Source: http://www.google.com/patents/US7189203?dq=6,587,403
Timestamp: 2016-04-30 04:28:24
Document Index: 418439180

Matched Legal Cases: ['art.\n3', 'art.\n14', 'art.\n15', 'art 43', 'art 172', 'art 172', 'art 172', 'art 172', 'art 172', 'art 172', 'art 172', 'art 172', 'art 172', 'art 2']

Patent US7189203 - Cardiac harness delivery device and method - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inPatentsThe apparatus includes and elongate body having a proximal portion and a distal portion. The body includes a cavity sized to contain a cardiac harness in a compacted configuration and also includes a plurality of elongate push rods movable with respect to the body. The cardiac harness is releasably connected...http://www.google.com/patents/US7189203?utm_source=gb-gplus-sharePatent US7189203 - Cardiac harness delivery device and methodAdvanced Patent SearchPublication numberUS7189203 B2Publication typeGrantApplication numberUS 10/715,150Publication dateMar 13, 2007Filing dateNov 17, 2003Priority dateNov 15, 2002Fee statusLapsedAlso published asCA2504555A1, CA2504555C, EP1560541A2, US7338435, US7361139, US7500946, US7572219, US20040210104, US20050033322, US20050049611, US20050055032, US20050090707, US20050182290, WO2004045456A2, WO2004045456A3Publication number10715150, 715150, US 7189203 B2, US 7189203B2, US-B2-7189203, US7189203 B2, US7189203B2InventorsLilip Lau, Joshua WallinOriginal AssigneeParacor Medical, Inc.Export CitationBiBTeX, EndNote, RefManPatent Citations (103), Non-Patent Citations (86), Referenced by (32), Classifications (15), Legal Events (5) External Links: USPTO, USPTO Assignment, EspacenetCardiac harness delivery device and method
US 7189203 B2Abstract
an elongate body having a proximal portion and a distal portion, said body having a cavity sized to contain said harness in a compacted configuration;
a plurality of elongate push rods longitudinally movable with respect to said body, said cardiac harness releasably connected to each of said push rods such that advancement of said push rods in a distal direction moves said harness from said compacted configuration in said cavity to an expanded configuration outside said cavity, said apparatus further comprising a releasing member which releases the connections between said push rods and said harness upon actuation of said member by a user; and
wherein said cardiac harness is releasably connected to each push rod at at least first and second longitudinally spaced locations.
2. The apparatus of claim 1, additionally comprising a positioning arrangement configured to secure said apparatus in a desired position relative to a heart.
3. The apparatus of claim 2, wherein said positioning arrangement comprises suction cup member.
4. The apparatus of claim 1, additionally comprising a handle and a control assembly, said handle being fixed to said proximal portion of said elongate body and said control assembly supporting said plurality of elongate push rods.
5. An apparatus for delivering a cardiac harness, comprising:
a support member, said cardiac harness being preloaded on said support member and attached to said support member by a line, said line comprised of a series of interconnected loops which form a releasable stitch; and
wherein said cardiac harness is releasably connected to each support member at at least first and second longitudinally spaced locations.
6. The apparatus of claim 5, wherein an end one of said interconnected loops of said stitch is retained by an anchoring member which prevents unravelment of said series of loops, and wherein the release of said loop from said anchoring member allows unravelment of said series of interconnected loops.
7. The apparatus of claim 6, wherein said anchoring member is fixed for movement with a release member, an end of said line being attached to said release member,
and wherein movement of said release member in a direction away from said support member releases said loop from said anchoring member and unravels said series of interconnected loops.
8. An apparatus for delivering a cardiac harness, comprising:
a plurality of push rods longitudinally movable with respect to said body, said cardiac harness releasably connected to each of the push rods such that movement of said push rods in a distal direction advances said harness onto said heart, said harness being releasable from the push rods such that the push rods may be withdrawn from said harness proximally along a withdrawal path while said harness remains on said heart, said distal portion of said push rods having an inward facing surface which presses against said harness during said withdrawal, said inward facing surface configured such that non-frictional force -components parallel to said path and attributable to forces exerted by said inner surface on said harness are directed distally, without substantial non-frictional force components directed proximally; and
9. The apparatus of claim 8, wherein the distal portions of the push rods splay outwardly during advancement.
10. The apparatus of claim 8, wherein the distal portions of the push rods are canted outwardly.
11. A method of delivering a cardiac harness, comprising:
providing a cardiac harness that is preloaded on a support member, said harness attached to said support member by a line forming a releasable stitch so that said cardiac harness is releasably connected to said support member at at least first and second longitudinally space locations;
positioning said harness so that said harness surrounds a portion of a heart of a patient; and
disconnecting said harness from said support member by releasing said releasable stitch without cutting said line.
