RV and positioning and expanding the component 398 within the left ventricle LV. As shown in FIG. 48B, the component 398 is pressed toward the partition wall S, and the other component 400 is expanded. Once expanded, component 400 is pressed toward septum S (eg, using sheath 396), pulling component 398 closer to the defect and removing device 394 (FIG. 48C).
[0088]
49A-49C, an anastomotic component constructed in accordance with another embodiment of the present invention is indicated primarily by the reference numeral 420. The anastomosis component includes a first portion 422 and a second portion 424 attached to the first portion 422. The second portion includes a tubular body adapted to be attached to a hollow body (eg, a blood vessel). The illustrated second portion 424 includes a plurality of openings 426 that can be used for a plurality of purposes. For example, these openings can promote tissue ingrowth to enhance engagement between component 420 and the blood vessel to which component 420 is attached. These openings 426 also provide the ability to allow the tubular body of portion 424 to flex or fold during use, thereby making delivery and deployment easier. Portion 424 can be formed from stainless steel, nitinol, or the like, and is preferably tapered outwardly (not shown), thereby engaging the interior of the blood vessel.
[0089]
FIG. 49A shows how the first portion 422 and the second portion 424 of the anastomosis component 420 are separated from each other, and FIG. 49B shows how these are assembled. In accordance with the present invention, each of the portions 422, 424 is provided with a mounting structure, thereby facilitating holding these portions in a watertight manner. The mounting structure in the embodiment of FIGS. 49A-49C includes a joining tab 428 and a recess 430. As can be seen from FIG. 49C, the tab 428 is formed on or attached to the second portion 424 and is received in a recess 430 formed in the first portion 422. As a result, the attachment is rigid, which allows the anastomosis component to be provided with continuous upper and lower surfaces that are substantially the same height.
[0090]
50A-50B illustrate another embodiment of the present invention, in which the anastomosis component 432 includes a first portion 434 and a second portion 436, the second portion 436 having an opening. Part 438. The first portion 434 has a tab 440. These tabs 440 are received in slots 442 formed in the second portion 434. FIG. 50A shows the two components being separated, while FIG. 50B shows the two components being assembled. The tubular body of the second portion 436 can be flexible (eg, due to the presence of the opening 438), thereby bending the second portion 436 as the tab 440 is inserted into the slot 442. Is possible. The anastomotic component of FIGS. 50A-50B may include other structures in addition to the illustrated structure. For example, one or more layers that do not allow liquid to penetrate (eg, ePTFE) are added to the tubular body of the second portion 436 and this additional structure can be used to facilitate attachment to the tubular body, radiopaque marker, etc. Can be. Also, the first portion 434 and the second portion 436 may be coupled using any desired number of tabs and slots.
[0091]
51A-51B illustrate another embodiment of the present invention, which includes one anastomosis component 444. FIG. The anastomosis component 444 includes a first portion 446 and a second portion 448. The first portion 446 is similar to that of the previous embodiment, and the second portion 448 includes a tubular body in the form of a lattice or web-like structure provided with openings 450. As shown in FIG. 51A, the end of the second portion 448 is received by the opening 452 of the first portion 446. In the figure, the entire second portion 448 includes a lattice structure. Instead, one or more portions (for example, an end fixed to the first portion 456) are made solid. Also good. The attachment of component portions 446, 448 may be performed using any suitable means. For example, the portions 446 and 448 may be joined using an adhesive or a thermal energy binder.
[0092]
52A-52C illustrate another embodiment, in which the anastomosis component 454 has a first portion 456 and a second portion 458. First portion 456 includes a rim or flange 460 adapted to couple to second portion 458. The second portion 458 has one or more extensions 462 (eg, wire ends). This extension passes through one or more openings 464 formed in the rim or flange 460 of the first portion 456. As with the above embodiments, additional means (eg, adhesive, weld, clip, etc.) can enhance the attachment between the first portion 456 and the second portion 458. FIG. 52C shows the assembled component 454, where the component 454 is secured to a real blood vessel or the component 454 is provided with artificial vascular material (eg, ePTFE or Dacron) Forming an implant that can be attached to another component.
[0093]
FIG. 53A shows a magnetic anastomosis component 466 constructed in accordance with another embodiment of the present invention. This component 466 includes a first portion 468 and a second portion 470. These first portion 468 and second portion 470 are attached to each other by any of the means described above at 472 (eg, adhesive or thermal bonding). As shown in FIG. 53A, the tubular body of the second portion 470 defines a lumen. This lumen communicates with an opening 474 defined by the first portion 468 (which itself is in communication with the vascular lumen).
[0094]
FIG. 53B shows the magnetic component 466 coupled to the hollow body 476, where the tubular body of the second portion 470 is disposed within the hollow body 476. This second portion 470 may be in the form of a stent or other expandable structure (eg, a pressure or self-expanding structure), applying pressure against the inner wall surface of the hollow body 476, Thereby, the component 466 is fixed to the hollow body 476.
[0095]
FIG. 53C shows the anastomosis component 466 of FIG. 53A attached to the hollow body 478. In this embodiment, the second portion 470 of the component 466 is positioned on the outer surface of the hollow body 478. In this embodiment, the distal end of the hollow body 478 passes through the opening 474 of the first component portion 468 and is turned upside down around the portion 468. The means for fixing the end of the hollow body 478 to the component 466 may be any means, and for example, an adhesive, a suture, or the like may be used. Further, the portion 470 of the component 466 can be configured such that the portion 470 engages the hollow body 478 and the structure is secured away from the distal end of the body 478. It should be understood that the embodiments of FIGS. 53B-53C can also be implemented using additional securing means located inside or outside the hollow body.
[0096]
54A-54F illustrate a magnetic anastomosis component constructed in accordance with another embodiment of the present invention. This component is indicated by reference numeral 480. This component 480 includes a plurality of first tabs 482 and second 484 supported by an annular body 486. FIG. 54A shows the tabs 482, 484 oriented with restriction or bias, and the tabs arranged in a circumferential direction. FIG. 54B shows the tabs 482, 484 oriented in an unbiased direction and extending alternately in the radial direction. As shown in FIGS. 54C-54D, sleeves or layers 488A, 488B are attached to a set of tabs 482, 484, respectively. The sleeves 488A, 488B are moved from the position shown in FIG. 54D to the position shown in FIG. 54D and then constrained to these sleeves using (eg, a suitable instrument (not shown)).
[0097]
As shown in FIG. 54E, this provides an annular space between the sleeve 488A and the sleeve 488B for receiving the end B of the hollow body. The tabs 482, 484 are released and the sleeves 488A, 488B are moved relative to each other to pinch the end of the hollow body (FIG. 54F). This embodiment can also be implemented using elastic, super-elastic, malleable or deformable tabs.
[0098]
55A-55C illustrate another embodiment of the present invention, in which the anastomosis component 494 includes a first portion 496 and a second portion 498. The end of the second portion 498 (which can be a real result or an artificial blood vessel) is secured to the outer surface of the first component portion 496. These components can be attached using an adhesive or any other suitable means as described above.
[0099]
The magnetic anastomosis component shown in FIGS. 49A-55C can include a permanent magnet, an electromagnet, or a ferromagnetic property material. Suitable materials for these components are disclosed in the above-mentioned copending patent application serial number 09 / 562,599. The magnetic anastomotic component has the ability to generate a magnetic field or be attracted by magnetism; that is, at least one of the first and second portions of the component includes a material having the ability as described above. Or formed of such materials. Those skilled in the art will recognize that many modifications can be made to the magnetic anastomosis components described herein without departing from the scope of the principles of the present invention. For example, if desired, the material (s) used, the arrangement or arrangement of materials on or around the component, the size, shape, and configuration of the component may be altered.
[0100]
Another aspect of the present invention allows various attachment mechanisms to be provided between the magnetic anastomosis component and the hollow body. It is understood that the term “hollow body” refers to any anatomical structure having a lumen. Exemplary structures include blood vessels (eg, coronary or peripheral arteries or veins) and urinary and gastrointestinal hollow bodies. In addition, the present invention can be used for applications other than those related to hollow bodies (eg, for closing an opening in tissue, for attaching a prosthesis, for delivering a device or substance, etc.). It should be understood that there is.
[0101]
There are other methods of attaching these magnetic anastomotic components to the hollow body, for example, adhesive methods, mechanical methods, and magnetic methods can be used. 56A-56B illustrate the process of magnetically attaching the anastomotic component 466 of FIG. 53B to a hollow body in the form of a blood vessel V. FIG. The first portion 468 of the component 466 is inserted through an opening in the wall of the blood vessel V and positioned so that the top surface of the portion 468 is adjacent to the inner surface of the blood vessel wall. As shown in FIG. 56B, the member 500 having an opening 502 sized to receive the tubular body 476 is slid down until the member 500 is adjacent to the vessel wall.
