SUPER ELASTIC LOOP EXTRALUMINAL MATERIALS DELIVERY INSTRUMENT
A materials delivery instrument is provided and includes an outer sheath and an instrument movably mounted within the outer sheath. The instrument includes a treatment lumen extending substantially the length of the instrument for receipt of treatment material. A super elastic wire is positioned in at least a distal end of the instrument. The super elastic wire forms a loop in an unstressed state to allow the instrument to encircle an anastomosis formed between a pair of tubular tissue sections. The super elastic wire is in a stressed state when the instrument is retracted within the outer sheath and in the unstressed state when the instrument is extended from the outer sheath to enclose the anastomosis. A proximal end of the super elastic wire is oriented substantially perpendicular to a plane formed by the loop to allow the instrument to lie parallel to the tubular tissue sections during the spraying of the anastomosis. A source of air pressure may be provided through the instrument to facilitate spraying the treatment material onto the anastomosis.
1. Technical Field
The present disclosure relates to a materials delivery instrument. More particularly, the present disclosure relates to a materials delivery instrument having a preformed loop of super elastic material for extraluminal delivery of treatment material to the circumference of an anastomotic site.
2. Background of Related Art
Various surgical procedures involve removal of a diseased section of tissue from a tubular tissue or organ and reconnecting the ends of the remaining healthy tubular tissue sections. This is termed forming an anastomosis between the tubular tissue sections. The methods of forming an anastomosis may be loosely grouped into two general categories. In the first category, the fasteners used to rejoin the healthy tubular tissue sections are applied within the lumen defined by the tissue sections while in the second category the fasteners are applied to the exterior of the tissue sections.
In the first category, such as, for example, in colon or bowel surgery, a diseased section of the tissue is excised and the remaining healthy sections of tissue are rejoined. This is typically accomplished by positioning an anvil within one tubular tissue section and a staple head within the opposite tubular tissue section. The free ends of the healthy tissue sections are secured or “purse stringed” radially inwardly adjacent a shaft connecting the anvil to the staple head. The anvil and staple head are then approximated to draw the healthy tubular tissue sections adjacent one another. Thereafter, staples are ejected from the staple head through the inwardly directed edges of the tissues and into the anvil to secure the tissue sections together. Excess tissue extending into the lumens of the tubular tissue sections is cutaway to complete the formation of the anastomosis.
Alternatively, in the second category, when relatively small tubular tissue sections, such as, for example, vascular tissue sections, are being operated upon, the cut free ends of the vascular tissue sections are everted or flared radially outwardly. The radially extending free ends of the tissues are then either stapled or sutured together to form the anastomosis.
When forming an anastomosis in either of the first or second categories, leakage of bodily fluids through gaps in the anastomosis can occur. Further, necrosis or death of substantial amounts of stapled or sutured tissue may occur before the healthy tissues have a chance to heal together resulting in an incomplete anastomosis.
Therefore, a need exists for a materials delivery system capable of applying a sealant or an adhesive to the external circumference of the anastomosis to hold the tissues together during healing. Additionally, a need exists for a delivery system capable of applying a variety of medicaments to the circumference of the anastomosis to facilitate and promote healing.
SUMMARYThere is disclosed a materials delivery instrument including an elongate tube having a treatment lumen. The treatment lumen extends from a proximal end of the instrument and terminates short of the distal end of the instrument. At least one port extends between the treatment lumen and an exterior of the distal end of the instrument. A super elastic wire is positioned within a distal end of the instrument. The super elastic wire has a straight configuration in a stressed condition and a loop configuration in the unstressed condition such that the distal end of the instrument assumes the shape of the super elastic wire for encircling a tubular tissue section.
An outer sheath is movably positioned over the instrument such that the super elastic wire is in the stressed condition when retracted into the sheath and in the unstressed condition when the instrument is extended beyond a distal end of the sheath.
A source of treatment material is provided at a proximal end of the treatment lumen for delivery to the at least one port. In one embodiment, the treatment material is an adhesive. In a specific embodiment, the adhesive is a fibrin glue. In another embodiment, the treatment material is a sealant. In an alternative embodiment, the treatment material is a medicament.
In one embodiment, the super elastic wire is embedded in the distal end of the instrument. In an alternative embodiment, the instrument includes a shaping lumen located within the distal end of the instrument and the super elastic wire is positioned within the shaping lumen.
In another embodiment, the super elastic wire has a proximal portion oriented perpendicular to a plane defined by the loop when the super elastic wire is in the unstressed condition.