12. The method of claim 11, wherein said line comprises a series of interconnected loops, including a retention loop, said releasing comprising releasing said retention loop and unraveling said series of loops.
13. The method of claim 11, wherein said positioning comprises positioning said harness to apply a compressive force to said portion of the heart.
14. The method of claim 11, wherein said positioning comprises orienting said harness in a predetermined orientation with respect to said heart.
15. The method of claim 11, wherein said positioning comprises forming an incision in the patient and inserting the harness through the incision in a compacted configuration.
16. The method of claim 15, comprising expanding said harness into an expanded configuration after inserting said harness through said incision.
17. The method of claim 16, comprising moving a releasing member outside the patient's body to release said stitch.
18. The method of claim 17, comprising using said releasing member to pull the line through the incision and out of the patient's body.
FIG. 4 is an enlarged view of a distal portion of the delivery device of FIG. 1 indicated by line 4—4 of FIG. 3.
FIG. 5 is a cross-sectional view of one of the plurality of push rods taken along line 5—5 of FIG. 4. FIG. 5 illustrates a line, forming a releasable stitch, to secure the cardiac harness to the push rod.
FIG. 6 is an enlarged, side view of the control assembly of the delivery device of FIG. 1 indicated by line 6—6 of FIG. 3. The illustrated control assembly includes a body portion, a cover and a release member.
FIG. 7 a is a plan view of the body portion of the control assembly of FIG. 6, taken along line 7—7 of FIG. 6. FIG. 7 a illustrates a plurality of channels defined by the body portion of the control assembly. The channels are configured to receive portions of the line associated with each push rod.
FIG. 8 is a cross-sectional view of the control assembly of FIGS. 6 and 7, taken along line 8—8 of FIG. 7 a. FIG. 9 is a cross-sectional view of the control assembly of FIGS. 6 and 7, taken along line 9—9 of FIG. 7 a. FIG. 10 is a cross-sectional view of one of the plurality of elongate push rods, taken along line 10—10 of FIG. 8.
FIG. 12 is a cross-sectional view of a distal tip of one of the plurality of elongate push rods, taken along line 12—12 of FIG. 4.
FIG. 13 is a side elevational view of an introducer sleeve portion of an introducer assembly for facilitating introduction of the delivery device of FIGS. 1–12 through the pericardium surrounding the heart of a patient.
FIG. 19 is a side elevational view of the delivery device of FIGS. 1–12, with a pump member, or, specifically, a syringe, attached to a suction assembly of the delivery device. The suction assembly includes a suction cup member, which is configured to securely hold the heart relative to the delivery device during advancement of the cardiac harness over the heart.
FIG. 25 is a cross-sectional view of the loading device of FIG. 24, taken along the line 25—25 of FIG. 24.
FIG. 26 is a bottom plan view of the loading device of FIG. 24, taken along the line 26—26 of FIG. 24.
FIG. 31 is an enlarged view of a distal portion of push rod of FIG. 30 taken along line 31—31.
FIG. 32 is cross-sectional view of the push rod of FIG. 30 taken along line 32—32.
FIGS. 1–11 illustrate a preferred embodiment of a cardiac harness delivery device, which is generally referred to by the reference numeral 30. In a preferred embodiment, the delivery device 30 is configured to releasably support a cardiac reinforcement device (CRD), such as a cardiac harness, and assist in the advancement of the cardiac harness over the heart of a patient. Once the cardiac harness is positioned on the heart, the delivery device 30 preferably is configured to release the harness and be retractable without causing undesired shifting of the cardiac harness relative to the heart.
