Source: https://patents.google.com/patent/WO2001058361A9/en
Timestamp: 2018-06-24 21:17:12
Document Index: 101761568

Matched Legal Cases: ['art 36', 'art 36', 'art 36', 'art 36', 'art 36', 'art 36', 'art 36', 'art 36', 'art 36', 'art 36', 'art 36', 'art 36', 'art 36', 'art 36', 'art 36', 'art 36', 'art 36', 'art 36', 'art 36', 'art 36', 'art 36', 'art 36', 'art 36', 'art 36', 'art 36', 'art 36', 'art 36', 'art 36', 'art 36', 'art 36', 'art.\n7']

WO2001058361A9 - Organ tissue manipulator - Google Patents
Organ tissue manipulator
WO2001058361A9
WO2001058361A9 PCT/US2001/004236 US0104236W WO2001058361A9 WO 2001058361 A9 WO2001058361 A9 WO 2001058361A9 US 0104236 W US0104236 W US 0104236W WO 2001058361 A9 WO2001058361 A9 WO 2001058361A9
PCT/US2001/004236
WO2001058361A1 (en )
Thomas G Adelman
Lorraine E Reeve
Devices and methods of manipulating and stabilizing organ tissue, such as heart tissue. The devices, which are of varying sizes, shapes and conformations, generally include a seal member having a chamber with a wall and a skirt-like member that extends outward from the chamber wall for contact with a surface of an organ. The skirt-like member is substantially compliant and tacky, thereby promoting adhesion with the organ surface. Adherence of the device to the tissue may be enhanced by the mechanical or hydraulic application of vacuum pressure. The methods describe steps for manipulating, including moving, lifting, immobilizing, turning and reorienting organ tissues. Additional methods describe steps for manipulating the heart.
Once the surgeon has access to the heart, it may be necessary to lift the heart from the chest or turn it to obtain access to a particular region of interest. Such manipulations are often difficult tasks. The heart is a slippery organ, and it is a challenging task to grip it with a gloved hand or an instrument without causing damage to the heart. Held improperly, the heart may suffer ischemia, hematoma or other trauma. Held insecurely, the heart may drop back into the chest, which may cause trauma to the heart and may interfere with the progress of the operation. A coronary bypass operation, for example, may involve concerns as to immobilization and as to reorientation of the heart. Once the surgeon has obtained access to the heart, the affected coronary artery may not be accessible without turning or lifting of the heart. Furthermore, the procedure of grafting a new vessel is a delicate one, and contractions of the heart muscle multiply the difficulties in performing the procedure. Similar concerns may arise in cases where the surgery is far less invasive. In a lateral thoracotomy, for example, the heart may be accessed through a smaller incision in the chest. Arresting of the heart may not be feasible. Yet it may be necessary or desirable for a surgeon to manipulate the heart, such as by moving it or by immobilizing a portion of it during the operation.
The present invention provides a device for providing adherence to an organ, allowing the organ to be manipulated or immobilized. It should be noted that any references to "adhesion" or related terms do not use the term as it is frequently used in medicine, namely to describe an abnormal union of an organ or part with some other part by formation of fibrous tissue. Rather, "adhesion" and related words refer to adherence, the process of one thing holding fast to another, without them becoming pathologically joined.
In some embodiments, the seal member may define multiple cavities and multiple vacuum ports, each vacuum port in fluid communication with each cavity. Upon application of independent vacuum pressure to each vacuum port, at least a portion of the seal member deforms and substantially forms a seal against the surface, providing vacuum-assisted adhesion between the device and the heart. Employment of multiple chambers and multiple vacuum ports, with independent vacuum pressure applied to each port, can provide an additional measure of safety. Leakage in one of the sealed chambers will not affect the others, and adhesion may be maintained even if the seal on one chamber fails. The adherence of the device can be aided by the use of particular materials to form the seal member. In particular, the chamber may be defined in part by a semi-rigid material, e.g., formed in a cup-like shape, that provides the device with structural integrity, and prevents the seal member from collapsing under vacuum pressure. The seal member also may include a skirt-like member, however, that is coupled to the chamber. The skirt-like member can be formed from a tacky, deformable material that promotes adhesion to the heart tissue at the point of contact. In some embodiments, the tacky, deformable material may take the form of a silicone gel that is molded, cast, deposited, or otherwise formed to produce the skirt-like member. With such a material, it may be possible to fix the seal member to the heart tissue even when no vacuum pressure is applied by a pump.
