WO2001058367A1 - Occlusion device - Google Patents

Occlusion device Download PDF

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Publication number
WO2001058367A1
WO2001058367A1 PCT/US2001/004399 US0104399W WO0158367A1 WO 2001058367 A1 WO2001058367 A1 WO 2001058367A1 US 0104399 W US0104399 W US 0104399W WO 0158367 A1 WO0158367 A1 WO 0158367A1
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WO
WIPO (PCT)
Prior art keywords
actuators
elastomeric
jaws
another
elastomer
Prior art date
Application number
PCT/US2001/004399
Other languages
French (fr)
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WO2001058367A9 (en
Inventor
Adam Gold
Terrence Buelna
Original Assignee
Novare Surgical Systems, Inc.
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to US18186200P priority Critical
Priority to US60/181,862 priority
Priority to US64548200A priority
Priority to US09/645,482 priority
Application filed by Novare Surgical Systems, Inc. filed Critical Novare Surgical Systems, Inc.
Publication of WO2001058367A1 publication Critical patent/WO2001058367A1/en
Publication of WO2001058367A9 publication Critical patent/WO2001058367A9/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/128Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips
    • A61B17/1285Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord for applying or removing clamps or clips for minimally invasive surgery
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/12Surgical instruments, devices or methods, e.g. tourniquets for ligaturing or otherwise compressing tubular parts of the body, e.g. blood vessels, umbilical cord
    • A61B17/122Clamps or clips, e.g. for the umbilical cord
    • A61B17/1227Spring clips
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/0042Surgical instruments, devices or methods, e.g. tourniquets with special provisions for gripping
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/0042Surgical instruments, devices or methods, e.g. tourniquets with special provisions for gripping
    • A61B2017/00429Surgical instruments, devices or methods, e.g. tourniquets with special provisions for gripping with a roughened portion
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00858Material properties high friction, non-slip
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B2017/00831Material properties
    • A61B2017/00862Material properties elastic or resilient
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/28Surgical forceps
    • A61B17/2812Surgical forceps with a single pivotal connection
    • A61B17/282Jaws
    • A61B2017/2825Inserts of different material in jaws

Abstract

A surgical occlusion device (50) is provided that is capable of being securely operated with a variety of applicator instruments, without requiring that the particular instrument be specially adapted to the occlusion device (50). Various embodiments of the device include actuators having elastomeric surfaces (92) that can deflect upon being engaged with any applicator instrument, resulting in increased traction between the actuators and the instrument.

Description

OCCLUSION DEVICE

FIELD OF THE INVENTION

This invention relates to surgical occlusion devices and more particularly to surgical occlusion devices for occlusion of body lumens such as blood vessels and ducts, having elastomeric gripping surfaces for ease of use.

BACKGROUND OF THE INVENTION

During surgery it is often necessary to temporarily occlude blood vessels or other lumens, e.g., to prevent blood flow at the incision site. Various devices and techniques exist for accomplishing temporary occlusion, including application of surgical occlusion devices to the vessels to be occluded. In many surgical procedures, a considerable number of surgical occlusion devices are used to occlude blood vessels and other body conduits, for example ducts such as the bile duct. Surgical occlusion devices are available in many configurations, including jaw-type surgical clamps or clips. Surgical clips are generally smaller and more compact, and are useful for occluding smaller vessels and restricted sites, allowing for a less obstructed field of view for the surgeon. Such surgical clips generally include two jaws coupled to each other in such a way that operating the proximal end of the occlusion device, that is the end nearest to the surgeon, causes the opening and closing of the jaws at the distal end of the occlusion device, that is the end that engages the blood vessel. Examples of such surgical clips are disclosed in United States Patent Nos. 5,984,934, 5,921,996, 5,9944,729, and 5,653,720, incorporated herein by reference in their entirety. While operating such surgical clips may be possible by hand, often such operation is not possible. For example, the target vessel may be difficult to access because of surrounding anatomical structures. In addition, the incision itself may be restricted, such that access by hand is difficult or awkward. In the case of laprascopic surgery, direct manual operation of the surgical clip becomes impossible as access to target sites is provided through laprascopic delivery devices.

