WO2007089985A1

WO2007089985A1 - Device and method for moving fill material to an implant

Info

Publication number: WO2007089985A1
Application number: PCT/US2007/060664
Authority: WO
Inventors: Jason A. Edie; John L. White; James D. Schwender
Original assignee: Medtronic, Inc
Priority date: 2006-01-31
Filing date: 2007-01-18
Publication date: 2007-08-09
Also published as: US7950155B2; US8074360B2; US20120174410A1; US8584364B2; US20070175049A1; US20110000089A1

Abstract

Abstract Devices and methods for inserting an implant within a patient. The device may generally include an insertion body, a supply reservoir, and a delivery device. The insertion body can be used for moving and positioning the implant within the body. In one embodiment, implant is mounted to the end of the body prior to movement and positioning. Fill material is maintained within the supply reservoir. Delivery device functions to move the fill material from the supply reservoir, through the insertion body, and to the implant. The device thus provides for both movement and placement of the implant, and a mechanism for delivering fill material to the implant.

Description

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SLITTING TOOL

FIELD OF TBE INVENTION

The present invention pertains to slitting tools and more particularly to slitting tools facilitating removal of an elongate sheath or catheter from about an elongate member disposed therein,

BACKGROUND OF TBE INVENTION

Sheaths, or catheters, are commonly used in minimally invasive medical procedures, for example, to provide a pathway for the introdu ction of elongate medical devices into the vascular system of a patient. Many medical devices, introduced in su ch a manner, through a lumen of die sheath, are intended to indwell within the patient for & prolonged period, for example, extending from a number of days to many years. After the indwelling medical device has been inserted within the ϊumen of the sheath, for positioning within the patient it is desirable to remove the sheath from the patient withou t dislodging the indwelling device.

A number of slitting tools, known to those skilled in the art, are u sed to remove sheaths from about indwelling medical devices. However, these tools present one or more difficu lties to the user, for example, with respect to handling.

BRIEF DESCRIPTION OF THE DRAWINGS

The following drawings are illustrative of particular embodiments of the present invention and therefore do not limit the scope of the invention. The drawings are not to scale (unless so stated) and are intended for u se in conjunction with the explanations in the following detailed description. Embodiments of the present invention will hereinafter be described m conjunction with, the appended drawings, wherein like numerals denote like elements.

Figures IA-B are an end. view and a side plan view, respectively, of a slitting tool according to one embodiment of the present, invention. Figu re 1C is a section view through section line A-A of Figure IB, Figure 2 is a schematic plan view, inclu ding a partial section, depicting a method for u sing a slitting tool according to some embodiments of the present invention .

Figu re 3A is a top view of the slitting tool, shown in Figures IA-C, cutting through a portion of a sheath wall.

Figu re 3B is a section view through, section line B-B of Figu re 3A.

Figures 4A-B are a side plan, view and an end view of a suiting tool according to another embodiment of the present invention.

Figu re 5A is a schematic showing an alternate embodiment of a slitting tool in a position for slitting a sheath.

Figure 5B is an end view of Figure 5A.

DETAILED DESCRIPTION OF THE ILLUSTRATED EMBODIMENTS The following detailed description is exemplar).' in nature and is not intended to limit the scope, applicability, or configuration, of the invention in any way. Rather, the following description provides practical illustrations for implementing exemplary embodiments of the present invention.

Figures IA-B are an. end view and a side plan view, respectively, of a slitting tool 10_> according to one embodiment, of the present invention; and Figu re J C is a section view through line A-A of Figure IB. Figures IA-C illu strate tool IO including a nose portion 16_r a handle portion 17, a slitting edge 12 extending between nose portion 16 and handle portion 17, a longitu dinally extending tail portion 14, and a passageway 15 disposed between aose portion 16 and tail portion 14, and. extending upward into handle portion 17. Figures IA-B further illustrate nose portion 16 including a lower surface 11 and a leading edgeϊ3. According to the illustrated embodiment, slitting edge 12 is part of a metallic blade member 120 mounted in handle 17; according to alternate embodiments_:, slitting edge is an integral part of material fønnϊag tool Ϊ0 as a whole. Tool .10 may be formed of a rigid plastic, a ceramic, a metallic material or a combination thereof.