When a tacky, deformable material is used in combination with vacuum pressure, the device may adhere to the heart safely and securely, and may permit the surgeon to reorient the heart or to immobilize a region of it. The semi-rigid chamber portion imparts structural integrity to the seal member, while the tacky, deformable material forming the skirt-like member provides a seal interface with the heart tissue that is both adherent and adaptive to the contour of the heart. Moreover, as the skirt-like member deforms, it produces an increased surface area for contact with the heart tissue. The increased surface area provides a greater overall contact area for adherence, and distributes the coupling force of the vacuum pressure over a larger tissue area to reduce tissue trauma. In general, materials suitable for forming the chamber may be too rigid, and may cause ischemia, hematoma or other trauma to the heart. The incorporation of a deformable, skirt-like member, in accordance with the present invention, provides a buffer between the more rigid chamber material and the heart tissue. Materials of the kind ordinarily used to form the chamber also provide little if any tackiness. By contrast, tacky materials ordinarily are not well suited for adherence in conjunction with a vacuum. A device in accordance with the present invention provides a two-part construction that exploits the advantages of both types of materials. In particular, the less deformable material forms a chamber that stands up to vacuum pressure, while the more deformable, tacky material forms a skirt-like member that provides an atraumatic yet robust seal interface with the heart tissue.
In one embodiment, the present invention provides an organ manipulation device comprising a seal member having a chamber with a wall and a skirt-like member that extends outward from the chamber wall for contact with a surface of an organ. The skirt- like member is substantially compliant and tacky, thereby promoting adhesion with the organ surface. The device may include a vacuum port in fluid communication with an interior of the chamber, and may further include a valve that regulates fluid flow through the vacuum port. The device may be of a variety of shapes and sizes. In another embodiment, the present invention provides a method for manipulating a heart, the method comprising engaging a seal member with the apex of the heart to define a chamber, at least a portion of the seal member being compliant and adhesive to heart tissue, applying vacuum pressure to a vacuum port associated with the chamber such that a portion of the seal member deforms to substantially seal the chamber against leakage, and using the seal member as a gripping point for lifting and turning the heart. The method may further include pacing the heart by applying electrical voltage or current to the apex of the heart through electrodes incorporated within the seal member.
FIG. 1 presents a cross-sectional side view of one embodiment of the present invention. FIG. 2 presents a perspective view of the embodiment of the invention depicted in
FIG. 1, being used to manipulate the heart. FIG. 3a presents a cross-sectional side view of another embodiment of the present invention, being used to engage the apex of the heart.
FIG. 3b presents a cross-sectional side view of another embodiment of the present invention, being used to engage the apex of the heart. FIG. 4 presents a cross-sectional side view of another embodiment of the present invention, being used to administer medicinal agents to the lumen of the pericardial sac.
FIG. 8 presents a cross-sectional side view of another embodiment of the present invention. FIG. 9 presents a top view of another embodiment of the present invention.
FIG. 11 presents a close-up cross-sectional view of a portion of a skirt-like member as depicted in FIG. 10. FIG. 12 presents a top view of another embodiment of the present invention.
FIG. 18 presents a perspective view of the embodiment of the invention depicted in FIG. 1 and the embodiment of the invention depicted in FIG. 17, applied to the heart. FIG. 19 is a perspective view of a cup-like seal member according to another embodiment of the present invention.
FIG. 21 is a perspective view of a cup-like seal member according to another embodiment of the present invention. FIG. 22 is a cross-sectional side view of the seal member of FIG. 21.
FIG. 24 is a cross-sectional side view of the seal member of FIG. 23. FIG. 25 is a perspective view of a cup-like seal member according to another embodiment of the present invention.
FIG. 27a is an enlarged view of a skirt member associated with a seal member as shown in any of FIGS. 19-26. FIG 27b shows the skirt member of FIG. 27a in use.
FIG. 30 is another side view of the seal member of FIG. 28. FIG. 31 is a top view of the seal member of FIG. 28.
FIG. 1 is a cross-sectional view of a device 10 for organ manipulation, in accordance with an embodiment of the present invention. As shown in FIG. 1 , device 10 may include a seal member 12. Seal member 12 may include cup-like member 14. Cup- like member 14 defines a general size and shape of the device 10, and may include components to serve various purposes. In the example of FIG. 1, cup-like member 14 defines a generally circular structure suitable for forming a cup-like shape. Cup-like member 14 may include a vacuum port 16 and a neck 18 suitable for receiving a vacuum tube 20. Vacuum tube 20 may be sealed in neck 18 with sealant 19. Vacuum tube 20 may include a valve such as stopcock 21, to prevent air from moving through vacuum tube 20, or to allow a quick release of vacuum pressure. Alternatively, a valve may be included in vacuum port 16 or neck 18. The cup-like member 14 may encompass a spacer 22 to prevent the tissue from being drawn too far into the chamber, and especially from being drawn into vacuum port 16, when vacuum pressure is applied. Although spacer 22 may be integrally formed with member 14, spacer 22 is shown in FIG. 1 as a separate element. Spacer 22 may bear against an inner ring 25. Spacer 22 may also be omitted from device 10. Cup-like member 14 may also include a flange 24 that aids the physical connection between cuplike member 14 and a skirt-like member 26. The interior wall of cup-like member 14 and skirt-like member 26 define a chamber 15. In addition to providing a basic structural framework of device 10, cup-like member 14 provides a firm structure by which device 10 may be securely gripped by a surgeon or by an instrument. Cup-like member 14 may include a structure such as a handle, knob or other attachment (not shown) for this purpose.
