US20030195535A1 - Medical grafting methods & apparatus - Google Patents

Abstract

Methods and apparatus for making an anastomotic connection between a first conduit and a second conduit. A connector structure having a first end portion and a second end portion is positioned about a balloon catheter, which when pressurized, expands to a significant extent at the distal end thereof. The balloon enlarges the connector structure when positioned at the distal end portion of the balloon to create the anastomosis, and at the same time reduces the axial length of the connector, thereby compressing the first conduit to the second conduit, creating a hemodynamic seal and a firm attachment of the two conduits. After enlargement, the connector structure remains in place and adds structure to the anastomosis. During introduction, the second end portion of the connector is covered by a nosecone assembly to prevent trauma to the second conduit while the apparatus is being introduced. The nosecone assembly has a flexible structure which may change configuration to expose the second set of members after insertion into the second conduit and to allow removal of the nosecone after deployment.

Description

• This application is a division of U.S. patent application Ser. No. 09/693,578, filed Oct. 20, 2000, which is a nonprovisional of U.S. provisional patent application No. 60/168,200, filed Nov. 30, 1999. All of these prior applications are hereby incorporated by reference herein in their entireties.[0001]
BACKGROUND OF THE INVENTION
• This invention relates to medical apparatus, and more particularly to apparatus for use in making anastomotic connections between tubular body fluid conduits in a patient.[0002]
• There are many medical procedures in which it is necessary to make an anastomotic connection between two tubular body fluid conduits in a patient. An anastomotic connection (or anastomosis) is a connection which allows body fluid flow between the lumen of the two conduits that are connected, preferably without allowing body fluid to leak out of the conduits at the location of the connection. As just one example of a procedure in which an anastomosis is needed, in order to bypass an obstruction in a patient's coronary artery, a tubular graft supplied with aortic blood may be connected via an anastomosis to the coronary artery downstream from the obstruction. The anastomosis may be between the end of the graft and an aperture in the side wall of the coronary artery (a so-called end-to-side anastomosis), or the anastomosis may be between an aperture in the side wall of the graft and an aperture in the side wall of the coronary artery (a so-called side-to-side anastomosis (e.g., as in published Patent Cooperation Treaty (“PCT”) patent application WO 98/16161, which is hereby incorporated by reference herein in its entirety)). The graft may be natural conduit, artificial conduit, or a combination of natural and artificial conduits. If natural conduit is used, it may be wholly or partly relocated from elsewhere in the patient (e.g., wholly relocated saphenous vein or partly relocated internal mammary artery). Alternatively, no relocation of the graft may be needed (e.g., as in above-mentioned application WO 98/16161 in which a length of vein on the heart becomes a “graft” around an obstruction in an immediately adjacent coronary artery). More than one anastomosis may be needed. For example, a second anastomosis may be needed between an upstream portion of the graft conduit and the aorta or the coronary artery upstream from the obstruction in that artery. Again, this second anastomosis may be either an end-to-side anastomosis or (as shown, for example, in above-mentioned application WO 98/16161) a side-to-side anastomosis. Alternatively, no second, upstream anastomosis may be required at all (e.g., if the graft is an only-partly-relocated internal mammary artery).[0003]
• The currently most common technique for making an anastomosis is to manually suture the two tubular body fluid conduits together around an opening between them. Manual suturing is difficult and time-consuming, and the quality of the anastomosis that results is highly dependent on the skill of the person doing the suturing. In the case of coronary artery bypass procedures, one source of difficulty for suturing of an anastomosis may be motion of the heart. There is also increasing interest in procedures which are less invasive or even minimally invasive. Such procedures have potentially important advantages for patients, but they may increase the difficulty of performing manual suturing of an anastomosis by reducing or limiting access to the site within the patient at which the anastomosis must be made. Various examples of such less invasive or minimally invasive procedures are shown in above-mentioned application WO 98/16161, Goldsteen et al. U.S. Pat. No. 5,976,178, Sullivan et al. U.S. Pat. No. 6,120,432, Sullivan et al. published PCT patent application WO 98/55027, and Berg et al. U.S. Pat. No. 6,475,222, all of which are hereby incorporated by reference herein in their entireties.[0004]
• In the case of making a conventional end-to-side anastomosis between a vein graft and the coronary artery, there are additional difficulties which may arise. First, the relative sizes of the coronary artery and the vein graft are different. For example, the coronary artery may typically have an inner diameter of about 1.0 to 3.0 mm, whereas a vein graft, such as the saphenous vein, may typically have an inner diameter of about 4 to 8 mm. This discrepancy between vessel diameters, i.e., a “caliber mismatch,” may present a challenge to the physician to match the end of the relatively larger vein graft to an aperture in the side wall of the relatively smaller coronary artery. The resulting quality and amount of flow between the vein graft and the coronary artery, along with the provision of an effective hemodynamic seal between the two conduits, is often dependent upon the physician's skill in making an effective junction between the two conduits.[0005]
• Second, conventional end-to-side anastomosis typically joins the graft conduit to the coronary artery at an angle with respect to the lumen of the coronary artery, thus forming a junction at the wall of the coronary artery. Further away from this junction, the vein graft tends to lie against the heart structure, or substantially parallel to the lumen of the coronary artery. The transition of the vein graft from a substantially perpendicular juncture to the coronary artery to a substantially parallel position with respect to the coronary artery wall often occurs abruptly, which may result in kinking of the vein graft, with possibly reduced blood flow.[0006]
• Third, joining vessels having relatively small diameters (e.g., 1-4 mm) presents the additional consideration of keeping the vessels open after the anastomosis has been made. It is therefore helpful to provide the anastomosis with a diameter equal to or larger than the diameter of the smaller vessel being joined. The larger anastomosis is performed in order to minimize the risk of closing off the flow due to the natural healing response. However, it is a challenge to provide a delivery system which is compatible with the dimensions of the anastomosis.[0007]
• In view of the foregoing, it is an object of this invention to provide apparatus that can be used to make anastomotic connections in lieu of manual suturing.[0008]
• It is another object of the invention to provide apparatus that can be used to make anastomotic connections even though access to the site of the anastomosis may be limited or even only indirect or remote.[0009]
• It is still another object of the invention to provide apparatus that can be used to make anastomotic connections without the need for a high degree of manual suturing skill.[0010]
• It is yet another object of the invention to provide apparatus for making anastomotic connections that is less adversely affected than manual suturing by adjacent or nearby body motion (e.g., motion of the patient's heart).[0011]
• It is a further object of this invention to provide apparatus for facilitating the making of higher quality anastomotic connections more rapidly and with more consistent results than is possible with prior art methods and apparatus such as manual suturing.[0012]
• It is another object of the invention to provide apparatus for making a high quality anastomotic connection when joining two conduits having different relative diameters.[0013]
• It is another object of the invention to provide apparatus for making a high quality anastomotic connection when joining two conduits having relatively small diameters.[0014]
• It is another object of the invention to provide apparatus for making high quality anastomosis which allows the conduits to be positioned in a substantially flat configuration with respect to one another and which prevents kinking of the conduits.[0015]
SUMMARY OF THE INVENTION
• An apparatus including a connector is provided to create an anastomosis between two conduits. A particular application of this invention is to join a saphenous vein graft (SVG) to a coronary artery in a side-to-side anastomosis. The connector structure has a first set of members that are used to secure the first conduit, typically the SVG, and a second set of members that engage the second conduit, typically the coronary artery.[0016]
• The connector structure is mounted on a balloon catheter, which when pressurized, expands to a significant extent at the distal end thereof. The balloon enlarges the connector structure when positioned at the distal end portion of the balloon to create the anastomosis, and at the same time reduces the axial length of the connector, thereby compressing the first conduit to the second conduit, creating a hemodynamic seal and a firm attachment of the two conduits. After enlargement, the connector structure remains in place and adds structure to the anastomosis.[0017]
• The second set of members is covered by a nosecone assembly to prevent trauma to the second conduit while the apparatus is being introduced. The nosecone assembly has a flexible structure which may change configuration to expose the second set of members after insertion into the second conduit and to allow removal of the nosecone after deployment.[0018]
• The method for creating the anastomosis may comprise providing a connector and a delivery apparatus including an expansion balloon and a nosecone assembly. A next step may include making an aperture in the wall of the first conduit proximal to the distal end of the first conduit. The first conduit is then attached to the connector structure. More particularly, the first set of members of the connector structure may then pierce the wall of the first conduit. A locating ring, which may be colored with titanium dioxide, is placed about the first conduit adjacent the first set of members to provide an indication to the physician during delivery.[0019]
• At the operative site, a second aperture is made in the second conduit wall. According to one embodiment, the second conduit may be cut and then dilated. The delivery system and the connector is introduced into the aperture in the second conduit. More particularly, the nosecone, in an introduction configuration, is inserted into the second conduit substantially axially to the lumen of the second conduit. The locating ring provides an indication that the first aperture in the first conduit is positioned adjacent the second aperture in the second conduit. The locating ring may provide a visual indication or a tactile indication when the locating ring is in contact with the wall of the second conduit.[0020]
• The nosecone may then be changed to the removal configuration to uncover the second set of members. In an embodiment, the nosecone is a balloon structure which is inflated to uncover the second set of members. The nosecone assembly may be flexible, such that further advancement of the nosecone allows the nosecone to be positioned substantially parallel to the lumen of the second conduit. The delivery system may then be turned from a substantially axial position to a position at 90 degrees with respect to the lumen and the wall of the second conduit.[0021]
• The balloon catheter is designed to allow significant expansion at its distal end portion. The connector, which has been positioned adjacent this distal end portion, may then be enlarged by expanding the balloon to make the anastomosis between the first and second conduits. More particularly, the connector structure enlarges radially and may shorten axially to approximate the first and second set of members of the connector, and thereby approximate the tissue of the first and second conduits to provide a seal, which is hemodynamic and has sufficient mechanical integrity and strength to provide durability. Once the connector structure is enlarged, the balloon and/or nosecone is deflated, and the delivery system may be removed and the first conduit may be ligated distal to the anastomosis without compromising the first conduit lumen.[0022]
BRIEF DESCRIPTION OF THE DRAWINGS
• FIG. 1 is a simplified sectional view of the apparatus and a first conduit in accordance with the invention.[0023]
• FIG. 2 is a planarized projection of a component apparatus of FIG. 1 in accordance with the invention.[0024]
• FIG. 3 is a perspective view of the component apparatus of FIG. 2 in accordance with the invention.[0025]
• FIG. 4 is a planarized projection of the component apparatus of FIG. 2 in another configuration in accordance with the invention.[0026]
• FIG. 5 is a perspective view similar to FIG. 3 of the component apparatus of FIG. 2 in another configuration in accordance with the invention.[0027]
• FIG. 6 is a planarized projection of another embodiment of the component of FIG. 2 in accordance with the invention.[0028]
