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Title:
ENDOSCOPIC COMBINATION GRASPING AND CUTTING INSTRUMENTS AND RELATED METHODS OF GENERALLY CONCURRENTLY CUTTING AND CAPTURING SUTURE REMNANTS
Document Type and Number:
WIPO Patent Application WO/2007/067556
Kind Code:
A2
Abstract:
Methods and surgical devices are described that can generally concurrently endoscopically cut and grasp a portion of a suture. The methods include: (a) endoscopically introducing a combination cutting and grasping instrument into the body; (b) grasping an excess length of suture using the combination instrument; (c) generally concurrently with the grasping step, cutting the excess length of the suture using the combination instrument; and (d) removing the combination instrument with the cut excess suture length from the body.

Inventors:
ISHIKAWA NORIHIKO (JP)
NIFONG L WILEY (US)
SUN YOU SU (US)
Application Number:
PCT/US2006/046430
Publication Date:
June 14, 2007
Filing Date:
December 06, 2006
Export Citation:
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Assignee:
UNIV EAST CAROLINA (US)
ISHIKAWA NORIHIKO (JP)
NIFONG L WILEY (US)
SUN YOU SU (US)
International Classes:
A61B17/04
Foreign References:
US20040167539A12004-08-26
US20050131390A12005-06-16
US20040254598A12004-12-16
US20050125013A12005-06-09
Attorney, Agent or Firm:
RICHARDSON, Julie, H. (P.A.P.O. Box 3742, Raleigh North Carolina, US)
Download PDF:
Claims:

THAT WHICH IS CLAIMED:

1. A method for generally concurrently endoscopically cutting and trapping a portion of a suture, comprising: endoscopically introducing a combination cutting and grasping instrument into the body; grasping a length of suture using the combination instrument; generally concurrently with the grasping step, cutting the grasped length of the suture to create a captured suture remnant using the combination instrument; and removing the combination instrument with the cut, grasped suture remnant from the body.

2. A method according to Claim 1 , wherein the endoscopically introducing the combination instrument comprises introducing the combination instrument into the body through an intra-body cannula port defining an access path using a robotic- assisted system.

3. A method according to Claim 1, wherein the introducing step comprises directing the combination instrument through a closed chest access path that extends into a left atrium of a heart.

4. A method according to Claim 2, wherein the intrabody cannula port is about a 10 mm wide cannula.

5. A method according to Claim 3, further comprising repeating the grasping, cutting and removing steps a plurality of times to carry out a mitral valve repair.

6. A method according to Claim 1, wherein the combination instrument comprises two opposing jaw blade scissor members that pivot relative to each other, the jaw members having a respective resilient member, and wherein the grasping step comprises pressing the resilient members against each other to pinch the excess length of suture therebetween, and wherein the cutting step is performed by the blade scissor members.

7. A method according to Claim 6, wherein the resilient members comprise sponge-like material, and wherein the combination instrument is single-use disposable.

8. A method according to Claim 1, wherein the combination instrument is a grasping scissors that comprises first and second opposing blades that close toward each other to cut the suture, and wherein the scissors comprises a suture trapping member disposed between the first and second blades in close proximity to cutting edges thereof so that, in operation, the trapping member is pushed by the first blade toward the second blade to trap the suture between the trapping member and an upstanding outer perimeter edge portion on the second blade as the blades come together to cut the suture.

9. A method according to Claim 8, wherein the first blade comprises a pushing portion that pushes the trapping member transversely against the upstanding portion of the second blade, and wherein the trapping member comprises a closed wire having sufficient rigidity to maintain its shape when the blades are opened and sufficient resiliency to deform to close against the upstanding portion when the blades are closed.

10. A method according to Claim 1, wherein the combination instrument comprises an elongate sheath that encloses endoscopic forceps and includes a cutting scalpel on a forward edge portion thereof, wherein the endoscopic forceps or the cutting scalpel is axially translatable relative to the other to each serially reside in a forward position on a tip of the instrument, whereby the forceps close to grasp the suture and the scalpel then cuts the grasped suture.

11. A method according to Claim 10, wherein the sheath is axially translatable between a first grasping configuration, wherein the sheath resides a distance rearward of the forceps to expose the forceps to allow the forceps to first grasp the suture, and a second cutting configuration, wherein the sheath encloses the forceps and positions the scalpel on a forward edge portion thereof to allow the scalpel to cut the grasped suture.