As shown in FIG.l, device 10 is not adhering to any tissue, and chamber 15 is open rather than enclosed. Upon engagement of seal member 12 with the surface of the tissue, chamber 15 becomes enclosed. Vacuum port 16 may be in fluid communication with chamber 15. Seal member 12 can be made, in part, of a compliant material that will permit it to conform to the surface of the organ. In the case of engagement between seal member 12 and a heart, the compliant qualities of seal member 12 will permit seal member 12 to maintain contact while the heart is contracting and relaxing. In some cases, adherence to the tissue may be improved by application of the vacuum pressure by way of vacuum port 16 and vacuum tube 20, where at least a portion of seal member 12 deforms and substantially forms a seal against the surface of the tissue. Vacuum pressure may be supplied by a number of devices, such as by a syringe, and may be maintained by shutting stopcock 21. A constant source of negative pressure may be employed but is not necessary.
The adhesive effectiveness of skirt-like member 26 may be aided not only by the tackiness of the material, but the greater surface area provided at the seal interface upon deformation. Skirt-like member 26 surrounds and may be coupled to flange 24 of cuplike member. In the embodiment shown in FIG.l, the skirt-like member includes three components. One component is main ring 28, which is made of a compliant material that can deform, but will ordinarily not deform sufficiently as to rupture any seal. Main ring 28 forms the general perimeter of the chamber 15. A second component is a reinforcing element 30, partly embedded within the main ring 28 and anchored by a fixing mechanism 32 within flange 24 of cup-like member.
A material suitable for the main ring 28 and the tacky material 34 is a biocompatible silicone gel. Examples of suitable silicone gels are MED-6340 and GEL- 8150, both commercially available from NuSil Silicone Technologies of Carpinteria, California. Each gel is provided as a two-component liquid, the components designated Part A and Part B, which may be blended together. The properties of the silicone depend generally upon the ratio of the mixture of Part A and Part B. In general, increasing the ratio of Part A to Part B produces a softer and tackier gel, while increasing the ratio of Part B to Part A produces a firmer and less tacky gel. Like silicone elastomers, silicone gels can be manufactured with a range of crosslink densities. Silicone gels, however, generally do not contain reinforcing filler and therefore have a much higher degree of malleability and conformability to desired surfaces. As a result, the compliance and tackiness of silicone gel materials can be exploited in skirt-like member 26 to provide a more effective seal. For skirt-like member 26, the MED 6340 silicone gel material, for example, exhibits a hardness characteristic such that a 19.5 gram shaft with a 6.35 mm diameter has been observed to penetrate the gel approximately 5 mm in approximately 5 seconds. This hardness characteristic is not a requirement, but merely representative of that exhibited by the commercially available MED 6340 material.
