Devices with a bendable tip for medical procedures Number:6,743,239 from the United States Patent and Trademark Office (PTO) owispatent An improved device for performing medical procedures, preferably minimally invasive medical procedures, includes a shaft with a proximal and distal end and a bendable tip extending from the distal end of the shaft. In some preferred embodiments, a fastener applicator extends from the bendable tip. In other preferred embodiments, a malleable section is located between the bendable tip and the shaft. The bendable tip can include a plurality of articulating segments. The improved directional device can be used to repair native valves in a patient, especially heart valves.<H procedures, bendable, Devices, with, a, , 6743239.html, Patent, pto, 6743239

Title: Devices with a bendable tip for medical procedures

Abstract: An improved device for performing medical procedures, preferably minimally invasive medical procedures, includes a shaft with a proximal and distal end and a bendable tip extending from the distal end of the shaft. In some preferred embodiments, a fastener applicator extends from the bendable tip. In other preferred embodiments, a malleable section is located between the bendable tip and the shaft. The bendable tip can include a plurality of articulating segments. The improved directional device can be used to repair native valves in a patient, especially heart valves.

Patent Number: 6,743,239 Issued on 06/01/2004 to Kuehn, et al.

Inventors: Kuehn; Stephen T. (Woodbury, MN), Montpetit; Karen P. (St. Paul, MN)
Assignee: St. Jude Medical, Inc. (St. Paul, MN)

Appl. No.: 09/578,984

Filed: May 25, 2000

Current U.S. Class: 606/139 ; 600/101; 600/139; 600/141; 606/101; 606/208

Current International Class: A61B 17/064 (20060101); A61B 17/128 (20060101); A61B 17/12 (20060101); A61B 17/28 (20060101); A61B 17/00 (20060101)

Field of Search: 606/1,51,52,108,170,171,174,180,169,205-210 604/22 600/101,139,146,147,562-567

References Cited [Referenced By]

U.S. Patent Documents


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Foreign Patent Documents


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WO 99/13777	Mar., 1999	WO

Other References

Written Opinion dated Jul. 9, 2002 (PCT/US01/15905). .
Invitation to Pay Additional Fees (PCT/US01/19505), dated Nov. 15, 2001. .
"Mitral Valve Reconstruction for Mitral Insufficiency" by Ross M. Reul et al., for Progress in Cardioascular Diseases, vol. XXXIX, No. 6, (May/Jun.) 1997, pp. 567-599. .
Daig Brochure: "Schwartz.TM. Introducers", Daig Corporation, Minnetonka, MN 1995. .
Daig Brochure: "Daig Fast-Cath.TM. Introducers", Daig Corporation, Minnetonka, MN 1994. .
"The edge-to-edge technique: A Simplified Method to Correct Mitral Insufficiency", by F. Maisano et al, for European Journal of Cardio-thoracic Surgery, 13:240-246, 1998..

Primary Examiner: Jackson; Gary
Attorney, Agent or Firm: Altera Group, LLC Finucane; Hallie A.

Claims

What is claimed is:

1. A device for medical procedures comprising: a shaft having a rigid section at a proximal end; a bendable tip comprising a plurality of articulated segments arranged at a distal end of the shaft; and an end segment extending from the bendable tip, wherein the end segment comprises a plurality of instrument deploying elements.

2. The device of claim 1 wherein the bendable tip has suitable dimensions for insertion into a human heart.

3. The device of claim 1 wherein the bendable tip can bend in either of two opposite directions in a plane relative to a linear configuration.

4. The device of claim 1 wherein the bendable tip further comprises a plurality of independent pivoting segments pivotable with respect to adjacent segments.

5. The device of claim 4 wherein each pivoting segment of the bendable tip is connected to an adjacent segment at two coaxial hinges.

6. The device of claim 1 wherein the bendable tip can be locked at a selected degree of bend.

7. The device of claim 1 further comprising two communicating elements extending from the bendable tip to the proximal end of the shaft, the communicating elements connecting to the bendable tip such that each communicating element functions as an opposing lever arm with respect to the bending of the tip.

8. The device of claim 1 further comprising a single communicating element extending from the bendable tip to the proximate end of the shaft, the communicating element being connected to the bendable tip such that tension on the communicating element tends to bend the bendable tip in one direction relative to a linear configuration.

9. The device of claim 1 further comprising a malleable section between the rigid section and the bendable tip.

10. The device of claim 1 further comprising: a handle having an elongated grip generally coaxial with the shaft and being attached to the rigid section of the shaft; the grip comprising a knob rotatable about the longitudinal axis of the handle; and a first cord connecting the bendable tip with the knob such that rotation of the knob changes the position and degree of bending of the tip.

11. The device of claim 10 further comprising a second cord connecting the bendable tip with the knob wherein rotation of the knob in one direction extends the first cord while retracting the second cord and rotation of the knob in the other direction extends the second cord while retracting the first cord.

12. The device of claim 1 wherein the plurality of instrument deploying elements at least include a first instrument deploying element and a second instrument deploying element, wherein the first instrument deploying element comprises a lumen centrally located in the end segment, the lumen being adapted for introducing an instrument through the end of the bendable tip, and the second instrument deploying element comprises at least two tabs extending from the end segment, the tabs being adapted to releasably secure another instrument therebetween.