12. A method according to Claim 1, wherein the combination instrument is used to cauterize target tissue.

13. A combination endoscopic surgical cutting and grasping device, comprising: suture grasping means for grasping a portion of a ligated suture; and suture cutting means for cutting the grasped suture, wherein the grasping means and cutting means are operated to generally concurrently endoscopically grasp and cut a suture.

14. A device according to Claim 13, wherein the device is a robotically controlled intra-heart device configured and sized to enter a patient's body through an intra-body port through a closed chest access path into a left atrium of a heart.

15. A device according to Claim 13, wherein the device is sized and configured to enter the body through a about a 10 mm wide cannula.

16. A device according to Claim 14, wherein the device is sized and configured to generally concurrently grasp and cut sutures in situ proximate the mitral valve site in response to robotic controlled direction of a surgeon for a mitral valve repair.

17. A device according to Claim 13, wherein the cutting means comprises two opposing cooperating scissor members that pivot relative to each other, and wherein the grasping means comprises a resilient member disposed on each blade member so that the resilient members press against each other to pinch a length of suture therebetween in response to the blade scissor members closing together to cut the suture.

18. A device according to Claim 17, wherein the resilient members comprise a sponge-like material, and wherein the device is single-use disposable.

19. A device according to Claim 13, wherein the cutting means comprises two opposing cooperating scissor members that pivot relative to each other, and wherein

the grasping means comprises an adherent disposed on at least one primary blade member surface so that the adherent captures a length of suture in response to the blade scissor members closing together to cut the suture.

20. A device according to Claim 13, wherein the cutting means comprises first and second opposing blades that close toward each other to cut the suture, and wherein the grasping means comprises a suture trapping member disposed between the first and second blades in close proximity to cutting edges thereof so that, in operation, the trapping member is pushed by the first blade toward the second blade to trap the suture between the trapping member and an upstanding outer perimeter edge portion on the second blade as the blades come together to cut the suture.

21. A device according to Claim 20, wherein the first blade comprises a pushing portion that pushes the trapping member against the upstanding portion of the second blade, and wherein the trapping member comprises a curvilinear wire having sufficient rigidity to maintain its shape when the blades are opened and sufficient resiliency to deform to close against the upstanding portion when the blades are closed.

22. A device according to Claim 13, wherein the device comprises an elongate sheath that encloses the grasping means, the grasping means comprising endoscopic forceps, and wherein the cutting means comprises a cutting scalpel disposed on a forward edge portion of the sheath, wherein, during operation in situ, the endoscopic forceps or the cutting scalpel is axially translatable so that each serially reside in a forward position on a tip of the device whereby the forceps close to grasp the suture and the scalpel then cuts the grasped suture.

23. A device according to Claim 22, wherein the sheath is axially translatable to a first grasping configuration, wherein the sheath resides a distance rearward of the forceps to expose the forceps to allow the forceps to first grasp the suture, and a second cutting configuration, wherein the sheath encloses the forceps and positions the scalpel on a forward edge portion thereof to allow the scalpel to cut the grasped suture.

24. A device according to Claim 13, further comprising cauterizing means disposed on a distal portion of the instrument.

Description:

ENDOSCOPIC COMBINATION GRASPING AND CUTTING INSTRUMENTS AND RELATED METHODS OF GENERALLY CONCURRENTLY CUTTING AND CAPTURING SUTURE REMNANTS

RELATED APPLICATION

This application claims the benefit of U.S. Provisional Application Serial No. 60/748,099, filed December 7, 2005, the contents of which are hereby incorporated by reference as if recited in full herein.

FIELD OF THE INVENTION

The invention relates to endoscopic suture scissors, the scissors may be particularly suitable for minimally invasive cardiac surgeries.

BACKGROUND OF THE INVENTION

During surgeries, surgical tools are introduced into the body to carry out the desired cutting, forming or ablation procedure in the target location in the body. Typically, one or more retractors can be used to provide a suitable access path or increased intra-body space for the tools to be able to reach the target location.

Relatively recently, a minimally invasive, robotic-assisted surgical system has been used to carry out closed chest (rather than open heart) cardiac surgeries. The closed chest surgeries can use both major and minor surgical access paths to allow for multiple instruments to be inserted into the body and used concurrently or serially during the procedure. One example of a cardio-surgical robotic-assisted system is the da VinciĀ® Surgical System by Intuitive Surgical Inc. of Sunnyvale, CA.

Using the robotic-assisted surgical system, a surgeon's hands do not typically enter the patient. After set-up incisions that are used to create the major or minor access paths, the surgeon controls the instruments, including at least one miniature camera used to carry out the surgery, from a console, usually located in the operating room, to guide the instruments into position and operate the instruments to carry out their intended functions. The camera provides real time (magnified) images of the operating site or access paths on a display that allows a surgeon to "see" the tools and operative site and remotely control the surgery.