• FIG. 7 is a sectional view of the component of FIG. 6 in another configuration in accordance with the invention.[0029]
• FIG. 8 is a sectional view of another component apparatus of FIG. 1 in accordance with the invention.[0030]
• FIG. 9 is a sectional view of a prior art apparatus.[0031]
• FIG. 10 is a simplified view of the component apparatus of FIGS.[0032]2-5 and the component apparatus of FIG. 8 in accordance with the invention.
• FIG. 11 is a sectional view taken along line[0033]11-11 of FIG. 10 in accordance with the invention.
• FIG. 12 is a sectional view of the component apparatus shown in FIG. 8 and the component apparatus of FIGS.[0034]2-5 in another configuration in accordance with the invention.
• FIG. 13 is a sectional view of a component apparatus of FIG. 1 in a first condition in accordance with the invention.[0035]
• FIG. 14 is a sectional view of the component apparatus of FIG. 13 in a second condition in accordance with the invention.[0036]
• FIG. 15 is perspective view of additional apparatus in accordance with the invention.[0037]
• FIG. 16 is a sectional view of the apparatus of FIG. 15, illustrated with the first conduit, in accordance with the invention.[0038]
• FIG. 17 is a sectional view similar to FIG. 16, illustrating the apparatus of FIG. 1 in an earlier stage of the procedure in accordance with the invention.[0039]
• FIG. 18 is a sectional view similar to FIG. 17, illustrating additional apparatus in accordance with the invention.[0040]
• FIG. 19 is an elevation view of a component apparatus of FIG. 1 in accordance with the invention.[0041]
• FIG. 20 is a side view of the component apparatus of FIG. 19, taken from[0042]direction20 of FIG. 19 in accordance with the invention.
• FIG. 21 is a view in partial section of the apparatus of FIG. 1 in an early stage of a procedure in accordance with the invention.[0043]
• FIG. 22 is a view similar to FIG. 21 illustrating a further stage of a procedure in accordance with the invention.[0044]
• FIG. 23 is a view similar to FIG. 22 illustrating a later stage of a procedure in accordance with the invention.[0045]
• FIG. 24 is a view similar to FIG. 23 illustrating a still later stage of a procedure in accordance with the invention.[0046]
• FIG. 25 is a view similar to FIG. 24 illustrating yet another stage of a procedure in accordance with the invention.[0047]
• FIG. 26 is a sectional view taken along lines[0048]26-26 of FIG. 25 in accordance with the invention.
• FIG. 27 is an elevational view in accordance with the invention.[0049]
• FIG. 28 is a sectional view similar to FIG. 21, illustrating another procedure in accordance with the invention.[0050]
• FIG. 29 is a sectional view similar to FIG. 21, illustrating yet another procedure in accordance with the invention.[0051]
• FIG. 30 is a sectional view similar to FIG. 1, illustrating another procedure in accordance with the invention.[0052]
• FIG. 31 is a perspective view of component apparatus similar to that illustrated in FIG. 18, according to another embodiment, in accordance with the invention.[0053]
• FIG. 32 is a perspective view of the component apparatus of FIG. 31 in another configuration, in accordance with the invention.[0054]
• FIG. 33 is a sectional view similar to FIG. 22, illustrating the component apparatus of FIGS.[0055]31-32 in an early stage of the procedure in accordance with the invention.
• FIG. 34 is a sectional view similar to FIG. 33, illustrating a later stage of the procedure in accordance with the invention.[0056]
• FIG. 35 is a sectional view similar to FIG. 34, illustrating a still later stage of the procedure in accordance with the invention.[0057]
• FIG. 36 is a sectional view of component apparatus similar to that illustrated in FIG. 18, according to another embodiment, in accordance with the invention.[0058]
• FIG. 37 is a perspective view of the component apparatus of FIG. 36 in another configuration, in accordance with the invention.[0059]
• FIG. 38 is a sectional view similar to FIG. 22, illustrating the component apparatus of FIGS.[0060]36-37 in an early stage of the procedure in accordance with the invention.
• FIG. 39 is a sectional view similar to FIG. 38, illustrating a later stage of the procedure in accordance with the invention.[0061]
• FIG. 40 is a sectional view of component apparatus similar to that illustrated in FIG. 18, according to still another embodiment, in accordance with the invention.[0062]
• FIG. 41 is a perspective view of the component apparatus of FIG. 40 in another configuration, in accordance with the invention.[0063]
• FIG. 42 is a sectional view similar to FIG. 22, illustrating the component apparatus of FIGS.[0064]40-41 in an early stage of the procedure in accordance with the invention.
• FIG. 43 is a sectional view similar to FIG. 42, illustrating a later stage of the procedure in accordance with the invention.[0065]
DETAILED DESCRIPTION OF THE DRAWINGS
• Although the invention has other possible uses, the invention will be fully understood from the following explanation of its use in providing a bypass around an obstruction in a patient's vascular system.[0066]
• FIG. 1 illustrates the[0067]apparatus100 in accordance with the invention, which is illustrated along with aconnector structure200, and afirst conduit10, which is typically a graft conduit and may be a natural conduit, such as a saphenous vein graft (SVG) or similar, or an artificial conduit. Apparatus l00 comprises a number of component elements for delivery and deploying theconnector apparatus200 and thefirst conduit10 to the operative site to make an anastomotic connection betweenfirst conduit10 and a second conduit, which is typically a patient's natural body conduit (see, e.g., FIG. 21). An apparatus for deploying theconnector structure200, such asballoon catheter300, is useful for enlarging theconnector structure200 to join the two conduits. Anosecone apparatus400 is useful to assist insertion ofapparatus100 into an aperture in the second conduit and to shield theconnector structure200 from damaging the second conduit during such insertion into the second conduit. Alocation ring500 is positioned about anaperture12 in thefirst conduit10 and about theconnector structure200. Thelocation ring500 may be helpful to indicate the position of thefirst conduit10 and theconnector structure200 during the anastomosis procedure.
• [0068]Apparatus100 andconnector structure200 are particularly useful in making a side-to-side anastomosis between the first and second conduits. This procedure accommodates theconnector structure200 to different sizes of conduits, provides an anastomosis size approximately equivalent to the second conduit diameter, and provides an optimal takeoff angle for the first conduit to prevent kinking.Apparatus100 andconnector structure200 are also useful in making an end-to-side anastomosis.
• FIG. 1 illustrates that the[0069]aperture12 has been made in thefirst conduit10 adjacent to thedistal end portion14 of thefirst conduit10. This configuration, as will be described in greater detail below, permits a side-to-side anastomotic connection to be made with the second conduit. More particularly, a fluid tight connection is made through the side wall offirst conduit10 and through the side wall of the second conduit. Moreover, theapparatus100 may be inserted through theend portion14, such that the opposite end portion of first conduit10 (not shown) is free. This configuration allows the side-to-side anastomosis to be made after a first anastomosis, e.g., at the aorta of the patient. Alternatively, theapparatus10 may be used to make an end-to-side anastomosis, when theend portion14 of thefirst conduit10 is attached to theconnector structure200, and which is described in greater detail herein with respect to FIG. 30.
Connector Structure
• FIGS. 2 and 3 illustrate an embodiment of the[0070]connector structure200. FIG. 2 shows a planar development of what is actually an integral, one-piece (unitary), annular structure. (Additional features of the connector structure and apparatus for applying the connectors are disclosed in Berg et al. published PCT patent application WO 99/38454; Swanson et al. U.S. Pat. No. 6,113,612; and Grudem et al. published PCT patent application WO 00/53104, each of which is incorporated by reference in their entirety herein.) In particular, the left and right edges of the structure shown in FIG. 2 are actually joined to and integral with one another. Thus, the actual structure is as shown in FIG. 3, although FIG. 2 is useful to more clearly reveal the details of various features of the structure.
• An illustrative material for[0071]connector structure200 is316 stainless steel. Other examples of suitable materials include tantalum, tungsten, platinum, other steels, and nitinol.Connector structure200 may be advantageously produced by starting with a single, unitary metal tube, such as a hypotube, and removing selected material until only the structure shown in FIG. 3 remains. For example, laser cutting may be used to remove material from the starting tube in order to produceconnector structure200. Althoughconnector structures200 can be made in various sizes for various uses, a typical connector structure has an inner diameter in the range from about 0.025 to about 0.100 inches. For example, an embodiment may have an initial inside diameter of about 0.042 inches, an outside diameter of about 0.05 inches, a material thickness of about 0.004 inches, and an initial length of about 0.075 to about 0.085 inches.
• [0072]Connector structure200 may be described as including axially spaced first andsecond cell portions202 and204, respectively. According to one embodiment, theconnector structure200 comprises six repeatingfirst cell portions202 and six repeatingsecond cell portions204. Theconnector structure200 may have fewer or more than six each offirst cell portions202 andsecond cell portions204, depending on the diameter of the tube used to manufacture theconnector structure200 and the resulting enlarged diameter desired. Alternatively, theconnector structure200 may have different configurations of cells and geometries.
• The[0073]width210 of the members which make up the first andsecond cell portions202 and204 is typically in the range of about 0.003 to about 0.0035 inches. Thedimensions212,214, and216 are each about 0.021 inches in the preferred embodiment. The segment of the connector structure associated withdimension212 defines adistal portion206 of theconnector structure200. The segment associated withdimension214 defines amedial portion207, and the segment associated withdimension216 defines aproximal portion208. Thesedimensions212/214/216 may be varied from these examples to suit the dimensions of the conduit and the aperture of the proposed anastomosis.
• [0074]First cell portion202 includes annularly spaced, but adjacent,longitudinal members230aand230b. The ends of these members are connected to one another at232a,234b, and236b. Annularly adjacent ones of these cells are connected to one another at234b. As will be described below, annular expansion ofcells202 permits annular enlargement ofconnector structure200. A pair ofmembers230a, along with theportion232ajoiningadjacent members230atogether, may comprise one of a second plurality offingers233 for engaging thesecond conduit20, as will be described herein. The embodiment shown in FIGS.2-5 are illustrated with six of the second plurality offingers233, for example.
• Some of the[0075]first cell portions202 may include an annularly spaceddistal member218 that in this case has afree end portion220, that is sharply pointed and that points towardproximal portion208.Member218 may be about 0.004 to about 0.020 inches in length for thin-walled conduits. The dimensions may be altered according to the thickness of the conduits to be joined. Each ofmembers218 is deflectable radially outwardly from the remainder ofconnector structure200 as shown, for example, in FIG. 3.Distal members218 may be deflected radially outward or angled backward towards theproximal end portion208 of theconnector structure200. This outward deflection is preferably at least partly plastic.
• [0076]First cell portion202 may also include an annularly spacedproximal member222 that in this case has afree end portion224 that is sharply pointed and that points towarddistal portion206.Proximal members222 are about 0.008 to about 0.120 inches in length, wherein a length of about 0.030 inches is preferable for the aorta. Each ofproximal members222 is deflectable radially out from the remainder ofconnector structure200 as shown, for example, in FIG. 3. Again, this outward deflection is preferably at least partly plastic.
• The above-mentioned outward deflection of[0077]distal members218 andproximal members222 may be produced by putting the connector structure on a mandrel and pryingmembers218 and222 radially outward. Following deflection ofmembers218 and222, an initialaxial spacing250 of about 0.050 inches is defined therebetween. This dimension is appropriate for thin-walled vessels. The dimension may be changed depending on the thickness of the first and second conduits to be joined.
• [0078]Second cell portions204 may include annularly adjacentlongitudinal members230b, and230c, the axially spaced ends of which are connected at234b,236b, and238c. (It should be noted thatmembers230bare in common withcells202 and204.) Annularly adjacent cells of this kind are connected to one another at locations like236b. As will be described below, annular expansion ofsecond cell portions204 permits annular enlargement ofconnector structure200. A pair ofmembers230c, along with theportion238cjoiningadjacent members230ctogether, may comprise one of a first plurality offingers235 for engaging thefirst conduit10. The embodiment shown in FIGS.2-5 are illustrated with six of the first plurality offingers235, for example.