13. The device of claim 12 further comprising a gripper extendible through the lumen from the end segment of the bendable tip.

14. The device of claim 1 wherein the articulated segments comprise at least one off-center channel having a cord extending through the channel to the proximal end of the shaft.

15. The device of claim 1 wherein the bendable tip has an asymmetric opening extending therethrough.

16. The device of claim 1 wherein the articulating elements have a central lumen with an elongated cross section with the major axis of the lumen being perpendicular to a pivot axis.

17. The device of claim 1 wherein adjacent articulating segments have hinge elements that snap into position.

18. The device of claim 1 wherein the plurality of instrument deploying elements at least includes a first instrument deploying element wherein the first instrument deploying element comprises a lumen centrally located in the end segment, the lumen being adapted for introducing an instrument through the end of the bendable tip.

19. The device of claim 1 wherein the plurality of instrument deploying elements at least includes a second instrument deploying element, wherein the second instrument deploying element comprises at least two tabs extending from the end segment, the tabs being adapted to releasably secure another instrument therebetween.

20. A device for medical procedures comprising: a shaft having a rigid section; a malleable section extending from the rigid section of the shaft; a bendable tip comprising a plurality of articulated segments extending from the malleable section; and a control mechanism arranged at a proximal end of the shaft and being connected to the bendable tip by at least one cord, the control mechanism comprising a knob rotatable about the longitudinal axis of the shaft, wherein adjustment of the knob controls the position and degree of bending of the bendable tip by manipulation of the cord.

21. The device of claim 18 wherein the malleable section comprises a spring metal.

22. The device of claim 18 wherein the malleable section comprises a soft metal.

23. The device of claim 18 wherein the malleable section comprises a flexible polymer.

24. The device of claim 18 wherein a straight section connects the malleable section and the tip.

25. The device of claim 18 wherein the bendable tip comprises an end segment comprising a plurality of instrument deploying elements.

26. A device for medical procedures comprising: a shaft with a distal end and a proximal end; a bendable tip extending from the distal end of the shaft, wherein the bendable tip can bend in either of two opposite directions in a plane relative to a linear direction; a handle having a grip generally coaxial with the shaft wherein the handle is attached to the proximal end of the shaft; the grip comprising a knob rotating around the axis of the grip; a first cord connecting the tip with the knob such that rotation of the knob in one direction retracts the cord to bend the tip; and an end segment extending from the bendable tip, wherein the end segment comprises a plurality of medical instrument deploying elements extending from the end segment.

27. The device of claim 24 further comprising a second cord connecting the tip with the knob wherein rotation of the knob in one direction extends the first cord while retracting the second cord and rotation of the knob in the opposite direction extends the second cord while retracting the first cord.

28. The device of claim 24 wherein the cord is connected to the tip such that tension on the cord tends to bend the tip in one direction relative to its linear configuration.

29. The device of claim 24 wherein the end segment further comprises at least two tabs extending from the end segment, the tabs being adapted to releasably secure a medical instrument comprising a fastener applicator.

30. The device of claim 24 wherein the end segment further comprises a lumen centrally located in the end segment, the lumen being adapted for introducing a medical instrument comprising a gripper through the end of the bendable tip.

31. The device of claim 24 wherein the end segment further comprises a medical instrument deploying element for deploying an endoscope.

32. The device of claim 24 wherein the end segment further comprises a medical instrument deploying element for deploying an ablation element.

33. The device of claim 24 wherein the end segment further comprises a medical instrument deploying element for deploying an ultrasound probe.

34. The device of claim 24 wherein the end segment further comprises a medical instrument deploying element for deploying a transducer.

35. The device of claim 24 wherein the tip comprises a plurality of articulating segments.

36. The device of claim 24 wherein a lumen extends from the handle through the shaft to the tip.

37. The device of claim 34 further comprising a medical instrument extending from the tip, the medical instrument having a control element extending from the medical instrument to the handle through the lumen.

38. A method of repairing a heart valve comprising: inserting a device into the heart, the device including a shaft, a bendable tip extending from the distal end of the shaft, an end segment extending from the bendable tip, the end segment being adapted to position and deploy a combination of different medical instruments, at least one medical instrument extending from the bendable tip; and performing a repair of the heart valve with the medical instrument.

39. The method of claim 37 further comprising extending a catheter within the heart and wherein inserting the device into the heart comprises introducing the device through the catheter.

40. The method of claim 38 wherein the catheter extends into the heart through the wall of the heart.

41. The method of claim 38 wherein the catheter extends into the heart from the precava.

42. The method of claim 38 wherein the catheter extends through the septum separating the right atrium and the left atrium.

43. The method of claim 37 further comprising locking the bendable tip at a desired degree of bending.

44. The method of claim 37 wherein the bendable tip can bend in a plane in either of two opposite directions in a plane relative to a linear configuration.

45. The method of claim 37 wherein the bendable tip comprises a plurality of articulating segments.

46. The method of claim 44 wherein the device further comprises a malleable section between the shaft and the articulating segments.