Preferably, the plurality of push rods 40 extend in a distal direction from the control assembly 38 and pass through the housing 36. With reference also to FIG. 2, a cardiac harness 42 is releasably supported on the distal end portions of the elongate push rods 40 in a compacted configuration within the housing 36. Preferably, the cardiac harness 42 comprises an elastic sleeve configured to fit around the heart and to exert a compressive force on the heart. In the illustrated embodiment, the harness 42 comprises several interconnected rows of undulating elastic members. Preferred cardiac harnesses are described in greater detail in U.S. patent application Ser. No. 09/634,043, filed Aug. 8, 2000; U.S. application Ser. No. 10/242,016, filed Sep. 10, 2002; U.S. application Ser. No. 10/287,723, filed Oct. 31, 2002; and U.S. application Ser. No. 60/409,113, filed Sep. 5, 2002, the entirety of each of which are incorporated by reference herein. It is to be understood that aspects of the delivery device 30 discussed herein can be used in connection with several other types of cardiac harnesses.
In the embodiment shown in FIGS. 1–3, the housing 36 is generally cylindrical. It is to be understood that, in another preferred embodiment, the housing is elliptical. As such, the housing may have a major axis and minor axis. This configuration may be especially beneficial for advancing the housing through body passages having relatively narrow clearance, such as advancing the housing between ribs.
With continued reference to FIGS. 1–4, the delivery device 30 preferably includes a positioning arrangement configured to hold the delivery device 30 in a desired position relative to the heart 43. In the illustrated arrangement, the positioning arrangement comprises a suction cup member 52 supported on a distal end of the shaft 34. A tube 54 extends through the shaft 34 and is connected to the suction cup member 52. A distal end of the tube 54 opens into an interior space defined by the suction cup member 52. The proximal end of the tube 54 includes a connector 58 that allows connection of the tube 54 to a pump member such as a syringe or other source of vacuum. Accordingly, once the delivery device is properly positioned, air may be withdrawn from within the tube 54 to create a vacuum condition within the interior space of the suction cup member 52, thereby permitting the suction cup member 52 to securely hold the heart of a patient.
With reference next to FIG. 5, preferably the cardiac harness 42 is secured to a distal end portion of each of the plurality of push rods 40 by a line, generally referred to by the reference numeral 60, that is configured into a releasable stitch. As shown in FIG. 5, a line 60 a is associated with one of the plurality of push rods 40 and is arranged into a releasable stitch configured to secure the cardiac harness 42 to the push rod 40. Although not individually illustrated, preferably, each of a plurality of such lines 60 b–f secure the cardiac harness 42 to a corresponding one of the remainder of push rods 40 in a manner similar to line 60 a, which is illustrated in FIG. 5. Desirably, the line 60 a is arranged into a series of interconnected loops that are releasable by actuation of the control assembly 38 in a manner described in greater detail below. Release of the interconnected loops, in turn, releases the cardiac harness 42 from the push rod 40.
The illustrated push rod 40 includes a plurality of throughholes, or openings 62, 64 a–i, extending from an outward facing surface 40 a of the push rod 40 to an inward facing surface 40 b of the push rod 40. In the illustrated embodiment, ten openings 62, 64 a–i are provided, however, other numbers of openings may be provided to permit other types and sizes of cardiac harnesses to be secured to the delivery device 30. Desirably, the openings 64 a–i are equally spaced from one another, with the space between the distal most opening 62 and the opening 64 a being less than the equal spacing between openings 64 a–i. Preferably, the space between the openings 62 and 64 a is sufficient to accommodate the diameter of an individual wire, which forms an uppermost row 66 a of the illustrated cardiac harness 42. In addition, preferably the remainder of the openings 64 a–i are spaced from one another a distance substantially equal to a height of one row 66 b–h of the cardiac harness. Such an arrangement permits positioning of the wire of a single row 66 b–h of the cardiac harness 42 between each pair of openings 64 a–i. Although the line 60 a is shown as being spaced from both the outward facing surface 40 a and inward facing surface 40 b in FIG. 5, preferably, the line 60 a is pulled tight after passing through the openings 62, 64 a–i to secure the cardiac harness 42 directly against the inward facing surface 40 b of the push rod 40. The spaced orientation, of the line 60 a depicted in FIG. 5 is merely for the purpose of clearly illustrating the configuration of the releasable stitch.