• The[0079]connector structure200 is preferably annealed. Theconnector structure200 may also be used in the full hard or partially hard state. Theconnector structure200 will also typically require other processing appropriate for an implantable device such as, for example, polishing, passivation, and cleaning.
• FIGS. 4 and 5 illustrate the enlarged condition of[0080]connector structure200. A design consideration forconnector structure200 is that its enlarged diameter should be similar to the inner diameter of the smaller of the two conduits being joined.Connector structure200 is formed in such a way that it is annularly enlargeable (e.g., by inflation of a balloon that is temporarily disposed inside the connector structure, such asballoon catheter300, as will be described in greater detail herein). An embodiment of theconnector structure200, enlarged with a balloon of 3.5 mm in diameter, will typically enlarge to an internal diameter of about 0.115 inches if unconstrained and to about 0.09 to about 0.11 inches when connecting two conduits, such as an SVG and a coronary artery. (Such difference is due to the constricting effect of the conduits, as will be described in greater detail herein.)
• A planar development of the annularly enlarged condition of[0081]connector structure200 is shown in FIG. 4. The annular enlargeability ofconnector structure200 is provided by annularly expanding cell portions, such as first and second cell portions, described above. In thisway connector structure200 is annularly enlargeable by annularly enlarging each of the above-mentionedfirst cell portions202. In addition to the cells that are described above,connector structure200 includes other, similarly annularlyexpandable cell portions204 that are axially and annularly offset from the first-describedcell portions202. Thus again theconnector structure200 is annularly enlargeable by annularly enlarging thesecell portions204.
• It will be appreciated that as[0082]connector structure200 annularly enlarges, it generally axially shortens. In other words, ascell portions202 and204 widen in the annular direction, they shorten in the axial direction. As theconnector structure200 is enlarged in position to join the two conduits together, it is desirable for thedistal portions206 and theproximal portions208 to deflect radially outward to greater diameter (distal diameter240 andproximal diameter242, respectively) than themedial diameter244 associated with themedial portion207. (See, e.g., FIGS. 5 and 12.) The overall annular enlargement ofconnector structure200 along with the relatively greater enlargement ofdistal portion206 andproximal portion208 together decrease the axial spacing betweencell portions202 and204, and more particularly decrease the axial spacing betweendistal members218, andproximal members224 to a reduced axial spacing250 (FIG. 5). The approximation ofmembers218 and222 also helps to draw the edges of the two conduits together to create a good seal therebetween (See, FIGS.24-25).
• Another embodiment of the connector structure is[0083]connector structure270, which is illustrated in FIGS.6-7.Connector structure270 is substantially identical toconnector200, with the differences noted herein. As shown in FIG. 6, a plurality of spacer members272 are added between pairs ofmembers230aand pairs ofmembers230b. Each spacer member272 is an integral portion ofconnector structure270, and it may have a length of about 0.010 inches. The spacer members272 extend thedimension214′ associated with themedial portion207′ of theconnector structure270.
• The spacer members[0084]272 extend the overall length of theconnector structure270, without substantially changing the diameters of the enlarged connector structure. This is helpful where the thickness of the vessel walls increases, but the anastomosis diameter remains constant. More particularly, when theconnector270 is enlarged, theend portions206 and208 are deflected todiameters240 and242, respectively, which is substantially the same extent as for aconnector200 not having a spacer member. In addition, thediameter244 associated with themedial portion207′ remains substantially constant as well. However, theaxial distance250 betweenmembers218 and222 is increased, preferably to accommodate an increased thickness of the conduit walls.
• Another embodiment of connector structure is contemplated which is substantially identical to[0085]connector structure200 described above, with the following distinctions. This connector structure also has a third set of members located betweenmembers218 and222 described above. The third set of members are located on the connector structure distal to the point of the connector structure's minimum enlarged diameter, as described above. The third set of members are used such that the perimeter of the hole made in the first conduit is pressed down against them. This configuration assists in drawing the perimeter of the hole in the first conduit through and into the hole in the second conduit before the connector structure is enlarged. The embodiment of the connector structure with three sets of prongs is useful for either a side-to-side anastomosis or an end-to-side anastomosis.
• A typical use of[0086]connector structure200 is in a coronary artery bypass procedure, to provide an anastomosis between an aperture in a first conduit, such as a tubular graft conduit, and an aperture in a side wall of a second conduit, such as a coronary artery.
Balloon Catheter
• A[0087]balloon catheter300 in accordance with the invention is illustrated in FIG. 8. Theballoon catheter300 may be comprised of theballoon302, an outertubular shaft304, an innertubular shaft306, and ahub308. Thehub308 has aport310 which allows access to thelumen312 of the innertubular shaft306, and anotherport314 which allows access to thelumen316 defined between the innertubular shaft306 and the outertubular shaft304. Thelumen316 is in communication with the interior of theballoon302 and introduces fluid to inflate theballoon302. Theballoon302 may comprise a substantially constantdiameter barrel portion318, a tapereddistal portion320, and a taperedproximal portion322.
• A[0088]balloon catheter30 known in the art is shown in FIG. 9, and may include aballoon32 and atubular structure34. Aport36 is typically defined in thetubular structure34 to supply the fluid to theballoon32. Theballoon32 may include a constantdiameter barrel portion38, a distal taperedportion40, and a proximal taperedportion42. Thetapered portions40 and42 are attached to thetubular structure34 in an “un-inverted manner.” The term “un-inverted,” as used herein, shall refer to the condition of an end portion of the balloon which gradually tapers from one axial end to another. For example, thetapered portions40 and42 ofballoon32 are mounted to thetubular shaft34 in an un-inverted manner, i.e., thetapered portions40 and42 gradually are reduced in size from thebarrel portion38 to the end portions attached to the tubular shaft. Similarly, theproximal end portion322 of balloon302 (as shown in FIG. 8) is un-inverted. A characteristic of the un-inverted configuration is that the portion of the balloon having the largest diameter is typically a proportionally long distance from the attachment point of the balloon.
• Conversely, the term “inverted” shall refer to the condition of the balloon wherein an inflated portion of the balloon extends beyond the[0089]distal bond352. Thus, the tapered portion of the balloon does not taper gradually, but may “double-back” on itself. With continued reference to FIG. 8, thedistal portion320 of theballoon302 may be attached to the innertubular shaft306 in an inverted manner. An advantage of an inverted configuration is that the distalmost portion of theballoon302 may achieve a relatively large diameter at a shorter distance from the distal end portion of the balloon. As will be described in greater detail herein, the inverted attachment configuration of distal taperedportion320 permits theconnector structure200 to be positioned close to the distal end portion of theballoon302, and still be sufficiently enlarged by theballoon302 when theballoon302 is expanded to install theconnector structure200.
• The[0090]connector structure200 may be placed annularly about theballoon302 ofballoon catheter300, as illustrated in FIGS. 10 and 11. Theconnector structure200 is typically installed whenballoon302 is disposed in its unexpanded configuration. As illustrated in FIG. 11, the unexpanded configuration ofballoon302 may define a plurality of foldedportions330 that are expanded upon introduction of fluid into theballoon302.
• With continued reference to FIG. 10, the[0091]connector structure200 is oriented such thatdistal members218 are positioned adjacent to the distal end portion of theballoon302. As will be described in greater detail herein, the design ofballoon302 allows theconnector structure200 to be positioned as close as possible to the distal end portion of theballoon302. Certain features may be useful to hold theconnector structure200 in place on theballoon302. Particularly when the connector is mounted adjacent the distal end of theballoon302 as described above, it is important to prevent the connector from slipping forward, where it may not be enlarged as fully as desired because it is positioned over a smaller diameter region of theballoon302. In one embodiment, theconnector structure200 is mounted over theballoon302, which is “pre-inflated,” or inflated to a low pressure to hold theballoon302 in place without enlarging theconnector structure200. According to another embodiment, a larger diameter may be heat set in theballoon302 just distal of the distal portion of theconnector structure200 to prevent the connector from sliding forward. According to yet another embodiment, theballoon302 may be covered with a material having a high coefficient of friction to create higher frictional forces between the balloon and the connector. A material such as, for example, urethane in the 30D-60D durometer range may be useful for this purpose. This material may be provided with a separate sleeve or with a co-extrusion of the softer material and the base balloon material at the time of extruding the balloon blank. According to yet another embodiment, nosecone400 (described in greater detail herein) may be positioned distal to theconnector structure200 to hold theconnector structure200 in position on theballoon302 at least until thenosecone400 is deployed to permit connector enlargement.
• As illustrated in FIG. 12, there are several design considerations with regard to the construction of the[0092]balloon302.
• First, the configuration of the[0093]balloon302 should allow the distal end of the connector structure200 (approximately adjacent thefree end portion220 of member218) to be positioned at a reduceddistance340 from the distal end of theballoon302.Distance340 is advantageously as small as possible because the anastomosis is made by inserting the distal end of theballoon302 and theconnector structure200 into an aperture in the second conduit to be joined. More particularly, thisdistance340 should fit within the conduit to be joined when thedelivery apparatus100 is at 90 degrees with respect to the conduit prior to deploying the connector structure200 (see, FIG. 23). Therefore, theballoon302 should be designed to avoid contacting the opposite inner wall of the second conduit, or dilating the inner lumen of the second conduit.
• Second, the[0094]balloon302 should expand sufficiently atdistance340 in order to adequately enlarge theconnector structure200. Consequently, theballoon302 must achieve a minimum required dimension342 (radius of theballoon302 is shown in FIG. 12) which is sufficient to enlarge theconnector structure200 to the required dimension. Moreover, since theend portions206 and208 of the connector are designed to expand to a greater extent than themedial portion207,balloon302 should be designed to expand to a dimension larger than the enlarged dimension of the connector structure.
• Third, the[0095]balloon302 should be configured to expand to a dimension at least as large as the diameter of the lumen of the second connector to be joined.
• To meet these design objectives, the[0096]balloon302 is configured to expand to a minimum requireddimension342 as close to the distal end of theballoon302 as possible. In other words,balloon302 is designed to achieve a substantially large diameter adjacent the distal end portion. This configuration may be achieved by maintaining the inverted configuration ofballoon302 and by minimizing the average radius ofcurvature344 of the distal end portion of the balloon. As the radius ofcurvature344 decreases, thedistance346 from the distal end of theballoon302 to minimum requireddimension342 also decreases.
• With reference to FIGS. 8 and 12, several features of the[0097]balloon catheter300 are helpful to maintain the inverted configuration and to minimize the radius ofcurvature344. First, theballoon catheter300 may be designed to prevent relative movement betweentubular shafts304 and306. This feature may help to prevent thedistal end portion320 of theballoon302 from un-inverting when theballoon302 is pressurized. If thedistal end320 of theballoon302 is permitted to become partially un-inverted, thedistance346 from the end of theballoon302 to the minimum requireddimension342 may increase. For example, theproximal balloon bond350 may also provide an attachment of the innertubular shaft306 to the outertubular shaft304. This bond may be an adhesive bond, a thermal weld, or by using a single extrusion having several lumens instead of the innertubular shaft304 and outertubular shaft306. (It is understood that the connection of innertubular shaft306 to outertubular shaft304 permits fluid flow intoballoon302 and does not completely blocklumen316.)