47. The method of claim 37 wherein the device further comprises: a handle having a grip generally coaxial with the shaft wherein the handle is attached to the proximal end of the shaft; a knob rotating around the axis of the grip; and a cord connecting the bendable tip with the knob such that rotation of the knob changes the position of the cord to control the degree of bending of the bendable tip.

48. The method of claim 37 wherein the repair comprises fastening together the leaflets of a heart valve.

49. The method of claim 46 wherein the instrument comprises a fastener applicator.

Description

BACKGROUND OF THE INVENTION

The invention relates to medical devices or tools for performing surgical procedures, including heart valve repairs. In particular, the invention relates to devices with bendable tips for positioning medical instruments during invasive procedures, preferably minimally invasive procedures.

Endoscopes, orthoscopes, probes, catheters and the like can be inserted into a patient for the performance of various medical procedures. To perform the procedure, a particular instrument is positioned at the appropriate location within the patient. The procedure can involve one or more processes, such as imaging, tissue ablation, tissue repair, tissue cutting and combinations thereof. These procedures can involve vascular, intestinal, urological, vaginal, oral or percutaneous delivery of the instrument to the specific location for performing the procedure. Procedures for the repair of a damaged or diseased heart, especially to correct heart valve insufficiency, are of particular interest.

Heart valve insufficiency can be a debilitating and possibly life threatening condition. For example, heart valve regurgitation, i.e., backward leakage of blood at a heart valve, results in reduced pumping efficiency. With respect to mitral valve regurgitation, compensatory mechanisms such as hypertrophy and dilation of the ventricle suggest early treatment to prevent progressive deterioration of ventricular function. Diagnosis of mitral regurgitation can be performed using visualization with transesophageal echocardiography or by echocardiography. In particular, defective leaflet coaptation and the site and direction of the regurgitant flow can be examined to evaluate likely modes of failure.

Mitral valve prolapse, i.e., myxomatous degeneration of mitral valve leaflets, is the most common cause of mitral regurgitation in North America. Rheumatic heart disease was the most common cause of mitral regurgitation in the U.S.A. thirty years ago and is still the most common cause of mitral regurgitation in developing countries. Chronic rheumatic heart disease results in retraction, deformity and rigidity of one or both mitral valve cusps as well as structural abnormalities in the commissures, chordae tendineae and papillary muscles. Ischemic mitral regurgitation (IMR), i.e., anemia of the valve tissue due to reduced arterial blood flow feeding the valve tissue, is the second most common cause of mitral valve regurgitation. Studies suggest that annular irregularities and posterior papillary muscle fibrosis with scarring of the underlying ventricular wall may be associated with IMR.

Many cases of mitral regurgitation can be repaired by modifications of the original valve in a procedure generally referred to as valvuloplasty. These repair procedures typically involve a full sternotomy and quadrangular resection of the anterior leaflet, while on cardiopulmonary bypass. Repairs can also involve reattachment of chordae tendineae, which tether the valve leaflets, or removal of leaflet tissue to correct misshapen or enlarged valve leaflets. In some cases, the annulus of the valve is secured using an annuloplasty ring. Valves that are heavily calcified or significantly compromised by disease may need to be replaced.

As an alternative to these repair techniques, an edge-to-edge suturing of the anterior and posterior mitral valve leaflets can be performed. Commonly referred to as a "bow-tie" repair, edge-to-edge suturing ensures leaflet, coaptation without performing a quadrangular resection of the anterior leaflet. The bow-tie repair generally involves the use of a centrally located suture, although a suture can be placed close to a commissure, or multiple sutures can be used to complete the repair. A centrally placed suture creates a double orifice valve, which resembles a bow-tie.

The edge-to-edge repair procedure has been applied using invasive procedures by placing the patient on extracorporeal circulation. An incision is made to provide access into the left atrium of the heart. Following suturing, the atrium is closed. Such repairs can result in a significant decrease in mitral regurgitation along with a corresponding increase in the ejection fraction. Corresponding repairs can be performed on tricuspid valves.

SUMMARY OF THE INVENTION

In a first aspect, the invention pertains to a device for medical procedures comprising a shaft, a bendable tip and a fastener applicator. The shaft has a distal end and a proximal end. The bendable tip extends from the distal end of the shaft. The fastener applicator extends from the bendable tip. In some embodiments, the bendable tip includes a plurality of articulating segments.

In a further aspect, the invention pertains to a device for medical procedures comprising a shaft, a malleable section, a bendable tip and a control mechanism. The shaft has a distal end and a proximal end. The malleable section extends from the distal end of the shaft. The bendable tip extends from the malleable section. The control mechanism is connected to the bendable tip wherein the control mechanism comprises a knob. The adjustment of the knob controls the bend of the bendable tip.

In another aspect, the invention pertains to a device for medical procedures comprising a shaft, a bendable tip, a handle, a knob and a cord. The shaft has a distal end and a proximal end. The tip extends from the distal end of the shaft. The handle has a grip generally coaxial with the shaft, and the handle is attached to the proximal end of the shaft. The knob rotates around the axis of the grip. The cord connects the tip with the knob such that rotation of the knob in one direction retracts the cord to bend the tip.