[0102]
FIG. 56B shows the first component portion 468 and member 500 (which can also be considered as part of the first component or the second anastomosis component) sandwiching the wall of vessel V. FIG. . The anastomosis component 466 has the ability to generate or be attached in whole or in part to the magnetic field. In the illustrated embodiment, the first anastomosis component portion 468 and the member 500 are attracted together using magnetism to compress the vessel wall, thereby providing water tightness of the attachment portion between the hollow body 476 and the vessel V. To ensure.
[0103]
57A-57B show the anastomosis component 466 and tubular body 478 of FIG. The first component portion 468 is magnetically attracted to the member 504 secured to the outer surface of the blood vessel V (FIG. 57B). The member 504 has an opening 506 aligned with the opening O formed in the side wall of the blood vessel V. When the anastomosis is complete, the opening 506 of the member 504 communicates with the tubular body 478 of the anastomosis 5 component 466 (FIG. 57C).
[0104]
58A-58C illustrate another embodiment of the present invention, in which the anastomosis component 508 includes a first portion 510 and a second portion 512. The first portion 510 includes a curved body 514 with an optional opening 516. Member 510 is preferably magnetic or ferromagnetic. Tubular body 518 has a lumen 520 that extends from first component portion 510 and communicates with an opening formed in portion 510. The first portion 510 is positioned inside the lumen of the blood vessel V and is drawn against the inner surface of the wall (FIG. 58B). The second portion 512 slides down until magnetism pulls between portions 510 and 512 to compress the vessel wall and secure the magnetic anastomosis component 508.
[0105]
59A-59B illustrate another embodiment of the present invention in which the magnetic anastomosis component 520 includes first and second portions 522 and 524 that compress the first and second blood vessels 526 and 528. Including. The magnetic force between portions 522 and 524 secures blood vessels 526 and 528 together. In addition, mechanical fastening means are provided to further enhance the attachment. The mechanical means may take a variety of forms (eg, clips, hooks, clasps, etc.) and the illustrated member 530 is in the form of a suture loop.
[0106]
Exemplary embodiments of the present invention that utilize mechanical coupling between a magnetic anastomosis component and a blood vessel will now be described. Referring to FIGS. 60A-60C, a magnetic anastomosis component 540 is shown in contact with the vessel V wall. The anastomosis component 540 includes an annulus 542 that defines an opening 544 that communicates with the opening O in the vessel wall. The annulus 542 has a plurality of passages 546 configured to receive a coupling member 548 to secure the component 540 to the blood vessel V.
[0107]
The coupling member 548 is held within a delivery device 550 that includes a push rod 552. The push rod 552 is used to move the coupling member 548 out of the distal end of the device 550, as shown in FIGS. 60A-60B. The coupling member 548 can be of any desired form, and in the illustrated embodiment is a super-elastic hook-type element. The coupling member 548 is configured to have the configuration shown in FIG. 60B when not deflected. Thus, as the coupling member 548 exits the delivery device 550, it moves from a deflected straight configuration (FIG. 60A) to an undeflected hook-type configuration (FIG. 60B). As a result, the hook exerts sufficient compressive force to engage the vessel wall and the annular body 542 of the component 540 and securely bond the component to the vessel.
[0108]
As shown in FIG. 60C, a plurality of coupling members 548 are preferably used to secure the magnetic anastomosis component 540 to the blood vessel V. However, it is understood that the exact number and position of the coupling members may differ from the illustrated embodiment.
[0109]
FIG. 60B shows another anastomosis component 552 that is secured to the magnetic anastomosis component 540 in phantom. Another component 552 (which can be coupled to a second blood vessel (not shown) that is anastomosed to blood vessel V) is secured to component 540 by magnetic force. The annulus 542 of the anastomotic component 540 preferably has a recessed region 554 that receives the end of the coupling member 548. This provides a continuous top surface of the same height or substantially the same height to join another component 552, thus enhancing magnetic force and sealing.
[0110]
It will be appreciated that this embodiment of the invention may be implemented in a manner different from that shown in FIGS. 60A-60C. For example, rather than using a separate coupling member to secure the annular body 542, a single annular coupling member having portions that engage tissue and components may be used. Furthermore, although the drawings show the coupling members being provided one by one, it is also possible to provide them simultaneously by a single delivery process using one or more push rods.
[0111]
61A-61C illustrate another embodiment in which the magnetic anastomosis component is mechanically secured to the blood vessel. The anastomotic component includes an exterior 556 and an interior 558 that sandwich the end of the blood vessel V. As shown in FIG. 61B, the exterior 556 can be deformed, preferably elastic or stretchable, and can extend to receive the end of a blood vessel. The exterior 556 is then released and compresses the blood vessel against the interior component portion 558. Component portions 556 and 558 may or may not be attracted magnetically to each other. However, at least one portion is preferably fully or partially magnetic or ferromagnetic (eg, for coupling to another magnetic anastomosis component (not shown) at the distal end).
[0112]
62A-62C illustrate an embodiment of the present invention similar to the previous embodiment, where the external component 560 has a flexible individual portion 562 as shown in FIGS. 62B and 62C. . This embodiment includes an internal anastomotic component portion 564 having a ledge 566 configured to support the end of the blood vessel V. (See FIG. 62C.) The ledge 566 can be a separate element or can be integrally formed with the portion 560 and is preferably magnetic.
[0113]
63A-63D illustrate another embodiment of the present invention where the magnetic anastomosis component is mechanically secured to the blood vessel. The anastomosis component 570 can generate or be attracted by a magnetic field and includes an annulus 572 that defines an opening 574 and a plurality of movable connecting elements 576. The connecting element 576 is constrained in a first state (FIG. 63A) and delivered through an opening in the wall of a hollow body, such as a blood vessel V (FIG. 63C). The connecting element 576 is released into the second state (FIG. 63B), where it is essentially parallel to the surface of the annular body 572. As a result, connecting element 576 captures the vessel wall and secures component 570 thereto (FIG. 63D).
[0114]
64A-64B illustrate a magnetic anastomosis component 580 constructed in accordance with another embodiment of the present invention. Component 580 includes an annular body 582 and a plurality of coupling members 584. Annulus 582 of component 580 is formed by one or more recesses 586 that receive the ends of coupling member 584. Each coupling member 584 has a leg 588 extending against the vessel V wall, a central portion 590 extending longitudinally through the vessel wall opening, and another leg 592 extending into the recess 586.
[0115]
FIGS. 65A and 65B show an embodiment of the present invention similar to the previous embodiment, wherein the anastomosis component 580 is secured to the wall of vessel V by a single coupling member 594. The coupling member 594 has an upper leg 596 that is received in a recess 586 formed in the annular body, the recess corresponding to the recess 586 in the annular body 582 of FIGS. 64A-64B. It should be noted that in either embodiment, leg 588 can be a continuous rim or flange, or can include one or more individual elements.
[0116]
66A-66C illustrate an exemplary device for deploying the anastomotic component shown in FIGS. 64A-64B and 65A-65B. Device 600 includes an inner shaft 602 having an anvil at the distal end, a split intermediate shaft 604 and a split outer shaft 606. (For clarity, the distal end (s) 588 of the coupling member 584 are shown already deformed by the anvil.) The intermediate shaft 604 has been moved in the direction of the arrow and raised. Surface 608 will come into contact with a corresponding raised surface 610 on external shaft 606 (FIG. 66B). The raised surface causes the arm of the external shaft 606 to move outward in the direction of the arrow and deflects the leg 592 of the coupling member 584 outwardly into the recess 586 in the annulus 582 of the anastomosis component 580. (FIG. 66B). The internal shaft 602 of the device 600 is rotated to position the anvil in a position such that it is removed via the anastomosis component 580 (FIG. 66C).
[0117]
67A-67C illustrate a magnetic anastomosis component 612 constructed in accordance with another embodiment of the present invention. Component 612 includes a body 614 that defines an opening 616 and an annular recess 618. FIG. 67B shows the anastomosis component 612 coupled to the end of the vessel V by the end of the vessel passing through the opening 616 and turning it around the outer surface of the body 614. A suitable member 620, such as a suture, may be provided to secure the end of the blood vessel to the component 612. Additionally or alternatively, the blood vessel can be secured to the component by an adhesive, clip, fastener, or the like.
[0118]
FIG. 67C shows a magnetic anastomosis component 612 coupled to the side wall of blood vessel V (with body 514 slightly shortened). The sidewall tissue is turned over and held over the outer surface of the body 614 of the component 612 as in the above embodiment. In the illustrated embodiment, the blood vessel is turned over the anastomotic component, but this aspect of the invention can also be practiced without turning the blood vessel (eg, the blood vessel at the end of the body 614). It should be understood that it is terminated or by fixing the vessel wall inside the component.
[0119]
Many of the embodiments of the present invention that utilize an adhesive to secure one or more anastomotic components to a hollow body will now be described. As used herein, an “adhesive” is any substance that can be used to bond an anastomotic component to a hollow body. The adhesive can be auto-active or by providing appropriate means (eg, heat, light, or chemical reaction (eg, by providing respective substances mixed in a manner such as epoxy to the blood vessels and components). )).