• Another feature which may maintain the inverted configuration and reduce the radius of[0098]curvature344 of theballoon302 is the strength of the innertubular shaft306 which resists elongation when under tension generated by the inflation of theballoon302. Elongation of the innertubular shaft306 may also allow thedistal portion320 of theballoon302 to partially un-invert. Therefore, the portion of the innertubular shaft306 between thelocation350 where the innertubular shaft306 and the outertubular shaft304 are bonded together and thedistal balloon bond352 should have relatively high tensile strength. According to a preferred embodiment, this may be accomplished by using a polymer encased stainless steel braid tubing for the innertubular member306. This tubing may have a PTFE inner layer for lubricity for introducing additional apparatus, such asnosecone400, as will be described in greater detail herein; a stainless steel middle layer; and a nylon outer layer which is bonded to theballoon302 and the outertubular shaft304. Alternative configurations for achieving adequate tensile strength and stiffness for this segment of the innertubular shaft306 may include reinforcing the tubing with straight wires, sheathing this region with a stiffer tubing material, or by using thicker wall dimensions or stiffer materials.
• A further feature which may maintain the inverted configuration and reduce the radius of[0099]curvature344 of theballoon302 concerns which portions of theballoon302 are inverted. The balloon configuration may include inversion of the distal taperedportion320 of theballoon302 as well as inversion of a portion of theconstant diameter barrel318. Typically, inverting only the distal taperedportion320 of theballoon302 may result in a larger radius ofcurvature344 than inverting the distal taperedportion320 along with a portion of theconstant diameter barrel318.
• Yet another feature that maintains the inverted configuration and a reduced radius of[0100]curvature344 of theballoon302 is providing resistance to bending of theballoon302. If theballoon302 is permitted to bend, this may increase the radius ofcurvature344 of theballoon302 as well. Resistance to bending may be promoted by providing uniform wall thickness of theballoon302 and by providing resistance against balloon elongation. Providing uniform wall thickness is largely a function of providing uniform wall thickness in the extruded balloon blanks. Other procedures known in the art promote uniform wall thickness. For example, balloon elongation may be minimized by reducing the overall length of the balloon and by forming the balloon from relatively inelastic, highly oriented materials. In a preferred embodiment, theballoon302 may have a length of about 0.5 to about 1 cm. Theballoon302 may be manufactured from a material, such as for example, a polyamide, such asNylon 12. Other preferred materials may include PET, polyamide copolymers, polyimide, or other materials known in the art.
• In use, the balloon may be subject to stresses, such as longitudinal forces during insertion into the opening in the second conduit. As a result of these stresses, the[0101]balloon302 may “roll,” or shift proximally with respect totubular shafts304 and306. This proximal rolling may cause the distal end portion of theballoon302 to become partially un-inverted. Another feature may be provided to inhibit the expandedballoon302 from rolling. As illustrated in FIG. 8, anouter sleeve376 may be positioned about the periphery of theproximal end portion322 of theballoon302, and spaced apart from theproximal bond350. Theouter sleeve376 provides additional stability to the balloon against rolling, by contacting theproximal portion322 and maintaining the inverted configuration illustrated in FIG. 8.
• The combination of any or all of these design features are useful in providing a balloon structure having a[0102]preferred distance340 of 2.0 mm or less (FIG. 12). Thisreduced distance340 is very valuable when theballoon302 is to be used to enlarge aconnector structure200 in conduits smaller than 4 mm. Fordistances340 greater than about 2 mm, then theconnector structure200 may be mounted on a portion of the balloon that is tapered distally (i.e., it is in a portion that has yet reached the minimum required dimension342) or theconnector structure200 may not be seated properly with respect to the conduit, if the tip of theballoon302 is in contact with the back wall of the second conduit when the system is rotated to its perpendicular configuration.
• In addition to minimizing the elongation of the balloon, there are yet other design factors which are important in selecting the balloon material. One factor is the pressure requirements of the balloon. To properly enlarge the connector, the balloon should be able to withstand a balloon inflation pressure of about 18 atmospheres for a 3.5 mm diameter balloon. Another factor is the ability to produce a predictable diameter when inflated to high pressures. The same materials described above which have low elongation as balloons are useful to meet the high pressure requirements and also have a predictable diameter at high pressure.[0103]
• In order to create the greater deflection of the ends of the[0104]connector structure200 as described above with respect to FIG. 12, aballoon302 having a diameter larger than theconnector structure200 may be used to enlarge the connector structure. The size of theballoon302 in its expanded state and the required pressure of the balloon to enlarge the connector structure along with the conduit are related. For example, a connector structure being enlarged by aballoon302 which is 0.5 mm larger than the connector structure's enlarged diameter may require 18 atm of pressure to reach full enlargement, while a balloon having a diameter 1 mm larger than the connector's enlarged diameter may require 14 atm of pressure to reach full enlargement. The design of the connector, when positioned around the balloon, may affect the expansion characteristics of the balloon.
• As described above, several design considerations with respect to the balloon and connector sizing are (1) the configuration of the balloon should allow the connector to be placed close to the distal end of the balloon so that the balloon does not dilate the inner lumen of the second conduit; (2) the diameter of the expanded balloon should be larger than the enlarged diameter of the connector to allow the end portions to enlarge to a greater degree than the medial portion; and (3) the diameter of the enlarged connector should be similar to the diameter of the smaller of the two conduits. An additional design consideration is that the diameter of the expanded balloon should be smaller than the inner diameter of the first conduit to avoid dilating the first conduit. Taking these design considerations into account, it is desirable to use a balloon with an expanded diameter that is about 0.5 mm to about 1.25 mm larger than the enlarged diameter of the connector. If the connector is mounted adjacent the distal end portion of the balloons constant[0105]diameter barrel portion318, and the expanded diameter of theballoon302 is 0.5 mm or more greater than the diameter of the expanded connector, then theconnector structure200 may constrain the expansion of the balloon distal to the connector by anywhere from 0.25 mm to about 0.5 mm depending on how close to the end of thebarrel portion318 theconnector structure200 is located. This is illustrated by the difference in the unconstrained diameter of balloon302 (FIG. 8) and the constrained diameter (FIG. 12). This constraint ofballoon302 byconnector200 is useful to reduce the diameter of theballoon302 inside the second conduit thereby reducing the risk of dilating the second conduit with the balloon while simultaneously expanding the connector.
• Continuing with the present example, the connector may be mounted 1.5 mm from the end of a 3.5 mm balloon wrapped (as illustrated in FIG. 11) to a profile of 0.038. This system is useful to join a larger[0106]first conduit10 to a smaller second conduit of about 2.5 mm in diameter with a resulting anastomosis diameter of 2.25 mm to about 2.5 mm. When theballoon302 is pressurized to deploy thisconnector structure200, the portion of the balloon extending beyond the connector will typically have a diameter of about 3.0 mm and a length of about 1.5 mm. In this case, the short length of the distal end portion of the balloon allows it to be inflated inside the 2.5 mm conduit, such that the conduit takes on an oval shape over the 3.0 mm by 1.5 mm balloon portion without being dilated or stretched by it.
• As will be described herein, the system is introduced in a substantially axial direction into the second conduit (see, FIG. 21), and subsequently rotated to a radial direction with respect to the second conduit (see, FIG. 23). For this type of installation, the diameter of the[0107]connector structure200 and the distance from thedistal members218 to the end of the balloon should both be shorter than the diameter of the second conduit. Thedistal members218 are less likely to snag the back wall of the second conduit if the diameter of the connector structure at thedistal members218 is at least 0.01 inches smaller than the diameter of the pressurized second conduit. The diameter of the connector structure at thedistal members218 depends, in part, on the length of thedistal members218 and on the diameter of theballoon302 under the connector. The length of thedistal members218 necessary to have them engage the tissue of the second conduit results in them adding about 0.5 mm to the diameter of the balloon distal end. Consequently, the wrappedballoon302 may have a diameter at least 0.5 mm less than the inner diameter of the second conduit, and preferably 1-1.5 mm less. Thedistal members218 are also less likely to be pushed out of theaperture22 in the second conduit when the system is rotated to an orientation perpendicular to the second conduit if the distance from thedistal members218 to the distal end portion of theballoon302 is less than the diameter of the second conduit.
• It is contemplated that the[0108]balloon302 may be configured for removal and reattachment with respect to theshaft portion304/306 (see, FIG. 8). According to one embodiment, thecatheter shafts304 may include ajunction370 in a region just proximal to theballoon302 which would allow the shaft portions proximal to thejunction370 and the shaft portions distal to thejunction370 to be separated and reconnected, repeatedly, as required. Similarly, thecatheter shaft306 may include ajunction372 in a region just proximal to theballoon302 which would allow the shaft portions proximal to thejunction372 and the shaft portions distal to thejunction372 to be separated and reconnected. Thesejunctions370/372 may be achieved by a pair of luer fittings to connect the twolumens312 and316 of theshafts304/306. A benefit of this construction when providing an anastomosis between a first and second conduit is to reduce the size and weight of the apparatus attached to the first conduit prior to performing the connection to the second conduit. This arrangement may be beneficial in cases where a connector is being used on each end of a conduit so that the connection apparatus for use at the first end is not in the way of the connection apparatus at the second end while the anastomosis at the first end is being made. This arrangement may also be beneficial in loading the first conduit onto the connector structure.
The Nosecone Assembly
• The[0109]nosecone assembly400 is illustrated in FIGS.13-14, and may comprise an elongatedtubular shaft402, anosecone balloon404, and anindicator wire406. Thetubular shaft402 may be made of nitinol, a composite braid tubing, a metal hypotube (e.g., steel), or of a polymer extrusion such as nylon. According to one embodiment, thetubular shaft402 has an outer diameter of approximately 0.014 inches and an inner diameter of approximately 0.010 inches. Thenosecone balloon404 may be fabricated of a number of materials such as, e.g., polyethylene, polyolefin copolymers, ethylene vinyl acetate, urethane, or other materials suitable for manufacturing an inflatable balloon. It is preferable that a relatively soft material be used (such as those described above) for the requirements of the application described herein. Thenosecone balloon404 may comprise a distal taperedportion408 and aproximal portion410. Theproximal portion410 may be attached to thetubular shaft402. The internal cavities of the distal taperedportion408, theproximal portion410, and thelumen412 of thetubular shaft402 are preferably in fluid communication. Anindicator wire406 is attached to thedistal tip414 of thenosecone balloon404, and extends proximally through thetubular shaft402. In a preferred embodiment, thewire406 is set in place by means of an adhesive407. Thenosecone assembly400 is flexible, and capable of bending to an angle of about 100 degrees or more with respect to the longitudinal axis thereof (see, e.g., FIG. 23).
• The[0110]nosecone balloon404 is illustrated in its “introduction configuration” or folded configuration in FIG. 14. FIG. 13 illustrates thenosecone balloon404 in its “removal configuration” or unfolded configuration. In the introduction configuration, theproximal portion410 is folded back in a concave manner, and defines anannular recess420 for receiving theconnector structure200 or the like, as will be described in greater detail herein. Expanding thenosecone balloon404 is typically achieved by introducing fluid into thenosecone balloon404 from thetubular shaft402, thereby changing the configuration of thenosecone balloon404 from the introduction configuration to the removal configuration, i.e., from the folded configuration ofproximal portion410 depicted in FIG. 14 to the unfolded condition depicted in FIG. 13. When the balloon moves from the introduction configuration of FIG. 14 to the removal configuration of FIG. 13, thenosecone balloon404 defines a smaller outer dimension. and smooth proximal surface to facilitate removal of thenosecone balloon404 from the second conduit and theconnector structure200, as will be described in greater detail herein.