FIG. 2 shows device 10 of FIG. 1 in an exemplary application. A surgeon 40 has obtained access to a heart 36 and has placed the device 10 over the apex 38 of the heart 36. The heart 36 has not been arrested. Device 10 has adhered to apex 38. If valve 21 on device 10 is left in the open position, the beating motion of the heart and the pressure of the surgeon's hand 40 will allow the heart tissue to move into the interior of chamber 15, displacing air from the chamber. The beating of the heart 36 naturally causes the apex 38 to rotate or twist reversibly to a degree during each contraction. The rotational movement causes the apex 38 to move into seal member 12, thereby expelling air through vacuum tube 20 and open valve 21, and engaging deformable skirt-like member 26. The surgeon 40 can determine visually and tactilely whether the apex 38 has penetrated the skirt-like member 26 or come in contact with the spacer 22. When the apex 38 has penetrated the skirt-like member 26, the valve 21 is closed, preventing air from entering the device 10 and creating a partial vacuum or negative pressure in the device. Atmospheric pressure acts to keep device 10 affixed to the heart tissue. No external vacuum source is required to create the partial vacuum. Moreover, the partial vacuum or negative pressure is sufficient to permit lifting of the apex 38 as shown in FIG. 2, and can support moving the heart 36 through a ninety-degree arc. The material employed to form skirt-like member 26 is sufficiently flexible and compressible that skirt-like member 26 conforms tightly to the shape of heart 36, yet the material is also atraumatic to the myocardial tissue. The apex 38 continues to twist during each contraction, but the seal member 12 holds the apex without causing trauma. . Removal of device 10 can be accomplished by opening valve 21, and allowing air to move through vacuum tube 20 to separate heart tissue from the inner surface of skirt-like member 26. If necessary, a syringe or other means can be used to force air through tube 20 to facilitate rapid detachment of device 10 from heart 36. Alternatively, an external vacuum source can be applied via vacuum tube 20 to remove air from inside device 10 and permit atmospheric pressure to hold the device to the tissue at apex 38. Valve 21 can be closed to prevent air from entering tube 20, and the external vacuum source can be removed. No additional external vacuum source is then required. Tacky material 34 shown in FIG. 1 helps promote adhesion. Compliant skirt-like member 26 of the device has conformed to the shape of apex 38 to create an airtight seal around the heart tissue. The compliance of skirt-like member 26 allows the seal to be maintained even as the heart 36 contracts. Stopcock 21 has been closed, so that a vacuum seal between device 10 and apex 38 may be maintained without constant application of vacuum pressure. With the combination of vacuum pressure and tackiness, surgeon 40 may move the heart 36 by manipulating the device 10 or the vacuum tube 20. FIG. 2 shows the surgeon 40 beginning to lift the apex 38 by holding the vacuum tube 20. By lifting the apex 38, the surgeon 40 may move the heart 36 about and obtain access to other areas of the heart. The beating heart 36 may be manipulated in this way so as not to compromise the heart's hemodynamic functions. In particular, the surgeon 40 may lift the heart 36 with device 10 without causing a drop in aortic blood pressure. In addition, device 10 provides a robust seal with the heart 36, allowing manipulation of the heart 36 without the need for other supporting devices, and is also atraumatic to the apex 38, avoiding ischemia, hematoma or other trauma.
Device 42 includes electrodes 46, 48, which may be used to pace the heart 36 by stimulation of the bundles of His 50, 52 and Purkinje fibers 54. Alternately, electrodes 47 and 49 can be positioned on spacer 22, as shown in FIG. 3b, or at other locations within the device. The normal pacemaker of the heart is the sinoatrial (SA) node (not shown in FIG. 3a). The SA node is a small specialized region in the right atrial wall near the opening of the superior vena cava. An action potential initiated within the SA node ordinarily spreads to both atria of the heart. An internodal pathway extends from the SA node to the atrioventricular (AV) node (not shown in FIG. 3a), which is a small bundle of specialized cardiac muscle cells near the junction of the atria and the ventricles 58, 60. Specialized cells known as the bundle of His extend from the AV node, through the ventricular septum 56, where they divide into the left branch bundle of His 50 and the right branch bundle of His 52. The branch bundles of His 50, 52 curve around the tip of the ventricular chambers 60, 58 and travel back toward the atria along the outer walls of the heart 36. Following receipt of an impulse by the AV node from the SA node, and after a brief AV nodal delay, the impulse travels rapidly down the bundles of His 50, 52. Purkinje fibers 54 extend from the bundles of His 50, 52 and spread throughout the ventricular myocardium 62. The impulse transmitted by the bundles of His 50, 52 is carried throughout the ventricular myocardium 62 by Purkinje fibers 54. The bundles of His 50, 52 and Purkinje fibers 54 have a normal rate of action potential discharge of 20 to 40 action potentials per minute. Stimulation of the bundles of His 50, 52 and Purkinje fibers 54 may cause the ventricular myocardium to beat at a faster rate and thus to help pace the heart 36. Electrodes 46, 48, 47 and 49, which may be coupled to a voltage or current source (not shown in FIGS. 3a or 3b) via conductors, may in this way be used to stimulate the bundles of His 50, 52 and Purkinje fibers 54 and help pace the heart 36. Because skirt-like member 28 adheres atraumatically to the apex 38, the device 42 can remain on the apex 38 for long periods of time without causing hematoma or other trauma. In addition, the placement of device 42 on the apex 38 allows for minimal interference with the surgical field. Consequently, device 42 can pace the heart 36 when needed, and can remain in place when pacing is not required.