[0120]
68A-68B show the anastomosis component 622 positioned in contact with the outside of the vessel V wall. An apparatus for applying adhesive is schematically shown at 624, showing the application of adhesive 626 between the component 622 and the vessel wall. As shown, the anastomosis component 622 has a flange 628 that defines a space configured to receive an adhesive. FIG. 68B illustrates another embodiment, wherein the magnetic anastomosis component 630 includes a beveled surface 632 that defines a space for receiving the adhesive 634 from the device 624. In each case, the adhesive serves to bond the magnetic anastomotic components 622 and 630 to the vessel wall in a manner that does not allow fluid to leak.
[0121]
69A-69B illustrate an embodiment of the present invention that includes an anastomosis component 636 that defines an opening 638 and a surface 640, the anastomosis component 636 being secured to the wall of vessel V adjacent to the opening O of the wall. Configured to be An intermediate member 642, which may be in the form of a blanket or sheet, is preferably disposed between the anastomosis component 636 and the vessel wall. FIG. 69A shows a blanket with no openings. This is because it may be desirable to first place a blanket, adhere and fix the component to the blood vessel, and then cut the opening in member 642. An opening in the vessel wall can also be formed at this time if desired. One advantage of this embodiment is that the component 636 is not specifically configured to hold the adhesive, but the intermediate member 642 can be used to hold the adhesive. The above-mentioned co-pending patent application 60 / 255,635 can be applied to this and other embodiments of the present invention. Components 636, particularly surface 640, may similarly hold adhesive.
[0122]
FIG. 70 illustrates an embodiment of the present invention that is similar to FIGS. 69A-69B in that an intermediate member 644 is used to secure the magnetic anastomosis component 646 to the vessel V wall. A second magnetic anastomosis component 648 having an annulus secured to the tubular member 650 is magnetically attracted to the component 646. As shown, the bonding surfaces of components 646 and 648 produce a seal that does not leak fluid when bonded. In addition, the end 652 of the tubular body 650 protrudes beyond the annulus of the component 648 and is received within the opening 654 defined by the component 646 and is between the connected component 646 and the component 648 (hence the vessel V). Between the tubular body 650).
[0123]
The anastomosis components 622, 630, 636, and 646 are adhesively secured to the outside of the vessel wall in the previous embodiment. During coupling, the component can be maintained in place relative to the blood vessel by any suitable means. For example, a placement member may be introduced into the vessel lumen to provide robustness and / or alignment to the external component. 71A-71D illustrate the use of an intraluminal attachment member to secure a magnetic anastomosis component to a blood vessel in a somewhat schematic manner.
[0124]
More particularly, FIG. 71A shows a magnetic anastomosis component 656 disposed on the outside of the wall of vessel V and an attachment member 658 disposed on the opposite surface of the vessel wall. A wire G or other grippable structure is provided on the attachment member 658. After component 656 and attachment member 658 are magnetically attracted to place member 658 in the desired location within the blood vessel, component 656 can be guided and secured. (For illustrative purposes, component 656 is considered already drawn to the blood vessel, as shown in FIG. 71A.)
FIG. 71B shows the attachment member 658 moved to overcome the magnetic force and the anastomosis component 656 coupled to the vessel wall. This can be done, for example, by manipulating member 658 via wire G. The attachment member 658 is then removed through the opening in the anastomosis component 656, as shown in FIG. 71C. It is understood that removing member 658 in this manner probably requires some manipulation or repositioning depending on the respective size and configuration of anastomosis component 656 and member 658.
[0125]
For example, member 658 can be rotated on the plane of the drawing to align its smaller dimensions with the opening of component 656. Alternatively or additionally, the attachment member can be foldable (either fully or partially). FIG. 71D shows the magnetic anastomosis component 656 affixed to the vessel V wall after the attachment member 658 has been removed.
[0126]
72A-72F illustrate another embodiment of the present invention wherein the magnetic anastomosis component is adhered and secured to the blood vessel. In this embodiment, component 660 is secured to vessel V, and more particularly to vessel 66 end 662. Furthermore, although the illustrated component 660 is coupled to the outside of the blood vessel V, it is understood that the present invention may be practiced by coupling the component to the inside of the blood vessel.
[0127]
72A shows a magnetic anastomosis component 660 placed around the wall of vessel V, and FIG. 72B shows a knife (by phantom line) used to cut the irregularly shaped end of the vessel. FIG. 72C shows an internal support in the form of a balloon 664 inserted into the lumen of blood vessel V and an adhesive applicator 666 that applies adhesive to the contact between component 660 and blood vessel V. FIG.
[0128]
72D shows the inflation of balloon 664 within the lumen of vessel V. FIG. Thereby, the blood vessel V is brought into contact with the inner surface of the component 660, and the component is attached to the blood vessel. Balloon 664 is then removed (FIG. 72E). The end of the blood vessel 662 can be cut off (after placing a mandrel or other internal support (not shown)) or the end of the blood vessel can be flipped over the component.
[0129]
73A-73D illustrate another embodiment of the present invention where an adhesive is used to secure the magnetic anastomosis component to the blood vessel. Unlike the conventional embodiment, this embodiment fixes a magnetic anastomosis component to the side wall of the blood vessel. As shown in FIG. 73A, an internal support in the form of a balloon 670 is inserted into the vessel lumen of vessel V. A scalpel, piercing scissor or other suitable instrument 672 is used to form the opening in the side wall of the vessel. FIG. 73B shows balloon 670 inflated to support the wall of vessel V with a guide device, which guide device supporting magnetic anastomosis component 676 is shown schematically at 674. Device 674 is used to guide component 676 into contact with the wall of vessel V, and adhesive 678 is applied to the vessel wall around the opening. Device 674 can project through an opening in the vessel wall and toward balloon 670. FIG. 73D shows the magnetic anastomosis component 676 after it is adhesively secured to the blood vessel V and aligned with the opening in the blood vessel wall.
[0130]
74A-74D illustrate another embodiment of the present invention where a magnetic anastomosis component is affixed to the vessel wall and an internal support component is used to support the vessel. 74A shows a device 680 having an expandable or inflatable structure, such as a balloon 682, that passes through an opening formed in the side wall of vessel V and aligned with the vessel lumen of vessel V. FIG. FIG. 74B shows a magnetic anastomosis component that slides across the device 680 and contacts an adhesive 686 disposed on the vessel wall around the device 680. FIG. 74C shows the internal support structure 682 in a collapsed relationship such that the internal support structure 682 is removed through the vessel wall and the magnetic anastomosis component 684. FIG. 74D shows a magnetic anastomosis component 684 adhered and secured to a blood vessel.
[0131]
75A-75D and FIGS. 76A-76D illustrate another embodiment of the present invention in which the magnetic anastomosis component is secured to the blood vessel by adhesive or other means. 75A and 76A show a blood vessel V that includes a partially occluded vessel lumen and an intraluminal placement member 690. FIG. The placement member is supported on shaft 692 and is passed over obstructions in the blood vessel. 75B-76B show the deployment member 690 in contact with the inside of the vessel V wall and expanded. 75C-76C show a magnetic anastomosis component 694 aligned with the outer surface of blood vessel V, with adhesive 686 applied to blood vessel V (FIGS. 75B, 76B). In this embodiment, the placement member 690 uses magnetic attraction to correctly place the anastomosis component 694 on the blood vessel V. More specifically, a suitable placement member 690 may take the form of a balloon inflated with magnetic fluid. As shown in FIGS. 75B and 76B, when the balloon is inflated, the magnetic anastomosis component 694 can be guided to the desired location due to magnetic attraction.
[0132]
It is noted that while an adhesive is used to adhere the illustrated magnetic anastomosis component to the vessel wall, alternative or additional means may be used to secure the component to the vessel.
[0133]
75C and 76C, the magnetic anastomosis component 694 is secured to the vessel V wall using tissue remaining between the component and the vessel lumen. 75D and 76D show the blood vessel after a portion of the tissue has been circumscribed at the opening of the anastomosis component 694. FIG. As a result, the opening 698 of component 694 communicates with the vessel lumen of vessel V. FIG. 77 is a perspective view showing the completed attachment of the magnetic anastomosis component 694 to the vessel V wall.
[0134]
With reference to FIGS. 78A-78C, yet another embodiment of the present invention is described in which an adhesive is used to form an anastomosis between two blood vessels. This embodiment uses magnetic attraction to hold the blood vessel in the desired relative position and an adhesive is used to form an anastomosis between the blood vessels. Although the illustrated embodiment forms a side-to-side anastomosis, it will be appreciated that this aspect of the invention may be used to form other types of anastomoses. FIG. 78A shows a first magnetic component 700 supported by a shaft 702 that extends through the vessel lumen of the first blood vessel 704. The second magnetic component 706 is supported by a shaft 608 that extends through the vessel lumen of the second blood vessel 710. As shown in the figure, the magnetic attraction between components 700, 706 compresses the side walls of blood vessels 704, 710 together.