• The[0111]indicator wire406 moves within thetubular shaft402 with thedistal tip portion414. Consequently, a proximal length of theindicator wire406 may extend out of the shaft ashort length406awhen thenosecone balloon404 is folded (FIG. 14). When thenosecone balloon404 is expanded (unfolded),distal tip414 and the distal taperedportion408 advance distally with respect to the tubular shaft402 (see also, FIGS.21-22). When thedistal tip portion414 advances distally, theproximal length406aofwire406 is drawn into the tubular shaft402 (FIG. 13). In this manner, theindicator wire406 provides a visual indication that thenosecone balloon404 has unfolded. During the distal advancement of distal taperedportion408, thetubular shaft402 remains stationary. Alternatively, the nosecone could be advanced mechanically, e.g., by advancing a substantially rigid indicator wire. According to another embodiment, the nosecone assembly may be manufactured without an indicator wire.
• The dimensions of the[0112]nosecone balloon414, i.e., the diameter and length, are selected in order to cover thedistal members218 of theconnector structure200 during introduction of the apparatus into the second conduit.
• While filled with expansion fluid in the unfolded condition of FIG. 13, the[0113]nosecone balloon404 may define a degree of rigidity. Typically, the rigidity is proportional to the pressure of the expansion fluid; theballoon404 becomes more flexible as more fluid is drained from theballoon404.
• The[0114]tubular shaft402 is configured to be axially received in thelumen312 ofballoon catheter300. FIG. 1 illustrates thenosecone assembly400 positioned with respect toballoon catheter300. Thenosecone balloon404 is folded about theexpansion balloon302 and theconnector structure200. In the folded condition, thedistal members218 of theconnector structure200 are covered, so that the periphery of the aperture in the second conduit does not snag on these members as the connector is inserted into this aperture, as will be described in greater detail herein.
• According to another embodiment of the invention, the[0115]nosecone balloon404 may be substituted by a solid cap, which covers the distal members during insertion into the aperture of the second conduit. Additional details of the nosecone structure are described in Swanson et al. U.S. Pat. No. 6,113,612, incorporated by reference in its entirety herein. Additional embodiments of the nosecone assembly are described herein with respect to FIGS.31-43.
• The[0116]first conduit10 is subsequently mounted to theconnector structure200 about anaperture12 made in thefirst conduit10. Thefirst conduit10 may be natural body tissue (e.g., a length of the patient's saphenous vein harvested for use as a graft, a partly severed internal mammary artery, etc.), an artificial graft (e.g., as shown in Goldsteen et al. U.S. Pat. No. 5,976,178, or published PCT patent application WO 98/19632, both of which are hereby incorporated by reference herein in their entireties), or a combination of natural and artificial conduits (e.g., a length of natural conduit disposed substantially concentrically inside a length of artificial conduit).
• An[0117]opening12 may be made in thefirst conduit10 at a location spaced from theend portion14 of theconduit10. The size of theopening12 in thefirst conduit10 is an important consideration. (It is understood that thedescription concerning opening12 is applicable to theopening22 insecond conduit20.) If the opening is too large, then a satisfactory hemodynamic seal may not be created between the two conduits. Conversely, if the opening is too small, one or more of the following undesirable effects may occur: the conduit wall may tear excessively when theconnector200 is enlarged, or the conduit may constrict enlargement of the connector. (When making the opening in the second conduit, the opening may not permit thenosecone400 to be inserted therethrough if it is too small.) Which of these above effects occurs is determined in part by tissue quality, the dimensions of the apparatus being used, and the inflation pressure of the balloon.
• The opening in the conduit should preferably be sized such that enlargement of the[0118]connector structure200 does not cause significant additional tearing of the wall to expand the periphery of the opening. Rather, it is generally desirable that the expansion of the opening to accommodate the enlarged connector is achieved within the elastic expansion range of the conduit wall. The elastic expansion is important since thedistal members218 engage the conduit wall as the connector structure expands. If the conduit wall tears a significant amount, e.g., at the locations of engagement with the distal members218 (rather than elastically expanding), it is possible that the desired tension created in the wall between thedistal members218 would be relieved, which may prevent the creation of a seal between the conduits being joined. As an example, the diameter of the aperture in the conduit should be between about 0.25 to about 1.0 mm smaller than the expanded diameter of the connector. This will preferably allow the elasticity of the conduit tissue to assist in creating a seal between the conduits as they are stretched to the diameter of the expanded connector.
• The openings in the conduits can be made by cutting, mechanical dilation, or by a combination of both. According to a preferred embodiment, the initial opening is made by cutting the conduit with a 20 gauge needle and then dilating the opening using a dilator between 2.0 and 2.5 mm to prepare an opening for a 2.25 mm connector. The size of the initial cut and the size of the dilator may be selected based upon the elastic characteristics of the conduits being used. In this case, the opening may recoil back to a range of about 1.5 to 2.0 mm after the dilator is withdrawn. An advantage of the cutting and dilating procedure is that the physician is able to effectively reduce the influence of the possible variations in conduit wall elasticity by dilating to a diameter similar to the connector size. Thus the amount of recoil, as a function of the elasticity of the conduit wall, is irrelevant to sizing the opening.[0119]
• According to another embodiment, an initial opening is made by piercing the conduit with a 20 gauge needle, and then dilating the opening by inserting and then expanding a 2.0 to 2.5 mm balloon. This embodiment provides the advantage of applying uniform dilating force from both the inside and the outside of the conduit. The use of balloon expansion reduces the risk of dissecting the layers of the conduit since a minimum of radial force is applied. This is particularly helpful in the case of diseased conduits, where the inner layer is typically harder than the outer layer. The harder inner layer may resist the application of radial force more strongly than the outer layer, which may result in the inner layer peeling away from the outer layer. A balloon may minimize this undesirable effect since the balloon is first introduced into the initial opening with a reduced profile, and then is expanded. Due to the resistance of the conduit wall, the balloon tends to expand on both the inside and outside of the conduit, and counteracts any unbalanced radial force that might separate the layers of the conduit.[0120]
• The opening in the conduit may also be created without a dilation step. This may be particularly useful where the conduit is diseased, and it is desired to reduce the risk of dissecting tissue layers. In the absence of a dilation step, the elasticity of the conduit wall may be reasonably estimated in order to cut an opening of the proper size to receive the connector therethrough. According to another embodiment, the opening in the conduit may be created by a cutting instrument. In this case, the deflated conduit is advanced a known distance into a scissors or semicircular cutter, and then the conduit is cut to yield a hole of known diameter and length.[0121]
• According to yet another embodiment, a coring cutter apparatus may be used to core an opening of known diameter in the conduit wall. The coring apparatus is useful if the conduit is stretched over the end of a loading sheath, or can be used with a pressurized conduit, or with a vacuum port in the bore of the cutter to support the wall of the conduit to be cut.[0122]
Transfer Sheath
• A[0123]transfer sheath600 androd603, illustrated in FIG. 15, may assist in the mounting of thefirst conduit10 onto theapparatus100, without compromising the delicate intima of thefirst conduit10. Thetransfer sheath600 androd603 may be fabricated from a low friction, biocompatible polymer such as, e.g., polyethylene or polytetrafluoroethylene, or similar material. Thetransfer sheath600 may alternatively be made of metal, such as, e.g., stainless steel. Therod603 may be rigid or expandable, as described below. Thetransfer sheath600 may have an elongatedbody portion602 with adistal end portion601 and aninternal lumen606. Arod603, having atapered end portion604, is sized to be coaxially positioned withinlumen606 such that thetapered end604 extends beyond the end of thelumen606 oftransfer sheath600. Thetapered end portion604 may be rigid or it may be configured to expand and contract. For example, thetapered end portion604 may be configured to expand as large as the outer diameter of thetransfer sheath600 for a smooth transition from thetapered end portion604 to thesheath body602, and then be configured to collapse to a smaller dimension to be retracted throughinternal lumen606. This allows thefirst conduit10 to be loaded over thetransfer sheath600, in the direction indicated by arrow A.
• The[0124]transfer sheath600 assists the physician by serving as a sizing instrument. The outer diameter of thebody portion602 is selected to accommodate thefirst conduit10, such as a graft, having a diameter which is compatible with theconnector structure200. For example, a first conduit that is too narrow will not be able to receive thesheath600 therethrough. Moreover, the internal diameter of the first conduit should be sufficiently large to allow for expansion ofballoon302 andconnector structure200 without dilating thefirst conduit10 during such expansion. Therefore,body portion602 oftransfer sheath600 has a diameter of about 3.5 mm, according to a preferred embodiment. The diameter ofbody portion602 may be fabricated with a different diameter, and corresponding connector size, depending upon the specific clinical indication of the graft size and desired anastomosis size.
• Once the[0125]first conduit10 is harvested, it is positioned overtransfer sheath600. As illustrated in FIG. 16, thedistal end portion14 ofconduit10 is positioned over thetransfer sheath600. Entry through thedistal end portion14 allows the remainder of theconduit10 to be free, which is useful, for example, when the proximal end of thefirst conduit10 is to be attached to another vessel, such as the aorta of the patient. As illustrated in FIG. 16, thetapered end portion604 ofrod603 extends distally fromtransfer sheath600 to provide a smooth transition astransfer sheath600 androd603 are advanced within the lumen offirst conduit10 in direction indicated by arrow B.
• When the transfer sheath is positioned at the location[0126]11 whereopening12 is to be made infirst conduit10,rod603 is withdrawn proximally, whiletransfer sheath600 remains in position. The wall of thefirst conduit10 is held taut over thedistal end601 of thetransfer sheath600.Opening12 is made in the wall offirst conduit10. Thisopening12 can be created by a combined cutting and dilating procedure as described herein.
• As illustrated in FIG. 17, the[0127]balloon catheter300,nosecone assembly400, andconnector structure200 are advanced through theinternal lumen606 oftransfer sheath600 to theopening12.
• FIG. 18 illustrates that[0128]nosecone assembly400 is advanced untilconnector structure200 partially protrudes through theopening12. Subsequently, thefirst conduit10 is retained in position (e.g., with an atraumatic grasping instrument), and thesheath600 is removed by passing thetransfer sheath600 coaxially over theballoon catheter300.
• With continued reference to FIG. 18, the periphery of an[0129]opening12 infirst conduit10 is placed about theconnector structure200. More particularly,conduit10 is positioned so thatproximal members222 penetrate and pass through the side wall of the graft conduit10 (e.g., as a result of compressing the graft against the fingers bytool440 such as the vein piercing tool described in Logan et al. U.S. patent application Ser. No. 09/587,112, filed Jun. 2, 2000, and incorporated by reference in its entirety herein, thereby forcing the fingers to pierce through the graft wall). The sharpened free ends224 ofmembers222 facilitate penetration ofconduit10 bymembers222. The blunt rear surfaces of enlargedfree end portions224 resist withdrawal ofmembers222 fromconduit10 aftermembers222 have penetrated the conduit. The graft may be additionally or alternatively directly sutured to the connector body. If the alternative of suturinggraft10 to theconnector structure200 is used, then thesecond cell portion204 of the connector may not need radially outwardlydeflectable members222 for engagement of the graft conduit. Alternatively, thefirst conduit10 may be secured to theconnector structure200 with glues, clips, or other connector elements.
• As an alternative to securing[0130]first conduit10 toconnector structure200 afterballoon catheter300 has been associated with the connector,balloon catheter300 may be installed inconnector structure200 after thefirst conduit10 has been secured to the connector structure.
The Locating Ring