FIG. 4 shows a cutaway view of device 64 for organ manipulation, in accordance with an embodiment of the present invention. Device 64 is similar to device 10 of FIG. 1. Device 64 is shown in another exemplary application. In the surgical operation depicted in FIG. 4, the pericardial sac 66 surrounding the heart has not been opened. The pericardial sac 66 is a double-walled membranous sac that encloses the heart 36. The sac 66 is a tough, fibrous membrane known as the pericardium 68. The surface of the heart is known as the epicardium 70. Pericardial fluid in the sac 72 lubricates the epicardial layer 70 and reduces friction between the pericardial and epicardial layers as the heart 36 beats. The device shown in FIG. 4 allows for medicinal agents to be introduced into the pericardial sac 66. Device 64 shown in FG. 4 is like the device 10 shown in FIG. 1, except that device 64 includes a port 74 to allow for drug delivery. A needle 76 has been introduced through the port 74. Device 64 had been placed upon the pericardial sac 66 and adheres due to the tackiness of the tacky material 78 lining the skirt-like member 80. Vacuum pressure has been applied to draw the outer layer of the pericardium 68 toward the needle 76. This procedure will generally not draw the epicardium 70 as much. By drawing the pericardium 68 toward needle 76, needle 76 may penetrate only the pericardium 68 and not the epicardium 70, and medicinal agents may be effectively delivered to the pericardial fluid 72 of the pericardial sac 66. Delivery of medicinal agents in this manner may be useful, for example, when injecting epinephrine, or when treating a viral or bacterial infection affecting the pericardial sac 66 known as pericarditis. FIG. 5 is a cross-sectional view of another device 82 for organ manipulation, in accordance with an embodiment of the present invention. Device 82 may include a seal member 84. Seal member 84 may include a cup-like member 86. Cup-like member 86 defines a general size and shape of the device 82, and as shown in FIG. 5 defines a generally circular structure suitable for forming a cup-like shape. Cup-like member 86 may also include a flange 88 that aids the physical connection between member 86 and a skirt-like member 90. Skirt-like member 90 is similar to skirt-like member 26 in FIG. 1. Skirt-like member 90 optionally can include a reinforcing element 91.
FIG. 7 shows device 82 of FIG. 5 and FIG. 6 in engagement with the apex 38 of a heart 36. Device 82 adheres to the apex 38 in part due to the compliant tacky material 98, upon the extraction of shaft 96 through aperture 102, drawing the tissue into cavity 100. The adherence may be created without a vacuum source, such as a pump or a syringe. In some embodiments, tissue may be drawn into chamber 100 to an extent that the tissue contacts membrane 92. FIG. 8 is a cross-sectional view of another device 104 for organ manipulation, in accordance with an embodiment of the present invention. Device 104 is similar to device 82 in FIG. 5 in that it includes a membrane 108 preferably manufactured of a flexible airtight and watertight material, affixed at an interface between cup-like member 112 and skirt-like member 106. Cup-like member 112 may include an aperture 118 and a neck 120 suitable fo receiving a fluid tube 114. Fluid tube 114 may be sealed in neck 120 with sealant 116.
In addition, structural member 164 provides a firm structure by which the ringlike device 160 may be securely gripped by a surgeon or by an instrument. In FIG. 9, attachments 170 have been affixed to the structural member 164, to provide sites for secure gripping. Attachments 170 may be located elsewhere on the device. A structure such as a handle or a knob may also be suitable for providing a site for secure gripping. Structural member 164 may be molded from many materials, including thermoplastic such as polycarbonate, ABS, polysulfone, polyester and polyurethane, and including corrosion-resistant metals such as titanium, and including rigid, semi-rigid and flexible elastomers such as silicone rubber and polyurethane.
FIG. 13 is a top view of another device 200 for organ manipulation, in accordance with an embodiment of the present invention. Although similar in overall shape and construction to the device 160 shown in FIG. 9, device 200 shown in FIG. 13 has a chamber 204 presented in a general C-shape instead of a ring. A gap 202 separates the two tines or "feet" 206, 208 of the device. The C-shape may vary in shape and dimension, but the near-oval shape with a generally oval-shaped inner diameter and a generally oval-shaped outer diameter as shown in FIG. 13, is exemplary. Gap 202 may also vary in size, such that the feet 206, 208 need not touch each other, and device 200 could assume a general U-shape.