In addition, the invention pertains to a method of repairing a heart valve including inserting a device through the catheter and performing a repair of the heart valve with the medical instrument. The device includes a shaft, a bendable tip extending from the distal end of the shaft and a medical instrument extending from the bendable tip. In some embodiments, the method includes placing a catheter extending within the heart, and the insertion of the device includes introducing the device through the catheter.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a side view of a directional medical device with a bendable tip.

FIG. 2 is a side view of an embodiment of a directional medical device having a control mechanism with two cords, some hidden structure being shown for clarity.

FIG. 3 is a side view of an alternative embodiment of a directional medical device having a control mechanism with one cord, some hidden structure being shown for clarity.

FIG. 4 is a perspective view of a portion of an articulating tip.

FIG. 5 is a bottom view of a repeating segment in the articulating tip of FIG. 4.

FIG. 6 is a top view of a repeating segment of the articulating tip of FIG. 4.

FIG. 7 is a sectional view of the articulating tip of FIG. 4 taken along line 7--7 of FIG. 4.

FIG. 8 is a top view of the end element of the articulating tip of FIG. 4.

FIG. 9 is a fragmentary, sectional view of the bottom segment of the articulating tip and a portion of a shaft or malleable section connected to the bottom segment.

FIG. 10 is a sectional view of a shaft allowing for the passage of a single control cord, the cross section being taken perpendicular to the axis of the shaft.

FIG. 11 is a sectional view of a shaft allowing for the passage of two control cords, the cross section being taken perpendicular to the axis of the shaft.

FIG. 12 is a perspective view of a handle and knob for use with a directional medical device with a single control cord.

FIG. 13 is a sectional view of the handle and knob of FIG. 12 taken along line 13--13 of FIG. 12.

FIG. 14 is a perspective view of a handle and knob for use with a directional medical device with two control cords.

FIG. 15 is a side view of the handle and knob of FIG. 14.

FIG. 16A is a sectional view of the handle and knob of FIG. 14 taken along line 16--16 of FIG. 15.

FIG. 16B is a sectional view of the handle and knob of FIG. 14 with the wing nut portion expanded and the cords shown.

FIG. 17 is a perspective view of a medical instrument that can be reversibly attached to the end segment of the articulating tip of FIG. 4.

FIG. 18 is a perspective view of a portion of a clip held by a deployment device at the tip of an directional medical device, the clip being useful for fastening heart valve leaflets.

FIG. 18A is a perspective view of the end of a first applicator used for deploying the clip.

FIG. 19 is a perspective view of the clip of FIG. 18 and associated deployment devices, with the two portions of the clip aligned.

FIG. 20 is a front view of a first portion of the clip of FIG. 19.

FIG. 21 is a side view of the first portion of the clip of FIG. 19.

FIG. 22 is a side view of the second portion of the clip of FIG. 19.

FIG. 23 is a rear view of the second portion of the clip of FIG. 19.

FIG. 24 is a side view of the second portion of the clip of FIG. 19 rotated 90 degrees relative to the view in FIG. 22.

FIG. 25 is a side view of the two portions of the clip of FIG. 19 fastened together.

FIG. 26 is fragmentary, perspective view of a gripper mounted adjacent a fastener applicator on a single shaft.

FIG. 27A is a sectional side view of the gripper of FIG. 26 taken along line 27A--27A of FIG. 26.

FIG. 27B is an exploded, sectional side view of an alternative embodiment of the gripper of FIG. 27A, the alternative embodiment being based on a cam, where the rod and moveable jaw have been removed from the remainder of the gripper.

FIG. 27C is a sectional side view of the embodiment shown in FIG. 27B.

FIG. 27D is a view down the end of the shaft from the proximal end toward the jaws, where the ball of the cam is shown in both an open and closed position.

FIGS. 28A-C are side views of the fastener applicator of FIG. 26 where the view in FIG. 28B is taken at a right angle relative to the views in FIGS. 28A and 28C. Hidden structures are shown with phantom lines.

FIG. 28D is a side view of the tack and cap of FIG. 28A secured together, shown in phantom.

FIG. 29 is a side view of a gripper with a plunger used to direct the leaflets to gripper arms.

FIG. 30 is a side view of a crimp ring in an uncrimped position.

FIG. 31 is a side view of the crimp ring of FIG. 30 following crimping.

FIG. 32 is a perspective view of a ring fastener being positioned with an applicator toward heart valve leaflets, where a portion of the cardiac catheter is cut away to permit the visibility of structure within the catheter.

FIG. 33 is a perspective view of the applicator of FIG. 32 following deployment of the ring fastener.

DETAILED DESCRIPTION OF THE ILLUSTRATIVE EMBODIMENTS

An improved steerable tip for a surgical device useful in medical procedures, including less invasive procedures, provides easy to control bending of the tip. The steerable tip can be located on a shaft for the performance of less invasive medical procedures, commonly referred to as minimally invasive procedures. However, the device can also be used in open cavity procedures. The steerable tip preferably includes pivoting, articulating segments that can be locked at a selected degree of bending. The directional device can further include a malleable section that provides a coarse position adjustment of the bent tip.

An instrument for the performance of a surgical procedure is generally positioned at the bendable tip. In preferred embodiments, a fastener applicator extends from a steerable, articulating tip. The fastener applicator can be used, for example, to perform heart valve repair, such as edge-to-edge heart valve leaflet fastening.