According to the illustrated embodiment, lower surface 11 of nose portion 16 is adapted to engage an elongate member .100, and Figure 1 C shows elongate member Ϊ00 extending from nose portion 16 into passageway 15 su ch that a proximal segment 100' of member 100 bends away from tύl portion 14. With reference to Figures IB-C, passageway 15 extends from nose portion 16 up into handle 17, being flanked on cither side by a sidewall 150; passageway 15 furthei extends into grooves 15', which aie formed along opposing outer surfaces 17' of handle 17 and either of which can accommodate segment 100". An operator, gripping handle 17 of tool 10, may hold proximal segment 100' of elongate member 100 in one of channel grooves 15', as illu strated in Figu re 2.

Figure 2 is a schematic plan view, inclu ding a partial section, depicting a method for using suiting tool 10 according to some embodiments of the present Invention Figure 2 illustrates elongate member 100, for example, art implantable medical electrical lead, disposed within a lumen 25 of a sheath 200: she ath 200 is shown including a tubular sheath, wall 20 terminated at a proximal end by a hub 22, Figure 2 further illustrates a first thumb 25 and forefinger 26 of an operator holding slitting tool 10 and proximal segment 100' of member 100, while a second thumb 205 and forefinger 206 hold a hub handle 220 to poll sheath 200, per arrow A, against slitting edge 12 of tool 10. Nose portion 16 of tool 10 is shown engaging elongate member 100 while proximal segment 100' bends through passageway 15 that extends along an operator grip zone 19, which, on opposing surfaces 17' of handle 17, is generally located in the zorse indicated by cross-hatching. According to the illustrated embodiment, tail portion 14 of tool 10 is approximately aligned with sheath lumen 25 and is sized to fit within sheath lumen 25. when slit, so that tail portion 14 will ride within sheath lumen 25 after slitting edge 12 cuts through hub and sheath wail 20. Accoiding to some embodiments, tail portion 14 further includes a profile closely conforming with slit sheath lumen 25, for example as illustrated in Figure 3 B.

Figure 3A is a top view of the slitting tool, shown in Figures 1 A-C, cutting through a portion of sheath wall 20; and Figure 3B is a section view through section line B-B of Figure 3A Figures 3A-B illu strate sheath 200 having been pulled, per arrow A, so that sheath wall 20 has been silt by tool slitting edge 12 (Figures 1A-B and 2) and tool tail portion 14 is disposed within lumen 25, downstream of slitting edge 12. slit edges 32 of sheath wall 20 emanate from slitting edge 12 beneath tool handle 17, shown by dashed lines, and extend downstream of tool 10; fingers 25, 26 and associated hand of the operator holding tool 10 (Figure 2) are not shown so that the view of tool 10 and slit edges 32 of sheath wall 20 h not obstructed Figure 3B further illu strates a profile of tail portion 14, for med by a continuous exterior surface extending thereabout, which closely mates with slit sheath lumen 25; a width P of tail portion 14 may be approximately equal to or slightly greater than a pre-siH diameter of sheath lumen 25» or .may be up Io two times greater than the pre-slit diameter of lumen 25. Figure 3B further ϋlu sf rates tool 10 including a shank 18 joining .handle .17 to tail portion 14; accordhig to some embodiments, a thickness T of shank 18 is greater than approximately 0.01 inch and less than width P of tail portion 14.

According to embodiments of the present invent? on, tail portion 14 may serve to stabilize tool 10 as it cuts through sheath wall 20 and may further prevent slit edges 32 from collapsing toward one another in a way which may cause slit sheath lumen 25 to 'grab' elongate member 100, as sheath 200 is pulled, per arrow A, thereby dislodging a distal end of member 100. An effective length of tail portion 14, for stabilizing tool 10 as it cuts through sheath wall 20, may be approximately equal to or greater than. 1/2 inch. Although, in Figu re 2, tail portion 14 is illu strated extending proximaliy from operator grip zone .19 of handle portion 1.7, embodiments of the present invention are not so limited.