To aid in the operation of surgical clips where direct manual operation is difficult, applicator instruments have been used to move and operate the surgical clip. Examples of such applicator instruments include forceps, clamps and tweezers. The use of such applicator instruments can be unreliable as the instruments can slip off the surgical clip during placement and engagement of the surgical clip.

To overcome this problem, particular applicator instruments have been made that are specially adapted to a particular surgical clip for its placement, operation and removal. These applicator instruments typically require that the surgeon accurately align an engaging element on the applicator, e.g., teeth, tips, with a reciprocal element pattern on the surgical clip, e.g., grooves, depressions. Examples of such surgical clips are described in United States Patent Nos. 5,984,934, 5,921,996, and 5,304,183, each requiring a specialized applicator instrument for its operation. As illustrated by these patents, these specialized applicator instruments require the surgeon to perform the task of accurately aligning teeth or tips and complementary grooves or depressions in order to place, operate and remove the surgical clip. This can prove especially difficult where the surgeon's field of vision is obstructed or the occlusion site is otherwise in an awkward or difficult to access location. Additionally, because the reciprocal engaging elements must be aligned with one another, there exists only a finite number of positions where a specialized applicator can successfully engage its corresponding surgical clip. Another disadvantage of surgical clips that require specialized applicator instruments for their operation is that a particular specialized applicator instrument can only be used with its corresponding surgical clip. Thus, a particular applicator instrument is generally not available for use with any other available surgical clips, and similarly the surgical clip used with a particular specialized applicator instrument is not available for use with any other applicator instruments. ,

Thus, there is a need for surgical occlusion devices, including surgical clips, that are capable of being operated using a variety of applicator instruments. There is likewise a need for applicator instruments capable of being used with a variety of occlusion devices. SUMMARY OF THE INVENTION The present invention meets these and other needs by providing surgical occlusion devices that are capable of being easily operated with a variety of applicator instruments, without the necessity of a particular applicator instrument specially adapted to a particular occlusion device as well as applicator instruments capable of easily operating a variety of occlusion devices.

In one embodiment of the invention, a surgical occlusion device is provided having first and second jaws, coupled to one another and mounted for movement toward and away from one another. The surgical occlusion device also includes first and second actuators coupled to the first and second jaws and movable relative to another from a first position to a second position. The first and second actuators are coupled to each other such that moving the actuators from the first position to the second urges the jaws apart. The actuators have elastomeric surfaces that can deflect upon being engaged with an applicator instrument, resulting in increased traction between the actuators and the instrument.

In a second embodiment of the invention a surgical clip is provided having first and second jaws that are mounted for movement toward and away from one another, biasing means that bias the jaws toward one another, and first and second actuators that are each coupled to the first and second jaws. These actuators are movable relative to one another from a first position to a second position, such that movement of the actuators from the first position to the second position opposes the bias and urges the jaws apart. The actuators likewise have elastomeric surfaces that can deflect upon being engaged with an applicator instrument to provide increased traction between the actuators and the instrument.

The invention also provides for methods of securing an elastomeric surface to an actuator of a surgical occluding device.

In one such method, a mold is provided having an inner surface defining an elastomeric surface space and an actuator space. A jaw having an actuator coupled thereto is placed in the mold so that the actuator is within the actuator space. A curable elastomer is injected into the elastomeric surface space, and the elastomer is allowed to cure to form the elastomeric surface on the actuator. Alternatively, the elastomer coated actuators may be formed by first making the elastomeric surface by injecting a curable elastomer into a mold having an elastomeric surface space, allowing the elastomer to cure to form the elastomeric surface, removing the elastomeric surface from the mold upon hardening, and then bonding the elastomeric surface to the actuator.