[0135]
FIG. 78B shows the components that hold the wall in place, and the cutting device 772 is introduced through the vessel lumen of one of the blood vessels (first blood vessel 704 in the figure). The cutting device 712 preferably has a seal 714 around its outer surface and is sized to cooperate with the magnetic components 700, 706 and placed between components without damaging the vessel wall or components. The desired amount of tissue T to be removed is removed. FIG. 78C shows the anastomosis after the cutting device has formed an opening and the first blood vessel 704 and the second blood vessel 710 are in communication with each other. Adhesive 716 (or other securing means) is applied around the periphery of the anastomosis to hold the blood vessels 704, 710. FIG. 78C shows the anastomosis after the magnetic components 700, 706 have been removed (after the adhesive 616 has hardened or has fully set).
[0136]
79A-79C show a first blood vessel 720 and a second blood vessel 722 provided with magnetic anastomosis components 724, 726, respectively. FIG. 79B shows blood vessels that are magnetically joined to form a side-to-side anastomosis, and blood leaks from the anastomosis, as indicated by 728. FIG. 79C illustrates an attempt to separate the magnetically attracted components 724, 726 to repair the leak 728. FIG. The magnetic force that couples components 724, 726 is greater than the force that attaches component 726 to vessel 722. As a result, component 726 continues to be coupled to component 724 by magnetism and separates from blood vessel 722. Thus, in view of problems that may be associated with magnetic anastomosis decoupling, it may be beneficial to determine the presence of any leakage between the anastomotic component and the blood vessel before completing the magnetic anastomosis.
[0137]
80A-80C show a first embodiment of an apparatus for checking a seal at an anastomotic junction. The device denoted by reference numeral 730 typically includes a shaft 732 that supports a magnetic component 734. Expandable structure 736 is disposed between shaft 732 and component 734. A blood vessel V is shown in which the magnetic anastomosis component 738 is secured. The anastomosis component 738 includes two component components that are magnetically attracted so that the walls of the blood vessel are sandwiched and the components can be held in place.
[0138]
Prior to joining another magnetic anastomosis component to component 738, device 730 is used to determine if there is any leakage at the junction of component 738 and vessel V. As shown in FIG. 80B, the device 730 is positioned relative to the magnetic anastomosis component 738 and the magnetic attraction including the components 734 (due to their respective polarities) creates a tight seal. Here, if the blood vessel is pressurized and a leak is present, it can be inferred that the leak is due to an inaccurate coupling of component 738 and blood vessel V. Once this step is complete, the device is removed by expanding the expandable structure 736, which can be, for example, a fluid inflated balloon. The expansion force is sufficient to overcome the magnetic attraction between component 734 of device 730 and attached component 738. The device 730 can then be removed simply by sliding from the magnetic anastomosis component 738.
[0139]
81A-81F illustrate another embodiment of a seal inspection device that includes a device 740 having a magnetic component 742 contained within an expandable structure 744. FIG. This allows a magnet with two polarities to be placed relative to the magnetic anastomosis component 746 attached to the blood vessel V, regardless of the polarity of the magnetic field generated by that component. In other words, the device 740, whether it is the component's magnetic north pole or magnetic south pole, faces the device by simply orienting the facing surfaces of the device 740 and component 742 towards the component. Can be combined. 81B and 81C correspond to FIGS. 80B and 80C, and FIG. 81C preferably illustrates the manner in which the magnet is housed by an interference fit within the expandable structure 744 (which can again be a balloon).
[0140]
82A-82F illustrate another embodiment of a seal inspection device 750 that includes a magnetic component 752 encapsulated in a mechanically expandable housing 754. FIG. 82B shows a device 750 mounted on and sealing an anastomotic magnetic component 756 secured to blood vessel V. FIG. FIG. 82C shows the housing 754 compressed longitudinally to bend the wall of the housing 754, overcoming the magnetic attraction between the magnetic component 752 and the component 756. FIG.
[0141]
The embodiment of FIGS. 80A-82C is described in connection with an anastomosis achieved by magnetic force, and this aspect of the invention applies to any anastomotic bond, where the binding and adhesion forces are Regardless of whether it is magnetic, mechanical, or sticky, the binding force between the two components (once the anastomosis has been completed) is greater than or greater than the force that attaches one of the components to the blood vessel. Good.
[0142]
83A-83B and 84A-84B have other functions, but are devices that determine whether a magnetic anastomosis component is properly oriented before being used during a medical procedure. Show. The illustrated device 770 includes a fixture that receives one or more magnetic anastomotic components 774, 776 by sliding them on an attached guide device 772. Device 770 is preferably configured such that guide device 772 can be slid in the direction of the arrow and aligns magnetic anastomosis components 774, 776 proximate to one or more magnetic ledges 778, 780, 782. .
[0143]
Since the polarity of the magnetic ledge 778 is selected, the magnetic anastomosis component 774 remains in the lower position shown in FIGS. 83A-83B when properly oriented. When the anastomosis component 774 is tampered with, the component 774 is pressed against the second ledge 780 (can be magnetized or not magnetized) as shown in FIGS. It is repelled upward. This also applies to the second magnetic anastomosis component 776 supported by the upper portion of the guide device 772. Thus, if the guide device 772 is aligned on a fixture 770 that includes either anastomically fitted anastomosis component, the component (s) require that the device be adjusted. Moved to alert the user.
[0144]
In addition to ensuring correct placement of the anastomotic component, the device 770 can further be used as a mounting tool to support the guide device 772, to which one or more anastomotic components are mounted. Finally, once the guidance device 772 is installed, the device 770 can be used to retain blood vessels or carry it to an end user.
[0145]
FIG. 85A is a cross-sectional view of a magnetic anastomosis component 780 configured in accordance with another embodiment of the present invention. Component 780 includes two portions 782, 784 that sandwich the end of a hollow body, such as blood vessel V, such that the blood vessel expands from the component at a particular angle θ. The angle shown is about 30 °, although other angles may be used. The angle is preferably 60 ° or less, and preferably about 45 ° or less. This is oriented so that the flow is more along the axis of the vessel lumen of the blood vessel, which may be desirable in some cases.
[0146]
FIG. 85B is a cross-sectional view of an anastomosis formed between a blood vessel V that includes a magnetic anastomosis component 780 and a second magnetic anastomosis component 786 that is secured to the wall W of the second blood vessel. The second anastomosis component can have any configuration. The illustrated component 786 is constructed in accordance with the teachings of previously referenced copending application serial number 09 / 638,805.
[0147]
FIG. 86A is a perspective view of a pair of closely spaced bipolar anastomotic components 790, 792 constructed in accordance with the present invention. The magnetic north pole and magnetic south pole (N, S) of each component 790, 792 are located at the ends of those components, and the magnetic field of the component attracts these components as indicated by the arrows.
[0148]
FIG. 86B is a perspective view of a pair of closely spaced tripolar magnetic anastomosis components 794, 796 configured in accordance with another embodiment of the present invention. In addition to the magnetic poles located at the ends of each component 794, 796, an additional pole is located at the central portion 798 of each component. As can be seen, this increases the attractive force between the two components 794, 796 and, in the case of anastomosis, prevents component movement and strengthens the seal.
[0149]
Other features, aspects and advantages of the present invention other than those specifically described will be apparent to those skilled in the art. Multiple alterations, modifications and variations of the illustrated embodiments may be made without departing from the scope and spirit of the invention as defined by the claims.
[Brief description of the drawings]
FIG. 1 is a perspective view of an anastomotic fixation component constructed in accordance with various embodiments of the invention.
FIG. 2 is a perspective view of an anastomotic fixation component constructed in accordance with various embodiments of the invention.
FIG. 3 is a perspective view of an anastomotic fixation component constructed in accordance with various embodiments of the invention.
FIG. 4 is a perspective view of an anastomotic fixation component constructed in accordance with various embodiments of the invention.
FIG. 5 is a perspective view of an anastomotic fixation component constructed in accordance with various embodiments of the invention.
FIG. 6 is a perspective view showing two hollow bodies adapted to communicate and join by end-to-side anastomosis.
FIG. 7 is a perspective view showing two hollow bodies adapted to communicate and join by side-to-side anastomosis.
FIG. 8 is a perspective view showing two hollow bodies adapted to communicate and join by end-to-end anastomosis.
FIG. 9 is a perspective view of the two hollow bodies shown in FIG. 6 with an anastomosis system including an anastomotic fixation component constructed in accordance with one embodiment of the present invention.
9A is a cross-sectional view taken along line AA of FIG. 9. FIG.
FIG. 10A is a cross-sectional view similar to FIG. 9A, including an alternative anastomotic fixation component used to join two hollow bodies.
FIG. 10B is a cross-sectional view similar to FIG. 10A, including another alternative anastomotic fixation component for joining two hollow bodies.
FIG. 10C is a cross-sectional view similar to FIG. 10A showing an alternative attachment between the hollow body and the anastomotic fixation component.