The preferred medical devices with a bendable tip, i.e. directional medical devices, include a relatively thin extension that can be projected into a patient. The patient is generally a mammal such as, a horse, a cow, a pig, a sheep, a dog, a cat, and preferably is a human. The steerable tip is located at the distal end of the shaft and a handle is located at the proximal end. The steering of the tip generally is controlled with a knob at or near the handle. Thus, the directional devices can be used for the performance of less invasive procedures in which the device is introduced into the patient such that the tip is located within the patient. The extension, which includes the shaft and optional malleable section, may be located partially within and partially external to the patient. Manipulations at the proximal end control the steering of the tip and manipulation of the instrument(s) used in the procedure.

The directional medical device generally includes a handle, a knob, a shaft, an optional malleable section and an articulating tip. The handle can be used by the surgeon to move the device into position. The knob is connected appropriately to the tip through a control mechanism such that movement of the knob at the proximal end alters the bending of the tip at the distal end of the device. The knob generally is attached at or near the handle such that the surgeon can easily move the knob to change the orientation of the tip. The shaft has appropriate dimensions for the corresponding procedure to be performed. The shaft is generally flexible such that gentle curves in the body can be negotiated during introduction of the device into the body.

The directional device can optionally include a malleable section between the shaft and the articulating tip. The malleable section, for example, can be made from a deformable polymer, memory metal or a soft metal. If a malleable section is used, the shaft can be short. The malleable section is bent manually prior to use of the device in the procedure. Bending of the malleable section provides for a gross direction of the tip. A malleable section is most useful for procedures performed in open cavities.

The articulating tip preferably includes a plurality of articulating segments or vertebrae that pivot relative to each other. Preferred articulating tips can bend in a plane in either direction relative to a straight orientation. In preferred embodiments, the tip can be locked into a particular bent position. The articulating tip is connected by way of cords or other transmission devices to the knob at the proximal end of the device such that the knob can be used to control the bending of the tip at the distal end.

A suitable instrument(s) can be mounted at or near the tip for performing the medical procedure. The instruments can be permanently mounted at the tip of the medical device with control of the instrument being provided at the proximal end of the directional device. Alternatively, the instrument can be reversibly mounted at the tip prior to beginning a procedure. In alternative embodiments, the directional medical device has an open lumen to provide for the introduction of instruments from the proximal end through the lumen to the tip. In this way, instruments can be introduced and/or changed during the procedure, and a wider range of instruments can be used since some instruments may require manipulation by moving one or more components of the instrument into position through the open lumen.

The directional medical device can be used for the delivery of a variety of instruments into a patient for the performance of less invasive, such as minimally invasive, medical procedures. Suitable instruments include, for example, lenses or transducers for imaging, visualization or laser transmission, electrodes for tissue ablation, electrodes for cauterization, ultrasound probes, grippers, fasteners, cutting blades, forceps and combinations thereof. For the performance of certain procedures, it may be useful or necessary to steer the instrument to a particular location within the patient. Depending on the delivery approach, this may require bending of a tip at the end of a shaft. However, for certain procedures, the tip must lock into position such that performance of the procedure can be successfully performed. In particular, forces applied against the tip by the instrument can move the tip if it is not locked into place.

A plurality of instruments can be positioned at or near the bending tip. For example, a visualization device, such as a lens at the end of a fiber optic element, along with an ablation element can be located at the tip. A variety of combinations of instruments can be combined to achieve desired results.

Generally, the directional medical device is introduced into the patient using a catheter, introducer and the like. The appropriate characteristics of the catheter and the directional medical device depend on the point of introduction and the point of deployment. In particular, the length and thickness of the directional medical device must be consistent with the path for placing the device within the body.

The improved directional medical devices can be useful for a variety of percutaneous procedures, such as laparoscopies as well as other forms of less invasive surgical techniques, cardiovascular and vascular manipulations, ligament manipulations, intestinal manipulations and manipulations performed by way of oral, urological, esophagal or vaginal introduction. Entrance to the particular location to perform the surgical procedure can be performed using conventional approaches. Preferred procedures include, for example, heart repair, especially heart valve repair. Heart valve repairs can be performed by way of a vascular approach or through the chest.

Methods have been developed for performing less invasive heart valve repairs, including repairs to the mitral and tricuspid valves. In particular, the repairs can be performed on a beating heart such that the patient does not have to be placed on cardiopulmonary bypass. While the discussion below focuses on the repair of mitral heart valves, the repair approaches can be used for the repair of tricuspid valves using straightforward modification of the described procedures and instruments to take into account anatomical constraints. These procedures are discussed further in copending and commonly assigned U.S. patent application Ser. No. 09/115,820, now U.S. Pat. No. 6,165,183, entitled "Mitral and Tricuspid Valve Repair," incorporated herein by reference.

Access into the heart for mitral valve repair is obtained by securing a passageway from the exterior of the body into the body and into the heart to provide access into the left atrium or left ventricle. With suitable instruments inserted through the passageway, the mitral leaflets are grabbed, and the edges of the leaflets are secured together. The gripping and securing or fastening procedures can be performed simultaneously in some embodiments of the invention, or they can be performed separately. A suitable method of visualization may be used to guide the manipulations. Manipulations to the mitral valve can be conducted under ultrasound or fluoroscopy to show correct placement of the devices and of the repair and to verify effectiveness of the repair.