There is also disclosed a materials delivery instrument including an elongate tube having a treatment lumen for receipt of treatment material therethrough. The treatment lumen extends from a proximal end of the instrument to a distal end of the instrument. An auxiliary lumen is provided for receipt of air pressure and extends from a proximal end of the instrument to the distal end of the instrument. A super elastic wire is positioned within a distal end of the instrument. The super elastic wire has a straight configuration in a stressed condition and a loop-shaped configuration in the unstressed condition such that the distal end of the instrument assumes the shape of the super elastic wire for encircling a tubular tissue section.
An outer sheath is movably positioned over the instrument such that the super elastic wire is in the stressed condition when retracted into the sheath and in the unstressed condition when the instrument is extended beyond a distal end of the sheath.
In one embodiment, a deflector is positioned adjacent the distal end of the auxiliary lumen for directing airflow towards treatment material ejected from a distal end of the treatment lumen.
In one embodiment, a shaping lumen is formed within the distal end of the instrument such that the super elastic wire is positioned within the shaping lumen.
In a specific embodiment, the super elastic wire has a proximal portion oriented substantially perpendicular to a plane defined by the loop when the super elastic wire is in the unstressed condition.
There is also disclosed a method of delivering treatment material to an anastomosis formed between a pair of tubular tissue sections. The method includes providing a materials delivery instrument including an elongate tube having a treatment lumen, the treatment lumen extending from a proximal end of the instrument and toward a distal end of the instrument; at least one port extending between the treatment lumen and an exterior of the distal end of the instrument; a super elastic wire positioned within a distal end of the instrument, the super elastic wire having a straight configuration in a stressed condition and a loop-shaped configuration in an unstressed condition such that the distal end of the instrument assumes the shape of the super elastic wire for encircling a tubular tissue section; and an outer sheath movably positioned over the instrument such that the super elastic wire is in the stressed condition when the instrument is retracted into the sheath and in the unstressed condition when the instrument is extended beyond a distal end of the sheath.
The method includes the steps of positioning a distal end of the materials delivery instrument adjacent an anastomosis formed between a pair of tubular tissue sections and extending the instrument beyond the distal end of the sheath to release the super elastic wire from the stressed condition to the unstressed condition such that the instrument encircles the anastomosis. Thereafter, treatment material is sprayed out of the at least one port and onto the outer surface of the anastomosis.
In one embodiment, the at least one port extends through a side wall in the instrument and the treatment material is sprayed through the at least one port and onto the entire outer circumference of the anastomosis simultaneously.
In an alternative embodiment, the treatment material is progressively sprayed onto the anastomosis as the instrument is extended from the sheath and around the anastomosis.
In a further alternative embodiment, the treatment material is sprayed onto the anastomosis as the instrument is retracted back into the sheath.
In a still further alternative embodiment, the distal end of the materials delivery instrument is positioned substantially perpendicular to the tubular tissue sections and reoriented substantially parallel to the tubular tissue sections prior to spraying the treatment material onto the anastomosis.
Various embodiments of the presently disclosed materials delivery instrument are disclosed herein with reference to the drawings, wherein:
Embodiments of the presently disclosed materials delivery instrument will now be described in detail with reference to the drawings wherein like numerals designate identical or corresponding elements in each of the several views. As is common in the art, the term ‘proximal” refers to that part or component closer to the user or operator, i.e. surgeon or physician, while the term “distal” refers to that part or component further away from the user.
Referring to
Lumen 16 of outer sheath 12 extends from a proximal end 22 of outer sheath 12 to a distal end 24 of outer sheath 12. A handle 26 is formed on proximal end 22 of outer sheath 12 to move outer sheath 12 relative to elongate tubular member 14. A relatively flexible center portion 28 extends distally from handle 26 to facilitate manipulation of materials delivery instrument 10 within the body of a patient. A relatively rigid distal portion 30 of outer sheath 12 extends distally from flexible center portion 28 of outer sheath 12. Rigid distal portion 30 is provided to restrain a distal portion 32 of elongate tubular member 14 when elongate tubular member 14 is in a proximal position relative to outer sheath 12 and to release distal portion 32 of elongate tubular member 14 when elongate tubular member 14 is moved distally relative to outer sheath 12. A proximal end 34 of elongate tubular member 14 is configured to receive source of treatment material 20.