During some conventional mitral valve repairs, sutures are placed in the heart. After ligation of each suture, a "side" surgeon inserts conventional endoscopic scissors to cut the suture excess, then grasps and removes the remnant of the suture with endoscopic forceps.

There is a need for instruments and methods that can facilitate minimally invasive surgeries, particularly robotic-assisted cardiac surgeries.

SUMMARY OF EMBODIMENTS OF THE INVENTION

Embodiments of the present invention are directed to grasping scissors and methods that can facilitate minimally invasive endoscopic and/or robotic-assisted surgeries. The instruments may be particularly suitable for intra-cardiac mitral valve repair procedures.

Some embodiments are directed to methods for generally concurrently endoscopically cutting and grasping a portion of a suture. The methods include: (a) endoscopically introducing a combination cutting and grasping instrument into the body; (b) grasping a length of suture using the combination instrument; (c) generally concurrently with the grasping step, cutting the grasped length of the suture to create a captured suture remnant using the combination instrument; and (d) removing the combination instrument with the cut grasped suture remnant from the body.

Other embodiments are directed to combination endoscopic surgical cutting and grasping devices that include: (a) suture grasping means for grasping a portion of a ligated suture; and (b) suture cutting means for cutting the grasped suture, wherein the grasping means and cutting means are operated to generally concurrently endoscopically grasp and cut a suture.

The devices may be sized and configured to enter the body through a about a 10 mm cannula. The devices may be sized and configured to generally concurrently grasp and cut sutures in situ proximate the mitral valve site in response to robotic controlled direction of a surgeon for a mitral valve repair.

In particular embodiments, the cutting means comprises two opposing cooperating scissor members that pivot relative to each other and the grasping means comprises a resilient member disposed on each blade member. In operation, the resilient members press against each other to pinch a length of suture therebetween in response to the blade scissor members closing together to cut the suture.

In other embodiments, the cutting means comprises first and second opposing blades that close toward each other to cut the suture and the grasping means comprises a suture trapping member disposed between the first and second blades in close proximity to cutting edges thereof. In operation, the trapping member is pushed by the first blade toward the second blade to trap the suture between the trapping member and an upstanding outer perimeter edge portion on the second blade as the blades come together to cut the suture.

In still other embodiments, the cutting means comprises first and second opposing blades that close toward each other to cut the suture and the grasping means comprises a suture trapping member disposed between the first and second blades in close proximity to cutting edges thereof. In operation, the trapping member is pushed by the first blade toward the second blade to trap the suture between the trapping member and an upstanding outer perimeter edge portion on the second blade as the blades come together to cut the suture.

In particular embodiments, the trapping member comprises a curvilinear wire having sufficient rigidity to maintain its shape when the blades are opened and sufficient resiliency to deform to close against the upstanding portion when the blades are closed.

In some embodiments, the cutting means includes two opposing cooperating scissor members that pivot relative to each other and the grasping means comprises a sticky member disposed on at least one primary blade member surface so that the sticky member captures a length of suture in response to the blade scissor members closing together to cut the suture.

It is noted that any of the features claimed with respect to one type of claim, such as a system, apparatus, or computer program, may be claimed or carried out as any of the other types of claimed operations or features.

Further features, advantages and details of the present invention will be appreciated by those of ordinary skill in the art from a reading of the figures and the detailed description of the embodiments that follow, such description being merely illustrative of the present invention.

BRIEF DESCRIPTION OF THE DRAWINGS

Figure 1 is a side perspective view of a robotic-assisted surgery system in position for cardiac surgery according to embodiments of the present invention.

Figure 2 is flow chart of operational steps that can be used to carry out embodiments of the present invention.

Figure 3 is a side view of a grasping scissors surgical instrument according to embodiments of the present invention.

Figure 4 A is a schematic side view of the instrument shown in Figure 3.

Figure 4B is a schematic end view of the instrument shown in Figure 3 with the scissors open (taken along line 4B-4B in Figure 4A), thereby cutting and grasping a suture remnant according to embodiments of the present invention.

Figure 4C is a schematic end view of the instrument shown in Figure 4B with the scissors closed and the grasping material compressed according to embodiments of the present invention.

Figure 5 is a schematic illustration of the device shown in Figure 3 in an exemplary mitral valve region of the heart cutting and removing a suture remnant from ligated tissue according to embodiments of the present invention.