The elastomeric surfaces abolish the need for a specialized applicator instrument in order to operate the surgical occlusion device. Instead, to operate a surgical occlusion device according to the present invention, a surgeon can use any applicator instrument that is capable of moving the actuators relative to one another. Examples of such applicator instruments include forceps, clamps, tweezers, hemostats, laprascopic graspers, or any other surgical instrument capable of moving objects relative to one another. In addition, the elastomeric surfaces allow the surgeon to engage the actuators of the surgical occlusion device from a variety of angles and orientations. This results in considerable simplification in the operation of the occlusion device, as the surgeon need not align, for example, teeth on a specialized applicator with grooves on the actuators in order to securely engage the occlusion device.

Another advantage to having elastomeric surfaces on the actuators is the increased grip provided for by the surfaces. As the elastomeric surface is compressed by the applicator instrument, it deflects and conforms to the instrument, providing increased traction between the surface, and thus the underlying actuator, and the instrument itself. This conformation helps the instrument maintain a tight grip on the elastomeric surfaces. In situations where the applicator instrument includes small protrusions or teeth on its clamping surfaces, these teeth can, in a sense, "bite" into the elastomeric surfaces. This "biting" effect further results in securely gripping the actuators of the surgical occlusion device with applicator instrument.

In another aspect of the invention, an occlusion device according to the present invention may be manufactured with appropriate dimensions, including appropriate thicknesses of the elastomeric surfaces, for use with the narrow diameters offered by laprascopic delivery devices, such as cannulas and trocar sleeves.

The invention also provides for applicator instruments with engaging elements that have elastomeric surfaces. These surfaces can likewise deflect upon being engaged with actuators of an occlusion device, again providing for increased traction between the actuators of the device and the engaging elements of the instrument. Applicator instruments according to the invention are thus likewise applicable for use with a number of occlusion devices, eliminating the need for a particular instrument and device combination, and simplifying the operation of such devices by eliminating the need for a surgeon to align specific engaging elements of an applicator instrument with corresponding elements in a particular occlusion device. In one embodiment, an applicator instrument is provided having elastomeric surfaces that are bonded to the engaging elements. In another embodiment of the invention, the elastomeric surfaces are provided in the form of elastomeric sleeves that are slidably received onto the engaging elements. These and other features and advantages of the invention will become more apparent by reference to the associated drawings and detailed description of the invention that follows.

BRIEF DESCRIPTION OF THE DRAWINGS FIGS. 1 A and IB are side elevation views of a surgical clip according to a first embodiment of the present invention, showing actuators having elastomeric surfaces;

FIG. 2 is a perspective view of the surgical clip of FIGS. 1 A and IB where the clip is engaged by applicator instruments at different angles;

FIG. 3 is a side elevation view with parts broken away of a jaw of the surgical occlusion device of FIGS. 1A and IB, showing the elastomeric surface of the actuator being engaged and deflected by an applicator instrument;

FIGS. 4A and 4B are side elevation views with parts broken away of a surgical clip according to a second embodiment of the present invention, with the clip jaws in opened and closed positions; FIGS. 5A and 5B are side elevation views of a clip according to a third embodiment of the present invention with jaws in opened and closed positions;

FIG. 6 is a side elevation view of a surgical clip according to a fourth embodiment of the present invention; FIG. 7 A is a side elevation view, with parts broken away, of an applicator instrument according to an embodiment of the invention, showing engaging elements having elastomeric surfaces;

FIG. 7B is a cross-sectional view of the applicator instrument of FIG. 7A taken on the plane designated by line 7B-7B of FIG. 7 A; FIG. 8 A is a side elevation view, with parts broken away, of an applicator instrument of another embodiment of the invention, showing engaging elements having elastomeric surfaces;

FIG. 8B is a cross-sectional view of the applicator instrument of FIG. 8 A taken on the plane designated by line 8B-8B of FIG. 8 A; FIG. 9 is a side elevation view with parts broken away of a surgical occlusion device and the applicator instrument of FIG. 7 A, showing the elastomeric surface of the engaging element of the instrument being engaged and deflected by an actuator of the occlusion device; and

FIG. 10 is a side elevation view with parts broken away of a surgical occlusion device and the applicator instrument of FIG. 8 A, showing the elastomeric surface of the engaging element of the instrument being engaged and deflected by an actuator or the occlusion device. DETAILED DESCRIPTION OF THE INVENTION This invention relates to a surgical occlusion device that is capable of being easily operated with a variety of applicator instruments, without need for the instrument to be specially adapted for the occlusion device. A surgical occlusion device according to the present invention comprises first and second jaws and first and second actuators coupled to the first and second jaws. The jaws are capable of being urged away from each other by applying force to the actuators such that the actuators move toward each other. The jaws of the surgical occlusion device subsequently move toward each other by releasing the force being applied to the actuators.