Referring to
Second lumen 38 is provided to receive source of treatment fluid 20 at a proximal end 44 thereof. Referring for the moment to
With continued reference to
As the best shown in
Referring now to
Referring now to FIGS. 1 and 3-6, the use of materials delivery instrument 10 to apply a treatment material circumferentially to an anastomosis formed between a pair of tubular tissue sections will now be described. Referring initially to
Elongate tubular member 14 is initially in a retracted position relative to outer sheath 12 such that super elastic wire 50 and thus distal portion 32 are restrained in a relatively straight configuration within rigid distal portion 30 of outer sheath 12.
Referring to
Referring now to
With specific reference to
Referring now to
Referring now to FIGS. 1 and 8-11, the use of materials delivery instrument 10, incorporating super elastic wire 80, to apply a treatment material to the circumference of anastomosis A formed between tubular tissue sections B and C will now be described. Referring initially to
As best shown in
Referring now to
Referring specifically to
Referring now to
Instrument 104 is similar to elongate tubular member 14 described herein above and includes an auxiliary or first lumen 116, a treatment or second lumen 118 and a shaping or third lumen 120. First lumen 116 is open to a distal end face 122 formed in distal end 124 of instrument 104 and extends through instrument 104 to a proximal opening 126 formed in proximal end 128 of instrument 104. First lumen 116 is provided to receive a source of air pressure such as source of air pressure 130 therethrough to assist in spraying treatment material on the tissue. Source of air pressure 130 generally includes a canister of pressurized air 132 and a valve 134 to control the release of air pressure from canister 132. A connector 136 is provided on valve 134 and is configured to engage proximal opening 138 of first lumen 116.
Second lumen 118 is also open to distal end face 122 and extends through instrument 104 to a proximal opening 138. Second lumen 118 is provided to receive a source of treatment material 140 which is substantially identical to source of treatment material 20 described herein above with respect to materials delivery instrument 10. Source of treatment material 140 generally includes a pressurized canister 142 containing the treatment material and a valve 144 provided on canister 142 for controlling the flow of treatment material out of canister 142, or another source, as discussed above. A tube 146 extends from valve 144 and terminates in a connector 148 configured to engage proximal opening 138 of second lumen 118.
Third lumen 120 is configured to receive a super elastic wire substantially identical to super elastic wire 50 described herein above with respect to materials delivery instrument 10 and as described in more detail here and below.
Referring now to
Referring now to FIGS. 12 and 14-18, and initially with respect to FIG. 12., the use of materials delivery instrument 100 to spray treatment material TM onto an anastomosis A formed between a pair of tubular tissue sections B and C will now be described. In the initial position, instrument 104 is in a proximal most position within the outer sheath 102. Source of treatment fluid 140 is connected to proximal opening 138 of second lumen 118 and source of air pressure 130 is connected to proximal opening 126 of first lumen 116. Referring now to
Referring now to
As best shown in
Referring now to
Thus, materials delivery instrument 100 provides the ability to progressively spray treatment material TM onto anastomosis A both as distal portion 154 it is advanced to form a loop about anastomosis A and as distal portion 154 is retracted from around anastomosis A. Alternatively, the spraying of treatment material TM may be stopped and reoriented in either direction to more accurately apply treatment material TM to anastomosis A. As noted herein above, this allows the surgeon to ensure that a complete and uniform layer of treatment material TM is applied to anastomosis A.
In a further embodiment of the present disclosure, the materials delivery instrument may be used intra luminally. Ports are disposed on an exterior side of the elongate tubular member so as to discharge the material outwardly. The instrument may otherwise be as described in
It will be understood that various modifications may be made to the embodiments disclosed herein. For example, and as noted herein above, the disclosed super elastic wire may either be contained within a lumen of the disclosed instrument or maybe directly embedded within the distal end of the disclosed instrument. Further, the preformed shape of the super elastic wire may assume other configurations such as, for example, spiral, oval, etc. Additionally, further additional lumens may be provided within the disclosed instrument to accommodate various other functions such as, for example, the provision of optical devices, electrocautery devices, etc. Therefore, the above description should not be construed as limiting, but merely as exemplifications of particular embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.
Claims
1. A materials delivery instrument comprising:
- an elongate tube having a treatment lumen, the treatment lumen extending from a proximal end of the instrument and terminating short of the distal end of the instrument;
- at least one port extending between the treatment lumen and an exterior of the distal end of the instrument; and
- a super elastic wire positioned within a distal end of the instrument, wherein the super elastic wire has a straight configuration in a stressed condition and a loop configuration in the unstressed condition such that the distal end of the instrument assumes the shape of the super elastic member for encircling a tubular tissue section.
2. The materials delivery instrument as recited in claim 1, further comprising an outer sheath movably positioned over the instrument such that the super elastic member is in the stressed condition when retracted into the sheath and in the unstressed condition when the super elastic member is extended beyond a distal end of the sheath.