Figures 4A-B are a si<ie plan, view and an end view of a slitting tool 40 according to another embodiment of the present invention. Figu res 4A-B illu strate tool 40 including a nose portion 46, a handle portion 47. a slitting edge 42 extending between nose portion 46 and handle portion 47, and a longitudinally extending tail portion 44. Figures 4A-B further illu strate nose portioa 46 inclu ding a lower surface 41 extending from a leading edge 43 to a passageway 45 that exlerads from between aose portion 46 and IaO portion.44, upward into handle portion 47. According to the illustrated embodiment, to facilitate loading of elongate member 100 info passageway 45, for example, as shown In Figure 4A, tail portion 44 is split into a first leg 404A and a second leg 404B. Figure 4B shows each leg 404A, B inclu ding a foot 44A and 44B, respectively; feet 44A, B together tbrm a tail profile, to mate with a slit lumen of a sheath or catheter, when legs are forced, per arrows B, together, as shown with dashed lines; the resulting profile ϊs similar to that of solid tail .! 4 illu strated in Figure 3B. Legs 404A, B would be. forced together in such a way when a sheath is pulled past slJttmg edge 42 of tool 40 such that tail 44 is enclosed by the slit lumen of the sheath. Figure SA is a schematic showing an alternate embodiment of a slitting tool 50 in a position for slitting sheath 200; and Figure SB is an end view of Figure 5 A. Figure 3 A illu strates tool 50 inclu ding a nose portion 56, a handle portion 57, a slitting edge 52, extending between, nose portion 56 and handle portion 57, and a longitudinally extending tail portion 54, which is joined to handle portion. 57 by a shank 58. Figure 5A further illustrates nose portion 56 engaging elongate member 100 and a passageway 55, disposed between nose portion 56 &nά tail portion 54, allowing proximal segment 100* of elongate member 1.00 to bend away from tail portion 54. According to the illustrated embodiment, fingers 25 and 26, associated with the hand of the operator, bold segment 100' against an. operator grip zone 5.9 of handle 57, the extent of which generally corresponds to the cross- hatched area shown in Figure SB.

In the foregoing detailed description, the invention has been described with reference to specific embodiments. However, it may be appreciated that various modifications and changes can be made without departing from the scope of the invention as set forth in the appended claims.

Claims

J. , A. too) for slitting an elongate sheath from about an elongate member disposed within a longitudinally extending lumen of the sheath_., the tool comprising; a slitting edge; a nose portion disposed beneath the suiting edge, the nose portion inclu ding a lower su rface, for engaging a portion of the elongate member, and a leading edge; a longitudinally extending tail portion projecting rearward of the slittiag edge and the nose portion, the tail portion approximately aligned with the sheath lumen when the lower surface of the nose portion engages the elongate member and the leading edge of the nose portion is within the sheath lumen, the tail portion including a profile closely conforming with the sheath lumen after the sheath is slit by the slitting edge; and & passageway disposed between the nose portion and the tail portion, the passageway allowing a segment of the elongate member to bend away from the tail portion when the lower surface of the nose portion engages the portion of the elongate .member, the segment being proximal to the portion engaged by the lower surface.

2. The tool of claim I₅ further comprising a handle portion projecting upward from the nose portion and rearward of the slitting edge, and wherein the passageway extends into the handle portion.

3. The tool of claim .1 , further comprising a handle portion projecting upward from the lower surface of the nose portion and rearward, of the slitting edge, and wherein the passageway extends to the handle portion.

4. The tool of claim .1 , further comprising a shank extending u pward from the tail portion, the shank including a thickness being greater than approximately 0.01 inch and les$ than approximately a maximum width of the profile of the tail portion.