Preferably, in a similar manner, interconnected loops 82 c through 82 h are formed. Each of the loops 82 c–h are positioned on the outward facing surface 40 a side of the push rod 40 and correspond with respective securing portions 84 c–84 h, which secure a respective wire of each row 66 c–h of the cardiac harness 42 against an inward facing surface 40 b of the push rod 40. Although, preferably, each securing portion 84 a–h of the line 60 a secures a single row 66 a–h of the cardiac harness 42 to the push rod 40, in other configurations more or less than one row of the harness 42 may be secured by a single securing portion 84 a–h. Further, although in the illustrated embodiment, one hole 64 of the push rod 40 generally corresponds to one row 66 of the associated harness 42, it is to be understood that, in other embodiments, one row 66 may correspond with more or less than one hole 64 and more or less than one securing portion 84.
In accordance with this arrangement, the cardiac harness 42 is secured to each push rod 40 at at least two longitudinally-spaced locations. In the illustrated embodiment, the harness 42 is secured to each push rod 40 at eight longitudinally-spaced locations, or each of the eight rows 66 a–h of the cardiac harness 42 is secured to each of the push rods 40.
Preferably, a proximal-most, or retaining, loop 86 a is arranged to inhibit the remaining loops 82 a–h from unraveling prematurely. In a preferred arrangement, the retaining loop 86 a passes through the next distal loop 82 h in a manner similar to the arrangement of loops 82 a–h as described above. The retaining loop 86 a, however, has a sufficient length to extend in a proximal direction along the push rod 40 to the control assembly 38. Preferably, the loop 86 a passes through the lowermost opening 64 i to the inward facing surface 40 b side of the push rod 40 and is extended along the push rod 40 in a proximal direction. Within the control assembly 38, the loop 86 a is looped around a retaining rod 68 (shown schematically in FIG. 5).
In an alternative arrangement, the retaining loop 86 a may not be looped around the retaining rod 68, but may be inhibited from unraveling by an alternatively suitable arrangement. For example, it is contemplated that the retaining loop 86 a may be formed approximately the same size as the remainder of the interconnected loops 82 a–h and may be tucked between the adjacent loop 82 h and the outward facing surface 40 a of the push rod 40. Thus, the retaining loop 86 a is inhibited from unraveling by a frictional force of the adjacent loop 82 h holding the retaining loop 86 a against the outward facing surface 40 a. When a sufficient pulling force is applied to the end portion 100, the retaining loop 86 a overcomes the frictional force of the loop 82 h and the outward facing surface 40 a and is drawn through the opening 64 h, thus permitting unraveling of the releasable stitch.
With reference next to FIGS. 6–9, a preferred embodiment of the control assembly 38 is described in greater detail. As indicated above, the control assembly 38 is movable axially relative to the shaft 34 of the delivery device 30. Preferably, the control assembly 38 includes a position-retaining arrangement, such as a friction brake assembly 102, for example. The friction brake assembly 102 is configured to permit the control assembly 38 to be selectively retained in a desired position relative to the shaft 34. Preferably, the friction brake assembly 102 is configured to be easily actuatable, along with movement of the control assembly 38, by one hand of a user of the device 30.
With reference also to FIG. 7 a, in a preferred embodiment, the body portion 112 includes six passages 114, referred to specifically by the reference numerals 114 a–114 f. As a matter of convenience, the passages 114 a–114 f are referred to herein by their relative positions as depicted in FIGS. 7 a–c. As such, passages 114 a and 114 f comprise an upper pair of passages, passages 114 b and 114 e comprise a central pair of passages and passages 114 c and 114 d comprise a lower pair of passages. Passage 114 a is positioned to the right of a vertical axis AV passing through the center of the shaft 34 in FIGS. 7 a and 7 b. The remaining passages 114 b–114 f are distributed in a clockwise direction in an equally spaced relation to one another.
With particular reference to FIGS. 7 a and 8, each of the above-described passages 114 a–f are configured to receive a proximal end of one of the push rods 40. The push rods 40 are secured within their respective passages 114 a–f by a shaft 150 passing through an opening (not shown) within the push rod 40 and being supported by the body portion 112 of the control assembly 38. Thus, as described above, the push rods 40 are fixed for axial movement with the control assembly 38.