Figure 6A is a schematic top view of a grasping scissor instrument in an open configuration according to yet other embodiments of the present invention.

Figure 6B is a schematic view of the instrument shown in Figure 6 A illustrating the instrument in a closed (cutting) configuration according to embodiments of the present invention.

Figure 7A is a side view of a grasping scissors instrument according to other embodiments of the present invention.

Figure 7B is a top schematic view of the instrument shown in Figure 7 A.

Figures 8A-8C are schematic illustrations of a sequence of operations that can be used to grasp and cut a suture according to embodiments of the present invention.

Figure 9 is an enlarged partial side view of a combination grasping and cutting surgical instrument illustrating grasping forceps in an open configuration according to yet other embodiments of the present invention.

Figure 10 is a side view of the device shown in Figure 9 illustrating the grasping forceps in a closed configuration.

Figures 11A-11C are schematic illustrations of a sequence of operation of the device shown in Figures 9 and 10 according to embodiments of the present invention.

Figure 12 is a schematic illustration of the device shown in Figures 9 and 10 in an exemplary position in the heart to cut, grasp and remove sutures in vivo at a mitral valve repair site.

DETAILED DESCRIPTION

The present invention now is described more folly hereinafter with reference to the accompanying drawings, in which embodiments of the invention are shown. : This invention may, however, be embodied in many different forms and should not be construed as limited to the embodiments set forth herein; rather, these embodiments are provided so that this disclosure will be thorough and complete, and will folly convey the scope of the invention to those skilled in the art.

Like numbers refer to like elements throughout. In the figures, the thickness of certain lines, layers, components, elements or features may be exaggerated for clarity. Broken lines illustrate optional features or operations unless specified otherwise.

The terminology used herein is for the purpose of describing particular embodiments only and is not intended to be limiting of the invention. As used herein, the singular forms "a", "an" and "the" are intended to include the plural forms as well, unless the context clearly indicates otherwise. It will be further understood that the terms "comprises" and/or "comprising," when used in this specification, specify the presence of stated features, integers, steps, operations, elements, and/or components, but do not preclude the presence or addition of one or more other features, integers, steps, operations, elements, components, and/or groups thereof. As used herein, the term "and/or" includes any and all combinations of one or more of the associated listed items. As used herein, phrases such as "between X and Y" and "between about X and Y" should be interpreted to include X and Y. As used herein, phrases such as "between about X and Y" mean "between about X and about Y." As used herein, phrases such as "from about X to Y" mean "from about X to about Y."

Unless otherwise defined, all terms (including technical and scientific terms) used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the specification and relevant art and should not be interpreted in an idealized or overly formal sense unless expressly so defined herein. Well-known functions or constructions may not be described in detail for brevity and/or clarity.

It will be understood that when an element is referred to as being "on", "attached" to, "connected" to, "coupled" with, "contacting", etc., another element, it can be directly on, attached to, connected to, coupled with or contacting the other element or intervening elements may also be present. In contrast, when an element is referred to as being, for example, "directly on", "directly attached" to, "directly connected" to, "directly coupled" with or "directly contacting" another element, there are no intervening elements present. It will also be appreciated by those of skill in the art that references to a structure or feature that is disposed "adjacent" another feature may have portions that overlap or underlie the adjacent feature.

It will be understood that, although the terms first, second, etc. may be used herein to describe various elements, components, regions, layers and/or sections, these elements, components, regions, layers and/or sections should not be limited by these terms. These terms are only used to distinguish one element, component, region, layer or section from another region, layer or section. Thus, a first element, component, region, layer or section discussed below could be termed a second element, component, region, layer or section without departing from the teachings of the present invention. The sequence of operations (or steps) is not limited to the order presented in the claims or figures unless specifically indicated otherwise.

Spatially relative terms, such as "under", "below", "lower", "over", "upper" and the like, may be used herein for ease of description to describe one element or feature's relationship to another element(s) or feature(s) as illustrated in the figures. It will be understood that the spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the figures. For example, if the device in the figures is inverted, elements described as "under" or "beneath" other elements or features would then be oriented "over" the other elements or features. Thus, the exemplary term "under" can encompass both an orientation of over and under. Similarly, the terms "upwardly", "downwardly", "vertical", "horizontal" and the like are used herein for the purpose of explanation only unless specifically indicated otherwise.