• A later step in preparing the[0131]first conduit10 for anastomosis may be to place a locatingring500 about the periphery of the opening, as illustrated in FIG. 1. Further details of the locatingring500 are illustrated in FIGS.19-20. Locatingring500 may be fabricated in a toroidal or serpentine ring configuration from silicone with high elastic strength. The locatingring500 may also be provided withapertures502 extending radially through the material for receivingproximal members222 therein once the locatingring500 has been placed about the periphery of theaperture12 in thefirst conduit10 as illustrated in FIG. 1. Use of the locatingring500 is optional, and may be omitted from the procedure as determined by the physician.
• The locating[0132]ring500 provides benefits to the procedure in accordance with the invention. The locatingring500 provides a visual indication of the edge of theaperture12 of thefirst conduit10. This assists the physician when delivering thefirst conduit10 to the anastomosis site, in order to properly align the apertures in the first and second conduits prior to deploying the connector. The locatingring500 also provides some protection to the second conduit by shielding the tissue of the second conduit from theproximal members222 when the apparatus is being introduced into the second conduit. In addition, the locatingring500 provides an abutment surface or a stop to inhibit theproximal members222 from being axially introduced into the second conduit when the tip of theballoon catheter302 and the distal end of theconnector structure200 are being introduced in the second conduit.
• Another embodiment of the locator ring is a structure which surrounds the periphery of the aperture in the[0133]first conduit10 about theproximal members222 aslocator ring500 described hereinabove, and is also removable from thefirst conduit10 prior to completion of the procedure. This embodiment of the locator ring may have a clip structure (or “C”-shaped structure) having an opening in the circumference to allow removal from the conduit. According to another embodiment, the locator ring structure may be substituted with a plurality of individual components which may be attached one ormore members222. According to yet another embodiment, the locator ring may be substituted by applying a color marking to the periphery of the aperture to provide a visual indication useful to the physician in aligning the first and second conduits.
Operation of the Apparatus
• FIGS.[0134]21-24 illustrate a typical use ofapparatus100 to deliverfirst conduit10 for connection to anaperture22 in a side wall ofsecond conduit20, typically the patient's tubular body conduit (e.g., a coronary artery requiring a bypass graft).
• [0135]Aperture22 is typically made insecond conduit20 in a manner described herein above with respect to making theaperture12 in thefirst conduit10. Theaperture22 is typically made downstream from an occlusion orlesion30 in thesecond conduit20. As illustrated in FIG. 21, thenosecone balloon404 ofnosecone assembly400 may be gradually forced into theaperture22 in a direction substantially coaxial with thelumen24 of thesecond conduit20. As thenosecone balloon404 passes through theaperture22, theannular space420 defined by the inverted proximaltapered portion410 may shield thedistal members218 from snagging on the tissue of thesecond conduit20. As long asnosecone balloon404 remains in the introduction configuration, adistal portion406aofindicator wire406 may extend partially beyond the proximal end portion oftubular shaft402. Locatingring500 may provide a visual indication thataperture12 offirst conduit10 andaperture22 ofsecond conduit20 are approximated. Locatingring500 may also inhibitproximal members222 from passing through theaperture22 ofsecond conduit20.
• The physician may determine if the[0136]connector structure200 has been properly positioned with respect to theapertures12 and22. As shown in FIG. 22, the next step in the use ofapparatus100 may be to inflatenosecone balloon404 by introducing fluid intotubular shaft402 andballoon404. As thenosecone balloon404 expands (i.e., moves from the introduction to the removal configuration), thedistal tip414 moves distally into thelumen24 of thesecond conduit20, and the proximaltapered portion410 returns to an unfolded condition similar to that shown in FIG. 19. In the unfolded condition, thedistal members218 ofconnector structure200 are exposed within thelumen24 of the second conduit. The distal advancement ofdistal tip portion414 also advances theindicator wire406 into thetubular shaft402. The position of theindicator wire406 with respect to thetubular shaft402 thus provides a visual indication that thenosecone balloon414 has successfully moved to the removal configuration.
• A next step in the use of[0137]apparatus100 is to drain the expansion fluid from thenosecone balloon404, as shown in FIG. 23. Thenosecone balloon404 is flexible, which allows the portion of theapparatus100 comprisingballoon catheter300,connector apparatus200, and a proximal portion ofnosecone assembly400 to be turned to a position at approximately a 90 degree angle with respect to thelumen24 of thesecond conduit20. As described above, theaxial distance250 between thedistal members218 and theproximal members222 when theconnector structure200 is in the unenlarged condition is sufficient to prevent thedistal members218 from being moved out of theaperture22 of thesecond conduit20 during rotation to the perpendicular orientation. As described hereinabove, the distance between theconnector apparatus200 and the distal end of theballoon302 is minimized to prevent dilating theinner lumen24 of thesecond conduit20 when theballoon302 is inflated.
• A next step in the use of[0138]apparatus100 is to inflateballoon302 as shown in FIG. 24. In order to create the greater deflection of the ends of theconnector structure200 as described above with respect to FIGS. 5 and 10,balloon302 has an inflated diameter larger than theconnector structure200 to enlarge theconnector structure200. Inflation ofballoon302 causes theconnector structure200 to annularly enlarge by enlarging cells202 (defined bymembers230a/230b) and204 (defined bymembers230b/230c) in the annular direction. In addition, theproximal portion208 anddistal portion206 ofconnector structure200 are deflected radially outwardly beyond themedial portion207 ofconnector structure200. These two actions, i.e., overall annular enlargement ofconnector structure200 and relatively greater enlargement ofportions206 and208, decrease the axial spacing betweenportions202 and204, and more particularly decreases theaxial spacing250 betweendistal members218, on the one hand, andproximal members222, on the other hand (FIG. 5). The free ends220 ofdistal members218 preferably penetrate the side wall ofsecond conduit20 to help ensure thatfirst conduit10 is securely attached to thesecond conduit20 and remains open where it connects tosecond conduit20. Consequentlymembers218 and222 are positioned to better engage the tissue of the conduits at the perimeter of theaperture22 in thesecond conduit20 being joined. The approximation ofmembers218 and222 also helps to draw the edges of the two conduits together to create a good seal therebetween. With this connector structure, the seal between the conduits is typically a lap joint between the two sets of prongs, wherein the edge of the hole in one of the conduits sits under the edge of the hole in the other conduit as the connector structure is expanded; or alternatively a butt joint may be formed between the two vessels.
• Assuming that the[0139]connector structure200 is approximately properly positioned relative to the side wall ofsecond conduit20 prior to inflation of balloon303, theconnector structure200 is effectively self-centering on the second conduit side wall as theballoon302 is inflated. Moreover, since theconnector structure200 is positioned adjacent the distal end portion ofballoon302, it is possible to position theconnector structure200 about the wall of thesecond conduit20 without dilating or damaging the opposite wall of thesecond conduit200 with theballoon302.
• A next step in the use of[0140]apparatus100 is to deflateballoon302 and withdraw all of theelements300 and400 (e.g., by pulling them proximally out of the first conduit10). Subsequently, thedistal end portion14 of thefirst conduit10 may be tied off with aligature50, to direct flow from thefirst conduit10 into thesecond conduit20. This leaves the side wall offirst conduit10 connected to the side wall ofsecond conduit20 byenlarged connector structure200 as shown in FIGS.25-27. In particular, in thisexample connector structure200 provides a side-to-side anastomosis between afirst conduit10 and asecond conduit20. Body fluid fromfirst conduit10 is able to flow intosecond conduit20 via this connection.Connector200 presses theaperture12 through the side wall of thefirst conduit10 radially outward against theaperture22 through the side wall ofsecond conduit20 all the way around theapertures12/22, thereby preventing body fluid from leaking out ofconduits10 and20.Connector structure200 also preventsfirst conduit10 from pulling away from the side wall ofsecond conduit20.
• According to another embodiment of the invention, the apparatus described herein may be useful in connection with creating an anastomosis between two body conduits in-situ. As illustrated in FIG. 28, the physician may wish to form an anastomosis between[0141]first conduit10 andsecond conduit20, wherein both conduits are relatively adjacent to one another, and it is not necessary to move either conduit a great distance to perform the anastomosis. Under these circumstances, theapparatus100 may be introduced intofirst conduit10, in the manner described above with respect to FIGS.16-18. More particularly,transfer sheath600 may be introduced percutaneously into the patient's vascular system and advanced to the anastomosis site, and anopening12 is made at the anastomosis site. Thenosecone assembly400,connector structure200, andballoon catheter300 are subsequently introduced to the anastomosis site within the lumen of thetransfer sheath600. Once thenosecone assembly400 protrudes from theopening12 in thefirst conduit10, the free ends222 ofconnector structure200 are secured about the periphery ofopening12. A locatingring500 may be used. Anopening22 is made in thesecond conduit20 as described above. The anastomosis is performed substantially as described above with respect to FIGS.21-25.
• According to another embodiment, the apparatus described herein may be useful for creating a series of anastomoses along the length of a single conduit or between two conduits. As illustrated in FIG. 29, the procedure described herein may be performed at a[0142]first anastomosis site700. After theconnector structure200 is deployed, thenosecone assembly400 and theballoon catheter300 are withdrawn; however, thefirst conduit10 remains open and is not tied off as described above with respect to FIG. 25. According to this embodiment, asecond connector structure200, along with theballoon catheter300 andnosecone assembly400 are positioned within thefirst conduit10 at asecond anastomosis location702. The second anastomosis is performed substantially as described herein.
• According to yet another embodiment, the apparatus described herein also be useful for making an end-to-side anastomosis. As illustrated in FIG. 30, the[0143]connector structure200 is attached to theend portion15 of thefirst conduit10, rather than about the periphery of anopening12 made in the side wall of thefirst conduit10. Theconnector structure200, theballoon catheter300, and thenosecone assembly400 are loaded onto the first conduit substantially as described above with respect to FIGS.16-18, with the following differences described herein. Thetransfer sheath600 is advanced within the lumen of thefirst conduit10 until it protrudes slightly from theend portion15. Theconnector structure200,balloon catheter300, and thenosecone assembly400 are subsequently advanced within thelumen606 of thetransfer sheath600 untilmembers222 protrude from theend portion15 of thefirst conduit10. (Transfer sheath600 may then be removed.) Thefree end portions224 are used to pierce the wall of thefirst conduit10 about theend portion15. A locatingring500 may be used. The anastomosis procedure is performed substantially as described herein with respect to the side-to-side anastomosis procedure.
• According to still another embodiment, the apparatus described herein may also be useful in making an anastomosis between a first vessel, such as a graft conduit, e.g., SVG, and the aorta or other arterial blood source.[0144]
• Another embodiment of the nosecone assembly is illustrated in FIGS.[0145]31-35, and is generally denoted byreference number450.Nosecone assembly450 may comprise an elongatedtubular shaft452, and anosecone454. Thetubular shaft452 may be substantially similar totubular shaft402, described hereinabove. However,tubular shaft452 may be a solid member. Thenosecone454 may comprise adistal tip portion456, which is attached to thetubular shaft452. A plurality ofcone sections458 extend from thetip portion456, and are each individually, flexibly attached to thedistal tip portion456.
• FIG. 31 illustrates the[0146]nosecone454 in its introduction configuration, which facilitates the introduction of thenosecone assembly450 and theconnector structure200 into thesecond conduit20. In this configuration, thecone sections458 extend both proximally and radially outward fromdistal tip portion456. Thecone sections458 define anannular space459 for receiving theconnector structure200. FIG. 32 illustrates thenosecone454 in the compacted, removal configuration, which facilitates the removal of the nosecone assembly from thesecond conduit20. In the removal configuration, thecone sections458 extend distally from thetip portion456. Preferably, thecone sections458 may be positioned closer together in the removal configuration to define a lower profile. The dimensions of thenosecone454, i.e., the diameter and length, are selected in order to cover thedistal members218 of theconnector structure200 during introduction of the apparatus into the second conduit.