FIG. 10D is a cross-sectional view similar to FIG. 10C showing another alternative fitting between the hollow body and the stationary component.
FIG. 11A is a transverse cross-sectional view through an end-to-side anastomosis formed in accordance with one embodiment of the present invention.
FIG. 11B is a transverse cross-sectional view through an end-to-side anastomosis formed according to another embodiment of the present invention.
FIG. 12 is a perspective view showing two hollow bodies provided with an anastomotic fixation component constructed in accordance with one embodiment of the present invention, the two hollow bodies being side-to-side anastomoses. It is adapted to join.
13 is a perspective view of the two hollow bodies of FIG. 12 provided with an anastomotic fixation component constructed in accordance with another embodiment of the present invention.
14A is a longitudinal cross-sectional view through the side-to-side anastomosis formed by the embodiment shown in FIG. 12. FIG.
14B is a transverse cross-sectional view through the side-to-side anastomosis formed by the embodiment shown in FIG. 12. FIG.
FIG. 15 is a perspective view showing two hollow bodies provided with an anastomotic fixation component constructed in accordance with one embodiment of the present invention, the two hollow bodies being end-to-end anastomosis. It is adapted to join.
16 is a perspective view of the two hollow bodies of FIG. 15 provided with an anastomotic fixation component constructed in accordance with another embodiment of the present invention.
FIG. 17A is a plan view of one of the hollow bodies and fixed components shown in FIG.
FIG. 17B is a longitudinal cross-sectional view of the hollow body and stationary component shown in FIG. 17A.
FIG. 18A is a top view of a stationary component constructed in accordance with the hollow body of FIGS. 17A-17B and an alternative embodiment of the present invention.
FIG. 18B is a longitudinal cross-sectional view of the hollow body and stationary component shown in FIG. 18A.
FIG. 19A is a perspective view of the anastomosis fixation component shown in FIGS. 18A-18B, wherein the anastomosis fixation component is positioned in an opening in a hollow body having an occluded lumen.
FIG. 19B shows an anastomotic fixation component constructed in accordance with a further alternative embodiment of the present invention, the anastomosis fixation component being shown positioned in the hollow body of FIG. 19A.
FIG. 19C shows an anastomotic fixation component constructed in accordance with a further alternative embodiment of the present invention, the anastomosis fixation component being shown positioned in the hollow body of FIG. 19A.
FIG. 20A is a perspective view of a delivery device constructed in accordance with one embodiment of the present invention, with the delivery device shown in a first position.
FIG. 20B is a perspective view of the delivery device shown in FIG. 20A, with the delivery device shown in the second position.
FIG. 21A is a perspective view of the delivery device shown in FIG. 20A with an anchoring component installed thereon and configured in accordance with one embodiment of the present invention, the delivery device shown in a first position. Has been.
FIG. 21B is a perspective view of the delivery device shown in FIG. 21A, shown in a second position because the delivery device has been manipulated to release the fixation component.
22A illustrates the delivery device shown in FIGS. 20A-20B used to position an anastomotic fixation component to form an end-to-side anastomosis according to one embodiment of the invention. It is sectional drawing shown typically.
FIG. 22B illustrates the delivery device shown in FIGS. 20A-20B used to position an anastomotic fixation component to form an end-to-side anastomosis according to one embodiment of the invention. It is sectional drawing shown typically.
FIG. 22C illustrates the delivery device shown in FIGS. 20A-20B used to position an anastomotic fixation component to form an end-to-side anastomosis according to one embodiment of the invention. It is sectional drawing shown typically.
FIG. 22D illustrates the delivery device shown in FIGS. 20A-20B used to position an anastomotic fixation component to form an end-to-side anastomosis according to one embodiment of the present invention. It is sectional drawing shown typically.
FIG. 22E illustrates the delivery device shown in FIGS. 20A-20B used to position an anastomotic fixation component to form an end-to-side anastomosis according to one embodiment of the invention. It is sectional drawing shown typically.
FIG. 22F illustrates the delivery device shown in FIGS. 20A-20B used to position an anastomotic fixation component to form an end-to-side anastomosis according to one embodiment of the invention. It is sectional drawing shown typically.
FIG. 23 is a perspective view of an exemplary application according to an embodiment of the present invention.
FIG. 23A is an enlarged view of a portion of the embodiment of FIG. 23, showing the completed anastomosis.
FIG. 24 is a perspective view of another exemplary application in accordance with another embodiment of the present invention.
FIG. 24A is an enlarged view of a portion of the embodiment of FIG. 24, showing the completed anastomosis.
FIG. 25 is a perspective view of an exemplary application according to yet another embodiment of the present invention.
FIG. 25A is an enlarged view of a portion of the embodiment of FIG. 25, showing the AV shunt completed with two anastomoses.
FIG. 26A is an exploded perspective view of an apparatus constructed in accordance with an embodiment of the present invention to form a magnetic port in a hollow body having a lumen.
FIG. 26B is an exploded perspective view of an apparatus constructed in accordance with an embodiment of the present invention to form a magnetic port in a hollow body having a lumen.
FIG. 26C is a collective perspective view of the apparatus shown in FIGS. 26A and 26B.
FIG. 26D is a cross-sectional view taken along line DD in FIG. 26C.
FIG. 27A is a cross-sectional view illustrating an alternate configuration of the apparatus shown in FIGS. 26A-26D.
FIG. 27B is a cross-sectional view illustrating an alternative configuration of the apparatus shown in FIGS. 26A-26D.
FIG. 28 shows two constructed in accordance with another embodiment of the present invention adapted to couple to tissue using magnetic force to form a magnetic port in a hollow body having a lumen. It is an exploded perspective view of an apparatus.
FIG. 29 is a cross-sectional view obtained through the blood vessel having a lumen with the device shown in FIG. 28 coupled to the tissue of the vessel wall.
FIG. 30 is a cross-sectional view of two magnets positioned in close proximity to each other, schematically illustrating the magnetic flux lines associated with the magnets.
FIG. 31 shows that the two magnets of FIG. 30 are provided with a magnetic flux concentrating mechanism constructed according to another embodiment of the present invention, and the magnetic flux lines associated with the magnets of the present invention are schematically illustrated. It is sectional drawing.
FIG. 32A is a perspective view of a device constructed in accordance with another embodiment of the present invention adapted to connect tissue using electromagnetic forces to form a magnet port.
FIG. 32B is a perspective view of the apparatus shown in FIG. 32A encased in a protective housing.
FIG. 33 is a perspective view of an apparatus constructed in accordance with yet another embodiment of the present invention adapted to close an opening using magnetic force.
FIG. 34A is a cross section obtained through a target vessel having a lumen shown to be coupled to the device of FIG. 32B with the graft tube shown (in microwires) before being anastomosed to the device. FIG.
34B shows a target vessel having a port defined by an anastomosis component in communication with a vessel lumen having the device of FIG. 33 positioned over the port before being used to close the opening. It is sectional drawing obtained through.
FIG. 35A is a sequential cross-sectional view taken through a target vessel having a lumen showing an anastomotic component constructed in accordance with another embodiment of the invention coupled to the vessel wall.
FIG. 35B is a sequential cross-sectional view taken through a target vessel having a lumen showing an anastomotic component constructed in accordance with another embodiment of the present invention coupled to the vessel wall.
FIG. 36A shows a device constructed according to another embodiment of the present invention to form a port in a blood vessel having a lumen in a device having a mechanical attachment shown in a low profile or crushing direction. FIG.
FIG. 36B is a device having a mechanical attachment shown in a low profile or collapse direction, constructed in accordance with another embodiment of the present invention to form a port in a blood vessel having a lumen. It is a lower perspective view of an apparatus.
FIG. 37A is a top plan view of the apparatus shown in FIGS. 36A-36B.
FIG. 37B is a side view of the apparatus shown in FIGS. 36A-36B.
FIG. 37C is a bottom plan view of the apparatus shown in FIGS. 36A-36B.
FIG. 38A is a top perspective view of the device shown in FIGS. 36A-36B, with the machine attachment of the device shown in a wide profile direction or an enlarged direction.
FIG. 38B is a bottom perspective view of the device shown in FIGS. 36A-36B, where the machine attachment of the device is shown in the wide profile direction or the enlarged direction.
FIG. 39A is a top plan view of the apparatus shown in FIGS. 38A-38B.
FIG. 39B is a side view of the apparatus shown in FIGS. 38A-38B.
FIG. 39C is a bottom plan view of the apparatus shown in FIGS. 38A-38B.
FIG. 40A is a side view sequentially showing the device of FIGS. 36A-39C deployed in a blood vessel having a lumen.
FIG. 40B is a side view sequentially illustrating the device of FIGS. 36A-39C deployed in a blood vessel having a lumen.
FIG. 40C is a side view sequentially showing the device of FIGS. 36A-39C deployed in a blood vessel having a lumen.