FIGS. 1-3 depict a first embodiment of a surgical occlusion device according to the present invention. As shown in FIGS. 1A and IB, surgical clip 50 comprises first and second jaws 60 and 61, each having a distal end 62 and a proximal end 65, and first and second actuators 90 and 91 coupled to the proximal ends 65 of first and second jaws 60 and 61. Elastomeric surfaces 92 and 93 are provided on each actuator 90 and 91. The surfaces include protrusions 95 for added texture and traction. First and second jaws 60 and 61 are pivotably coupled to each other via rivet 72, and the closing force of the occlusion device is provided by compression spring 75 located between the two actuators. If desired, the interior portions of the jaws 85 may be coated with a soft material, such as an elastomeric material or foam, to reduce trauma to the occlusion site. In addition, first and second jaws 60 and 61 are biased in a proximate position as shown in FIG. 1A, and are urged away from each other to a spaced position as shown in FIG IB by force applied simultaneously to first and second actuators 90 and 91.

Elastomeric surfaces 92 and 93 provide for secure engagement of the occlusion device by an applicator instrument. Specifically, as the elastomeric surface is compressed by the applicator instrument, the elastomeric surface deflects and conforms to the surgical instrument. This results in a "biting" effect as previously described, wherein the instrument "bites" into the elastomeric surface and results in securely gripping the occlusion device.

Applicator instruments that may be used to grip the elastomeric surfaces of the actuators of occlusion devices according to the present invention include any surgical instrument that functions as a gripping tool for engaging and moving other objects relative to one another, for example, forceps, tweezers, hemostats, laprascopic graspers, and clamps. Such applicator instruments may be applied from a variety of angles and orientations, as shown in FIG. 2. This figure shows the application of applicator instrument 410 to actuators 90 and 91 of surgical clip 50 from two different angles.

The engagement of the elastomeric surfaces 92. and 93 from a variety of angles is possible because of the elastic nature of the elastomeric surfaces. As shown in FIG. 3, elastomeric surface 92 is elastically deformed and deflected at the site of application of applicator instrument 410. This is essentially a

"biting" effect of the surgical instrument into the elastomeric coating, resulting in a secure grip.

Any elastomer may be used for the elastomeric surfaces of surgical occlusion devices according to this invention. Examples of such elastomers include but are not limited to silicone, urethane, and vinyl. Preferred elastomers have a Shore A durometer of between about 15 to about 60, and include, for

example, elastomers sold under the trade names Versafiex® (Krayton) (GLS),

Soft Flex (Diamond Polymers), HTP 10-096-1 (Hi-Tech Polymers), Flexchem®

(Colorite Polymers), and C-Flex (Consolidated Polymers). In addition, the jaws and actuators of the surgical occlusion device according to the invention may be made from any relatively hard material, such as metals or plastics, such as polycarbonate.

The elastomeric surfaces may be of any thickness appropriate for the particular application and for the Shore A durometer of the particular elastomer. The preferred thickness range is from 0.01" to 0.042", depending on the particular configuration of the occlusion device, the particular application, and the Shore A durometer of the elastomer. The lower durometer rating, the more easily the elastomer can be deflected. Thus, for thinner elastomeric surfaces, lower durometer elastomers are preferred in order to still provide sufficient deflection for increased traction with an applicator instrument. For thicker surfaces, higher durometer ratings are preferred, as lower durometer elastomers can become unstable and allow too much lateral movement at certain thicknesses. Table 1 below lists the optimal thickness ranges for certain durometer ratings. Table 1 - Optimal thickness ranges for varying elastomer durometers.