The term "axially" and derivatives thereof mean in a generally lengthwise direction. The term "small opening" means an opening, port or incision that is less than about 5 inches wide and/or long, typically between about 0.25-3 inches, and more typically about 10 mm. The small opening can be disposed above, below or to

the side of the sternum, or through an intercostals space in the sternum while the chest is closed (no separation of the sternum is needed).

The term "endoscopically" refers to a minimally invasive surgery that uses an endoscope and/or a robotic-assisted system. The endoscope and/or robotic system can include a camera and video (for providing real-time vision of the internal site) and can include a lighted medical instrument comprising a long tube that can be inserted into the body, usually through a small incision and/or cannula defining an intraoperative access path into the body.

The term "grasping" means securely capturing and includes trapping, adhesively attaching, clasping, pinching, and the like.

The surgical instruments described herein may be particularly suitable for robotic-assisted cardiac surgeries in which the heart of the patient is arrested for a brief period while the patient is placed on a heart-lung machine so that a surgeon can operate. For example, surgeries of the left atrium are carried out to repair, remove and/or replace faulty valve tissue (or the mitral valve itself). However, the surgical instruments may also be used for other surgeries, typically minimally invasive surgeries, of other target regions in the body, within or outside the mediastinum.

For clarity of description, the inventions) will be discussed primarily below in relationship to robotic-assisted closed chest cardiac surgeries. Such surgeries are typically carried out using a small thoracotomy and several thoracoports to provide operative visibility and access to the target cardiac site. However, the instruments and methods are not limited thereto as they can be useful for other surgeries and/or for other target organs or tissue, such as non-robotic endoscopic surgeries.

Generally stated, in robotic mitral repairs, sutures for annular closure, intraleaflet closure and/or annuloplasty can be placed robotically using, for example, 2-0 braided sutures and 4-0 monofilament sutures, all of which may be shortened to a desired length beforehand. A side surgeon can cut and pick up the sutures using conventional scissors and forceps after ligation of the sutures. The number of sutures can vary with a patient, but for a quadrantectomy, more than 10 sutures are typically used with the ordinary sliding technique, and in an annuloplasty, between about 10-14 sutures can be used.

Recognizing that faster interventions and reduced insertions and extractions of endoscopic instruments can provide enhanced patient treatments, particularly as myocardial function can be depressed after cardiopulmonary bypass with extended

time of heart arrest, embodiments of the present invention are directed to endoscopic instruments that can cut and grasp (ligated sutures) at the same time.

Figure 1 illustrates a robotic system 178 positioned to carry out a closed chest surgical procedure. For more description of suitable systems and/or components, see, e.g., U.S. Patent Nos. 6,936,042; 6,522,906; 6,371,952; 6,364,888; 6,346,072; 6,331,181; 6,312,435; 6,309,397; 6,246,200; 6,206,903; and 6,132,368, the contents of which are hereby incorporated by reference as if recited in foil herein. See also, Ng et al., "Robotic surgery" IEEE Engineering in Medicine and Biology (1993) 120-125. As shown in Figure 1, an exemplary lifting retractor system 10 can be used to provide increased chest cavity access space. The system 10 includes a lifting retractor 20, a retractor connector 22, a mounting arm 30, and a mounting leg 40. A lead, such as a chain, cable or wire can extend between the connector 22 and the mounting arm 30. The lifting retractor 20 is inserted generally lengthwise into the body under the chest wall using an opening 75 proximate the xiphoid process or tip of the sternum cavity. This increased space can help provide suitable chest cavity space for surgical access. Other types of lifting retractors as well as cardiac (intra- wall) lifting retractors may also be used. In other embodiments, no lifting retractors are required. As such, the instruments contemplated by the instant invention can be used alone or with different lifting retractors.

Supplemental incisions for side entry via percutaneous penetration can provide additional, typically minor, surgery access paths 176, 177 to the heart or great vessel (or other target regions) to allow surgery via visualization of the target site. One or more paths 175-177 (or even additional paths) can be used by one or more surgeons for inserting tools used to carry out minimally invasive surgeries, such as endoscopic procedures. These paths 175-177 can be particularly suitable for robotic-assisted systems as noted above. Tools can be inserted serially through each path, and in some embodiments, cooperating tools can be inserted concurrently, one or more through a different access path to meet at a common location in situ.

One or more of the entry paths, such as the side or minor entry paths 176, 177 can be defined by an intra-body port with a cannula (also generally known as a trocar). In some embodiments, one or more intra-body ports can be provided by a small cannula, typically one that is between about 5-15 mm wide, and more typically about 10 mm wide. An example of a commercially available port suitable for

providing side access paths, is the THORACOPORTā„¢, available from U.S. Surgical, Inc., a division of Tyco Healthcare, having a place of business in Norwalk, CT.