FIG. 41A is a perspective view of a delivery device constructed according to another embodiment of the present invention, wherein the device has a retainer shown in a first position to hold an anastomotic component.
FIG. 41B is a perspective view of the apparatus shown in FIG. 41A, sequentially illustrating a retainer that moves to release components.
FIG. 41C is a perspective view of the apparatus shown in FIG. 41A, sequentially illustrating a retainer that moves to release components.
FIG. 42A is a perspective view of a delivery device having a retainer shown in a first position to retain an anastomotic component constructed in accordance with yet another embodiment of the present invention.
FIG. 42B is a perspective view of the apparatus shown in FIG. 42A, sequentially illustrating a retainer that moves to release a component.
FIG. 42C is a perspective view of the apparatus shown in FIG. 42A sequentially illustrating a retainer that moves to release a component.
43A is a partial cross-sectional view of the device shown in FIGS. 42A-42C sequentially illustrating the device used to couple the anastomotic component to the blood vessel.
FIG. 43B is a partial cross-sectional view of the device shown in FIGS. 42A-42C sequentially illustrating the device used to couple the anastomotic component to the blood vessel.
FIG. 43C is a partial cross-sectional view showing the anastomosis component in the final position.
FIG. 44 is a perspective view sequentially illustrating a flexible magnetic component constructed in accordance with an embodiment of the present invention that has been crushed.
FIG. 45A is a perspective view illustrating a flexible magnetic component constructed in accordance with an embodiment of the present invention in an enlarged direction.
FIG. 45B is a perspective view illustrating a flexible magnetic component constructed in accordance with an embodiment of the present invention in a collapse direction.
FIG. 46A illustrates an alternative flexible magnetic component constructed in accordance with a further embodiment of the present invention.
FIG. 46B shows an alternative flexible magnetic component constructed in accordance with a further embodiment of the present invention.
FIG. 46C is a component adapted to substantially or completely close an opening of tissue or another component, constructed according to yet another embodiment of the present invention. It is a perspective view of the flexible component which has this.
46D is a perspective view of an alternative flexible magnetic component having an opening for placement in communication with the lumen of a blood vessel and having a configuration similar to that of the component of FIG. 46C.
FIG. 46E schematically illustrates and illustrates the delivery of the components shown in FIG. 46D in a low profile manner by a catheter or sheath.
FIG. 47A is a perspective view of a device constructed in accordance with another embodiment of the present invention for closing a tissue opening in a restrained position for delivery.
FIG. 47B is a perspective view showing a device constructed in accordance with another embodiment of the present invention for closing a tissue opening in a partially deployed position.
FIG. 47C shows a fragmented side view of the device shown in FIGS. 47A-47B, fully deployed.
FIG. 48A is a side view sequentially illustrating the apparatus of FIGS. 47A-47C used to close a ventricular septal defect.
FIG. 48B is a side view sequentially illustrating the device of FIGS. 47A-47C used to close a ventricular septal defect.
FIG. 48C is a side view sequentially illustrating the apparatus of FIGS. 47A-47C used to close a ventricular septal defect.
FIG. 49A is an exploded perspective view of a magnetic anastomosis component constructed in accordance with an embodiment of the present invention.
FIG. 49B is an assembled perspective view of a magnetic anastomosis component constructed in accordance with an embodiment of the present invention.
FIG. 49C is a cross-sectional view taken along line CC in FIG. 49B.
FIG. 50A is an exploded perspective view of a magnetic anastomosis component constructed in accordance with another embodiment of the present invention.
FIG. 50B is an assembled perspective view of a magnetic anastomosis component constructed in accordance with another embodiment of the present invention.
FIG. 51A is an exploded perspective view of a magnetic anastomosis component constructed in accordance with yet another embodiment of the present invention.
FIG. 51B is a collective perspective view of a magnetic anastomosis component constructed in accordance with yet another embodiment of the present invention.
FIG. 52A is a perspective view sequentially illustrating the formation of a magnetic anastomosis component constructed in accordance with yet another embodiment of the present invention.
FIG. 52B is a perspective view sequentially illustrating the formation of a magnetic anastomosis component constructed in accordance with yet another embodiment of the present invention.
FIG. 52C is a perspective view sequentially illustrating the formation of a magnetic anastomosis component constructed in accordance with yet another embodiment of the present invention.
FIG. 53A is a perspective view of a magnetic anastomosis component including an attachment constructed in accordance with an embodiment of the present invention.
FIG. 53B is a perspective view of the magnetic anastomosis component shown in FIG. 53A with an attachment coupled to a blood vessel.
FIG. 53C is a perspective view of the magnetic anastomosis component shown in FIG. 53A having an attachment coupled to a blood vessel in an alternative manner.
FIG. 54A is a perspective view of a magnetic anastomosis component including an attachment constructed in accordance with another embodiment of the present invention.
FIG. 54B is a perspective view of a magnetic anastomosis component including an attachment constructed in accordance with another embodiment of the present invention.
FIG. 54C is a perspective view of a magnetic anastomosis component including an attachment constructed in accordance with another embodiment of the present invention.
FIG. 54D is a perspective view of a magnetic anastomosis component including an attachment constructed in accordance with another embodiment of the present invention.
54E is a perspective view of the magnetic anastomosis component illustrated in FIGS. 54A-54D secured to a blood vessel. FIG.
54F is a perspective view showing the magnetic anastomosis component illustrated in FIGS. 54A-54D secured to a blood vessel. FIG.
FIG. 55A is an exploded perspective view of a magnetic anastomosis component constructed in accordance with an embodiment of the present invention.
FIG. 55B is an assembled perspective view of a magnetic anastomosis component constructed in accordance with an embodiment of the present invention.
FIG. 55C is a cross-sectional view taken along line CC in FIG. 49B.
56A is a perspective view of the anastomosis component illustrated in FIG. 5B that is magnetically secured to a blood vessel.
56B is a perspective view of the anastomosis component illustrated in FIG. 5B that is magnetically secured to a blood vessel.
FIG. 57A is a perspective view of the anastomosis component illustrated in FIG. 5C that is magnetically secured to a blood vessel.
FIG. 57B is a perspective view of the anastomosis component illustrated in FIG. 5C that is magnetically secured to the blood vessel.
FIG. 58A is a perspective view showing an anastomotic component constructed in accordance with another embodiment of the present invention that is magnetically and mechanically secured to a blood vessel.
FIG. 58B is a cross-sectional view sequentially illustrating an anastomotic component constructed according to another embodiment of the present invention that is magnetically and mechanically secured to a blood vessel.
FIG. 58C is a cross-sectional view sequentially illustrating an anastomotic component constructed according to another embodiment of the present invention that is magnetically and mechanically secured to a blood vessel.
FIG. 59A is a cross-sectional view illustrating an anastomotic component constructed according to another embodiment of the present invention that is mechanically secured to a blood vessel.
FIG. 59B is a perspective view sequentially illustrating an anastomosis component constructed according to another embodiment of the present invention that is mechanically secured to a blood vessel.
FIG. 60A is a cross-sectional view illustrating an anastomotic component constructed according to another embodiment of the present invention that is mechanically secured to a blood vessel.
FIG. 60B is a perspective view showing an anastomosis component constructed in accordance with another embodiment of the present invention that is mechanically secured to a blood vessel.
FIG. 60C is a plan view of the anastomosis component shown in FIG. 60B secured to a blood vessel.
FIG. 61A is a perspective view sequentially illustrating an anastomotic component constructed according to another embodiment of the present invention that is mechanically secured to a blood vessel.
FIG. 61B is a perspective view sequentially illustrating an anastomotic component constructed in accordance with another embodiment of the present invention that is mechanically secured to a blood vessel.
FIG. 61C is a perspective view sequentially illustrating an anastomotic component constructed according to another embodiment of the present invention that is mechanically secured to a blood vessel.
62A is a perspective view sequentially illustrating an anastomotic component constructed in accordance with yet another embodiment of the present invention that is mechanically secured to a blood vessel. FIG.
FIG. 62B is a perspective view sequentially illustrating an anastomotic component constructed according to yet another embodiment of the present invention that is mechanically secured to a blood vessel.
FIG. 62C is a perspective view sequentially illustrating an anastomotic component constructed according to yet another embodiment of the present invention that is mechanically secured to a blood vessel.
FIG. 63A is a side view showing a magnetic anastomosis component constructed in accordance with another embodiment of the present invention in a constrained configuration.
FIG. 63B is a side view showing a magnetic anastomosis component constructed in accordance with another embodiment of the present invention in an unrestrained configuration.
63C is a perspective view of the magnetic anastomosis component illustrated in FIGS. 63A-63B secured to a hollow body. FIG.
63D is a perspective view of the magnetic anastomosis component illustrated in FIGS. 63A-63B secured to a hollow body. FIG.
FIG. 64A is a plan view of a magnetic anastomosis component constructed in accordance with another embodiment of the present invention that is mechanically secured to a blood vessel.
64B is a cross-sectional view taken along line BB of FIG. 64A.