Figure imgf000013_0001

In a preferred embodiment, the thickness of the elastomeric coating is preferably between about 0.021 to about 0.024 inches for an elastomer having a Shore A durometer of about 30.

The elastomeric surfaces may be smooth, or they may be textured for even more secure engagement with the applicator instrument. For example, texture may be provided with elastomeric protrusions projecting from the elastomeric surface, such as elastomeric protrusions 95 shown in FIG. 1 A and IB.

The dimensions of surgical occlusion devices, including surgical clips, of the present invention may be of any size suitable for a particular application. For example, in laprascopic applications where a surgical occlusion device is deployed with a delivery device such as a cannula or trocar sleeve, the occlusion device should have a generally low profile to render the device capable of being introduced into and passed through the delivery device. A surgical clip according to the invention is deemed to have a low profile where it is capable of being delivered through a cannula or a trocar sleeve having a diameter in the range of 5 to 10 mm. In an embodiment suitable for use with a trocar, a surgical clip according to the invention has jaws that are approximately 3/4" in length and the height of the clip in the closed state is about 1/2". To aid in minimizing the profile of such a clip, lower durometer elastomers are used which provide for elastomeric surfaces having a minimal thickness. This facilitates use of the clip in a trocar or tube having a 10-millimeter diameter.

The elastomeric surfaces may be secured to the actuators by methods described herein and others known in the art. The surfaces may be applied, for example, by overmolding the elastomer onto the actuators of the surgical occlusion device using conventional overmolding methods. In such methods, the jaw surfaces may also be concurrently overmolded with the elastomer. Alternatively, the elastomeric surfaces may be separately molded and bonded onto the actuators, as well as the inner surfaces of the jaws using adhesives or bonding agents generally known in the art.

A second embodiment of a surgical occlusion device according to the present invention is a surgical clip shown in FIGS. 4 A and 4B. This embodiment includes some features of the type of the surgical clip described, for example, in United States Patent No. 5,653,720, incorporated herein by reference in its entirety. Surgical clip 100 comprises first and second jaws 110 and 112, and first and second actuators 120 and 121 coupled to first and second jaws 110 and 112 via spring 140 contained in first telescoping barrel 145. Specifically, first telescoping barrel 145, telescopingly located within second telescoping barrel 147, is coupled to first actuator 120 and second jaw 112. Similarly, second telescoping barrel 147 is coupled to second actuator 121 and first jaw 110. First telescoping barrel 145 contains spring 140. Spring 140 is normally in an uncompressed position, urging the barrels apart and first and second jaws 110 and 112 together in a proximate position as shown in FIG. 4A. The jaws 110 and 112 are then urged away from each other to a spaced apart position as shown in FIG. 4B as result of force simultaneously applied to first and second actuators 120 and 121, the jaws remaining substantially parallel relative to each other during this movement. First and second jaws 110 and 112 subsequently move toward each other when force is released from actuators 120 and 121. First and second actuators 120 and 121 have elastomeric surfaces 130 and 131 for securing the grip between an applicator instrument (not shown) and first and second actuators 120 and 121 as described above. As in the previous embodiment, the interior portions 150 of first and second jaws 110 and 112 may be coated with a soft material such as an elastomer or foam to reduce trauma at the occlusion site.

A third embodiment of a surgical clip according to the present invention is shown in FIGS. 5A and 5B. This embodiment includes some features of the type of the surgical clip described, for example, in United States Patent No. 5,984,934, incorporated herein by reference in its entirety. This embodiment is essentially a variation of the second embodiment as described above, with the surgical clip 200 again comprising first and second jaws 210 and 212, first and second actuators 220 and 222, having elastomeric surfaces 230 and 232, and being coupled to first and second jaws 210 and 212 via spring 240 contained in first telescoping barrel 245. First and second actuators 220 and 221 have elastomeric surfaces 230 and 231 for securing the grip between a surgical applicator instrument (not shown) and first and second actuators 220 and 221. This third embodiment differs from the second embodiment mainly in that first telescoping barrel 245 is coupled to first actuator 220 and first jaw 210, and second telescoping barrel 247 is coupled to second actuator 222 and second jaw 212. Another difference is that this embodiment has a lower profile than the surgical clip of the second embodiment, as the height of the clip is generally dictated by the height of the jaws 210 and 212. In the closed state illustrated in FIG. 5A, the clip 200 is biased to the closed state and has a very low profile. In the open state illustrated in FIG. 5B, the clip 200 of course has a higher profile, but this profile is generally not greater than the height of the jaws 210 and 212.