FIG. 16 is a top view of another device 224 for organ manipulation, in accordance with an embodiment of the present invention. Device 224 is similar in overall shape and construction to the device 200 shown in FIG. 13, and further includes a first electrode 226. First electrode 226 is connected to a power supply (not shown) via wire 228 that may follow the same path as vacuum tube 230. First electrode 226 may be affixed to another element of device 224 at various locations. First electrode 226 may be attached to or partly incorporated within chamber 232, for example, or attached to or partly incorporated within a skirt-like member 234. First electrode 226 ordinarily would be located such that electrode 226 would come in contact with tissue when device 224 is engaged against the tissue. A second matching electrode, connected to the same power supply, may be attached to a scalpel (not shown). Such an arrangement of electrodes may be useful for bipolar surgery, in which electric current is a part of the procedure. During bipolar surgery, current passing between the second scalpel electrode and the first electrode 226 on device 224 may serve to provide immediate cauterization to an incision. FIG. 17 is a top view of another device 236 for organ manipulation, in accordance with an embodiment of the present invention. Device 236 is similar in overall shape and construction to the device 224 shown in FIG. 16. Like device 224 shown in FIG. 16, device 236 includes a first electrode 238. In FIG. 17, however, second electrode 240 is included within device 236, rather than within another surgical instrument. Both electrodes 242, 244 preferably come in contact with tissue when device 236 is engaged against the tissue. Electrodes 238, 240 may be connected to associated circuitry by wires 242, 244. In device 236, first electrode 238 may be capable of sending electrical signals, and second electrode 240 may be capable of substantially receiving the electrical signals sent by first electrode 238. Such an arrangement of electrodes may be useful in many kinds of surgical procedures, such as those in which electric current is a part of the procedure. In accordance with the present invention, a surgeon may, for example, wish to measure the impedance or other characteristics of the tissue between the electrodes, or the time needed for an electrical signal to conduct along the tissue. Further, the electrodes may be connected to an external pulse generator and be useful in pacing the heart.
FIG. 18 provides a perspective view of two embodiments of the present invention, in two contemporaneous exemplary applications. One embodiment of the invention is a cup-shaped device 10, like the device shown in FIG. 1 or other embodiments such as 42, 82, 104, 280. Another embodiment is a C-shaped device 236, as shown in FIG. 18. Both devices 10, 236 have been applied to the heart 36 at the same time. In FIG. 18, cup- shaped device 10 has been adhered to the apex 38 of the heart 36, in a manner like that depicted in FIG. 2. By manipulation of apex 38, a surgeon can lift or turn the heart 36 to obtain access to areas of the organ not easily accessible. The surgeon may then immobilize device 10 by securing it to a securing device 249. When positioned appropriately device 10 may be further immobilized by attaching the securing device 249 to either the rib expander or the operating table. In FIG. 18, the heart 36 has been lifted and turned to allow access to a region of the right atrium 250. C-shaped device 236 has been applied to the atrium 250 in a manner similar to that shown in FIG. 14. Engagement of C-shaped device 236 may stabilize the tissue within field 252, relative to the rest of the heart. By further affixing device 236 to a securing device 220 which is in turn attached to either a rib expander or the operating table. Having obtained access to the right atrium 250, the surgeon may perform an operation in the field 252. For example, the surgeon may use an ablation probe to ablate tissue within the field 252, and sever pathways of electrical conduction. Such a severing may be helpful, for example, as a treatment for a kind of arrhythmia. To determine whether the pathways have been properly severed, the surgeon may measure a quantity such as conduction time or impedance using electrodes 238, 240.
FIG. 19 is a perspective view of a cup-like seal member 260 according to another embodiment of the present invention. FIG. 20 is a cross-sectional side view of the seal member of FIG. 19. As shown in FIG. 19, seal member 260 may be somewhat similar to other seal members described above in that it defines an inner chamber 262 for application of vacuum pressure and affixation to the surface of the heart. Seal member 260 may have an upper portion 264 formed form a semi-rigid material, e.g., a silicone elastomer of Shore A 30 to 70 durometer. A lower skirt-like member 266 may be coupled to or molded with upper portion 264, and may be formed from a substantially compliant material, such as a silicone elastomer of Shore A 5 to 10 elastomer.
Alternatively, skirt-like member 266 may be formed from a silicone gel that is both compliant and tacky, enhancing sealing pressure. As mentioned above, the MED 6340 silicone gel material available from Nu-Sil may be acceptable for fabrication of skirt-like member 266. Seal member 260 may include a vacuum port 268 for communication with a vacuum tube and an external vacuum source. Also, seal member 260 may include two exterior circumferential ribs 270, 272 that can be molded into upper portion 264. Ribs 270, 272 provide seal member 260 with added strength to prevent collapse under vacuum pressure and consequent failure of the seal. As will be explained, skirt-like member 266 provides a canted surface 274 that promotes sealing on both the inner and outer diameters 276, 278 of the skirt-like member.