FIG. 65A is a plan view of a magnetic anastomosis component constructed in accordance with yet another embodiment of the present invention that is mechanically secured to a blood vessel.
65B is a cross-sectional view taken along line BB of FIG. 65A.
66A is a perspective view sequentially illustrating a delivery device used to be mechanically secured to a blood vessel with a magnetic anastomosis component constructed in accordance with another embodiment of the present invention. FIG.
FIG. 66B is a perspective view sequentially illustrating a delivery device used to be mechanically secured to a blood vessel with a magnetic anastomosis component constructed in accordance with another embodiment of the present invention.
66C is a perspective view sequentially illustrating a delivery device used to be mechanically secured to a blood vessel with a magnetic anastomosis component constructed in accordance with another embodiment of the present invention. FIG.
FIG. 67A is a side view of a magnetic anastomosis component constructed in accordance with another embodiment of the present invention.
67B is a cross-sectional view of the components illustrated in FIG. 67A secured to the end wall of a blood vessel.
67C is a cross-sectional view of the components illustrated in FIG. 67A secured to the side wall of a blood vessel.
68A is a cross-sectional view illustrating a magnetic anastomosis component constructed in accordance with an alternative embodiment of the present invention that is adhered and secured to a blood vessel. FIG.
FIG. 68B is a cross-sectional view showing a magnetic anastomosis component constructed in accordance with an alternative embodiment of the present invention that is adhered and secured to a blood vessel.
FIG. 69A is a perspective view sequentially illustrating a magnetic anastomosis component constructed in accordance with another embodiment of the present invention that is adhesively secured to a blood vessel.
FIG. 69B is a perspective view sequentially illustrating a magnetic anastomosis component constructed in accordance with another embodiment of the present invention that is adhered and secured to a blood vessel.
FIG. 70 is a perspective view of a blood vessel of a magnetic anastomosis component constructed in accordance with yet another embodiment of the present invention.
FIG. 71A shows an internal magnet used to align external magnets.
FIG. 71B shows an internal magnet used to align external magnets.
FIG. 71C shows an internal magnet used to align the external magnet.
FIG. 71D shows an inner magnet used to align the outer magnet.
72A is a perspective view sequentially illustrating a magnetic anastomosis component constructed in accordance with another embodiment of the present invention that is adhesively secured to the end of a blood vessel. FIG.
72B is a perspective view sequentially illustrating a magnetic anastomosis component constructed in accordance with another embodiment of the present invention that is adhesively secured to the end of a blood vessel. FIG.
72C is a perspective view sequentially illustrating a magnetic anastomosis component constructed in accordance with another embodiment of the present invention that is adhesively secured to the end of a blood vessel. FIG.
72D is a perspective view sequentially illustrating a magnetic anastomosis component constructed in accordance with another embodiment of the present invention that is adhesively secured to the end of a blood vessel. FIG.
FIG. 72E is a perspective view sequentially illustrating a magnetic anastomosis component constructed in accordance with another embodiment of the present invention that is adhesively secured to the end of a blood vessel.
FIG. 72F is a perspective view sequentially illustrating a magnetic anastomosis component constructed in accordance with another embodiment of the present invention that is adhesively secured to the end of a blood vessel.
FIG. 73A is a cross-sectional view sequentially illustrating a magnetic anastomosis, adhesively secured to a blood vessel wall, according to another embodiment of the present invention.
FIG. 73B is a cross-sectional view sequentially illustrating a magnetic anastomosis, adhered and secured to the vessel wall, according to another embodiment of the present invention.
FIG. 73C is a cross-sectional view sequentially illustrating a magnetic anastomosis adhered and secured to the vessel wall according to another embodiment of the present invention.
FIG. 73D is a cross-sectional view sequentially illustrating a magnetic anastomosis, adhered and secured to the vessel wall, according to another embodiment of the present invention.
FIG. 74A is a cross-sectional view sequentially illustrating a magnetic anastomosis adhered and secured to a blood vessel wall according to yet another embodiment of the present invention.
FIG. 74B is a cross-sectional view sequentially illustrating a magnetic anastomosis that is adhered and secured to a vessel wall according to yet another embodiment of the present invention.
FIG. 74C is a cross-sectional view sequentially illustrating a magnetic anastomosis that is adhered and secured to a vessel wall according to yet another embodiment of the present invention.
FIG. 74D is a cross-sectional view sequentially illustrating a magnetic anastomosis that is adhesively secured to the vessel wall according to yet another embodiment of the present invention.
FIG. 75A is a sequential cross-sectional view showing a magnetic anastomosis secured to a vessel wall according to an embodiment of the present invention.
FIG. 75B is a sequential cross-sectional view illustrating a magnetic anastomosis secured to a vessel wall in accordance with an embodiment of the present invention.
FIG. 75C is a sequential cross-sectional view showing a magnetic anastomosis secured to a vessel wall in accordance with an embodiment of the present invention.
FIG. 75D is a sequential cross-sectional view showing a magnetic anastomosis secured to a vessel wall in accordance with an embodiment of the present invention.
FIG. 76A is a sequential plan view corresponding to FIG. 75A.
FIG. 76B is a sequential plan view corresponding to FIG. 75B.
FIG. 76C is a sequential plan view corresponding to FIG. 75C.
FIG. 76D is a sequential plan view corresponding to FIG. 75D.
77 is a perspective view corresponding to FIGS. 75D and 76D. FIG.
FIG. 78A is a cross-sectional view sequentially illustrating the creation of a side-to-side anastomosis using magnetism according to another embodiment of the present invention.
FIG. 78B is a cross-sectional view sequentially illustrating the creation of a side-to-side anastomosis using magnetism according to another embodiment of the present invention.
FIG. 78C is a cross-sectional view sequentially illustrating the creation of a side-to-side anastomosis using magnetism according to another embodiment of the present invention.
FIG. 79A is a perspective view of two blood vessels each provided with an anastomotic component.
FIG. 79B is a cross-sectional view showing two blood vessels joined by a side-to-side anastomosis.
79C is a cross-sectional view of the anastomosis shown in FIG. 79B illustrating one of the components separated from the associated blood vessel.
FIG. 80A is a cross-sectional view illustrating a device constructed in accordance with an embodiment of the present invention used to check the seal at the junction between an anastomotic component and a blood vessel.
FIG. 80B is a cross-sectional view illustrating a device constructed in accordance with an embodiment of the present invention that is used to check the seal at the junction between the anastomotic component and the blood vessel.
FIG. 80C is a cross-sectional view illustrating a device constructed in accordance with an embodiment of the present invention used to check the seal at the junction between the anastomotic component and the blood vessel.
FIG. 81A is a cross-sectional view illustrating a device constructed in accordance with another embodiment of the present invention used to check the seal at the junction between an anastomosis component and a blood vessel.
FIG. 81B is a cross-sectional view illustrating a device constructed in accordance with another embodiment of the present invention used to check the seal at the junction between the anastomotic component and the blood vessel.
FIG. 81C is a cross-sectional view illustrating a device constructed in accordance with another embodiment of the present invention used to check the seal at the junction between the anastomotic component and the blood vessel.
FIG. 81D is a cross-sectional view of the device illustrated in FIGS. 81A-81C.
FIG. 81E is a cross-sectional view of the device illustrated in FIGS. 81A-81C.
FIG. 81F is a cross-sectional view of the device illustrated in FIGS. 81A-81C.
FIG. 82A is a cross-sectional view illustrating a device constructed in accordance with yet another embodiment of the present invention used to check the seal at the junction between the anastomotic component and the blood vessel.
FIG. 82B is a cross-sectional view illustrating a device constructed in accordance with yet another embodiment of the present invention used to check the seal at the junction between the anastomotic component and the blood vessel.
FIG. 82C is a cross-sectional view illustrating a device constructed in accordance with yet another embodiment of the present invention used to check the seal at the junction between the anastomotic component and the blood vessel.
FIG. 83A is a top view of a device constructed in accordance with an embodiment of the present invention to confirm proper orientation of a magnetic anastomosis component shown to be correctly mounted on a delivery device. .
FIG. 83B is a side view of a device constructed in accordance with an embodiment of the present invention to confirm proper orientation of the magnetic anastomosis component, shown to be correctly mounted on the delivery device. is there.
FIG. 84A is a front view of the device shown in FIGS. 83A-83B showing a magnetic anastomosis component incorrectly mounted on the delivery device.
FIG. 84B is a side view of the device shown in FIGS. 83A-83B showing a magnetic anastomosis component incorrectly mounted on the delivery device.
FIG. 85A is a cross-sectional view of a magnetic anastomosis component constructed in accordance with another embodiment of the present invention attached at an angle to a blood vessel.
FIG. 85B is a cross-sectional view of the anastomosis formed between the blood vessel and the magnetic anastomosis component of FIG. 85A and the second component secured to the second blood vessel.
FIG. 86A is a perspective view of a bipolar magnetic anastomosis component constructed in accordance with an embodiment of the present invention.