Unlike the second embodiment, spring 240 is normally in a first extended position as shown in Fig. 5A, urging the barrels and first and second jaws 210 and 212 toward each other in a proximate position. The application of force simultaneously to first and second actuators 220 and 221 causes the movement of first telescoping barrel 245 away relative to second telescoping barrel 247, which causes the extension of the spring into a second extended position as shown in Fig. 5B. This movement results in jaws 210 and 212 being urged away from each other to a spaced apart position while remaining substantially parallel relative to each other during this movement, as shown in FIG. 5B. First and second jaws 210 and 212 subsequently move toward each other when force is released from actuators 220 and 221. In an alternative embodiment (not shown), first telescoping barrel 245 is coupled to first actuator 220 and second jaw 210, and second telescoping barrel 24*7 is coupled to second actuator 222 and first jaw 212. This alternative embodiment requires that actuators 220 and 221 be moved away from each other (rather than toward each other) for the operation of the surgical clip.

A fourth embodiment of a surgical clip according to the present invention is a surgical clip shown in FIG. 6. This embodiment includes some features of the type of the surgical clip described, for example, in United States Patent No. 5,944,729, incorporated herein by reference in its entirety. Surgical clip 300 is constructed as a single-piece body with a proximal end 316, a midpoint 318 and a distal end 320. The surgical clip comprises first and second jaws 326 and 328 and first and second actuators 312 and 322. First and second jaws 326 and 328 are originally biased in clamping contact with each other and are urged away from each other by force applied simultaneously to move first actuator 312 toward second actuator 322. Again, elastomeric surfaces 330 and 332 are provided on first and second actuators 322 and 312. The present invention is also directed to applicator instruments that can be used with a variety of occlusion devices, and without the need for the instrument to be specially adapted for a particular occlusion device. FIGS. 7A and 7B show a first embodiment of such an instrument. Applicator instrument 510 includes opposed engaging elements 512 and 514, each of which includes elastomeric surfaces 522 and 524 respectively. Engaging elements 512 and 514 are moveable toward and away from one another. As shown in FIG. 9, elastomeric surface 522 is elastically deformed and deflected when engaged with actuator 552 of surgical clip 550. This action provides for increased traction between the applicator instrument and the actuator similar to that described previously, although in this case, the elastomeric surface is provided on the engaging element of the applicator instrument, rather than the actuator of the surgical clip. Elastomers suitable for use for elastomeric surfaces 522 and 524 are the same as those mentioned above. Likewise the preferred thickness and durometer ratings of the surfaces are essentially those referred to above and illustrated in Table 1.

Elastomeric surfaces 522 and 524 can be bonded to engaging elements 512 and 514 using adhesives or bonding agents generally known in the art. In an alternative embodiment, as depicted in FIGS. 8 A, 8B, and 10, elastomeric surfaces 622 and 624 are provided as portions of elastomeric sleeves 632 and 634. The sleeves are slidably received onto engaging elements 612 and 614 of applicator instrument 610. The sleeves can be configured such that they must be stretched somewhat in order to be completely fit over the engaging elements, ensuring a snug fit of the sleeves onto the elements. Although the present invention has been described with reference to preferred embodiments, those skilled in the art will recognize that changes can be made in form and detail without departing from the spirit and scope of the invention.