• FIGS.[0147]33-35 illustrate a typical use of thenosecone assembly450. As illustrated in FIG. 33 (which corresponds to FIG. 21, above), thenosecone454 is used to introduce theconnector structure200 and theballoon catheter300 into theopening22 in the second conduit.Nosecone454 is in the introduction configuration, and shields the first members218 (not visible in FIG. 33). As illustrated in FIG. 34 (which corresponds to FIG. 22, above),nosecone454 is advanced into thelumen24 ofsecond conduit20, thereby exposing thefirst members218. Such advancement may be achieved by remotely advancingtubular member452. FIG. 35 illustrates the condition in the procedure afterballoon302 has been expanded to enlargeconnector structure200 and attach first conduit10 (illustrated with dashed lines) tosecond conduit20.Nosecone454 may be removed from the operative site by proximally withdrawingtubular shaft452. When thecone sections458 comes in contact with theballoon302, they are deflected distally to the removal configuration shown in FIG. 32.
• Yet another embodiment of the nosecone assembly is illustrated in FIGS.[0148]36-39, and is generally denoted byreference number460.Nosecone assembly460 may comprise an elongatedtubular shaft462, and anosecone464. Thetubular shaft462 may be substantially similar totubular shaft402, described hereinabove. Thenosecone464 may comprise acollapsible cone portion466, a flexibledistal tip portion465, and aproximal portion467. Theproximal portion467 is configured for longitudinal movement within the lumen oftubular shaft462. Thedistal tip portion465 may be biased to define a bend, or “knee” portion between theproximal portion467 and thecone portion466.
• FIG. 36 illustrates the[0149]nosecone464 in its introduction configuration, which facilitates the introduction of thenosecone assembly460 and theconnector structure200 into thesecond conduit20. In this configuration, thecone portion466 extends both proximally and radially outward fromdistal tip portion465. Thecone portion466 defines anannular space469 for receiving theconnector structure200. FIG. 37 illustrates thenosecone464 in the compacted, removal configuration, which facilitates the removal of the nosecone assembly from thesecond conduit20. In the removal configuration, theproximal portion467 is withdrawn proximally, and thedistal tip portion465 bends against its bias towards parallelism with the lumen of thetubular shaft462. Thecone portion466 is collapsed and also withdrawn into thetubular shaft462.
• FIGS.[0150]38-39 illustrate a typical use of thenosecone assembly460. As illustrated in FIG. 38 (which corresponds to FIG. 21, above), thenosecone464 is used to introduce theconnector structure200 and theballoon catheter300 into theopening22 in the second conduit.Nosecone464 is in the introduction configuration, and shields the first members218 (not visible in FIG. 38).Nosecone464 may be advanced into thelumen24 ofsecond conduit20, as illustrated in FIG. 34, above. FIG. 39 illustrates the condition in the procedure afterballoon302 has been expanded to enlargeconnector structure200 and attach first conduit10 (illustrated with dashed lines) tosecond conduit20.Nosecone464 may be removed from the operative site by proximally withdrawingproximal portions467 intotubular shaft462. Thedistal tip portion465 will straighten as it is withdrawn intotubular shaft462, which in turn will cause thecone portion466 to collapse to a size which can also be removed intotubular shaft462.
• Still another embodiment of the nosecone assembly is illustrated in FIGS.[0151]40-43, and is generally denoted byreference number470.Nosecone assembly470 may comprise an elongatedtubular shaft472, and anosecone474. Thetubular shaft472 may be substantially similar totubular shaft402, described hereinabove. Thenosecone474 is fabricated from a highly elastic material that may be expanded from a substantially narrow cylindrical configuration to substantially tapered configuration upon the introduction of expansion fluid. Upon draining the expansion fluid,nosecone474 returns to the narrow initial configuration.
• FIG. 40 illustrates[0152]nosecone474 in its introduction configuration, which facilitates the introduction ofnosecone assembly470 andconnector structure200 intosecond conduit20. In this configuration, adistal portion475 extends both proximally and radially outward fromdistal tip portion476. In this configuration,nosecone474 defines anannular space479 for receiving theconnector structure200. A centrallongitudinal member477 may be optionally provided for additional stability. Alumen478 allows expansion fluid to be introduced intonosecone474 to expand it to the configuration shown in FIG. 40. FIG. 41 illustratesnosecone474 in the compacted, removal configuration, which facilitates the removal of the nosecone assembly fromsecond conduit20. In the removal configuration,nosecone474 elastically returns to a narrow configuration having approximately the same profile astubular shaft472.
• FIGS.[0153]42-43 illustrate a typical use ofnosecone assembly470. As illustrated in FIG. 42 (which corresponds to FIG. 21, above),nosecone474 is used to introduceconnector structure200 andballoon catheter300 into opening22 in the second conduit.Nosecone474 is in the introduction configuration, and shields first members218 (not visible in FIG. 42).Nosecone474 may be advanced into thelumen24 ofsecond conduit20, as illustrated in FIG. 34, above. FIG. 43 illustrates the condition in the procedure afterballoon302 has been expanded to enlargeconnector structure200 and attach first conduit10 (illustrated with dashed lines) tosecond conduit20.Nosecone474 may be removed from the operative site by draining the expansion fluid and allowingnosecone474 to return to the configuration of FIG. 41, and by subsequently withdrawingtubular shaft472 andnosecone474.
• It will be understood that the foregoing is only illustrative of the principles of this invention, and that various modifications can be made by those skilled in the art without departing from the scope and spirit of the invention. For example, the number and shape of the annularly enlargeable connector cells can be different from what is shown in the drawings herein. The number of axially adjacent rows of annularly enlargeable cells can be different from the numbers of such rows that are shown herein (i.e., two rows of cells in the case of connectors[0154]200). For example, a connector may have one, two, three, four, or more rows of cells. The cells may have any of many forms, depending on the desired degree of expansion and final radial strength. The number of cells, the number of rows of cells, the size of the cells, and the geometry of the cells can all be selected to control the expansion, strength, and sizing of the finished connector. The number and shape of the radially outwardly deflectable connector members can also differ from what is shown herein.
• Although considerable variation in the connectors of this invention is thus possible and contemplated, in general such connectors comprise a unitary structure disposed annularly about a longitudinal axis. It will be appreciated that, in general, the structure of the connectors of this invention is such that radial enlargement of the connector reduces the axial spacing between the above-mentioned first and second members. This helps the connector draw together in a fluid-tight way the two body fluid conduits that are to be connected by the connector. In the embodiment shown in FIGS.[0155]2-5, for example, annular enlargement of cells defined bymembers230a/230b/232a/236band230b/230c/234b/238ccauses a decrease in the axial spacing betweenmembers218, on the one hand, andmembers222, on the other hand. The above-described axial shortening of the connector advantageously applies compressive forces (for sealing) to the body fluid conduits being connected.
• In general, most of the deformation of the connectors of this invention is preferably plastic strain and therefore permanent. The deformation thus referred to includes both the above-described radially outward deflection of members like[0156]218 and222, etc., and the above-described radial enlargement of the connector.
• The radially outwardly deflectable members or portions of the connector may also include barbs, hooks, spikes, loops, clips, or suture rings.[0157]
• The connectors of this invention may be constructed so that different portions of the connector annularly enlarge in response to different amounts of applied annular enlargement force. For example, in the embodiment shown in FIGS.[0158]2-5, the portions of the structure associated withlengths212 and216 in FIG. 2 may be made so that they are less resistant to inflation of aballoon302 inside theconnector200 than portions of the structure associated withlength214. In an application of the type shown in FIGS.2-5 this causes these less resistant portions to annularly enlarge by deflecting radially out insidesecond conduit20 before the remainder of the connector begins to significantly annularly enlarge. This early response of the less resistant portions insidesecond conduit20 may help to ensure that the connector does not slip out of engagement withsecond conduit20 during annular enlargement of theconnector200. This technique of making different portions of the connector with different strengths can be used to provide any sequence or phasing of annular enlargement of various portions of the connector. Alternatively or additionally, the connector can be shaped, molded, or phased in any desired way by providing aballoon structure302 which is shaped, molded, or phased in that way. For example,balloon structure302 may comprise two or more separately inflatable balloons of the same or different inflated circumferential size. Two such balloons may be axially displaced from one another inside the connector so that axially different portions of the connector can be annularly enlarged at different times and/or by different amounts.
• Radiologically (e.g., x-ray) viewable markers can be used anywhere on the[0159]connectors200 and/or delivery apparatus (e.g.,300 or400) or locatingring500 of this invention to facilitate radiologic observation of the proper placement and deployment of a connector in a patient if the connector-utilizing procedure is such that more direct visual observation is not possible or sufficient. One way to enhance the radiologic viewability of connectors in accordance with this invention is to make them from clad tubing. Clad tubing has two (or more) substantially concentric layers of metal, each with a desired property. For example, clad tubing may have a tantalum layer over a stainless steel layer. The tantalum layer provides radiodensity, thereby making aconnector200 that is cut from this material radiologically viewable. The stainless steel layer provides rigidity to the connector. The medial section can be ground to reduce the thickness ratio to favor the tantalum. This improves the ability for balloon expansion. Althoughconnector200 may thus be made of two or more layers of different materials, the tube and the connector are still accurately described as unitary, one-piece, or integral. As an alternative to using clad tubing, the connector may be plated with a radiologic material to give it a desired radiodensity. Another example of a material suitable for radiologic layer is platinum.
• The connectors of this invention may also be made of a super-elastic material such as nickel-titanium (“nitinol”), which would allow a similar geometry as stainless steel to self-deploy or actuate in-vivo.[0160]
• It will be appreciated that the fact that the connectors of this invention can be initially relatively small in circumference, and that they can be remotely controlled to position them in the patient and to then annularly expand them for final deployment, facilitates use of these connectors and associated apparatus at remote and/or inaccessible locations in a patient. For example, a connector of this invention may be delivered into and installed in a patient (using[0161]apparatus300,400) through relatively small instrumentation such as laparoscopic apparatus, a cannula, or an intraluminal catheter. Thus a connector and associated apparatus (e.g.,apparatus300,400) of this invention can be used in any of the procedures mentioned earlier in this specification, and in particular in procedures and with other elements shown in any of above-mentioned references WO 98/16161, U.S. Pat. No. 5,976,178, U.S. Pat. No. 6,120,432, WO 98/55027, and U.S. Pat. No. 6,475,222. Alternatively, the connector and/or apparatus (e.g.,apparatus300,400) of this invention can be used in more traditional or conventional surgical procedures or in other, known, less invasive or minimally invasive procedures. As just some examples of possible uses of the connectors and apparatus of this invention, they can be used to perform an anastomosis to a beating or still heart without the use of sutures or direct access.
• Among the advantages of the invention are that it eliminates suturing and reduces the time required to produce an anastomosis. In major circulatory system repair procedures such as cardiac bypass procedures, this can reduce cardiopulmonary pump time, which is of great benefit to the patient. The invention provides improved flow dynamics, e.g., from a graft to the coronary artery. The blood entrance angle can be engineered into the connector geometry rather than relying on suture skill or technique. The invention eliminates possible suture injury to conduits. At the high stress site of an anastomosis sutures are eliminated. The connector and a graft can be delivered percutaneously, e.g., as in several of the references that are mentioned above. Direct access required for suturing is eliminated. An anastomotic connection can be made to a beating heart.[0162]