Figure 2 is a flow chart of operations that can be used to carry out embodiments of the present invention. A combination cutting and grasping instrument can be endoscopically introduced into the body (block 100). A length of suture can be grasped using the combination instrument (block 105). Generally concurrently with the grasping step, the grasped (captured) suture can be cut using the combination instrument (block 110). The combination instrument can be removed from the body with the grasped portion (remnant) of the cut suture (block 115).

In particular embodiments, the grasping and cutting can be carried out at a mitral valve repair site in the body using a cannula access path and a robotic-assisted system (block 107). In some embodiments, the combination instrument (or portions thereof) can be rotated before, during and/or after the grasping and/or before and/or during the removing step (block 111).

It is noted that, for ease of discussion, the combination instrument will be referred to generally by reference number 200, with particular embodiments of the combination instrument 200 noted by numerical derivatives thereof (i.e., 201, 202, 203, and 204). In the past, a surgeon typically used a forceps instrument to capture the suture and a separate pair of scissors to cut the suture. Using a device that can carry out both functions can decrease the number of insertions and tools needed to carry out the operations and increases the speed of the tissue ligation procedure.

Figure 3 illustrates a grasping scissors 201 embodiment of a combination instrument 200. As shown, the distal portion of the instrument 201 comprises cooperating first and second blade members 220, 230. Each of the blade members 220, 230 includes a resilient member 225, 235 on a primary surface thereof. The resilient members 225, 235 are configured to press against each other to pinch or trap a segment or length of suture therebetween. In operation, as the blade members 220, 230 close to cut a suture, the resilient members 225, 235 meet to press against the other to capture the cut suture remnant, and the instrument can be withdrawn from the body, thereby removing the captured suture remnant. As shown, the blade members 220, 230 can be pivotably attached via distal pivot 238 to be controllably opened and closed by a surgeon.

The resilient members 225, 235 can occupy a portion of at least one primary surface of the blade member 220, 230. In some embodiments, the resilient members

225, 235 can occupy at least a major portion of an outermost primary surface of the respective blade member 220, 230. In some embodiments, as shown in Figure 3, the resilient members 225, 235 can occupy or cover substantially all of one of the primary surfaces of the respective blade member 220, 230. Figure 4A illustrates that the other side of the blade members 220, 230 may be devoid of the resilient material. Although not shown, the resilient members 225, 235 may also be configured to wrap around the blade members 220, 230 (or attach to both sides of the respective blade member) in a manner that allows the blade members 220, 230 to still cut a target suture 275 (Figure 4B) or other target item. In some embodiments, the resilient members 225, 235 can compress in at least two directions, typically both side-to-side and up-and-down, as the blade members 220, 230 close together to cut the suture or other item.

In some embodiments (not shown), one or both of the resilient members 220, 230 may be configured to extend just beyond a cutting edge of the respective blade 225, 235 and to be resiliently pushed back to allow the cutting surface or edge to cut the suture while the major facing surfaces of the resilient members press against each other and trap the suture.

In some embodiments, as shown in Figure 5, the cutting side (201c, Figure 4A) of the instrument can reside facing the mitral valve 102 inside the left atrium while the resilient grasping side (201 g, Figure 3) faces out of the heart. This allows for a longer cut length or for the ligated suture 275 to be cut closer to the repair site. The instrument 201 can be rotated in situ to grasp the suture in a desired orientation or location.

The resilient members 225, 235 can have a thickness that is greater than the blade member thickness, typically between about 1.25-10 times greater. As shown in Figures 3, 4B and 4C, the thickness (T 2, Figure 4B) of the resilient members 225, 235 can be at least about twice to about four times that of the blade members 220, 230 (T 1 , Figure 4B). The resilient members 225, 230 can be formed of the same or different material, of the same or different thickness, and each can have the same or a different suitable compressive modulus of elasticity. The resilient members 225, 235, can be configured to provide sufficient compressive strength (grasping strength) for at least about 10 different cutting and grasping retrievals during a single patient use. The resilient members 225, 235 can be sprayed, coated and/or adhesively attached onto the respective blade members 220, 230 or otherwise secured thereto.

The resilient members 225, 235 can comprise a material with sponge-like properties such as elastomers, rubber and cellulose including polymers or copolymers and derivatives thereof, or combinations thereof. Some exemplary resilient members can comprise foam, nitrile, neoprene, latex, polyethylene, and/or high-density polyethylene forms. In some particular embodiments, the resilient members 225, 235 can comprise neoprene.