Claims

We claim:
1. A surgical occlusion device, comprising: first and second jaws coupled to one another and mounted for movement toward and away from one another; and first and second actuators coupled respectively to said first and second jaws and movable relative to one another from a first position to a second position such that movement of said actuators from said first position to said second position urges said jaws apart, said actuators having elastomeric surfaces that can deflect upon engagement with an applicator instrument to provide increased traction between said actuators and said instrument.
2. The surgical occlusion device according to claim 1, wherein said elastomeric surfaces are formed of an elastomer selected from the group consisting of silicone, urethane, and vinyl.
3. The surgical occlusion device according to claim 1, wherein said elastomeric surfaces are formed of an elastomer having a Shore A durometer of between about 15 to about 60.
4. The surgical occlusion device according to claim 1, wherein said elastomeric surfaces are textured.
5. The surgical occlusion device according to claim 1, wherein said occlusion device has a low profile.
6. The surgical occlusion device according to claim 3, wherein said elastomer has a Shore A durometer of about 30 and said elastomeric surfaces have a thickness of about 0.021 to about 0.024 inches.
7. The surgical occlusion device according to claim 1, wherein said first and second jaws remain parallel when moving toward and away from one another.
8. A surgical clip, comprising: first and second jaws mounted for movement toward and away from one another; biasing means that bias said jaws toward one another; and first and second actuators coupled respectively to said first and second jaws and movable relative to one another from a first position to a second position such that movement of said actuators from said first position to said second position opposes said bias and urges said jaws apart, said actuators having elastomeric surfaces that can deflect upon engagement with an applicator instrument to provide increased traction between said actuators and said instrument.
9. The surgical clip according to claim 8, wherein said elastomeric surfaces are formed of an elastomer selected from the group consisting of silicone, urethane, and vinyl.
10. The surgical clip according to claim 8, wherein said elastomeric surfaces are formed of an elastomer having a Shore A durometer of between about 15 to about 60.
11. The surgical clip according to claim 8, wherein said elastomeric surfaces are textured.
12. The surgical clip according to claim 8, wherein said surgical clip has a low profile.
13. The surgical clip according to claim 10, wherein said elastomer has a Shore A durometer of about 30 and said elastomeric surfaces have a thickness of about 0.021 to about 0.024 inches.
14. The surgical clip according to claim 8, wherein said first and second jaws are mounted for pivotal movement toward and away from one another.
1 . The surgical clip according to claim 8, wherein said first and second jaws remain parallel when moving toward and away from one another.
16. A method of occluding a vessel, comprising:
(a) providing a surgical clip, having first and second jaws mounted for movement toward and away from one another, biasing means that bias said jaws toward one another, and first and second actuators coupled, respectively, to said first and second jaws and movable relative to one another from a first position to a second position, such that movement of said actuators from said first position to said second position opposes said bias and urges said jaws apart, said actuators further having elastomeric surfaces that can deflect upon engagement with an applicator instrument to provide increased traction between said actuators and said instrument;
(b) providing an applicator instrument for engaging said first and second actuators;
(c) engaging the elastomeric surfaces of said first and second actuators with said applicator instrument;
(d) moving said first and second actuators relative to one another from said first position to said second position against said bias;
(e) positioning said surgical clip to engage a vessel; and
(f) releasing said surgical clip applicator instrument.
17. The method according to claim 16, wherein said elastomer is selected from said group consisting of silicone, urethane and vinyl.
18. The method according to. claim 16, wherein said elastomeric surfaces are formed of an elastomer having a Shore A durometer of between about 15 to about 60.
19. The method according to claim 16, wherein said elastomeric surfaces are textured.
20. The method according to claim 16, wherein said surgical clip has a low profile.
21. The method according to claim 18, wherein said elastomer has a Shore A durometer of 30 and said elastomeric surface a thickness of about 0.021 to about 0.024 inches.
22. The method according to claim 16, wherein said first and second jaws are mounted for pivotal movement toward and away from one another.
23. The method according to claim 16, wherein said first and second jaws remain parallel when moving toward and away from one another.