One approach to introduce the surgical instruments into the heart involves the direct introduction of a passageway through the wall of the heart. To introduce the passageway into the body, an incision is made in the chest or rib cage, and a cardiac catheter is placed into the incision. Tools generally used to position catheters can be used to guide the cardiac catheter to the heart and into the heart wall, as described further below. Use of properly selected tools for the introduction of the cardiac catheter reduces the amount of trauma to the heart. The directional medical devices with the bendable tips described herein can be inserted through the cardiac catheter to perform the repairs. Upon completion of the heart valve repair, the instruments are removed through the cardiac catheter, the cardiac catheter is removed, and the incision in the heart wall is repaired, for example, with suture.

Alternatively, the surgical instruments can be introduced into the heart by a vascular approach. In these approaches, a vascular catheter is introduced into an artery or vein and directed into the heart. These vascular approaches are described further below.

Suitable gripping and fastening instruments have appropriate dimensions to fit through the cardiac or vascular catheter into the heart. The instruments can be part of a directional medical device with a bendable tip, as described herein. Alternatively, the instruments can be introduced into the lumen of the device for positioning at or near the bendable tip.

If the instruments are introduced through the lumen of a medical device with a bendable tip, the instruments generally have a shaft between a distal end and a proximal end. The shaft may be flexible. The distal end of the instrument is inserted through the medical device such that the instrument protrudes at or near the bendable tip. The gripping and/or securing/fastening elements are located at the distal end of the instrument. One or more actuating elements are located at the proximal end.

In some embodiments for performing heart valve repair, a single element performs the gripping and fastening functions. In other words, a fastening element grips the tissue during the fastening process such that a separately identifiable gripping element is not present. For example, suture can be placed through each leaflet such that tightening of the suture draws the two portions of the leaflets together.

Alternatively, the gripping and fastening elements can be distinct, separate instruments. These can both be located at the end of a medical device with a bendable tip. Alternatively, they can be simultaneously introduced through the lumen of the directional medical device. For certain embodiments involving the introduction of instruments through the lumen of the directional medical device, functionally distinct gripping and fastening elements can be integrated into a single structure. Alternatively, the distinct gripping and fastening elements can be located on separate structures, such that the two elements can be inserted simultaneously through the lumen of the medical device. The directional medical device can have a single lumen or multiple lumens for the introduction of medical instruments. Alternatively, one or more additional medical devices with bendable tips can be introduced into the heart to provide separate instrument passageways for the gripping and fastening instruments and any other instruments used to facilitate the procedure and/or to provide visualization.

Medical Device with a Bendable Tip

The improved directional medical device has a bendable tip to provide appropriate orientation for the performance of a medical procedure. In preferred embodiments, the bendable tip has articulating segments that can be locked into position. Furthermore, preferred bendable tips can bend in either of two directions such that various positions within a plane can be reached by selecting the degree and direction of bending of the tip. Easy to manipulate control knobs preferably can be used to regulate the degree of bending of the tip. A malleable section can be included between the bendable tip and a shaft. The malleable section provides a gross manipulation for positioning the bendable tip for use of the device in certain locations within the patient, especially in open cavity procedures.

An improved directional medical device, as described herein, is depicted schematically in FIG. 1. Device 100 includes a handle 102, a shaft 104, an optional malleable section 106, a bendable tip 108, a knob 110, an optional medical instrument 112, and an optional actuator 114 for controlling instrument 112. Furthermore, directional device 100 includes a control mechanism that allows for control of the bending of tip 108 by movement of knob 110.

Generally, handle 102 includes an opening to a central lumen that extends to bendable tip 108. This opening to the central lumen preferably includes a hemostasis valve to prevent blood from flowing out of the device. Standard designs used in the catheter art can be used for the hemostasis valve.

Handle 102 is located at the proximal end of directional device 100. Handle 102 can have any convenient configuration. Two preferred embodiments of handle 102 are shown in FIGS. 2 and 3, respectively. Handles 120 (FIG. 2) and 122 (FIG. 3) have a generally cylindrical gripping section. Two easy to control knobs 128, 130, connect handles 120, 122 with respective shafts. The interface of knobs 128, 130 with a control mechanism is described further below.

Referring to FIG. 1, shaft 104 generally has a length and thickness consistent with its intended use. If device 100 includes a malleable section 106, shaft 104 may be short since shaft 104 provides for connection between handle 102 and malleable section 106. If no malleable section 106 is present, shaft 104 provides for the placement of the tip at its desired location, so that shaft 104 then needs to have a sufficient length for this purpose. For example, if the device is intended for vascular entry into the heart, the shaft must be long enough to reach the heart from the intended entry point into the vascular system. If shaft has a significant length, shaft 104 generally is somewhat flexible such that tip 108 can be guided to the location for the performance of the procedure. For example, for a vascular entry, shaft 104 should be flexible enough to follow the vascular system to the vicinity of the procedure. Similarly, for other delivery approaches, shaft 104 may need to follow gentle curves in the body to reach its destination.