3. The materials delivery instrument as recited in claim 2, further comprising a source of treatment material provided at a proximal end of the treatment lumen for delivery to the at least one port.
4. The materials delivery instrument as recited in claim 3, wherein the treatment material is an adhesive.
5. The materials delivery instrument as recited in claim 4, wherein the adhesive is a fibrin glue.
6. The materials delivery instrument as recited in claim 3, wherein the treatment material is a sealant.
7. The materials delivery instrument as recited in claim 3, wherein the treatment material is a medicament.
8. The materials delivery instrument as recited in claim 2, wherein the super elastic wire is embedded in the distal end of the instrument.
9. The materials delivery instrument as recited in claim 2, wherein the instrument includes a shaping lumen located within the distal end of the instrument and the super elastic member is positioned within the shaping lumen.
10. The materials delivery instrument as recited in claim 1, wherein the super elastic member has a proximal portion oriented perpendicular to a plane defined by the loop when the super elastic member is in the unstressed condition.
11. A materials delivery instrument comprising:
- an elongate tube having a treatment lumen for receipt of treatment material therethrough, the treatment lumen extending from a proximal end of the instrument to the distal end of the instrument;
- an auxiliary lumen for receipt of air pressure and extending from a proximal end of the instrument to the distal end of the instrument; and
- a super elastic wire positioned within a distal end of the instrument, wherein the super elastic wire has a straight configuration in a stressed condition and a loop configuration in the unstressed condition such that the distal end of the instrument assumes the shape of the super elastic wire for extending around a tubular tissue section.
12. The materials delivery instrument as recited in claim 11, further comprising an outer sheath movably positioned over the elongate delivery instrument such that the super elastic wire is in the stressed condition when retracted into the sheath and in the unstressed condition when the super elastic wire is extended beyond a distal end of the sheath.
13. The materials delivery instrument as recited in claim 11, further comprising a deflector positioned adjacent a distal end of the auxiliary lumen for directing airflow towards treatment material ejected from a distal end of the treatment lumen.
14. The materials delivery instrument as recited in claim 11, further comprising a shaping lumen formed within a distal end of the instrument such that the super elastic member it is positioned within the shaping lumen.
15. The materials delivery instrument as recited in claim 11, wherein the super elastic wire has a proximal portion oriented perpendicular to a plane defined by the loop when the super elastic wire is in the unstressed condition.
16. A method of delivering treatment material to an anastomosis formed between a pair of tubular tissue sections comprising:
- providing a materials delivery instrument including: an elongate tube having a treatment lumen, the treatment lumen extending from a proximal end of the instrument and toward a distal end of the instrument; a port extending between the treatment lumen and an exterior of the distal end of the instrument; a super elastic wire positioned within a distal end of the instrument, the super elastic wire having a straight configuration in a stressed condition and a loop configuration in an unstressed condition such that the distal end of the instrument assumes the shape of the super elastic wire for encircling a tubular tissue section; and an outer sheath movably positioned over the instrument such that the super elastic wire is in the stressed condition when the instrument is retracted into the sheath and in the unstressed condition when the instrument is extended beyond a distal end of the sheath;
- positioning a distal end of the materials delivery instrument adjacent an anastomosis formed between a pair of tubular tissue sections;
- extending the instrument beyond the distal end of the sheath to release the super elastic wire from the stressed condition to the unstressed condition such that the instrument encircles the anastomosis; and
- spraying treatment material out of the port and onto the anastomosis.
17. The method as recited in claim 16, wherein the port extends through a side wall in the instrument and the treatment material is sprayed through the port and onto the anastomosis.
18. The method as recited in claim 16, wherein the treatment material is sprayed onto the anastomosis as the instrument is extended from the sheath and around the anastomosis.
19. The method as recited in claim 16, wherein the treatment material is sprayed onto the anastomosis as the instrument is retracted back into the sheath.
20. The method as recited in claim 16, further comprising the steps of positioning the distal end of the materials delivery instrument substantially perpendicular to the tubular tissue sections and reorienting the materials delivery instrument substantially parallel to the tubular tissue sections prior to spraying the treatment material onto the anastomosis.
Type: Application
Filed: Nov 13, 2008
Publication Date: May 13, 2010
Inventor: David Fowler (Cheshire, CT)
Application Number: 12/270,108
International Classification: A61M 5/00 (20060101); A61M 25/00 (20060101); A61M 29/00 (20060101); A61M 31/00 (20060101);