The resilient members 225, 235 may be single-use disposable, and can be releaseably attachable to the instrument 201 to allow for reuse of the blade instrument 201, or the instrument 201 may also be single-use disposable. In other embodiments, where the resilient members 225, 235 are integral to the respective blade, and if the instrument 201 is reused, the sponge-like material should be configured to be (re) sterilizable. The sterilization can be via fluid, irradiation and/or other suitable means. In some embodiments, a biocompatible coating or material can be used to coat or enclose an underlying resilient material to inhibit bacterial growth and/or facilitate sanitation/sterilization.

As also shown in Figure 3, one of the blade members 220, 230 (shown as blade member 220, but it can also be blade member 330) can have a stop member 245 that stops the movement of the other blade member in the cutting stroke. This stop member 245 can be configured to extend a distance sufficient to impose compressive force onto the resilient member 235 or to just stop the blade member 230 from advancing past the closed cutting position. This can help the resilient members 225, 235 remain in grasping contact after the cutting is carried out.

In some embodiments, one or both of the resilient members 225, 235 may have an increased-friction gripping surface to inhibit excessive sliding between the surfaces during the grasping step. In particular embodiments, one or more of the resilient members 225, 235 may have a tacky, sticky or adhesive portion to provide additional capturing and trapping/retention means for the target suture and/or contact between the resilient bodies during extraction.

The instrument 201 can include a remotely steerable arm 240. The arm 240 can be configured to rotate as well as to translate in and out of a desired position in the body.

Figures 6 A and 6B illustrate another embodiment of grasping scissors 202 that form the combination instrument 200. The device 202 includes blade members 220, 230 that are pivotally attached via pivot 238. In this embodiment, an inner

primary surface 221 can have an adhering or sticky portion that can trap and hold the suture 275 thereon as the blades close to cut the suture 275. Figure 6B illustrates that the sticky surface 221 can hold the suture remnant 275 after the suture is cut from the target site (such as the mitral valve repair site 102). As also shown in Figures 6A and 6B, one or more of the blade members 220, 230 (shown as member 230) can include a cauterizing member 260 such as an electrode or other heating element. Typically, the cauterizing member 260 will be disposed proximate a tip portion of the instrument. An activation (power) lead can be disposed in or on the steering arm 240. It is noted that although not further described herein, each of the embodiments may include additional elements, such as the cauterizing member 260 described above. The steering arm 240 can allow for the distal portion of the instrument 202 to rotate to position the scissors and cauterizing tip at the desired location.

Figure 7A illustrates another embodiment of grasping scissors 203 that form the combination instrument 200. In this embodiment, the instrument 203 also includes first and second scissor blade members 220, 230 that pivot to close to cut and trap the target suture 275. However, this embodiment employs a trapping member 305 disposed between the blade members 220, 230. One blade member 230 includes a pushing member 310 and the other blade member 220 includes an upstanding stop member 315. In operation the trapping member 305 is pushed toward one blade member 220 by the other blade member 230 to trap the suture remnant between the outer perimeter of the trapping member 305 and the blade member 230. The instrument 203 can be rotated or reticulated to orient the blade members 220, 230 and/or trapping member 305 as desired with respect to the suture 275 during the grasping and/or cutting.

The trapping member 305 can be resiliently biased to compress to trap the suture remnant, then return to a non-compressed configuration a plurality of times. As shown in Figures 7A and 7B, the trapping member 305 can be a curvilinear wire or lead having a sufficient rigidity to hold its shape and position between the blade members 220, 230 when the instrument is in an open position and having sufficient resiliency to be compressed to trap the suture then decompressed to return to its non- compressed shape at least about 10 times. Figures 8A-8B schematically illustrate exemplary operations that can be used to trap, cut and remove suture remnants 275 using the instrument 203.

The trapping member 305 can be formed of a metallic or an elastomeric material. In some embodiments, the trapping member 305 can comprise NITINOL, a stainless steel or other biocompatible metallic material. The trapping member 305 can be releasably attachable to the instrument 203. In other embodiments, the trapping member 305 is integral to the instrument 203 and the instrument 203 can be a multi-use or single-use disposable device.