Shaft 104 can be constructed from similar materials and using similar techniques as used for the productions of corresponding components of catheters and the like. In particular, the wall of shaft 104 can have one or more layers. At least one of the layers generally is made from a rigid plastic or a suitable metal, such as stainless steel or titanium. The inside of shaft 104 can include appropriate support structures for the control mechanism and an open central lumen or lumens. Shaft 104 can be very short if a malleable section 106 is included. In other embodiments, shaft 104 must belong enough to carry the tip to its intended location.

Malleable section 106 is located between shaft 104 and tip 108. The presence of a malleable section is optional. The malleable section is designed for adjustment independent of tip 108 and provides for gross positioning of the device in the body which can involve an approach to a specific site for a procedure. The malleable section can include most of the distance between the distal and proximal ends of the device, or the malleable section can be a shorter section near the tip.

Suitable materials for malleable section 106 can bend significant amounts in response to forces applied distal to malleable section 106 where malleable section 106 retains its shape when the forces are no longer applied. Malleable section 106 bends in response to larger forces but remains resilient against lesser forces. Thus, the bending of section 106 is very non-linear with respect to the application of forces. Malleable section 106 can be made from metals, flexible polymers or combinations thereof. Suitable metals include, for example, soft metals, such as soft stainless steel or copper, and spring metals, such as Elgiloy.RTM., a cobalt chromium nickel alloy, aid MP35N, a nickel-cobalt-chromium-molybdenum alloy, and Nitinol.RTM., a nickel-titanium alloy. Suitable flexible polymers include elastomers, thermoplastics and other polymers that can sustain significant flexure, bending, twisting and/or deformation without structural failure. Particularly preferred flexible polymer materials include, for example, polyurethane. Polymers for malleable section 106 can be formed in an accordion configuration to impart added malleability to the section. Generally, the malleable section is bent manually and holds its position in that configuration. Therefore, appropriate materials hold a shape once bent into that shape. The manually induced bend may only occur in a small portion of the malleable section.

As shown in FIGS. 2 and 3, malleable sections 136, 138 can include a straight section 140, 142 as well as a bending portion 144, 146. A straight section 140 can be used as part of a malleable section to separate the bending of the tip from the bending of the malleable section. The presence of a straight section provides a connection point between the malleable section and the bent tip.

Bendable tips can have various structures that provide for the bending of the tip in response to forces from the control mechanism. For example, bendable tips can be formed from malleable metals or polymers that bend in response to off axis tension applied to the tip. Alternatively, the tip can include accordion pleated metals or polymers that bend in response to forces applied by the control mechanism. In preferred embodiments, bendable tips 148, 150 include articulating segments, as shown in FIGS. 2 and 3. A variety of constructions of the articulating segments can be used. A preferred embodiment of a bendable tip with articulating segments is shown in FIGS. 4-7. As shown in the perspective view of FIG. 4, articulating tip 200 includes repeating segments 202 with interlocking hinges. A bottom view of a repeating segment is shown in FIG. 5, and a top view is shown in FIG. 6.

Two inner hinge elements 204 project from bottom surface 205 of each repeating segment 202, and two outer hinge elements 206 project from top surface 207 of each repeating segment 202. The location of the top and bottom hinge elements of the repeating segments 202 can be reversed without altering the function of the pivot as long as the connections of the pivots at the ends are correspondingly adjusted. Each inner hinge element 204 and outer hinge element 206 can include a hole through which a pin 208 is inserted to hold the hinge together. A hinge pivots around pin 208. Alternatively, the hinge elements can snap together without separate pins to pivot similarly around the snaps. Prong components of the snaps are shown in phantom lines in FIG. 6, and the prongs can snap into holes in inner hinge elements 204. The hinges allow tip 200 to pivot in either of two opposite directions along a plane such that the end of the tip can be oriented as desired in a plane.

Repeating segments 2202 further include channels 216. Channels 216 extend through the entire segment 202, as shown in the sectional view of FIG. 7. Repeating segments 202 can include a single channel, two channels, as shown in the FIGS. 5-6, or more than two channels. The use of two channels permits locking of the tip at a desired degree of bending and a greater degree of bending, i.e., a larger range of motion that can extend up to 180.degree.. Channels 216 are off center and generally are located near an edge of repeating segment 202. Channels are used for elements of a control mechanism extending between the knob and end segment 220. The control mechanism, discussed further below, controls the degree of bending of tip 200. Also, each repeating segment 202 includes an open central lumen 222. Lumen 222 preferably has an oval or similar elongated shape with its major axis oriented toward channels 216. With an elongated shape, the lumen can better accommodate a cylindrical instrument when the tip is bent.

In FIGS. 4 and 7, four repeating segments are shown. Articulating tip 200 can include more or fewer repeating segments, as appropriate for the particular application. In preferred embodiments, adjacent segments pivot up to about 10.degree. to 15.degree. relative to each other. For most applications, a desired degree of bending is accessible with between about 4 and about 18 repeating segments, and generally between about 6 and about 9 repeating segments are appropriate. Articulating tip 200 includes an end segment 220, as the last segment, and a connecting segment 224 (FIG. 9), as a first segment that connects the tip to the rest of the device.