24. A method of manufacturing an occlusion device having moveable jaws and actuators for moving said jaws, said method comprising the steps of; providing a jaw having an actuator coupled thereto; and securing an elastomeric surface to said actuator, whereby said elastomeric surface can deflect upon engagement with an applicator instrument to provide increased traction between said actuator and said instrument.
25. A method according to claim 24, wherein said step of securing the elastomeric surface to said actuator further comprises the steps of: providing a mold having an inner surface defining an elastomeric surface space and an actuator space; placing said jaw in said mold such that said actuator is within said actuator space; injecting a curable elastomer into said elastomeric surface space; allowing said elastomer to cure to form said elastomeric surface on said actuator; and removing said jaw from said mold.
26. The method according to claim 25, wherein said elastomer is selected from said group consisting of silicone, urethane and vinyl.
27. The method according to claim 25, wherein said elastomer has a Shore A durometer of between about 15 to about 60.
28. Th& method according to claim 25, wherein said elastomeric surface is textured.
29. The method according to claim 27, wherein said elastomeric surface has a Shore A durometer of about 30 and a thickness of about 0.021 to about 0.024 inches.
30. A method according to claim 24, wherein said step of securing the elastomeric surface to said actuator further comprises the steps of: providing a mold having an inner surface defining an elastomeric surface space; injecting a curable elastomer into said elastomeric surface space; allowing said elastomer to cure to form said elastomeric surface; removing said elastomeric surface from said mold; and bonding said elastomeric surface to said actuator.
31. The method according to claim 30, wherein said elastomer is selected from said group consisting of silicone, urethane and vinyl.
32. The method according to claim 30, wherein said elastomer has a Shore A durometer of between about 15 to about 60.
33. The method according to claim 30, wherein said elastomeric surface is textured.
34. The method according to claim 32, wherein said elastomeric surface has a Shore A durometer of about 30 and a thickness of about 0.021 to 0.024 inches.
35. An applicator instrument for operating a surgical occlusion device, said instrument comprising: first and second engaging elements moveable toward and away from one another for engaging actuators of a surgical occlusion device, said engaging elements having elastomeric surfaces that can deflect upon engagement with actuators of a surgical occlusion device to provide increased traction between said actuators and said instrument.
36. The applicator instrument of claim 35, wherein said elastomeric surfaces are formed of an elastomer selected from the group consisting of silicone, urethane, and vinyl.
37. The applicator instrument of claim 35, wherein said elastomeric surfaces are formed of an elastomer having a Shore A durometer of between 15 and 60.
38. The applicator instrument of claim 35, wherein said elastomeric surfaces are textured.
39. The applicator instrument of claim 37, wherein said elastomer has a Shore A durometer of about 30 and said elastomeric surfaces have thicknesses from about 0.021 to about 0.024 inches.
40. The applicator instrument of claim 35 wherein said elastomeric surfaces are bonded to said engaging elements.
41. The applicator instrument of claim 35, wherein said elastomeric surfaces comprise elastomeric sleeves slidably received onto said engaging elements.
42. A method of occluding a vessel comprising the steps of:
(a) providing a surgical clip having first and second jaws moveable toward and away from one another, biasing means that bias the jaws toward one another, and first and second actuators moveable relative to one another from a first to a second position, such that movement of the actuators from the first to second position opposes said bias and urges said jaws apart;
(b) providing an applicator instrument having first and second engaging elements moveable toward and away from one another for engaging the actuators of the surgical clip, said engaging elements having elastomeric surfaces that can deflect upon engagement with said actuators to provide increased traction between said actuators and said instrument;
(c) engaging said first and second engaging elements of said applicator instrument with said first and second actuators;
(d) moving said engaging elements relative to one another, thereby moving said actuators relative to one another from said first position to said second position against said bias;
(e) positioning said surgical clip to engage a vessel; and
(f) disengaging said engaging elements of said applicator instrument from said actuators.
PCT/US2001/004399 2000-02-11 2001-02-08 Occlusion device WO2001058367A1 (en)

Priority Applications (4)

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US18186200P true 2000-02-11 2000-02-11
US60/181,862 2000-02-11
US64548200A true 2000-08-24 2000-08-24
US09/645,482 2000-08-24

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