In the illustrated embodiment, the push rods are supported generally in the center of the passages 114 a–f, with their respective inner surfaces 40 a arranged generally tangentially to the center axis of the shaft 34. In addition, with reference also to FIG. 10, a center portion 40 c of each push rod 40 is generally semicircular in cross-section such that the inward facing surface 40 a defines a recess 152. Preferably, the recess 152 is configured to accommodate one of the lines 60 a–f, respectively, as described above in relation to FIG. 5. As shown in FIG. 10, the line 60 a consists of the retaining loop 86 a and the free end 100 a, as is also described above in relation to FIG. 5.
With reference next to FIGS. 7 a–c, a plurality of channels, referred to generally by the reference numeral 122, are defined by a proximal end surface of the body portion 112 of the control assembly 38. Each of the channels 122 interconnect two of the passages 114 a–114 f and are configured to accommodate a portion of one or more lines, such as the line 60 a, as is described in greater detail below. Specifically, in a preferred arrangement, a first channel 122 a extends generally parallel to the vertical axis AV and interconnects the passages 114 a and 114 c. Similarly, a second channel 122 b extends generally parallel to the channel 122 a and interconnects the passages 114 d and 114 f. Third and fourth channels 122 c, 122 d interconnect the passages 114 a and 114 b and passages 114 b and 114 c, respectively. Similarly, fifth and sixth channels 122 e, 122 f interconnect passages 114 f and 114 e and passages 114 e and 114 d, respectively.
Preferably, each of the channels 122 a–f are arranged to generally intersect a center of the passages 114 that they interconnect. The channels 122 a, 122 c and 122 d form a triangular shape on the right-hand side of the vertical axis AV. The channels 122 b, 122 e and 122 f form a triangular shape on the left-hand side of the vertical axis AV, which shape is a mirror image of the triangular shape defined by channels 122 a, 122 c and 122 d. An additional channel 134 interconnects the passages 114 a and 114 f and extends in a direction generally parallel to a horizontal axis AH as depicted in FIGS. 7 a–c. The channel 134 is defined by a proximal surface of the body portion 112 and, preferably, is substantially larger in both width and depth than the channels 122 a–f. Preferably, the channel 134 has a width approximately one-half the diameter of the passages 114 a, 114 f and is semicircular in cross-sectional shape. Desirably, the channel 134 passes approximately through the centers of the passages 114 a, 114 f. The control assembly 38 also includes a release member 136 that preferably is configured to selectively release the releasable stitch, thereby releasing the cardiac harness 42 from the delivery device 30. With reference also to FIG. 9, a portion of the release member 136 preferably is received within a cavity 137 of the body portion 112, which is located on an opposite side of the horizontal axis AH from the channel 134. The cavity 137 defines a support surface 138 which, along with a corresponding portion of the distal surface of the cover 116 (see FIG. 6), supports a portion of the release member 136.
Desirably, the retaining rod 68, illustrated schematically in FIG. 5, comprises a pair of rods 68 a,b that are part of the release member 136 as shown in FIGS. 7 a–c and 9. The pair of rods 68 a,b extend outwardly (depicted vertically in FIGS. 7 a–c) from the release member 136 and are slidably received in corresponding bores 139 formed within the body portion 112 of the control assembly 38. Preferably, the bores 139 are spaced on opposing sides of the vertical axis AV. The rods 68 a,b preferably are long enough such that distal end portions of the rods 68 a,b pass through the channel 134.
With reference again to FIGS. 7 a–c and 8, the attachment portion 146 preferably includes a plurality of holes 148 extending therethrough in a direction generally parallel to a longitudinal axis of the shaft 34. In the illustrated embodiment, there are six holes 148, one hole 148 corresponding to each of the passages 114 a–f. With particular reference to FIG. 7 b, the free ends 100 of the lines 60 preferably are tied to corresponding holes 148 of the attachment portion 146. As a more specific example, free end 100 a of line 60 a extends downwardly along the corresponding rod 40 (see FIG. 10) and enters passage 114 a, from which it is directed into channel 122 a and into the cavity 142. The free end 100 a is then tied onto one of the holes 148 of the attachment portion 146. Thus, the free end 100 a of the line 60 a is affixed to the release member 136.
The other free ends 100 b–f and retention loops 86 b–f preferably are arranged similarly, although they are customized for their respective positions in the device. For example, free end 100 b extends from passage 114 b through channel 122 d into the cavity 142 and is affixed to a hole 148. Free end 100 c is directed directly from passage 114 c into the cavity 142 and is affixed to a hole 148. Free end 100 d also extends directly from the passage 114 b into the cavity 142 and is affixed to a hole 148. Free end 100 e extends out of passage 114 e through channel 122 f into the cavity 142 and is affixed to a hole 148. Free end 100 f extends from passage 114 f and through channel 122 b into the cavity 142 and is affixed to a hole 148.