The pushing member 310 can be integral to the blade member 230, i.e., the blade member 230 can have an increased thickness portion or may be a discrete member attached thereto. The stop member 315 can also be integral to the blade or a discrete separate member attached thereto. The trapping member 305 can be fixedly attached to the stop member 315 as shown or free floating but held between the first and second blade members 220, 230. The trapping member 305 can be free floating with respect to the pushing member 305 or may be attached to a portion thereof. Particularly for the former, the trapping member 305 can be biased to return to a non- compressed configuration upon opening of the scissor members 220, 230. If the latter, the opening of the scissor members 220, 230 can pull the trapping member to an open configuration. The trapping member 305 may be configured as a leaf spring of one more components.

Figures 9 and 10 illustrate a sliding cutting and grasping instrument 204 that defines the combination instrument 200. In this embodiment, the instrument 204 includes a sheath 400 that encloses forceps 410, and a blade 420 (also known as a scalpel) held on a distal end portion of the sheath body 400b. The sheath body 400b can translate to enclose the forceps 410 or to expose the forceps. Alternatively, the forceps 410 can translate to recede into the sheath 400 or to extend a distance beyond a distal portion of the sheath body 400b. Figure 9 illustrates the forceps 410 in an open configuration 41Oe that positions the distal portion of the forceps 410 beyond the distal end of the sheath body 400b. Figure 10 illustrates the forceps 410 in a closed configuration 410c positioned ready to enter the sheath 400 to be encased or enclosed by the sheath body 400b.

The instrument 204 can include a compression clip 425 or other mechanical fixation device(s) or configurations that allows the sheath 400 and forceps 410 to controllably axially translate with respect to each other and also allows the sheath 400 and forceps 410 to controllably rotate relative to each other. For example, the sheath and forcep bodies can include concentric sliding sleeves, bearings, bushings and the

like. The forceps 410 can have a fixed axially translating distance within the sheath (such as at the distal portion) or can axially translate further distances or even the entire sheath length. In some embodiments, the sheath 400 can remain in the body while the forceps are withdrawn with the suture remnant.

The blade 420 can be configured to angularly extend at an acute angle on a forward edge portion of the sheath as shown. Typically, the blade 420 has an exposed sharp edge portion that extends a short axial distance over the sheath body. The blade 420 can extend from a forward or distal edge portion a distance rearward at an angle of between about 20-75 degrees from an axial centerline 400c drawn through the center of the sheath 400. The region of the sheath 400 above the blade 420 can be open as shown in Figure 9. The blade 420 can have an axial length of between about lmm to about 25 mm.

Figures 1 IA-11C illustrate an exemplary sequence of operations according to certain embodiments of the present invention. As shown in Figure HA, in position proximate a target suture site, the forceps 410 can be exposed (extended distally out of the sheath 400). The forceps 410 close to hold a portion of the target suture 275 as shown in Figure HB. The sheath 400 can be axially translated forward to swallow the forceps 410c. The sheath 400 or forceps 410 can be rotated to bring the tensioned suture 275 against the blade 420 as the forceps holds the suture 275. The suture 275 . is cut as shown in Figure HC and the remnant is trapped by the forceps 410 and withdrawn from the body. By translating the sheath 400 forward to cut the suture rather than withdrawing the forceps into the sheath 400, the suture can be cut closer to the tissue. Figure 12 illustrates the sheath 400 axially extended proximate the repair site 102 whereby the suture 275 is cut and the remnant trapped by the forceps 410 in the sheath body 400b. A (side) surgeon can leave the sheath body 400b and/or forceps 410 in the body during certain procedures or for longer periods (non active use periods) with reduced risk of inadvertent trauma to tissue.

The blade 420 can be releaseably attached to the sheath body 400b to keep the blade sharp to allow for multiple reuses with new blades. Alternatively, the device 204 can be reused a limited number of times or made as a single-use disposable instrument. The sheath 400 and forceps 410 can be made of any suitable biocompatible material. The forceps 410 can include teeth or ridges 411 as shown in Figure 9 but such is not required. Further, any combination of the trapping or

grasping configurations described above can also be used with the forceps 410. The forceps 410 and/or sheath 400 may be metallic.

In other embodiments, instead of a scalpel or sharp blade, a hot blade can be used whereby a heated edge of the sheath can sever the suture (not shown).

The documents incorporated herein are to illustrate the state of the art with respect to some aspects of systems and devices and the references and are not cited to limit the scope of the invention.

The foregoing is illustrative of the present invention and is not to be construed as limiting thereof. Although a few exemplary embodiments of this invention have been described, those skilled in the art will readily appreciate that many modifications are possible in the exemplary embodiments without materially departing from the novel teachings and advantages of this invention. Accordingly, all such modifications are intended to be included within the scope of this invention as defined in the claims. The invention is defined by the following claims, with equivalents of the claims to be included therein.