End segment 220 includes an open central lumen 226 that lines up with the central lumen 222 of repeating segments 202, as shown in FIG. 7. Preferably, central lumen 226 has an oval shape at bottom surface 225 that aligns with the oval central lumen 222 of repeating segments 202 and an asymmetrical opening 227 at the top, such as a D-shape as shown in FIG. 8. Asymmetrical opening 227 can align an instrument at a desired orientation at the tip. A top view of end segment 220 is shown in FIG. 8.

In some embodiments, end segment 220 also includes tabs 228, as shown in FIGS. 4, 7 and 8. Notches 230 provide some added resiliency to tabs 228. Prongs 232 extend inward from tabs 228. Tabs 228 can be used to secure instruments on the top of end segment 220 with prongs 232 helping to secure a medical instrument at the end of tip 200.

Inner hinge elements 204 project from bottom surface 225 of end segment 220. Inner hinge elements 204 connect with outer hinge elements 206 of the last repeating segment 202. Referring to FIG. 7, end segment 220 includes connectors .236 aligned with channels 216 for attachment to a control mechanism. Connectors 236 can simply be a cavity for holding a ball connector at the end of a cord. Alternative embodiments are described below.

Attachment segment 224 connects articulating tip 200 with the remaining portions of the device. Attachment segment 224 can be connected to malleable section 106, with or without a straight segment 140, 142, as shown in FIGS. 2 and 3, or directly to shaft 104 if there is no malleable section. In any case, attachment segment 224 can be a distinct element, or it can be formed as part of the adjacent element (malleable section or the shaft) connected to articulating tip 200.

A fragmentary, sectional side view of attachment segment 224 is shown in FIG. 9. A top view looks essentially as shown in FIG. 6 for a repeating segment 202. Outer hinge elements 206 project from top surface 252. Outer hinge elements 206 engage inner hinge elements 204 of the first repeat segment 202. Attachment segment 224 includes channels 254 that line up with channels 216 of repeating segments 202 and an open central lumen 256 that lines up with central lumen 222 of repeating segments 202. If attachment segment 224 is a distinct element, a weld, clamp, brace or other attachment device 258 connects attachment segment 224 with adjacent element 260 (malleable section or shaft), as shown in FIG. 9. The components of the articulating tip preferably are formed from rigid polymers, stainless steel, titanium or other biocompatible metals.

Referring to FIG. 1, knob 110 can have any of a variety of configurations. For example, knob 110 can include a lever or slide that pivots or slides to actuate bending of the tip. A control mechanism links knob 110 with bending tip 108, such that movement of knob 110 adjusts the degree of bending of tip 108. In some preferred embodiments, knob 110 is configured as a rotating cylindrical section 128, 130, as shown in FIGS. 2 and 3. In these embodiments, knobs 128, 130 rotate along an axis generally aligned with the axis of a cylindrical portion of handles 120, 122. Rotation of knobs 128, 130 result in adjustment of components of the control mechanism.

The control mechanism transfers an adjustment of the knob at the proximal end of the device to the tip where the degree of bending is altered according to the adjustment. Thus, the control mechanisms includes a communication conduit, such as one or more strands, cords, tubes or the like, to communicate movement of the knob to the tip. The control mechanism further includes a transfer device that converts movement of the knob to forces on the strands or other communication conduit. In some preferred embodiments, the control mechanism includes one or two cords that connect tip 108 with a distance varying component of the control mechanism. The cords can be formed from, for instance, stainless steel, titanium or other rigid metal, or from braided wire. An embodiment with one cord 300 is shown in FIG. 3, and an embodiment with two cords 302, 304 is shown in FIG. 2. Other embodiments may include more than two cords.

One end of the cord(s) is attached to the end segment of an articulating tip or comparable structure at the end of the tip for nonarticulating bendable tips. For example, in the structure shown in FIG. 7, balls at the end of cords fit into cavities 236 to secure the cords. Alternatively, the cords can be molded on or glued to the end segment. The other end of the cord is attached to the distance varying component of the control mechanism which applies appropriate tension to the cords to control the bending of the tip under the control of the knob.

Referring to FIG. 3, cord 300 extends from knob 130 through shaft 306 and malleable section 138. Shaft 306 can include guide loops 310 to guide the passage of cord 300, as shown in the cross section of shaft 306 in FIG. 10. Alternatively, shaft 306 can include a channel for cord 300 that separates cord 300 and lumen 312. Similarly, malleable section 138 can include loops or channels to guide or segregate cord 300.

In the two cord embodiment of FIG. 2, cords 302, 304 extend through shaft 320 and malleable section 136. Shaft 320 can include separate guide loops 324, 326, as shown in the cross section in FIG. 11. Alternatively, shaft 320 can include channels for cords 302, 304 that separate cords 302, 304 from lumen 328, as an alternative to guide loops which just guide the cords. Similarly, malleable section 136 can include loops or channels to guide and/or segregate cords 302, 304.

The control mechanism includes a transfer component connected to the knob. This transfer component transfers the torque applied to the knob to induce forces on the strands or other communication conduits. An embodiment of a control mechanism suitable for a one cord based communication conduit is shown in F