With regard to the retention loops 86, retention loop 86 b extends from passage 114 b through channel 122 c into channel 134 and is looped around the right rod 68 a. Loop 86 c extends from passage 114 c through channel 122 a into channel 134 and is looped about the right rod 68 a. Retention loop 86 d extends from passage 114 d through channel 122 b into channel 134 and is looped about the left rod 68 b. Retention loop 86 e extends out of passage 114 e through channel 122 e into channel 134 and is looped about the left rod 68 b. Retention loop 86 f extends from passage 114 f into channel 134 and is looped about the left rod 68 b. In operation, the release member 136 is configured to release loops 86 a–f, unravel the lines 60 a–f from the push rods 40 and thereby release the cardiac harness 42 from the push rods 40. More specifically, and with reference to FIG. 7 c, as the release member 136 is pulled away from the body 112 of the control assembly 38, the rods 68 a–b are also pulled through the channel 134 such that the retention loops 86 a–f are released from the rods 68 a–b. Simultaneously, because the free ends 100 a–f of the lines 60 a are tied onto one of the holes 148 of the attachment portion 146, the release member 136 pulls on the free ends 100 a–f. Since the retention loops 86 a–f are released from the rods 68 a–b, pulling of the free ends 100 a–f unravels the lines 60 a–f, thereby releasing the cardiac harness 42 from the push rods 40, as is described further below in connection with FIGS. 11 a–c. FIGS. 11 a through 11 c illustrate a preferred sequence of unravelment of the releasable stitch of line 60 a. With additional reference to FIG. 5, as described above, in a secured position of the releasable stitch, preferably the retaining loop 86 a is looped around the rod 68 of the release member 136 to inhibit unravelment of the stitch. However, when the rod 68 is retracted to release the retaining loop 86 a, and the free end 100 a is pulled by the release member 136, the retaining loop 86 a is pulled through the loop 82 h by the free end 100 a. Returning to FIG. 11 a, as the release member 136 continues to be pulled away from the main body 112 of the control assembly 38, the loop 82 h is pulled through the loop 82 g in a manner similar to that described above. With reference to FIG. 11 b, as the free end 100 a continues to be pulled, each successive loop 82 g, 82 f, 82 e, 82 d, 82 c, 82 b, 82 a is pulled through its distally-adjacent loop. In FIG. 11 b, loop 82 e is illustrated as being pulled through loop 82 d. Subsequently, loop 82 d is pulled through loop 82 c, which is then pulled through loop 82 b. Finally, loop 82 b is finally pulled through the initial loop 82 a, as illustrated in FIG. 12 c. The initial loop 82 a, which preferably comprises a slip knot 80, preferably completely unties itself and is pulled through the distal-most opening 62 to release the cardiac harness 42 from the push rod 40. In a similar manner, because the remainder of the lines 60 b–f are also secured to the release member 136, the cardiac harness 42 preferably is simultaneously released from each of the plurality of push rods 40.
The distal end of the push rod 40 includes a tip portion 154 that, in a preferred arrangement, is canted outwardly away from a center axis of the shaft 34. Thus, the inner surface 40 b of the tip portion 154 defines an angle θ with respect to a line 156 extending from the inner surface 40 b of the remainder of the push rod 40. In a preferred arrangement, the angle θ is between about 5–60 degrees, and more preferably is between about 10–45 degrees. Most preferably, the angle is between about 15–35 degrees.
With next reference to FIGS. 13–17, an introducer assembly 160 assists in creating an access opening in the pericardium of a patient's heart to permit access of the delivery device 30 to the heart. In the illustrated embodiment, the introducer assembly 160 includes an introducer sleeve 162 and a dilator sleeve 164.
FIGS. 19–23 illustrate the use of a delivery device 30, preferably configured substantially as described above, to deliver a cardiac harness 42 onto a heart 172. Preferably, the delivery device 30 is configured to locate and grasp the heart 172, accurately position the cardiac harness 42 onto the heart 172, and permit withdrawal of the delivery device 30 without disturbing the positioning of the cardiac harness 42.