FIG. 21 is a perspective view of a cup-like seal member 280 according to another embodiment of the present invention. FIG. 22 is a cross-sectional side view of the seal member 280 of FIG. 21. Seal member 280 corresponds to seal member 260 of FIG. 19 but omits circumferential ribs 270, 272. FIG. 23 is a perspective view of a cup-like seal member 282 according to another embodiment of the present invention. FIG. 24 is a cross-sectional side view of the seal member 282 of FIG. 23. Seal member 282 corresponds to seal member 280 of FIG. 21 but incorporates internal circumferential ribs 284, 286. FIG. 25 is a perspective view of a cup-like seal member 288 according to another embodiment of the present invention. FIG. 26 is a cross-sectional side view of the seal member 288 of FIG. 25. Seal member 288 corresponds to seal member 260 of FIG. 19 but instead of circumferential ribs 284, 286, incorporates external vertical ribs 290. FIG. 27a is an enlarged partial view of a skirt member associated with a seal member as shown in any of FIGS. 19-26. WTien vacuum pressure is applied to the respective seal member, the conformable canted surface 274 gives way and flexes inward and downward such that it contacts the tissue at both inner diameter 276 and outer diameter 278, producing greater surface contact area, and promoting an effective seal. FIG. 27b illustrates canted surface 274 upon application to a tissue surface 275.
FIG. 28 is a side view of a seal member 292 incorporating a reinforcing structure and a swivel connection in accordance with a further embodiment of the present invention. FIG. 29 is bottom view of the seal member 292 of FIG. 28. FIG. 30 is another side view of the seal member 292 of FIG. 28. FIG. 31 is a top view of the seal member 292 of FIG. 28. FIG. 32 is a bottom perspective view of the seal member 292 of FIG. 28. As shown, seal member 292 includes an upper portion 294 defining a semi-rigid cup-like member 296 with a set of finger-like extensions 298. Molded around extensions 298 is a lower portion 299 having a compliant skirt-like member 300. Cup-like member 296 may be formed from a variety of materials such as silicone elastomers in the range of Shore A 30 to 70 durometer. Extensions 298 may be integrally formed with cup-like member 296 by molding. Skirt-like member 300 may extend below extensions 298 to a lip 302 and just above the extensions to a channel indicated by reference numeral 304. Extensions 298 may thin in both thickness and width as they approach the lower extent of skirt-like member 300. Extensions 298 provide added support to seal member 292, helping to resist collapse under vacuum pressure. Skirt-like member 300 may be formed from a substantially compliant material, such as a silicone elastomer of Shore A 5 to 10 elastomer. Alternatively, skirt-like member 300 may be formed from a silicone gel such as Nu-Sil MED 6340 that is both compliant and tacky, enhancing sealing pressure. Seal member 292 also may include a swivel-mount 306 designed to receive a vacuum tube 308. Swivel 306 may take the form of an extension or "stem" 309 that can be bonded inside a stainless steel tube 308. Seal member 292 defines a "notch-out" area 310 that accommodates the tube when the tube is bent relative to the seal member, e.g., at 90 degrees. In this manner, vacuum tube 308 can be bent relative to seal member 292 to permit positioning of the seal member over the apex of the heart while the vacuum tube is held by the surgeon at an angle to the apex. Stem 309 is inserted into vacuum port 312, which is positioned within a recess 314. Cup recess area 314 may have a width sufficient to permit swiveling of seal member 292 approximately 30 degrees relative to the longitudinal axis of stem 309. This design may provide a number of advantages. In particular, seal member 292 may be relatively simple to construct and reconstruct. The swivel capability permits the heart to twist and slightly bob with each beat while seal member 292 is affixed to the apex. Also, the seal member 292 is able to self-center on the apex by reducing side bending moments. Further, seal member 292 can be oriented at 90 degrees relative to the vacuum tube with the vacuum tube residing in notch-out area 310 to permit it to be mounted on the apex without heart manipulation. To lift the heart, the vacuum tube then gradually moves out of notch-out area 310. As in other embodiments, seal member 292 and, in particular, skirt-like member 300 may incorporate electrodes and conductors for pacing or diagnosis. FIG. 33 is side view of a device incorporating a seal member as shown in FIG. 28.
As shown in FIG. 33, seal member 292 may be coupled to a length of vacuum tubing 308 having a distal end 318 at seal member 292 and a proximal end 320 at a valve device 322 coupled to a vacuum source.
FIG. 34 is a side view of a device incorporating a seal member as shown in FIG. 28. The seal member 292 is engaged to the apex 38 of a heart 36. The seal member 292 is coupled to vacuum tubing 330. Vacuum tubing includes or is coupled to a manually- operable valve 332, and is further equipped with a fitting 334 such as a Luer fitting. A pressure device 336 is coupled to the fitting 334. The pressure device 336 shown in FIG. 34 includes a flexible bulb 338, an inlet valve 340 and an exhaust valve 342. The bulb 338 may be constructed of material such as rubber or an elastic polymer, and is biased to resume its shape after deformation. The inlet valve 340 is configured to allow fluid flow into the bulb 338, but internal valve opening 344 is biased to prevent fluid flow out of the bulb 338 through the inlet valve 340. Exhaust valve 342, by contrast, is configured to allow fluid flow out of the bulb 338, but is biased to restrict or prevent fluid flow into the bulb 338.