Claims (36)

What is claimed is:

1. Introducing apparatus associated with a first vessel for introduction of a portion of the first vessel into an opening of a second vessel for making an anastomotic connection between the first vessel and the second vessel with a connector structure, comprising:

a distal tapered portion;

a intermediate portion extending from the distal tapered portion and flexible between a compacted configuration and an un-compacted configuration; and

an elongated tubular portion extending from the intermediate portion and configured for positioning within an internal lumen of the first vessel;

wherein the moving the intermediate portion from the compacted configuration to the uncompacted configuration advances the distal tapered portion distally with respect to the elongated tubular portion.

2. Introducing apparatus defined inclaim 1, wherein the distal tapered portion, the intermediate portion and the elongated tubular portion define a common internal space in fluid communication.

3. Introducing apparatus defined inclaim 1, wherein the intermediate portion is configured to flexibly move between the compacted configuration and the un-compacted configuration upon introduction of fluid into the common internal space.

4. Introducing apparatus defined inclaim 2, wherein the distal tapered portion and the intermediate portion in the tapered configuration define a substantially rigid structure in proportion to the pressure of the expansion fluid in the common internal space.

5. Introducing apparatus defined inclaim 1, wherein the intermediate portion, the distal tapered portion and the elongated tubular portion are flexible between a substantially straight configuration and a substantially curved configuration defining an angle of between about 0 degrees and about 90 degrees.

6. Introducing assembly defined inclaim 1, wherein the intermediate portion in the compacted configuration defines an annular recess for receiving a portion of the connector structure.

7. Introducing apparatus associated with a first vessel for introduction of a portion of the first vessel into an opening of a second vessel for making an anastomotic connection between the first vessel and the second vessel with a connector structure, comprising:

an elongated tubular portion configured for positioning within an internal lumen of the first vessel and defining a distal tip; and

a plurality of tabs flexibly attached to the distal tip of the elongated tubular portion, movable between a first configuration extending proximally and radially outward from the distal tip to define a substantially conical configuration and a second configuration extending distally from the distal tip.

8. Introducing apparatus associated with a first vessel for introduction of a portion of the first vessel into an opening of a second vessel for making an anastomotic connection between the first vessel and the second vessel with a connector structure, comprising:

an elongated tubular portion configured for positioning within an internal lumen of the first vessel and defining a distal tip; and

an expandable balloon structure attached to the distal tip of the elongated tubular portion, expandable between a first unexpanded configuration and a second configuration defining a substantially conical shape.

9. Introducing apparatus associated with a first vessel for introduction of a portion of the first vessel into an opening of a second vessel for making an anastomotic connection between the first vessel and the second vessel with a connector structure, comprising:

an elongated tubular portion configured for positioning within an internal lumen of the first vessel and defining an internal lumen; and

an expandable structure defining a first collapsed configuration when positioned within the internal lumen of the elongated tubular portion and a second configuration expandable to conical configuration when released from the internal lumen of the elongated tubular configuration.

10. Apparatus for use with a connector structure for making an anastomotic connection between the first vessel and the second vessel, the connector structure expandable between a first size and a second size to attach the first vessel and the second vessel, the apparatus comprising:

a support structure;

an expandable balloon comprising a proximal portion attached to the support structure and a distal portion attached to the support structure in an inverted manner, such that the expandable balloon defines a maximum diameter at a position substantially adjacent the distal end portion of the expandable balloon.

11. Apparatus defined inclaim 10, wherein the expandable balloon defines the maximum diameter at a distance of about 2.5 mm from the distal end portion of the expandable balloon.

12. Apparatus defined inclaim 10, wherein the support structure comprises an inner tubular shaft and an outer tubular shaft, and wherein the proximal portion of the expandable balloon is attached to the outer tubular shaft and the distal portion of the balloon is attached to inner tubular shaft in the inverted manner.

13. Apparatus defined inclaim 12, wherein the outer tubular shaft and the inner tubular shaft are attached at a location adjacent to the location of attachment of the proximal portion of the balloon to the outer tubular shaft.

14. Apparatus defined inclaim 10, wherein the expandable balloon comprises a shoulder portion adjacent the distal end portion to retain the connector structure in position about the expandable balloon.

15. Apparatus defined inclaim 10, wherein the support structure and the expandable balloon are each provided with a junction to allow the support structure and the expandable balloon to be separated and reconnected.

16. Apparatus for inserting a distal portion of a hollow annular anastomotic connector into an aperture in a side wall of a body tissue conduit in a patient comprising:

a structure comprising a selectively inflatable and deflatable balloon, the structure having an exterior surface that is reconfigurable, in use, from an early configuration to a subsequent configuration, the early configuration having annular periphery that gradually increases from a first relatively small value at a distal end of the early configuration to a second relatively large value at a more proximal portion of the early configuration, and the subsequent configuration having annular periphery that is substantially free of abrupt increases in annular periphery in the distal direction, the structure inside the more proximal portion of the early configuration defining an annular hollow that is open in the proximal direction for substantially concentrically receiving the distal portion of the connector.

17. The apparatus defined inclaim 16 wherein the structure is further configured so that in the subsequent configuration the distal portion of the connector is no longer disposed in an annular hollow.

18. The apparatus defined inclaim 16 wherein the structure is further configured so that in the subsequent configuration the structure can be withdrawn from the patient by pulling it proximally through the connector.

19. The apparatus defined inclaim 16 wherein the structure is further configured to convert from the early configuration to the subsequent configuration while inside the lumen of the body tissue conduit and without injuriously deforming the body tissue conduit.

20. The apparatus defined inclaim 16 wherein the structure comprises a member of flexible polymeric material.

21. The apparatus defined inclaim 16 wherein the balloon has a proximal annular portion that initially defines the annular hollow when the balloon is not inflated.

22. The apparatus defined inclaim 21 wherein the balloon is configured so that inflation of the balloon substantially eliminates the hollow and thereby exposes the distal portion of the connector.

23. The apparatus defined inclaim 16 wherein the balloon has a proximal annular portion that initially defines the annular hollow when the balloon is inflated.

24. The apparatus defined inclaim 23 wherein the balloon is configured so that deflation of the balloon substantially eliminates the hollow and thereby exposes the distal portion of the connector.

25. The apparatus defined inclaim 16 wherein a proximal portion of the balloon is initially folded in the proximal direction over the distal portion of the connector.

26. The apparatus defined inclaim 25 wherein the balloon is configured to unfold when inflated and to thereby uncover the distal portion of the connector.

27. The apparatus defined inclaim 16 wherein a wire is attached to the distal end of the structure such that the wire runs out of the structure and connector in the proximal direction.

28. The apparatus defined inclaim 27 wherein the wire is substantially rigid and capable of altering the structure from the early configuration to the subsequent configuration by advancing the wire in the distal direction.

29. The apparatus defined inclaim 27 wherein the wire is utilized to indicate when the transformation from the early configuration to the subsequent configuration is complete.

30. Apparatus for inserting a distal portion of a hollow annular anastomotic connector into an aperture in a side wall of a body tissue conduit in a patient comprising:

a structure having an exterior surface that is reconfigurable, in use, from an early configuration to a subsequent configuration, the early configuration having annular periphery that gradually increases from a first relatively small value at a distal end of the early configuration to a second relatively large value at a more proximal portion of the early configuration, and the subsequent configuration having annular periphery that is substantially free of abrupt increases in annular periphery in the distal direction, the structure inside the more proximal portion of the early configuration defining an annular hollow that is open in the proximal direction for substantially concentrically receiving the distal portion of the connector; and

annularly enlargeable componentry disposed substantially concentrically inside the connector and configured to selectively annularly enlarge the connector.

31. The apparatus defined inclaim 30 wherein the componentry is additionally configured to selectively return to a less enlarged state after annularly enlarging the connector.

32. The apparatus defined inclaim 31 wherein the componentry is configured, in its less enlarged state, for proximal removal from the annularly enlarged connector.

33. The apparatus defined inclaim 30 wherein the componentry comprises:

a selectively inflatable and deflatable balloon.

34. The apparatus defined inclaim 30 wherein the structure and the componentry are separately controllable for substantially independent operation.

35. The apparatus defined inclaim 30 wherein the componentry has a hollow annular configuration disposed substantially concentrically inside the connector, and wherein the structure is at least partly supported relative to the componentry by support elements that pass concentrically through the hollow annular configuration.

36. The apparatus defined inclaim 30 wherein the componentry is further configured to annularly enlarge the connector into engagement with the side wall of the body tissue conduit.

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