With reference to FIG. 19, preferably, the suction cup 52 of the delivery device 30 engages an apex portion 180 of the heart 172, which is illustrated schematically in FIGS. 19–23. The distal end of the delivery device 30 may access the heart 172 through any suitable method, but preferably through a minimally invasive procedure such as that described in relation to FIGS. 16–18. In FIGS. 19–23, the pericardium 174 (FIG. 16) is omitted to ease illustration.
With reference to FIG. 21, the control assembly 38 continues to be advanced until the cardiac harness 42 is properly positioned on the heart 172. Once the cardiac harness 42 is properly positioned, the release member 136 is pulled away from the main body 112 of the control assembly 38, as indicated by the arrow 192. Accordingly, the cardiac harness 42 is released from the plurality of push rods 40, preferably in a manner similar to that described above with reference to FIGS. 11 a–c. With reference to FIG. 22, once the cardiac harness 42 has been released from the plurality of push rods 40, the generally-elastic harness preferably contracts onto the heart. The control assembly 38 is then retracted relative to the shaft 34 to retract the plurality of push rods 40 from the cardiac harness 42, which remains on the heart 172. As noted above, preferably, the push rods 40 are configured such that retraction of the push rods 40 does not tend to pull the cardiac harness 42 from its desired position on the heart 172. Specifically, in the illustrated embodiment, the outwardly canted tips 154 of the plurality of push rods 40 help prevent the push rods 40 from exerting a pulling force on the cardiac harness 42.
Although the delivery device 30 is especially well suited for use in a minimally invasive delivery procedure, the device 30 may also be used for open chest procedures, wherein the sternum of the patient is split to provide access to the heart 172. Accordingly, the delivery device 30 may be used with or without the delivery arrangement illustrated in FIGS. 13–18. In addition, although the device 30 described herein utilizes a plurality of push rods 40, other suitable structures may also be used as support structures to support the cardiac harness 40, when being advanced over the heart. For example, an expandable sleeve can serve as a support structure. Furthermore, it is to be understood that a cardiac harness 42 may be releasably supported in an expanded, or substantially expanded, configuration to a variety of support structures by the releasable stitch described herein, or by a similar releasable stitch arrangement.
With reference next to FIGS. 24–27, an embodiment of a cardiac harness loading device 200 is illustrated. The loading device 200 is configured to cooperate with the delivery device 30 to support the plurality of push rods 40 in an outwardly splayed orientation so that the cardiac harness 42 may be secured to the push rods 40. The loading device 200 may also be useful to assist in urging the cardiac harness 42 from an expanded or at rest configuration to a compacted configuration, so as to be insertable into the housing 36 of the delivery device 30.
Desirably, the loading device 200 includes a plurality of cut out portions 210 corresponding with an elongate portion of each upper portion 208 b of the channels 208. Preferably, the cut out portions 210 are disposed on an outer surface of the loading device 200 and expose an elongate portion of a push rod 40 disposed in the upper portion 208 b of the channel 208 (see FIG. 27). In addition, preferably the entire channel 208 is open toward an inner surface of the loading device 200. Desirably, the cut out portions 210 correspond with a portion of the corresponding push rods 40 in which the through holes 62, 64 a–i (FIG. 5) are provided. As such, the loading device 200 secures the push rods 40 in a splayed orientation with the through holes 62, 64 a–i exposed so that the cardiac harness 42 may be releasably secured to each of the push rods 40 by a releasable stitch.
With reference next to FIGS. 28 a–c, a preferred method for creating the releasable stitch from a line 60 a is illustrated. With reference to FIG. 28 a, the cardiac harness 42 preferably is positioned relative to the push rod 40 such that an upper most row 66 a of the harness 42 is positioned between through holes 62 and 64 a of the push rod 40, or the two uppermost through holes. The line 60 a is passed along the inward facing surface 40 b of the push rod 40 in an upward direction positioning the cardiac harness 42 between the line 60 a and the surface 40 b of the push rod 40. An upper end of the line 60 a is passed through the through hole 62 and, preferably, formed into a slip knot 80, which forms the initial loop 82 a of the releasable stitch.