WTien the bulb 338 is compressed 346, air is ejected through the exhaust valve 342. Wϊien the bulb 338 is released, the internal volume of the bulb 338 begins to expand as the bulb returns to its undeformed shape. As the internal volume of the bulb 338 expands, the bulb 338 draws air through the inlet valve 340, creating a partial vacuum between the seal member 12 and the heart 36. The partial vacuum may cause the seal member 292 to deform to create a more robust seal with the myocardial tissue. When the partial vacuum is created, the manually-operable valve 332 may be closed, thus maintaining the partial vacuum. The heart 36 may then be manipulated by moving the device 292 or the vacuum tube 330. An advantage of a fitting 334 such as a Luer fitting is that the pressure device 336 may be quickly uncoupled from the fitting 334. An additional advantage of a Luer fitting is that the pressure device 336 may quickly be reversed, and the exhaust valve 342 coupled to the fitting 334. In this configuration, with manually-operable valve 332 opened, compression of the bulb 338 forces air through tube 330 to facilitate rapid detachment of device 292 from heart 36.
Although FIG. 34 shows pressure device 336 used with seal member 292, pressure device 336 may be used with other embodiments of the invention described above. The details of one or more embodiments of the invention are set forth in the accompanying drawings and the description below. Other features, objects, and advantages of the invention will be apparent from the description and drawings, and from the claims.
1. An organ manipulation device comprising: a seal member having a wall defining a chamber and a skirt-like member that extends outward from the wall for contact with a surface of an organ, wherein the skirt-like member is substantially compliant and tacky, thereby promoting adhesion with the organ surface.
3. The device of claim 1 , further comprising a vacuum port in fluid communication with an interior of the chamber, and a valve to regulate fluid flow through the vacuum port.
4. The device of claim 1, further comprising a vacuum port in fluid communication with an interior of the chamber, and a spacer configured to prevent tissue from being drawn beyond a certain distance toward the vacuum port.
5. The device of claim 1, further comprising a firm structure affixed to the device configured to permit the device to be manipulated and to be immobilized relative to the body of a patient.
6. The device of claim 1, wherein the device has a generally cup-like shape, and is sized and shaped to fit the apex of the heart.
7. The device of claim 1, wherein the device has a generally ring-like shape.
8. The device of claim 1, wherein the device has a generally C-shaped shape.
9. The device of claim 8, wherein the C-shape of the device defines a gap, the device being substantially deformable to allow the gap to widen.
10. The device of claim 1 , the skirt-like member further comprising a reinforcing member to resist deformation of at least a portion of the seal member.
11. The device of claim 1 , wherein the material that promotes adhesion to the organ tissue at the point of contact is formed from a compliant, tacky silicone gel.
12. The device of claim 11 , wherein the skirt-like member includes a first portion formed of a first silicone gel, and a second portion formed of a second silicone gel that is more compliant than the first silicone gel.
13. The device of claim 1, wherein the seal member defines a plurality of chambers, none of the chambers being in fluid communication with any of the other chambers, and the device further comprising a vacuum port in fluid communication with each of the chambers.
14. The device of claim 1, further comprising a flexible, watertight membrane affixed between the wall and skirt-like member; an aperture in the seal member, the axis of the aperture substantially perpendicular to the membrane and intersecting substantially the midpoint of the membrane; a substantially semi-rigid disk affixed at substantially the midpoint of the membrane, and a substantially rigid shaft coupled to the midpoint of the disk and extending substantially perpendicular to the disk through the aperture.
15. The device of claim 14, wherein the membrane and the seal member define a hydraulic chamber, the device further comprising hydraulic fluid within the hydraulic chamber.
16. The device of claim 1 , further comprising an electrode affixed to the seal member.
17. The device of claim 1, further comprising: a fluid tube in fluid communication with the interior of the chamber; and a source of pressure coupled to the fluid tube configured to move fluid through the fluid tube, wherein the source of pressure is one of a pump, syringe or flexible bulb.
PCT/US2001/004236 2000-02-11 2001-02-09 Organ tissue manipulator WO2001058361A9 (en)
US60/181,295 2000-02-11
US60/210,299 2000-06-08
US09/663,917 2000-09-18
US09/692,524 2000-10-19
WO2001058361A1 true WO2001058361A1 (en) 2001-08-16
WO2001058361A9 true true WO2001058361A9 (en) 2002-10-24
EP0157888B1 (en) 1984-03-23 1987-09-02 Storz, Karl, Dr.med. h.c. Single hand operated hysteroscope
DE69214690D1 (en) 1991-03-06 1996-11-28 D & D Srl Apparatus for washing, for therapeutic or hygienic reasons, of human or animal internal lines
US6558314B1 (en) 2003-05-06 grant
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