FIG. 86B is a perspective view of a bipolar magnetic anastomosis component constructed in accordance with another embodiment of the present invention.

Claims (51)

A method of securing a magnetic anastomosis component to a hollow body, the method comprising:
Providing the anastomotic component, which can generate or be attracted by a magnetic field, the anastomotic component having an opening adapted to be placed in communication with the lumen of the hollow body Having a process;
Placing a deployment member in a first configuration within a hollow body lumen at a selected location, wherein the deployment member can generate or be attracted by a magnetic field; ,
Using a magnetic attraction between the anastomosis component and the placement member to place the component at a selected location;
Fixing the anastomotic component to the hollow body;
Changing the placement member from the first configuration to a second configuration;
Removing the placement member from the lumen of the hollow body;
Including the method. The method of claim 1, wherein the hollow body is a blood vessel and an adhesive is used to secure the component to the wall of the hollow body. The method of claim 2, wherein the adhesive is used to secure the component to an end of the hollow body. The method of claim 1, wherein the first configuration is expanded and the second configuration is reduced. The method of claim 4, wherein the first configuration is inflated with a fluid. The method of claim 5, wherein the first configuration is expanded by a magnetic field. The method of claim 1, wherein the first configuration corresponds to a first direction and the second configuration corresponds to a second direction in which the placement member moves from the first direction. . The method of claim 1, wherein the hollow body is a blood vessel and the placement member comprises a catheter. A method of securing a magnetic anastomosis component to a blood vessel having a lumen, the method comprising:
Placing the anastomotic component having an opening adjacent to a blood vessel having a lumen, wherein the anastomotic component can generate or be attracted by a magnetic field;
Providing a plurality of individual attachment members each configured to be engaged with the anastomosis component;
Securing the anastomotic component to the blood vessel by using the individual attachment member;
Including the method. The method of claim 9, wherein the attachment member is deformed to secure the component to a hollow body. The method of claim 10, wherein the attachment member is superelastic and returns to an undeflected state to attach the component and the blood vessel. The method of claim 9, wherein the attachment member cooperates with a junction recess in the anastomotic component to provide a substantially flat surface for coupling to another anastomotic component. The method of claim 9, wherein the attachment member comprises a separate hook-type element. The method of claim 9, wherein the attachment members are applied simultaneously. A method of adhering and fixing a magnetic anastomosis component to an end of a hollow body having a lumen, the method comprising:
Providing the anastomotic component, which can generate or be attracted by a magnetic field, the anastomotic component having an opening adapted to be placed in communication with the lumen of the hollow body Having a process;
Applying an adhesive to at least one of the anastomotic component and a hollow body adjacent an end of the hollow body;
Securing the anastomotic component to the hollow body adjacent to the end of the hollow body using the adhesive;
Including the method. The method of claim 15, wherein the adhesive is applied to the anastomotic component. A first portion of the adhesive is applied to the anastomosis component, a second portion of the adhesive is applied to the hollow body, and the first portion and the second portion are connected to the component. 16. The method of claim 15, wherein the method is mixed to bond with a blood vessel. A method of securing a magnetic anastomosis component to an end of a hollow body having a lumen, the method comprising:
Providing the anastomotic component comprising a first portion and a second portion, wherein at least one of the first portion and the second portion can generate or be attracted by a magnetic field. Obtaining a process;
Placing the first portion of the anastomotic component within the lumen of the hollow body;
Positioning the second portion of the anastomotic component at least partially around the exterior of the hollow body;
Allowing the first portion and the second portion to compress the tissue of the hollow body to secure the anastomotic component to the hollow body;
Including the method. A second portion of the anastomotic component is at least partially elastic to compress the tissue. The method of claim 18. The method of claim 18, wherein the hollow body is a blood vessel. A method for inspecting a seal between an anastomotic component and a blood vessel to which the anastomotic component is secured, the method comprising:
Providing the anastomotic component that can generate or be attracted by a magnetic field, wherein the anastomotic component has an opening;
Attaching the anastomotic component to the blood vessel having the lumen so as to place the opening of the anastomotic component in fluid communication with the lumen of the blood vessel;
Using a cover to block the opening of the anastomotic component, wherein the cover may generate or be attracted by a magnetic field;
Using magnetic attraction to maintain a seal between the cover and the anastomotic component and prevent blood from flowing through the opening of the anastomotic component, any blood leaking Can result from a leak in the attachment between the anastomotic component and the hollow body; and
Including the method. The method of claim 21, wherein the cover is movable from a first configuration to a second configuration for removal from the anastomotic component. 23. The method of claim 22, wherein the cover is inflatable and is inflated for removal from the anastomotic component. The method of claim 21, wherein the cover is reversible for use on anastomotic components having different magnetic polarities. A method for confirming the proper orientation of a magnetic anastomosis component, the method comprising:
Providing a delivery device that supports at least one of the anastomotic components having an opening, the anastomotic components being capable of generating a magnetic field;
Providing an attachment that includes at least a portion that is magnetized in response to a selected polarity and is movable to a position adjacent to the anastomotic component;
Using the fitting to determine whether the anastomosis component is properly oriented on the delivery device;
Including the method. The delivery device that supports the anastomosis component is disposed on the fixture, and the anastomosis component is moved over the delivery device by a magnetized portion of the fixture when facing the wrong direction. 26. The method of claim 25. 26. The method of claim 25, wherein the fixture is used to confirm the orientation of more than one anastomotic component. 28. The method of claim 27, wherein the delivery device supports two anastomotic components that are magnetically attracted to each other. 30. The method of claim 28, wherein the fixture has a plurality of magnetized portions. 26. The method of claim 25, wherein the fitting and delivery device have a complementary configuration in which the delivery device can be placed on or removed from the fitting independent of the anastomotic component. Magnetic anastomosis component
A first portion having an opening that is adapted to be placed in communication with the lumen of the hollow body when the component is attached;
A second portion including an extensible tubular body attached to the first portion and configured to be attached to an end of the hollow body;
The first part and the second part are arranged substantially transverse to each other, and at least one of the first part and the second part can generate or be attracted by a magnetic field. obtain,
Magnetic anastomosis component. 32. The component of claim 31, wherein the first portion and the second portion are disposed substantially perpendicular to each other. 32. The component of claim 31, wherein the first portion is substantially flat and is located at an end of the second portion. 34. The component of claim 33, wherein the tubular body of the second portion is superelastic, constrained to a first configuration, and released to assume a second configuration. 35. The component of claim 34, wherein the tubular body comprises a stent. 32. The component of claim 31, wherein at least one of the first portion and the second portion has an opening that promotes tissue ingrowth and allows the portion to stretch. 32. The component of claim 31, wherein the second portion is configured to be secured to a synthetic vessel and a natural vessel. 32. The component of claim 31, wherein the first portion and the second portion are individual elements that are secured together by individual mounting structures. 40. The component of claim 38, wherein the mounting structure includes engagement protrusions and recesses in the first portion and the second portion. 40. The component of claim 38, wherein the mounting structure includes at least one aperture and a joint extension in the first portion and the second portion. 40. The component of claim 38, wherein the mounting structure includes a thermal energy bond between the first portion and the second portion. 42. The component of claim 41, wherein the tubular portion defines an annular space configured to receive an end of the hollow body to secure the component to the hollow body. 43. The component of claim 42, wherein the tubular portion is radially contractible to compress an end of the hollow body. 42. The component of claim 41, wherein the first portion is a permanent magnet and the second portion is ferromagnetic. A magnetic anastomosis component secured to a hollow body having a lumen comprising:
An annular body defining an opening;
A plurality of individual attachment members that can be selectively engaged with the annular body to secure the annular body to the hollow body;
Including
At least one of the annular body and the plurality of attachment members may generate or be attracted to the magnetic field;
Magnetic anastomosis component. 46. The component of claim 45, wherein the annular body is a permanent magnet and the mounting member is superelastic. 46. The component of claim 45, wherein the annulus has a portion configured to engage the attachment member and lock the structure together, while providing a flat coupling surface. An apparatus for inspecting a seal between an anastomotic component and a hollow body to which the component is secured, the apparatus comprising:
An extensible structure comprising a substantially fluid impermeable surface;
A material that can generate or be attracted by a magnetic field;
Including
The extensible structure may be disposed across the component such that the fluid impermeable surface is magnetically attracted to a magnetic anastomosis component or a ferromagnetic anastomosis component that secures the hollow body, thereby blocking the flow. A device wherein the stretchable structure is stretched to break the magnetic attraction between the material and the component. 49. The device of claim 48, wherein the stretchable structure is a balloon that expands to separate the fluid impermeable surface from the anastomotic component. 50. The apparatus of claim 49, wherein the material is a permanent magnet disposed within the balloon. 49. The material is a permanent magnet with two polarities disposed adjacent to two fluid-impermeable surfaces to allow use of the device with anastomotic components having different magnetic polarities. The device described in 1.

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