With reference to FIG. 28 c, preferably an instrument, such as a hook 220 is passed through the loop 82 a and grasps a portion of the line 60 a below the upper row 66 a of the cardiac harness 42. The line 60 a is pulled through the through hole 64 a and through the initial loop 82 a, to secure the upper row 66 a of the cardiac harness 42 to the push rod 40. With reference to 28 c, the line 60 a is pulled further through the loop 82 a to create the second loop 82 b. This process is repeated until each of the rows 66 a–h are secured to each of the plurality of push rods 40. With reference again to FIG. 5, the final loop, or retention loop 86 a, preferably is retained by the rod 68 a of the release member 136, as previously described. In addition, preferably the end 100 a of the line 60 a is tied off on the release member 136, as also described above.
With reference next to FIGS. 29–32, another embodiment of a control assembly 238 and associated push rods 240 is illustrated. In the illustrated embodiment, the control assembly 238 comprises a body portion 242 and a handle portion 244 which are configured to slide axially over the shaft 34.
With particular reference to FIG. 29, the body portion 242 includes a first and a second friction brake assembly 246, 248. Preferably, each friction brake assembly 246, 248 is constructed in a manner similar to the assembly 102 described above in connection with FIGS. 6–9. However, the pivoting direction and orientation of the brake element 104 portion in the first brake assembly 246 is reversed relative to such orientation in the second brake assembly 248. As such, axial movement of the control assembly 238 over the shaft 34 can be selectively inhibited in either a distal or proximal direction by selectively engaging the first or second brake assembly 246, 248.
With particular reference to FIGS. 30–32, the elongate push rod 240 includes a plurality of through holes, or openings 262, 264 extending therethrough. The push rod 240 is configured to accept a releasable stitch such as that discussed above in connection with FIG. 5 and as will be discussed below in connection with FIG. 33. Preferably, the push rod is constructed of a radiopaque material.
With reference next to FIG. 33, another arrangement for releasably holding a harness 42 onto a push rod 40 is illustrated. This embodiment is quite similar to the embodiment discussed above in connection with FIG. 5, in that several interconnected loops 82 a–h are arranged to create securing portions 84 a–h of a line 60 a in order to engage and secure rows 66 a–h of the cardiac harness 42 to secure the harness onto the push rod 40. In the illustrated embodiment, a proximal-most loop, referred to as a free loop 280, extends along an outer surface 40 a of the push rod 40 proximal of a proximal-most throughhole 64 i. A retaining loop 282 portion of the line 60 a extends from the inner surface 40 b of the push rod 40 through the hole 64 i and loops about the free loop 280. From the retaining loop 282, an end portion 100 a of the line 60 a extends to the release member 68. Tension in the line 60 a holds the free loop 280 in place, and a friction force resists drawing of the free loop 280 through the retaining loop 282 in order to release the releasable stitch. Further, in this arrangement, only a single line 60 a is drawn down through the line path 272 and into the control assembly 38 or 238.
With continued reference to FIG. 33, once the harness 42 is in place upon a patient's heart, the release member 68 is actuated in order to pull the line 60 a. As such, the retaining loop 282 engages and pulls on the free loop 280. This interaction between the loops 280, 282 creates frictional resistance; however, upon continued pulling by the clinician, the frictional resistance is overcome and the retaining loop 282 is disengaged from the free loop 280, at which point the releasable stitch disengages in the same manner as discussed above with reference to FIGS. 11 a–c. In the illustrated embodiment, the push rod 40 resembles the push rod 40 presented in FIG. 5. It is to be understood that the just-discussed embodiment can also be employed in connection with a push rod 240 as depicted in FIGS. 30–32, or with any suitable push rod.
With reference next to FIG. 34, an interior view of the control assembly 238 of FIG. 29 is shown. In this embodiment, the line and stitching arrangement of FIG. 33 is employed. As such, only a single line 100 a extends into the control assembly 238 from each push rod 240, and no loop extends into the control assembly 238. An end of each line 100 a–f is tied onto the release member 268. As shown in FIG. 34, (channels 284 a,b, 286 a,b extend between each control assembly passage line portion to the release member 268 in order to accommodate each line 100 a–f. The lines 100 a–f associated with each push rod 240 extend through the associated channels 284 a,b, 286 a,b to the release member 268. As such, when the release member 268 is pulled outwardly, the lines 100 a–f are pulled so as to release the loops holding the harness 42 onto the push rod.
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