5. The tool of claim 1 _> wherein the profile of the tail portion includes a maximum width being between approximately equ al to a ρre*slit diameter of the lumen and approximately two times greater than, the pre-slit diameter of the sheath lu men.

6. The tool of claim S _% further comprising a handle portion projecting upward from the nose portion and rearward of the slitting edge, wherein the handle portion includes an operator gap zone and the tail portion further projects rearward of the grip zone.

?, The tool of claim 3 , wherein the tail portion includes a longitudinal length greater than or equal to approximately one inch.

8. The tool of claim I₁ wherein the tall portion is includes a continuous exterior surface extending around the profile mating with the slit sheath lumen.

9. The tool of claim I₅ wherein the tail portion is split, including opposing interior su rfaces.

10. A tool for slitting an elongate sheath from about, an elongate member disposed within a longitudinally extending lumen of the sheath, the tool comprising: a slitting edge; a nose portion disposed beneath the slitting edge, the nose portion including a lower surface for engaging a portion of the elongate member and a leading edge; a longitudinally extending tali portion projecting rearward of the slitting edge and the nose portion, the tail portion approximately aligned with the sheath lumen when the lower surface of the nose portion engages the elongate member and the leading edge of the nose portion is within the sheath h$men, the tail portion sized to fit within the sheath lumen after the sheath is slit by the slitting edge; and a passageway disposed between the nose portion and the tail portion, the passageway allowing a segment of the elongate member to bend away from the tail portion when the lower su rface of the nose portion engages the portion of the elongate member, the segment being proximal to the portion engaged by the lower surface, and the tail portion projecting a distance greater than about '4 inch rearward of the passageway.

11. The tool of claim 10,, further comprising a handle portion projecting upward from the lower surface of the nose portion, and rearward of the slitting edge, and wherein the passageway extends into the handle portion.

.

12. The tool of claim KX further comprising a handle portion projecting upward from the lower surface of the nose portion and rearward of the slitting edge, and wherein the passageway extends to the handle portion.

13. The tool of claim 10, fu rther comprising a shank extending upward from the tail portion, the shank including a thickness being greater than approximately 0.0.1 inch and less than approximately a maximum width of the profile of the tail portion.

14. The tool of claim 10, wherein the profile of the tail portion includes a maximu m width being between approximately equal to a pre»siϊt diameter of the lumen atid approximately two times greater than the pre-βlit. diameter of the sheath lumen.

15. The tool of claim 1O₅ wherein the tail portion is includes a continuous exterior surface extending around the profile sized to fit within the slit sheath lumen.

16. The tool of claim 10, wherein the tail portion Is SpHt₁ inclu ding opposing interior surfaces.

17. A tool for slitting an elongate sheath from about an elongate member disposed within a longitudinally extending lumen of the sheath, the tool comprising: a slitting edge; a nose portion disposed beneath the slitting edge, the nose portion Including a lower surface for engaging a portion of the elongate member and a leading edge; a longitudinally extending tail portion projecting rearward of the slitting edge and the nose portion, the tail portion approximately aligned with the sheath lumen when the lower surface of the nose portioii engages the elongate member and the leading edge of the lower surface is within the sheath lumen, the tail portion sized; to fit within the sheath lumen after the sheath is slit by the slitting edge arid a continu ous exterior surface extending around the profile; and a passageway disposed between the nose portion and the tail portion, the passageway allowing a segment of the elongate member to bend away from the tali portion when the lower su rface of the nose portion, engages the portion of the elongate member, the segment being proximal to the portion engaged by the lower surface,

1.8. The tool of claim ^'17, further comprising a handle portion projecting upward from the lower surface of the nose portion and rearward of the slitting edge, and wherein the passageway extends into the handle portion.

19. The tool of claim 17, further comprising a handle portion projecting upward from the lower surface of the nose portion and rearward, of the slitting edge, and wherein the passageway extends to the handle portion.

20. The tool of claim 17, further comprising a shank extending upward from the tail portion, the shank, including a thickness- being greater than approximately 0.01 inch and less than approximately a maximum width of the profile of the tali portion.